Greentree Medical Center

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 review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1 (CMS 209), the laboratory failed to verify the accuracy of the PT results obtained for 1 of 3 API Microbiology testing events in 2023. Findings Include: 1. On the day of survey, 05/23/2024 at 12:02 pm., review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following analytes that were not scored by the PT agency in 2023: - 1st event: Influenza A (RSP - 04) 2. The API Proficiency Testing performance Evaluation form states " Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the QIAstat-DX Respiratory SARS-CoV 2 Panel (Quiagen) analyzer validation records and interview with Testing Personnel # 2 (TP),the laboratory failed to establish criteria for acceptable performance specifications for the 17 of 17 virology and 3 of 3 bacteriology analytes performed on the QIAstat-DX Respiratory SARS-CoV 2 Panel (Quiagen) analyzer from 03/06/2021 to 08/02/2022. Findings Include: 1. On the day of survey, 08/02/2022 at 11:45 am, review of the QIAstat-DX Respiratory SARS-CoV 2 Panel (Quiagen) analyzer validation records revealed, the validation performed on 02/16/2021 did not include the acceptable criteria for performance specifications for precision and accuracy. 2. Review of the CMS116 form showed that the annual testing volume for bacteriology/virology was 12,390 in 2021. 3. TP# 2 confirmed the findings above on 08/02/2022 around 03:00 pm. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- 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 -- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with Testing Personnel # 2 (TP), the laboratory failed to include a negative and positive control material, each day of patient testing for Respiratory SARS-CoV-2 Panels analyzed on the Quiagen QIASTAT-Dx Respiratory SARS-CoV-2 Panel Analyzer from 03/06/2021 to the date of survey. Findings include: 1. On the day of survey, 08/02/2022 at 11:45 am , review of Respiratory SARS-CoV-2 Panel quality control records revealed that the laboratory performed external quality controls on the Quiagen:QIASTAT-Dx Respiratory SARS- CoV-2 Panel analyzer only when new lots of reagent were put into use from 03/03 /2021 to 08/02/2022. 2. In 2021, 12,390 bacteriology/virology testing was performed. 3. TP #2 confirmed the findings above on 08/03/2022 around 03:00 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratories microscope and interview with testing personnel (TP) #1, the laboratory failed to document maintenance of 1 of 1 microscopes on site used to analyze microscopic urinalysis examinations from 2016 to the time of survey. Findings include: 1. The Select Medical Products PSS600R Series microscope operations manual, under maintenance states, "To keep microscope in top condition for years, we recommend that you have the microscope professionally serviced once a year." 2. On the day of survey, 01/14/2020, the Laboratory could not provide yearly microscope maintenance performed on 1 of 1 Select Medical Products PSS600R Series microscope, used to analyze microscopic urinalysis examinations from 03/14/2018 to 01/14/2020. 3. 60 Microscopic urinalysis examination were analyzed in 2019. 4. TP #1 confirmed the findings above on 01/14/2020 around 1:30 pm. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory quality assessment records and interview with testing personnel (TP) #1, the laboratory director (LD) failed to ensure quality assessment (QA) programs were maintained to assure the quality of laboratory from 2018 to the day of survey. Findings Include: 1. On the day of survey, 01/14/2020, the laboratory provided QA activities performed from March of 2018 to December of 2019, but they were not reviewed and signed by the LD. 2. TP# 1 confirmed the findings above on 01/14/2020 around 02:15 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on laboratory procedure review and interview with the assigned laboratory testing person, laboratory testing personnel did not follow the laboratory's procedure manual for Urine Microscopic examination . Findings include: 1 At the time of the survey, (13:30 03/14/2018) the procedure for Urine Microscopic examination requires urine to be centrifuged between 2,000 and 3,000 revelutions per minute(rpm). 2 The only centrifuge in the lab was set above 3,000 rpm for serum separation, and can not be adjusted by the end user. 3 During the survey the assigned testing person confirmed the above findings. 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 --