Summary:
Summary Statement of Deficiencies 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 observation and interview with technical consultant #1 (TC #1) revealed that the laboratory failed to have a written Potassium hydroxide (KOH) procedure. Findings: 1. No procedure manual for Potassium hydroxide (KOH) testing from this facility was provided/available for review at the time of survey. 2.. Interview with the TC #1 on December 9, 2021 at 10:30 a.m. confirmed, the laboratory failed to have a written Potassium hydroxide (KOH) procedure D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on the lack of documentation and interview with TC #1, the technical consultant failed to evaluate and document competency on two of two testing personnel for the Potassium hydroxide (KOH) procedure for all of 2020 and to date 2021. Findings: 1. Request was made for competency documentation for the KOH procedure for two of two testing personnel at the time of survey. 2. No documentation 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 -- of competency assessment for the KOH procedure for two of two testing personnel for all of 2020 and to date 2021 was made available at the time of survey. 3. Interview with TC# 1 on December 9,2021 at 10:30 a.m. confirmed, the technical consultant failed to evaluate and document competency on two of two testing personnel for the KOH procedure for all of 2020 and to date 2021. -- 2 of 2 --