Lab Corp Of America Holdings

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was completed at Labcorp of America Holdings on July 13-14, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: A. Based on a laboratory tour, review of policies and procedures, Quality Assurance (QA) records, lack of documentation, patient test logs, and an interview, the laboratory failed to establish and follow a policy to perform and evaluate a comparison of manual differentials with automated blood cell differentials performed on the Sysmex XS-1000ic hematology instrument for twenty-seven (27) of 27 months reviewed (review timeframe: April 2020 to date of the survey July 13-14, 2022). Findings include: 1. During a laboratory tour on 7/13/22 at approximately 10 AM, the inspector noted patient Complete Blood Count (CBC) samples were being assayed on a Sysmex XS-1000ic (Serial Number A10553) hematology instrument in the Stat Laboratory. The inspector also noted a manual differential counter and Hematek slide stainer. 2. Review of the laboratory's policies and procedures revealed a procedure for Manual Differential Protocol. The inspector noted there was no documentation of a policy/procedure to evaluate a comparison of their manual differential method with the automated blood cell differential method reported on the Sysmex instrument. 3. Review of the laboratory's QA documentation from April 2020 through the end 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 survey on 7/14/22 revealed no documentation of blood cell differential test result comparison studies for the two (2) methods outlined above during the 27 months of review. 4. The inspector requested to review a policy for a comparison of the 2 blood cell differential count methods. The technical supervisor (TS) stated on 7 /14/22 at approximately 12:00 PM, "We do not have a policy. I will consult with our Director of QA to see if we have a corporate policy that we can use site specific." 5. The inspector inquired of the number of manual differentials reported during the 27 months from 4/1/20-7/14/22. The TS consulted the patient test logs and stated at approximately 2 PM, "We have reported two thousand four hundred thirty (2,430) manual differentials in that time" 6. An exit interview with the TS on 7/14/22 at approximately 3 PM confirmed the above findings. B. Based on a laboratory tour, review of policies and procedures, Quality Assurance (QA) records, lack of documentation, and an interview, the laboratory failed to follow their policy for a method comparison of twenty-five (25) of 25 chemistry analytes assayed on two (2) Roche C501 instruments in calendar year 2021. Findings include: 1. During a laboratory tour on 7/13/22 at approximately 10 AM, the inspector noted patient chemistry analyte testing on 2 Roche C501 instruments in the Stat laboratory (Serial Numbers SN - 16Z309, 16Z315). 2. Review of the laboratory's policies and procedures revealed a policy ("Multiple Instrument Comparison") that stated: "This procedure is designed to compare instruments of same type and applies to all disciplines. Any assay performed on multiple instruments must have a correlation performed semiannually between all instruments performing the assays." 3. Review of the laboratory's QA documentation for calendar year 2021 revealed one (1) "Multiple Instrument Comparison Worksheet" record dated as performed on 7/30/21 for the following 25 analytes: Amylase, Chloride, Direct Bilirubin, Creatine Kinase, Creatinine, Triglycerides, Potassium, Sodium, Lipase, Alanine Transaminase (ALT /SGPT), Magnesium, Carbon Dioxide, Gamma-Glutamyl Transferase (GGT), Aspartate Aminotransferase (AST), Total Protein, Albumin, Total Bilirubin, Alkaline Phosphatase, Lactate Dehyrogenase (LDH), Glucose, Blood Urea Nitrogen (BUN), Uric Acid, Cholesterol, Calcium, Phosphorus. The inspector requested to review additional Roche analyzer comparison studies conducted in 2021 for the 25 analytes outlined above assayed on Roche C501 SN 16Z309 and 16Z315. No additional records were available for review. 4. An exit interview with the TS on 7/14/22 at approximately 3 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA complaint survey was conducted at LabCorp of America Holdings on June 29, 2020 to July 10, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, laboratory missed /delayed specimen documents, patient records and interviews, the laboratory failed to establish and follow a written policy to ensure the reporting of missed or delayed specimen test results for four (4) of twenty-seven (27) patients collected on April 30, 2020. Findings include: 1. Review of the laboratory's list of specimens sent by the doctor's office (client) revealed 27 patients had specimens collected on April 30, 2020. 2. Review of the laboratory's "Missed/Delayed Specimen Pick-up Form- Reported Missed Pick-up" form revealed the following information: "Date notification received: 5/1/2020 Time received: 11:44 AM Client Account Number 45805080 Additional Client Information Location where specimens were found: Inside the Lab-Counter Touch Lavender Tubes Left Out of Lab Ready. Technical Missed specimen types? 4 lavenders Specimens accepted for tested? Yes Accessioning /Testing @RV Stat Lab per IOP[In Office Personnel]." 3. Review of the laboratory's "Richmond Missed Pick Up-Stat Lab and Customer Services Documentation' form revealed the following information: "Stat Lab Account Number: 45805080 Number of Specimens: 4 Number of Patients: 4 Date of Collection: 04/30/2020 Date Samples Received 05/01/2020 Specimen Types: 4 lavenders Reason for Missed Pickup: Touch 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 -- Lavenders left out of Lab Ready. How were samples stored? Inside Lab on Counter Is Integrity of samples compromised? No What testing can be saved? All CBC's ran in RV Lab per IOP Request) What testing will be rejected? None Is the Client aware of the problem? Yes Customer Services KAE notified? Yes Client notified? Yes Name of Client notified N/a office closed Date/Time Client Notified Office closed Response of Client N/A Specimens commented out by Burlington N/A Specimens commented out by Branch N/A" 3. Review of the "Missed Pick-up Accessioned 305780-LabCorp Upload Manifest Log" and patient test requisitions for April 30, 2020 revealed the following client's regional specimen numbers with tests requested listed: 121-496- 4529-0 tests requested-Complete Blood Cell count with differential (CBC/diff), Hemoglobin A1C, Thyroid Stimulating Hormone (TSH), Free Thyroxine (Free T4), Complete Metabolic Panel (CMP), Lipid Profile (LP), Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus Antibody (HCV), 121-496-9878-0 tests requested-CBC /diff, Hgb A1C, TSH, Free T4, CMP, LP, HBsAg, HCV; 121-646-0339-0 tests requested CBC/diff, Hgb A1C, TSH, Free T4, CMP, LP, HBsAg, HCV and; 121-646- 0774-0 tests requested-CBC/diff, TSH, Free T4. Total=4 patients 4. In an interview on July 7, 2020 at approximately 1:00 PM with the client's Medical Assistant (MA), the MA stated the office was not notified by the laboratory of any missed specimens or delayed results from April 30, 2020. The MA stated they became aware of an issue with results on June 12, 2020 when a patient called the office for their test results collected on April 30, 2020. The MA was unable to give the patient their results because the CMP, TSH, Free T4, LP, HBsAg and HCV were reported as "deleted" in the laboratory information system. 5. In an interview on July 7, 2020 at approximately 3:00 PM with the branch Laboratory Manager (LM), the LM stated, "On May 1, 2020, the laboratory received a telephone call from the client's In Office Phlebotomist (IOP) informing the branch laboratory four patient's lavender top tubes were left at the client's office on the counter on April 30, 2020. The four lavender top tubes (regional laboratory specimen numbers 121-496-4529-0, 121-496-9878-0, 121-646-0339-0 and 121-646-0774-0) were not sent for analysis at the regional laboratory. The 4 patient's other specimens for the CMP, TSH, Free T4, LP, HBsAg and HCV were picked up on April 30, 2020, sent to the regional laboratory, analyzed and results were reported on May 1, 2020. On May 1, 2020, the laboratory courier picked up the four missed lavender top specimens and brought the specimens to the branch laboratory for analysis. The branch laboratory accessioned the four lavender tops with the branch laboratory's specimen numbers. The branch laboratory analyzed and resulted the four- missed specimen at approximately 3:00 PM on May 1, 2020. Between 3:40 and 5:00 PM on May 1, 2020, a technologist from the branch laboratory deleted the regional laboratory specimen numbers along with the corresponding test (CMP, TSH, Free T4, LP, HBsAg and HCV) results." The LM stated the laboratory was not aware of the "deleted" results until the surveyor notified them. 6. Review of the laboratory's policies and procedures revealed the laboratory failed to establish a policy to ensure the reporting of missed or delayed specimen test results. The surveyor requested a policy from the laboratory. The laboratory provided no policy for ensuring the reporting of missed or delayed specimen test results. 7. In an interview on July 7, 2020 at approximately 3:30 PM, the LM confirmed the findings -- 2 of 2 --