CRA-F-05-15189-S-04-Molecular Diagnostics Inspection

ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES

Suite # 113-114, Level 1, Master Mind IV, Royal Palms, Aarey Colony,

Goregaon East, Mumbai – 400 065. India.

Tel/Fax: 91-22-28794410, 28794411, 28794412

E-Mail: info@accab.org Website: www.accab.org

ON SITE ASSESSMENT REPORT

ISO 15189:2012 - Medical Laboratories –

Requirement for quality and competence

SUPPLEMENTARY CHECKLIST - MOLECULAR DIAGNOSTICS

INSPECTION CHECKLIST

ACCAB Reference No.:

Part-I: GENERAL INFORMATION

Date(s) of Assessment:

Re-Instatement Visit

On-site Clearance

Assessment Type:

Short Notice Visit

Assessment Team:

Assessor / Technical

Expert(s)::

Persons Interviewed:

Laboratory Details:

Laboratory’s Name:

Address:

Country:

Telephone No.

Email address:

Principal Contact Name:

Postcode:

Fax. No.

Web Site:

Designation:

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014

This report shall not be reproduced in part without the permission of ACCAB

Page 1 of 11




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CLAUSE

NO.

1.0

1.1

1.1.1

1.2

1.2.1

1.2.2

1.2.3

1.2.4

1.2.5

1.2.6

1.2.7

1.2.8

1.2.9

1.2.10

1.2.11

1.2.12

1.2.13

1.2.14

1.2.15

PART - II DETAILED CHECKLIST: MOLECULAR DIAGNOSTICS

INSPECTION CHECKLIST

REQUIREMENT

(Doc.

Ref. /

Clause

No.)

ASSESSMENT

COMPLIANCE

Y/N/NA NOTES

QUALITY CONTROL

Test systems using only external controls

Are two levels of external controls run each day of use?

Test systems using internal controls

Are internal controls run each day of use?

Has the laboratory validated the internal quality control?

Are criteria established for frequency of performing external quality control?

Are controls for each analyte within a multiplex test included in each run?

Does the laboratory have a procedure to assess inhibition for each specimen type in those assays without an internal control?

For quantitative tests, has a statistically valid target range (mean, SD, CV) been established for each lot of control material?

For qualitative tests that use a cut-off value to distinguish positive from negative; is the cut-off value established initially?

Are control specimens tested in the same manner and by the same personnel as patient samples?

Is quality control data reviewed at least monthly by the laboratory director or designate?

Is this review documented?

Are results of controls verified for acceptability before reporting results?

Are criteria for what is considered to be out of control available to staff?

Are criteria for referral of “out of control” results to the supervisor and/or senior staff identified?

Is there documentation of corrective action taken when controls exceed defined tolerance limits?

Does the documentation include:

What was out of control?

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


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2.3

2.3.1

2.3.2

2.3.3

2.3.4

2.3.5

2.3.6

2.3.7

2.3.8

2.3.9

2.3.10

2.3.11

2.3.12

2.3.13

2.3.14

2.3.15

1.2.16

1.2.17

1.2.18

1.2.19

1.2.20

1.2.21

1.2.22

2.0

2.1

2.2

2.4

2.5

2.6




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Why the analysis was out of control?

Corrective action taken?

Signature/initials of individual responsible?

Are control data organized and presented so they can be evaluated daily by technical staff to detect problems, trends, etc.?

Is lot number change of quality control material documented on the quality control record?

Are quality control records retained for at least two years?

Are quality control statistics (ie. SD and CV) calculated at specified intervals to define analytical imprecision?

PROCEDURE MANUAL

Is a current procedure manual available for laboratory staff?

Is the procedure manual maintained as per the documented procedure?

Are the following included for each procedure:

(if applicable)

Purpose

Specimens (type, source, amount, storage)

Directions for calibration

Derivation of results (ie. mathematical calculations, dilutions)

Quality control

Equipment and Materials required

Preparation and storage of reagents, standards and controls

Procedure – including Step by step instructions

Linearity limits

Precision

Reference ranges

Clinical Significance

Critical values

Safety

Reporting results (units, stats, critical values)

Is there documentation of annual review of the procedure manual by the laboratory director or designate?

Is there documentation of annual review of the procedure manual by the laboratory staff?

Are all changes in methodology signed and

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


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2.7

2.8

2.9

2.10

3.0

3.1

3.2

3.2.1

3.2.2

3.2.3

3.2.4

3.2.5

4.0

4.1

4.2

4.2.1

4.2.2

4.2.3

4.2.4

4.2.5

4.2.6

4.2.7

4.2.8

4.2.3

5.0




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dated by whoever made the changes?

Are all new procedures reviewed by the medical director or designate?

Are discontinued procedures retained for two years after the procedure is taken out of service?

Is there a current file on manufacturer’s

Inserts/updates?

Are there adequate and up to date reference text books available to laboratory staff?

SPECIMEN COLLECTION MANUAL

Is a specimen collection manual available at all collection sites?

Does the specimen collection manual include:

Patient preparation

Specimen type and amount (ie. midstream)

Proper handling (ie. preservative/anticoagulant)

Labelling with patient first and last name and personal health number

Labelling with patient first and last name and personal health number

REQUISITIONS

Are all specimens accompanied by an adequate requisition?

Does the requisition include: adequate patient identification – name and other identification ordering physician or legally authorized person ordering the test date of birth and gender date and time of collection tests requested source of specimen clinical information, history or clinical diagnosis, when appropriate accession number

Is the date and time that the specimen was received by the laboratory recorded?

REAGENTS

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


Page 4 of 11

5.6

6.0

6.1

5.1

5.2

5.3

5.3.1

5.3.2

5.3.3

5.3.4

5.4

5.5

6.2

6.3

6.4

6.5

6.6

6.7

6.8

6.9

6.10

6.11

6.12




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Are all reagents used within their expiry date?

Are all reagents used according to manufacturer’s instructions?

Are all reagents labelled with:

Date of receipt?

Date prepared or opened?

Expiry date?

Content and concentration?

Are all reagents stored according to manufacturer’s instructions?

Are test reagents and controls stored properly and in a manner which minimizes target

DNA/RNA contamination and degradation?

Are new reagent lots and/or shipments validated prior to patient testing?

INSTRUMENTS AND EQUIPMENT

Is there a procedure for maintenance of all instruments and equipment?

Are the maintenance records reviewed by a supervisor?


Are there instructions for troubleshooting?

Are service records maintained for the life of the instrument, plus two years?

Is there emergency power for instruments and equipment?

Are instruments equipped with surge protection?

(this also includes computers)

If the laboratory uses more than one instrument/method to test for a given analyte, are the instruments/methods checked against each other at least twice a year for correlation of results?

Are there defined tolerance limits for result agreement of inter-instrument assays?

Does the laboratory have a procedure for evaluating automatic pipette systems for carryover?

Are pipettors and dilutors (fixed volume or adjustable) checked at least annually for accuracy and reproducibility, and results recorded?

Is the temperature of water baths and/or heat blocks checked on days of use?

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


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6.13

6.13.1

6.13.2

6.13.3

6.14

6.15

6.16

6.17

6.17.1

6.18

6.18.1

6.18.2

6.18.3

6.18.4

6.19

6.19.1

6.19.2

6.20

6.20.1

6.20.2

6.20.3

6.21

6.21.1

6.22

6.22.1

6.23

6.23.1

6.24

6.24.1




Tel/Fax: 91-22-28794410, 28794411, 28794412


Is the temperature of refrigerators and other temperature dependent equipment documented daily:

Room temperature

Freezer

Refrigerator

Is there evidence of active review of results of instrument maintenance and temperature?

Is there a procedure available if acceptable temperature ranges are exceeded?


Glassware

Are there appropriate documented procedures for handling and cleaning glassware, including methods for testing for detergent removal?

Microscopes

Are there an adequate number of microscopes for the workload?

Are all microscopes clean, well maintained and suitable for their intended use?

Is there an adequate selection of objective lenses for the specimens examined?

Is there a procedure for Koehler illumination?

Centrifuges

Is there a schedule for maintenance of all centrifuges?

Are operating speeds checked and documented?

Balances

Are balances mounted on vibration-free benches?

Are balances clean and regularly serviced?

Are NIST/Equivalent reference weights available and used for checking accuracy?

Autoclaves

Is the autoclave monitored weekly for proper functioning?

Pipettes

Does your laboratory check pipettes for calibration?

Thermometers

Are certified thermometers used in the laboratory?

Thermocyclers

Are individual wells (or a representative sample thereof) of thermocyclers checked for

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


Page 6 of 11

6.24.2

7.0

7.1

7.1.1

7.1.2

7.1.3

7.2

7.2.1

7.2.2

7.2.3

7.3

7.3.1

7.3.2

7.3.3

7.3.4

7.3.5

7.3.6

7.3.7

7.3.8




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temperature accuracy before being placed into service?

And at least annually thereafter?

TESTING

Calibration - is the set of operations that establish, under specified conditions, the relationship between reagent system and the corresponding concentration value of an analyte.

Is calibration performed according to the manufacturer’s specification for quantitative tests?

Are calibrations documented for each test?

Are criteria established for frequency of calibration?

Linearity – 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.

Is linearity of the instrument validated initially? and thereafter every six months?

Is there documentation of linearity?

Assay Performance

Is there documentation that the laboratory has performed assay verification studies on all reportable tests and specimen types?

Does the laboratory perform validation studies on those specimen types not listed in the package insert?

Are all analytes detected in a multiplex test verified for each new shipment and/or lot?

Are tests performed and results reported as specified in package inserts without substitution of reagents or modification of testing protocol?

Has the laboratory validated all cut-off values?

Is sufficient information documented regarding the nature of any probe or primer used in an assay to permit interpretation and troubleshooting of tests results?

Are nucleic acid amplification procedures (eg.

PCR) designated to minimize carryover using appropriate physical containment and procedure controls?

Are nucleic acid isolation/preparation procedures evaluated?

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


Page 7 of 11

7.3.9

7.3.10

7.3.11

7.3.12

7.3.13

7.3.14

7.3.15

7.3.16

7.4

7.4.1

7.4.2

7.4.3

7.4.4

8.0

8.1

8.2

8.3

8.4




Tel/Fax: 91-22-28794410, 28794411, 28794412


Are melting temperature ranges (+/- 2.5



C) defined and monitored?

Are the autoradiographs and gel photographs of sufficient resolution and quality (low background, clear signal, absence of bubbles, etc.) to permit the reported interpretation?

Are known molecular weight markers that span the range of expected bands used for each electrophoretic run?

Are visual or fluorescent markers used to determine the endpoint of gel electrophoresis?

Is there a procedure to prevent or detect potential cross-contamination of samples and/or amplicons?

Does the laboratory have a procedure in place to investigate sample or amplicon contamination?

Does your laboratory track percent positives per run?

Does the laboratory monitor turnaround times and that they are appropriate?

Sequence-Based Assays

Are criteria established for the acceptability and interpretation of primary sequencing data?

Have the alternative databases been validated for the interpretation of the sequence data?

Are the sequence data correlated with phenotypic data?

Does the laboratory have a procedure in place to investigate and resolve problems with potential contamination of sequencing reactions?

SPECIMEN HANDLING & PROCESSING

Are procedures in place to prevent specimen loss, alteration or contamination during collection, transport, processing and storage?

Is there a written procedure to prevent any possible cross-contamination of the aliquot containers?

Are there procedures to ensure absence of crosscontamination of samples?

Is there a system to positively identify all patient specimens, specimen types and aliquots through all phases of the analysis, including specimen receipt, nucleic acid extraction, nucleic acid quantification, hybridization, detection,

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


Page 8 of 11




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8.5

8.6 documentation and storage?

Are patient samples processed promptly or stored appropriately to minimize degradation of nucleic acids?

Does the final report include a summary of the test method and information regarding clinical interpretation if appropriate?

9.0

9.1

9.2

9.3

9.4

9.5

9.6

9.7

PROFICIENCY TESTING

Is the laboratory enrolled in an external PT program?

For analytes where graded PT is not available, is there an alternative assessment procedure in place?

Is alternative assessment performed twice a year and documented?

Does the laboratory integrate all PT samples within the routine workload?

Are PT samples analyzed by personnel who routinely test patient samples?

Is there documentation of corrective action of unacceptable PT results?

Is there documented evidence of review by the laboratory director or designate of the external

PT results?

Are PT survey results retained for two years? 9.8

10.0

REPORTS

10.1 Do the report forms include:

10.1.1 patient name and other identification

10.1.2 physician or legally authorized person ordering test date and time of specimen collection 10.1.3

10.1.4 test result(s) and units of measurement (when applicable) reference values 10.1.5

10.1.6 date and time of report release

10.1.7 conditions of specimen that may limit adequacy of testing name of laboratory performing the test(s) 10.1.8

10.1.9 specimen source

10.1.10 specimen collected by

10.2 Are there established criteria for immediate

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


Page 9 of 11

10.3

10.4

10.5

10.5.1

10.5.2

10.5.3

10.5.4

10.6

10.7

10.8

10.9

10.10

10.11

10.12

10.13

10.14

10.15

10.16

10.17




Tel/Fax: 91-22-28794410, 28794411, 28794412


notification of critical test results?

Is there documentation of notification to the proper clinical individual of results of all critical values?

Does the laboratory have a policy regarding

“read back” of critical values that are communicated verbally or by phone?

Is confidentiality ensured for laboratory results received and distributed by the laboratory via:

Fax

Electronic Mail

Mail

Delivery

Is there a procedure to identify and trace late/lost reports?

Is there a policy for retention of patient reports?

Does the laboratory promptly notify clinical personnel and issue a corrected report when errors are detected in patient test reports?

Is there a documented system to ensure that all revised reports for previously reported incorrect patient results are identified as amended on all forms of patient reports?

Is there a policy regarding the communication and documentation of reportable diseases?

Are all patient results reported with reference ranges?

Are references ranges verified or established by the laboratory for the population being tested?

Is there a stat list in place?

Are stat results available within a reasonable time?

Are routine results available within a reasonable time?

Is the referral laboratory identified on the final report, if specimens are referred out?

Do reports for laboratory-developed assays contain a description of the method, a statement that the assay was developed by the laboratory, and appropriate performance characteristics?

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


Page 10 of 11




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Bibliography:

FAIR USE ACT 1976 NOTICE: This document may contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. such material is made available to advance understanding of political, human rights, economic, scientific, moral, ethical, and social justice issues. this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the 1976 us fair use copyright act. in accordance with title 17 U.S.C. section 107, this material is distributed without profit, to those who have expressed a prior general interest in receiving similar information for research and educational purposes . In the event that any content of this checklist causes harm/unlawful use/loss/unhappiness to anyone, the same should be brought to the notice of Accreditation

Commission For Conformity Assessment Bodies Private Limited, Mumbai India info@accab.org

1.

College of Physicians & Surgeons of Saskatchewan

2.

College of Physicians & Surgeons of Alberta

3.

Various other internet sources.

CRA-F-05-15189-S-04MDIC RD-00-01/07/2014


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CRA-F-05-15189-S-04-Molecular Diagnostics Inspection

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