Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 28, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies was cited: 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 (LD) failed to delegate the duties of the technical consultant (TC) to personnel meeting the required qualifications. Findings include: 1. TP competency document review revealed all TP competencies for 2017, 2018, and 2019 thus far were performed by unqualified personnel due to lack of educational qualifications. 2. An interview with Staff #6 (CMS 209) in a medical office on 2-28-19 at approximately 1:30 p.m. confirmed all TP competencies for the aforementioned dates were performed by unqualified personnel due to lack of educational qualifications. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview, the technical consultant (TC) failed to perform a required TP annual competency. Findings include: 1. TP document review revealed the TC failed to perform an annual competency for Staff #6 (CMS 209) in 2018. 2. An interview with Staff #6 (CMS 209) in a medical office on 2/28/19 at approximately 1:30 p.m. confirmed there was no annual competency performed on her (Staff #6 - CMS 209) in 2018. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual (SOP) and staff interview, the laboratory director (LD) failed to specify in writing the duties and responsibilities of each individual that participates in any phase of laboratory testing as required. Findings include: 1. SOP review revealed the LD failed to establish a duties and responsibilities policy. 2. An interview with Staff #6 (CMS 209) in a medical office on 2/28/29 at approximately 1:30 p.m. confirmed there was no duties and responsibilities policy in the SOP. -- 2 of 2 --