Laboratory Corporation Of America

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of 2025 temperature and humidity records, laboratory instrumentation manuals, and interview with laboratory staff, the laboratory failed to document daily humidity in one of three rooms. Survey findings include: A. A review of laboratory instrumentation manuals revealed performance specifications of a maximum of 80% relative humidity for the Hologic ThinPrep Imaging System Workstation and 90% for the Hologic ThinPrep Imaging System Imaging Station (ThinPrep Imaging System Technical Information Reference Guide, MAN-02144, Rev. 008). B. Through a review of temperature and humidity records for 2025 it was revealed the laboratory failed to document humidity on one (of three) ThinPrep stations for 12 of 12 months for 2025 C. In an interview, at 09:39am on 12/9/2025, the General Supervisor (as listed on entrance/exit interview form) confirmed the laboratory humidities were not documented on days the laboratory was in operation. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for 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 -- high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Through a review of personnel files, lack of documentation, and interviews with laboratory staff, it was determined the general supervisor failed to be evaluated for competency at least semiannually in the first year of testing. Survey findings follow: A. A review of General Supervisor records revealed that the Laboratory Directory, listed on the form CMS-209, had other personnel approval within the employee training documented "AP Competency - Supervisor/Manager 2025". No competency evaluation performed by the current Laboratory Directory. B. In an interview, at 1:09 p.m. on 12/9/2025, General Supervisor, as listed on the form CMS-209, confirmed the competency was not signed by the Laboratory Directory. -- 2 of 2 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Through a review of the laboratory policy for Gynecologic Pap Test, a review of ten electronic requisitions for patients with Pap smears requested, and interviews with laboratory staff, it was determined that one of ten Pap requisitions did not include the date of the last menstrual period (LMP). A. A review of the "Special Instructions" section of the Gynecologic Pap Test policy revealed, "Include date of birth, Social Security number (or other identification number), previous malignancy, drug therapy, radiation therapy, last menstrual period (LMP), postmenopausal patient,..." B. Through review of ten electronic requisitions for patients with Pap smears requested, one of ten requisitions failed to include the LMP. The requisition, dated 4/4/2024, was for patient #14522668 (a 29 year old female). The requisition did not include the date 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 -- of the LMP nor did it include a line where an LMP could be documented. C. In an interview, at 12:40 on 4/18/2024, the Cytology General Supervisor (as listed on the form CMS-209) confirmed the lack of LMP on the requisition listed above. 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 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 upon review of personnel records, lack of documentation, and interview it was determined that the laboratory director failed to specify in writing the examinations and procedures that personnel are authorized to perform for four of four testing personnel for which records were presented. Findings follow: A. Upon request, the laboratory was unable to provide a written authorization to perform procedures signed by the laboratory director for four of four testing personnel. B. In an interview on 4/18 /24 at 1:27 p.m., the general supervisor confirmed there were no written authorizations to perform testing, signed by the laboratory director. -- 2 of 2 --