Chester County Rheumatology Pc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of laboratory records, lack of documentation, and interview with the Billing Manager, the laboratory failed to monitor and document room temperature and humidity for 518 of 724 days to ensure reliable test system operation and test result reporting for instrumentation used to perform microscopic slide examinations of synovial fluid crystals from 11/28/2023 to the date of survey. Findings include: 1. The operating conditions listed in the instruction manual for the Nikon Eclipse 50i microscope stated: "temperature: 0 C to 40C, humidity: 85%. RH max." 2. On the date of the survey, 11/21/2025 at 10:23 am, the laboratory could not provide documentation for monitoring room temperature and humidity to ensure operating conditions were met for 1 of 1 Nikon Eclipse 50i microscope (s/n 112824) used to perform microscopic slide examinations of synovial fluid crystals for 518 of 724 days from 11/28/2023 to 11/21/2025. 3. Review of the laboratory's test logs revealed the laboratory performed 45 synovial fluid crystal microscopic slide examinations from 11 /28/2023 to 11/21/2025. 4. The Billing Manager confirmed the findings above on 11 /21/2025 at 11:00 am. 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 D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the office manager (OM), the laboratory failed to have the required records accessible during the laboratory survey performed on 11/28/2023. Findings Include: 1. On the day of the survey, 11/28 /2023 at 09:14 am, the laboratory could not provide the following records upon request: -Quality assessment (QA) records for 4 of 4 quarters in 2022. -Twice annual verification of accuracy records (peer review) for 2022. 2. The OM confirmed the finding above on 11/28/2023 at 10:00 am. 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 D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of the laboratory personnel records and personnel interview with the office manager and Testing Personnel 2 (TP), the Laboratory Director failed to ensure competency was maintained for 1 of 2 TP, performing synovial fluid examination. Findings Include: 1. On the day of survey, 01/27/2022, the laboratory failed provide documentation of competency assessment performed on TP2 from 08/09/2019 to 01 /27/2022. 2. 61 synovial fluid examinations were performed from January 2021 through the date of the survey. 3. During the survey the Office Manager confirmed the findings above. 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 D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: By review of the personnel record and personnel interview of the Practice Manager, at the time of inspection (10:00/06/2019), the Technical Supervisor failed to document the performance of all testing personnel annually for , (12/01/2017 through (08/06 /2019). Findings include: 1.. Review of the personnel record revealed no documentation of annual competency for 1 of 2 Testing Personnel from (12/01/2017 through (08/06/2019). 2. During the survey (10:45 08/06/2019), the Practice Manager confirmed the above finding. 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 --