Heritage Medical Associates, Pc

Summary Statement of Deficiencies 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 observation of the laboratory, review of analyzer instructions-for-use (IFU), review of environmental records, and staff interviews, the laboratory failed to monitor ambient humidity in the areas where staff utilized Hematology, Chemistry, and Urinalysis instruments to conduct patient testing in 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on 04/17/24 at 8:15 a.m. revealed the following test systems in use for patient testing: - A Sysmex XN-2000 hematology test system (ID: 227007) - A Roche Cobas-8000 chemistry test system (ID: 21E5-10 and 2117-06) - Siemens Cliniteck Novus (ID: S001547) and Sysmex UN-2000 (ID: 227678) urinalysis test systems. 2. A review of the manufacturer's IFUs revealed the following: - The Sysmex XN-2000 IFU states an "operating environment (relative humidity)" range of "20 to 85%." - The Roche Cobas-8000 IFU states, "The following environmental conditions must be fulfilled during operation," with an ambient humidity range of "30-85% (non-condensing)." - The Siemens Cliniteck Novus IFU states, "The ambient operating humidity range is 20 to 80% relative humidity." - The Sysmex UN-2000 IFU states an "operation environment relative humidity" range of "30 to 85% (no-condensation)." 3. A review of the laboratory's 2022, 2023, and 2024 environmental records revealed no documentation of ambient humidity. 4. In an interview on 04/17/24 at 1:30 p.m., the lab manager and supervisor confirmed 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 did not monitor ambient humidity in the area where personnel used analyzers to perform hematology, chemistry, and urinalysis patient testing in 2022, 2023, and 2024. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and staff interviews, the laboratory failed to compare results between the automated and the manual methods used for White Blood Cell (WBC) differential and urine sediment evaluation twice per year (4 of 4 events) in 2022 and 2023. The findings include: 1. Observation of the laboratory on 04/17/24 at 8:15 a.m. revealed the following: - A Sysmex XN- 2000 hematology test system (ID: 227007) performing WBC automated differentials. - A microscope (ID: 700636) in the hematology section for performing WBC manual differentials. - A Sysmex UN-2000 urinalysis test system (ID: 227678) performing automated urine sediment evaluations. - A microscope (ID: 20110100) in the urinalysis section for performing manual urine sediment evaluations. 2. No comparison studies were documented to evaluate the results obtained between the automated and manual methods for WBC differentials and urine sediment evaluations from 2022 and 2023. 3. In an interview on 04/17/24 at 1:30 p.m., the lab manager and supervisor confirmed the laboratory did not compare the automated and manual methods for WBC differentials and urine sediment evaluations. -- 2 of 2 --

Summary Statement of Deficiencies 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: The laboratory failed to maintain satisfactory participation in two out of three proficiency testing (PT) events for Phenytoin, resulting the 1st unsucessful PT performance in 2021. . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper report 155D (CMS 155) and American Proficiency Institute (API) evaluation reports, the laboratory failed to acheieve satisfactory performance for Phenytoin analyty in two out of three testing events, resulting in the 1sth unsucessful PT performance in 2021. The findings include: 1. Review of the CMS 155D revealed the following scores: Event 2-2021 Phenytoin 60% Event 3-2021 Phenytoin 60% 2. Review of the laboratory's API evaluation report revealed the following scores: Event 2-2021 Phenytoin 60% Event 3-2021 Phenytoin 60% -- 2 of 2 --