Summary:
Summary Statement of Deficiencies D0000 An announced onsite recertification survey was conducted at Pain & Spine & Sports Medicine Laboratory on October 24, 2025. The facility was found to be out of compliance with the Medicare Condition at 42 CFR Part 493. Laboratory Requirements. The following STANDARD LEVEL DEFICINCIES were found to be out of compliance: 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 observations, records review and staff interview, the laboratory failed to ensure thermometers were consistent with the manufacturer's instructions. 2 out of 2 thermometers were expired. Findings included: 1. During a tour of the laboratory on October 24, 2025, at 3:19 pm the surveyor directly observed one case of Tencell Cuvettes with storage requirements 10 to 80 degrees C. 2. The surveyor directly observed a room traceable thermometer revealing it expired May 19, 2016, and a refrigerator thermometer expired May 14, 2016. 3. It was confirmed during an exit interview on October 24, 2025, at 3:19 pm with the testing personnel that these thermometers are used to monitor temperatures for the moderately complex testing performed in the office. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure 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 -- that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on records review, lack of documentation and staff interview, the laboratory director failed to ensure documentation of personnel competencies for 1 of 1 employee listed on the CMS 209 personnel form. Findings included: 1. Review of CMS 209 personnel report form reveals one laboratory director and one testing personnel. 2. No dated signature of laboratory director for 2023, 2024, or 2025 (3 of 3 years) reviewed. 3. In an exit interview with testing personnel on October 24, 2025, at 3:19 pm the above findings were confirmed. -- 2 of 2 --