Prime Medical Group Pllc

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 manufacturer's instruction, temperature and humidity logs, and interview with staff, the laboratory failed to follow manufacturer's instructions for operational environment relative humidity for the HistoStar. Findings follow: A) Review of the HistoStar instrument manual ( HistoStar Operator Guide, A81010100 Issue 10, September 2020), revealed the operating environment for relative humidity is " Max. 80% RH up to 31C decreasing linearly to 50% RH at 40C". B) Upon request the laboratory was unable to provide humidity measurements for the laboratory. C) During an interview on 2/25/26 at 10:28 am the testing personnel #3 (as listed on the CMS-209 form) confirmed that humidity was not recorded in the laboratory. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. 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 a review of the quality control records and through interviews with laboratory personnel, the laboratory failed to document quality control of histological staining. Findings follow: A. A review of the "Consolidated Complete Staining Run" log for February 2026 revealed 123 stains performed and no doumentation of quality control checks. B A review of the "Monthly Hand Stain QC" log from July through December of 2025 revealed 44 stains performed and no documentation of quality control checks. B. Upon request the laboratory was unable to provide alternative documentation of quality control checks for the above tests. C. In an interview at 10: 48 a.m. on 3/20/26, testing personnel #3 (as listed on the form CMS-209) confirmed that documentation of stain quality control for the above tests was not available. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on policy, lack of documentation, and interview the laboratory failed to follow established written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in analytic systems. Finding follow: A. The laboraotry's Quality Assurance Manual states "The Laboratory Director reviews all quality control charts and logs on a regular basis." B. Upon request, no documentation showing Laboratory Director Review of "Monthly Hand QC Stain" logs for July through December 2025 and "Consolidated Completed Staining Run" logs for February 2026 was available. C. At 10:38am on 3/20/26 testing personnel #3 (as listed on the CMS-209 form) confirmed that documentation of laboratory director review for the above quality control logs was not available. -- 2 of 2 --

Summary Statement of Deficiencies 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 8/8/2024 at 10:45 am one (of one) opened container Biocare PRAME [EPR20330] Reagent (REF API3252AA, lot 030122A-2, expiration date 6/2024) was observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 8/8/2024 at 10:45 am one (of one) opened package of Biocare Treponema palladium [Spirochete] Reagent (REF APA135AA, lot 060122A, expiration date 6/2024) was observed in the laboratory, available for use beyond the expiraton date. C) Laboratory policy stated "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." D) In an interview on 8/8/2024 at 10:48am the technical supervisor, confirmed that the items, identified above, had exceeded the expiration date and were available for use. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) 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 -- Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Through a review of Laboratory test reports and interview with staff it was determined the laboratory test reports failed to include the address of the laboratory where the test was performed. Survey findings include: A) A review of laboratory test reports (one of one) revealed the laboratory results reports reviewed failed to include the address of the laboratory where testing was performed. B) Laboratory policy stated " The test report must indicate the following: ... The name and address of the laboratory location where the test was performed... " C) In an interview at 11:06 am on 8/8/2024 the technical supervisor confirmed the laboratory test report did not include the laboratory address. -- 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: Through a review of maintenance records for January through September 2020, lack of documentation, and interviews with laboratory personnel, it was determined the laboratory failed to perform weekly maintenance for the Histostar Embedding Center, the Shandon Linistain H&E Stainer, and the Tissue-Tek Film Coverslipper as required by the manufacturer. Survey findings include: A. The Histostar Embedding Center weekly maintenance is listed on the maintenance log as the following: Clean forceps wells, touch screen display, and any wax build up on case work. B. In a review of Histostar Embedding Center maintenance records, it was determined there were weeks without weekly maintenance documented in six of nine months reviewed. Weekly maintenance was missing for the third week in January 2020, first and second week of March 2020, first and fourth weeks in April 2020, first, second and fourth weeks in June 2020, first, second, third, and fourth weeks in July 2020, and first, second, third, and fourth weeks in August 2020. C. The Shandon Linistain H&E Stainer weekly maintenance is listed on the maintenance log as the following: On Fridays the entire stain line is dumped and containers are washed. On Mondays the stainer is re-filled with fresh reagents. D. In a review of Shandon Linistain H&E Stainer maintenance records, it was determined there were weeks without weekly maintenance documented in three of nine months reviewed. No maintenance documented in the third week in March 2020, the first, second, third or fourth week of June 2020, and the second, third, or fourth week of August 2020. E. The Tissue-Tek Film Coverslipper weekly maintenance is listed on the maintenance log as the following: Xylene is changed weekly. F. In a review of Tissue-Tek Film Coverslipper 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 -- maintenance records, it was determined there were weeks without weekly maintenance documented in one of nine months reviewed. No maintenance documented in the first and third week of June 2020. G. In an interview (10:42 on 9/23 /2020) laboratory employee #4 (as listed on the form CMS-209) confirmed the laboratory failed to consistently document weekly maintenance. -- 2 of 2 --