Laboratory professionals have long expressed concern about the quality of testing performed in waived laboratories since waived testing is exempt  from federal requirements for personnel qualification and training, quality control (except as specified by the manufacturer), proficiency testing, quality assurance, and the need for routine inspection.  The lack of personnel qualification, training and competency standards is the progenitor of many of these concerns.

As the number of waived testing sites increased dramatically, these concerns led CMS to conduct on-site surveys of a representative sample of these sites in ten states from 1999-2001.  These pilot surveys identified quality issues that could result in medical errors.  Contributing factors included inadequate training in good laboratory practices, and high turnover rates of testing personnel. As a result from 2002-2004, CMS conducted nationwide on-site surveys of Certificate of Waiver facilities to collect additional data that would provide an assessment of testing, promote good laboratory practices, encourage educational outreach, and make recommendations.  The data collected supported the initial findings of gaps in good laboratory practices at these sites.  In addition, a 2001 report issued by the HHS office of the Inspector General identified the lack of routine on site visits to Certificate of Waiver sites by surveyors from state agencies or private accreditation organizations as representing vulnerabilities in these sites.

Since CMS has no education or training requirements for either the director or testing personnel of Certificate of Waiver laboratories, the data collected showed sharp divergences from CLIA regulated non-waived laboratories:  CMS surveys of Certificate of Waiver laboratories showed 69% of laboratory directors were physicians; followed by nurses at 17%.  Subsequent on-site surveys of waived laboratories by state health agencies showed that 59% of laboratory directors were physicians; and 41% had other backgrounds or degrees.

The top categories of Certificate of Waiver laboratory testing personnel, according to CMS data, were nurses (46%), medical assistants (25%), physicians (9%), and (non-specific) high schools graduates (7%). Only 2% of the laboratory directors and testing personnel were trained laboratory personnel (Medical Technologists/CLS, and Medical Laboratory Technicians/CLT).

An interesting finding is that the largest percentage of personnel training in waived labs was conducted by nurses, followed by manufacturer’s representatives.  A significant number of testing staff were self-trained.  The majority of training took place in a day or less.

While the majority of Certificate of Waiver laboratories were aware of and followed some practices to ensure the accuracy and reliability of their testing, lapses in quality were identified at certain sites, some of which could result in patient harm.   For example, 5% of these laboratories surveyed by CMS were determined to be performing tests that were not actually “waived,” and were therefore outside the scope of the laboratory; and thus were performed in the absence of CLIA-required quality measures.

Additionally, of the Certificate of Waiver facilities CMS surveyed:

  • 12% did not have the most recent instructions for the waived test systems they were using
  • 21% reported they did not routinely check the product insert or instructions for changes to the information
  • 21% did not perform Quality Control testing as specified by manufacturer’s instructions
  • 18% did not use correct terminology or units of measure when reporting results
  • 6% failed to adhere to proper expiration dates for the test system, reagents, or control materials
  • 3% failed to adhere to the storage conditions as described in the product insert
  • 6% did not perform follow-up confirmatory tests as specified in the instructions
  • 5% did not perform function checks or calibration checks to ensure the test system was operating correctly

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. CMS surveys of the Certificate of Waiver sites indicated that:

  • 45% did not document the name, lot number, and expiration dates for tests performed
  • 35% did not maintain logs with records of their Quality Control testing
  • 31% did not maintain a log or record of tests performed
  • 9% did not require a requisition or test orders be documented in a patient chart before performing a test.

Among the waived laboratories surveyed, the study found:

  • High staff turnover
  • Lack of formal laboratory education
  • Limited training in test performance & QA
  • Lack of awareness concerning “good laboratory practice”
  • Partial compliance with manufacturer’s Quality Control instructions (approx. 55%- 60%)

As you can see, so many of these issues can be traced back to our starting point:  lack of CLIA requirements for personnel qualification, training and competency assessment. Strategies for addressing these issues must begin with instituting good laboratory practices for hiring qualified personnel, properly training them, and assessing competency.

Resources

  1. CDC MMWR November 11, 2005 /54(RR13): “Good Laboratory Practices For Waived Test Systems”; 1-25.    http://cdc.gov/mmwr/preview/mmwrhtml/rr5413a l.htm.

  2. COLA White Paper: “Federal Government Questions Quality In Waived Testing. The Hard Facts and What Can Laboratories Do Now?” 2013