Advanced Dermcare Pc

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 record review and staff interview, the laboratory failed to provide an approved MOHS written procedure in the subspecialty of histopathology. Findings include: 1. Record review on 05/12/2022 of the 'Advanced DermCare Histology Q.A., Q.C., SOP's' binder revealed lack of an approved MOHS micrographics standard operating procedure. 2. Staff interview on 05/12/2022 at 1:15 PM with the laboratory manager confirmed the above finding and stated that "he cannot find the MOHS procedure in the laboratory". 3. The laboratory performs 800 MOHS surgeries annually in the subspecialty of Histopathology. 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 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 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 staff interview, the laboratory failed to have a policy in place to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's personnel competency records on 11/20/19 revealed the following: a. The laboratory did not have policy in place to assess the competency of the clinical consultant, technical supervisor, and general supervisor. b. Competency documentation for the above laboratory personnel was not available. 2. Staff interview with the testing personnel on 11/20/19 at 11:10 AM confirmed the laboratory did not have a policy in place to assess the competency of the above laboratory personnel and they were not assessed. 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 verify the accuracy of microscopic potassium hydroxide (KOH) tests twice annually in the specialty of microbiology. Findings include: 1. Record review of the laboratory's personnel competency assessment records on 11/20/19 revealed that bi-annual 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 -- verification for accuracy for microscopic KOH was not performed in 2017 and 2018 for 6 of 6 testing personnel. 2. Staff interview with laboratory testing personnel on 11 /20/19 at 11:30 AM confirmed the above findings. 3. The laboratory performs 597 microscopic KOH tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document maintenance(s) for laboratory equipment(s) to ensure accurate and reliable test results. Findings include: 1. Record review on 11/20/19 of the equipment(s) preventive maintenance (PM) log revealed the following: a. Annual PM of the Nikon microscope (Serial # 27438) in use to read microscopic KOH was not performed and documented since 2017. b. Annual PM of the fume hood (Serial # 04D2FE327H) was not performed and/or documented since 10/4/17. 2. Staff interview with the testing personnel (TP) #1 on 11/20/19 at 11:00 am confirmed the above findings. TP#1 further stated fume hood PM was not performed to save money and the microscope was not performed because the technician was in a rush and only did PM for 2 of 3 microscopes. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Advanced Dermcare Laboratory was surveyed pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) on January 22, 2018. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to document stain reactivity and characteristics on each day of testing patient samples in the sub- specialty of Histopathology. Findings include: 1. Record review of the laboratory procedure manual on 1/22/18 revealed it did not have a procedure for the evaluation of the H&E stain reactivity. 2. Record review of the H&E slides on 1/22/18 revealed documentation was not available for H&E stain quality and acceptability on each day of testing. 3. Staff interview with the testing personnel on 1/22/18 at 11:00 AM confirmed the following: a. The laboratory does not have a procedure for the evaluation of H&E stain reactivity. b. The laboratory does not document H&E stain reactivity on each day of testing to ensure stain acceptability. 4. The laboratory performs 9085 Histopathology tests annually. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education 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 -- appropriate for the type and complexity of the laboratory services performed; (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 record review and staff interview, the technical supervisor (TS) failed to evaluate the competency of the testing personnel (TP) in all the 6 required components to perform high complexity laboratory testing. Findings include: 1. Record review of TP competency documents on 1/22/18 revealed TP did not have an annual competency evaluation in 2016 and 2017. 2. Staff interview with TP on 1/22 /18 at 10:00 AM confirmed only a semiannual competency evaluation was performed and documented on 2/4/16 and no other competency assessment was performed thereafter. 3. The laboratory performs 9085 tests annually in the sub-specialty of Histopathology. -- 2 of 2 --