The federal regulation governing laboratory testing, known as the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), classifies testing into four complexity levels: high complexity, moderate complexity, PPM (Provider Performed Microscopy, a sub-set of moderate complexity), and waived testing.

• Standard PC.16.1022
• Standard PC.16.20
• Standard PC.16.30
• Standard PC.16.40
• Standard PC.16.50
• Standard PC.16.60

References: http://www.fda.gov/cdrh/clia/index.html, http://www.phppo.cdc.gov/clia, and http://www.cms.hhs.gov/clia

Effective January 1, 2005

Standard PC.16.1022 The hospital establishes policies and procedures that define the context in which waived test results are used in patient care, treatment, and services.

Elements of Performance for PC.16.1022

1. Quantitative test result reports in the clinical record are accompanied by reference intervals specific to the test method used and are appropriate to the population served.

2. Criteria for confirmatory testing for each test, qualitative or quantitative, is specified in the written procedure as dictated by clinical usage and methodology limitations.

3. Actual usage is consistent with the hospital's policies and the manufacturer's recommendations for each waived test.

Standard PC.16.20 The hospital identifies the staff responsible for performing and supervising waived testing.

Elements of Performance for PC.16.20

1. Staff members who perform testing are identified.

2. Staff members who direct or supervise testing are identified.

Standard PC.16.30 Staff performing tests have adequate, specific training and orientation to perform the tests and demonstrate satisfactory levels of competence.

Rationale for PC.16.30 For waived tests to be performed properly, the staff performing them must be qualified to do so. Staff members who perform waived testing have specific training in each test performed.

Elements of Performance for PC.16.30

1. Current competence of testing staff is demonstrated.

2. Each staff member who performs testing has been trained specifically to each test he or she is authorized to perform.

3. Each staff member who performs testing has been oriented according to the hospital's specific needs.

4. Testing that requires the use of an instrument is performed by staff with adequate and specific training on the use and care of that instrument.

5. Competence is assessed according to hospital policy at defined intervals, but at least at the time of orientation and annually thereafter.

6. These assessments have considered the following:

   1. The frequency by which staff members perform tests; the technical backgrounds of the staff.

   2. The complexity of the test methodology and the consequences of an inaccurate result

7. Methods to assess current competency include at least two of the following:

   1. Performing a test on an unknown specimen

   2. Having the supervisor or qualified delegate periodically observe routine work

   3. Monitoring each user's quality control performance

   4. Having written testing that is specific to the method assessed

8. The hospital evaluates and documents the information listed above.

Note: All staff who perform instrument-based testing, including but not limited to physicians, licensed independent practitioners, contracted staff, and RNs, must participate in training and competence demonstrations.

Standard PC.16.40 Approved policies and procedures governing specific testing-related processes are current and readily available.

Rationale for PC.16.40

Current and up-to-date policies and procedures are an important reference tool in managing laboratory testing activities, particularly when individual staff members perform them infrequently.

Elements of Performance for PC.16.40

1. Written policies and procedures address specific sections<<>>

2. The policies and procedures for each item are applicable to the specific hospital.

3. Current and complete policies and procedures are readily available to the person performing the test.

4. The director named on the waived testing certificate or a designee approves policies and procedures at defined intervals.

Standard PC.16.50 Quality control checks, as defined by the hospital, are conducted on each procedure.

Elements of Performance for PC.16.50

1. The hospital has a written quality control plan that specifies how procedures will be controlled for quality, establishes timetables, and explains the rationale for choice of procedures and timetables.

2. Quality control procedures are performed at least as frequently as recommended by the manufacturer, according to the hospital's policies.

3. For instrument-based waived testing, quality control requirements include two levels of control, if commercially available.

4. Quality control procedures are performed at least once each day on each instrument used for patient testing.

5. The documented quality control rationale is based on the following:.

   1. How the test is used

   2. Reagent stability

   3. Manufacturers' recommendations

   4. The hospital's experience with the test

   5. Currently accepted guidelines

6. At a minimum, manufacturers' instructions are followed.

Standard PC.16.60 Appropriate quality control and test records are maintained.

Elements of Performance for PC.16.60

1. All quality control test results are documented, including internal, external, liquid, and electronic.

2. Test results are documented. Note: Test results may be located in the clinical record.

3. Quality control records, instrument problems, and individual results are correlated.

4. A formal log is not required, but a functional audit trail is maintained that allows retrieval of results and associated quality control values for a minimum of two years.