Laboratory Corporation Of America Holdings

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 record review and staff interview, the laboratory failed to follow its written policies and procedures for quality control performance in the subspecialty of endocrinology. Findings include: 1. Record review on 03/01/2023 of the 'Pregnancy Test, Serum' standard operating procedure quality control section revealed 'testing personnel should perform quality control testing weekly in order to maintain competency'. 2. Record review on 03/01/2023 of the 'quality control and patient log' revealed lack of weekly quality control performance for the month of March, April, June, July, and August of 2021. 3. Staff interview on 03/01/2023 at 10:55 AM with the laboratory director confirmed the above findings. 4. The laboratory performs 2 tests annually in the subspecialty of endocrinology. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 record review and staff interview, the laboratory failed to follow manufacturer's instructions for specimen storage for human chorionic gonadotropin (HCG) test in the subspecialty of endocrinology. Findings include: 1. Record review on 03/01/2023 of the 'Sure-Vue Serum/Urine hCG-STAT' manufacturer package insert revealed specimen storage requirement at 2 - 8 degrees Celsius for up to 48 hours. 2. Record review on 03/01/2023 of the 'Pregnancy Test, Serum' standard operating procedure specimen requirements section revealed storage requirement at 2 - 8 degrees Celsius for up to 14 days. 3. Record review on 03/01/2023 of the 'On-Site Validation Sure-Vue Stat Qualitative Serum hCG' revealed lack of specimen storage /stability validation for up to 14 days. 4. Staff interview on 03/01/2023 at 10:30 AM with the laboratory director confirmed the above findings and further commented that the storage/stability validation was performed at another laboratory. 5. The laboratory performs 2 tests annually in the subspecialty of endocrinology. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to evaluate testing personnel competency to perform and report accurate test results in the subspecialty of endocrinology. Findings include: 1. Record review on 03/01/2023 of the laboratory's CMS 209 form revealed 2 testing personal (TP) employed to perform human chorionic gonadotropin (HCG) test. 2. Record review on 03/01/2023 of the 'STAT LAB OPERATIONS MANUAL' competency assessment binder revealed lack of annual competency assessment for 1 of 2 TP in the year of 2022. 3. Staff interview on 03/01/2023 at 10:06 AM with the laboratory director confirmed the above findings. 4. The laboratory performs 2 tests annually in the subspecialty of endocrinology. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow its policy to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's personnel competency records on 6/21/21 revealed the following: a. The laboratory did not follow the policy in place to assess the competency of the clinical consultant and the technical consultant. b. The laboratory did not have competency documentation for the above laboratory personnel. c. An electronic record of the consultant(s) competency policy revealed they need to be assessed as required. 2. Staff interview with the laboratory director on 6/21/21 at 11:10 AM confirmed the laboratory did not follow its policy in place to assess the competency of the above laboratory personnel and they were not assessed or documented. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document annual competency of testing personnel (TP) to assess the knowledge and skills necessary to 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 -- perform moderate complexity laboratory testing. Findings include: 1. Training and competency record review on 6/21/21 revealed the laboratory did not have annual competency documentation for 3 of 4 TP performing moderate complexity tests for 2019 and 2020. 2. Staff interview with the laboratory director (LD) on 6/21/21 at 11: 00 AM confirmed the above finding. The LD further stated it is difficult to perform TP competency assessments as the TP are working at multiple locations. 3. The laboratory performs 2 moderate complexity tests per year in the sub-specialty of Endocrinology. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to ensure personnel performing moderate complexity testing had documentation of training appropriate for the testing performed prior to analyzing patient specimens. Findings include: 1. Record review of the testing personnel (TP) training documentation on 6/21/21 revealed the laboratory did not have training documentation for TP#4 performing moderate complexity testing. 2. Record review of the patient test records and proficiency testing (PT) records on 6/21/21 revealed TP#4 was testing patient samples and PT samples from 2019. 3. Staff interview with the laboratory director (LD) on 6 /21/21 at 11:30 AM confirmed the above findings. The LD further stated training records for TP#4 were misplaced and not available for review. -- 2 of 2 --