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946 EAST REED

HAYTI, MO 63851

WRITTEN PROTOCOL FOR TISSUE SPECIMENS

Tag No.: A0585

Based on interview and record review the facility failed to develop and maintain written policies, procedures, or written instructions directing staff in appropriate documentation of the receipt and reporting of tissue specimens. Laboratory services' failure to develop and maintain written policies and procedures could affect the identification and accuracy of tissue sample results. The facility census was 38.

Findings included:

1. Record review of the facility's undated job description titled, "Laboratory Director" (also known as the non-physician supervisor of Laboratory Services) showed that one of the responsibilities of the Laboratory Director was to ensure that approved and relevant procedure manuals were available for staff.

2. During an interview on 09/15/15 at 5:15 PM, Staff L, Laboratory Supervisor, stated that:
- Laboratory Services had no policy, procedure, or written instructions for managing patient's tissue specimens.
- Tissue specimens were sent off-site to a Pathologist (a physician who interprets and diagnoses the changes caused by disease in tissues and body fluids) for processing.
- Test results were sent from the Pathologist's off-site office to the facility and entered into a patient's medical record.
- The laboratory stored tissue specimens until they were picked up and delivered to the off-site Pathologist for processing and reporting of test results.
- Staff L maintained no record of the receipt and release of tissue specimens; and
- Laboratory Services had no written instructions for storage.

3. During an interview on 09/15/15 at 4:30 PM, Staff B, Infection Control and Patient Safety Officer stated that there was no policy or procedures found for the receipt, storage, release, and/or reporting of tissue specimens.

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