Summary:
Summary Statement of Deficiencies 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 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 laboratory personnel interviews and written competency policies and procedures record review on May 11, 2026 at 10:15 am, the laboratory director, moderate complexity testing, failed to ensure that written procedures were established for monitoring individuals who conduct preanalytic, analytic, and postanaltytic phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and repot test results promptly and proficiently and whenever necessary, identify needs for remedial training and continuing education to improve skills. Findings included: a. Although the laboratory maintained a written laboratory personnel competency policy document and written documentation indicating that the laboratory had evaluated the competency of all testing personnel pursuant to 42 CFR 493.1413(b)(8), the laboratory maintained no documentation detailing procedures for the activities used to meet the CLIA regulations at 42 CFR 493.1413(b)(8). b. These findings were confirmed by laboratory personnel on May 11, 2026 at 10:15 am. c. According to laboratory documents, the laboratory performed and reported approximately 49,441 patient routine chemistry and hematology test results annually. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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 -- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and 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 results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and written laboratory personnel responsibilities and duties record review on May 11, 2026 at 10:00 am, the laboratory director, moderate complexity testing, failed to specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanaltytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervisor is required for specimen processing, test performance of results reporting, and whether consultant or director review is required prior to reporting patient test results. Findings included: a. Although the laboratory maintained written documentation specifying the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanaltytic phases of testing, the laboratory maintained no written documentation indicating that the laboratory director had specified these reponsibilities and duties. b. These findings were confirmed by laboratory personnel on May 11, 2026 at 10:00 am. c. According to laboratory documents, the laboratory performed and reported approximately 49,441 patient routine chemistry and hematology test results annually. -- 2 of 2 --