Petersburg Medical Center

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: 1. Based on interviews with testing personnel two (TP2) and technical supervisor two (TS2), review of the manual differential procedure, and the lack of control documents the laboratory failed to have control procedures to monitor the accuracy of stain quality for Wright's Stain used for performing a manual differential on patient samples from a complete blood count (CBC). The findings include: a) In an on-site interview 11/19/25 at 11:30 AM, TP2 stated no Wright's Stain quality control was documented. b) A review of the manual differential procedure did not include instructions to document quality control on Wright's Stain. c) A request was made for documentation of manual differential stain control and no documentation was available. d) An on-site interview with TS2 11/19/25 at 1:30 PM confirmed the findings. e) The laboratory reports 303 manual differentials from 8/1/24 to 8/31/25. 2. Based on review of test result logs and an interview with technical supervisor two (TS2) the laboratory failed to monitor the accuracy of controls for three (3) of three (3) qualitative tests Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) on the Cepheid, manual human immunodeficiency virus (HIV), and mononucleosis (Mono). The findings include: a) Review of test result logs for CT/GC, HIV, and 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 -- Mono tests revealed there was no documented review of controls. b) In an on-site interview with TS2 11/19/25 at 1:30 PM confirmed that the laboratory is not reviewing control records. c) The laboratory reports performing 131 tests for CT/GC, HIV, and Mono from 8/1/24 to 8/31/25. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of testing personnel competency assessments and quality control records, lack of delegation and competency records, and an interview with technical supervisor one (TS1) the laboratory director failed to document the delegated responsibilities to the technical and general supervisor for two (2) of two (2) personnel. The findings include: 1. Review of competency assessments revealed personnel evaluating competency for five (5) of five (5) testing personnel did not have a delegation by the laboratory director. 2. Review of control records from Siemens Dimension ExL and Sysmex XN-450 from 2024 and 2025 revealed personnel reviewing quality control records did not have a delegation by the laboratory director. 3. A request was made for technical and general supervisor delegation and competency forms and could not be provided. 4. An interview with TS1 11/18/25 at 11:00 AM confirmed delegations were not done. 5. The laboratory reports performing 62694 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of education, training and competency records and an interview with the technical supervisor (TS1), the laboratory failed to ensure one of seven laboratory testing personnel had the appropriate education prior to performing non-waived patient testing. Findings: 1. A review of testing personal educational records revealed the degree from one of seven testing persons was from a foreign institution. 2. A request was made to review the equivalency evaluation of their credentials, and the evaluation could not be provided. 3. The TS1 confirmed these findings during an interview on 10/25/2023 at 10:00 AM. 4. The laboratory reports performing approximately 63,000 patient tests annually. 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 D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) record review and staff interview, the laboratory did not evaluate ungraded PT results for satisfactory performance for the specialties of Hematology and Microbiology. Findings: 1. The laboratory subscribes to PT from the American Proficiency Institute. 2. Proficiency Testing records from 2017 3rd event, 2018 1st, 2nd and 3rd events, and 2019 1st and 2nd events were reviewed. 3. The laboratory did not evaluate their ungraded results for the following PT events: 2017-3: Hematology Advanced and Educational Blood Cell Identification (ID) 2017-3: Microbiology Educational Culture ID and Susceptibility 2018-1: Hematology Blood Cell ID and Advanced Blood Cell ID 2018-1: Microbiology Educational Culture ID and Susceptibility 2018-2: Hematology Blood Cell ID, Advanced and Educational Blood Cell ID 2018-2: Microbiology Educational Culture ID and Susceptibility 2018- 2: Microbiology Urine Culture MIC/Zone Diameter 2018-3: Hematology Advanced and Educational Blood Cell ID 2018-3: Microbiology Educational Culture ID and Susceptibility 2019-1: Hematology Advanced and Educational Blood Cell ID 2019-1: Hematology Urine Sediment and Vaginal Wet Prep 2019-1: Microbiology Educational Culture ID and Susceptibility 2019-1: Microbiology CSF Culture MIC /Zone Diameter and Interpretation 2019-1: Microbiology Urine Culture MIC/Zone Diameter and Interpretation 2019-2: Microbiology Educational Culture ID and Susceptibility 2019-2: Microbiology Blood Culture ID 2019-2: Microbiology Urine Culture MIC Testing 4. The laboratory was unaware of the requirement to evaluate 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 -- ungraded responses. 5. The technical consultant confirmed these finding on 9/18/19 at 12:00 pm. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records and staff interview, the laboratory did not test, at a minimum, two levels of external quality control material to monitor the accuracy and precision of Cepheid GeneXpert chlamydia and gonorrhoeae tests each day of patient testing. 1. A review of the Cepheid GeneXpert quality control logs from 5/8/19, when the test was approved for patient testing, to 9/18/19 revealed the laboratory had performed 2 levels of external quality control (QC) when the new lot of cartridges was opened on 4/27/19. 2. The procedure states external quality controls will be performed with each new lot and or shipment of cartridges. 3. The laboratory performed 19 patient tests from 5/8/19 to 9/18/19. 4. The technical consultant confirmed these finding on 9/18/19 at 12:00 pm. -- 2 of 2 --