Summary:
Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on the lack of documentation and interview with the office manager (November 9, 2018, approximately 9:45 A.M.), the laboratory lacked documentation verifying the accuracy of their Moh's procedure. Findings include: a. Upon requesting evidence of the Moh's procedure accuracy, the laboratory was unable to provide such document (s). b. The office manager confirmed that the laboratory did not have a process that verified the accuracy of their Moh's procedure. c. The laboratory reportedly performs approximately 300 Moh's procedure a year, even though they lacked having a process that verified the accuracy of their Moh's procedure. 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 the lack of documentation and interview with the office manager (November 9, 2018, approximately 9:30 A.M.), the laboratory lacked a written procedure for the examination of fungal elements. Findings include: a. The laboratory was unable to 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 -- produce a written procedure for fungal element examination when requested by the surveyor on November 9, 2018. b. The office manager confirmed that the laboratory did not have a written procedure for fungal element examination. c. The laboratory reportedly perform approximately 15 wet mounts for fungal elements per year, without have a written procedure for this test. -- 2 of 2 --