Upmc Falk Dermatology

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) documents and interview with the laboratory director (LD), the laboratory failed to document a negative and positive control material each day of patient testing for mycology and parasitology microscopic examinations performed in 2022 and 2023. Findings Include: 1. On the day of the survey, 01/08/2024 at 12:02 pm, the laboratory failed to provide documentation of Potassium Hydroxide (KOH) and Wet mount positive and negative QC for the following days of patient testing performed in 2022 and 2023. 1/26/2023- KOH 12/28/2022- Wet Mount 2. The laboratory performed 59 KOH and wet mount testing in 2023. 3. LD confirmed the findings above on 01/08/2024 at 02:30 pm. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 review of the laboratory's PS-L-001 Physician Office Laboratory Quality Assurance Surveillance Review Policy, record review, and interview with the Laboratory Director (LD), the Laboratory failed to follow the Laboratory's written policies and procedures to assess the competency for 1 of 12 testing personnel (TP) who performed potassium hydroxide (KOH) microscopic examinations in 2021. Findings include: 1. The laboratory's PS-L-001 Physician Office Laboratory Quality Assurance Surveillance Review Policy under Pre-analytic Aspects of Care states "Physicians and APPs who perform any microscopic testing must also complete staff competencies annually". 2. On the day of the survey, 4/08/2022, review of the competency assessment records revealed the laboratory could not provide the annual competency for 1 of 12 TP (CMS 209 personnel #12) who performed KOH microscopic examinations in 2021. 3. The laboratory performed 79 KOH microscopic examinations in 2021. 4. The LD confirmed the findings above on 04/08/202 at 1:45 p. m. . 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, review of peer review records, and interview with the Laboratory Director (LD), the laboratory failed to verify twice annually the accuracy of potassium hydroxide (KOH) scabies and Tzancks microscopic examinations performed by 12 of 12 testing personnel (TP) in 2020 and 2021. Findings include: 1. The Laboratory procedure manual states: " peer review are to be done twice annually for each interpreting physician/App" for KOH, scabies and Tzancks microscopic examinations. 2. On the day of survey, 04/08/2022, review of peer review records revealed, the laboratory did not separate peer review by analyte (KOH, Scabies and Tzanck microscopic examinations) performed by 12 of 12 TP in 2020 and 2021. 3. 125 KOH, 21 scabies, and 7 Tzancks microscopic examinations were analyzed in 2020. 4. 79 KOH, 18 Scabies, and 0 Tzanck microscopic examinations were analyzed in 2021. 5. The LD confirmed the findings above on 04 /08/2022 at 01:45 pm. 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)

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 review of laboratory procedure manuals and interview with the laboratory director (LD) and two senior practice managers, the laboratory failed to establish a competency assessment procedure to assess the competency of consultants, supervisors and testing personnel (TP) who performed potassium hydroxide (KOH) microscopic examinations, scabies microscopic examinations, tzanck Smear examinations, tissue pathology microscopic examinations in 2018. Findings Include: 1. On the day of survey, 07/16/2019, the laboratory could not provide a written procedure to assess the competency of consultants, supervisors and TP who performed KOH microscopic examinations, scabies microscopic examinations, tzanck Smear examinations, tissue pathology microscopic examinations in 2018. 2. The laboratory could not provide competency assessment records from 2018 for: - 1 of 1 testing personnel performing tissue pathology microscopic examinations. - 1 of 1 general supervisor. 3. In 2018, 840 microscopic examinations were analyzed. 4. The LD and senior practice managers confirmed the findings above on 07/16/2019 around 08:50 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --