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Re: Clia Forum

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Q - If a hospital does not have a Cytyc 2000 and sends their vials to another hospital that does have the machine, and if the slides are stained and coverslipped and returned to the first hospital for screening, how can cytotechs be sure of the patient's identifiers (original vial, req. form, computer generated history)?

A - Refer to 493-1232. "The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results".

I get the impression that your lab is not accessing the specimens and entering the patient information and history from the requisition into your LIS before sending to the reference laboratory. This would give you the assurance that the requisition and vial are correctly identified and ensure positive identification prior to processing. Both labs must have in place procedures to ensure positive patient identification throughout the testing process. Before tests results are reported the information on the requisition should be compared with data entered into the LIS.

Q - Does the final report need to indicate that the processing" took place at another hospital, but the "screening" of slides was done at the first hospital?

A - Refer to Subpart A - General Provisions, 493.2 Definitions. "Facilities only collecting or preparing specimens (or both) and not performing testing are not considered laboratories."

The diagnosis is the test not the preparation. Only the laboratory that performed the test needs to be indicated on the report

Q - What kind of controls are needed?

A - Refer to the Interpretive Guideline for 493.2. "Laboratories that screen or interpret cytopathology slides are responsible for ensuring that cytology slides are stained in compliance with the applicable requirements at 493.1274(b). In addition for laboratories that prepare cytology specimens using automated or semi-automated liquid-based preparatory techniques. They must comply with the manufacture's instructions for the preanalytic, analytic, and postanalytic phases of testing."

To ensure the reference laboratory's compliance with 493.2, the laboratory director should review the reference laboratory's procedures and quality control and quality control records for processing their specimens to ensure compliance and positive patient identification.

Sandra K. Fite, CT(ASCP)

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