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Highlights of Changes Included in the Clinical Laboratory Improvement Amendments of 1988 Final Rule Published January 24, 2003


Note: These changes, listed below, apply to "nonwaived" (moderate and high complexity only) laboratory tests. No changes to current "waived" testing requirements. Provider Performed Microscopy (PPM) tests are moderate complexity "non-waived" tests with special personnel standards. The changes, listed below, apply to PPM tests.

Retention Requirements

  • Laboratories ceasing operation must now make provisions to retain and to make available records and specimens such as slide and tissue blocks, as applicable, for the amount of time specified as if the laboratory were in operation. [NEW]

Proficiency Testing (PT) Review Requirements

  • Regulated analytes (those listed in Subpart I of the regulation) that are not evaluated or scored by a PT program must be evaluated for accuracy by the laboratory. [Now specified - though previously implied]
  • Any analyte, specialty, or subspecialty assigned a score that does not reflect the laboratory's performance must be evaluated for accuracy by the laboratory. Conditions meeting this requirement include:
    • 100% score given due to analyte, specialty, or subspecialty not being graded because of a lack of consensus
    • 0% score given due to lab's failure to participate in PT
    • 0% score given due to lab's failure to return results to PT program in required timeframe [Now specified - though previously implied]

Procedure Manual

The previous standard required Moderate Complexity laboratories to have a "procedure manual describing the processes for testing and reporting patient test results." However, the new requirements list 14 specific elements for ALL laboratories to include in a procedure. Most of these elements will be contained in a manufacturer's package insert. Two elements, specific to each laboratory, that may need to be updated in a Moderate Complexity laboratory are as follows:

  • Description of the laboratory's system for entering results in the patient record and reporting patient results including when and how to report imminent life threatening results, or panic, or alert values. [Previous Requirement]
  • Description of what steps are to be taken if a test system (instrument or kit test) becomes inoperable. [NEW]

The regulation specifies that manufacturer instructions may be used for meeting all requirements except for the two listed above. [NEW - for Moderate Complexity tests]

Test Systems, Equipment, Instruments, Reagents, Materials, and Supplies

Most of this section, while new to moderate complexity labs specifically, has in actuality been covered by the requirement to "follow all manufacturer's instructions." [Now specified - though previously implied]

  • Labeling of reagents is new to moderate complexity laboratories. All reagents, solutions, culture media, control materials, calibration materials, as appropriate, must be labeled to indicate the following:
    • Identity and if relevant - titer, strength, or concentration
    • How it is to be stored
    • Dates for when it was prepared and when it expires
    • Other pertinent information

Many of these things will already be on reagent bottles and kit boxes when you receive them. Be alert for kits and reagents with an expiration date that changes upon opening. The new expiration date should be placed on the item at the time of opening. [NEW - for moderate complexity tests]

Establishment and Verification of Performance Specifications

This section modifies the previous high complexity requirements for the establishment and verification of performance specifications to include some less stringent requirements for those tests that are FDA approved. This section implements the performance specification requirements on moderate complexity tests. The requirements are broken down into FDA approved tests and non-FDA approved tests or FDA-approved tests that have been modified or "home-brew" tests, rather than moderate or high complexity. [NEW]

  • A grandfather clause is established. Tests being used in the laboratory prior to April 24, 2003, do not have to meet this requirement. [NEW]
  • New tests introduced into the laboratory after April 24, 2003, must be assessed for:
    • Accuracy (closeness to the true value)
    • Precision (ability to get the similar values on the same specimen)
    • Reportable range (range of values over which the instrument or test system is accurate)

The results of the assessment obtained by the individual laboratory should be comparable to the claims of the manufacturer for the test system or instrument. [NEW]

  • If the manufacturer's reference (normal value) range is going to be used by the laboratory it must verify that the range stated is appropriate for the laboratory's patient population. [NEW - for Moderate Complexity tests]

Calibration and Calibration Verification Procedures

  • Additional requirements for Calibration and Calibration verification are present for previously moderate complexity tests, but are the same as the previous high complexity requirements. [NEW - for Moderate Complexity tests]
  • The previous standard required calibration verification every 6 months. This remains the same with calibration verification required additionally under the following conditions:
    • Whenever a complete change of reagents is introduced (there is an exception to this upon certain documentation).
    • Whenever major preventative maintenance is done on an instrument or a critical part is replaced
    • Whenever controls materials do not perform as expected (trend, shift, out of range) and other methods of assessment fail to identify and correct the problem
    • Whenever verification of patient reportable range is more frequent than 6 months [NEW - for Moderate Complexity tests]

Control Procedures

A number of requirements specified within this section will be met if manufacturer directions are followed. A few that are either slightly different from the previous high complexity test requirements or that deserve attention are highlighted below:

  • For each test system that has an extraction phase, include two control materials, including one that is capable of detecting errors in the extraction process. [Modification]
  • When using calibration material as a control, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. [NEW]
  • Check each batch or lot number and shipment of reagents, disks, stains, antisera and identification systems when prepared or opened for positive and negative reactivity if applicable. [NEW - for Moderate
  • Complexity tests if not previously specified in manufacturer's instructions]
  • Check each batch of (bacteriological or immunological) media for sterility if sterility is required for testing. [NEW for Moderate complexity tests}
  • One option that could reduce the frequency of control testing is included in these new regulations. The laboratory can set its own number, type, and frequency of testing the control materials if it can document that its control procedures can detect immediate errors due to a test system failure, adverse environmental conditions, and operations performance that monitor the accuracy and precision of the method over time. Control procedures that differ from the regulations must be approved by CMS. This gives much more flexibility to laboratories that wish to reduce their control costs on test systems that are stable. A little homework needs to be done, but this is an option that did not exist in the prior regulations. [NEW]

Comparison of Test Results

This section combines several sections of the previous Quality Assurance regulation. However, there is an additional criterion in the patient test assessment section and a documentary requirement that previously did not exist, see below. [Modified]

  • The laboratory must have a system to identify and assess patient results that appear inconsistent with the following criteria:
    • Patient age
    • Sex
    • Diagnosis or pertinent clinical data
    • Distribution of patient test results
    • Relationship with other test parameters (NEW)

All test result comparison activities must be documented. (NEW)

Test Report

This section did not change significantly. It addresses some of the newer means of transmitting laboratory results that the previous regulation did not address. Among the highlights of the changes are:

  • Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. [Now specified - previously allowed]
  • Either the patient's name and identification number, or two identifiers must be contained in the report for positive patient identification. [Modification]
  • The test result and, if applicable, the units of measurement or interpretation, or both. [Modification - addition of interpretation]

Quality Assessment

Throughout the regulation are sections specifying the requirement for assessing each step in the testing process: pre-analytical, analytical, and post-analytical. These requirements essentially have the same three steps to them throughout the testing process:

  • Establish and follow written policies and procedures…to monitor, assess, and when indicated, correct problems.
  • The assessment must include a review of effectiveness of corrective actions taken to resolve problems, policy and procedure changes for prevention of problems, and discussion of the assessment and changes with appropriate staff.
  • The assessment activities must be documented.

The above steps replace the Quality Assurance review activities (plan) required under the previous regulations. The final regulation is a little more specific as to what is required, so it should help diminish the confusion that exists regarding the requirements of a laboratory in the realm of Quality Assessment.

Personnel for Nonwaived Testing

The laboratory director's responsibilities include:

  • Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. [Modified]

The list of requirements for a laboratory director now includes the following requirements:

  • The laboratory director must hold an earned doctoral degree in chemical, physical, biological, or clinical laboratory science from an accredited institution;
  • The laboratory director must be certified by a board approved by HHS; or
  • The laboratory director must have served or be serving as a director of a laboratory performing high complexity testing, prior to February 24, 2003, with at least two years of laboratory training or experience or both and two years of laboratory experience.

Effective Date of Regulation: April 24, 2003, except for the personnel standard change which goes into effect February 24, 2003.

The Friday, January 24, 2003, final edition of the regulation is clearly written, unlike previous regulations, and should be easily understood by people familiar with laboratory procedures. This document is meant to provide highlights of the new regulation, but is not necessarily comprehensive in nature. To assess the full text of the regulation see the Federal Register listing for January 24, 2003.

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