Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 04/14/2026. The laboratory was found out of compliance with the following CLIA Condition. 493.1409; D6033: Technical Consultant 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 a review of records and interview with the laboratory director and testing person #1, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Medonic M-Series analyzer during the review period of April 2025 through March 2026. Findings include: (1) On 04/14/2026 at 08:53 am, the laboratory director and testing person #1 stated CBC (Complete Blood Count) testing was performed using the Medonic analyzer; (2) A review of the Medonic manufacturer's maintenance logs required the following maintenance procedures: (a) Monthly: (i) Clean using hypochlorite solution; (ii) Perform enzymatic clot prevention. (3) A review of maintenance logs from April 2025 through March 2026 identified maintenance had not been documented as performed for the following: (a) Monthly: (i) Between 04/30/2025 and 06/03/2025; (ii) Between 07/31/2025 and 09/02/2025 (Cleaning with hypochlorite not performed). (4) The records were reviewed with the laboratory director and testing person #1 who stated on 04/14/2026 at 01:35 pm, maintenance procedures had not been documented as performed as stated above. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory director, the technical consultant failed to provide technical supervision in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant met the qualifications to perform competency evaluations for four of four competency evaluations reviewed during 2024 through the current date. Findings include: (1) A review of records for four persons performing moderate complexity testing during 2024 through the current date identified the following for four of four testing persons: (a) Testing Person #2 - The 06/23/2024 and 06/26/2025 annual competency evaluations had been performed by an individual who did not meet the regulatory requirements of a technical consultant; (b) Testing Person #4 - The 06/19/2024 and 06/21/2025 annual competency evaluations had been performed by an individual who did not meet the regulatory requirements of a technical consultant; (c) Testing Person #6 - The 06/02/2024 and 06/17/2025 annual competency evaluations had been performed by an individual who did not meet the regulatory requirements of a technical consultant; (d) Testing Person #7 - The 09/19 /2024 and 06/28/2025 annual competency evaluations had been performed by an individual who did not meet the regulatory requirements of a technical consultant. (2) Phone call communication with the laboratory director following the survey on 04/15 /2026 at 07:24 pm confirmed the evaluations for the testing persons as stated above had been performed by an individual who did not meet the qualifications of a technical consultant. -- 3 of 3 --