Professional Gynecological Services, Pc

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on November 20, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, 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 -- laboratory failed to successfully participate in the CMS approved PT program for two consecutive testing events in the Endocrinology subspecialty for the Vitamin B12 test analyte in 2025 resulting in unsuccessful performance. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on CMS PT CASPER 0155D and API PT summary reports from 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive testing events for the analyte Vitamin B12. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Vitamin B12 Analyte: 2025 Second Event = 60% 2025 Third Event = 60% b. A review of the PT scores from API (2025) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API PT summary reports from 2025, the Laboratory Director (LD) failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API 2025-2 and 2025-3 PT summary reports, the LD failed to ensure successful participation in an HHS approved PT program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's procedure manual, Bio-rad Unity Peer Review reports for 2017 & 2018, QC file for the Siemens DPC Immunlite 2000 in Laboratory Information System (LIS), GeneXpert DX system and an interview with the technical consultant/testing person, the laboratory failed to retain chemistry, endocrinology, general immunology, syphilis screening and bacteriology quality control (QC) records and QC & calibration control Bio-rad assay sheets from January 2, 2017 through March 12, 2019. FINDINGS: 1. The current technical consultant /testing person confirmed on March 12, 2019 at approximately 11:00 AM the surveyor's findings that the laboratory failed to retain chemistry, endocrinology, general immunology, syphilis screening and bacteriology QC records and QC & calibration control Bio-rad assay sheets from January 2, 2017 through March 12, 2019. The following number of patient samples were tested and results reported for these specialties during the above time-period: a. approximately 780 patient samples for bacteriology b. approximately 1500 patient samples for both chemistry and endocrinology c. approximately 1000 patient samples for both syphilis screening and general immunology 2. The current technical consultant/testing person stated, "that he only keeps a current lot of QC raw data in the LIS LABDAQ software system and deletes the QC data after he enters the results to Bio-rad Unity QC Peer Review program" 3. Surveyor could not determine if the QC raw data entered into the Bio-rad system was accurate due to the lack of QC packet inserts. 4. The laboratory's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- information system (LIS) using LABDAQ software was down during this survey and the records were not available for review of the current lot of controls for the Immunlite 2000 and GeneXpert analyzers. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review the American Proficiency Institute (API) Proficiency Testing (PT) records on-line in the LABDAQ system, observed College of Pathologist (CAP) PT report and interview with the technical consultant/testing person, the laboratory failed to retain API & CAP PT records and documentation to include signed attestation forms, instrument printouts and a signed PT summary reports for the 3rd event of 2017, all three events in 2018 and 1st event of 2019. FINDINGS: The technical consultant/testing person confirmed on March 12, 2019 at approximately 11: 15 AM the surveyor's findings that the laboratory failed to retain API & CAP PT records and documentation to include signed attestation forms, test results & instrument printouts and a signed PT summary reports for the 3rd event of 2017, all three events in 2018 and 1st event of 2019. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of API PT summary reports on-line and an interview with the technical consultant/testing person, the laboratory failed to evaluate 3rd event of 2017, all three events in 2018 and 1st event of 2019 PT summary reports; perform and document remedial action for the PT scores of less than 100% and for the following analytes: 2018 first event: Thyroid Stimulating hormone (TSH)= 80% Endocrinology = 93% 2018 third event: Thyroid Stimulating hormone (TSH)= 80% Endocrinology = 93% D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policies and procedures and confirmed in an interview with the technical consultant/testing person, at the time of this survey, the laboratory failed to follow their established QA policy and perform a QA review for the 2017 and 2018 calendar years. -- 2 of 5 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a lack of humidity records, room temperature records, refrigerator temperature logs an and interview with the technical consultant/testing person, the laboratory failed to follow the manufacturer's instructions for the GeneXpert DX bacteriology test system to monitor and document the room humidity, room temperature and to take