SUBJECT: WAIVED CLIA TESTING Page 3 of 3

SUBJECT: WAIVED CLIA TESTING Page 3 of 3

SUBJECT: WAIVED CLIA TESTING

Date BOD Approval: 09/27/2012

Date BOD Revised:

Date BOD Reviewed:

Pages: 3 Manual Section(s): Departmental

Department(s): Medical

File Name: waived CLIA testing.doc Attachments/Forms: None

Supersedes: lab test results.doc

labtest results.doc

control logs.doc

POLICY

Waived CLIA testing will occur according to the regulatory guidelines of the Clinical Laboratory Improvement Amendment (CLIA) of 1988. Test results will be used in conjunction with clinical factors and will not be used as an isolated parameter for decision-making.

RATIONALE

CLIA 1988 CFR 42.993 - Laboratory Requirements

AAAHC Chapter 12 Pathology and Medical Laboratory Services Subchapter 1 CLIA Waived Tests.

PROCEDURE

Laboratory testing plays a critical role in health assessment, health care, and ultimately, the public’s health. Test results contribute to diagnosis and prognosis of disease, monitoring of treatment and health status, and population screening for disease.

Increasingly, these decisions are based on simple tests performed at the point-of-care. Although by law waived tests should have insignificant risk for erroneous results, these tests are not completely error-proof and practices for ensuring the accuracy and reliability of waived testing is important. This will be accomplished through the promotion and use of good laboratory practices and the use of clinical guidelines adopted from evidence-based findings.

Use of Tests

Type of Test / Used for
Fecal Occult Blood / Screening
Fingerstick Glucose (Blood) / Screening and Diagnostic
Hemoglobin / Screening and Diagnostic
Hemoglobin A1C / Screening and Diagnostic
Infectious Mononucleosis / Screening and Diagnostic
Influenza A&B / Screening
Nitrazine pH / Screening
Prothrombin Time / Diagnostic
Rapid Strep / Screening
Respiratory Syncytial Virus (RSV) / Screening and Diagnostic
Urine Dipstick / Screening and Diagnostic
Urine Pregnancy / Screening and Diagnostic

Testing that is used for screening may necessitate further testing or treatment, based on additional findings as determined by the treating provider.

Recording Documentation and Results

All Waived CLIA test results are recorded in the electronic health record. Results are recorded in the patient record based on a matched patient name and date of birth. The initial test order will include the reason ordered, time and date of order, and ordering provider. The test documentation will show the results value and accepted normal range value..

The results of all tests performed are recorded immediately and forwarded to the ordering provider for review. Critical results are handled per the Critical Results policy.

Procedures

Instructions for all tests will follow the manufacturer’s guidelines. Staff members should review the Point of Care procedure for each specific test, will follow all procedures as written, and only perform testing for Waived CLIA tests that they are trained and competency validated. Staff performing the test will personally record all tests they perform in the EHR, allowing for documentation of the testing personnel.

Any unusual or unexpected test results must be followed up on. Troubleshooting any technical or reagent problems is expected. If unexpected results are received, staff will immediately notify the ordering provider and Site Facility Manager, or his/her designee, immediately.

Product will be stored according to the manufacturer’s recommended guidelines

Quality Control Monitoring

Quality control logs are maintained on each type of Waived CLIA laboratory test performed according to the manufacturer’s guidelines. The following information is documented on the Control Log Sheet.

·  Date and time of control testing

·  Manufacturer Name

·  Lot Number

·  Expiration Date

·  Expected Control Value

·  Actual Control Value

·  Initials of the person performing the test

In the event that the quality control does not meet expected values, it will then be recorded on the corrective action log. All test results (patient and controls) will be reviewed on monthly and will be reviewed by the Site Facility Manager, or his/her designee. The Site Facility Manager, or his/her designee, will address with staff any incomplete or inaccurate testing records, any failure to follow established procedures, or any issues identified.

Competency

Initial competency and quality control testing will be completed during departmental orientation by the Site Facility Manager, or his/her designee that has demonstrated competency. The assessment of qualified staff is completed semiannually, then annually after the first year of operation.

Competency will be assessed by direct observation of actual performance of routine testing and written testing.

Competency will be documented on the appropriate forms and kept on file in the staff members Personnel file.