Advanced Pathology Solutions Llc

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Through a review of proficiency activities of 2023 and 2024, lack of documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to document review of proficiency testing results for histopathology. Survey findings follow: A. The surveyor requested documentation of review of histopathology proficiency testing activities, no documentation was provided. B. Review of histopathology proficiency testing activities records provided did not demonstrate documented review of the results. C. In an interview on 10/3/2024 at 2:40 pm, laboratory director confirmed that no systemic review of proficiency testing activities was documented to ensure all histopathology testing personnel were participating in proficiency activities twice annually. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Observation, review of temperature records, lack of documentation and interview demonstrated that the laboratory failed to monitor the temperature on each day of operation in one of two rooms in which equipment with temperature and humidty requirements were stored. Findings follow: A) During a tour of the laboratory on 10/3 /24 at 9:35am the surveyor observed two separate rooms (Histology Laboratory and Molecular Laboratory) containing laboratory items with a temperature storage requirement. B) During a review of the laboratory's temperature records it was noted that no temperature and humidity measurements of the molecular lab were recorded for 3 of 21 days in September of 2023, 2 of 22 days in October of 2023, 1 of 23 days in November of 2023, 8 of 21 days in March of 2024, and 9 of 22 days in September of 2024. C) During a tour of the laboratory on 10/3/24 at 2:50 p.m. the surveyor observed a Quant Studio 12K Flex instrument in the molecular lab and noted it's operating temperatures of 15-30C and humidity of 20-80% (Quant Studio 12K Flex Real-Time PCR System User Guide, Maintenance and Administration. Publication #4470689, Rev D). D) In an interview on 10/3/2024 at 3:30 pm, the general supervisor confirmed that no temperature and humidty records for the molecular lab were available for the above dates. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 10/3/24 at 2:47 pm, one (of one) unopened container of QuantStudio Digital PCR plates (Applied Biosystems, lot 4603632, REF 4470186, expiration date 3/27/24) was observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 10/3/24 at 2:48 pm, one (of one) opened container of Apex Bond Superior Adehsive Slides(Leica, lot 4900063898, REF 3800040 White, expiration date 4/2023) was observed in the laboratory, available for use beyond the expiraton date C) During a tour of the laboratory on 10/3/24 at 2:50 pm, one (of one) opened container of Gold Chloride Solution, 0.1% w/v (Histology Connections, lot 2324002, Item # HCSS4562-1L, expiration date 9/3/24) was observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 10/3/24 at 2:50 pm the general supervisor, confirmed that the items, identified above, had exceeded the expiration date and were available for use. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Through a review of proficiency test documentation for 2021 and 2022, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to maintain a copy of attestation sheets signed by the director and testing personnel. Survey findings include: A. The surveyor reviewed proficiency test documentation for 2021 and 2022. The laboratory documented participating in the 1st, 2nd, and 3rd Microbiology Proficiency Testing Event of 2021 and the 3rd Microbiology Proficiency Testing Event of 2022. B. In an interview at 3:13 p.m. on 2 /21/2023, the surveyor requested signed attestation sheets for the proficiency testing events in 2021 and 2022. C. At 3:40 p.m. on 2/21/23, the surveyor was provided attestation sheets for the proficiency events in 2021 and 2022. All attestation sheets provided to the surveyor lacked director and testing person signatures. At that time, the microbiology supervisor (#34 from the Form CMS-209) confirmed that there were no other attestation sheets available other than the unsigned ones that she had presented to the surveyor. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- D5781

Summary Statement of Deficiencies 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: . Through a review of the Individualized Quality Control Plan (IQCP) for QuantStudio 12K Flex (Wound Panel) and the Biofire FilmArray Gastrointestinal Panel, lack of documentation and interviews with staff, it was determined the laboratory failed to include the Quality Assessment component in the developing of their IQCPs and failed to include the environment and testing personnel components as part of the Risk Assessment. Survey Findings Follow: A. A review of IQCP for the QuantStudio 12 K Flex and the Biofire FilmArray Gastrointestinal Panel (2 of 2 IQCPs) revealed the following components: 1) Quality Control Component and 2) Risk Assessment which included the Specimen, Test System and Reagent components. B. The surveyor requested the Quality Assessment component, and the Environment and Testing Personnel components as part of the Risk Assessment. None was provided. C. In an interview at 1300 on 01/26/2021, laboratory personnel #12 (as listed on Form CMS 209) confirmed the laboratory failed to include the Quality Assessment, environment and testing personnel components in the developing of the IQCPs. 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 --