Most Common Deficiencies Checklist Questions



Most Common Deficiencies Checklist Questions

NOTE: all checklist items in this document are from the Proposed Checklists that are available at the CAP website

Outline:

I. Top Eight Deficiencies

II. Checklist-Specific Common Deficiencies

III. Common Inspector Errors

I. Most Common Deficiencies

Number 8

Reference Ranges Reported with Patient Results

Inspection Scenario

You are inspecting a nursing station POCT site which performs whole blood glucose monitoring. Test results are manually transcribed by the glucometer operator from the glucometer into a “flow” sheet on the patient’s record. The flow sheet does not include pre-printed reference ranges. You are told that the nurse transcribing the result is responsible for also recording the reference range. On review of actual patient records, you notice that the reference ranges are missing from approximately 80% of the patient records.

Would you:

A. Not cite a deficiency; the laboratory is in compliance, and this is just an issue with the personnel,

B. Not cite a deficiency and informally comment on the lack of reference ranges,

C. Not cite a deficiency but make a written recommendation,

D. Cite a deficiency ?

QUESTION: 30.0450 / POC.04500 PHASE: II

When applicable, are all patient results reported with accompanying reference (normal) or interpretive ranges?

Solutions:

1. Have the reference ranges printed on the report form.

2. Use a sticker with the reference range printed on it.

3. Use a stamper with the reference range on it.

4. Have a separate form on the chart which lists reference ranges (logistically can be a problem to keep up to date).

5. Take steps to ensure the people who record the result also record the reference range each time they transcribe a result.

- would require a policy/procedure

- would require a documented tracking mechanism to ensure on-going compliance (such as a QI indicator)

Number 7

Annual Review of Chemical Hygiene Plan

Inspection Scenario

You are conducting an inspection of a laboratory’s safety program and are reviewing the Chemical Hygiene Plan (CHP). You are provided a document that simply states the CHF has undergone annual review, including a review of the effectiveness of the program, signed each year by the director of the laboratory. You do not find a description of the criteria by which the effectiveness of the CHP is reviewed.

Would you:

A. Not cite a deficiency; the laboratory is in compliance,

B. Not cite a deficiency but make an informal recommendation,

C. Not cite a deficiency but make a written recommendation,

D. Cite a deficiency because the review appears to be in name only?

QUESTION: 01:7050 / GEN.70500 PHASE: II

Is there annual review and evaluation of effectiveness of the laboratory's Chemical Hygiene Plan?

Solutions:

1. Develop a mechanism to document the annual review.

- Include a description of this review mechanism in the CHP (i.e. develop the policy for review)

- Document the review annually

2. Include evaluation of the plan’s effectiveness.

- Track the number of accidents (needle sticks, hazardous chemical spills/mishaps, body fluid exposures)

- Track the results of periodic safety audits (i.e. see if the number of deficiencies noted during safety audits is stable or decreasing instead of increasing)

- Track employees’ compliance and knowledge of the elements of the CHP (possibly as part of their annual competency evaluation, possibly use a quiz for this and track the scores, i.e. are they showing evidence of deterioration or improvement)

Number 6

Evacuation Plan

Inspection Scenario

You are reviewing a laboratory’s evacuation plan. The laboratory is a freestanding facility and does not perform on-site collection of patient specimens. The evacuation plan is documented, posted, and addresses the needs of workers with disabilities but does not address visitors to the laboratory. The laboratory manager claims they do not need to address evacuation of visitors because they never have patients on-site.

Would you:

A. Not cite a deficiency; the laboratory is in compliance,

B. Not cite a deficiency but make an informal recommendation

C. Not cite a deficiency but make a written recommendation

D. Cite a deficiency?

QUESTION: 01:7080 / GEN.70800 PHASE: II

Is there a comprehensive, documented and workable evacuation plan, including specific plans for any persons with disabilities?

Solutions:

1. Plan should be detailed enough and employees should be sufficiently trained to describe it to the inspector.

2. Include plans regarding evacuation of persons with disabilities (employees and patients). If no disabled persons are currently employed, state that in the written plan. Also indicate the plan will be updated when any disabled personnel are employed.

3. Plan should address employees, patients, and visitors (including vendors/sales representatives).

Number 5

Direct Antigen Testing Quality Control

Inspection Scenario

You are inspecting the immunology section of a laboratory. The laboratory uses a direct antigen detection kit, without built-in controls, for urine hCG tests. Each day of use, they run an external positive control but do not run a negative control. When you question this, the immunology supervisor states that they do not run a negative control if the patient sample is negative because that indicates that the kit is capable of producing a negative reaction and, therefore, the patient sample is, in effect, the negative control.

Would you:

A. Not cite a deficiency; their explanation makes sense,

B. Not cite a deficiency but make an informal recommendation,

C. Not cite a deficiency but make a written recommendation,

D. Cite a deficiency?

QUESTION: 06:3430 / IMM.34300 PHASE: II

For tests that do NOT include built-in positive and negative controls, are known positive and negative controls tested on each day of analysis for all qualitative or semi-quantitative antigen/antibody tests (e.g., rheumatoid factor, rapid plasma reagin, ASO, hCG, heterophile antibody, etc.)?

QUESTION: 06:DXAB / IMM.DXAB0 PHASE: II

For tests that DO include built-in positive and negative controls, is a positive and negative external control tested WITH EACH NEW KIT OR LOT NUMBER for all qualitative or semi-quantitative antigen-antibody tests (e.g., rheumatoid factor, rapid plasma reagin, ASO, hCG, heterophile antibody, etc.)?

Solutions:

1. If the kit does not include built-in controls, run external positive and negative controls each day of use.

2. If the kit does include built-in controls, then run external positive and negative controls with each new kit or lot. Internal positive and negative controls will be run as a part of each test performed.

- Test system must be classified as waived or unmodified moderate complexity test under CLIA-88

- At a minimum, manufacturer’s commendations must be followed

Number 4

Parallel Testing of New Reagents in Immunology

Inspection Scenario

You are inspecting the immunology section of a laboratory. They provide you with their documentation of new reagent testing for their Infectious Mononucleosis kit. Parallel testing of new kits consists of running known positive and negative patient specimens from the previous day using reagents from the new kit.

Would you:

A. Not cite a deficiency; this is acceptable practice,

B. Not cite a deficiency but make an informal recommendation,

C. Not cite a deficiency but make a written recommendation,

D. Cite a deficiency because they need to run reference materials or previous kit controls to adequately parallel check the new reagents?

QUESTION: 06:3315 / IMM.33150 PHASE: II

Are new reagent lots checked against old reagent lots or with suitable reference material before or concurrently with being placed in service?

Solutions:

1. Use suitable reference material.

2. Use retained positive and negative patient sera for qualitative tests.

3. Clarify documentation of parallel testing. Consider using a separate log sheet for this purpose.

Number 3

Review of QC Records

Inspection Scenario

You are reviewing a laboratory’s temperature and maintenance records for a chemistry instrument. Each record page covers one month of data. The records are initialed and dated by the section supervisor on a line at the bottom of each page next to the words “Reviewed by ____”. There is no evidence of weekly review by anyone.

Would you:

A. Not cite a deficiency; this is acceptable practice,

B. Not cite a deficiency but make an informal recommendation to have weekly review.

C. Not cite a deficiency but make a written recommendation,

D. Cite a deficiency for lack of weekly review and/or lack of review by the laboratory director ?

QUESTION: 03:2010 / AGC.20100 PHASE: II

Is there evidence of active review of results of instrument maintenance and function, temperature, etc. for routine procedures on all shifts?

Solutions

1. Include instrument maintenance records and temperature records in QC review.

2. Document laboratory director’s approval of designee to perform QC review.

3. Include description of QC review scope and frequency in laboratory’s QC plan. Weekly review is no longer required.

4. Exercise diligence in carrying out prescribed QC reviews.

Numbers 2 and 1

Procedure Manuals

Inspection Scenario

You are reviewing procedure manuals for the chemistry section. The procedures are written in NCCLS format. The first page of each procedure includes evidence of annual review by the chemistry supervisor. The laboratory director’s signature is not on any of the procedures.

Would you:

A. Not cite a deficiency; this is acceptable practice,

B. Not cite a deficiency but make an informal recommendation,

C. Not cite a deficiency but make a written recommendation,

D. Cite a deficiency for failure of the laboratory director to approve and review procedures?

QUESTION: 03:2100 / AGC.21000 PHASE: II

Is a complete procedure manual available at the workbench or in the work area?

QUESTION: 03:2110 / AGC.21100 PHASE: II

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?

Solutions

1. Have procedures in substantial NCCLS format for all procedures performed.

2. Personalize manufacturer’s inserts/manuals for the specifics of the laboratory (e.g. controls, reporting instructions, reflexive testing, critical values, reportable range).

3. Have current manuals in the work areas.

4. Keep work cards current.

5. Document annual review of manuals.

a. Date and sign each procedure

b. Date and sign each procedure in the table of contents

c. Laboratory director’s designee can perform the annual review if the designee is qualified and the laboratory director has documented designation.

6. Keep records of electronic manuals including documentation regarding who is authorized to make changes.

Part II: Common Deficiencies from Discipline-Specific Checklists

Laboratory General

Source water evaluated for silicates

QUESTION: 01:4165 / GEN.41650 PHASE: I

Has the laboratory evaluated its source water to determine if a high concentration of silicates is present?

Solutions

1. Test source water (not the purifier effluent) for silicate concentration. If silicate levels are high, select a water purification system which will handle removal of silicates.

2. NCCLS Guideline C3-A3 provides detailed steps for silicate testing.

3. Routine repeat testing for silicates is not a requirement of the Checklist.

Hematology

Recommendations on Use of Lab Tests in Anticoagulant Therapy

QUESTION: 02:3712 / HEM.37120 PHASE: I

Are recommendations provided to clinicians concerning which laboratory tests to use for monitoring heparin and/or oral anticoagulant therapy, and the therapeutic range for the tests?

Solutions:

1. Inform clinicians which tests are recommended for monitoring heparin and oral anticoagulants.

2. State test values that indicate the anticoagulant therapeutic range.

3. Use of International Normalized Ratio (INR) is recommended.

Chemistry

Criteria Established for Determining Need for Calibration Verification

QUESTION: 03:2500 / AGC.25000 PHASE: II

Are calibration procedures for each method adequate, and are the calibration results documented?

Solutions:

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 complete change of reagents that affects the range used to report patient results or QC values; or

2. QC fails to meet established criteria; or

3. After major maintenance or service; or

4. Calibration verification data fail laboratory acceptance criteria; or

5. When recommended by the manufacturer.

Each laboratory must establish its own criteria.

CALIBRATION VERIFICATION INTERVAL: Calibration verification must be performed at least once every 6 months, as specified under CLIA-88 regulations at CFR493.1217(b)(2)(ii)(C). Successful verification certifies that the calibration is still valid; unsuccessful verification requires remedial action. The performance of a calibration verification procedure resets the calendar to a new maximum 6-month interval before the next required reassessment.

Urinalysis

Procedure for Correlation of Microscopic with Macroscopic Results

QUESTION: 03A:3085 / URN.30850 PHASE: II

Is there a documented procedure for correlation of microscopic sediment findings (such as casts, RBC, or WBC) with macroscopic results (presence of protein, positive occult blood, positive leukocyte esterase, etc.)?

Solutions:

1. Document procedure to correlate results of these tests, including reflexive testing, if applicable.

- Casts and urine protein

- Red cells and positive blood

- White cells and leukocyte esterase

Toxicology and Special Chemistry

Evaluation of Test System for Carryover Effects

QUESTION: 03C:3040 / SPC.30400 PHASE: I

If automatic pipetting is used, has the laboratory evaluated the testing system for carryover effects?

Solutions:

1. Document procedure.

- Run known high sample followed by low samples (suggest TSH or hCG). If carryover exists, determine high level past which low levels are affected and define appropriate course of action (e.g. repeat testing of low samples that immediately follow a high sample).

Microbiology

Guidelines for Collection of Stool Samples

QUESTION: 04:2244 / MIC.22440 PHASE: I

Does the laboratory have guidelines (developed with clinicians) for the number and/or timing of collection of stool specimens submitted for routine bacterial testing?

Solutions:

1. Develop guidelines for clinicians for the number and/or timing of stool specimens. Suggestions include:

- Submit no more than 2 specimens per patient (limited yield)

- Do not submit specimens from inpatients after the third hospital day without prior consultation (hospital colonization).

- Consider use of Clostridium difficile toxin assay instead of cultures

Anatomic Pathology

Frozen Section Interpretations Rendered Within 20 Minutes

QUESTION: 08:1182 / ANP.11820 PHASE: I

Are at least 90% of frozen section interpretations rendered within 20 minutes of specimen arrival in the frozen section area?

Solutions:

1. Revise frozen section turn-around monitoring to reflect new 20 minute guideline (specimen arrival in lab to time interpretation rendered).

Cytopathology

Separate Processing of Gyn/Non-Gyn Specimens

QUESTION: 08A:0440 / CYP.04400 PHASE: I

Is there a documented policy for ensuring that non-gynecologic specimens with a high potential for cross-contamination are processed and stained separately from other specimens?

Solutions:

1. One procedure to detect highly cellular specimens is to use a toluidine blue, or other rapid stain, on a wet preparation.

2. Minimize cross contamination by using cytocentrifuge, filter, and monolayer prep methods.

3. Direct smears made from the sediment of highly cellular cases should be stained after the other cases.

4. The staining fluids must be changed or filtered between each of the highly cellular cases.

5. One procedure to detect possible contamination is to insert a clean blank slide in each staining run and examine it for contaminating cells.

Cytogenetics

Preliminary Reports Documented on Final Reports

QUESTION: 09:3200 / CYG.32000 PHASE: II

Are preliminary reports (especially verbal, telephone reports) documented on the final report?

Solutions:

1. Include preliminary reports (including telephoned reports and other verbal reports) in the final diagnosis report.

Blood Gas Laboratory

Unacceptable Proficiency Test Results

QUESTION: 26.0015 / BGL.00150 Phase II

Is there evidence of evaluation and, if indicated, prompt corrective action in response to “unacceptable” results on the Surveys report?

Solutions:

1. Main laboratory can assist blood gas laboratory with developing troubleshooting procedures for unacceptable PT results.

a. Investigate the failure. Categorize the most likely problem (see next page)

b. Apply corrective action, if applicable

c. Seek evidence that problems have been resolved

- Next survey acceptable

- Wayward QC shifts, trends, etc., have been corrected

d. Document investigation and corrective actions

Categories of Responses to Unacceptable Proficiency Testing Results:

1. Methodology Problems

- Instrument problem identified

- Instrument repaired or replaced

- Faulty standard or other reagent

- Incorrect calibration

- Other method problem

2. Technical Problems

- Misinterpretation/misidentification

- Dilution error or incorrect pipetting

- Time delay between reconstitution and analysis

- Calculation error

- Run accepted in nonlinear range

- Run accepted even though controls were out of range

- Sample mix-up

- Other technical problem

3. Clerical Errors

- Transcription error

- Transposition error

4. Problems with Survey Materials

- Hemolyzed specimen

- Bacterial contamination

- Perceived Survey bias

- Poor growth in culture

- Unstable Survey material

- Matrix effect incompatible with method

- No comparable peer group

- Acceptable range too narrow

- Late shipment

5. No Explanation after Investigation

- Use this choice only when a thorough investigation has yielded no satisfactory explanation.

Reference: Archives of Pathology & Laboratory Medicine 1987; 111:1011

Part III: Common Inspector Errors

Deficiencies Most Commonly Cited in Error

Number One

Review of Test Results in the Absence of an On-site Supervisor.

QUESTION: 30:0380 / POC.03800 PHASE: II

In the absence of a designated on-site supervisor, are the results of tests performed by personnel reviewed by the POCT director, laboratory supervisor, nursing supervisor, or the person in charge of the POCT section on the next routine working shift?

- Only applies to high complexity tests (per CLIA)

- Supervisor can be anyone who meets the CLIA qualifications of general supervisor

- For POCT, supervisor can also include nursing supervisor (per Checklist)

Number Two

Availability of Service Records

QUESTION: 03:2786 / AGC.27860 PHASE: II

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.

Solutions:

1. Keep records locally.

2. Computer access.

3. Fax access.

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