Planned Parenthood Of Western Pa Inc

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to verify the accuracy of the PT results obtained for 1 of 1 API Hematology/Coagulation testing event in 2022. Findings Include: 1. On the day of survey, 12/07/2023 at 09:30 am., review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following analyte that was not graded by the PT agency: - API 2022 (2nd Event): Microscopy/Urine sediment, vaginal wet preparation VA-02 2. The API Proficiency Testing performance Evaluation form states "Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to sign the API attestation statement documents in 2020 and 2021. Findings include: 1. On the day of survey, 03/04/2022, review of API revealed the following attestation statement documents were not signed by the LD: API Immunology /Immunohematology: - 2020: Event#2 and Event #3. - 2021: Event #1, Event#2, and Event#3. API Hematology/Coagulation: - 2020: Event #2 and Event#3. - 2021: Event#1, Event#2, and Event#3 3. The TC confirmed the findings above on 03/04 /2022 at 09:35 a.m. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based of review of laboratory's procedure manuals, review of competency assessment records and interview with the Technical Consultant (TC), the technical consultant failed to evaluate and document the Competency Assessment (CA) of 2 of 22 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) responsible for performing Rh Type, Potassium Hydroxide (KOH) and Wet Mounts examinations from 12/02/2019 to 03/04/2022 Findings include: 1. At the day of survey, 03/04/2022. the laboratory was unable to produce the semi-annually competency assessment records for 2 of 22 TP (CMS209 personnel #4 and #17) 2. The TC confirmed the finding above on 03/04/2022 at 09:35 a.m. -- 2 of 2 --

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 technical consultant (TC), the laboratory failed to establish a complete competency assessment procedure to assess the competency of consultants and testing personnel (TP) who performed Rhesus (Rh) factor testing, potassium hydroxide (KOH) microscopic examinations, wet mount microscopic examinations, and clue cell microscopic examination in 2018. Findings Include: 1. On the day of survey, 07/16/2019, the laboratory failed to provide a complete policy on how to assess the competency of consultants and TP who performed Rh factor testing, potassium hydroxide (KOH) microscopic examinations and wet mount microscopic examinations in 2018. 2. The laboratory did not assess the competency of 11 out of 12 TP for each test performed (Rh factor testing, potassium hydroxide (KOH) microscopic examinations, wet mount microscopic examinations, and clue cell microscopic examination) in 2018. 3. In 2018, 2,909 patient tests were analyzed. 4. The TC confirmed the findings above on 07 /16/2019 around 12:45 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 --