Precision Labs Llc

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 the Thermo Fisher Scientific KingFisher Flex operator's guide, lack of polymerase chain reaction (PCR) laboratory temperature logs, review of patient results and interview with the technical supervisor (TS) #2, the laboratory failed to ensure the room temperature and humidity was monitored and documented as required by the manufacturer in 2024, 2025 and to date September 2, 2026. Findings: 1. Review of the Thermo Fisher Scientific KingFisher Flex operator's guide states "operating conditions (indoor use) +5 degrees Celsius to +40 degrees Celsius; maximum relative humidity 80% for temperatures up to 31 degrees Celsius decreasing linearly to 50% relative humidity at 40 degrees Celsius; Indoor use only". 2. Lack of PCR laboratory temperature logs where the Thermo Fisher Scientific KingFisher Flex is located showed the laboratory failed to document room temperature and humidity in 2024, 2025 and to date September 2, 2026. 3. Review of patient results showed the laboratory performs approximately 19,200 PCR patient tests per year. 4. Interview with the technical supervisor (TS) #2 on September 2, 2026, at 11:00 AM confirmed the laboratory failed to ensure the room temperature and humidity was maintained as required by the manufacturer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 polymerase chain reaction (PCR) laboratory safety hood, review of patient results and interview with the technical supervisor (TS) #2, the laboratory failed to define, perform and document maintenance for the laboratory safety hood in 2024, 2025 and to date September 2, 2026. Findings: 1. Observation of the PCR laboratory safety hood showed no documentation of maintenance for the laboratory safety cabinet in 2024, 2025 and to date September 2, 2026. 2. Review of patient results showed the laboratory performs approximately 19,200 PCR patient tests per year. 3. Interview with the TS #2 on September 2 at 11:00 AM confirmed the laboratory failed to perform and document maintenance for the PCR laboratory safety hood. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, Sysmex CA-500 analyzer quality control (QC), review of patient results and interview with the office manager, the laboratory failed to include two levels of control material each 8 hours of operation for prothrombin time (PT) for two of forty patient testing days in April and May 2026. Findings: 1. Review of laboratory procedure "Prothrombin Time (PT) Seconds" states, "Controls should be tested at the initiation of testing, upon reagent changes, and at least once each 8-hour shift." 2. Review of Sysmex CA-500 analyzer QC for April and May 2026 showed two levels of prothrombin time (PT) QC was not performed on April 6, 2026, and May 8, 2026. 3. Review of patient results showed 11 prothrombin time (PT) patient results were reported on April 6, 2026, and 3 prothrombin time (PT) patient results were reported on May 8, 2026 without QC being performed. 4. Interview with the office manager on September 1, 2026, at 12:00 PM confirmed the laboratory failed to perform two levels of prothrombin time (PT) QC each 8 hours of operation. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

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: Based on a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and College of American Pathologists (CAP) 2025 and 2026 proficiency testing records and phone interview with the clinical operations manager on June 25, 2026 at 10:00 AM the laboratory failed to successfully participate in a proficiency testing program approved by CMS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the speciality of routine chemistry for the analyte cholesterol, total. (Refer to D2096). 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, and College of American Pathologists (CAP) 2025 and 2026 proficiency records and phone interview with the clinical operations manager on June 25, 2026, at 10:00 AM, the laboratory failed to achieve satisfactory performance for cholesterol, total for two out of three consecutive testing events. Findings: 1. Review of the CASPER 0155 report showed the following results: Routine chemistry 2025 2nd event the laboratory received an unsatisfactory score of 60 percent for the analyte cholesterol, total. Routine chemistry 2026 1st event the laboratory received an unsatisfactory score of 20 percent for the analyte cholesterol, total. 2. Review of the College of American Pathologists (CAP) 2025 and 2026 proficiency records confirmed the CASPER 0155 report results. 3. Phone interview with the clinical operations manager on June 25, 2026 at 10:00 AM confirmed the laboratory failed to achieve satisfactory performance for cholesterol, total for two out of three consecutive testing events. -- 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: Based on a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and College of American Pathologists (CAP) 2024 and 2025 proficiency records and phone interview with the laboratory manager on May 5, 2025 at 11:25 AM, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of routine chemistry for the analyte glucose, non-waived. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, review of College of American Pathologists (CAP) 2024 and 2025 proficiency records and phone interview with the laboratory manager on May 5, 2025, at 11:25 AM, the laboratory failed to achieve satisfactory performance for glucose, non-waived in two out of three consecutive testing events. Findings: 1. Review of the CASPER 0155 report showed the following results: Routine chemistry 2024 2nd event the laboratory received an unsatisfactory score of 40 percent for the analyte glucose, non-waived. Routine chemistry 2025 1st event the laboratory received an unsatisfactory score of 20 percent for the analyte glucose, non-waived. 2. Review of the College of American Pathologists (CAP) 2024 and 2025 proficiency records confirmed the CASPER 0155 report results. 3. Phone interview with the laboratory manager on May 5, 2025 at 11: 25 AM confirmed the laboratory failed to achieve satisfactory performance for glucose, non-waived in two out of three consecutive testing events. -- 2 of 2 --

Summary Statement of Deficiencies D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, Sysmex CA-500 analyzer quality control (QC), patient results and interview with the technical consultant (TC), the laboratory failed to include two levels of control material each 8 hours of operation for prothrombin time (PT). Findings: 1. Review of laboratory procedure "Prothrombin Time (PT) seconds" states, " Controls should be tested at the initiation of testing, upon reagent changes, and at least once each 8 hour shift." 2. Review of Sysmex CA-500 analyzer QC for August 2022 showed two levels of PT QC was not performed on August 10, 2022. 3. Review of patient results showed 24 patient PT results were reported without QC being performed on August 10, 2022. 4. Interview with the TC on August 29, 2022 at 3:30 PM confirmed the laboratory failed to perform two levels of PT QC each 8 hours of operation. 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 --