D.42- WAIVED TESTING REGULATIONS.pdf

Pathology & Laboratory Medicine Service VA Central Office 1575 I Street NW Washington, DC 20006

PLMS.8 Waived Testing Regulations

Copy of version 1.1 (approved and current)

Last Approval or Periodic Review Completed

3/4/2022

Next Periodic Review Needed On or Before

3/4/2024

Effective Date 3/4/2022

Controlled Copy ID 11946

Location P&LMS Website and P&LMS Education Center SharePoint

Organization VA Central Office

Comments for version 1.1 Added page breaks for correct spacing

Approval and Periodic Review Signatures

Type Description Date Version Performed By Notes

Periodic review

SME 3/4/2022 1.1

Jill Hancock

Periodic review

Supervisor 3/4/2022 1.1 Anne Chenow eth

Approval Lab Director 3/25/2020 1.0 Anne Chenow eth Recorded w hen document uploaded to MediaLab

Periodic review

Designated Review er

3/25/2020 1.0 Anne Chenow eth Recorded w hen document uploaded to MediaLab

Signatures from prior revisions are not listed.

Approvals and periodic reviews that occured before this document was added to the MediaLab Document Control system may not be listed.

Version History

Version Status Type Date Added Date Effective Date Retired

1.1 Approved and Current Minor revision 3/2/2022 3/4/2022 Indefinite

1.0 Retired First version in Document Control 2/10/2022 3/25/2020 3/4/2022

D.42- WAIVED TESTING REGULATIONS RFP 36C24225R0047

Department of Veterans Affairs

VHA Laboratory Waived Testing Regulations

Reagents VA College of American Pathologists Joint Commission New lots of reagents must be verified. The verification must meet the manufacturer’s requirements at a minimum.

Must follow CLIA and accrediting agency requirements.

Reagents cannot be used beyond the expiration date.

Process in place to track reagent lot numbers.

Lot-to-lot reagent verification not required.

Follow manufacturer instructions and include these instructions in the written procedure for each waived test.

Reagents cannot be used beyond the expiration date.

Follow manufacturer instructions.

Reagents cannot be used beyond the expiration date.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

Controlled copy ID 11946. Printed on 3/25/2022 10:19 AM (EDT). Page 1 of 13

Competency and Personnel VA College of American Pathologists Joint Commission A system is in place to provide ongoing assessment of the competency of the individuals performing patient testing.

Ancillary Testing Coordinator ensures that training and competency assessment for all persons who perform ancillary testing is completed and that employee records are complete

The lab director determines who performs tests in written policy and they should maintain a list of authorized operators and preceptors testing.

Prior to starting patient/client testing and prior to reporting results for new methods or instruments, each individual must have training and be evaluated for proper test performance.

After an individual has performed his/her duties for one year, competency must be assessed annually.

Retraining and reassessment of competency must occur when problems are identified with an individual's performance.

Written procedure defining the method and frequency for assessing competency.

Competence is assessed according to hospital policy at defined intervals, but at least at the time of orientation and annually thereafter.

Note: Staff who perform instrument-based testing, including but not limited to physicians, licensed independent practitioners, contracted staff and RN’s participate in training and competence demonstrations

When a licensed independent practitioner performs waived testing that does not involve an instrument and the test falls within his or her specialty, the organization may use the medical staff credentialing and privileging process to document evidence of training and competency in lieu of annual competency assessment.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Competency Elements

Follow accrediting agency requirements. It is not necessary to assess all six elements listed below at each assessment event. The POCT program may select which elements to assess. Elements of competency assessment include but are not limited to:

1. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing

2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results

3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records

4. Direct observation of performance of instrument maintenance and function checks, as applicable

5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and

6. Evaluation of problem-solving skills

Current competency is assessed using at least two of the following methods per person per test:

1. Performing a test on a blind specimen

2. Having the supervisor or qualified delegate periodically observe routine work

3. Monitoring each user’s quality control performance

4. Use of a written test specific to the test assessed

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Initial Correlation

Initial correlation studies must be performed between the new test or method and current instruments or methods providing results for the same analyte. The extent of the correlations can be defined by the laboratory director or designee

For testing sites located on a different campus or address but within the same healthcare system, correlations must be performed between the main medical center laboratory and the remote testing site to define relationship between all test methods (waived and non-waived) prior to the implementation of new tests or methodologies.

Initial correlation between waived instruments

Glucose meters—not required

Initial correlation between waived instruments

Glucose meters—not required

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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6 Month Correlation

Correlation studies must be performed between non-waived and waived instruments/tests semiannually within the same CLIA number and/or address. The non-waived to waived correlation can be performed on a rotating subset of waived instruments. The extent of the correlations can be defined by the laboratory director in written policy

Correlation studies between multiple instruments/methods (waived to waived) are not required on an ongoing basis.

Proficiency survey samples or patient samples may be used for this correlation study provided they are compared with predefined acceptability.

Correlation between waived instruments and main lab instrument not required.

Multi-instrument comparison not required

Correlation between waived instruments and main lab instrument not required. Multi-instrument comparison not required

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

Controlled copy ID 11946. Printed on 3/25/2022 10:19 AM (EDT). Page 5 of 13

Quality Control

Follow manufacturer instructions and include these instructions in the written procedure for each waived test.

Quality control is verified in accordance with current accepted scientific guidelines or accrediting agency requirements

When a manufacturer does not specify QC requirements, the laboratory should assess the testing process and implement a QC plan based on Risk Assessment. The CLSI Guidelines, EP18-A2 and EP23-A, are recommended references to perform a risk assessment.

Follow manufacturer instructions and include these instructions in the written procedure for each waived test.

Follow manufacturer instructions and organization policy Lab Director approves written quality control plan for waived testing that specifies the method(s) for controlling procedures for quality, establishes timetables, and explains the rationale for choice of procedures and timetables.

The documented quality control rationale for waived testing is based on the following:

- How the test is used

- Reagent stability

- Manufacturers' recommendations

- The organization's experience with the test

- Currently accepted guidelines

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Quality Control Documentation

Patient and quality control test results, internal and external, must be documented.

For non-instrument based waived patient tests performed by privileged providers (such as occult blood tests), the quality control results may be documented in the patient chart or in separate logs.

The quality control lot number used for the patient testing must also be documented.

Must follow accrediting agency requirements.

Staff must record and review quality control data on days when controls are run prior to reporting patient results

With respect to internal controls, acceptable control results must be documented, at a minimum, once per day of patient testing for each device.

Internal control results need not be documented for instruments using such controls if, and only if, an unacceptable instrument control automatically locks the instrument and prevents the release of patient results

Document corrective action if control results exceed tolerance limits

The Laboratory Director or designee must review QC data at least monthly.

Quality control test results are documented, including internal and external (liquid and electronic).

Quality control results may be located in the clinical record

Individual test results are associated with quality control and instrument records.

Note: A formal log is not required, but a functional audit trail is maintained that allows retrieval of individual test results and their association with quality control and instrument records.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Quality Control Frequency

Must follow manufacturer and accrediting agency requirements.

Frequency of QC is defined by the manufacturer and external controls run as required by the manufacturer

Quality control procedures are performed at least as frequently as recommended by the manufacturer or defined by the hospital’s policies.

For instrument-based waived testing, quality control requirements include two levels of control, if commercially available. Quality control procedures are performed at the frequency required by the manufacturer instructions.

The director named on the CLIA certificate establishes a written quality control plan that specifies how procedures will be controlled for quality, establishes timetables, and explains the rationale for choice of procedure and timetables.

Calibration and Calibration Verification VA College of American Pathologists Joint Commission Must follow manufacturer and accrediting agency requirements.

Follow manufacturer instructions and include these instructions in the written procedure for each waived test.

Calibration verification every six months is not necessary unless required by the manufacturer. Maintain records for calibration/calibration verification-related functions as required by the manufacturer and records of recalibration or other appropriate corrective action when calibration verification is unacceptable

Follow manufacturer instructions.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Analytical Measurement Range

Must follow manufacturer and accrediting agency requirements.

Follow manufacturer instructions and include these instructions in the written procedure for each waived test.

Initial analytical measurement range verification and six-month interval verification are not necessary unless required by the manufacturer.

Follow manufacturer instructions.

Method Performance Specifications VA College of American Pathologists Joint Commission The method must be verified. The verification protocol is at the discretion of the Lab Director or designee. It must meet the manufacturer and accrediting agency requirements at minimum.

Test must be performed following the manufacturer instructions exactly. If the manufacturer instructions are modified, the checklist requirements for high complexity testing apply

Follows manufacturer's instructions for the introduction of the instrument or device

Test must be performed following the manufacturer instructions exactly. If the manufacturer instructions are modified, the checklist requirements for high complexity testing apply.

Changes in the specimen type or collection device are examples of common modifications

Follow local policy. The Joint Commission would expect that VA requirements would also be followed.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Proficiency Testing

Each P&LM and all Ancillary Testing Sites must subscribe to external proficiency testing programs that meet CLIA’88 requirements for all analytes for which proficiency testing is available, including waived testing and unregulated analytes.

For analytes that do not have proficiency testing available, an alternative method must be in place to assess the method accuracy at least twice a year (e.g., split samples analyzed in conjunction with another laboratory, or testing materials with assigned values as unknowns).

The laboratory must perform proficiency testing on every instrument/method (including backups) utilized for patient testing and for every site where patient testing is performed.

The laboratory director delegates who can sign PT attestation pages.

Proficiency testing requirements are the same for Waived and non-Waived testing.

Multiple instrument reporting not required

Follow local policy. The Joint Commission would expect that VA requirements would also be followed.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Result Reporting

All laboratory tests, regardless of where they are performed, will have the results entered into the laboratory module of the patient’s electronic medical record.

Tests must be interfaced when available by the vendor.

If the test is not interfaced, the laboratory must have a written quality system in place to ensure timely review of the accuracy of manually entered results.

Privileged providers performing waived testing as a part of their routine exam may enter testing results in the progress notes.

All other results (qualitative or quantitative) require entry into laboratory module of the VHA computer system.

Results are reported with reference (normal) intervals or interpretations as appropriate

Test results for waived testing are documented in the patient's clinical record.

Quantitative test result reports in the patient's clinical record for waived testing are accompanied by reference intervals (normal values) specific to the test method used and the population served.

Semiquantitative results, such as urine macroscopic and urine dipsticks, are not required to comply with this element of performance.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Procedure Manual

Standards, procedures, and policies are developed for reporting of timely, accurate, reliable and clear test results.

Policies for detection of potential errors or differences in test results for the same analyte between the clinical laboratory and all ancillary testing sites in the VA medical facility are established.

All test methods and instruments must have clearly written manuals available in each testing area to substantially comply with current laboratory accreditation requirements.

Appropriate written policies and procedures are in place for a comprehensive QM Program designed to monitor, evaluate, and improve the overall quality of the laboratory testing process in all testing sites in the medical center and its outreach functions, including ancillary testing and satellite outpatient laboratories. These policies must meet the requirements of the accrediting agencies.

All laboratory testing, functions, and/or processes must be addressed in written policies and/or procedures, with appropriate approval, to assure clarity and consistency. The procedure manual should be used by personnel at the workbench and must include the elements listed in the Procedure Manual section of the CAP All Common Checklist

The manual should address relevant pre-analytic and post-analytic considerations, as well as the analytic activities of the laboratory. The specific style and format of procedure manuals are at the discretion of the laboratory director.

All processes need to be in document control and available to all applicable personnel.

The laboratory has procedures for each laboratory test.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

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Other

Other VA Privileged Provider Minimal Testing Requirements - Personnel performing procedures must follow good laboratory practices in terms of quality control, quality assurance, and proficiency testing.

Written policies and procedures must be in place for performance.

Other checklist requirements— proficiency testing, instrument maintenance, procedure manuals, personnel, specimen handling, results reporting, and safety—remain the same for waived and non-waived testing.

Approved and current. Effective starting 3/4/2022. PLMS.8 (version 1.1) Waived Testing Regulations

Controlled copy ID 11946. Printed on 3/25/2022 10:19 AM (EDT). Page 13 of 13