Summary:
Summary Statement of Deficiencies D6100 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(10) The laboratory director must ensure that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under 493.1489(b)(4). This STANDARD is not met as evidenced by: Based on record review of the CMS-209 laboratory personnel form, the laboratory's personnel competency records, personnel job descriptions, and interview with the identified technical supervisor (TS-1) on the CMS-209 form, on August 09. 2022. the laborataory Director (LD) failed to ensure a competent general supervisor (GS) was onsite at all times when patient testing is performed. The findings include: 1 The laboratory CMS-209 form identifies three high complexity testing personnel as GS, GS-1, GS-2 and GS-3. 2. The laboratory provided 1 (GS-1) annual competency records signed by the TS-1. The competency did not include the responsibilities or delegation of authority of the GS-1 by the LD. The TS-1 did not have a delegation of authority or job description from the LD to perform competency evaluations. 3. Two of three GS identified (GS-2, GS-3) did not have documentation of competency or delegation of responsibilities by the laboratory director for test years 2021 and 2022. 4. The TS-1 confirmed by interview on August 09, 2022 at 10:30 a.m., the lack of GS position descriptions, delegation of authority, or competency for 2021, 2022 . 5. The laboratory projects performing 18,476 Hematology patient tests annually. 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 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 -- 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 record review of the laboratory's CMS-209 Personnel record, the laboratory's training and competency records, and interview with the Technical Supervisor (TS) on Augusts 09, 2022, the laboratory director (LD) failed to specify, in writing, the responsibilities and duties for the two (2) technical supervisors (TS) and three (3) general supervisors (GS) responsible for the proper performance of high complexity test results. The findings Include: 1. The laboratory has identified two (2) Technical Supervisors for this location as identified on the CMS-209 personnel form, the laboratory does not have a signed delegation of authority for 2 of 2 TS with listed responsibilities and duties. a. The TS-1 performed and signed off annual training and competency for 2021, and 2020 for (3) of (3) testing personnel/GS. 2. The laboratory did not have a delegation of duty signed by the laboratory director for the (3) of (3) GS's identified on the CMS-209 personnel form, as technical supervisors. a. The three (3) GS identified on the CMS-209, work independently (alone) as the testing personnel without LD or TS oversight. 3. The laboratory TS-1 and TS-2 confirmed by interview on August 09, 2022 at 10:15 a.m., the laboratory does not have delegations of authority by the laboratory director for the individuals identified on the CMS-209 as TS or GS. 4. The laboratory records indicates the laboratory performs 18,476 Hematology specimens annually. -- 2 of 2 --