Summary:
Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted on 01/06/2026. The facility was found to be out of compliance with CLIA regulations 42 CFR Part 493. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.801 Enrollment and testing of samples 493.1441 Laboratory Director, high complexity D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the CMS (Center for Medicare & Medicaid Services) 116 form, API (American Proficiency Institute) 2025 catalog, 155 CASPER (Certification and Survey Provider Enhanced Reporting) report, proficiency testing records, and confirmed in staff interview, the laboratory failed to meet the requirements of enrollment in proficiency testing for one of one subspecialty (Virology) in 2025 and to the date of the survey in January 2026. Findings included: 1. Review of the CMS 116 form submitted on the day of the survey listed the subspecialty of virology to include molecular testing for the following viruses on their UTI (urinary tract infection) panel: BK Virus (Human Polyomavirus 1) JC Virus (John Cunningham /Human Polyomavirus 2) HSV 1/2 (Herpes Simplex Virus) Adenovirus CMV (Cytomegalovirus) 2. Review of the API 2025 catalog revealed the proficiency testing company offered a molecular virology program. The API catalog stated: "Laboratories Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year." 3. Review of the 155 CASPER report and the laboratory's proficiency testing records revealed no proficiency testing scores for the virology subspecialty. 4. During an interview, in the office, on 01/06 /2026 at 10:54 a.m., the Laboratory Supervisor was asked to provide proficiency testing enrollment records for 2025. She stated that the UTI panel that the facility was enrolled in with the proficiency testing company did not include virology testing, confirming the above findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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: Based on direct observation, review of laboratory records, patient records, and confirmed in interview, the laboratory failed to ensure hematology reagents did not exceed their expiration dates prior to patient CBC (complete blood count), hemoglobin and hematocrit testing for 2230 of 2230 patients from October 23, 2025, through January 6, 2026. Findings included: 1. During a tour of the laboratory on 01 /06/2026 at 2:30 p.m., the surveyor observed the following in a cabinet in the hematology section of the laboratory: One opened box containing eight Cellclean Auto tubes; lot #A4169 expiration date 10/22/2025. One unopened Cellclean Auto box; lot #A4169 expiration date 10/22/2025. 2. During an interview, in the laboratory, on 01/06/2026 at 2:38 p.m., Testing Person-4 was asked if the laboratory had any other Cellclean Auto reagents that were available for use. She stated that the Cellclean Auto in the cabinet were the only ones available for use in patient testing. 3. Review of laboratory records identified 2230 patients from October 23, 2025, through January 6, 2026, who had CBC, hemoglobin or hematocrit testing using the expired Cellclean Auto reagents. The following is a random sampling of patients who were tested for CBC, hemoglobin or hematocrit using Cellclean Auto reagents that had exceeded their expiration dates: Test date: 12/04/2025 Patient ID: 919000; test: CBC Test date: 12/08 /2025 Patient ID: 2311920; test: CBC Test date: 12/09/2025 Patient ID: 126390; test: CBC Test date: 12/10/2025 Patient ID: 898440; test: CBC Patient ID: 1475030; test: CBC Test date: 12/11/2025 Patient ID: 2346600; test: CBC Patient ID: 244190; test: hemoglobin and hematocrit Test date: 12/12/2025 Patient ID: 136850; test: hemoglobin and hematocrit Test date: 12/16/2025 Patient ID: 2353320; test: CBC Test date: 12/18/2025 Patient ID: 57020; test: CBC The laboratory failed to ensure hematology reagents did not exceed their expiration dates prior to patient testing. 4. During an interview, in the office, on 01/06/2026 at 2:42 p.m., the Laboratory Supervisor confirmed the laboratory failed to ensure hematology reagents did not exceed their expiration dates prior to patient testing. D5781