Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey conducted on 8-06-20, found that Skin Care Physicians LLC D/B/A clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 staff Interview, the laboratory failed to perform peer- review proficiency testing twice a year for Scabies a subspecialty of parasitology from 2018 to 2019. Findings Include: A review of KOH Log sheet revealed the laboratory was performing scabies testing on 4 out 4 patients from 8/21/18 to 11/19/19. A review of the proficiency testing log showed no documentation of scabies peer review testing twice a year for 2018 and 2019. During an interview on 8-6-2020 at 11:54 am, the office manager confirmed that scabies peer review proficiency was not perform twice annually for 2018 and 2019. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on record review and Staff interview, the laboratory failed to have a quality assurance policy and review for Scabies a subspecialty of parasitology . Findings Include: A review of KOH Log sheet revealed the laboratory was performing scabies testing on 4 out 4 patients from 8/21/18 to 11/19/19. A review of Quality Assurance Policy revealed no documentation of a written policy or review for scabies testing. During an interview on 8-6-2020 at 11:54 am, the office manager confirmed there was no quality assurance policy for Scabies and was not listed as a test preformed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)