Monday, February 07, 2022

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

Introduction

The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) created the concept of waived tests which are defined as tests that are so simple to perform, and produce accurate results so reliably, as to render the likelihood of erroneous results negligible; and which also pose no reasonable risk of harm to the patient even if the test is performed incorrectly. Thus, these tests are exempt from federal requirements for personnel qualification, training, and competency assessment; quality control (except as specified by the manufacturer), proficiency testing, quality assessment, and the need for routine inspection 

As a result, laboratory professionals have long expressed concern about the quality of testing performed in these laboratories.  This concern has only grown with the rapid proliferation of waived tests, along with point of care /remote testing sites. 

Quality Concerns 

As a response to these concerns, both CMS and the CDC conducted random surveys of waived laboratories several years after CLIA 88 was enacted.  These labs had significant quality issues, including the lack of available written procedures; adequate personnel training, quality control performed as required; also, the lack of a proper attention to reagent expiration dates and storage requirements; and the failure to enter test results into electronic medical records[i].   Although not usually specified in the product insert (and therefore not a CLIA requirement), proper documentation and recordkeeping of patient and testing information are also important elements of good laboratory practices.

 Among the waived laboratories surveyed, the study also found[ii]:

• High staff turnover
• Lack of formal laboratory education
• Limited training in test performance and quality assessment

 Strategies to Address These Concerns

1. Competent Management and Organization

To be effective, efforts to achieve quality waived testing through good lab practice must start even before the testing process, all the way back to assessing the laboratory structure, organization, and purpose. These include: 

1. Commitment to Constant Oversight of the Testing Process

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. 

1. Anticipating and Addressing Personnel Needs

Personnel competency and turnover are important factors affecting the quality and reliability of waived testing results. While there are no CLIA requirements for personnel performing waived testing, all applicable state or local personnel regulations must be met.

 Personnel issues to consider include assessment of present staffing levels and training, to ascertain whether employees have sufficient time and skills to reliably perform all activities needed for testing. 

1. Personnel Training

Personnel should be trained and competent in each test they will perform before reporting patient results.   It is the responsibility of the laboratory director or other supervisory staff to ensure that this training has occurred, along with proper documentation of these efforts. 

2. 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.

1. Development and Maintenance of Procedure Manuals

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

New testing procedures should be reviewed, signed, and dated by the laboratory 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, the date of discontinuance should be noted, and they should be removed from the manual.  The manual should always be readily available to all testing personnel.

1. Maintenance of Complete and Accurate Documents and Records

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. 

1. Performance of Quality Assessment

Good laboratory practices can be expanded to include activities to evaluate and improve the quality of waived site testing, utilizing both internal and external quality assessment activities. Results from these assessment activities should be documented and evaluated, noting any irregularities and the actions taken to resolve problems or improve processes or procedures. 

1. Follow Best Practices During Testing

1. The Pre-analytic phase[iii]
2. Test orders

Confirm that the written test order is correct. If there is a question, check with the ordering clinician before proceeding. 

2. Patient identification

Use two unique identifiers to ensure accurate identification of the patient before the specimen is collected. Names can be similar and lead to confusion, therefore use birth dates, middle initials, patient identification numbers or other means to ensure correctness. 

3. Pretest instructions and information

Some tests require special preparation on the patient’s part (e.g. fasting), or that the patient collect the specimen (e.g. urine or stool). Provide the patient with pretest instructions when appropriate, and verify that patients have received and understood the instructions before collecting or accepting the specimen. 

4. Specimen collection and handling

The product insert provides details on proper collection, handling and storage of patient specimens. Specimens need to be adequately labeled to prevent mix-up. Always label specimens as soon as they are collected with pertinent patient information. Labeling should also include the date and time of collection and identification of the collector. 

1. The Analytic Phase[iv]
2. Quality Control (QC)

Quality control provides assurance that the test system has performed as expected, and alerts the user when problems occur which may affect patient results; these can be problems due to operator error, reagent or test kit deterioration, instrument malfunction or improper environmental conditions.

If quality control testing fails to perform as expected, patient testing should not be performed or results should not be reported until the problem is identified and corrected. QC test results should be recorded and monitored. Records of control results should be periodically reviewed by the person responsible for testing oversight to detect shifts or changes in performance over time which may affect patient results. 

2. Test Performance

Follow the steps in the test procedure exactly as described in the manufacturer’s product insert and /or the written procedures. 

3. Results Interpretation.

Results can be recorded directly in a patient's chart, in log books, or on a separate report form. Interpretation of the results should be in accordance with instructions in the product insert. 

4. Resolving problems

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 repeat the test and record the correct result. Good laboratory practice includes recording what happens, whether acceptable or not, and what is done to correct problems encountered during testing. Results should not be reported until the problem is resolved. Follow the steps in the product insert to resolve problems with the test results. If repeat testing does not resolve the problem, contact the manufacturer or technical representative. 

1. The Post-analytic phase[v]:
2. Reporting Test Results

Patient reports should be legible and reported in a timely manner to the appropriate person. All verbal reports of test results should be documented and followed by a written report. Critical values require immediate notification of the clinician, and procedures should be in place to ensure documentation of these values along with the time of notification of the proper medical personnel. 

2. Confirmatory testing

The product insert should explain when additional testing is needed to confirm a waived test result or when the test is to be used as part of a multi-test algorithm (e.g. throat culture needed to confirm a negative result for rapid group A strep antigen). There should be written policies and procedures to ensure that all confirmatory and supplemental testing is performed when needed. When collecting specimens for referral to another laboratory, the instructions provided by the reference laboratory must be followed, and the appropriate request form completed. 

3. Maintaining records of referred testing

Important for patient care and follow-up. Logs and other records should have sufficient information to track and retrieve the test results and reports, such as:

• Information linking the referred specimen to patient identification.
• The name and contact information for the referral laboratory.
• The test name and date referred.
• Complete test results and the date received.
• The date the final report is issued. 

A designated employee should be responsible for ensuring that all tests ordered from a referral laboratory are returned and charted appropriately for review by the ordering clinician.

Conclusion

The findings of multiple surveys of sites performing waived testing throughout the United States have shown widespread lapses in quality. These studies highlight the need additional education, training and planning related to waived testing for Certificate of Waiver laboratory directors and testing personnel. 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for 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.

[i] Howerton, D., Anderson, N., Bosse, D., Granade, S. and G. Westbrook.  Division of Public Health Partnerships, National Center for Health Marketing, Coordinating Center for Health Information and Service.   “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.” CDC/ MMWR, Reports and Recommendations, November 11, 2005. 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.  https://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf

[ii] Ibid.

[iii] Ibid.

[iv] Ibid. 

[v] Ibid