Dermatology Assoc Of Western Pa

Summary Statement of Deficiencies D5781

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 lack of documentation, laboratory procedure review, and interview with the Laboratory Director (LD), the Laboratory failed to establish a written policy to assess the competency for 3 of 4 testing personnel (TP) who performed potassium hydroxide (KOH) and Scabies microscopic examinations in 2020 and 2021. Findings Include: 1. On the day of survey 02/14/2022 at 13:02, The LD could not provide a complete competency assessment policy that reviews how to assess the competency for 3 of 4 TP (CMS 209 personnel #2, #3, and #4) who performed KOH and Scabies microscopic examinations from 02/14/2020 to 02/14/2022. 2. The LD could not provide competency assessment records for 3 of 4 TP (CMS 209 personnel #2, #3, and #4) who performed KOH and Scabies microscopic examinations. 3. The LD confirmed the findings above on 02/14/2022 at 14:35. 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 review of peer review records and interview with the Laboratory director (LD), the LD failed to ensure that 3 of 4 Testing personnel (TP) performed the 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 -- biannual verification of accuracy for the scabies microscopic examinations in 2020 and 2021. Findings Include: 1. On the day of survey, 02/14/2022 at 13:05, the LD could not provide the following peer review records for 3 of 4 TP who performed Scabies Examinations: - TP#1 (CMS 209 personnel #1) peer review records in 2020 and second event for 2021 - TP#3 (CMS209 personnel #3) peer review records for first event in 2021 - TP#4 (CMS 209 Personnel #4) peer review records for second event in 2020 and first event in 2021. 2. The LD confirmed the findings above on 2/14 /2022 around 14:35. -- 2 of 2 --

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 quality control record review and interview with the Laboratory Director and Histology Laboratory Assistant on (06/11/2019), the laboratory failed to include a positive and negative control each day of patient testing for KOH and Scabies examination. Findings include: 1.The labororatory did not include a negative and positive control at least once a day patients specimens were examined for KOH and Scabies tests preformed from (01/26/2019) through the date of survey (06/11/2019). 2. 30 specimens were examined for Scabies from 11:30/2017 through 03/15/2019. 3. 185 specimens were examined for KOH test from 11:15/2017 through 06/11/2019. 4. During the survey (15:00 06/11/2019), the Histology Laboratory Assistant , confirmed that positive and negative controls are not documented each day of patient testing for KOH and Scabies Examination. 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 --