Summary:
Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure 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: Review of personnel records for all personnel listed on the form CMS-209, review of the 2024 KOH examination log, lack of documentation, and interviews with laboratory staff, determined the technical supervisor failed to evaluate competency of laboratory personnel at least annually after the first year. Survey findings follow: A) Review of the KOH examination log for 2024 revealed employees #2, #3, and #4 (as listed on the form CMS-209) performed and reported KOH examinations in 2024 B) Upon request, the laboratory was unable to provide documentation of competency assessments for employees #2, #3, and #4 (as listed on the form CMS 209) C) In an interview, at 4:45 p.m. on 12/7/2017, laboratory staff member #1 (as listed on a separate staff identification list) confirmed the lack of competency documentation for the staff members identified above and that they have been employed and performing KOH examinations for over one year. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) 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 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: .Review of personnel records of six testing personnel performing moderately complex laboratory assays, lack of documentation and interviews with laboratory staff, determined the laboratory director failed to give written authorization for three of five testing personnel to perform moderately complex procedures without direct supervision. Survey findings follow: A) A review of personnel records of five testing peronnel, who perform moderately complex procedures, revealed that three (#2, #3, #4, as listed on the form CMS-209) failed to have the laboratory director's written authorization to perform moderately complex testing without supervision. B) Upon request, the laboratory was unable to provide documentation of the authorization to perform moderately complex testing for the personnel identified above. C) In an interview, at 4:15 p.m. on 5/22/24, laboratory staff member (#1 as listed on a separate personnel identification list) confirmed the lack of written authorizations for the three personnel identified above and that they performed moderately complex testing.. -- 2 of 2 --