Summary:
Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on surveyor review of the Electronic Wet Mount Report (EWMR) and interview with the Laboratory Manager (LM), the laboratory failed to record the collection time specimens were received from 1/1/24 to 3/26/24. The findings include: 1. A review of the EWMR revealed there were no collection times for specimens received for wet mount testing. 2. The LM confirmed on 3/26/24 at 11:40 am that the laboratory failed to ensure that specimen collections time were recorded. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Wet Mount Test Records (WMTR) and interview with the Laboratory Manager (LM), laboratory personnel failed to follow the procedure for "Record Keeping" from 1/1/24 to 3/26/24. The findings include: 1. The PM states " The clinician or lab technician will record wet smear results as either negative or positive for each organism on the client's medical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- record in the designated area." 2. Five out of Five WMTR had results documented as " + " and " - " and not written as either positive or negative. 3. The LM confirmed on 3 /26/24 at 11:00 am, laboratory personnel failed to follow the PM. -- 2 of 2 --