Good Lab Practices for Waived Testing: Management Responsibilities

LabOratory – Physician Office Resource, September 2016

   Good Lab Practices for Waived Testing: Management Responsibilities

 

By Irwin Z. Rothenberg, MBA, MS, M.T. (ASCP),Technical Writer /Quality Advisor, COLA Resources, Inc.

 

Waived tests, defined as "simple tests with an insignificant risk of an erroneous result," are so designated because they are waived from most federal oversight requirements. Thus, facilities performing only waived testing are only required to obtain a Certificate of Waiver (CW), pay biennial certificate fees, and follow manufacturers' test instructions. They have no CLIA requirements for personnel qualifications and training, quality control (QC) (unless specified as required in the test system instructions), proficiency testing (PT), and routine quality assessment)[i].

Patient Safety Concerns Related to Waived Testing

Nonetheless, waived tests are not completely error-proof, and are not always used in settings that employ a systemic approach to quality and patient safety. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system and how testing is integrated into the facility's workflow[ii].

A lack of required management oversight and requirements for personnel qualifications and training is a concern, and may contribute to errors and patient harm. A key contributing factor has been inadequate training in good laboratory practices. These are management practice standards to ensure the quality, reliability, and integrity of laboratory testing.

Good laboratory practices begin with the assignment of roles and responsibilities to staff in order to ensure good operational management (planning, monitoring, recording, reporting, archiving) of all phases of testing (pre-analytic, analytic, and post-analytic)[iii].

Following is a summary of good laboratory practices applied to all phases of waived testing:

A. Prior to Introducing Waived Testing or Adding New Waived Tests

Management Responsibility and Commitment

Each testing site should identify at least one person responsible for testing oversight and decision-making. In POLs, this might be a physician or someone in a senior management position who has the appropriate background and knowledge to make decisions about laboratory testing.

Personnel Considerations

Personnel competency and turnover are important factors affecting the quality and reliability of waived testing results. While no CLIA requirements exist for waived testing personnel qualifications, all applicable state or local personnel regulations must be met. Personnel issues to consider include assessment of present staffing as to whether employees have sufficient time and skills to reliably perform all activities needed for testing; and whether adequate training and competency assessment is performed.

Written Test Procedures

It is good practice to develop written policies and procedures so that responsibilities and testing instructions are clearly described for the testing personnel and facility director. The testing procedures also form the basis of training for testing personnel. These procedures should be derived from the manufacturer's instructions, and should include directions for specimen collection and handling, control procedures, test and reagent preparation, and instructions for test performance, interpretation, and reporting.

A comprehensive procedure manual is a valuable resource for CW sites. New testing procedures should be reviewed and signed by the CW site director before incorporating them into the procedure manual. The manual should be updated as tests or other aspects of the testing service change and should be reviewed by the director whenever changes are made. When procedures are no longer used, they should be removed from the manual.

Personnel Training

Personnel should be trained and competent in each test they will perform before reporting patient results. The CW site director or other person responsible for overseeing testing should ensure that testing personnel receive adequate training and are competent to perform the procedures for which they are responsible.

Competency Assessment

To ensure testing procedures are performed consistently and accurately, periodic evaluation of competency is recommended, with retraining, as needed, on the basis of results of the competency assessment.

B. Recommended Practices Pre-Testing

Before collecting the specimen, confirm the test(s) ordered and the patient's identification and verify that pretest instructions or information, as applicable, have been provided. This includes:

  • Test orders - CW sites performing various waived tests should routinely confirm that the written test order is correct. If there is a question, check with the ordering clinician.
  • Patient identification - Identify the patient before collecting the specimen. Because names can be similar and lead to confusion, use birth dates, middle initials, identification numbers, or other means to ensure the specimen is collected from the correct patient.
  • Pretest instructions - Some tests require special preparation on the patient's part (e.g., a fasting state for glucose testing). Provide the patient with pretest instructions, when appropriate, and when special preparation is needed, verify that patients received instructions before testing.

Specimen Collection and Handling

The product insert provides details on proper collection, handling, and storage of patient specimens. Collect waived test specimens exactly as described in the test system instructions. Improperly collected, stored, or compromised specimens should not be tested.

C. Recommended Practices During Testing

Important activities during the testing phase include QC testing, test performance, result interpretation and recording.

Quality Control Testing

Performing QC testing procedures provides assurance that the test performs as expected and alerts the user when problems occur. QC testing is designed to detect problems that might arise because of operator error, reagent or test kit deterioration, instrument malfunction, or improper environmental conditions. Test procedures should describe the type of controls to be used, how to perform QC testing (including QC testing frequency), and corrective actions to be taken when QC results are unacceptable.

Documenting and monitoring control testing results provides an indication that the test was properly performed by the operator and the test system (reagents, instruments, or any components) performed as expected. Records of control results should be periodically reviewed to detect shifts or changes in performance over time.

Performing the Test

The following points are important to remember when performing the test:

·         Follow the steps in the test procedure in the exact order described in the product insert.

·         Test controls at the frequency determined by the CW site.

·         Pay attention to timing for waived tests.  Incorrect timing of these types of tests can give erroneous test results.

Test Results Interpretation

When the test is complete, interpret the results according to instructions in the product insert.

Resolving Problems

If a discrepancy is identified between the patient's test results and the clinical information or if the results are invalid or otherwise compromised, testing should be repeated. Results should not be reported until the problem is resolved. Follow the steps in the product insert to resolve problems with test results.

Recording Results

Results can be recorded directly in a patient's chart, in log books, or on a separate report form. If a test result is not acceptable or requires repeat testing (e.g., out of range or invalid), record the initial result, noting it was unacceptable, take steps necessary to resolve the problem, then record the correct result. Good laboratory practices include recording what happens, whether acceptable or not, and what is done to correct problems encountered during testing.

D. Recommended Practices Post-Testing

Test Reports

After the completion of the test, results should be documented and reported. Patient reports should be legible and reported in a timely manner to the appropriate person. Verbal reports of test results should be documented and followed by a written report.

Critical values are test results necessary for patient evaluation or treatment that require immediate notification to the clinician. Each site should define the critical values, if appropriate, for the tests in use and ensure that testing personnel are aware of these values and the procedure for alerting the clinician. Procedures should be in place to ensure documentation of critical values and timely notification of the proper medical personnel.

Confirmatory Testing

The product insert should explain when supplemental testing is needed to confirm a waived test result or when the test is to be used as part of a multi-test algorithm. When non-waived confirmatory testing is needed, the patient can be sent to another facility for specimen collection and testing, or the specimen can be collected at the CW site and sent to a referral laboratory.

Maintaining recordsof referred testing is important for patient care and follow-up. Logs and other records should have sufficient information to track and retrieve the test results and reports.

Documents and Records

Documentation is essential to assure quality waived testing. Proper documentation is necessary for monitoring and assessing test performance, identifying and resolving problems that could affect patient testing, retrieving and verifying information, and maintaining adequate patient and personnel records. Log books or electronic systems can be used for maintaining and tracking information. In some cases, records might be part of the patient's medical chart.

Quality Assessment

Good laboratory practices can be expanded to include assessment activities to evaluate and improve the quality of CW site testing.

Conclusion

These recommendations are intended to serve as a guide to improve the quality of testing in CW sites and enhance patient safety. Continued surveillance and monitoring of waived testing performance by those in management is needed to ensure the effectiveness of these GLP recommendations in protecting and improving the public health.                    

 

[i] Laboratory Requirements, 42 C.F.R. Chapter IV, Part 493 (2003).

 

[ii] CDC. Transmission of hepatitis B virus among persons undergoing blood glucose monitoring in long-term-care facilities---Mississippi, North Carolina, and Los Angeles County, California, 2003--2004. MMWR 2005;54:220--3.

 

[iii]Much of the information in this report was gleaned from “Good Laboratory Practices for Waived Testing Sites: Survey Findings from Testing Sites Holding a Certificate of Waiver Under the Clinical Laboratory Improvement Amendments of 1988 and Recommendations for Promoting Quality Testing,” which appeared in the CDC’s MMWR, Reports and Recommendations, November 11, 2005. Report prepared by D. Howerton, N. Anderson, D. Bosse,S.Granade, and G. Westbrook. The material in the MMWR report originated in the Coordinating Center for Health Information and Service, Steven L. Solomon, MD, Director; National Center for Health Marketing, Jay M. Bernhardt, PhD, Director; and the Division of Public Health Partnerships, Robert Martin, DrPH, Director.

 

 

Irwin Z. Rothenbergis a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals. CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

 

 

 

 


Irwin Z. Rothenberg, MBA, MS, M.T. (ASCP)

Technical Writer/ Quality Advisor, COLA Resources, Inc.