Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed on July 16, 2026 at The Pathology Laboratory, INC, CLIA ID # 19D2082565. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) 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 record review and interview with personnel, the Laboratory Director failed to ensure the 2025 and 2026 annual competency assessments were performed for one (1) of seven (7) testing personnel performing high complexity testing. Refer to D6128. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's policies, CMS-209 (Laboratory Personnel Report) form, and personnel records and interview with personnel, the Technical Supervisors failed to perform competency assessments annually in 2025 and 2026 for one (1) of seven (7) testing personnel reviewed. Findings: 1. Review of the laboratory's "Competency Assessment" policy revealed "Competency is documented for all testing personnel at the following intervals: initial (prior to patient testing), six months post hire, twelve months post hire, and annually thereafter." 2. Review of the laboratory's CMS-209 revealed the following testing personnel: Personnel 1 Personnel 2 Personnel 3 Personnel 4 Personnel 5 Personnel 6 Personnel 7 3. Review of the laboratory's personnel records for Personnel 7 revealed an annual competency assessment performed in March 2024 but no documentation of an annual competency assessment performed in 2025 and 2026. 4. In interview on July 16, 2026 at 9:24 a.m., the Quality Assurance Manager confirmed annual competency assessments were not performed as identified above. -- 2 of 2 --