Referral of Laboratory Testing: in-house and external ...



|Author: Munyaradzi P. Mangwendeza |Document Number: |Pro10-03 |

| |Effective (or Post) Date: |Unknown |

|Document Origin |Company: |BHHRL |

|BHHRL, Botswana | | |

| |SMILE Approved by: |Penny Stevens |

|Reviewed by |Heidi Hanes |Review Date |25 February 2020 |

|pSMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific |

|processes and/or specific protocol requirements. Users are encouraged to ensure compliance with local laws and study protocol |

|policies when considering the application of this document. If you have any questions contact SMILE. |

| Title: | |

| |Referral of Laboratory Testing |

| |Name, Title |Signature, Date |

|Prepared By: | | |

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| |Munyaradzi P. Mangwendeza, Quality Manager | |

| |Name, Title |Signature, Date |

|Approved By: | | |

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| |Review Date |Revision Date |Signature, Date |

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|Annual Review | | | |

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| |Location: |Copy Number: |Location: |Copy Number |

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|Distributed To: | | | | |

| |Master file |1 | | |

| |Director – |2 | | |

| |Dr. Musonda | | | |

| |Director – |3 | | |

| |Dr. Mine | | | |

| |Lab Manager |4 | | |

| |Lab Co-ordinator |5 | | |

Copy Number: _________

1. General Policy

1. It the policy of BHHRL that any work that needs to be referred, in-house or to external laboratories, for whatever reason is placed with competent referral laboratories or back-up instruments that are on the Back-up Plan List and are in compliance with this Quality Management System and requirements of ISO/IEC 17025:2005 or ISO/IEC 15189 International Standards and other regulatory agency requirements.

2. Referral laboratories are evaluated, selected and monitored by the management of BHHRL except in cases where the client or regulatory agency specifies which subcontractor is to be used.

3. All method and instrument validations and comparisons are performed before work is placed with a referral laboratory or with a back up instrument.

2. Purpose

1. The purpose of this procedure is to ensure that the use of back-up instruments/methods and the use of referral laboratories is done in a standard way that does not compromise the Quality of BHHRL service to its clients.

3. Scope

1. This procedure covers the entire test schedule of BHHRL and refers to any occasion that may require the use of a back up system or referral of test work.

4. Responsibilities

1. Quality Manager

1. Responsible for the evaluation and monitoring of referral laboratories.

2. Method and instrument validation and comparison of referral laboratories instruments and BHHRL instruments.

3. Performance comparison between primary and back-up instruments at BHHRL.

2. Lab Manager

1. Selection of the referral laboratories to use when the need arises.

2. Approval of the use of referral laboratories or changing equipment used to the back-up machinery as required.

3. Identify all tests that require the use of referral laboratories.

4. Before work can be referred, the Lab Manger shall draw up, and supply referral lab with, conditions of service regarding work being referred.

3. All staff

1. Ensure that they report all malfunctioning equipment to the Lab Manager by filling out a corrective action and problem report form.

4. Referral Laboratories

1. Ensure that they fulfill BHHRL conditions of service and requirements for referred work.

5. Procedures

1. Evaluation of Referral Laboratories

1. All referral laboratories shall be evaluated before they can be short listed for selection.

2. The evaluation form document number BHHRL/001FR026 shall be used in the collection of information from potential referral laboratories during the first phase of the evaluation process.

3. The second phase of the evaluation process shall involve method and instrument performance comparison between the referral lab and BHHRL.

2. Selection

1. Once a method and instrument performance comparison is accepted, the laboratory can then be selected for use as a referral lab depending on other factors such as cost and this is the responsibility of the Laboratory Manager.

2. Reasons for selections shall be fully documented.

3. Monitoring

1. The referral laboratory shall be subjected to constant monitoring for continued compliance to requirements.

2. This shall include bi-annual instrument comparison studies and annual initial evaluation process, EQA reports analysis, IQC reports analysis and Instrument performance checks.

4. Instrument Comparison

1. Instrument comparison studies should be done to ensure results from referral laboratory instruments and BHHRL instruments agree. This should be done biannually and should follow the procedures laid down in the SOP on Method and Instrument Validation.

2. The same should be done for BHHRL back-up systems.

3. All maintenance checks should be performed to the back up system.

5. Using Back up Measures for Testing:

1. Fill in the CAPR form when the non-conformity has been identified.

2. Send CAPR form to the Laboratory Manager for assessment of the problem

3. Lab Manager approves the use of back up instrument or referral laboratory.

4. Notify appropriate personnel, e.g. at referral lab that u will be sending samples, Lab staff to prepare the back up instruments e.t.c

5. Send samples for testing ensuring that specimen integrity is maintained through the proper transport procedures.

6. Evaluate results all result reports obtained from back up instruments or referral labs to ensure they conform to requirements.

7. When corrective actions have been implemented and evaluated to have been effective, the original testing system can then be put back in place for normal operations to resume.

6. Results reporting

1. All final reports sent to clients shall state that backup system or referral laboratory was used for testing the samples. This can be achieved via the use of memos or indicating on the reports.

2. Network personnel (ACTG) should be notified when testing has moved to back-up systems

7. Quality Assurance and Quality Control

1. Thorough evaluation process

2. Thorough monitoring of selected referral labs or system

3. Appropriate documentation and record keeping

8. Records

1. Method and Instrument Validation and Comparison Records

2. Back-up Plan list

3. Corrective action and problem report forms

4. Evaluation and Selection Criteria Reports.

5. Conditions of Service for referred work

9. Co-applicable documents

1. Method and Instrument Validation BHHRL/001PR018

2. Control of no-conforming test work BHHRL/001PR07

3. Sample collection and transport BHHRL/002PR02

10. Reference

1. BHHRL Quality Manual Current Version

2. ISO/IEC 17025 International Standard

Appendix 1 – Back-up System for BHHRL

Appendix 2 – Evaluation and Selection Criteria Form

Revision History:

|Revision Level: |Revision Date: |Revised By: |Brief description of revision: |

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Appendix 1

|Assay |Primary |Back-up |

|CD4 Cell Count |BD FACSCalibur Flow Cytometer (S/N E4451); BHHRL |BD FACSCalibur Flow Cytometer (S/N E4453); BHHRL |

| |Ground Floor |Second Floor |

| | |BD FACSCalibur Flow Cytometer(S/N 146000763); BHHRL|

| | |Ground Floor |

|Clinical Chemistry |Roche Integra 400 plus; BHHRL Ground Floor |Lancet Laboratory, Gaborone (Roche Integra 400 |

|Albumin | |plus), except |

|ALP | | |

|ALT (SGPT) | |Lancet Laboratory, Johannesburg (Roche Integra 400 |

|Amylase | |plus): |

|AST (SGOT) | |Creatine Kinase |

|Bicarbonate (CO2) | |Lipase |

|Bilirubin, Direct | |Prealbumin |

|Bilirubin, Total | | |

|BUN/Urea | | |

|Calcium | | |

|Chloride | | |

|Cholesterol | | |

|Creatine Kinase | | |

|Creatinine | | |

|Ferritin | | |

|GGT | | |

|Glucose | | |

|HDL_C | | |

|Iron | | |

|Lactate | | |

|LDL_C | | |

|LDH | | |

|Lipase | | |

|Prealbumin | | |

|Potassium | | |

|Sodium | | |

|Phosphorus/Phosphate | | |

|Total Protein | | |

|Transferrin | | |

|Triglycerides | | |

|Haematology |Sysmex XE 2100; BHHRL Ground Floor |Sysmex SF 3000; BHHRL Ground Floor |

|Full Blood Count | |OR Lancet laboratory (Gaborone) |

| | |Beckman Coulter Act5Diff (Primary) or Beckman |

| | |Coulter HMX (Back-up) |

|RNA PCR |Roche AmpliPrep/Amplicor; BHHRL Ground Floor * |Lancet Laboratory, Johannesburg |

| | |(Roche AmpliPrep/Amplicor) |

|DNA PCR |Amplification: Perkin Elmer Thermocycler; BHHRL |Amplification: Perkin Elmer Thermocycler; BHHRL |

| |Ground Floor |Second Floor |

| |Detection: Molecular Devices Emax Microplate |Detection: Bio-Tek Instruments Ex 800 (Universal |

| |Reader |Plate Reader BHHRL 1st floor). |

|Serology (HIV ELISA & Wester Blot, Syphilis |Manual Methods | |

|RPR, Hepatitis B Surface Antigen, Hepatitis | | |

|C) |Bio-Tek Universal AutoStrip Washer (ELx 50 BHHRL |Bio-Tek Universal AutoStrip Washer (ELx 50 BHHRL |

| |ground floor) |1st floor) |

| |Bio-Tek Universal Plate Reader |Bio-Tek Universal Plate Reader |

| |(ELx 800 BHHRL ground floor) |(ELx 800 BHHRL 1st floor |

Document No; BHHRL/001FR26

Laboratory’s Name: ..................................................................................

Contact Person and Details: ......................................................................

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Reason for Evaluation: Routine Testing

Back-up System

Special Circustance (Explain):

…………......................................................................................................................................................................................................................................................................................................................................................................................................................................................................

Evaluated for the following tests:

|Analyte / Test |Matrix |

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Evaluation done by: ...........................................................................................

Date: ...............................................

PLEASE ATTACH SUPPORTING DOCUMENTS AS AND WHEN NECESSARY

A. Laboratory’s Capabilities (maximum 25 points)

1. Background (1-5 points): --

a) Does the laboratory have a reputation for high quality and integrity? ……..

b) How long has the lab been in business (e.g. 5 years, 10, more)? ……..

c) What are clients' general observations regarding the lab's services? ……..

2. Experience and references (1-5 points): --

a) Has the laboratory provided a list of References? …….

b) How long have clients been served by the lab? ………..

3. Quality Management (1-5 points): --

a) Does the lab have a QMS? …………………

b) Does the Lab have a Quality Assurance Plan? …………….

c) Is the Laboratory accredited? Is the documentation available? ……..

4. Equipment (lab and data handling) (1-5 points): --

a) Is the testing equipment adequate for the scope and volume of services offered? ………..

b) Is there adequate backup in the event of equipment failure? ……….

c) Does the automated data processing equipment capability appear to be adequate for the scope of the work contract (e.g., direct transmissions, online result reporting)? ……………

5. Accreditation and certifications (1-5 points): --

a) SANAS ? ……………

b) Other? ………………..

Total points for section A: …………………….

Document where the lab was lacking : ................................................................................. ………………………………………………………………………………………………

B. Quality assurance (maximum 25 points; assign 1-5 points for each question)

a) Is a written, organized, comprehensive quality control (QC) program in place? --

b) Is there a process for remedial action when QC tolerance limits are exceeded? --

c) Is an ongoing monitoring program in place to review, detect, and correct system errors? --

d) Is a copy of proficiency testing (PT) results available for at least the previous 24 months, and for deficiencies noted, were appropriate and timely corrective actions documented? Attach copies --

e) Does the laboratory have a written, clearly defined protocol for notifying clients of critical values? --

Total points for section B: --

Document where the lab was lacking : …………………………………………………………

C. Efficiency of referral services (maximum 25 points; assign 1-5 points for each question)

a) Does the lab offer a sufficient range of services to satisfy our needs? --

b) Does the lab provide a written TAT for each test performed, and does the TAT meet our needs? --

c) Are data elements for each test complete? --

d) Operational systems: (1-5 points for each item below) --

1. General management/overall assessment of policies/procedures --

2. Methods used for testing/reporting results --

3. Specimen handling policies/procedures. Includes clearly defined, comprehensive instructions for preparing specimens as well as criteria for rejecting unsatisfactory specimens --

4. Equipment maintenance policies --

5. Information and data handling policies/procedures --

6. Printing of reports via computer or printer in participating lab (is printer provided?) --

7. Adequate specimen pick-up service?...

8. Does the lab have a written protocol for reviewing test reports for possible errors? --

9. Is the test report format clear and can it be read easily? --

10. Does the lab provide client consultation services on a daily basis, including client services, technical advice, and medical consultation concerning appropriate test ordering and interpretation of results? --

Points for d) should be awarded subjectively, based on past experience, if possible. If not, call references for information.

Total points for section C: --

Document where the lab was lacking: .......................................................................... .......................................................................................................................................

D. Personnel (maximum 30 points; assign 0-5 points for each question)

1. Percentage of technologists to technicians: [is greater than] 75% (5 points); 50% (3 points); [is less than] 25% (0 points) --

2. Does the lab employ a qualified supervisor during all hours of operation? Yes (5 points); No (0 points) --

3. Are specific staff members assigned to assist us at all times? Yes (5 points); No (0 points) --

4. Are doctoral-level scientists or pathologists available for consultation? Yes (5 points); No (0 points) --

5. Does the technical staff have expertise in all areas required? Yes (5 points); No (0 points) --

6. Does the technical staff receive continuing education on an ongoing basis and is this education documented? Yes (5 points); No (0 points) --

Total points for section D: --

Document where the lab was lacking: .................................................................................. ......

E. Results for method and instrument comparison studies: Acceptable/Unacceptable.

Explain:

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Evaluator’s comments: ....................................................................................................................... .........................................................................................................................................................................................................................................................................................................................

Lab Manager:

Comments: ............................................................................................................................ ...............................................................................................................................................

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Lab Approved/Not Approved

Signature: .................................................. Date: ...........................

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