Automated-General Chemistry Checklist
AUTOMATED/GENERAL CHEMISTRY
OUTLINE
INTRODUCTION 2
PROFICIENCY TESTING 2
QUALITY CONTROL AND QUALITY IMPROVEMENT 7
SUPERVISION 7
PROCEDURE MANUAL 10
SPECIMEN COLLECTION AND HANDLING 14
Blood Gas Specimens 15
RESULTS REPORTING 17
REAGENTS 23
CALIBRATION AND STANDARDS 27
CONTROLS 35
INSTRUMENTS AND EQUIPMENT 40
Glassware 41
Automatic Pipets - Fixed Volume Adjustable and/or Micropipets 44
Thermometers 46
Temperature-Dependent Equipment 47
Centrifuges 48
Analytic Balances 49
Blood Gas Instruments 50
Colorimeters and Spectrophotometers 53
Atomic Absorption Spectrophotometers 54
Immunoassays/Immunoanalyzers 55
Thin Layer Chromatography (TLC) 57
Gas Chromatography 59
Mass Spectrometry 62
High Performance Liquid Chromatography (HPLC) 66
Instrument Maintenance 69
PERSONNEL 72
PHYSICAL FACILITIES 72
LABORATORY SAFETY 76
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INTRODUCTION
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The College of American Pathologists (CAP) recognizes that each laboratory may have different physical and functional groupings of routine automated chemistry assays and, specialized chemistry procedures, and toxicology testing. This may create mismatches between the contents of a checklist and the way a particular laboratory is organized. It is expected that nearly all laboratories will complete this Automated/General Chemistry Checklist, which is now revised to incorporate the previous Toxicology Checklist. Whether Toxicology andthe Special Chemistry Checklists needs to be completed depends on the specific testing repertoire of the laboratory. In all cases, the Laboratory General Checklist also must be completed.
This Checklist is intended for common, general clinical chemistry tests that are typically performed on automated instruments, including blood gas analysis and toxicology.
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PROFICIENCY TESTING
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CAP-accredited laboratories must participate in the CAP Surveys or a CAP-approved alternative proficiency- testing program. This must include attempted enrollment in programs with graded analytes matching those for which the laboratory performs patient testing.
AGC.10150 Phase II N/A YES NO
Is the laboratory enrolled in the appropriate available graded CAP Surveys or a CAP-approved alternative proficiency- testing program for the patient testing performed?
COMMENTARY:
THE LABORATORY MUST PARTICIPATE IN A CAP SURVEYS OR CAP-APPROVED PROGRAM OF GRADED INTERLABORATORY COMPARISON TESTING APPROPRIATE TO THE SCOPE OF THE LABORATORY, IF AVAILABLE. THIS MUST INCLUDE ENROLLMENT IN PROFICIENCY-TESTING PROGRAMSSURVEYS WITH ANALYTES MATCHING THOSE FOR WHICH THE LABORATORY PERFORMS PATIENT TESTING. LABORATORIES WILL NOT BE PENALIZED IF THEY ARE UNABLE TO PARTICIPATE IN AN OVERSUBSCRIBED PROGRAMSURVEY.
REFERENCES: 1) Lott JA, et al. Proficiency testing of serum enzymes based on medical-needs criteria. Arch Pathol Lab Med. 1991;115:11-14; 2) McQueen MJ, et al. Results of a province-wide quality assurance program assessing the accuracy of cholesterol, triglycerides, and high-density lipoprotein cholesterol measurements and calculated low-density lipoprotein cholesterol in Ontario, using fresh human serum. Arch Pathol Lab Med. 1991;115:1217-1222; 3) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7146 [42CFR493.801]; 24) Tholen DW. Reference values and participant means as targets in proficiency testing. Arch Pathol Lab Med. 1993;117:885-889; 35) Borsotti M. External quality assessment scheme in Tuscany, Italy. Ann 1st Super Sanita. 1995;31:175-186; 46) Westgard JO, et al. Laboratory precision performance. State of the art versus operating specifications that assure the analytical quality required by clinical laboratory improvement amendments proficiency testing. Arch Pathol Lab Med. 1996;120:621-625;; 57) National Committee for Clinical Laboratory StandardsNCCLS. Continuous quality improvement: essential management approaches and their use in proficiency testing; proposed guideline GP22-P. Wayne, PA: NCCLS, 1997; 68) Ross JW, et al. The accuracy of laboratory measurements in clinical chemistry. A study of 11 routine chemistry analytes in the College of American Pathologists chemistry survey with fresh frozen serum, definitive methods, and reference materials. Arch Pathol Lab Med. 1998;122:587-608; 79) College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; standard III. Northfield, IL: CAP, 1998; 810) Dale JC, Hamrick HJ. Neonatal bilirubin testing practices. Reports from 312 laboratories enrolled in the College of American Pathologists Excel proficiency testing program. Arch Pathol Lab Med. 2000;124:1425-1428; 9) Plebani M, et al. External quality assessment for serum proteins: state of the art. Clin Chem. 2001;47(suppl):A35; 10) Panteghini M, et al. External quality assessment scheme for biochemical markers of cardiac damage. Clin Chem. 2001;47(suppl):A195.
AGC.10180 Phase II N/A YES NO
For analytes where graded proficiency testing is not available, are other procedures used to validate performance at least semi-annually?
NOTE: Other appropriate performance assessment procedures may include: participation in ungraded proficiency-testing programs, split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means. It is the responsibility of the Laboratory Director to define such alternative performance assessment procedures, as applicable, in accordance with good clinical and scientific laboratory practice.
COMMENTARY:
FOR ANALYTES WHERE GRADED PROFICIENCY TESTING IS NOT AVAILABLE, PERFORMANCE ASSESSMENT MUST BE CONDUCTED AT LEAST SEMI-ANNUALLY BY OTHER APPROPRIATE PROCEDURES SUCH AS: PARTICIPATION IN UNGRADED PROFICIENCY-TESTING, SPLIT SAMPLE ANALYSIS WITH REFERENCE OR OTHER LABORATORIES, SPLIT SAMPLES WITH AN ESTABLISHED IN-HOUSE METHOD, ASSAYED MATERIAL, REGIONAL POOLS, CLINICAL VALIDATION BY CHART REVIEW, OR OTHER SUITABLE AND DOCUMENTED MEANS. IT IS THE RESPONSIBILITY OF THE LABORATORY DIRECTOR TO DEFINE SUCH PROCEDURES, AS APPLICABLE, IN ACCORDANCE WITH GOOD CLINICAL AND SCIENTIFIC LABORATORY PRACTICE.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7184 [42CFR493.1709]; 2) Shahangian S, et al. A system to monitor a portion of the total testing process in medical clinics and laboratories. Feasibility of a split-specimen design. Arch Pathol Lab Med. 1998;122:503-511; 3) Shahangian S, Cohn RD. Variability of laboratory test results. Am J Clin Pathol. 2000;113:521-527; 4) NCCLS. Validation of laboratory tests when proficiency testing is not available; proposed guideline GP29-P. Wayne, PA: NCCLS, 2001.
AGC.10200 Phase II N/A YES NO
Does the laboratory integrate all proficiency testingthe external Surveys samples within the routine laboratory workload, and are those samples analyzed by personnel who routinely test patient samples, using the same primary method systems as for patient samples?
NOTE: Replicate analysis of Surveys samples is acceptable only if patient specimens are routinely analyzed in the same manner. If the laboratory uses multiple methods for an analyte, Surveys samples should be analyzed by the primary method. There must not be any interlaboratory communication on proficiency testing data before results reporting. When external proficiency testing materials are not available, the semi-annual alternative performance assessment process should also be integrated within the routine workload.
COMMENTARY:
BOTH EEXTERNAL PROFICIENCY TESTING AND ALTERNATIVE PERFORMANCE ASSESSMENT SAMPLES MUST BE INTEGRATED WITHIN THE ROUTINE LABORATORY WORKLOAD, AND ANALYZED BY PERSONNEL WHO ROUTINELY TEST PATIENT SAMPLES, USING PRIMARY METHOD SYSTEMS. ONE OR MORE OF THESE REQUIREMENTS ARE NOT BEING MET BY THE LABORATORY, AND MUST BE CORRECTED. THERE MUST NOT BE ANY INTERLABORATORY COMMUNICATION ON PROFICIENCY TESTING DATA BEFORE RESULTS REPORTING. THE EDUCATIONAL PURPOSES AND DOCUMENTATION OF PROFICIENCY ARE BEST SERVED BY A ROTATION THAT ALLOWS ALL TECHNOLOGISTS TO BE INVOLVED IN THE PROFICIENCY -TESTING PROGRAM. RECORDS OF THESE STUDIES MUST BE KEPT AND CAN BE AN IMPORTANT PART OF THE PERSONNEL AND CONTINUING EDUCATION FILES OF THE INDIVIDUALS.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7146 [42CFR493.801(b)]; 2) Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43; 3) Parsons PJ. Evaluation of blood lead proficiency testing: comparison of open and blind paradigms. Clin Chem. 2001;47:322-330.
AGC.10220 Phase II N/A YES NO
Is there evidence of evaluation and, if indicated, prompt corrective action in response to "unacceptable" results on the proficiency-testing report and results of the alternative performance assessment system?
COMMENTARY:
THERE MUST BE EVIDENCE OF COMPLETE EVALUATION AND, IF INDICATED, CORRECTIVE ACTION IN RESPONSE TO EACH "UNACCEPTABLE" RESULT ON THE PROFICIENCY-TESTING REPORTS AND RESULTS OF THE ALTERNATIVE PERFORMANCE ASSESSMENT SYSTEM. THE EVALUATION MUST DOCUMENT THE SPECIFIC REASON(S) FOR THE "UNACCEPTABLE" RESULT(S) AND ACTIONS TAKEN TO REDUCE THE LIKELIHOOD OF RECURRENCE. THIS MUST BE DONE WITHIN ONE MONTH AFTER THE LABORATORY RECEIVES ITS PROFICIENCY TESTING EVALUATION.
REFERENCES: 1) Ehrmeyer SS, et al. Use of alternative rules (other than the 1-2s) for evaluating interlaboratory performance data. Clin Chem. 1988:34:250-256; 2) Klee GG, Forsman RW. A user's classification of problems identified by proficiency testing surveys. Arch Pathol Lab Med. 1988;112:371-373; 3) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7173 [42CFR493.1407(e)(4)(iv)]; 4) Steindel SJ, et al. Reasons for proficiency testing failures in clinical chemistry and blood gas analysis. A College of American Pathologists Q-Probes study in 655 laboratories. Arch Pathol Lab Med. 1996;120:1094-1101; 5) NCCLS. Using proficiency testing (PT) to improve the clinical laboratory; approved guideline GP27-A. Wayne, PA: NCCLS, 1998; 6) Shahangian S, e al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43.
AGC.10250 Phase II N/A YES NO
Is there documented evidence of ongoing evaluation by the Laboratory Director or designee of the proficiency testing results?
COMMENTARY:
THERE MUST BE DOCUMENTED EVIDENCE OF ONGOING EVALUATION BY THE LABORATORY DIRECTOR OR DESIGNEE OF PROFICIENCY TESTING RESULTS.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7173 [42CFR493.1407(e)(4)(iii)]; 2) Steele BW, et al. The effects of modifying proficiency testing materials on thyroid function tests. A College of American Pathologists ligand assay survey study. Arch Pathol Lab Med. 1997;121:1241-1246; 3) National Committee for Clinical Laboratory StandardsNCCLS. Using proficiency testing (PT) to improve the clinical laboratory; approved guideline GP27-A. Wayne, PA: NCCLS, 1998; 4) Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43; 5) Zaki Z, et al. Self-improvement by participant interpretation of proficiency testing data from events with 2 to 5 samples. Clin Chem. 2000;46:A70.
AGC.10300 Phase II N/A YES NO
Is there evidence of evaluation and, if indicated, prompt corrective action in response to "unacceptable" results on the Surveys report?
COMMENTARY:
THERE MUST BE THOROUGH EVALUATION AND, IF INDICATED, CORRECTIVE ACTION IN RESPONSE TO EACH "UNACCEPTABLE" RESULT ON THE PROFICIENCY SURVEYS REPORT. THE EVALUATION MUST DOCUMENT THE SPECIFIC REASON(S) FOR THE "UNACCEPTABLE" RESULT(S) AND ACTIONS TAKEN TO REDUCE THE LIKELIHOOD OF RECURRENCE. THIS MUST BE DONE WITHIN ONE MONTH AFTER THE LABORATORY RECEIVES ITS SURVEYS EVALUATION.
REFERENCES: 1) Ehrmeyer SS, et al. Use of alternative rules (other than the 1-2s) for evaluating interlaboratory performance data. Clin Chem. 1988:34:250-256; 2) Klee GG, Forsman RW. A user's classification of problems identified by proficiency testing surveys. Arch Pathol Lab Med. 1988;112:371-373; 3) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7173 [42CFR493.1407(e)(4)(iv)]; 4) Steindel SJ, et al. Reasons for proficiency testing failures in clinical chemistry and blood gas analysis. A College of American Pathologists Q-Probes study in 655 laboratories. Arch Pathol Lab Med. 1996;120:1094-1101; 5) National Committee for Clinical Laboratory Standards. Using proficiency testing (PT) to improve the clinical laboratory; approved guideline GP27-A. Wayne, PA: NCCLS, 1998; 6) Shahangian S, e al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43.
AGC.10400 Phase II N/A YES NO
For analytes where graded proficiency testing is not available, are other procedures used to validate performance at least semi-annually?
NOTE: Other appropriate performance assessment procedures may include: participation in ungraded proficiency survey programs, split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means. It is the responsibility of the Laboratory Director to define such procedures, as applicable, in accordance with good clinical and scientific laboratory practice.
COMMENTARY:
FOR ANALYTES WHERE GRADED PROFICIENCY TESTING IS NOT AVAILABLE, PERFORMANCE ASSESSMENT MUST BE CONDUCTED AT LEAST SEMI-ANNUALLY WITH APPROPRIATE PROCEDURES SUCH AS: PARTICIPATION IN UNGRADED PROFICIENCY SURVEYS, SPLIT SAMPLE ANALYSIS WITH REFERENCE OR OTHER LABORATORIES, SPLIT SAMPLES WITH AN ESTABLISHED IN-HOUSE METHOD, ASSAYED MATERIAL, REGIONAL POOLS, CLINICAL VALIDATION BY CHART REVIEW, OR OTHER SUITABLE AND DOCUMENTED MEANS. IT IS THE RESPONSIBILITY OF THE LABORATORY DIRECTOR TO DEFINE SUCH PROCEDURES, AS APPLICABLE, IN ACCORDANCE WITH GOOD CLINICAL AND SCIENTIFIC LABORATORY PRACTICE.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7184 [42CFR493.1709]; 2) Shahangian S, et al. A system to monitor a portion of the total testing process in medical clinics and laboratories. Feasibility of a split-specimen design. Arch Pathol Lab Med. 1998;122:503-511; 3) Shahangian S, Cohn RD. Variability of laboratory test results. Am J Clin Pathol. 2000;113:521-527.
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QUALITY CONTROL AND QUALITY IMPROVEMENT
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SUPERVISION
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Judgment of the acceptability of quality control (QC) data must be made before patient results are reported. Oversight review must occur at least monthly by the Laboratory Director or designee. Beyond these specific requirements, a laboratory may (optionally) perform more frequent review at intervals that it determines appropriate for its setting and the assays involved. Because of the many variables, the CAP makes no specific recommendations on the frequency of any additional assessment/review of QC data.
Quality improvement issues are addressed in the Laboratory General Checklist.
AGC.20000 Phase II N/A YES NO
Is there a document for the design and evaluation of the laboratory quality control (QC) and quality improvement (QI) programs?
NOTE: The QC/QI program must provide the system design and evaluation of proper patient identification and preparation; specimen collection, identification, preservation, transportation, and processing; and accurate result reporting. This system must ensure optimum patient specimen and result integrity throughout the pre-analytical, analytical, and post-analytical processes. Opportunities for system improvement are identified and, based on such evaluations, corrective plans are developed and implemented.
COMMENTARY:
THE LABORATORY MUST HAVE A COMPREHENSIVE PROGRAM FOR QUALITY CONTROL (QC) AND QUALITY IMPROVEMENT (QI) IN THE AUTOMATED/GENERAL CHEMISTRY SECTION OF THE LABORATORY. THE QI PROGRAM MUST PROVIDE THE SYSTEM DESIGN AND EVALUATION OF PROPER PATIENT IDENTIFICATION AND PREPARATION; SPECIMEN COLLECTION, IDENTIFICATION, PRESERVATION, TRANSPORTATION, AND PROCESSING; AND ACCURATE RESULT REPORTING. THIS SYSTEM MUST ENSURE OPTIMUM PATIENT SPECIMEN AND RESULT INTEGRITY THROUGHOUT THE PREANALYTICAL, ANALYTICAL, AND POST-ANALYTIC PROCESSES. OPPORTUNITIES FOR SYSTEM IMPROVEMENT ARE IDENTIFIED AND, BASED ON SUCH EVALUATIONS, CORRECTIVE PLANS ARE DEVELOPED AND IMPLEMENTED. JUDGMENT OF THE ACCEPTABILITY OF QC DATA MUST BE MADE BEFORE PATIENT RESULTS ARE REPORTED. OVERSIGHT REVIEW MUST OCCUR AT LEAST MONTHLY BY THE LABORATORY DIRECTOR OR DESIGNEE. BEYOND THESE SPECIFIC REQUIREMENTS, A LABORATORY MAY (OPTIONALLY) PERFORM MORE FREQUENT REVIEW AT INTERVALS THAT IT DETERMINES APPROPRIATE FOR ITS SETTING AND THE ASSAYS INVOLVED. BECAUSE OF THE MANY VARIABLES, THE CAP MAKES NO SPECIFIC RECOMMENDATIONS ON THE FREQUENCY OF ANY ADDITIONAL ASSESSMENT/REVIEW OF QC DATA.
AGC.20050 PHASE II N/A YES NO
Is there a documented procedure describing methods for patient identification, patient preparation, specimen collection and labeling, specimen preservation, and conditions for transportation, and storage before testing, consistent with good laboratory practice?
COMMENTARY:
THE LABORATORY MUST HAVE A COMPLETELY DOCUMENTED PROCEDURE DESCRIBING METHODS FOR PATIENT IDENTIFICATION, PATIENT PREPARATION, SPECIMEN COLLECTION AND LABELLING, SPECIMEN PRESERVATION, CONDITIONS FOR TRANSPORTATION, AND STORAGE BEFORE TESTING. SUCH PROTOCOLS MUST BE CONSISTENT WITH GOOD LABORATORY PRACTICE.
AGC.20100 PHASE II N/A YES NO
Is there evidence of ongoing evaluation of results of instrument maintenance and function, temperature, etc. for routine procedures on all shifts?
COMMENTARY:
THERE MUST BE EVIDENCE OF ONGOING EVALUATION OF RECORDS OF INSTRUMENT FUNCTION AND MAINTENANCE, TEMPERATURES, ETC., ON ALL SHIFTS.
AGC.20200 PHASE II N/A YES NO
Is there a documented system in operation to detect and correct significant clerical and analytical errors, and unusual laboratory results?
COMMENTARY:
THE LABORATORY MUST HAVE A DOCUMENTED SYSTEM IN OPERATION TO DETECT AND CORRECT SIGNIFICANT CLERICAL AND ANALYTICAL ERRORS, AND UNUSUAL LABORATORY RESULTS. ONE COMMON METHOD IS REVIEW OF RESULTS BY A QUALIFIED PERSON (TECHNOLOGIST, SUPERVISOR, PATHOLOGIST) BEFORE RELEASE FROM THE LABORATORY, BUT THERE IS NO REQUIREMENT FOR SUPERVISORY REVIEW OF ALL REPORTED DATA. THE SELECTIVE USE OF DELTA CHECKS ALSO MAY BE USEFUL IN DETECTING CLERICAL ERRORS IN CONSECUTIVE SAMPLES FROM THE SAME PATIENT. IN COMPUTERIZED LABORATORIES, THERE SHOULD BE AUTOMATIC "TRAPS" FOR IMPROBABLE RESULTS.
REFERENCE: Dufour D, et al. The clinical significance of delta checks. Am J Clin Pathol. 1998;110:531.
AGC.20250 PHASE II N/A YES NO
Does the system provide for the timely correction of errors?
COMMENTARY:
THE SYSTEM FOR DETECTING CLERICAL ERRORS, SIGNIFICANT ANALYTICAL ERRORS, AND UNUSUAL LABORATORY RESULTS MUST PROVIDE FOR TIMELY CORRECTION OF ERRORS, I.E., BBEFORE RESULTS BECOME AVAILABLE FOR CLINICAL DECISION MAKING. FOR SUSPECTED ERRORS DETECTED BY THE END USER AFTER REPORTING, CORRECTIONS MUST BE PROMPTLY MADE IF SUCH ERRORS ARE CONFIRMED BY THE LABORATORY.
AGC.20300 PHASE II N/A YES NO
In the absence of on-site supervisors, are the results of tests performed by personnel reviewed by the Laboratory Director or general supervisor within 24 hours?
NOTE: The CAP does NOT require supervisory review of all test results before or after reporting to patient records. Rather, this question is intended to address only that situation defined under CLIA-88 for "high complexity testing" performed by trained high school graduates qualified under 42CFR493.1489(b)(5) when a qualified general supervisor is not present.
COMMENTARY:
IN THE ABSENCE OF ON-SITE SUPERVISORS, THE RESULTS OF TESTS PERFORMED BY PERSONNEL MUST BE REVIEWED BY THE LABORATORY DIRECTOR OR GENERAL SUPERVISOR WITHIN 24 HOURS. THE CAP DOES NOT REQUIRE SUPERVISORY REVIEW OF ALL TEST RESULTS BEFORE OR AFTER REPORTING TO PATIENT RECORDS. RATHER, THIS QUESTION IS INTENDED TO ADDRESS ONLY THAT SITUATION DEFINED UNDER CLIA-88 FOR "HIGH COMPLEXITY TESTING" PERFORMED BY TRAINED HIGH SCHOOL GRADUATES QUALIFIED UNDER 42CFR493.1489(B)(5) WHEN A QUALIFIED GENERAL SUPERVISOR IS NOT PRESENT.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7182 [42CFR493.1463(a)(3) and 42CFR493.1463(c)]: 7183 [42CFR493.1489(b)(1) and 42CFR493.1489(b)(5)].
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PROCEDURE MANUAL
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The complete procedure manual should be written in substantial compliance and meet the intent of the National Committee for Clinical Laboratory Standards (NCCLS) GP2-A3 (1996) without having to precisely copy it. The procedure manual should be available to, and used by, personnel at the workbench and shouldmust include: principle, clinical significance, specimen type, required reagents, calibration, quality control, procedural steps, calculations, reference intervalsranges, and interpretation. Pre-analytic, analytic, and post-analytic considerations should be provided. The specific style and format of procedure manuals are at the discretion of the Laboratory Director.
The inspection team should review the procedure manual in detail to understand the laboratory's standard operating procedures, ensure that all significant information and instructions are included, and that actual practice matches the contents of the procedure manuals. Deficiencies detected in the procedure manual should be listed in the Inspector's Summation Report.
AGC.21000 PHASE II N/A YES NO
Is a complete procedure manual available at the workbench or in the work area?
NOTE 1: The use of inserts provided by manufacturers is not acceptable in place of a procedure manual. However, such inserts may be used as part of a procedure description, if the insert accurately and precisely describes the procedure as performed in the laboratory. Any variation from this printed or electronic procedure must be detailed in the procedure manual. In all cases, appropriate reviews must occur.
NOTE 2: A manufacturer's procedure manual for an instrument/ reagent system may be acceptable as a component of the overall departmental procedures. Any modification to or deviation from the procedure manual must be clearly documented.
NOTE 3: Card files or similar systems that summarize key information are acceptable for use as quick reference at the workbench provided that:
a. a complete manual is available for reference.
b. the card file or similar system corresponds to the complete manual and is subject to document control.
NOTE 4: Electronic (computerized) manuals are fully acceptable. There is no requirement for paper copies to be available for the routine operation of the laboratory, so long as the electronic versions are readily available to all personnel. Such electronic versions must be subjected to proper document control (i.e., only authorized persons may make changes, changes are dated/signed (manual or electronic), and there is documentation of periodic review). Current paper copies of electronically stored procedures should be available at the time of the CAP inspection, or rapidly generated at the request of the inspector.
COMMENTARY:
A DOCUMENTED PROCEDURE MANUAL MUST BE DEVELOPED FOR THE AUTOMATED/GENERAL CHEMISTRY SECTION OF THE LABORATORY AND BE AVAILABLE AT THE WORKBENCH. ITS ELEMENTS SHOULD INCLUDE: TEST PRINCIPLE, CLINICAL SIGNIFICANCE, SPECIMEN TYPE(S), REQUIRED REAGENTS, CALIBRATION, QUALITY CONTROL, PROCEDURAL STEPS, CALCULATIONS, REFERENCE INTERVALS, AND INTERPRETATION, AS APPLICABLE.
NOTE 1: The use of inserts provided by a manufacturer is not acceptable in place of a procedure manual. However, such inserts may be used as part of a procedure description, if the insert accurately and precisely describes the procedure as performed in the laboratory. Any variation from this procedure must be detailed in the procedure manual. In all cases, appropriate reviews must occur.
NOTE 2: A manufacturer's procedure manual for an instrument/reagent system may be acceptable as a component of the overall departmental procedures. Any modification to or deviation from the procedure manual must be clearly documented.
NOTE 3: Card files or similar systems that summarize key information are acceptable for use as quick reference at the workbench provided that:
a. a complete manual is available for reference,
b. the card file or similar system corresponds to the complete manual and is subject to document control.
NOTE 4: Electronic (computerized) manuals are fully acceptable. There is no requirement for paper copies to be available for the routine operation of the laboratory, so long as the electronic versions are readily available to all personnel. Such electronic versions must be subjected to proper document control (i.e., only authorized persons may make changes, changes are dated/signed (manual or electronic), and there is documentation of periodic review). Current paper copies of electronically stored procedures should be available at the time of the CAP inspection, or rapidly generated at the request of the Inspector.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7164 [42CFR493.1211]; 2) National Committee for Clinical Laboratory Standards. Clinical laboratory technical procedure manuals - third edition; approved guideline GP2-A3. Wayne, PA: NCCLS, 1996; 3) van Leeuwen AM. 6 Steps to building an efficiency tool. Advance/Laboratory. 1999:8(6):88-91; 3) NCCLS. Clinical laboratory technical procedure manuals - fourth edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002.
AGC.21100 Phase II N/A YES NO
Is there documentation of at least annual review of all policies and procedures in the automated chemistry laboratory section by the current Laboratory Director or designee?
NOTE: The Director must ensure that the collection of policies and technical protocols is complete, current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be scientifically valid and clinically relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be developed whereby roughly 1/12 of all procedures are reviewed monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures. A single signature on a Title Page or Index of all procedures is not sufficient documentation that each procedure has been carefully reviewed. Signature or initials on each page of a procedure is not required.
COMMENTARY:
THERE MUST BE DOCUMENTATION OF AT LEAST ANNUAL REVIEW OF ALL POLICIES AND PROCEDURES IN THE AUTOMATED/GENERAL CHEMISTRY LABORATORY SECTION BY THE CURRENT LABORATORY DIRECTOR OR DESIGNEE. THE DIRECTOR IS RESPONSIBLE FOR ENSURING THAT THE COLLECTION OF TECHNICAL PROTOCOLS IS COMPLETE, CURRENT, AND HAS BEEN THOROUGHLY REVIEWED BY A KNOWLEDGEABLE PERSON. TECHNICAL APPROACHES MUST BE SCIENTIFICALLY VALID AND CLINICALLY RELEVANT. TO MINIMIZE THE BURDEN ON THE LABORATORY AND REVIEWER(S), IT IS SUGGESTED THAT A SCHEDULE BE DEVELOPED WHEREBY ROUGHLY 1/12 OF ALL PROCEDURES ARE REVIEWED MONTHLY. PAPER/ELECTRONIC SIGNATURE REVIEW MUST BE AT THE LEVEL OF EACH PROCEDURE, OR AS MULTIPLE SIGNATURES ON A LISTING OF NAMED PROCEDURES. A SINGLE SIGNATURE ON A TITLE PAGE OR INDEX OF ALL PROCEDURES IS NOT SUFFICIENT DOCUMENTATION THAT EACH PROCEDURE HAS BEEN CAREFULLY REVIEWED. SIGNATURE OR INITIALS ON EACH PAGE OF A PROCEDURE IS NOT REQUIRED.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7173 [42CFR493.1407(e)(13)]; 2) National Committee for Clinical Laboratory Standards. Clinical laboratory technical procedure manuals - third edition; approved guideline GP2-A3. Wayne, PA: NCCLS, 1996.
AGC.21125 Phase II N/A YES NO
Does the Director or designee review and approve all new policies and procedures, as well as substantial changes to existing documents, before implementation?
NOTE: Current practice must match the policy and procedure documents.
COMMENTARY:
THE DIRECTOR OR DESIGNEE MUST REVIEW AND APPROVE ALL NEW POLICIES AND PROCEDURES, AS WELL AS SUBSTANTIAL CHANGES TO EXISTING DOCUMENTS BEFORE IMPLEMENTATION. CURRENT PRACTICE MUST MATCH THESE DOCUMENTS.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7164 [42CFR493.1211(f)].
AGC.21150 PHASE II N/A YES NO
Does the laboratory have a system documenting that all personnel are knowledgeable about the contents of procedure manuals (including changes) relevant to the scope of their testing activities?
COMMENTARY:
THE LABORATORY MUST HAVE A SYSTEM DOCUMENTING THAT ALL PERSONNEL ARE KNOWLEDGEABLE ABOUT THE CONTENTS OF PROCEDURE MANUALS (INCLUDING CHANGES) RELEVANT TO THE SCOPE OF THEIR TESTING ACTIVITIES. THIS DOES NOT SPECIFICALLY REQUIRE ANNUAL PROCEDURE SIGN-OFF BY TESTING PERSONNEL. THE FORM OF THIS SYSTEM IS AT THE DISCRETION OF THE LABORATORY DIRECTOR.
AGC.21160 PHASE II N/A YES NO
If there is a change in directorship, does the new director ensure (over a reasonable period of time) that laboratory procedures are well-documented and undergo at least annual review?
COMMENTARY:
IF THERE IS A CHANGE IN DIRECTORSHIP OF THE LABORATORY, THE NEW DIRECTOR MUST ENSURE (OVER A REASONABLE PERIOD OF TIME) THAT ALL CHEMISTRY LABORATORY PROCEDURES ARE WELL-DOCUMENTED AND UNDERGO AT LEAST ANNUAL REVIEW.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7164 [42CFR493.1211(e)].
AGC.21170 PHASE II N/A YES NO
When a procedure is discontinued, is a paper or electronic copy maintained for at least 2 years, recording initial date of use, and retirement date?
COMMENTARY:
A PAPER OR ELECTRONIC COPY OF A DISCONTINUED PROCEDURE MUST BE MAINTAINED FOR AT LEAST 2 YEARS, RECORDING INITIAL DATE OF USE, AND RETIREMENT DATE.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7164 [42CFR493.1211(g)].
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SPECIMEN COLLECTION AND HANDLING
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AGC.22000 PHASE II N/A YES NO
Are procedures adequate to verify sample identity and integrity (includes capillary specimens, aliquots and dilutions)?
COMMENTARY:
THERE MUST BE ADEQUATE IDENTIFICATION OF SPECIMENS TO ENSURE SPECIMEN IDENTITY AND INTEGRITY (INCLUDES CAPILLARY SPECIMENS, ALIQUOTS, AND DILUTIONS).
AGC.22050 PHASE II N/A YES NO
Are there documented criteria for the rejection of unacceptable specimens and the special handling of sub-optimal specimens?
NOTE: This question does not imply that all "unsuitable" specimens are discarded or not analyzed. If, for example, a serum potassium or lactate dehydrogenase is ordered and the blood sample is hemolyzed, there must be a mechanism to notify the requesting physician, and to note the condition of the sample on the report if the result is desired by the ordering physician. Some or all tests may not be analytically valid on such a specimen. The laboratory may wish to record that a dialogue was held with the physician, when such occurs.
COMMENTARY:
DOCUMENTED CRITERIA MUST BE AVAILABLE FOR UNACCEPTABLE SPECIMENS, AND SPECIAL HANDLING OF SUBOPTIMAL SPECIMENS. THIS DOES NOT IMPLY THAT ALL "UNSUITABLE" SPECIMENS ARE DISCARDED OR NOT ANALYZED. IF, FOR EXAMPLE, A SERUM POTASSIUM OR LACTATE DEHYDROGENASE IS ORDERED AND THE BLOOD SAMPLE IS HEMOLYZED, THERE MUST BE A MECHANISM TO NOTIFY THE REQUESTING PHYSICIAN, AND TO NOTE THE CONDITION OF THE SAMPLE ON THE REPORT IF THE RESULT IS DESIRED BY THE ORDERING PHYSICIAN. SOME OR ALL TESTS MAY NOT BE ANALYTICALLY VALID ON SUCH A SPECIMEN. THE LABORATORY MAY WISH TO RECORD THAT A DIALOGUE WAS HELD WITH THE PHYSICIAN, WHEN SUCH OCCURS.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7183 [42CFR493.1703(c)]; 2) Jones BA, et al. Chemistry specimen acceptability. A College of American Pathologists Q-Probes study of 453 laboratories. Arch Pathol Lab Med. 1997;121:19-26.
AGC.22100 Phase II N/A YES NO
Is the disposition of all unacceptable specimens documented in the patient report and/or quality improvement records?
COMMENTARY:
A RECORD OF ALL REJECTED SPECIMENS MUST BE MAINTAINED IN THE PATIENT REPORT AND/OR QUALITY IMPROVEMENT RECORDS. THIS INFORMATION IS ESSENTIAL TO PROPER PATIENT TEST MANAGEMENT AND TO THE LABORATORY QUALITY IMPROVEMENT PROGRAM.
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Blood Gas Specimens
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AGC.22300 PHASE II N/A YES NO
Are personnel performing arterial punctures knowledgeable about the more significant complications of this procedure compared with venipuncture?
COMMENTARY:
PERSONNEL PERFORMING ARTERIAL PUNCTURES MUST BE KNOWLEDGEABLE ABOUT THE MORE SIGNIFICANT COMPLICATIONS OF THIS PROCEDURE COMPARED WITH VENIPUNCTURE.
REFERENCES: 1) National Committee for Clinical Laboratory StandardsNCCLS. Blood gas preanalytical considerations: specimen collection, calibration, and controls; approved guideline C27-A. Wayne, PA: NCCLS, 1993; 2) National Committee for Clinical Laboratory StandardsNCCLS. Procedures for the collection of arterial blood specimens - third edition; approved standard H11-A3. Wayne, PA: NCCLS, 1999.
AGC.22400 Phase II N/A YES NO
For radial artery sampling, is a test for collateral circulation performed before arterial puncture, as applicable?
NOTE: The various technologies available have been evaluated in the published literature. Consensus should be established between the laboratory and involved clinicians to define in which patients and under what circumstances such a test is medically useful in averting potential patient injury.
COMMENTARY:
FOR RADIAL ARTERY SAMPLING, A TEST FOR COLLATERAL CIRCULATION MUST BE PERFORMED BEFORE ARTERIAL PUNCTURE, AS APPLICABLE. THE VARIOUS TECHNOLOGIES AVAILABLE HAVE BEEN EVALUATED IN THE PUBLISHED LITERATURE, AS LISTED BELOW. CONSENSUS SHOULD BE ESTABLISHED BETWEEN THE LABORATORY AND INVOLVED CLINICIANS TO DEFINE IN WHICH PATIENTS AND UNDER WHAT CIRCUMSTANCES SUCH A TEST IS MEDICALLY USEFUL IN AVERTING POTENTIAL PATIENT INJURY.
REFERENCES: 1) Vaghadia H, et al. Evaluation of a postocclusive circulatory hyperaemia (PORCH) test for the assessment of ulnar collateral circulation. Can J Anaesth. 1988;35:591-598; 2) Cheng EY, et al. Evaluation of the palmar circulation by pulse oximetry. J Clin Monit. 1989;5:1-3; 3) Levinsohn DG, et al. The Allen's test: analysis of four methods. J Hand Surg. 1991;16:279-282; 4) Fuhrman TM, et al. Evaluation of collateral circulation of the hand. J Clin Monit. 1992;8:28-32; 5) Furhman TM, et al. Evaluation of digital blood pressure, plethysmography, and the modified Allen's test as a means of evaluating the collateral circulation to the hand. Anaesthesia. 1992;47:959-961; 6) Fuhrman TM, McSweeney E. Noninvasive evaluation of the collateral circulation to the hand. Acad Emerg Med. 1995;2:195-199; 7) O'Mara K, Sullivan B. A simple bedside test to identify ulnar collateral flow. Ann Intern Med. 1995;123:637; 8) Starnes SL, et al. Noninvasive evaluation of hand circulation before radial artery harvest for coronary artery bypass grafting. J Thorac Cardiovasc Surg. 1999;117:261-266; 9) Cable DG, et al. The Allen test. Ann Thorac Surg. 1999;67:876-877.
AGC.22500 Phase II N/A YES NO
Is there a system to prevent ambient air contamination of blood gas samples before analysis?
COMMENTARY:
THERE MUST BE A SYSTEM TO ENSURE THAT SAMPLES COLLECTED FOR BLOOD GAS ANALYSIS ARE NOT CONTAMINATED WITH AMBIENT ROOM AIR, AS THIS MAY ALTER THE ANALYTIC VALIDITY OF PATIENT RESULTS.
REFERENCES: 1) Ishikawa S, et al. The effects of air bubbles and time delay on blood gas analysis. Ann Allergy. 1974;33:72-77; 2) Mueller RG, et al. Bubbles in samples for blood gas determinations. Am J Clin Pathol. 1976;65:242-249; 3) Madiedo G, et al. Air bubbles and temperature effect on blood gas analysis. J Clin Pathol. 1980;33:864-867; 4) Biswas CK, et al. Blood gas analysis: effect of air bubbles in syringe and delay in estimation. Brit Med J. 1982;284:923-927; 5) McKane MH, et al. Sending blood gas specimens through pressurized transport tube systems exaggerates the error in oxygen tension measurements created by the presence of air bubbles. Anesth Analg. 1995;81:179-182; 6) Astles JR, et al. Pneumatic transport exacerbates interference of room air contamination in blood gas samples. Arch Pathol Lab Med. 1996;120:642-647.
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REPORTING OF RESULTS REPORTING
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AGC.23000 Phase II N/A YES NO
Are reference intervals (normal ranges) established or verified by the laboratory for the population being tested?
COMMENTARY:
AGE- AND SEX-SPECIFIC REFERENCE INTERVALS (NORMAL VALUES) MUST BE VERIFIED OR ESTABLISHED BY LABORATORY. IF A FORMAL REFERENCE INTERVAL STUDY IS NOT POSSIBLE OR PRACTICAL, THEN THE LABORATORY SHOULD CAREFULLY EVALUATE THE USE OF PUBLISHED DATA FOR ITS OWN REFERENCE RANGES, AND RETAIN DOCUMENTATION OF THIS EVALUATION.
REFERENCES: 1) Fulwood R, et al. Hematological and nutritional biochemistry reference data for persons 6 months-74 years of age: United States, 1976-80. Hyattsville, MD: Dept Health and Human Services pub no (PHS) 83-1682; 2) Department of Health and Human Services, Health Care Financing Administration. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Federal Register. 1992(Jan 19):5231 [42CFR493.1213(b)(2)(i)(F)]; 3) Knight JA. Laboratory issues regarding geriatric patients. Lab Med. 1997;28:458-461; 4) Slovacek KJ, et al. Use of age-specific normal ranges for serum prostate-specific antigen. Arch Pathol Lab Med. 1998;122:330-332; 5) Soldin S, Hicks J (eds). Pediatric reference ranges, 3rd edition. Washington, DC: American Association of Clinical Chemistry Press, 1999; 6) National Committee for Clinical Laboratory StandardsNCCLS. How to define and determine reference intervals in the clinical laboratory; approved guideline C28-A2. Wayne, PA: NCCLS, 2000.
AGC.23050 Phase II N/A YES NO
Where possible, are all patient results reported with accompanying reference (normal) intervals or interpretations?
COMMENTARY:
THE LABORATORY MUST REPORT REFERENCE (NORMAL) INTERVALS OR INTERPRETATIONS WITH PATIENT RESULTS, WHERE SUCH EXIST. THIS IS IMPORTANT TO ALLOW PROPER INTERPRETATION OF PATIENT DATA. IN ADDITION, THE USE OF HIGH AND LOW FLAGS (GENERALLY AVAILABLE WITH A COMPUTERIZED LABORATORY INFORMATION SYSTEM) IS RECOMMENDED.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7162 [42CFR493.1109(d)].
AGC.23120 PHASE II N/A YES NO
Are upper and lower limits of the ANALYTICAL MEASUREMENT RANGE (AMR) for all analytes on instrument systems defined, so that results that falling outside these limits are appropriately reviewed and reassayed if necessary before reporting?
NOTE: Two types of ranges must be considered: the AMR and the Clinically Reportable Range (CRR). The AMR is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process. Each laboratory establishes the AMR that provides acceptable results for the intended clinical use. In many cases, the manufacturer specifies the AMR and the lab must validate this parameter. This range can be established or verified using appropriate reference materials; patient specimens, unaltered or altered (i.e., diluted or concentrated) with known analyte concentrations; or calibration materials. The laboratory must establish criteria for verifying the acceptability over time, of the full AMR, and document compliance. The AMR must be revalidated at least every 6 months, and following changes in lots of analytically critical reagents (as determined by the laboratory) or major system components.
Apparent analyte values that are lower or higher than the AMR do not routinely require repeat analysis if the result is reported as less than the lower limit, or greater than the upper limit, respectively, and the laboratory has evidence that the low result is not due to sampling/dilution errors, immunologic "hook effects," etc.
In special cases, the procedure should state if an analyte cannot be diluted or concentrated, or if there are limitations to the amount of dilution or concentration that can be successfully used.Each laboratory must specify how to handle results that exceed the AMR. If results outside this range are reported, the appropriate dilution or concentration protocols must be specified.
Some instruments have integral automatic dilution systems when a result exceeds the amr. Validation of the amr refers to the inherent measurement range of the method, not to the range extended by an automatic dilution process. A separate validation of the automatic dilution process should be performed.
The CLINICALLY REPORTABLE RANGE (CRR) is the range of analyte values that a method can report as a quantitative result, allowing for specimen dilution, concentration or other pretreatment used to extend the direct AMR. For example, if it is desired to report a result that exceeds the AMR, the specimen is commonly diluted to bring the analyte into that range, the diluted specimen is reassayed, and the final result calculated using the dilution factor.
The establishment of the CRR is a medical judgment based in part on the assay technology. It is established at the time of initial validation of a method in a laboratory. The method manufacturer frequently will specify the AMR and procedures to use for dilution or concentration of specimens with values outside the AMR. Once established, the CRR does not need to be re-evaluated unless the methodology changes for the analyte.
The lower limit of the CRR is typically the lower limit of the AMR of the method, as verified during method validation and stated in the procedure manual. Values lower than this limit will be reported as less than the limit. The upper limit of the CRR is typically not specified unless there is a measurement limitation of a dilution protocol for an analyte. It is acceptable to dilute until a value in the AMR is achieved. The diluent should be specified for each analyte that can be successfully diluted to bring its quantity into the AMR.
An example of a CRR with both low and high limits is given for hCG as follows: Assume that the AMR is 3-1,000 mIU/mL. A Laboratory Director establishes that, for proper patient care, the CRR is 5-1,000,000 mIU/mL. The lower CRR is based on medical judgment that lower values are not diagnostic for pregnancy, while values above the upper CRR are not useful for diagnostic or prognostic purposes. Patient specimens with analytical measured results of 1,000 are diluted and rerun to obtain quantitative values up to 1,000,000 mIU/mL; specimens with analytic results >1,000,000 mIU/mL are reported as ">1,000,000 mIU/mL".
An example of a CRR with only a low limit is given for aspartate aminotransferase (AST) as follows: assume the AMR is 4-900 IU/L. A Laboratory Director establishes that numeric values 900 are clinically useful. Patient specimens with measured results of 900 are diluted and reassayed until a quantitative result is obtained. In this case, the upper CRR is not specified because specimens are diluted until a quantitative value is obtained.
COMMENTARY:
UPPER AND LOWER LIMITS OF THE ANALYTICAL MEASUREMENT RANGE (AMR) FOR ALL ANALYTES MUST BE DEFINED. , AND RRESULTS THAT FALL OUTSIDE THESE LIMITS MUST BE APPROPRIATELY REVIEWED AND REASSAYED IF NECESSARY BEFORE REPORTING.
The AMR is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process. Each laboratory establishes the AMR that provides acceptable results for the intended clinical use. This range can be established or verified using appropriate reference materials; patient specimens, unaltered or altered (i.e., diluted or concentrated) with known analyte concentrations; or calibration materials. The laboratory must establish criteria for verifying the acceptability over time, of the full AMR, and document compliance. The AMR range must be revalidated at least every 6 months, and following changes in lots of analytically critical reagents or major system components.
Apparent analyte concentrations that are lower or higher than the AMR do not routinely require repeat analysis if the result is reported as less than the lower limit, or greater than the upper limit, respectively, and the laboratory has evidence that the low result is not due to sampling/dilution errors, immunologic "hook effects," etc.
Each laboratory must specify how to handle results that exceed the AMR. If results outside this range are reported, the appropriate dilution of concentration protocols must be specified.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7164 [42CFR493.1213].
AGC.23125 PHASE II N/A YES NO
Are dilution protocols and diluents (or concentration protocols) specified for all methods for which the CRR exceeds the AMR?
NOTE: When a test result exceeds the AMR, the laboratory may dilute or concentrate the specimen to adjust the analyte content to be within the AMR, then repeat the assay to obtain a quantitative result. The procedure manual must include the protocol for dilution or concentration, any diluents or other components used in the process, and the calculation of the final reportable result. The procedure should state if there is a limit to the amount of dilution or concentration that is appropriate for a method and specify how to report results that exceed the CRR.
COMMENTARY:
DILUTION PROTOCOLS MUST BE SPECIFIED FOR ALL METHODS FOR WHICH THE CLINICALLY REPORTABLE RANGE (CRR) EXCEEDS THE ANALYTIC MEASUREMENT RANGE (AMR).
AGC.23135 Phase II N/A YES NO
Is the CLINICALLY REPORTABLE RANGE (CRR) identified for all analytes, so results that fall outside the range are reported appropriately?
NOTE: The CRR is the range of analyte values that a method can report as a quantitative result, allowing for specimen dilution, concentration or other pretreatment used to extend the direct analytical measurement range. For example, if it is desired to report a result that exceeds the ANALYTIC MEASUREMENT RANGE, the specimen is commonly diluted to bring the analyte into that range, the diluted specimen is reassayed, and the final result calculated using the dilution factor. The dilution fluid used to obtain valid results must be specified in the procedure.
Each laboratory establishes the CRR that provides appropriate results for the intended clinical use. For example, it may be possible to use patient specimens (obtained from patients with disease conditions that produce very abnormal analyte concentrations/activities) in a dilution or concentration protocol to establish or verify the CRR. Analyte values less than or greater than the CRR are usually reported as greater than or less than some measurable value.
Any limitations to the CRR are usually characteristics of the assay technology and are established at the time of initial validation of a method in a laboratory, or as experience is gained with the method. Once established, the CRR does not need to be re-evaluated unless there are methodology changes for the analyte. The CRR does NOT need to be revalidated every 6 months.
An illustration of the CRR for hCG is as follows: Assume that the ANALYTICAL MEASUREMENT RANGE is 3-1,000 mIU/mL. A Laboratory Director establishes that, for proper patient care, the CRR is 5-1,000,000 mIU/mL. The lower CRR is based on medical judgment that lower values are not diagnostic for pregnancy, while values above the upper CRR are not useful for diagnostic or prognostic purposes. Patient specimens with analytical measured results of 1,000 are diluted and rerun to obtain quantitative values up to 1,000,000 mIU/mL; specimens with analytic results >1,000,000 mIU/mL are reported as ">1,000,000 mIU/mL".
COMMENTARY:
THE CLINICALLY REPORTABLE RANGE (CRR) FOR ALL ANALYTES MUST BE SPECIFIED SO RESULTS THAT FALL OUTSIDE THESE LIMITS ARE REPORTED APPROPRIATELY.
The CRR is the range of analyte values that a method can report as a quantitative result, allowing for specimen dilution, concentration or other pretreatment used to extend the direct analytical measurement range. For example, if it is desired to report a result that exceeds the analytic measurement range, the specimen is commonly diluted to bring the analyte into that range, the diluted specimen is reassayed, and the final result calculated using the dilution factor. The dilution fluid used to obtain valid results must be specified in the procedure.
Each laboratory establishes the CRR that provides appropriate results for the intended clinical use. For example, it may be possible to use patient specimens (obtained from patients with disease conditions that produce very abnormal analyte concentrations/activities) in a dilution or concentration protocol to establish or verify the CRR. Analyte values less than or greater than the CRR are usually reported as greater than or less than some measurable value.
Any limitations to the CRR are usually characteristics of the assay technology and are established at the time of initial validation of a method in a laboratory, or as experience is gained with the method. Once established, the CRR does not need to be re-evaluated unless there are methodology changes for the analyte. The CRR does NOT need to be revalidated every 6 months.
An illustration of the CRR for hCG is as follows: Assume that the ANALYTICAL MEASUREMENT RANGE is 3-1,000 mIU/mL. A Laboratory Director establishes that, for proper patient care, the CRR is 5-1,000,000 mIU/mL. The lower CRR is based on medical judgment that lower values are not diagnostic for pregnancy, while values above the upper CRR are not useful for diagnostic or prognostic purposes. Patient specimens with analytical measured results of 1,000 are diluted and rerun to obtain quantitative values up to 1,000,000 mIU/mL; specimens with analytic results >1,000,000 mIU/mL are reported as ">1,000,000 mIU/mL".
AGC.23150 PHASE II N/A YES NO
Are documented criteria established for immediate notification of a physician or other clinical personnel responsible for patient care when the results of certain tests exceed critical limits important for prompt patient management decisions (for example, unusually low and/or high values for potassium, calcium or glucose)?
NOTE: May be indicated either in the procedure manual and/or in a separate manual. The bench technologists must be familiar with critical limits for procedures that they perform.
COMMENTARY:
CRITERIA FOR IMMEDIATE NOTIFICATION OF A PHYSICIAN OR OTHER CLINICAL PERSONNEL RESPONSIBLE FOR PATIENT CARE MUST BE ESTABLISHED FOR CRITICAL TESTS (GLUCOSE, POTASSIUM, CALCIUM, ETC). THIS MAY BE INDICATED IN THE PROCEDURE MANUAL AND/OR IN A SEPARATE MANUAL OR POLICY. THE BENCH TECHNOLOGISTS MUST BE FAMILIAR WITH CRITICAL LIMITS FOR PROCEDURES THAT THEY PERFORM.
REFERENCES: 1) Kost GJ. Critical limits for urgent clinician notification at US medical centers. JAMA. 1990;263:704-707; 2) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):[42CFR493.1109(f)]; 3) Steindel SJ, Heard NV. Critical values: data analysis and critique. Q-Probes 92-04. Northfield, IL: College of American Pathologists, 1992; 4) Kost GJ. Using critical limits to improve patient outcome. Med Lab Observ. 1993;25(3):22-27; 5) Tate KE, Gardner RM. Computers, quality, and the clinical laboratory: a look at critical values. Proc Annu Symp Comput Appl Med Care. 1993;193-197; 6) Kaufman HW, Collins C. Notifying clients of life-threatening results. Med Lab Observ. 1994;26(8):44-45; 7) Lum G. Evaluation of a laboratory critical limit (alert value) policy for hypercalcemia. Arch Pathol Lab Med. 1996;120:633-636; 8) Emancipator K. Critical values. ASCP practice parameter. Am J Clin Pathol. 1997:108:247-253; 9) Howanitz PJ, Cembrowski GS. Postanalytical quality improvement. A College of American Pathologists Q-Probes study of elevated calcium results in 525 institutions. Arch Pathol Lab Med. 2000;124:504-510; 10) Dalton-Beninato K. Critical value notifications are never welcome news. Lab Med. 2000;31:319-323; 11) Howanitz PJ, et al. Laboratory critical values policies and procedures. A College of American Pathologists Q-probes study in 623 institutions. Arch Pathol Lab Med. 20002;126:663-669.
AGC.23200 Phase II N/A YES NO
Is there documentation of prompt notification of the physician (or other clinical personnel responsible for patient care) of results of all critical values?
NOTE: In addition, the laboratory should document any failure of attempts to notify the appropriate person of critical results, and document the action taken to prevent recurrence of this problem.
COMMENTARY:
RECORDS MUST BE MAINTAINED INDICATING THE NOTIFICATION OF THE APPROPRIATE CLINICAL INDIVIDUAL PROMPTLY AFTER OBSERVING RESULTS IN CRITICAL RANGE. THESE RECORDS SHOULD INCLUDE: DATE, TIME, RESPONSIBLE LABORATORY INDIVIDUAL, PERSON NOTIFIED AND TEST RESULTS. IN ADDITION, THE LABORATORY SHOULD DOCUMENT ANY FAILURE OF ATTEMPTS TO NOTIFY THE APPROPRIATE PERSON OF CRITICAL RESULTS, AND DOCUMENT THE ACTION TAKEN TO PREVENT RECURRENCE OF THIS PROBLEM.
REFERENCES: 1) Kost GJ. Critical limits for urgent clinician notification at US medical centers. JAMA. 1990;263:704-707; 2) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):[42CFR493.1109(f)]; 3) Steindel SJ, Heard NV. Critical values: data analysis and critique. Q-Probes 92-04. Northfield, IL: College of American Pathologists, 1992; 4) Kost GJ. Using critical limits to improve patient outcome. Med Lab Observ. 1993;25(3):22-27; 5) Dalton-Beninato K. Critical value notifications are never welcome news. Lab Med. 2000;31:319-323; 6) Howanitz PJ, et al. Laboratory critical values policies and procedures. A College of American Pathologists Q-probes study in 623 institutions. Arch Pathol Lab Med. 20002;126:663-669.
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REAGENTS
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The verification of reagent performance is required and must be documented. Any of several methods may be appropriate, such as direct analysis with reference materials, parallel testing of old vs. new reagents, or checking against routine controls. The intent of the questions is for new reagents to be checked by an appropriate method and the results recorded before being placed in service. Where individually packaged reagents/kits are used, there should be criteria established for monitoring reagent quality and stability, based on volume of usage and storage requirements. Processing of periodic "wet controls" to validate reagent quality and operator technique is a typical component of such a system.
AGC.24000 Phase II N/A YES NO
Are reagents and solutions properly labeled, as applicable and appropriate, with the following elements:
1. content and quantity, concentration or titer,
2. storage requirements,
3. date prepared or reconstituted by laboratory,
4. expiration date?
NOTE: Some materials, such as separate boxes or vials of control substances shipped in a single primary container, do not have to be individually labeled with all elements if the original primary container was fully labeled, and the vials are maintained in the primary container. Alternately, a reagent/solution log file may be used to track materials put into use if it is not practical to fully label small containers, and so long as unique identifiers are applied. While perhaps useful for inventory management, labeling with "date received" is not routinely required. There is no requirement to routinely label individual containers with "date opened"; however, a new expiration date must be recorded on the container if opening the container changes the expiration date, storage requirement, etc. The inspector will describe specific issues of non-compliance in the Inspector's Summation Report.
COMMENTARY:
ALL REAGENTS MUST BE PROPERLY LABELED, AS APPLICABLE AND APPROPRIATE, WITH THE FOLLOWING ELEMENTS:
1. content and quantity, concentration or titer,
2. storage requirements,
3. date prepared or reconstituted by laboratory,
4. expiration date?
Some materials, such as separate boxes or vials of control substances shipped in a single primary container, do not have to be individually labeled with all elements if the original primary container was fully labeled, and the vials are maintained in the primary container. Alternately, a reagent/solution log file may be used to track materials put into use if it is not practical to fully label small containers, and so long as unique identifiers are applied. While perhaps useful for inventory management, labeling with "date received" is not routinely required. There is no requirement to routinely label individual containers with "date opened"; however, a new expiration date must be recorded on the container if opening the container changes the expiration date, storage requirement, etc. One or more of the above elements were absent during the on-site inspection. Details are provided in the Inspector's Summation Report.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7164 [42CFR493.1205(d)]; 2) National Committee for Clinical Laboratory Standards. Clinical laboratory technical procedure manuals - third edition; approved guideline GP2-A3. Wayne, PA: NCCLS, 1996; 3) Gonzales Y, Kampa IS. The effect of various storage environments on reagent strips. Lab Med. 1997;28:135-137; 3) NCCLS. Clinical laboratory technical procedure manuals - fourth edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002..
AGC.24020 Phase II N/A YES NO
Are all reagents stored as recommended by the manufacturer?
COMMENTARY:
REAGENTS MUST BE STORED AS RECOMMENDED BY THE MANUFACTURER IN ORDER TO PREVENT ENVIRONMENTALLY-INDUCED ALTERATIONS THAT COULD AFFECT TEST PERFORMANCE. IF AMBIENT TEMPERATURE IS INDICATED, THERE MUST BE DOCUMENTATION THAT THE DEFINED AMBIENT TEMPERATURE IS MAINTAINED AND CORRECTIVE ACTION IS TAKEN WHEN TOLERANCE LIMITS ARE EXCEEDED.
REFERENCE: Gonzales Y, Kampa IS. The effect of various storage environments on reagent strips. Lab Med. 1997;28:135-137.
AGC.24050 PHASE II N/A YES NO
Are all reagents used within their indicated expiration date?
COMMENTARY:
REAGENTS MUST NOT BE USED BEYOND THEIR STATED OR ASSIGNED EXPIRATION DATE.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7164 [42CFR493.1205(e)(1)].
AGC.24130 PHASE I N/A YES NO
Are common interferences evaluated for all analytes measured with each reagent system, or is credible information available?
NOTE: NCCLS Guideline EP7-P (Interference Testing In Clinical Chemistry) is a useful reference source. Neither this document nor its methods are mandatory for CAP accreditation.
COMMENTARY:
COMMON INTERFERENCES SHOULD BE EVALUATED FOR EACH ANALYTE MEASURED WITH EACH REAGENT SYSTEM, OR INFORMATION SHOULD BE AVAILABLE THAT IS CONSISTENT WITH NCCLS GUIDELINE EP7-P.
REFERENCES: 1) Letellier G, Dejarlais F. Analytic interference of drugs in clinical chemistry. 1: Study of twenty drugs on seven different instruments. Clin Biochem. 1985;18:345-351; 2) National Committee for Clinical Laboratory StandardsNCCLS. Interference testing in clinical chemistry; proposed guideline EP7-P. Wayne, PA: NCCLS, 1986; 3) Kroll MH, Elin RJ. Interference with clinical laboratory analyses. Clin Chem. 1994;40:1996-2005; 4) Kazmierczak SC, Catrou PG. Analytical interference. More than just a laboratory problem. Am J Clin Pathol. 2000;113:9-11; 5) Tang Z, et al. Effects of drugs on glucose measurements with handheld glucose meters and a portable glucose analyzer. Am J Clin Pathol. 2000;113:75-80; 6) Tang Z, et al. Effects of pH on glucose measurements with handheld glucose meters and a portable glucose analyzer for point-of-care testing. Arch Pathol Lab Med. 2000;124:577-582; 7) Young DS. Effects of drugs on clinical laboratory tests, 5th ed. Washington, DC: American Association for Clinical Chemistry, 2000.
AGC.24150 Phase II N/A YES NO
If there are multiple components of a reagent kit, does the laboratory use components of reagent kits only within the kit lot unless otherwise specified by the manufacturer?
COMMENTARY:
IF THERE ARE MULTIPLE COMPONENTS OF A REAGENT KIT, THE LABORATORY MUST USE COMPONENTS OF REAGENT KITS ONLY WITH OTHER KITS THAT ARE IN THE SAME LOT NUMBER UNLESS OTHERWISE SPECIFIED BY THE MANUFACTURER.
AGC.24575 PHASE II N/A YES NO
Are new reagent lots checked against old reagent lots or with suitable reference material before or concurrently with being placed in service?
NOTE: For quantitative tests, reagent validation is usually performed by assaying the same patient specimens with both the old and new lots to ensure consistent resultstypically done in conjunction with validation of the analytical measurement range. For qualitative tests, minimum cross-checking includes retesting at least one known positive and one known negative patient sample from the old reagent lot against the new reagent lot, ensuring that the same results are obtained with the new lot. Good clinical laboratory science includes patient-based comparisons in many situations, since it is patient results that are "controlled". A weakly positive control should also be used in systems where patient results are reported in that fashion.
COMMENTARY:
NEW REAGENTS MUST BE TESTED IN PARALLEL WITH OLD REAGENTS OR CHECKED BY SOME OTHER REFERENCE MATERIAL BEFORE OR CONCURRENTLY WITH BEING PLACED IN SERVICE. FOR QUANTITATIVE TESTS, REAGENT VALIDATION IS USUALLY PERFORMED BY ASSAYING THE SAME PATIENT SPECIMENS WITH BOTH THE OLD AND NEW LOTS TO ENSURE CONSISTENT RESULTS.FOR QUANTITATIVE TESTS, REAGENT VALIDATION IS TYPICALLY DONE IN CONJUNCTION WITH VALIDATION OF THE ANALYTICAL MEASUREMENT RANGE. FOR QUALITATIVE TESTS, MINIMUM CROSS-CHECKING INCLUDES RETESTING AT LEAST ONE KNOWN POSITIVE AND ONE KNOWN NEGATIVE PATIENT SAMPLE FROM THE OLD REAGENT LOT AGAINST THE NEW REAGENT LOT, ENSURING THAT THE SAME RESULTS ARE OBTAINED WITH THE NEW LOT. GOOD CLINICAL LABORATORY SCIENCE INCLUDES PATIENT-BASED COMPARISONS IN MANY SITUATIONS, SINCE IT IS PATIENT RESULTS THAT ARE "CONTROLLED". THE USE OF A WEAKLY POSITIVE CONTROL IS REQUIRED WHEN PATIENT RESULTS ARE REPORTED IN THAT FASHION.
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CALIBRATION AND STANDARDS
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INTRODUCTION: Calibration of a test method, calibration verification, and validation of the analytical measurement range (AMR) are required to substantiate the continued accuracy of the method. For affected laboratories, the U.S. CLIA-88 regulations use the term "calibration verification" to refer to both the verification of correct method calibration and validation of the AMR. This Checklist uses separate terms (AMR, CRR) to identify two distinct processes that are required for good laboratory practice. The following definitions of terms are offered as a guide to inspectors and laboratories:
ANALYTICAL MEASUREMENT RANGE VALIDATION: The process of confirming that the assay system will accurately measure the concentration or activity of the analyte over the AMR. The materials used for validation must be known to have matrix characteristics appropriate for the method. The matrix of the sample (i.e., the environment in which the sample is suspended or dissolved) may influence the measurement of the analyte. In many cases, the method manufacturer will recommend suitable materials. The test specimens must have analyte values which, at a minimum, are near the low, midpoint, and high values of the AMR. Specimen target values can be established by comparison with peer group values for reference materials, by assignment of reference or comparative method values, and by dilution ratios of one or more specimens with known values. Each laboratory must define limits for accepting or rejecting validation tests of the AMR. The AMR must be revalidated at least every 6 months, atand following changes in lots of analytically critical reagents or major system components, and when a complete change in reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results. Routine reagent lot changes may not require AMR revalidation if they occur within the 6-month interval. The Laboratory Director should determine what constitutes a major system component change or a “complete” change in reagents that would require revalidation of the AMR. Manufacturers’ instructions should be followed.
CALIBRATION: The set of operations thatwhich establish, under specified conditions, the relationship between system/instrument response and the corresponding concentration/activity values of an analyte. Calibration procedures are typically specified by a method manufacturer, but may also be established by the laboratory.
CALIBRATION VERIFICATION: The process of confirming that the current calibration settings remain valid for a method. If calibration verification confirms that the current calibration settings are valid, it is not necessary to perform a complete calibration or recalibration of the method. Calibration verification can be accomplished in several ways. If the method manufacturer provides a calibration validation or verification process, it should be followed. Other techniques include (1) assay of the current method calibration materials as unknown specimens, and determination that the correct target values are recovered, and (2) assay of matrix-appropriate materials with accurate target values that are specific for the method.assay system will accurately recover the concentration or activity of the analyte over the AMR. One must use matrix-appropriate materials (i.e., materials with a matrix closely resembling the patient test samples) with known or determined values, and analyze them in the same manner as patient specimens. Accurate results are defined as results within the analytical goals established by the laboratory for each analyte, or comparison with peer group values or reference material.
Calibration verification requires assaying specimens having at least minimum, midpoint, and maximum values of the analytical measurement range. If calibration verification includes these 3 values, and the data obtained meet the laboratory's acceptance criteria, recalibration is not necessary. The routine use of 2 levels of quality control (QC) material does not satisfy the requirements for calibration verification, as these verify only the area of the curve between these 2 levels; full calibration verification involves at least 3 levels of material with assayed values at the mid-point and the extremes of the analytical measurement range.
CALIBRATION VERIFICATION ACCEPTABLE LIMITS: Each laboratory must define limits for accepting or rejecting calibration verification tests.
CALIBRATION OR CALIBRATION VERIFICATION INTERVAL: Calibration or cCalibration verification must be performed at least once every 6 months, as specified under CLIA-88 regulations at 42CFR493.1217(b)(2)(ii)(C). Successful calibration verification certifies that the calibration is still valid; unsuccessful calibration verification requires remedial action, which usually includes recalibration. The performance of recalibration or a calibration verification procedure resets the calendar to a new maximum 6-month interval before the next required reassessment. Methods that are recalibrated more frequently than every 6 months do not require a separate calibration verification procedure.
CALIBRATION VERIFICATION OR -AMR VALIDATION MATERIALS: The matrix of the materials must be appropriate for the clinical specimens assayed by that method, and the target. The values must be appropriate for the measurement systemAMR as noted above. Materials may include, but are not limited to:
1. linearity material of appropriate matrix, e.g., CAP Calibration Verification/Linearity Survey or Calibration Verification/Linearity Survey Validated Material or suitable calibration verification material sources other than CAP,
2. proficiency testing survey material or proficiency testing survey-validated material,
3. previously tested patient specimens, unaltered,
4. previously tested patient specimens, altered to elevated analyte concentrations by spiking in known amounts of an analyte,
5. previously tested patient specimens, altered to lower analyte concentrations by dilution or other technique,
6. primary or secondary standards or reference materials with matrix characteristics and target values appropriate for the method,
7. calibrators used to calibrate the analytic measurement system.
In general, routine control materials are not suitable for calibration verification, except in specific situations where the material is specifically designated as suitable for verification of the manufacturervendor's calibration process.
RECALIBRATION: The repeat performance of the calibration procedure after a certain period of time or when an event occurs that is suspected to significantly change the accuracy of patient values.
RECALIBRATION INTERVAL: This is established by each laboratory. Manufacturers of method systems often recommend a standard interval when the method system is stable. The recalibration interval may be extended if calibration verification is performed and the results meet the established criteria of the laboratory. Criteria for determining the recalibration or calibration verification interval include:
1. a change of chemically or physically active or critical reagents,
2. QC fails to meet established criteria,
3. after major maintenance or service,
4. calibration verification data fail laboratory acceptance criteria,
5. when recommended by the manufacturer.
Each laboratory must establish its own criteria for recalibration interval.
AGC.25000 PHASE II N/A YES NO
Are calibration procedures for each method adequate, and are the calibration results documented?
COMMENTARY:
CALIBRATION PROCEDURES FOR EACH METHOD MUST BE ADEQUATE, AND CALIBRATION RESULTS DOCUMENTED FOR EACH SYSTEM EMPLOYED.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7165 [42CFR493.1217]; 2) Kroll MH, Emancipator K. A theoretical evaluation of linearity. Clin Chem. 1993;39:405-413; 3) National Committee for Clinical Laboratory StandardsNCCLS. Evaluation of matrix effects; proposed guideline EP14-P. Wayne, PA: NCCLS, 1998; 4) Miller WG. Quality control, In Professional practice in clinical chemistry: a companion text, ed DR Dufour. Washington, DC: AACC Press, 1999:12-1 to 12-22; 5) Kroll MH, et al. Evaluation of the extent of nonlinearity in reportable range studies. Arch Pathol Lab Med. 2000;124:1331-1338.
AGC.25050 Phase II N/A YES NO
Are high quality materials with method- and matrix-appropriate target valuesmaterials used for calibration and calibration verification whenever possible?
NOTE: Calibration materials establish the relationship between method/instrument response and the corresponding concentration/activities of an analyte. They have defined analyte target values and appropriate matrix characteristics for the clinical specimens and specific assay method. Many instrument systems require calibration materials with system-specific target values to produce accurate results for clinical specimens. Illustrative materials are given above.
COMMENTARY:
HIGH QUALITY MATERIALS WITH METHOD- AND MATRIX-APPROPRIATE CALIBRATION MATERIALS TARGET VALUES MUST BE USED WHENEVER POSSIBLE. CALIBRATORS OR CALIBRATION MATERIALS HAVE DEFINED ANALYTE TARGET VALUES AND APPROPRIATE MATRIX CHARACTERISTICS FOR THE CLINICAL SPECIMENS AND SPECIFIC ASSAY METHOD. MANY INSTRUMENT SYSTEMS REQUIRE CALIBRATION MATERIALS WITH SYSTEM-SPECIFIC TARGET VALUES TO PRODUCE ACCURATE RESULTS FOR CLINICAL SPECIMENS.
REFERENCE: NCCLS. Evaluation of matrix effects; approved guideline EP14-A. Wayne, PA: NCCLS, 2001.
TOX.25070 Phase II N/A YES NO
Are all drug calibration materials documented as to quality?
NOTE: The laboratory may use manufacturer's certification data for the purity of the drug calibration standards, but the laboratory must still independently document the quantitative accuracy of any calibrator solutions created from the calibration standard. If manufacturer's certification of purity is not available, then the laboratory must validate the purity by determining if any significant extraneous compounds are present using the appropriate analytical methods. Minimum requirements would be the analysis of a pure drug standard solution using the assay method used for drug analysis to demonstrate that no interfering compounds are present.
COMMENTARY:
THERE MUST BE DOCUMENTATION OF THE QUALITY OF DRUG STANDARDS USED BY THE LABORATORY. THE LABORATORY MAY USE MANUFACTURER'S CERTIFICATION DATA FOR THE PURITY OF THE DRUG CALIBRATION STANDARDS, BUT THE LABORATORY MUST STILL INDEPENDENTLY DOCUMENT THE QUANTITATIVE ACCURACY OF ANY CALIBRATOR SOLUTIONS CREATED FROM THE CALIBRATION STANDARD. IF MANUFACTURER'S CERTIFICATION OF PURITY IS NOT AVAILABLE, THEN THE LABORATORY MUST VALIDATE THE PURITY BY DETERMINING IF ANY SIGNIFICANT EXTRANEOUS COMPOUNDS ARE PRESENT USING THE APPROPRIATE ANALYTICAL METHODS. MINIMUM REQUIREMENTS WOULD BE THE ANALYSIS OF A PURE DRUG STANDARD SOLUTION USING THE ASSAY METHOD USED FOR DRUG ANALYSIS TO DEMONSTRATE THAT NO INTERFERING COMPOUNDS ARE PRESENT.
TOX.25080 PHASE II N/A YES NO
If the laboratory prepares toxicology calibrators and controls in-house, does it use different sources or lot numbers of drug calibration standards (when possible) for the creation of calibrators and controls, or at least prepare these materials separately?
COMMENTARY:
FOR TOXICOLOGY ASSAYS, THE LABORATORY MUST (1) USE DIFFERENT SOURCES OR LOT NUMBERS OF CALIBRATION STANDARDS (WHEN POSSIBLE) FOR THE PREPARATION OF CALIBRATORS AND CONTROLS, OR (2) SEPARATELY PREPARE ITS CALIBRATORS AND CONTROLS.
AGC.25100 PHASE II N/A YES NO
Are all calibration materials properly labeled as to content and calibration values?
NOTE: Complete values need not necessarily be recorded directly on each vial of calibrator material, so long as there is a clear indication where specific values may be found for each analyte tested and each analyzer used by the laboratory.
COMMENTARY:
CALIBRATION MATERIALS MUST BE PROPERLY LABELED AS TO CONTENT AND CALIBRATION VALUES. COMPLETE VALUES NEED NOT NECESSARILY BE RECORDED DIRECTLY ON EACH VIAL OF CALIBRATOR MATERIAL, SO LONG AS THERE IS A CLEAR INDICATION WHERE SPECIFIC VALUES MAY BE FOUND FOR EACH ANALYTE TESTED AND EACH ANALYZER USED BY THE LABORATORY.
AGC.25150 PHASE II N/A YES NO
Do labels on calibration materials include dates placed in service and expiration dates?
COMMENTARY:
LABELS ON CALIBRATION MATERIALS MUST INCLUDE DATES PLACED IN SERVICE AND EXPIRATION DATES.
AGC.25250 PHASE II N/A YES NO
Are criteria established for frequency of calibration or calibration verification, and the acceptability of results?
NOTE: Criteria typically include:
1. at changes of reagent lots for chemically or physically active or critical components, unless the laboratory can demonstrate that the use of different lots does not affect the accuracy of patient test results and the range used to report patient test data,
2. QC fails to meet established criteria,
3. after major maintenance or service,
4. when recommended by the manufacturer,
5. at least every 6 months.
COMMENTARY:
CRITERIA MUST BE ESTABLISHED FOR CALIBRATION OR CALIBRATION VERIFICATION. SUCH CRITERIA TYPICALLY INCLUDE:
1. at changes of reagent lots for chemically or physically active or critical components, unless the laboratory can demonstrate that the use of different lots does not affect the accuracy of patient test results and the range used to report patient test data,
2. QC fails to meet established criteria,
3. after major maintenance or service,
4. when recommended by the manufacturer,
5. at least every 6 months.
A laboratory must also have documented criteria for acceptable calibration verification results. When calibration verification criteria are exceeded, the laboratory must recalibrate.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7165 [42CFR493.1217]; 2) Miller WG. Quality control, In Professional practice in clinical chemistry: a companion text, ed DR Dufour. Washington, DC: AACC Press, 1999:12-1 to 12-22.
AGC.25280 Phase II N/A YES NO
Is the method system recalibrated when calibration verification fails to meet the established criteria of the laboratory?
COMMENTARY:
THE METHOD SYSTEM MUST BE RECALIBRATED WHEN CALIBRATION VERIFICATION FAILS TO MEET THE ESTABLISHED CRITERIA OF THE LABORATORY.
AGC.25300 PHASE II N/A YES NO
Is verification of the analytical measurement range (AMR) performed with matrix-appropriate materials of known analyte value appropriate to the AMR of the method system, and is the process documented?
COMMENTARY:
CALIBRATION, CALIBRATION VERIFICATION, AND VALIDATION OF THE ANALYTICAL MEASUREMENT RANGE (AMR) ARE REQUIRED TO SUBSTANTIATE THE CONTINUED ACCURACY OF A TEST METHOD. THE CLIA-88 REGULATIONS USE THE TERM "CALIBRATION VERIFICATION" TO REFER TO BOTH VERIFICATION OF CORRECT METHOD CALIBRATION AND VALIDATION OF THE ANALYTICAL MEASUREMENT RANGE. THIS CHECKLIST USES SEPARATE TERMS TO IDENTIFY TWO DISTINCT PROCESSES THAT ARE BOTH REQUIRED FOR GOOD LABORATORY PRACTICE.
The AMR is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment that is not part of the usual assay process. Validation of the AMR is the process of confirming that the assay system will accurately measure the concentration or activity of the analyte over the AMR. The materials used for validation must be known to have matrix characteristics appropriate for the method. The matrix of the sample (i.e., the environment in which the analyte is dissolved/suspended) may influence or alter the measurement of the analyte. In many cases, the method manufacturer will recommend suitable materials. The test specimens must have analyte values thatwhich as a minimum are near the low, midpoint, and high values of the AMR. Specimen target values can be established by comparison with peer group values for reference materials, by assignment of reference or comparison method values, and by dilution ratios of one or more specimens with known values. Each laboratory must define limits for accepting or rejecting validation tests of the AMR. The AMR must be revalidated at least every 6 months, and following changes in lots of analytically critical reagents or major system components.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7165 [42CFR493.1217].
AGC.25400 PHASE II N/A YES NO
Are criteria established for verifying the analytical measurement range, and is compliance documented?
NOTE: If the materials used for calibration or for calibration verification include low, midpoint, and high values that are near the stated AMR, and if calibration verification data are within the laboratory's acceptance criteria, the AMR has been verified; no additional procedures are required. If the calibration and/or calibration verification materials do not include the full AMR, or the laboratory extends the AMR beyond the manufacturer's stated range, the AMR must be verified by assaying materials reasonably near the lowest and highest values of the AMR.
COMMENTARY:
CRITERIA MUST BE ESTABLISHED AND DOCUMENTED FOR VERIFYING THE ANALYTICAL MEASUREMENT RANGE (ARMR). IF THE MATERIALS USED FOR CALIBRATION OR FOR CALIBRATION VERIFICATION INCLUDE LOW, MIDPOINT, AND HIGH VALUES THAT ARE NEAR THE STATED AMR, AND IF CALIBRATION VERIFICATION DATA ARE WITHIN THE LABORATORY'S ACCEPTANCE CRITERIA, THE AMR HAS BEEN VERIFIED; NO ADDITIONAL PROCEDURES ARE REQUIRED. IF THE CALIBRATION AND/OR CALIBRATION VERIFICATION MATERIALS DO NOT INCLUDE THE FULL AMR, OR THE LABORATORY EXTENDS THE AMR BEYOND THE MANUFACTURER'S STATED RANGE, THE AMR MUST BE VERIFIED BY ASSAYING MATERIALS REASONABLY NEAR THE LOWEST AND HIGHEST VALUES OF THE AMR.
AGC.25700 PHASE II N/A YES NO
If the laboratory has more than one method-system for performing tests for a given analyte, are they checked against each other at least twice a year for correlation of patient results?
NOTE: This includes same or different instrument makes/models. The selection of fresh human samples (whole blood, serum, plasma, urine, etc.), rather than simply stabilized commercial controls with potential matrix effects, is important to directly address the issue of whether a patient sample yields the same results on all of the laboratory's instruments. Statistical agreement of commercial control materials across instruments does not guarantee comparability of patient specimen results. In cases when pre-analytical stability of patient specimens is a limiting factor, alternative protocols based on QC or reference materials may be necessary but the materials used should be validated to have the same response as fresh human samples for the instruments/methods involved.
COMMENTARY:
WHEN MORE THAN ONE INSTRUMENT-REAGENT SYSTEM IS USED TO GENERATE ANY PATIENT-REPORTABLE ANALYTE, IT IS IMPORTANT THAT THE LABORATORY VERIFY COMPARABILITY OF RESULTS FOR PATIENT SPECIMENS. CHECKS FOR CALIBRATION AGREEMENT AND CORRELATION OF PATIENT RESULTS MUST BE DONE AT LEAST TWICE A YEAR. THE SELECTION OF FRESH SAMPLES (WHOLE BLOOD, SERUM, PLASMA, URINE, ETC.), RATHER THAN SIMPLY STABILIZED COMMERCIAL CONTROLS WITH POTENTIAL MATRIX EFFECTS, IS IMPORTANT TO DIRECTLY ADDRESS THE ISSUE OF WHETHER A PATIENT SAMPLE YIELDS THE SAME RESULTS ON ALL OF THE LABORATORY'S INSTRUMENTS. STATISTICAL AGREEMENT OF COMMERCIAL CONTROL MATERIALS ACROSS INSTRUMENTS DOES NOT GUARANTEE COMPARABILITY OF PATIENT SPECIMEN RESULTS. IN CASES WHEN PRE-ANALYTICAL STABILITY OF PATIENT SPECIMENS IS A LIMITING FACTOR, ALTERNATIVE PROTOCOLS BASED ON QC OR REFERENCE MATERIALS MAY BE NECESSARY BUT THE MATERIALS USED SHOULD BE VALIDATED TO HAVE THE SAME RESPONSE AS FRESH HUMAN SAMPLES FOR THE INSTRUMENTS/METHODS INVOLVED.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Federal Register. 1993(Jan 19):5236 [42CFR493.1709(a)]; 2) Podczasy JJ, et al. Clinical evaluation of the Accu-Chek Advantage blood glucose monitoring system. Lab Med. 1997;28:462-466; 3) Ross JW, et al. The accuracy of laboratory measurements in clinical chemistry: a study of eleven analytes in the College of American Pathologists Chemistry Survey with fresh frozen serum, definitive methods and reference methods. Arch Pathol Lab Med. 1998;122:587-608.
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CONTROLS
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Controls are samples that act as surrogates for patient specimens. They are periodically processed like a patient sample to monitor the ongoing performance of the entire analytic process.
Most quantitative tests are traditionally monitored with 2 levels of liquid control material (procedural control). This is done at a frequency within which the accuracy and precision of the measuring system is expected to be stable (based upon manufacturer's recommendations), but at least each day that patient testing is performed. The daily use of two levels of liquid control may NOT be required for certain test systems, where the daily use of instrument and/or electronic controls is demonstrably sufficient to validate that calibration status is maintained within acceptable limits.
The daily use of 2 levels of instrument and/or electronic controls as the only QC system is acceptable only for unmodified test systems cleared by the FDA and classified under CLIA-88 as "waived" or "moderate complexity." The laboratory is expected to provide documentation of its validation of all instrument-reagent systems for which daily controls are limited to instrument and/or electronic controls, and the inspector will review these data to assess the adequacy of the QC system. This documentation must include the Federal complexity classification of the testing system AND data showing that calibration status is monitored.
AGC.26000 Phase II N/A YES NO
For QUANTITATIVE tests, are control materials at more than one concentration (level) used at least daily?
COMMENTARY:
FOR QUANTITATIVE TESTS, AN APPROPRIATE QUALITY CONTROL (QC) SYSTEM MUST BE IN PLACE. THE DAILY USE OF 2 LEVELS OF INSTRUMENT AND/OR ELECTRONIC CONTROLS AS THE ONLY QC SYSTEM IS ACCEPTABLE ONLY FOR UNMODIFIED TEST SYSTEMS CLEARED BY THE FDA AND CLASSIFIED UNDER CLIA-88 AS "WAIVED" OR "MODERATE COMPLEXITY." THE LABORATORY IS EXPECTED TO PROVIDE DOCUMENTATION OF ITS VALIDATION OF ALL INSTRUMENT-REAGENT SYSTEMS FOR WHICH DAILY CONTROLS ARE LIMITED TO INSTRUMENT AND/OR ELECTRONIC CONTROLS. THIS DOCUMENTATION MUST INCLUDE THE FEDERAL COMPLEXITY CLASSIFICATION OF THE TESTING SYSTEM AND DATA SHOWING THAT CALIBRATION STATUS IS MONITORED.
REFERENCES: 1) Department of Health and Human Services, Health Care Financing Administration. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Federal Register. 1993(Jan 19):5232 [42CFR493.1218(b)(2)]; 2) Steindel SJ, Tetrault G. Quality control practices for calcium, cholesterol, digoxin, and hemoglobin. A College of American Pathologists Q-Probes study in 505 hospital laboratories. Arch Pathol Lab Med. 1998;122:401-408; 3) Voss EM, et al. Determining acceptability of blood glucose meters. Statistical methods for determining error. Lab Med. 1996;27:601-606; 4) National Committee for Clinical Laboratory StandardsNCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998; 5) Ye JJ, et al. Performance evaluation and planning for patient-based quality control procedures. Am J Clin Pathol. 2000;113:240-248.
AGC.26100 Phase II N/A YES NO
Has a statistically valid target range been established for each lot of control material by repetitive analysis in runs that include previously tested control materials (quantitative tests)?
COMMENTARY:
FOR QUANTITATIVE TESTS, THE LABORATORY MUST ESTABLISH A STATISTICALLY VALID TARGET RANGE FOR EACH LOT BY REPETITIVE ANALYSIS IN RUNS THAT INCLUDE PREVIOUSLY TESTED CONTROL MATERIALS.
REFERENCES: 1) National Committee for Clinical Laboratory StandardsNCCLS. Evaluation of precision performance of clinical chemistry devices; approved guideline EP5-A. Wayne, PA: NCCLS, 1998; 2) National Committee for Clinical Laboratory StandardsNCCLS. User demonstration of performance for precision and accuracy; approvedproposed guideline EP15-AP. Wayne, PA: NCCLS, 20021998.
AGC.26150 Phase II N/A YES NO
For QUALITATIVE tests, is a positive and negative control included with each run of patient specimens?
COMMENTARY:
FOR QUALITATIVE TESTS, A POSITIVE AND NEGATIVE CONTROL MUST BE INCLUDED WITH EACH RUN OF PATIENT SPECIMENS.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7166 [42CFR493.1218(b)(1)].
AGC.26200 PHASE II N/A YES NO
Are quality control data organized and presented so they can be evaluated daily by the technical staff to detect problems, trends, etc?
COMMENTARY:
RESULTS OF CONTROLS MUST BE RECORDED OR PLOTTED TO READILY DETECT A MALFUNCTION IN THE INSTRUMENT OR IN THE ANALYTIC SYSTEM. THESE CONTROL RECORDS MUST BE READILY AVAILABLE TO THE PERSON PERFORMING THE TEST. QUALITY CONTROL DATA MUST BE ORGANIZED AND PRESENTED SO THEY CAN BE EVALUATED DAILY BY THE TECHNICAL STAFF TO DETECT PROBLEMS, TRENDS, ETC.
REFERENCE: National Committee for Clinical Laboratory StandardsNCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998.
AGC.26250 PHASE II N/A YES NO
Are tolerance limits defined for control procedures?
NOTE: For tests with numeric results, recovery ranges supplied by manufacturers of assayed controls must not be substituted for quality control range limits determined by the laboratory on its own equipment.
COMMENTARY:
TOLERANCE LIMITS FOR CONTROL PROCEDURES MUST BE DEFINED. FOR TESTS WITH NUMERIC RESULTS, RECOVERY RANGES SUPPLIED BY MANUFACTURERS OF ASSAYED CONTROLS MUST NOT BE SUBSTITUTED FOR QUALITY CONTROL RANGE LIMITS DETERMINED BY THE LABORATORY ON ITS OWN EQUIPMENT.
REFERENCES: 1) Ross JW, Lawson NS. Analytic goals, concentration relationships, and the state of the art for clinical laboratory precision. Arch Pathol Lab Med. 1995;119:495-513; 2) Steindel SJ, Tetrault G. Quality control practices for calcium, cholesterol, digoxin, and hemoglobin. A College of American Pathologists Q-Probes study in 505 hospital laboratories. Arch Pathol Lab Med. 1998;122:401-408.
AGC.26275 Phase II N/A YES NO
For numeric QC data, are Gaussian or other quality control statistics (e.g., SD and CV) calculated at specified intervalsleast monthly to define analytic imprecision?
COMMENTARY:
THE LABORATORY MUST CALCULATE IMPRECISION STATISTICS (E.G., SD AND CV) AT SPECIFIED INTERVALSLEAST MONTHLY FOR NUMERIC QC DATA. FOR WHOLE BLOOD METHODSCBC DATA, WHERE STABILIZED WHOLE BLOOD OR OTHER SUITABLE MATERIAL IS NOT AVAILABLEUSED FOR QC, SUCH STATISTICS MAY BE GENERATED FROM PREVIOUS PATIENT SAMPLES USING THE SD OF DUPLICATE PAIRS.
REFERENCES: 1) Mukherjee KL. Introductory mathematics for the clinical laboratory. Chicago: American Society of Clinical Pathologyists Press, 1979:81-94; 2) Barnett RN. Clinical laboratory statistics, 2nd ed. Boston, MA: Little, Brown, 1979; 3) Weisbrodt IM. Statistics for the clinical laboratory. Philadelphia. PA: JB Lippincott, 1985; 4) Matthews DF, Farewell VT. Understanding and using medical statistics. New York, NY: Karger, 1988; 5) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7146 [42CFR493.1218(d)]; 6) Ross JW, Lawson NS. Analytic goals, concentrations relationships, and the state of the art for clinical laboratory precision. Arch Pathol Lab Med. 1995;119:495-513; 7) NCCLS. Laboratory statistics – standard deviation; a report. Wayne, PA: NCCLS, 1995; 87) National Committee for Clinical Laboratory StandardsNCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998; 98) Brooks ZC, et al. Critical systematic error supports used of varied QC rules in routine chemistry. Clin Chem. 2000;46:A70.
AGC.26300 Phase II N/A YES NO
Is there evidence of corrective action when control results exceed defined tolerance limits?
NOTE: Where practical, patient test results obtained in an analytically unacceptable test run or since the last acceptable test run must be evaluated to determine if there is a significant clinical difference in patient results.
COMMENTARY:
THERE MUST BE DOCUMENTATION OF CORRECTIVE ACTION TAKEN WHEN CONTROL VALUES EXCEED THE DEFINED TOLERANCE LIMITS. WHERE PRACTICAL, PATIENT TEST RESULTS OBTAINED IN AN ANALYTICALLY UNACCEPTABLE TEST RUN OR SINCE THE LAST ACCEPTABLE TEST RUN MUST BE EVALUATED TO DETERMINE IF THERE IS A SIGNIFICANT CLINICAL DIFFERENCE IN PATIENT RESULTS.
AGC.26325 PHASE II N/A YES NO
Does the laboratory have an action protocol when data from imprecision statistics change significantly from previous data?
NOTE: As an example, if the laboratory's normal-level commercial control usually yields a monthly CV of 2% for a given analyte, but the most recent month shows a 4% CV, then something has caused increased imprecision, and investigation with documentation is required. Similarly, if commercially sponsored interlaboratory QC data for the same control lot and instrument model show SD/CV values markedly smaller or larger than the peer group, an explanation is required.
COMMENTARY:
THE LABORATORY MUST HAVE AN ACTION PROTOCOL WHEN DATA FROM PRECISION STATISTICS CHANGE SIGNIFICANTLY FROM PREVIOUS DATA. AS AN EXAMPLE, IF THE LABORATORY'S NORMAL-LEVEL COMMERCIAL CONTROL USUALLY YIELDS A MONTHLY CV OF 2% FOR A GIVEN ANALYTES, BUT THE MOST RECENT MONTH SHOWS A 4% CV, THEN SOMETHING HAS LED TO INCREASED IMPRECISION, AND INVESTIGATION WITH DOCUMENTATION IS REQUIRED. SIMILARLY, IF COMMERCIALLY SPONSORED INTERLABORATORY QC DATA FOR THE SAME CONTROL LOT AND INSTRUMENT MODEL SHOW SD/CV VALUES MARKEDLY SMALLER OR LARGER THAN THE PEER GROUP, AN EXPLANATION IS REQUIRED.
AGC.26350 PHASE II N/A YES NO
Are control specimens tested in the same manner and by the same personnel as patient samples?
COMMENTARY:
IT IS IMPLICIT IN QUALITY CONTROL (QC) THAT CONTROL SPECIMENS ARE TESTED IN THE SAME MANNER AS PATIENT SPECIMENS. MOREOVER, QC SPECIMENS MUST BE ANALYZED BY PERSONNEL WHO ROUTINELY PERFORM PATIENT TESTING - THIS DOES NOT IMPLY THAT EACH OPERATOR MUST PERFORM QC DAILY, SO LONG AS EACH INSTRUMENT AND/OR TEST SYSTEM HAS QC PERFORMED AT REQUIRED FREQUENCIES. TO THE EXTENT POSSIBLE, ALL STEPS OF THE TESTING PROCESS MUST BE CONTROLLED, RECOGNIZING THAT PRE-ANALYTIC AND POST-ANALYTIC VARIABLES MAY DIFFER FROM THOSE ENCOUNTERED WITH PATIENTS.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7166 [42CFR493.1218(c)].
AGC.26400 PHASE II N/A YES NO
Are the results of controls verified for acceptability before reporting results?
COMMENTARY:
CONTROLS MUST BE REVIEWED BEFORE REPORTING PATIENT RESULTS. IT IS IMPLICIT IN QUALITY CONTROL THAT PATIENT TEST RESULTS WILL NOT BE REPORTED WHEN CONTROLS DO NOT YIELD ACCEPTABLE RESULTS.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7166 [42CFR493.1218(e)].
TOX.26500 Phase II N/A YES NO
If the laboratory handles pure controlled substances, is there a current Drug Enforcement Administration (DEA) license?
NOTE: It is not necessary to have a DEA license if controlled substances are analyzed, only if they are possessed in pure form. Many manufacturers prepare commercial solutions of controlled substances. It may not be necessary to have a DEA license to purchase these. Applicable only to U.S. laboratories.
COMMENTARY:
IF A U.S. LABORATORY IS HANDLING THE PURE CONTROLLED SUBSTANCE, THERE MUST BE A CURRENT DRUG ENFORCEMENT ADMINISTRATION (DEA) LICENSE. IT IS NOT NECESSARY TO HAVE A DEA LICENSE IF CONTROLLED SUBSTANCES ARE ANALYZED, ONLY IF THEY ARE POSSESSED IN PURE FORM. MANY MANUFACTURERS PREPARE COMMERCIAL SOLUTIONS OF CONTROLLED SUBSTANCES - IT MAY NOT BE NECESSARY TO HAVE A DEA LICENSE TO PURCHASE THESE.
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INSTRUMENTS AND EQUIPMENT
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A variety of instruments and equipment are used to support the performance of analytical procedures. All instruments and equipment should be properly operated, maintained, serviced, and monitored to ensure that malfunctions of these instruments and equipment do not adversely affect the analytical results. The inspection team should review the procedures for instrument/equipment operations, maintenance, and monitoring records to ensure that these devices are properly used.
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Glassware
.................................................................
AGC.27000 PHASE II N/A YES NO
Are glass volumetric flasks of certified accuracy (Class A, National Institute of Standards and Technology (NIST) Standard or equivalent) or if non-certified volumetric glassware is used, are all items checked for accuracy of calibration before initial use?
COMMENTARY:
GLASS VOLUMETRIC FLASKS MUST BE OF CERTIFIED ACCURACY; EITHER CLASS A, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY (NIST) STANDARD OR EQUIVALENT; OR ALL NONCERTIFIED GLASSWARE MUST BE CALIBRATED BEFORE INITIAL USE.
AGC.27060 PHASE II N/A YES NO
Are glass volumetric pipets of certified accuracy (Class A); or are they checked by gravimetric, colorimetric, or some other verification procedure before initial use?
NOTE: The following Table shows the American Society for Testing and Materials' calibration (accuracy) specifications for Class A volumetric pipets:
|Nominal Capacity (mL) |Variation (± mL) |
|0.5 - 2 |0.006 |
|3 - 7 |0.01 |
|8 - 10 |0.02 |
|15 - 30 |0.03 |
|40 - 50 |0.05 |
|100 |0.08 |
COMMENTARY:
GLASS VOLUMETRIC PIPETS MUST EITHER BE OF CERTIFIED ACCURACY (CLASS A) OR BE CALIBRATED BEFORE INITIAL USE. RECONSTITUTION OF LYOPHILIZED CALIBRATORS, CONTROLS, OR PROFICIENCY TESTING MATERIALS, OR ANY OTHER TASKS REQUIRING ACCURATE VOLUMETRIC MEASUREMENT, MUST BE PERFORMED ONLY WITH MEASURING DEVICES OF CLASS A ACCURACY, OR THOSE FOR WHICH ACCURACY HAS BEEN DEFINED AND DEEMED ACCEPTABLE FOR THE INTENDED USE. THE FOLLOWING TABLE SHOWS THE AMERICAN SOCIETY FOR TESTING AND MATERIALS' CALIBRATION (ACCURACY) SPECIFICATIONS FOR CLASS A VOLUMETRIC PIPETS:
|Nominal Capacity (mL) |Variation (± mL) |
|0.5 - 2 |0.006 |
|3 - 7 |0.01 |
|8 - 10 |0.02 |
|15 - 30 |0.03 |
|40 - 50 |0.05 |
|100 |0.08 |
REFERENCES: 1) CURTIS RH. PERFORMANCE VERIFICATION OF MANUAL ACTION PIPETS. PART I. AM CLIN LAB. 1994;12(7):8-9; 2) CURTIS RH. PERFORMANCE VERIFICATION OF MANUAL ACTION PIPETS. PART II. AM CLIN LAB. 1994;12(9):16-17; 3) PERRIER S, ET AL. MICRO-PIPETTE CALIBRATION USING A RATIOMETRIC PHOTOMETER-REAGENT SYSTEM AS COMPARED TO THE GRAVIMETRIC METHOD. CLIN CHEM. 1995;41:S183; 4) AMERICAN SOCIETY FOR TESTING AND MATERIALS. STANDARD SPECIFICATION FOR GLASS VOLUMETRIC (TRANSFER) PIPETS, DESIGNATION E 969-95. PHILADELPHIA, PA: ASTM, 1995; 5) JOHNSON B. CALIBRATION TO DYE FOR: ARTEL'S NEW PIPETTE CALIBRATION SYSTEM. SCIENTIST. 1999;13(12):14; 6) CONNORS M, CURTIS R. PIPETTING ERROR: A REAL PROBLEM WITH A SIMPLE SOLUTION. PARTS I AND II. AM LAB NEWS. 1999;31(13):20-22; 7) SKEEN GA, ASHWOOD ER. USING SPECTROPHOTOMETRY TO EVALUATE VOLUMETRIC DEVICES. LAB MED. 2000;31:478-479.
AGC.27070 Phase II N/A YES NO
Are non-class A pipets that are used for quantitative dispensing of material checked for accuracy and reproducibility at specified intervals, and results documented?
NOTE: Such checks are most simply done gravimetrically. This consists of transferring a number of measured samples of water from the pipet to a balance. Each weight is recorded, the weights are converted to volumes, and then means (for accuracy), and SD/CV (for imprecision) are calculated. Alternative approaches include spectrophotometry or (less frequently) the use of radioactive isotopes, and commercial kits are available from a number of vendors. Computer software is useful where there are many pipets, and provides convenient documentation.
COMMENTARY:
NON-CLASS A PIPETS USED FOR QUANTITATIVE DISPENSING OF MATERIAL MUST BE CHECKED FOR ACCURACY AND REPRODUCIBILITY AT SPECIFIED PERIODIC INTERVALS. RESULTS OF SUCH CHECKS MUST BE DOCUMENTED. SUCH CHECKS ARE MOST SIMPLY DONE GRAVIMETRICALLY. THIS CONSISTS OF TRANSFERRING A NUMBER OF MEASURED SAMPLES OF WATER FROM THE PIPET TO A BALANCE. EACH WEIGHT IS RECORDED, THE WEIGHTS ARE CONVERTED TO VOLUMES, AND THEN MEANS (FOR ACCURACY), AND SD/CV (FOR IMPRECISION) ARE CALCULATED. ALTERNATIVE APPROACHES INCLUDE SPECTROPHOTOMETRY OR (LESS FREQUENTLY) THE USE OF RADIOACTIVE ISOTOPES, AND COMMERCIAL KITS ARE AVAILABLE FROM A NUMBER OF VENDORS. COMPUTER SOFTWARE IS USEFUL WHERE THERE ARE MANY PIPETS, AND PROVIDES CONVENIENT DOCUMENTATION.
REFERENCES: 1) Curtis RH. Performance verification of manual action pipets. Part I. Am Clin Lab. 1994;12(7):8-9; 2) Curtis RH. Performance verification of manual action pipets. Part II. Am Clin Lab. 1994;12(9):16-17; 3) Perrier S, et al. Micro-pipette calibration using a ratiometric photometer-reagent system as compared to the gravimetric method. Clin Chem. 1995;41:S183; 4) Bray W. Software for the gravimetric calibration testing of pipets. Am Clin Lab. Oct 1995 (available on the internet at ); 5) Kroll MH, et al (eds). Laboratory instrument evaluation, verification & maintenance manual, 5th edition. Northfield, IL: College of American Pathologists, 1999:126-127; 6) Johnson B. Calibration to dye for: Artel's new pipette calibration system. Scientist. 1999;13(12):14; 7) Connors M, Curtis R. Pipetting error: a real problem with a simple solution. Parts I and II. Am Lab News. 1999;31(13):20-22; 8) Skeen GA, Ashwood ER. Using spectrophotometry to evaluate volumetric devices. Lab Med. 2000;31:478-479.
AGC.27080 Phase I N/A YES NO
Is the use of less precise measuring devices such as serological plastic pipets and graduated cylinders limited to situations where the accuracy and precision of calibrated glass pipets are not required?
NOTE: In contrast with the more stringent accuracy requirements of glass pipets, ASTM requirements for plastic pipets are ± 3% of the stated volume.
COMMENTARY:
THE USE OF DISPOSABLE PLASTIC PIPETS AND GRADUATED CYLINDERS SHOULD BE LIMITED TO SITUATIONS WHERE THE ACCURACY AND PRECISION OF CALIBRATED GLASS PIPETS ARE NOT REQUIRED. THE ASTM ACCURACY SPECIFICATION FOR DISPOSABLE SEROLOGICAL PIPETS IS ± 3% OF THE STATED CAPACITY. THE PROCEDURE MANUAL SHOULD SPECIFY WHEN THE USE OF NON-CLASS A MEASURING DEVICES IS PERMISSIBLE.
REFERENCE: American Society for Testing and Materials. Standard specification for serological pipets, disposable plastic, designation E 934-88, In 1993 Annual Book of ASTM Standards, section 14 (general methods and instrumentation). Philadelphia, PA: ASTM, 1993:14.02:485-486.
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Automatic Pipets - Fixed Volume Adjustable and/or Micropipets
.................................................................
Automatic pipets and diluting devices of all types must be checked for accuracy and reproducibility before being placed in service and periodically thereafter.
AGC.27100 PHASE II N/A YES NO
Is there a documented procedure defining how pipets are checked for accuracy of calibration (gravimetric, colorimetric or other verification procedure) before being placed in service initially, and results documented?
COMMENTARY:
AUTOMATIC PIPETS (FIXED VOLUME ADJUSTABLE AND/OR MICROPIPETS) MUST BE CHECKED FOR CALIBRATION ACCURACY EITHER BY VOLUMETRIC, COLORIMETRIC, GRAVIMETRIC, OR OTHER MEANS BEFORE BEING PLACED IN SERVICE INITIALLY, AND RESULTS DOCUMENTED.
REFERENCES: 1) Curtis RH. Performance verification of manual action pipets. Part I. Am Clin Lab. 1994;12(7):8-9; 2) Curtis RH. Performance verification of manual action pipets. Part II. Am Clin Lab. 1994;12(9):16-17; 3) Perrier S, et al. Micro-pipette calibration using a ratiometric photometer-reagent system as compared to the gravimetric method. Clin Chem. 1995;41:S183; 4) Bray W. Software for the gravimetric calibration testing of pipets. Am Clin Lab. Oct 1995 (available on the internet at ); 5) Kroll MH, et al (eds). Laboratory instrument evaluation, verification & maintenance manual, 5th edition. Northfield, IL: College of American Pathologists, 1999:126-127; 6) Johnson B. Calibration to dye for: Artel's new pipette calibration system. Scientist. 1999;13(12):14; 7) Connors M, Curtis R. Pipetting error: a real problem with a simple solution. Parts I and II. Am Lab News. 1999;31(13):20-22; 8) Skeen GA, Ashwood ER. Using spectrophotometry to evaluate volumetric devices. Lab Med. 2000;31:478-479.
AGC.27150 Phase II N/A YES NO
Are automatic pipets used for quantitative dispensing checked for accuracy and reproducibility (gravimetric, colorimetric or other verification procedure) at specified, periodic intervals, and are the results recorded?
NOTE: For analytic instruments with integral automatic pipettors, the accuracy and precision of the pipetting system should be checked periodically, unless that is notit may not be practical for the end-user laboratory to conduct its own tests of pipetting accuracy and precision. Manufacturers' recommendations should be followed.
COMMENTARY:
AUTOMATIC PIPETS USED FOR QUANTITATIVE DISPENSING MUST BE CHECKED FOR ACCURACY AND REPRODUCIBILITY AT SPECIFIED, PERIODIC INTERVALS, DEPENDING UPON THE LABORATORY'S INTENSITY OF PIPET USAGE. RESULTS OF SUCH CHECKS MUST BE DOCUMENTED. FOR ANALYTIC INSTRUMENTS WITH INTEGRAL AUTOMATIC PIPETTORS, THE ACCURACY AND PRECISION OF THE PIPETTING SYSTEM SHOULD BE CHECKED PERIODICALLY, UNLESS IT IS NOTIT MAY NOT BE PRACTICAL FOR THE END-USER LABORATORY TO CONDUCT ITS OWN TESTS OF PIPETTING ACCURACY AND PRECISION. MANUFACTURERS' RECOMMENDATIONS SHOULD BE FOLLOWED.
REFERENCES: 1) Curtis RH. Performance verification of manual action pipets. Part I. Am Clin Lab. 1994;12(7):8-9; 2) Curtis RH. Performance verification of manual action pipets. Part II. Am Clin Lab. 1994;12(9):16-17; 3) Perrier S, et al. Micro-pipette calibration using a ratiometric photometer-reagent system as compared to the gravimetric method. Clin Chem. 1995;41:S183; 4) Bray W. Software for the gravimetric calibration testing of pipets. Am Clin Lab. Oct 1995 (available on the internet at ); 5) Kroll MH, et al (eds). Laboratory instrument evaluation, verification & maintenance manual, 5th edition. Northfield, IL: College of American Pathologists, 1999:126-127; 6) Johnson B. Calibration to dye for: Artel's new pipette calibration system. Scientist. 1999;13(12):14; 7) Connors M, Curtis R. Pipetting error: a real problem with a simple solution. Parts I and II. Am Lab News. 1999;31(13):20-22; 8) Skeen GA, Ashwood ER. Using spectrophotometry to evaluate volumetric devices. Lab Med. 2000;31:478-479.
AGC.27160 Phase I N/A YES NO
If automatic pipetting is used, has the laboratory evaluated the testing system for carryover effects?
NOTE: The laboratory must have a procedure in place for evaluating whether carryover effects are present. One suggested method is to run known high samples (calibrators, standards, reference material, assayed controls), followed by known low samples to see if the results of the low-level material are affected. If carryover is detected, the laboratory must determine the level past which low-level samples are affected and this must be defined in the procedure. Results of each analytical run must be reviewed to ensure that no results exceed this level. If results that exceed the defined level are detected, then the appropriate course of action must be defined (repeat subsequent samples, for example).
COMMENTARY:
WHEN AUTOMATIC PIPETTING IS USED, THE LABORATORY MUST HAVE A PROCEDURE IN PLACE FOR EVALUATING WHETHER CARRYOVER EFFECTS ARE PRESENT. ONE SUGGESTED METHOD IS TO RUN KNOWN HIGH SAMPLES (CALIBRATORS, STANDARDS, REFERENCE MATERIAL, ASSAYED CONTROLS), FOLLOWED BY KNOWN LOW SAMPLES TO SEE IF THE RESULTS OF THE LOW-LEVEL MATERIAL ARE AFFECTED. IF CARRYOVER IS DETECTED, THE LABORATORY MUST DETERMINE THE LEVEL PAST WHICH LOW-LEVEL SAMPLES ARE AFFECTED AND THIS MUST BE DEFINED IN THE PROCEDURE. RESULTS OF EACH ANALYTICAL RUN MUST BE REVIEWED TO ENSURE THAT NO RESULTS EXCEED THIS LEVEL. IF RESULTS THAT EXCEED THE DEFINED LEVEL ARE DETECTED, THEN THE APPROPRIATE COURSE OF ACTION MUST BE DEFINED (REPEAT SUBSEQUENT SAMPLES, FOR EXAMPLE).
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Thermometers
.................................................................
AGC.27200 Phase II N/A YES NO
Is an appropriate thermometric standard device of known accuracy (NIST-certified or guaranteed by manufacturer to meet NIST Standards) available?
COMMENTARY:
THE LABORATORY MUST HAVE AN APPROPRIATE THERMOMETRIC STANDARD DEVICE (REFERENCE THERMOMETER) AND ALL NON-CERTIFIED THERMOMETERS MUST BE CHECKED AGAINST IT. THERMOMETERS SHOULD BE PRESENT ON ALL TEMPERATURE-CONTROLLED INSTRUMENTS AND ENVIRONMENTS AND CHECKED DAILY.
REFERENCE: National Committee for Clinical Laboratory Standards. Temperature calibration of water baths, instruments, and temperature sensors - second edition; approved standard I2-A2. Wayne, PA: NCCLS, 1990.
AGC.27250 PHASE II N/A YES NO
Are all non-certified thermometers in use checked against an appropriate thermometric standard device before initial use?
COMMENTARY:
ALL NON-CERTIFIED THERMOMETERS MUST BE CHECKED AGAINST THE THERMOMETRIC STANDARD DEVICE (REFERENCE THERMOMETER) BEFORE INITIAL USE.
REFERENCE: National Committee for Clinical Laboratory Standards. Temperature calibration of water baths, instruments, and temperature sensors - second edition; approved standard I2-A2. Wayne, PA: NCCLS, 1990.
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Temperature-Dependent Equipment
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AGC.27300 PHASE II N/A YES NO
Are temperatures checked and recorded appropriately for the following types of equipment:
1. water baths,
2. dry baths (heating blocks),
3. automated/general clinical chemistry components (water baths, dialyzers, heating baths),
4. incubators and ovens (where temperature control is necessary for a procedure),
5. refrigerators and freezers?
NOTE: Temperature-dependent equipment containing reagents and patient specimens must be monitored daily, as equipment failures could affect accuracy of patient test results. Items such as water baths and heat blocks used for procedures need only be checked on days of patient testing. The Inspector must provide specific details of any deficiencies in Part B (Deficiency Summary) of the Inspector's Summation Report.
COMMENTARY:
TEMPERATURES MUST BE CHECKED APPROPRIATELY FOR THE FOLLOWING TYPES OF EQUIPMENT:
1. water baths,
2. dry baths (heating blocks),
3. automated/general clinical chemistry components (water baths, dialyzers, heating baths),
4. incubators and ovens (where temperature control is necessary for a procedure),
5. refrigerators and freezers.
Temperature-dependent equipment containing reagents and patient specimens must be monitored daily, as equipment failures could affect accuracy of patient test results. Items such as water baths and heat blocks used for procedures need only be checked on days of patient testing. Specific details of non-compliance are identified in part B (deficiency summary) of the Inspector's Summation Report.
AGC.27350 PHASE II N/A YES NO
Have acceptable ranges been defined for all temperature-dependent equipment?
COMMENTARY:
ACCEPTABLE TEMPERATURE RANGES FOR EACH PIECE OF TEMPERATURE-DEPENDENT EQUIPMENT MUST BE DEFINED.
AGC.27360 PHASE II N/A YES NO
Is there evidence of corrective action taken if acceptable temperature ranges for refrigerators and/or freezers are exceeded, including evaluation of contents for adverse effects?
COMMENTARY:
THERE MUST BE EVIDENCE OF CORRECTIVE ACTION TAKEN IF ACCEPTABLE TEMPERATURE RANGES FOR REFRIGERATORS AND/OR FREEZERS ARE EXCEEDED. IN PARTICULAR, THERE MUST BE A RECORD THAT REAGENTS, CONTROLS, CALIBRATORS, ETC. ARE EVALUATED FOR POSSIBLE ADVERSE EFFECTS.
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Centrifuges
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AGC.27400 PHASE I N/A YES NO
Are all centrifuges used in the automated/general chemistry section clean and properly maintained?
COMMENTARY:
CENTRIFUGES SHOULD BE KEPT CLEAN AND PROPERLY MAINTAINED.
AGC.27420 PHASE II N/A YES NO
Is there a documented protocol and schedule for maintenance of all centrifuges (cleaning, changing brushes, etc.)?
COMMENTARY:
A DOCUMENTED PROTOCOL AND SCHEDULE FOR CENTRIFUGE MAINTENANCE MUST BE AVAILABLE.
AGC.27440 PHASE II N/A YES NO
Are the operating speeds of all centrifuges checked periodically as needed for the intended use, and is this done in a safe manner?
COMMENTARY:
THE OPERATING SPEEDS OF ALL CENTRIFUGES MUST BE CHECKED PERIODICALLY (WHEN INDICATED), AND THIS MUST BE DONE IN A SAFE MANNER. FOR CENTRIFUGES HAVING A SAFETY MECHANISM PREVENTING THE OPENING OF THE LID WHILE IN OPERATION, THE CHECKS OF RPM SHOULD BE PERFORMED ONLY BY AN AUTHORIZED SERVICE REPRESENTATIVE OF THE MANUFACTURER OR AN APPROPRIATELY TRAINED CLINICAL ENGINEER.
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Analytic Balances
.................................................................
AGC.27500 PHASE I N/A YES NO
Are balances cleaned, serviced and checked periodically only by qualified service personnel (i.e., service contract or as needed)?
COMMENTARY:
BALANCES SHOULD BE CLEANED, SERVICED, AND RECALIBRATED ONLY BY EXPERIENCED PERSONNEL.
AGC.27520 PHASE I N/A YES NO
Are analytic balances mounted such that vibrations do not interfere with readings?
COMMENTARY:
ANALYTIC BALANCES SHOULD BE MOUNTED SO THAT VIBRATIONS DO NOT INTERFERE WITH READINGS.
AGC.27540 PHASE II N/A YES NO
Are standard weights of the appropriate ANSI/ASTM Class available and used for checking accuracy?
NOTE: The verification of accuracy of the analytical balance must be performed each time it is used for the creation of analytical calibrators and/or weighed-in controls from standard materials, as well as when gravimetrically checking the accuracy of pipets. Weights with a Class tolerance factor greater than the readability of the balance should be used. ASTM Class 1 weights are appropriate for calibrating high precision analytical balances (0.01 to 0.1 mg). ASTM Class 2 weights are appropriate for calibrating high precision top-loading balances with readabilities from 0.001 to 0.01 g. ASTM Class 3 weights are appropriate for calibrating moderate precision balances, from 0.01 to 0.1 g. Verification of accuracy need not be performed more than once per shift.
COMMENTARY:
STANDARD ANSI/ASTM WEIGHTS OF THE APPROPRIATE CLASS MUST BE AVAILABLE TO CHECK BALANCES FOR ACCURACY, AND RESULTS OF TESTING MUST BE DOCUMENTED. APPROPRIATE ANSI/ASTM CLASS WEIGHTS MUST BE USED TO VERIFY BALANCE ACCURACY WHEN WEIGHING STANDARD MATERIALS TO PREPARE ANALYTICAL CALIBRATORS OR ASSAYED CONTROLS, AS WELL AS WHEN GRAVIMETRICALLY CHECKING THE ACCURACY OF PIPETS. THE VERIFICATION OF ACCURACY OF THE ANALYTICAL BALANCE MUST BE PERFORMED EACH TIME IT IS USED FOR THE CREATION OF ANALYTICAL CALIBRATORS AND/OR WEIGHED-IN CONTROLS FROM STANDARD MATERIALS. WEIGHTS WITH A CLASS TOLERANCE FACTOR GREATER THAN THE READABILITY OF THE BALANCE SHOULD BE USED. ASTM CLASS 1 WEIGHTS ARE APPROPRIATE FOR CALIBRATING HIGH PRECISION ANALYTICAL BALANCES (0.01 TO 0.1 MG). ASTM CLASS 2 WEIGHTS ARE APPROPRIATE FOR CALIBRATING HIGH PRECISION TOP-LOADING BALANCES WITH READABILITIES FROM 0.001 TO 0.01 G. ASTM CLASS 3 WEIGHTS ARE APPROPRIATE FOR CALIBRATING MODERATE PRECISION BALANCES, FROM 0.01 TO 0.1 G. VERIFICATION OF ACCURACY NEED NOT BE PERFORMED MORE THAN ONCE PER SHIFT.
REFERENCE: American Society for Testing and Materials. Standard specification for laboratory weights and precision mass standards, designation E 617-91, In 1993 Annual Book of ASTM Standards, section 14 (general methods and instrumentation). Philadelphia, PA: ASTM, 1993:14.02:280-295.
AGC.27560 PHASE II N/A YES NO
Are weights well-maintained (clean, in a covered container, not corroded)?
COMMENTARY:
WEIGHTS MUST BE WELL-MAINTAINED (COVERED WHEN NOT IN USE, NOT CORRODED).
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Blood Gas Instruments
.................................................................
If the institution has blood gas testing sites that are medically and/or administratively separate from the main laboratory, and the blood gas testing Medical Director is different from the central laboratory Medical Director, then the Blood Gas Laboratory Checklist must be completed. If blood gas analyses are performed in a central laboratory with other automated chemistry assays, and/or testing occurs physically separate from the main laboratory, but the Medical Director is the same as the main laboratory, then complete this section.
AGC.27610 PHASE II N/A YES NO
Are there documented procedures for operation, calibration, and function checks of all blood gas instruments?
COMMENTARY:
PROCEDURES FOR THE OPERATION, CALIBRATION, AND ROUTINE CHECKING OF THE INSTRUMENT MUST BE DOCUMENTED AND AVAILABLE AT THE WORK-BENCHWORKBENCH.
AGC.27620 PHASE II N/A YES NO
Are the materials used for calibration of the pH, CO2, and O2 sensors either in conformance with the instrument manufacturer's specifications or traceable to NIST Standard Reference Materials?
COMMENTARY:
THE MATERIALS USED FOR CALIBRATION OF THE PH, CO2, AND O2 ELECTRODES MUST BE IN CONFORMANCE WITH THE INSTRUMENT MANUFACTURER'S SPECIFICATIONS OR TRACEABLE TO NIST STANDARDS.
AGC.27630 PHASE II N/A YES NO
Is the calibration rechecked periodically throughout the day utilizing barometric pressure (appropriate for the frequency of use)?
NOTE: Calibration must be performed at a frequency no less than that recommended by the manufacturer.
COMMENTARY:
INSTRUMENTS USED CONTINUALLY MUST BE RECALIBRATED PERIODICALLY THROUGHOUT THE DAY. INSTRUMENTS USED INFREQUENTLY MUST BE RECALIBRATED EACH TIME OF USE. SOME INSTRUMENTS ARE SELF-CALIBRATING; HOWEVER, THERE MUST BE SOME DEFINED PROCEDURE FOR VERIFYING THE RELIABILITY OF THIS PROCESS. FOR ALL INSTRUMENTS, CALIBRATION AND CALIBRATION VERIFICATION MUST BE PERFORMED ACCORDING TO MANUFACTURER'S SPECIFICATIONS WITH AT LEAST THE FREQUENCY RECOMMENDED BY THE MANUFACTURER.
AGC.27640 PHASE II N/A YES NO
Are at least 2 levels of quality control specimens (tonometered samples or liquid control materials) analyzed at least every 8 hours of operation for all parameters when patient specimens are tested?
COMMENTARY:
AT LEAST 2 LEVELS OF QUALITY CONTROL SPECIMENS (TONOMETERED SAMPLES OR LIQUID CONTROL MATERIALS) MUST BE ANALYZED AT LEAST EVERY 8 HOURS OF OPERATION FOR ALL PARAMETERS WHEN PATIENT SPECIMENS ARE TESTED.
REFERENCES: 1) National Committee for Clinical Laboratory StandardsNCCLS. Blood gas preanalytical considerations: specimen collection, calibration, and controls; approved guideline C27-A. Wayne, PA: NCCLS, 1993; 2) National Committee for Clinical Laboratory StandardsNCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998.
AGC.27650 Phase II N/A YES NO
Do the control materials cover the analytical measurement range of the analyzer?
COMMENTARY:
BLOOD GAS CONTROLS MUST COVER THE ANALYTIC MEASUREMENT RANGE OF THE ANALYZER.
REFERENCES: 1) National Committee for Clinical Laboratory StandardsNCCLS. Blood gas preanalytical considerations: specimen collection, calibration, and controls; approved guideline C27-A. Wayne, PA: NCCLS, 1993; 2) National Committee for Clinical Laboratory StandardsNCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998; 3) Ng VL, et al. The rise and fall of i-STAT point-of-care blood gas testing in an acute care hospital. Arch Pathol Lab Med. 2000;114:128-138.
AGC.27660 Phase I N/A YES NO
Is at least one control or calibrator sample included each time patient specimens are tested, unless automated instruments internally calibrate at least once every 30 minutes of use?
COMMENTARY:
UNLESS THE BLOOD GAS ANALYZER INTERNALLY RECALIBRATES ITSELF AT LEAST ONCE EVERY 30 MINUTES, AT LEAST ONE CONTROL OR CALIBRATOR SAMPLE SHOULD BE INCLUDED EACH TIME PATIENT SPECIMENS ARE TESTED.
REFERENCES: 1) National Committee for Clinical Laboratory StandardsNCCLS. Blood gas preanalytical considerations: specimen collection, calibration, and controls; approved guideline C27-A. Wayne, PA: NCCLS, 1993; 2) National Committee for Clinical Laboratory StandardsNCCLS. Statistical quality control for quantitative measurements: principles and definitions - second edition; approved guideline C24-A2. Wayne, PA: NCCLS, 1998.
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Colorimeters and Spectrophotometers
.................................................................
TOX.27710 Phase II N/A YES NO
Are absorbance and linearity checked periodically with filters or standard solutions, if required by the instrument manufacturer?
COMMENTARY:
COLORIMETER/SPECTROPHOTOMETER ABSORBANCE AND LINEARITY MUST BE CHECKED PERIODICALLY WITH FILTERS OR STANDARD SOLUTIONS, IF SO SPECIFIED BY THE INSTRUMENT MANUFACTURER.
TOX.27730 Phase II N/A YES NO
Is the spectrophotometer wavelength calibration checked regularly with appropriate solutions, filters or emission line source lamps, (if required by the instrument manufacturer), and are the results documented?
COMMENTARY:
THE WAVELENGTH CALIBRATION OF SPECTROPHOTOMETERS MUST BE CHECKED REGULARLY WITH APPROPRIATE SOLUTIONS, FILTERS OR EMISSION LINE SOURCE LAMPS, IF SO SPECIFIED BY THE INSTRUMENT MANUFACTURER. RESULTS MUST BE DOCUMENTED.
TOX.27740 Phase II N/A YES NO
Is stray light checked periodically with extinction filters or appropriate solutions, if required by the instrument manufacturer?
COMMENTARY:
STRAY LIGHT MUST BE CHECKED PERIODICALLY WITH EXTINCTION FILTERS OR APPROPRIATE SOLUTIONS, IF SO SPECIFIED BY THE INSTRUMENT MANUFACTURER.
TOX.27750 Phase II N/A YES NO
For procedures using calibration curves, are all the curves rerun regularly and/or verified after servicing or recalibration of instruments?
COMMENTARY:
CALIBRATION CURVES MUST BE CHECKED (RERUN OR VERIFIED) AFTER SERVICING OR RECALIBRATION OF SPECTROPHOTOMETERS AND COLORIMETERS.
.................................................................
Atomic Absorption Spectrophotometers
.................................................................
TOX.27810 PHASE II N/A YES NO
Are routine function checks defined, performed, and recorded on each day of use?
COMMENTARY:
ROUTINE FUNCTION CHECKS MUST BE CLEARLY DEFINED, CONDUCTED, AND RECORDED EACH DAY OF USE FOR THE ATOMIC ABSORPTION SPECTROPHOTOMETER.
TOX.27820 Phase II N/A YES NO
Is the burner head and aspirator flushed thoroughly with water each day of use?
COMMENTARY:
THE BURNER HEAD AND ASPIRATOR MUST BE FLUSHED THOROUGHLY WITH WATER EACH DAY OF USE.
TOX.27830 Phase II N/A YES NO
Is the optical beam alignment checked regularly (at least weekly), and are results recorded?
COMMENTARY:
THE ALIGNMENT OF THE OPTICAL BEAM MUST BE CHECKED REGULARLY (AT LEAST WEEKLY), AND RESULTS RECORDED.
TOX.27840 Phase II N/A YES NO
Is the atomizer cleaned and flow rate optimized at regular, specified intervals, and are the results recorded?
COMMENTARY:
THE ATOMIZER MUST BE CLEANED AND FLOW RATE OPTIMIZED AT REGULAR, SPECIFIED INTERVALS, AND RESULTS RECORDED.
TOX.27850 Phase II N/A YES NO
Are automatic sampler systems (e.g., on graphite furnace) checked for precision at specified periodic intervals?
COMMENTARY:
AUTOMATIC SAMPLER SYSTEMS (E.G., ON GRAPHITE FURNACES) MUST BE CHECKED FOR PRECISION AT SPECIFIED PERIODIC INTERVALS.
.................................................................
Immunoassays/Immunoanalyzers
.................................................................
TOX.27870 Phase II N/A YES NO
If immunoassay reagents are NOT used according to instrument and/or kit manufacturer's instructions, are there validation data to support that modifications produce reliable results consistent with the original assay claims of the kit manufacturer?
NOTE: It is not required that the modified assay show equivalent reaction characteristics (i.e., assay signal response) but the laboratory must validate the original assay's claims of sensitivity and specificity for the detection of the target analyte. If all assays follow manufacturer's instructions, mark this question "N/A."
COMMENTARY:
FOR MODIFICATIONS SUCH AS DILUTION ENRICHMENTS, THERE MUST BE VALIDATION DATA TO SUPPORT THAT THE MODIFICATION IS EQUIVALENT TO KIT MANUFACTURERS' ORIGINAL ASSAY CLAIMS.
TOX.27880 Phase II N/A YES NO
Are appropriate calibrators and controls used in each run or batch of samples?
NOTE: Appropriate calibrators for screening assays should consist of at least one calibrator or calibration standard in each analysis. If only one calibrator or calibration standard is used, it must be at the cutoff value. Quantitative assays should use appropriate calibrators to properly characterize the immunoassay's non-linear response (or follow directions for calibration supplied by the kit manufacturer). Appropriate quality controls must include a negative control and at least one positive control (near the assay cutoff value) for qualitative assays. For quantitative assays, 2 positive controls must be used that should challenge the reportable test range or be at critical decision points.
COMMENTARY:
SPECIFIED APPROPRIATE CALIBRATORS AND CONTROLS ARE NOT USED IN EACH RUN OR BATCH OF SAMPLES. APPROPRIATE CALIBRATORS FOR SCREENING ASSAYS SHOULD CONSIST OF AT LEAST ONE CALIBRATOR OR CALIBRATION STANDARD IN EACH ANALYSIS. IF ONLY ONE CALIBRATOR OR CALIBRATION STANDARD IS USED, IT MUST BE AT THE CUTOFF VALUE. QUANTITATIVE ASSAYS SHOULD USE APPROPRIATE CALIBRATORS TO PROPERLY CHARACTERIZE THE IMMUNOASSAY'S NON-LINEAR RESPONSE (OR FOLLOW DIRECTIONS FOR CALIBRATION SUPPLIED BY THE KIT MANUFACTURER). APPROPRIATE QUALITY CONTROLS MUST INCLUDE A NEGATIVE CONTROL AND AT LEAST ONE POSITIVE CONTROL (NEAR THE ASSAY CUTOFF VALUE) FOR QUALITATIVE ASSAYS. FOR QUANTITATIVE ASSAYS, 2 POSITIVE CONTROLS MUST BE USED THAT SHOULD CHALLENGE THE REPORTABLE TEST RANGE OR BE AT CRITICAL DECISION POINTS.
TOX.27890 Phase II N/A YES NO
If automatic pipetting is used, has the laboratory evaluated the testing system for carryover effects?
NOTE: The laboratory must have a procedure in place for evaluating whether carryover effects are present. One suggested method is to run known high samples (calibrators, standards, reference material, assayed controls), followed by known low samples to see if the results of the low-level material are affected. If carryover is detected, the laboratory must determine the level past which low-level samples are affected and this must be defined in the procedure. Results of each analytical run must be reviewed to ensure that no results exceed this level. If results that exceed the defined level are detected, then the appropriate course of action must be defined (repeat subsequent samples, for example).
COMMENTARY:
WHEN AUTOMATIC PIPETTING IS USED, THE LABORATORY MUST HAVE A PROCEDURE FOR EVALUATING WHETHER CARRYOVER EFFECTS ARE PRESENT. ONE SUGGESTED METHOD IS TO RUN KNOWN HIGH SAMPLES (CALIBRATORS, STANDARDS, REFERENCE MATERIAL, ASSAYED CONTROLS), FOLLOWED BY KNOWN LOW SAMPLES TO SEE IF THE RESULTS OF THE LOW-LEVEL MATERIAL ARE AFFECTED. IF CARRYOVER IS DETECTED, THE LABORATORY MUST DETERMINE THE LEVEL PAST WHICH LOW-LEVEL SAMPLES ARE AFFECTED AND THIS MUST BE DEFINED IN THE PROCEDURE. RESULTS OF EACH ANALYTICAL RUN MUST BE REVIEWED TO ENSURE THAT NO RESULTS EXCEED THIS LEVEL. IF RESULTS THAT EXCEED THE DEFINED LEVEL ARE DETECTED, THEN THE APPROPRIATE COURSE OF ACTION MUST BE DEFINED (REPEAT SUBSEQUENT SAMPLES, FOR EXAMPLE).
TOX.27900 Phase II N/A YES NO
Are spectrophotometers (if part of an immunoanalyzer) calibrated appropriately (if necessary as directed by the instrument manufacturer), and results documented?
COMMENTARY:
THE WAVELENGTH CALIBRATION OF SPECTROPHOTOMETERS MUST BE CHECKED REGULARLY (IF REQUIRED BY THE MANUFACTURER) WITH APPROPRIATE SOLUTIONS, FILTERS, OR EMISSION LINE SOURCE LAMPS, AND RESULTS DOCUMENTED.
TOX.27920 Phase II N/A YES NO
Are gamma counters and/or scintillation counters calibrated, results recorded and compared to previous values each day of use?
COMMENTARY:
THERE MUST BE RECORDS OF RADIOISOTOPE CALIBRATIONS, INCLUDING COMPARISONS WITH PREVIOUS VALUES.
TOX.27930 Phase II N/A YES NO
Is the background radioactivity determined each day of use, including the background in each well of a multi-well counter?
COMMENTARY:
THE BACKGROUND RADIOACTIVITY (INCLUDING THE BACKGROUND IN EACH WELL) OF A MULTI-WELL COUNTER MUST BE DETERMINED ON EACH DAY OF USE.
.................................................................
Thin Layer Chromatography (TLC)
.................................................................
TOX.27950 PHASE II N/A YES NO
Are appropriate standards included on each TLC plate?
NOTE: Appropriate standards must include drugs/compounds that test the chromatographic range of the TLC plate, and that test all phases of the staining/development system. This may consist of a standard solution or dot that contains multiple drug/compound standards.
COMMENTARY:
APPROPRIATE STANDARDS MUST BE INCLUDED ON EACH TLC PLATE. APPROPRIATE STANDARDS MUST INCLUDE DRUGS/COMPOUNDS THAT TEST THE CHROMATOGRAPHIC RANGE OF THE TLC PLATE, AND THAT TEST ALL PHASES OF THE STAINING/DEVELOPMENT SYSTEM. THIS MAY CONSIST OF A STANDARD SOLUTION OR DOT THAT CONTAINS MULTIPLE DRUG/COMPOUND STANDARDS.
TOX.27960 Phase II N/A YES NO
Is an appropriate negative and positive control extracted and run through the entire procedure for each run?
COMMENTARY:
AN APPROPRIATE NEGATIVE AND POSITIVE CONTROL MUST BE EXTRACTED AND RUN THROUGH THE ENTIRE PROCEDURE.
REFERENCE: Department of Health and Human Services, Health Care Financing Administration. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Fed Register. 1993(Jan 19):5232 [42CFR493.1218(b)(1)].
TOX.27970 PHASE II N/A YES NO
Are solvents prepared fresh as needed?
NOTE: If a mixture of solvents is used, certain components will evaporate with time faster than others. This leads to poor reproducibility of migration rates. If a commercial kit is used, the manufacturer's instructions should be followed.
COMMENTARY:
SOLVENTS MUST BE PREPARED FRESH AS NEEDED. IF A MIXTURE OF SOLVENTS IS USED, CERTAIN COMPONENTS WILL EVAPORATE WITH TIME FASTER THAN OTHERS. THIS LEADS TO POOR REPRODUCIBILITY OF MIGRATION RATES. IF THE LABORATORY USES A COMMERCIAL KIT, THE MANUFACTURER'S INSTRUCTIONS SHOULD BE FOLLOWED.
................................................................
Gas Chromatography
.................................................................
TOX.28010 PHASE II N/A YES NO
Are appropriate calibrators or standards run with each analytic batch?
NOTE: For qualitative assays, an appropriate calibrator should be run at a level near the assay's limit of detection (LOD) or at critical decision point(s) (i.e., toxic level). For quantitative assays, at least one calibrator must be run that is within the assay's reportable linear range.
COMMENTARY:
APPROPRIATE CALIBRATORS OR STANDARDS MUST BE RUN WITH EACH ANALYTIC BATCH. FOR QUALITATIVE ASSAYS, AN APPROPRIATE CALIBRATOR SHOULD BE RUN AT A LEVEL NEAR THE ASSAY'S LIMIT OF DETECTION OR AT CRITICAL DECISION POINT(S) (I.E., TOXIC LEVEL). FOR QUANTITATIVE ASSAYS, AT LEAST ONE CALIBRATOR MUST BE RUN THAT IS WITHIN THE ASSAY'S REPORTABLE LINEAR RANGE.
TOX.28020 Phase II N/A YES NO
Are internal standards used in each assay?
COMMENTARY:
INTERNAL STANDARDS MUST BE USED IN EACH ASSAY.
TOX.28030 Phase II N/A YES NO
Is a control sample included in each batch analysis?
NOTE: For qualitative assays, appropriate controls must include at least a negative and a positive sample. The positive sample may be at a concentration near the assay's LOD or may be at another critical decision point, (e.g., toxic level). For quantitative assays, appropriate controls must include a negative control and at least 2 positive controls that should test the reportable assay range.
COMMENTARY:
A CONTROL SAMPLE MUST BE INCLUDED IN EACH BATCH ANALYSIS. FOR QUALITATIVE ASSAYS, APPROPRIATE CONTROLS MUST INCLUDE AT LEAST A NEGATIVE AND A POSITIVE SAMPLE. THE POSITIVE SAMPLE MAY BE AT A CONCENTRATION NEAR THE ASSAY'S LIMIT OF DETECTION OR MAY BE AT ANOTHER CRITICAL DECISION POINT, (E.G., TOXIC LEVEL). FOR QUANTITATIVE ASSAYS, APPROPRIATE CONTROLS MUST INCLUDE A NEGATIVE CONTROL AND AT LEAST 2 POSITIVE CONTROLS THAT SHOULD TEST THE REPORTABLE ASSAY RANGE.
TOX.28040 Phase I N/A YES NO
If a hydrolysis step is required in the assay, does the laboratory include a control (when available) with each batch to evaluate the effectiveness of hydrolysis?
COMMENTARY:
THE LABORATORY SHOULD INCLUDE A HYDROLYSIS CONTROL (WHEN AVAILABLE) IN EACH ANALYTIC BATCH ANALYSIS.
TOX.28050 Phase II N/A YES NO
Are sample run order, chromatographic peak shape, retention time, detector response for calibrators, controls and unknowns recorded and maintained for review?
COMMENTARY:
THE SAMPLE RUN ORDER, CHROMATOGRAPHIC PEAK SHAPE, RETENTION TIME, AND DETECTOR RESPONSE FOR CALIBRATORS, CONTROLS, AND UNKNOWNS MUST BE RECORDED AND MAINTAINED FOR REVIEW.
TOX.28060 Phase II N/A YES NO
Whether an automatic sampler is used or there is manual injection, are there criteria for the detection of potential carryover in each analytical batch run?
COMMENTARY:
NO MATTER WHAT TYPE OF INJECTION IS USED, THE PROCEDURE MUST ADDRESS CRITERIA FOR THE EVALUATION OF POTENTIAL CARRYOVER FROM A PRECEDING ELEVATED (HIGH CONCENTRATION) TO THE FOLLOWING SAMPLE IN EACH ANALYTICAL BATCH ANALYSIS.
TOX.28070 Phase I N/A YES NO
Are new columns verified for performance before being used?
COMMENTARY:
NEW COLUMNS SHOULD BE VERIFIED FOR PERFORMANCE BEFORE BEING USED.
TOX.28080 Phase II N/A YES NO
Are procedures documented for operation, calibration, and maintenance?
COMMENTARY:
PROCEDURES MUST BE DOCUMENTED FOR OPERATION, CALIBRATION, AND MAINTENANCE.
TOX.28090 Phase II N/A YES NO
Does the documented procedure require analysis of unextracted standard(s) on each day of use to monitor the performance of the column and detector?
NOTE: An unextracted standard(s), typically containing the target compound(s) of interest must be analyzed on each day of use to monitor critical aspects of the GC performance (e.g., absolute or relative retention times, chromatography quality, detector response intensity). Appropriate criteria used for evaluating this standard must be developed and used to determine acceptability of instrument performance. These records must be kept as part of the instrument's maintenance records.
COMMENTARY:
THE LABORATORY MUST ANALYZE AN UNEXTRACTED STANDARD(S), TYPICALLY CONTAINING THE TARGET COMPOUND(S) OF INTEREST ON EACH DAY OF USE TO MONITOR CRITICAL ASPECTS OF GC PERFORMANCE (E.G., ABSOLUTE OR RELATIVE RETENTION TIMES, CHROMATOGRAPHY QUALITY, DETECTOR RESPONSE INTENSITY). APPROPRIATE CRITERIA USED FOR EVALUATING THIS STANDARD MUST BE DEVELOPED AND USED TO DETERMINE ACCEPTABILITY OF INSTRUMENT PERFORMANCE. THESE RECORDS MUST BE KEPT AS PART OF THE INSTRUMENT'S MAINTENANCE RECORDS.
TOX.28100 PHASE II N/A YES NO
Is the need for routine maintenance assessed on each day of use (e.g., tank pressures, flow rates, septum changes, column changes)?
COMMENTARY:
THE NEED FOR ROUTINE GAS CHROMATOGRAPHY MAINTENANCE MUST BE ASSESSED ON EACH DAY OF USE. TYPICAL ITEMS INCLUDE, BUT ARE NOT LIMITED TO, TANK PRESSURES, FLOW RATES, SEPTUM CHANGES, AND COLUMN CHANGES.
TOX.28120 Phase I N/A YES NO
Are gas lines checked regularly for leaks?
COMMENTARY:
GAS LINES SHOULD BE CHECKED REGULARLY FOR LEAKS.
TOX.28130 Phase II N/A YES NO
Are reagents and solvents of appropriate grade for the purpose intended in use?
COMMENTARY:
REAGENTS AND SOLVENTS MUST BE OF THE APPROPRIATE GRADE FOR THE PURPOSE INTENDED IN USE.
TOX.28150 Phase II N/A YES NO
Are retention times checked periodically and after major instrument maintenance by running appropriate standards?
COMMENTARY:
RETENTION TIMES MUST BE CHECKED BY RUNNING APPROPRIATE STANDARDS, BOTH PERIODICALLY AND AFTER MAJOR INSTRUMENT MAINTENANCE.
----------------------------------------------------------------
Mass Spectrometry
-----------------------------------------------------------------
TOX.28210 PHASE II N/A YES NO
Are procedures documented for operation, calibration, and maintenance of the mass spectrometer?
COMMENTARY:
PROCEDURES MUST BE DOCUMENTED FOR OPERATION, CALIBRATION, AND MAINTENANCE OF MASS SPECTROMETRY EQUIPMENT.
TOX.28220 Phase II N/A YES NO
Does the documented procedure require analysis of an unextracted standard(s) on each day of use to monitor the performance of the column and detector?
NOTE: An unextracted standard(s), typically containing the target compound(s) of interest must be analyzed each day of use to monitor critical aspects of the GC/MS performance (i.e., absolute or relative retention times, chromatography quality, detector response intensity, etc). Appropriate criteria used for evaluating this standard must be developed and used to determine the acceptability of the instrument's performance. These records must be kept as part of the instrument's maintenance records.
COMMENTARY:
THE LABORATORY MUST ANALYZE AN UNEXTRACTED STANDARD EACH DAY OF INSTRUMENT USE TO MONITOR CRITICAL ASPECTS OF GC/MS PERFORMANCE (E.G., ABSOLUTE OR RELATIVE RETENTION TIMES, CHROMATOGRAPHY QUALITY, DETECTOR RESPONSE INTENSITY). APPROPRIATE CRITERIA USED FOR EVALUATING THIS STANDARD MUST BE DEVELOPED AND USED TO DETERMINE THE ACCEPTABILITY OF THE INSTRUMENT'S PERFORMANCE. THESE RECORDS MUST BE KEPT AS PART OF THE INSTRUMENT'S MAINTENANCE RECORDS.
TOX.28230 Phase II N/A YES NO
Is regularly scheduled maintenance of mass spectrometers performed as recommended by the manufacturer?
COMMENTARY:
MASS SPECTROMETERS MUST BE MAINTAINED AS RECOMMENDED BY THE MANUFACTURER. IF THE MASS SPECTROMETERS ARE MAINTAINED USING DIFFERENT CRITERIA THAN SUGGESTED BY THE MANUFACTURER, THE BASIS FOR THIS CHANGE MUST BE DOCUMENTED.
TOX.28240 Phase II N/A YES NO
Are the mass spectrometers tuned each day of patient testing, have acceptable tolerance limits for tune parameters been defined, and are tune records maintained?
COMMENTARY:
MASS SPECTROMETERS MUST BE TUNED EITHER MANUALLY OR AUTOMATICALLY FOR EACH DAY OF PATIENT TESTING, THERE MUST BE TOLERANCE LIMITS, AND TUNE RECORDS MAINTAINED.
TOX.28250 Phase II N/A YES NO
Are appropriate calibrators or standards run with each analytical batch run?
NOTE: For qualitative assays, an appropriate calibrator may be run at a level near the assay's LOD or at critical decision point(s) (e.g., toxic level). For quantitative assays, at least one calibrator must be run that is within the assay's reportable linear range.
COMMENTARY:
APPROPRIATE CALIBRATOR(S)/STANDARD(S) MUST BE RUN WITH EACH ANALYTICAL BATCH ANALYSIS. FOR QUALITATIVE ASSAYS, AN APPROPRIATE CALIBRATOR MAY BE RUN AT A LEVEL NEAR THE ASSAY'S LIMIT OF DETECTION OR AT CRITICAL DECISION POINT(S) (E.G., TOXIC LEVEL). FOR QUANTITATIVE ASSAYS, AT LEAST ONE CALIBRATOR MUST BE RUN THAT IS WITHIN THE ASSAY'S REPORTABLE LINEAR RANGE.
TOX.28260 Phase II N/A YES NO
Are internal standards used in each assay run?
NOTE: The use of deuterated internal standards of target compounds may be very helpful in quantitative assays.
COMMENTARY:
INTERNAL STANDARDS MUST BE USED IN EACH ASSAY. THE USE OF DEUTERATED INTERNAL STANDARDS OF TARGET COMPOUNDS MAY BE VERY HELPFUL IN QUANTITATIVE ASSAYS.
TOX.28270 PHASE II N/A YES NO
Are appropriate control samples included in each batch analysis?
NOTE: For qualitative assays, appropriate controls must include at least a negative and a positive sample. The positive sample may be at a concentration near the assay's LOD or may be at another critical decision point (e.g., toxic level). For quantitative assays, appropriate controls must include a negative control and at least 2 positive controls that test the reportable assay range.
COMMENTARY:
CONTROL SAMPLES MUST BE INCLUDED IN EACH RUN. FOR QUALITATIVE ASSAYS, APPROPRIATE CONTROLS MUST INCLUDE AT LEAST A NEGATIVE AND A POSITIVE SAMPLE. THE POSITIVE SAMPLE MAY BE AT A CONCENTRATION NEAR THE ASSAY'S LIMIT OF DETECTION OR MAY BE AT ANOTHER CRITICAL DECISION POINT (E.G., TOXIC LEVEL). FOR QUANTITATIVE ASSAYS, APPROPRIATE CONTROLS MUST INCLUDE A NEGATIVE CONTROL AND AT LEAST 2 POSITIVE CONTROLS THAT TEST THE REPORTABLE ASSAY RANGE.
TOX.28280 Phase I N/A YES NO
If a hydrolysis step is required in the assay, does the laboratory include a control (when available) with each batch to evaluate the effectiveness of hydrolysis?
COMMENTARY:
THE LABORATORY SHOULD INCLUDE A HYDROLYSIS CONTROL (WHEN AVAILABLE) IN EACH ANALYTIC BATCH ANALYSIS.
TOX.28300 Phase II N/A YES NO
For mass spectrometric identifications by ion ratios, are sample run order, chromatographic peak shape, retention time, and spectral data for calibrators, controls, and unknowns recorded and maintained for review?
COMMENTARY:
THE SAMPLE RUN ORDER, CHROMATOGRAPHIC PEAK SHAPE, RETENTION TIME, AND SPECTRAL DATA FOR CALIBRATORS, CONTROLS, AND UNKNOWNS MUST BE RECORDED AND MAINTAINED FOR REVIEW.
TOX.28320 Phase II N/A YES NO
For mass spectrometric identifications by total spectra, are the identification criteria using either ion ratios or total spectra in compliance with recommendations?
NOTE: Acceptable criteria for compound identification using ion ratios is that the unknown result must have ion ratios within ± 20% of the standard(s)/calibrator(s). Identification using ion ratios usually requires the use of at least 2 ion ratios; however, one ion ratio of 2 characteristic ions may be acceptable if few high abundance ions are generated by the MS. The internal standard's identification should be monitored with at least one ion ratio. Acceptable criteria for compound identification using total spectra is that the unknown result must have a "spectral match" quality or fit that is within the defined limits that the laboratory has set and validated. Ion ratios determined from total spectra analysis is an acceptable identification method and should fulfill the same criteria as given above for ion ratio identifications.
COMMENTARY:
MASS SPECTRAL IDENTIFICATION CRITERIA MUST COMPLY WITH RECOMMENDATIONS. ACCEPTABLE CRITERIA FOR COMPOUND IDENTIFICATION USING ION RATIOS IS THAT THE UNKNOWN RESULT MUST HAVE ION RATIOS WITHIN ± 20% OF THE STANDARD(S)/CALIBRATOR(S). IDENTIFICATION USING ION RATIOS USUALLY REQUIRES THE USE OF AT LEAST 2 ION RATIOS; HOWEVER, ONE ION RATIO OF 2 CHARACTERISTIC IONS MAY BE ACCEPTABLE IF FEW HIGH ABUNDANCE IONS ARE GENERATED BY THE MS. THE INTERNAL STANDARD'S IDENTIFICATION SHOULD BE MONITORED WITH AT LEAST ONE ION RATIO. ACCEPTABLE CRITERIA FOR COMPOUND IDENTIFICATION USING TOTAL SPECTRA IS THAT THE UNKNOWN RESULT MUST HAVE A "SPECTRAL MATCH" QUALITY OR FIT THAT IS WITHIN THE DEFINED LIMITS THAT THE LABORATORY HAS SET AND VALIDATED. ION RATIOS DETERMINED FROM TOTAL SPECTRA ANALYSIS IS AN ACCEPTABLE IDENTIFICATION METHOD AND SHOULD FULFILL THE SAME CRITERIA AS GIVEN ABOVE FOR ION RATIO IDENTIFICATIONS.
TOX.28330 PHASE II N/A YES NO
Whether an automatic sampler is used or there is manual injection, are there criteria for the detection of carryover?
COMMENTARY:
NO MATTER WHAT TYPE OF INJECTION IS USED, THE PROCEDURE MUST DISCUSS CRITERIA FOR THE EVALUATION OF CARRYOVER FROM A PRECEDING ELEVATED (HIGH CONCENTRATION) SAMPLE TO THE FOLLOWING SAMPLE.
.................................................................
High Performance Liquid Chromatography (HPLC)
.................................................................
TOX.28350 PHASE II N/A YES NO
Are HPLC-grade reagents and Type I reagent grade water used?
COMMENTARY:
HPLC-GRADE REAGENTS AND TYPE I WATER MUST BE USED FOR HIGH PERFORMANCE LIQUID CHROMATOGRAPHY ASSAYS.
TOX.28360 Phase II N/A YES NO
Are appropriate calibrators or standards run with each analytical batch run?
NOTE: For qualitative assays, an appropriate calibrator may be run at a level near the assay LOD or at critical decision point(s) (e.g., toxic level). For quantitative assays, at least one calibrator must be run that must be within the assay's reportable linear range.
COMMENTARY:
APPROPRIATE CALIBRATOR(S)/STANDARD(S) MUST BE RUN WITH EACH ANALYTICAL BATCH ANALYSIS TO ENSURE OPTIMAL PERFORMANCE. FOR QUALITATIVE ASSAYS, AN APPROPRIATE CALIBRATOR MAY BE RUN AT A LEVEL NEAR THE ASSAY'S LIMIT OF DETECTION OR AT CRITICAL DECISION POINT(S) (E.G., TOXIC LEVEL). FOR QUANTITATIVE ASSAYS, AT LEAST ONE CALIBRATOR MUST BE RUN THAT MUST BE WITHIN THE ASSAY'S REPORTABLE LINEAR RANGE.
TOX.28370 Phase II N/A YES NO
Are appropriate control samples included in each batch analysis?
NOTE: For qualitative assays, appropriate controls must include at least a negative and a positive sample. The positive sample may be at a concentration near the assay's LOD or may be at another critical decision point (e.g., toxic level). For quantitative assays, appropriate controls must include a negative control and at least 2 positive controls that test the reportable assay range.
COMMENTARY:
APPROPRIATE CONTROL SAMPLES MUST BE INCLUDED IN EACH BATCH ANALYSIS. FOR QUALITATIVE ASSAYS, APPROPRIATE CONTROLS MUST INCLUDE AT LEAST A NEGATIVE AND A POSITIVE SAMPLE. THE POSITIVE SAMPLE MAY BE AT A CONCENTRATION NEAR THE ASSAY'S LIMIT OF DETECTION OR MAY BE AT ANOTHER CRITICAL DECISION POINT (E.G., TOXIC LEVEL). FOR QUANTITATIVE ASSAYS, APPROPRIATE CONTROLS MUST INCLUDE A NEGATIVE CONTROL AND AT LEAST 2 POSITIVE CONTROLS THAT TEST THE REPORTABLE ASSAY RANGE.
TOX.28380 Phase I N/A YES NO
If a hydrolysis step is required in the assay, does the laboratory include a control (when available) with each batch to evaluate the effectiveness of hydrolysis?
COMMENTARY:
THE LABORATORY SHOULD INCLUDE A HYDROLYSIS CONTROL (WHEN AVAILABLE) IN EACH ANALYTIC BATCH ANALYSIS.
TOX.28390 Phase II N/A YES NO
Are internal standards used where appropriate for each assay?
COMMENTARY:
INTERNAL STANDARDS MUST BE USED WHERE APPROPRIATE FOR EACH ASSAY.
TOX.28400 Phase II N/A YES NO
Are new columns verified for performance before being used?
COMMENTARY:
NEW COLUMNS MUST BE VERIFIED FOR PERFORMANCE BEFORE USE.
TOX.28410 Phase II N/A YES NO
Are procedures documented for operation, calibration, and maintenance?
COMMENTARY:
PROCEDURES MUST BE DOCUMENTED FOR OPERATION, CALIBRATION, AND MAINTENANCE.
TOX.28420 Phase II N/A YES NO
Does the documented procedure require analysis of an unextracted standard(s) each day of use to monitor the performance of the column and detector?
NOTE: An unextracted standard(s), typically containing the target compound(s) of interest must be analyzed each day of use to monitor critical aspects of HPLC performance (e.g., absolute or relative retention times, chromatography quality, detector response intensity). Appropriate criteria used for evaluating this standard must be developed and used to determine the acceptability of the instrument's performance. These records must be maintained as part of the instrument's maintenance records.
COMMENTARY:
THE LABORATORY MUST REQUIRE THE ANALYSIS OF AN UNEXTRACTED STANDARD EACH DAY OF INSTRUMENT USE. AN UNEXTRACTED STANDARD(S), TYPICALLY CONTAINING THE TARGET COMPOUND(S) OF INTEREST MUST BE ANALYZED EACH DAY OF USE TO MONITOR CRITICAL ASPECTS OF HPLC PERFORMANCE (E.G., ABSOLUTE OR RELATIVE RETENTION TIMES, CHROMATOGRAPHY QUALITY, DETECTOR RESPONSE INTENSITY). APPROPRIATE CRITERIA USED FOR EVALUATING THIS STANDARD MUST BE DEVELOPED AND USED TO DETERMINE THE ACCEPTABILITY OF THE INSTRUMENT'S PERFORMANCE. THESE RECORDS MUST BE MAINTAINED AS PART OF THE INSTRUMENT'S MAINTENANCE RECORDS.
TOX.28500 Phase II N/A YES NO
Whether an automatic sampler is used or there is manual injection, are there criteria for the detection of carryover?
COMMENTARY:
NO MATTER WHAT TYPE OF INJECTION IS USED, THE PROCEDURE MUST DISCUSS CRITERIA FOR THE EVALUATION OF CARRYOVER FROM A PRECEDING ELEVATED (HIGH CONCENTRATION) SAMPLE TO THE FOLLOWING SAMPLE.
TOX.29000 Phase II N/A YES NO
Is there evidence that the limit of detection (sensitivity) and the linearity for quantitative methods has been determined for each procedure?
COMMENTARY:
THERE MUST BE EVIDENCE THAT THE LIMIT OF DETECTION (SENSITIVITY) AND THE LINEARITY FOR QUANTITATIVE METHODS HAVE BEEN DETERMINED FOR EACH PROCEDURE.
.................................................................
Instrument Maintenance
.................................................................
Questions in this section apply to ALL instruments in the general/automated chemistry section. The procedures and schedules for instrument maintenance must be as thorough and as frequent as specified by the manufacturer.
TOX.27600 Phase II N/A YES NO
Are there documented standard procedures for setup, operation, and shutdown of instruments?
COMMENTARY:
PROCEDURES FOR SETUP, OPERATION, AND SHUTDOWN OF INSTRUMENT SYSTEMS MUST BE DOCUMENTED AND AVAILABLE TO THE OPERATOR.
AGC.27800 PHASE II N/A YES NO
Is there a schedule or system AVAILABLE AT THE INSTRUMENT for the regular checking of the critical operating characteristics for all instruments in use?
NOTE: This must include, but is not limited to electronic, mechanical, and operational checks. The procedure and schedule must be as thorough and as frequent as specified by the manufacturer. Any specific deficiencies must be identified in part B of the Inspector's Summation Report.
COMMENTARY:
THERE MUST BE A ROUTINE PLAN OR SCHEDULE AVAILABLE AT THE INSTRUMENT FOR THE REGULAR CHECKING OF THE CRITICAL OPERATING CHARACTERISTICS OF ALL THE INSTRUMENTS IN USE. THIS MUST INCLUDE, BUT IS NOT LIMITED TO ELECTRONIC, MECHANICAL, AND OPERATIONAL CHECKS. THE PROCEDURE AND SCHEDULE MUST BE AS THOROUGH AND AS FREQUENT AS SPECIFIED BY THE MANUFACTURER. FUNCTION CHECKS SHOULD BE DESIGNED TO CHECK THE CRITICAL OPERATING CHARACTERISTICS TO DETECT DRIFT, INSTABILITY, OR MALFUNCTION, BEFORE THE PROBLEM IS ALLOWED TO AFFECT TEST RESULTS. ALL SERVICING AND REPAIRS SHOULD BE DOCUMENTED. THE INSPECTOR SHOULD HAVE IDENTIFIED THE SPECIFIC INSTRUMENTS INVOLVED AT THE SUMMATION CONFERENCE.
AGC.27810 PHASE II N/A YES NO
Are there documented instructions for instrument check systems (i.e., manufacturer's manual or system prepared by the laboratory)?
COMMENTARY:
THERE MUST BE DOCUMENTED PROCEDURES FOR INSTRUMENT FUNCTION CHECKS.
AGC.27820 PHASE II N/A YES NO
Are instrument function checks documented BY THE TECHNICAL OPERATOR and readily available to detect trends or malfunctions?
COMMENTARY:
ROUTINE INSTRUMENT FUNCTION CHECKS MUST BE PERFORMED, DOCUMENTED, AND RECORDED BY THE TECHNICAL OPERATOR. THESE RECORDS MUST BE READILY AVAILABLE TO DETECT TRENDS OR MALFUNCTIONS.
AGC.27830 PHASE II N/A YES NO
Are tolerance limits for acceptable function documented for specific instruments wherever appropriate?
COMMENTARY:
TOLERANCE LIMITS FOR ACCEPTABLE FUNCTION OF SPECIFIC INSTRUMENTS MUST BE ESTABLISHED AND DOCUMENTED.
AGC.27840 PHASE II N/A YES NO
Are instructions provided for minor troubleshooting and repairs of instruments (such as manufacturer's service manual)?
COMMENTARY:
SERVICE MANUALS OR INSTRUCTIONS FOR MINOR TROUBLESHOOTING AND REPAIRS MUST BE AVAILABLE FOR MAJOR INSTRUMENTS.
AGC.27850 PHASE II N/A YES NO
Are records maintained AT OR NEAR each instrument to document all repairs and service procedures?
COMMENTARY:
A COMPLETE RECORD OF DATE OF PURCHASE, SERIAL NUMBER, AND ALL REPAIRS AND ROUTINE SERVICE PROCEDURES MUST BE MAINTAINED FOR ALL INSTRUMENTS AT OR NEAR EACH INSTRUMENT.
AGC.27860 PHASE II N/A YES NO
Are RECENT instrument maintenance, service, and repair records (or copies) promptly available to, and usable by, all technical staff operating the equipment on all shifts?
NOTE: The investigation of method failure begins with the bench technologist. Instrument records are essential to such investigations. Off-site storage, such as with centralized medical maintenance or computer files, is not precluded if the Inspector is satisfied that prompt retrieval exists.
COMMENTARY:
THE EFFECTIVE UTILIZATION OF INSTRUMENTS BY THE TECHNICAL STAFF DEPENDS UPON THE PROMPT AVAILABILITY OF MAINTENANCE, REPAIR, AND SERVICE DOCUMENTATION (COPIES ACCEPTABLE). THE LABORATORY PERSONNEL ARE RESPONSIBLE FOR THE RELIABILITY AND PROPER FUNCTION OF THEIR INSTRUMENTS AND MUST HAVE ACCESS TO THE INFORMATION ON ALL SHIFTS OF PATIENT TESTING.
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PERSONNEL
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AGC.30000 PHASE II N/A YES NO
Does the technical person in charge of automated chemistry have education and experience equivalent to an MT(ASCP) and at least 4 years experience (one of which must be in clinical chemistry) under a qualified Director?
COMMENTARY:
THE TECHNICAL PERSON IN CHARGE OF AUTOMATED/GENERAL CHEMISTRY MUST HAVE EDUCATION AND EXPERIENCE EQUIVALENT TO THAT OF AN MT(ASCP) AND AT LEAST 4 YEARS OF EXPERIENCE (ONE OF WHICH MUST BE IN CLINICAL CHEMISTRY) UNDER A QUALIFIED DIRECTOR.
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PHYSICAL FACILITIES
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Sufficient space and utilities need to be provided for the overall workload of the automated chemistry section, and to meet all safety requirements.
AGC.40000 PHASE I N/A YES NO
Is there adequate space for administrative functions?
COMMENTARY:
ADDITIONAL SPACE SHOULD BE PROVIDED FOR ADMINISTRATIVE FUNCTIONS.
AGC.40050 PHASE I N/A YES NO
Is there adequate space for clerical work?
COMMENTARY:
ADDITIONAL SPACE SHOULD BE PROVIDED FOR CLERICAL WORK.
AGC.40100 PHASE I N/A YES NO
Is there adequate space for technical work (bench space)?
COMMENTARY:
ADDITIONAL SPACE SHOULD BE PROVIDED FOR TECHNICAL WORK (BENCH SPACE).
AGC.40150 PHASE I N/A YES NO
Is there adequate space for instruments?
COMMENTARY:
ADDITIONAL SPACE SHOULD BE PROVIDED FOR INSTRUMENTS.
AGC.40200 PHASE I N/A YES NO
Is there adequate space for shelf storage?
COMMENTARY:
ADDITIONAL SPACE SHOULD BE PROVIDED FOR STORAGE FOR REAGENTS AND SUPPLIES.
AGC.40250 PHASE I N/A YES NO
Is there adequate refrigerator/freezer storage space?
COMMENTARY:
ADDITIONAL SPACE SHOULD BE PROVIDED FOR REFRIGERATOR/FREEZER STORAGE.
AGC.40300 PHASE I N/A YES NO
Is the available space efficiently utilized?
COMMENTARY:
EXISTING SPACE SHOULD BE USED MORE EFFICIENTLY.
AGC.40350 PHASE II N/A YES NO
Is the space available so there is no compromise of the quality of work, safety of personnel, or limitation of quality control activities?
COMMENTARY:
SPACE MUST BE IMPROVED. LIMITATIONS WERE SO SEVERE AS TO INTERFERE WITH THE QUALITY OF WORK, THE SAFETY OF PERSONNEL, AND/OR THE ABILITY OF PERSONNEL TO CARRY OUT ADEQUATE QUALITY CONTROL PROCEDURES WITH APPROPRIATE DOCUMENTATION.
AGC.40400 PHASE I N/A YES NO
Are floors and benches clean, free of clutter and well-maintained?
COMMENTARY:
FLOORS AND BENCHES WERE CLUTTERED OR OTHERWISE DETERIORATED. ADDITIONAL CLEANING AND MAINTENANCE PROCEDURES SHOULD BE IMPLEMENTED.
AGC.40450 PHASE I N/A YES NO
Are water taps, sinks, and drains adequate?
COMMENTARY:
WATER TAPS, SINKS, AND DRAINS SHOULD BE IMPROVED TO SUPPORT THE TYPES OF PROCEDURES AND WORKLOAD OF THE LABORATORY.
AGC.40500 PHASE I N/A YES NO
Is emergency power adequate?
COMMENTARY:
EMERGENCY POWER SHOULD BE IMPROVED TO SUPPORT THE TYPES OF PROCEDURES AND WORKLOAD OF THE LABORATORY.
AGC.40550 PHASE I N/A YES NO
Are electrical outlets adequate?
COMMENTARY:
ELECTRICAL OUTLETS SHOULD BE IMPROVED TO SUPPORT THE TYPES OF PROCEDURES AND WORKLOAD OF THE LABORATORY.
AGC.40600 PHASE I N/A YES NO
Is ventilation adequate?
COMMENTARY:
VENTILATION SHOULD BE IMPROVED TO SUPPORT THE TYPES OF PROCEDURES AND WORKLOAD OF THE LABORATORY.
AGC.40650 PHASE I N/A YES NO
Is lighting adequate?
NOTE: A minimum average illumination of 40-foot candles measured at 30 inches above the floor should be maintained in any area where printed material must be read by employees in the customary performance of their normal function. Direct sunlight should be avoided because of its extreme variability and the need for low light levels necessary to observe various computer consoles, etc. Lighting control should be sectionalized so general levels of illumination can be controlled in areas of the room if desired.
COMMENTARY:
LIGHTING SHOULD BE IMPROVED. A MINIMUM AVERAGE ILLUMINATION OF 40-FOOT CANDLES MEASURED AT 30 INCHES ABOVE THE FLOOR SHOULD BE MAINTAINED IN ANY AREA WHERE PRINTED MATERIAL MUST BE READ BY EMPLOYEES IN THE CUSTOMARY PERFORMANCE OF THEIR NORMAL FUNCTION. DIRECT SUNLIGHT SHOULD BE AVOIDED BECAUSE OF ITS EXTREME VARIABILITY AND THE NEED FOR LOW LIGHT LEVELS NECESSARY TO OBSERVE VARIOUS COMPUTER CONSOLES, ETC. LIGHTING CONTROL SHOULD BE SECTIONALIZED SO GENERAL LEVELS OF ILLUMINATION CAN BE CONTROLLED IN AREAS OF THE ROOM IF DESIRED.
REFERENCE: College of American Pathologists. Medical laboratory planning and design. Northfield, IL: CAP, 1986.
AGC.40700 PHASE I N/A YES NO
Is temperature/humidity control adequate?
COMMENTARY:
TEMPERATURE/HUMIDITY CONTROL SHOULD BE IMPROVED TO SUPPORT THE TYPES OF PROCEDURES AND WORKLOAD OF THE LABORATORY.
AGC.40800 PHASE I N/A YES NO
Are telephones conveniently located, and are calls easily transferred?
COMMENTARY:
TELEPHONES (NUMBER AND/OR LOCATION) SHOULD BE IMPROVED TO SUPPORT THE TYPES OF PROCEDURES AND WORKLOAD OF THE LABORATORY.
AGC.40850 PHASE II N/A YES NO
Is there evidence of remedial actions to correct undesirable environmental conditions and/or inadequate utilities noted at the last on-site inspection?
COMMENTARY:
UNDESIRABLE ENVIRONMENTAL CONDITIONS AND/OR INADEQUATE UTILITIES WERE OBSERVED AT BOTH THE PRESENT AND THE PREVIOUS ON-SITE INSPECTION. SUCH PROBLEMS MUST BE PROMPTLY CORRECTED.
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LABORATORY SAFETY
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NOTE TO THE INSPECTOR: Please review ALL safety questions in the Laboratory General checklist. These questions have been omitted from this checklist to avoid repetition. Deficiencies should be marked in the Laboratory General checklist. Please elaborate upon the location and the details of each deficiency in the Inspector's Summation Report.
AGC.50000 PHASE I N/A YES NO
Is the automated/general chemistry laboratory in compliance with all safety requirements as identified in the Laboratory General Checklist?
COMMENTARY:
ONE OR MORE SAFETY DEFICIENCIES FOR THE AUTOMATED/GENERAL CHEMISTRY LABORATORY ARE ITEMIZED IN THE LABORATORY GENERAL CHECKLIST.
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