Because surveying all waived sites is not feasible, the proposed actions to improve and promote quality testing in these sites emphasize the importance of training and competency for site directors and testing personnel. To provide a guide that can be adapted for use, either in part or as a whole, by persons or facilities considering the initiation of waived testing and personnel performing waived testing, CLIAC provided recommendations for good laboratory practices. By implementing these recommendations, Certificate of Waiver sites could improve quality, reduce testing errors, and enhance patient safety.

Considerations Before Introducing Waived Testing, Offering a New Waived Test, or Improving Your Present Operation:

Forethought, planning, and preparation are critical for achieving high-quality waived testing in any type of setting. Questions to address include the following:

  • Management responsibility for testing. Who will be responsible and accountable for testing oversight at this waived site, and does this person have the appropriate training for making decisions on testing?
  • Safety. What are the safety considerations for persons conducting testing and those being tested?
  • Testing space and facilities. What are the physical and environmental requirements for testing?
  • Staffing. Are there sufficient personnel to conduct testing, and how will they be trained and maintain testing competency?
  • Documents and records. What written documentation will be needed, and how will test records be maintained

Management Responsibility

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. The management staff should demonstrate a commitment to the quality of testing service by promoting good laboratory practices.

Testing Environment

Some tests have specific environmental requirements described in the manufacturer’s product insert that need to be met to ensure reliable test results. Factors to consider include:

  • Humidity- Unusually high, low, or extreme fluctuations in humidity can cause deterioration of reagents and test components, affect the rate of chemical reactions and specimen interaction, or make test endpoints blurred and difficult to read.
  • Temperature- Temperature ranges for storage of test components and controls and for test performance are defined by the manufacturer to maintain test integrity. Extreme temperatures can degrade reagents and test components, impact reaction times, cause premature expiration of test kits, and affect the test results.
  • Lighting- Inadequate lighting can negatively affect specimen collection, test performance, and interpretation of test results.
  • Work space- Work surfaces should be stable and level and be able to be adequately disinfected; work space should be adequate in size for patient confidentiality, ease of specimen collection, test performance, and storage of supplies and records.

Cost Considerations

A fiscal assessment of testing is part of a good management program. Before offering a new test, consider the level of reimbursement and factors that contribute to total test cost. These factors include:

  • Test kits or instruments, supplies not provided with the test, control and calibration materials, inventory requirements for anticipated test volume (including seasonal testing), and the shelf life of test components and supplies.
  • Equipment maintenance, such as repairs or preventive maintenance contracts.
  • Additional safety and biohazard equipment.
  • Personnel training, competency assessment, and the potential need for additional personnel.
  • Recordkeeping and information systems.

Personnel Considerations

Personnel competency and turnover are important factors affecting the quality and reliability of waived testing results. No CLIA requirements exist for waived testing personnel qualifications; however, applicable state or local personnel regulations must be met. Personnel issues to consider include:

  • Is staffing adequate?
    • Determine whether employees have sufficient time and skills to reliably perform all activities needed for testing in addition to their other duties.
    • Be aware that temporary or part time personnel might be less proficient in performing testing.
    • Evaluate staff for color-blindness because this can limit their ability to interpret test results based on color endpoints.
  • How much training will be needed?
    •  Take into account the staff turnover rate and the ongoing need to provide training for new personnel.
    • Factor in the time and resources for adequate training and competency evaluation of staff before they perform testing.
    • Consider how testing personnel will maintain competency, especially when testing volume is low.

Developing Procedures and Training Personnel

It is good laboratory 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 form the basis of training for testing personnel. These procedures should be derived from the manufacturer’s instructions and should be in a language understandable to testing personnel.

Personnel Training

Trained and competent testing personnel are essential to good quality testing and patient care. Personnel should be trained and competent in each test they will perform before reporting patient results. In addition, training should include aspects of safety (including Universal Precautions) and QC. The 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. Training checklists are helpful to ensure the training process is comprehensive and documented.

The training process

Training should be provided by a qualified person (e.g., experienced co-worker, facility expert, or outside consultant) with knowledge of the test performance, good laboratory practices, and the ability to evaluate the efficacy of the training.

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. Assessment activities should be conducted in a positive manner with an emphasis on education and promoting good testing practices. Competency can be evaluated by methods such as observation, evaluating adequacy of documentation, or the introduction of mock specimens by testing control materials or previously tested patient specimens. External quality assessment or evaluation programs, such as voluntary PT programs, are another resource for assessment.

Additional Measures to Help Testing Staff Ensure Reliable Results

The site director or person overseeing testing should promote quality testing and encourage staff to ask questions and seek help when they have concerns. Recommendations include:

  • Identifying a resource person or expert (e.g., a consultant or manufacturer’s technical representative), available either off-site or on-site, to answer questions and be of assistance.
  • Posting telephone numbers for manufacturers’ technical assistance representatives.
  • Designating an appropriately trained person, who understands the responsibilities and impact of changing from one test system to another, to discuss new products with sales representatives.

This is a fairly extensive list of actions that a Certificate of Waiver facility can take. It is very comprehensive, indicating the systemic nature of any laboratory operation. Quality failures often are not due to just a single factor, but to a multiplicity of factors that need to be addressed, for a successful outcome.

1. CDC MMWR November 11, 2005 /54(RR13): “Good Laboratory Practices For Waived Test Systems”; 1-25. l.htm.
2. COLA White Paper: “Federal Government Questions Quality In Waived Testing. The Hard Facts and What Can Laboratories Do Now?” 2013