Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 20, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director/technical consultant (LD/TC) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. American Association of Bioanalysts (AAB) PT document review revealed the LD/TC did not sign the 2020 Nonchemicstry (Immunohematology) attestation statement for the 2020 Q2 event. 2. An interview in a medical office with Staff #1 (CMS 209) at approximately 3:15 p.m. confirmed the lack of LD/TC signature on the aforementioned PT document. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (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 maintenance document review and staff interview, the laboratory failed to monitor and document equipment temperature as required. Findings include: 1. Maintenance document review revealed no Barnstead Thermolyne Rh View Box temperature logs were available at the time of survey for: 2018 -- September through December; 2019, 2020, and 2021 thus far. 2. An interview with Staff #1 (CMS 209) in a medical office on 1/20/2021 at approximately 3:45 p.m. confirmed the lack of the aforementioned temperature logs at the time of survey. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the laboratory director/technical consultant (LD/TC) failed to delegate responsibilities to qualified TP as required. Findings include: 1. TP competency document review revealed the 2021 annual competency for Staff #2 (CMS 209) was performed by unqualified TP due to failure to meet TC educational requirements. 2. An interview with Staff #1 (CMS 209) on 1/20/2021 in a medical office at approximately 2:00 p.m. confirmed the aforementioned annual TP competency was performed by unqualified TP. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require