Molecular In My Pocket™…

Establishing a Molecular Laboratory - Best Practices Around the Globe

Pre-Analytical DO DON'T
Quality Management • Have a written quality management (QM) program that ensures quality • Don't forget to investigate and document
and Quality Control control checkpoints are implemented throughout the pre-analytic, analytic, all incidents/errors and corrective actions.
and post-analytic (reporting) phases of testing. • Don't forget to define a periodic review of
• Note that a good QM program includes monitoring key indicators of quality results by a qualified person.
in the pre-analytic, analytic, and post-analytic phases. • Don't forget to put a laboratory policy in
place to ensure compliance with applicable
federal, state, and local laws and
regulations.
Test Menu Design • Determine and verify the best tests for your location and patient population. Don't try to do every available test in the world;
• Determine the best available tests for actionable/treatable mutations and test selection should reflect the needs of your
diagnoses. community.
• Check the impact of turn-around time requirements on the test menu.
Don’t forget to review and update test menu
periodically (e.g. both paper and online
requisitions) to ensure up-to-date information.
Collection, Transport, • Prepare written procedures consistent with good laboratory practice that Don't forget to check for any laws in your
Preparation, and describe methods for 1. patient identification, 2. patient preparation, 3. country that specify different requirements.
Storage of Specimens specimen collection and labeling, 4. specimen preservation, and 5.
conditions for transportation and storage before testing.
• Use at least two patient-specific identifiers for primary specimens.

Physical Facilities • Ensure that function checks on instrument/equipment maintenance are Don't forget to observe the workflow in each
reviewed periodically. area so as to avoid contamination during
• Perform laboratory environmental monitoring to meet equipment molecular procedures (e.g. pre-analytical-
specifications (e.g. humidity, temperature). >analytical->post-analytical).
• Monitor refrigerators and freezers containing any samples or reagents;
record data (note the temperature fluctuations in frost free freezers)
• Make sure that there is enough space so that quality of work, safety of
personnel, and patient care services are not compromised.
• Verify whether dedicated areas for pre- and post-amplification, depending
on your test menu, are required.
• Check these other important points: fire prevention, electrical safety,
chemical safety, radiation safety, environmental safety
Federal/State/Local Verify local laws and regulations for a clinical laboratory and determine the Don't assume that USA regulations are valid for
minimum requirements for staff training. other countries.
Regulations
Personnel • Define all laboratory personnel policies and job descriptions that outline • Never allow non-trained personnel to
qualifications and duties for all positions. perform tests.
• Keep personnel files with records of educational qualifications (e.g. copies of • Don't forget to check local regulations for
diplomas, transcripts, primary source verification reports), laboratory minimal training requirements for each
personnel licenses (where required), training and continuing education for kind of test.
each employee. • Don't forget to check local regulations for
• Check local regulation requirements for ascertaining the competency of the minimal competence requirements for each
laboratory person who will sign off on laboratory reports. role in the test process.
Laboratory Safety • Have required laboratory safety policies and procedures including • Don't forget to be prepared for
bloodborne hazard control and chemical hygiene plans. emergencies (fire safety and evacuation
• Have required written laboratory policies and procedures for infection plan, disasters)
control that comply with national, state, and local guidelines on • Don't forget to verify local regulations for
occupational exposure to bloodborne pathogens and to the institution's buying, and storage of, dangerous
exposure control plan. products.
• Never forget your personal protective
equipment (gloves, gowns, masks and eye
protectors, etc.)!
 Analytical DO DON'T
Procedure Manual • Have a complete and up to date laboratory procedure manual available for • Don't use inserts provided by
each test at the workbench or in the work area. Procedure manuals shall manufacturers as procedure manuals.
contain necessary instructions to perform each test. • Don't forget to notify all personnel of any
• Procedures must be reviewed periodically and approved/signed off by the alterations in procedure manuals and, when
Laboratory Director and/or designee. necessary, retrain staff.
• Don’t have uncontrolled copies of printed
procedures stored in lab areas.
Assay Validation • Make sure that all tests in the laboratory menu are validated before use Don't forget to verify local regulations for test
(Accuracy, Precision, Analytical Sensitivity, Analytical Specificity, Analytical validation requirements.
Interferences, and Reportable Range, as applicable).
• Validate each assay modification, each sample type, and each extraction
method.
• Validations must be reviewed and approved/signed off by the Laboratory
Director and/or designee.
Reagents • Always follow manufacturer instructions for handling and storing reagents, • Never use any reagent after the expiration
cartridges, test cards, etc. date, unless there are exceptions approved
• Properly label all reagents, calibrators, controls, stains, chemicals, and and/or documented in the lab.
solutions with the following elements: Content and quantity, concentration • Never use a reagent that is not properly
or titer, storage requirements, date prepared, filtered or reconstituted by identified.
laboratory, and expiration date.
• Dispose of waste according to local, state, or federal regulations.
• Ensure safety data sheets are readily accessible to all laboratory staff.
Controls • Ensure that all procedures have the proper controls in order to assure the Never validate a test with missing controls or use
quality of the test. This must be validated and defined in each procedure controls out of the expected range. Discrepant
manual. Good practice includes wipe tests and harmonization of instruments. results shall be investigated and/or documented.
• Ensure that controls include a positive and negative control as well as a blank
in all applicable tests.
Proficiency • The best practice is to have an External Quality Assessment (EQA) program • Never send proficiency test samples out to
for every test method performed in the laboratory. Each EQA program has a reference laboratories.
Testing
different periodicity, but proficiency tests are performed twice a year on • Don't forget any test on the laboratory
average. menu.
• Treat proficiency test samples in the same way as any patient sample. • If there is no EQA, remember to organize an
alternative PT.

Post-Analytical DO DON'T
Results Reporting • Ensure there is a system for reporting results in the lab; this may be • Don't forget to check the minimal reporting
supported by a policy and/or procedure. requirements for a laboratory report in your
• The best practice for a report is to have at least the following elements: country.
1. Name and address of testing laboratory • Don't forget to follow best practice
2. Patient name and identification number, or unique patient guidelines for the type of report you are
identifier Name of physician of record, or issuing.
legally authorized person ordering test, as appropriate • Don’t forget to have a policy that describes
3. Date of specimen collection, and if appropriate, time of collection how discrepant results are managed in the
4. Date of release of report (if not on the report, this information lab, for example, if a corrected or altered
should be readily accessible) report is generated.
5. Time of release of report, if applicable (if not on the report, this
information should be readily accessible)
6. Specimen source, when applicable
7. Test result(s) and units of measurement, when applicable.
8. Reference intervals, as applicable
9. Conditions of specimen that may limit adequacy of testing
10. Limitations of the test, where applicable
11. Methodology used
• Always ensure that internal and external storage conditions and transfer of
laboratory data maintains patient confidentiality and security.
Records • Retain laboratory records for the appropriate time as defined in your Don't forget that retention of records must
laboratory policies. comply with federal, state, and local laws and
• Check these important points: Data safety, IT structure, LIS regulations (use always the more stringent one).
For testing on minors (under the age of 21),
stricter state regulations may apply.

References:
Biswas et al., 2016. Clinical Performance Evaluation of Molecular Diagnostic Tests. J Mol Diagn 18: 803e812; [Link]
Burd et al., 2010. Validation of Laboratory-Developed Molecular Assays for Infectious Diseases. Clin Microbiol Reviews, 23(3): 550–576
Claustres et al. 2014. Recommendations for reporting results of diagnostic genetic testing (biochemical, cytogenetic and molecular genetic).
[Link]
Forbes et al., 2013. Introducing a Molecular Test Into the Clinical Microbiology Laboratory Development, Evaluation, and Validation. Arch Pathol Lab Med.
127:1106–1111
Jennings et al., 2009. Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests. Arch Pathol Lab Med. 133:743–755
Jennings et al. 2017. Guidelines for Validation of NGS - Based Oncology Panels, J Mol Diagn 19(2): 341-365
Li et al. 2017. Standards and Guidelines for Interpretation and Reporting of Sequence Variants in Cancer "J Mol Diagn (19)
Mackinnon et al., 2012. Certification in Molecular Pathology in the United states, J Mol Diagn Vol 16/6
OECD Guidelines for Quality Assurance in Genetic Testing ([Link]

Prepared by the Association for Molecular Pathology International Affairs

Committee and sponsored by the AMP Training and Education Committee
For more educational resources, see: [Link]/AMPEducation

“Molecular in My Pocket” reference cards are educational resources created by the Association of Molecular Pathology (AMP) for laboratory and other health care professionals.
The content does not constitute medical or legal advice, and is not intended for use in the diagnosis or treatment of individual conditions. See [Link] for the full “Limitations of Liability” statement.

7/2023

Prepared by the Association for Molecular Pathology Training and Education Committee
For more educational resources, see: [Link]/AMPEducation

“Molecular in My Pocket” reference cards are educational resources created by the Association of Molecular Pathology (AMP) for laboratory and other health care professionals.
The content does not constitute medical or legal advice, and is not intended for use in the diagnosis or treatment of individual conditions. See [Link] for the full “Limitations of Liability” statement.