Berks Aids Network Wellness Services

Summary Statement of Deficiencies 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 procedure review, lack of documentation, and interview with testing personnel (TP) #1, the laboratory failed to verify twice annually the accuracy of Mycology Potassium Hydroxide Preparations (KOH) and Parasitology Wet Mount (PWM) microscopic examinations performed for 2 of 2 years from 07/23/2024 to 05 /06/2026. Findings include: 1. On the day of survey, 05/06/2026 at 1:45 p.m., review of the Laboratory Quality Assurance (QA) Plan revealed, " III. Proficiency Testing (PT): A. Handling: 1. Wet mount proficiency testing for clinicians will be done in house at each site every six months .... These will be reviewed and signed by the medical director upon completion of the testing. 2. Proficiency testing will be done as an internal blind assessment under the supervision of the Laboratory or a designated technical consultant." 2. Further review of the laboratory's QA Plan revealed the policy was updated and approved by the Laboratory Director on 9/24/2024. The updated policy stated, "It shall be noted that proficiency testing and competency assessment will now be performed annually instead of biannually." 3. The laboratory failed to provide documentation for the verification of accuracy (internal blind assessment) performed twice annually for KOH and PWM microscopic examinations performed for 2 of 2 years from 06/23/2024 to the day of survey. 4. The laboratory performed 302 microbiology tests in 2025 (CMS 116, estimated annual volume, dated 05/06/2026). 5. TP#1 confirmed the findings above on 05/06/2026 at 2:05 p.m. 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 competency assessment records and interview with the Technical Consultant (TC) #2, the laboratory failed to establish a procedure to assess the competency of 1 of 2 technical consultants for their supervisory responsibilities in 2020 and 2021. Findings include: 1. On the day of survey, 09/20/2022 at 11:30 am, the TC could not provide a procedure for the competency assessment for 1 of 2 technical consultants ( personnel #6 on CMS 209) for their supervisory responsibilities in 2020 and 2021. 2. No documentation was found that competency assessment was performed for 1 of 2 TC (personnel #6 on CMS 209) for their supervisory responsibilities from 2020 to the date of survey. 3. The TC confirmed the findings above on 09/20/2022 around 01:15 pm. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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 review of the competency assessment (CA) records and interview with the Technical Consultant (TC) #2, the TC failed to assess the competency of 4 of 4 testing 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 -- personnel (TP) for each assay in mycology and parasitology microscopic examinations performed in 2020 and 2021. Findings Include: 1. On the day of Survey, 09/20/2022 at 12:15 pm, review of the competency assessment records revealed, the forms used to document competency did not separate the two microscopic examinations for Potassium Hydroxide (KOH) Mycology and Wet Mounts (Trichomonas) Parasitology for 4 of 4 TP (CMS personnel #1, #3, #4, #5) in 2020 and 2021. 2. The TC confirmed the finding above on 09/20/2022 at 1:15 pm. -- 2 of 2 --

Summary Statement of Deficiencies 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 proficiency testing (PT) records and interview with the deputy director, testing personnel (TP) #2 and #3, the Laboratory failed to ensure the accuracy of wet mount and KOH microscopic examinations performed at the Schuylkill site was verified at least twice annually as required from 2018 to 2020. Findings Include: 1. The CLIA certificate is associated with two locations (Reading and Pottsville). 2. According to the Co. County Wellness Service Laboratory Quality Assurance Plan, "wet mount and KOH PT for all clinicians will be done in house every 6 months". 3. On the day of survey, 07/14/2020, the laboratory could not provide the verification performed on the wet mount and KOH microscopic examinations at the Schuylkill site from 2018 to 2020. 4. In 2018: 138 wet mount and KOH microscopic examinations were analyzed. 5. In 2019: 375 wet mount and KOH microscopic examinations were analyzed. 6. In 2020: (01/01/2020 to 07/14/2020) 52 wet mount and KOH microscopic examinations were analyzed. 7. The deputy director, TP #2 and #3 confirmed the findings above on 07/14/2020 around 9:50 am. ***KOH= Potassium Hydroxide 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 --