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Guide to Waived Testing at MCL- Special Topics

Physician performed tests

These have waived status, but may be performed only by physicians within their scope of practice. Physician performed tests allowed by the Medical Center include Strep. A, Heliobacter Pylori and occult blood (e.g. Hemoccult).

Physician performed microscopy (PPM):

Physician performed microscopic exams include such exams as urine sediment exam, qualitative semen exam, vaginal wet preps, fern tests, pinworm preps, etc. These are allowed under CLIA and are also exempt from proficiency testing. The Medical Center allows these procedures to be performed by physicians within their appropriate specialty.

Regulatory Requirements:

• The Health Care Financing Authority (HCFA) requires institutions performing waived testing to have an approved provider application. Once approved, the institution is issued a "CLIA number". HCFA requires that personnel who perform these tests have ongoing competency assessment and that testing procedures are followed exactly in accordance with the manufacturer's instructions.
• JCAHO requires laboratory oversight to the performance of waived testing. In addition, the standards require that we answer the following questions:

Question Our answer

Who may perform the test?	The list is maintained by the Nurse Managers.
Which tests will be performed?	See the above list of approved tests.
Where the tests will be performed?	List maintained by the audit section.
Is the test for screening or definitive use?	Hemocue – Definitive All others Screening

• The MCLNO waived testing policy meets both JCAHO and HCFA requirements. It also describes the oversight process. The policy states that individual units may perform waived tests provided that they meet all requirements. Nurse managers are responsible for maintaining lists of personnel, competency records, quality control records and all other required documentation.

Other Notes:

• There is a detailed nursing policy for glucose testing and for hemoglobin testing.
• Procedures for the rest of the waived tests are available, in your waived test binder. These are in a one-page format and cover test performance and quality control requirements.
• Some tests have internal controls, which are built in to verify that the test is working.
• Other tests require external quality controls. These are independent sources of positive and negative analytes. (see below)
• Oversight and audits: The MCLNO policy describes the oversight and audit role.
• See the audit criteria here.
• An auditor from the lab makes unannounced visits to verify compliance.
• Corrective action is required for any discovered deficiencies.
• The unit manager corrects deficiencies and documents the process in writing.
• The oversight group reports to the Clinical Laboratory Utilization Committee (CLUC) which recommends status to the Executive Committee.
• Any units that fail to meet waived test requirements will have their testing privileges revoked by the Executive Committee.

Competency and Quality Control:

• All waived tests require that competency be verified on an annual basis. A competency checklist is available for each procedure. Competency verification is reviewed in the audit process. For urine dipstick and pregnancy, colorblind testing is required.
• Quality Control requirements vary by procedure as summarized in this table:

Test name	Internal control	External Control	How is this documented?
Urine dipstick	none	Performed by the laboratory before reagents are issued	Documented on the bottle.
Urine pregnancy	Yes, see the built-in quality indicator. (Document both positive and negative internal controls with each patient.)	Performed by the laboratory before reagents are issued	Documented on the bottle.
Glucose	No.	Performed by operators on a daily basis.	Documented in the software
Hemoglobin	Yes, the control cuvette tests the optics / electronics.	Performed by operators on a daily basis	Documented in the data management software
pH	None	Performed by the laboratory before reagents are issued	Documented on the bottle.