Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was conducted at The Dermasurgery Center, LLC-CLIA ID # 19D2045915 on March 26, 2019. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's CMS 209 (Laboratory Personnel Report) form revealed the following testing personnel: Personnel 1 (who also serves as the Laboratory Director) Personnel 2 Personnel 3 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 3. In interview on March 26, 2019, Personnel 1 stated the laboratory was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- unaware that a competency assessment policy that included the six (6) procedures was needed. Personnel 1 further stated he was unaware it was required since doctors are performing the testing. 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 on record review and interview with personnel, the laboratory failed to verify the accuracy of the performance of Mycology testing at least twice annually. Findings: 1. Review of the laboratory's Task 1 and 3 form revealed the laboratory performs KOH preps. 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a written policy for verification of the accuracy of Mycology testing, KOH preps. 3. In interview on March 26, 2019 at 1:30 pm, Personnel 4 stated the laboratory did not perform peer reviews for KOH preps. Personnel 4 confirmed the laboratory did not verify the accuracy of Mycology testing at least twice annually. 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 record review and interview with personnel, the laboratory failed to establish complete policies and procedures. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not establish complete policies for the following: a) Twice a year verification for accuracy of Mycology testing to include