Women's Health Group, Pa East, The

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on the review of the IQCP for serum human chorionic gonadotropin (hCG) using Consult hCG combo test kit, package insert for Consult hCG combo test cassette, serum hCG quality control (QC) records, and interview with testing personnel (TP) #1, the laboratory failed to perform QC for serum hCG as required by the manufacturer's instructions for 5 of 15 months from 9/18/21 to 3/30/23. Findings: 1. Review of the IQCP for serum human chorionic gonadotropin (hCG) using Consult hCG combo test kit required QC to be performed monthly. 2. Review of the package insert for Consult hCG combo test cassette, serum hCG revealed the manufacturer required serum QC testing to follow federal, state and local guidelines. CMS has defined monthly as a time period not to exceed 31 days. 3. Review of QC records from 9/18/21 to 3/30/23, revealed QC test interval exceeded 31 days for 5 of 15 months from 1/1/22 to 3/30/23. a. QC for 10/21 was performed 44 days after the last acceptable QC: 9/15/21 to 10/28/21. Sixteen patient results were reported. b. QC for 1 /22 was performed 44 days after the last acceptable QC: 12/7/21 to 1/20/22. Fifteen patient results were reported. c. QC for 4/22 was performed 49 days after the last acceptable QC: 3/7/22 to 4/25/22. Four patient results were reported. d. QC for 8/22 was performed 57 days after the last acceptable QC: 7/5/22 to 8/31/22. Fifteen patient results were reported. e. QC for 10/22 was performed 54 days after the last acceptable QC: 8/31/22 to 10/24/22. Thirteen patient results were reported. 4. Interview with 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 -- TP#1 on 3/30/23 at 10:15 a.m. confirmed, the laboratory failed to perform QC for serum hCG as required by the manufacturer's instructions for 5 of 15 months from 9 /18/21 to 3/30/23. 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 on review of CMS form 209, competencies, and interview with TP #1, the technical consultant (TC) failed to evaluate and document competency at least semiannually during the first year the individual tests patient specimens for 1 of 4 new testing personnel (TP). Findings: 1. Review of the site's CMS for 209 for personnel revealed 4 new testing personnel since last survey that had worked at the site for more than 6 months. 2. Review of personnel competency records revealed no semiannual competency was performed by the TC during 2022 for TP#2. 3. Interview with the TP #1 on 3/30/23 at 9:10 a.m. confirmed, the technical consultant failed to evaluate and document competency at least semiannually during the first year the individual tests patient specimens for 1 of 4 new TP. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the current CMS-209, lack of documentation and interview, the technical consultant (TC) failed to document the annual competency for 1 of 7 testing personnel (TP). Findings: 1. The CMS-209 document listed 7 persons as active testing personnel whom had been testing for more than 1 year. 2. No annual competency document performed by the TC on TP #2 (due 2/23) was made available at the time of survey. 3. Interview with TP #1 on 3/30/23 at 9:10 a.m. confirmed, the technical consultant failed to document the annual competency for 1 of 7 TP. -- 2 of 2 --

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Due to a lack of policies, procedures, specimen rejection logs and interview with the Technical Consultant (TC), the laboratory failed to have written policies, procedures, and Quality Assurance (QA) documentation available for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic sytem. Findings: 1. A request was made to review the preanalytical policies and procedures. None were made availiable at the time of survey. 2. A request was made to review the specimen rejection log for QA documentation. None were made availiable at the time of survey. 3. Interview with the TC 9/17/21 at 12:00 p.m. confirmed, the laboratory failed to have written policies, procedures, and QA documentation available for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic sytem. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must 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 -- be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on an absence of certificates of accuracy, protocols for thermometer function checks and interview with the TC, the laboratory failed to define and perform a function check protocol for two of two thermometers. Findings: 1. Documentation made available for function checks on two of two thermometers were performed with another thermometer beyond its certificate of accuracy period. Accuracy was not verified. 2. No documentation was available for the certification of accuracy (NIST traceble) on two of two thermometers at the time of survey. 3. Proctocols for function checks of the thermometers were not made available at the time of survey. 4. Interview with the TC on 9/17/2021 at 12:30 a.m. confirmed, the laboratory failed to define and perform a function check protocol for two of two thermometers. -- 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 the lack of documentation and interview, the laboratory failed to follow written policies and procedures to assess consultant competency for two of two consultants. Findings: 1. No competency documentation for Technical Consultant (TC) #1 and TC #2 was available at the time of survey. 2. Interview on October 10, 2019 at 10:40 AM with TC #1 confirmed the laboratory failed to follow written policies and procedure to assess consultant comptetency for two of two consultants. 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 on review of competencies and interview, the Technical Consultant (TC) failed to evaluate and document competency at least semiannually during the first year the individual tests patient specimens for two of three testing personnel. Findings: 1. Review of records revealed one semiannual compentency for testing personnel (TP) #3. No semiannual records for TP #1 and TP #2 were available at time of survey. 2. Interview with TC #2 October 10, 2019 at 10:45 AM confirmed the technical 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 -- consultant failed to evaluate and document competency at least semiannually during the first year the individual tests patient specimens for two of three testing personnel. -- 2 of 2 --