Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based upon review of competency records and discussion with the Laboratory Director (LD), the laboratory failed to perform bi-annual competency assessment. Findings include: 1. There was no written documentation of bi-annual competency assessment for sub-specialties Mycology, Parasitiology or Virology available for review during survey 07/14/2020. 2. The LD confirmed that bi-annual assessment was not being performed on the three sub-specialties mentioned above during interview at approximately 1100 on 07/14/2020. 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 upon review of records and procedures provided during survey and interview 07 /14/2020, no written procedures for specimen preparation or slide examination could be produced. Findings include: 1. There was no written procedure available for review for sub-specialties Mycology, Parasitology, Virology during survey 07/14/2020. 2. The Laboratory Director (LD) confirmed there was no written procedure for the above 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 -- three sub specialties during interview on 07/14/2020 at approximately 1200. 3. There was no written procedure available for review for Histopathology tissue processing send outs or Histopathology slide interpretation on slides returned to the lab from processing lab during survey 07/14/2020. -- 2 of 2 --