Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Due to a lack of policies, procedures, specimen rejection logs and interview with the testing personnel (TP) # 2, the laboratory failed to have written policies, procedures, and Quality Assurance (QA) documentation available for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic system. Findings: 1. A request was made to review the preanalytical policies and procedures. A "General QA" policy was provided. Review of this document found information for specimen labeling and identification only. No information for an ongoing mechanism to monitor, assess, and when indicated, correct problems in the preanalytic system was included. 2. A request was made to review the specimen rejection log for QA documentation. None were made available at the time of survey. 3. Interview with the TP #2 on 5/31/23 at 8:30 a.m. confirmed, the laboratory failed to have written policies, procedures, and QA documentation available for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic system. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the review of the procedure "Proficiency Testing", proficiency testing (PT) submission forms,

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, PT procedure and staff interview reveals that the laboratory failed to evaluate its proficiency testing results that were not scored by the PT program. Findings: 2019 1st event Hematology /Coagulation PT performance evaluation included three ungraded results. 1. Ungraded samples included: Urine Sediment US-02, Vaginal Wet Preparation (KOH) VKP-01 and Urobilinogen UA-01. 2. Lab investigation and evaluation was performed for UA- 02 only. No evidence of lab investigation and evaluation was available for US-02 or VKP-01 at the time of survey. 3. LabCorp proficiency testing procedure, page 3 states "If there is a deficiency or an unacceptable result for any survey specimen (graded, non-graded or educational), then investigation and

Summary Statement of Deficiencies D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require