Laboratory Corporation Of America

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Revisit 11/15/22 to 11/16/22 Based on review of the quality control (QC) records for the Sysmex XS1000i complete blood count (CBC) instrument and interview with the laboratory manager, the laboratory failed to retain quality control ranges for the Sysmex XS1000i CBC instrument for a period of two years. The findings include: 1. Review of the laboratory's QC records for the Sysmex XS1000i CBC instrument revealed no retention of records that included the laboratory's quality control ranges prior to 01/27/22. 2. Interview with the laboratory manager on 11/16/22 at 2 pm confirmed the laboratory failed to retain documentation of the quality control ranges that were being used for the Sysmex XS1000i prior to 01/27/22. 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 D0000 The facility was found to be NOT in compliance with the following 42 CFR Part 493, Requirements for Laboratories for the specialties/subspecialties for which it was surveyed: 493.1240 Pre-Analytic Systems 493.1250 Analytic Systems 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 a review of personnel files and interview of personnel, the laboratory failed to document competency assessments for all testing personnel. Findings: 1. A review of personnel files revealed that five of five laboratory assistants performing patient testing did not have any documentation of competency assessments. 2. An interview on 04/28/2022 at 2:00 PM with the Quality Manager confirmed the above findings. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION 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 21 -- Based on direct observation, review of laboratory policies and records, manufacturer's instructions, patient test reports and staff interview, the laboratory failed to meet the requirements for the preanalytical system, as evidenced by: 1. The laboratory failed to ensure patients were processed according to their policy and Cobas manufacturer's instructions for the preanalytic phase of testing (Ammonia and Lactic acids). Refer to D5311, I 2. The laboratory failed to centrifuge serum chemistry specimens within the allotted 1-hour processing time frames per their policy. Refer to D5311, II 3. The laboratory failed to follow the manufacturer's instructions for specimen stability and storage for Partial Thromboplastin Time (PTT) patient samples. Refer to D5311, III. 4. The laboratory failed to follow their own written procedure and reject visibly hemolyzed prothrombin time and activated partial thromboplastin time patient samples. Refer to D5311, IV 5. The laboratory failed to accurately document the date and time it received Ammonia and Lactic acid specimens. Refer to D5313. 6. The laboratory failed to provide clients with defined storage and transport instructions for coagulation tests (D-Dimer, PT, and PTT). Refer to D5317. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policy, laboratory's testing menu website, manufacturer's instructions, patient test reports, and interviews with Processing Manager, Emergency Room (ER) Nursing, the laboratory failed to ensure patients samples were processed according to their policy and Cobas manufacturer's instructions for the preanalytic phase of testing (Ammonia and Lactic acids) for the month of April 2022 as evidenced by: Ammonia a. In review of the manufacturer's instructions for the Cobas instrument states (version 11.0) under Specimen Collection and Preparation stated , "Place immediately on ice and centrifuge, preferably at 4 degrees C.Perform analysis within 20-30 minutes of venipuncture or freeze separated plasma immediately...Ammonia concentrations can increase in vitro due to breakdown of nitrogen-containing plasma components." b. In review of the laboratory's policy stated, "Place in immediately on ice and centrifuge....15-25 degree C 30 minutes... 2-8 degrees C 2 hours..." The policy did not follow the manufacturer's instructions. c.In review of the laboratory's website on 4/28/2022 at 1400 stated the following under stability requirement for ammonia: "2 hours (stability provided by manufacturer or literature reference)." d. In review of patients for the Month of April 2022 until the start of the survey, the laboratory had 50 of 198 patients that were not centrifuged within the 30 minute time frame. The following patients are a select listing of those: 1. Accession #22-094-0024471;collection date and time: 4-4-2022 1340; receive date and time: 4-4-2022 1619 total time elapsed: 159 minutes 2. Accession #22-096- 000692 ;collection date and time: 4-6-2022 0630; receive date and time: 4-6-2022 712; total time elapsed: 42 minutes 3. Accession #22-098-001374;collection date and time: 4-8-2022 1140; receive date and time: 4-8-2022 1309; total time elapsed: 89 minutes 4. Accession #22-098-001477;collection date and time: 4-8-2022 1101; receive date and time: 4-8-2022 1153; total time elapsed: 52 minutes 5. Accession -- 2 of 21 -- #22-100-000350;collection date and time: 4-9-2022 2343; receive date and time: 4-10- 2022 053; total time elapsed: 70 minutes 6. Accession #22-103-001810;collection date and time: 4-13-2022 0909; receive date and time: 4-13-2022 1000; total time elapsed: 51 minutes 7. Accession #22-104-000629;collection date and time: 4-14- 2022 0501; receive date and time: 4-14-2022 546; total time elapsed: 45 minutes 8. Accession #22-104-000424;collection date and time: 4-14-2022 0054; receive date and time: 4-14-2022 129; total time elapsed: 35 minutes 9. Accession #22-107- 002270;collection date and time: 4-17-2022 2051; receive date and time: 4-17-2022 2145; total time elapsed: 54 minutes 10. Accession #22-108-001696;collection date and time: 4-18-2022 0939; receive date and time: 4-18-2022; 1022 total time elapsed: 43 minutes e. In interview with an ER nurse 4-27-2022 at 1348 the federal surveyor asked how long do they have until the ammonia specimen could not be tested in the laboratory. He stated he wasn't sure for ammonia and would have to refer to the procedure order. f. In review the procedure order document referred to by the ER nurse stated, "Lavender top keep on ice deliver immediately." The document failed to state the 30 minute limitation specified in the manufacturer's instructions. g.In interview with Processing Manager on 04-26-2022 at 1150 she stated that it was on them (processing) to reject the specimen if it did not meet the 30 minute time frame. Lactic Acid a. In review of the manufacturer's instruction for the Cobas instrument version 13.0 states under specimen collection and preparation, "Centrifuge within 15 minutes of collecting the specimen." b. In review of the laboratory's policy stated, "The venipuncture samples should be kept on ice and centrifuged as soon as possible after collection (15 minutes) " c. In review of the laboratory's website on 4/28/2022 at 1405 stated the following under causes for rejection for lactic acid, "Specimen not separated from cells within 15 minutes of draw" d. In review of patients for the Month of April 2022 until the start of the survey, the laboratory had 149 of 1616 patients were not centrifuged within the 15 minute time frame. The following patients are a select listing of those: 1. Accession #22-092-001084;collection date and time: 4-2- 2022; 617; receive date and time: 4-2-2022 635; total time elapsed:18 minutes 2. Accession #22-092-00519;collection date and time: 4-2-2022 520;receive date and time: 4-2-2022 545; total time elapsed: 25 minutes 3. Accession #22-092-001124; collection date and time: 4-2-2022 747;receive date and time: 4-2-2022 0806; total time elapsed: 19 minutes 4. Accession #22-092-001435 ;collection date and time: 4-2- 2022 1127; receive date and time: 4-2-2022 1143; total time elapsed: 16 minutes 5. Accession #022-092-002066;collection date and time: 4-2-2022 1943; receive date and time: 4-2-2022 2007; total time elapsed: 24 minutes 6. Accession #022-092- 00088;collection date and time: 4-2-2022 1915; receive date and time: 4-2-2022 1933; total time elapsed: 18 minutes 7. Accession #22-108-001035;collection date and time: 4-18-2022 1039; receive date and time: 4-18-2022 1118; total time elapsed: 39 minutes 8. Accession #22-108-000858 ;collection date and time: 4-18-2022 1650; receive date and time: 4-18-2022 1755; total time elapsed: 65 minutes 9. Accession #22-108-001591;collection date and time: 4-18-2022 907; receive date and time:4-18- 2022 946; total time elapsed: 39 minutes 10. Accession #22-108-003252;collection date and time: 4-18-2022 1729; receive date and time: 4-18-2022 1847; total time elapsed:78 minutes e. In interview with ER nurse 04-27-2022 at 1349, federal surveyor asked how long do they have until the specimen could not be tested for lactic acid in the laboratory. He stated he wasn't sure for lactic acid but thought 15 minutes to the laboratory. The ER nurse stated he would have to refer to the procedure order. f. In review the procedure order document referred to by the ER nurse stated, "Gray top on ice delivered within 30 minutes." This document failed to follow manufacturer's instructions or laboratory policy. II. Based on review of the laboratory's policy, direct observation, and review of patient test reports, the laboratory failed to centrifuge two serum chemistry specimens within the allotted 1 hour processing time frames per their -- 3 of 21 -- policy as evidenced by: Unspun Specimens a. In review of the laboratory's policy for Vitamin B12, TSH, AST, ALT, CO2 states "The venipuncture sample should be centrifuged as soon as possible after collection (1 hr). The serum portion of the sample may be transported in an appropriately separated barrier tube (SST) or transferred in a transfer tube...." b. In direct observation at 4-27-2022 1825 in the accessing room, two tiger top (serum separate tubes) were unspun and on the clot (patient 1978716) . In review of the patient's test record (test ordered TSH, 25 OH Vitamin D, Vitamin B12) , it showed the documented specimen collection date and time was 04/27/2022 1600 and the specimen received date was 04/28/2022.The time the specimen was observed to be at the laboratory (1825) was 2 hours and 25 minutes after the collection time (1600). The documented received date (04/28/2022) was more than 8 hours after the time that the specimen was observed to be at the laboratory. c. In interview with the LabCorp courier on 4-27-2022 at 1826, he stated that the doctor's office didn't have time to spin the specimen. d. In direct observation on 04-27-2022 at 1850 in the accessing room, one tiger top tube (serum separator tube) was unspun and on the clot (patient 7846432) . In review of the patient's test record (test order complete metabolic panel (CMP) which includes AST, ALT, CO2). The documented collection date and time was 04-27-2022 at 0000 and the specimen received date was 04-27-2022 (no time indicated). The time the specimen was observed to be in the laboratory (1850) was more than 18 hours after the collection time (0000). The laboratory failed to ensure specimens was centrifuged within the 1- hour time limit. 41090 III. Based on a review of the manufacturer's instructions, the laboratory's policy and procedures, patient final reports, and an interview with General Supervisor #2, the laboratory failed to follow the manufacturer's instructions for specimen stability and storage for 14 of 15 partial thromboplastin time (PTT) patient samples in April 2022. a. A review of the package insert Dade Actin FSL Activated PTT Reagent (B4219G1E11 Rev. 10) page 2, revealed "Specimen Collection and Preparation ...Centrifuge the blood specimen at 1500 x g for no less than 15 minutes at room temperature as soon as possible after collection. Store in unopened tube at room temperature. If immediate testing is to be done, the plasma may remain on the packed cells. Otherwise plasma should be separated from the cells. Do not store on ice. Nonheparinized plasma should be tested within four (4) hours of blood collection ...Please refer to CLSI document H21-A5 for detailed information on sample preparation and storage." b. A review of the CLSI document H21-A5 (released Jan 2012) page 13, revealed "7. Storage...7.1.1 Short-Term Storage of Plasma and Coagulation Testing ...Specimens for routine APTT assays from nonheparinized patients can be maintained uncentrifuged or centrifuged, with plasma remaining on top of the cells in an unopened tube kept at room temperature for up to four hours from time of specimen collection. If laboratories choose to maintain APTT samples for more than four hours before testing, in-house studies should be performed." c. A review of the laboratory's procedure Sysmex CS Series Prothrombin Time and Activated Partial Thromboplastin Time (LC-TN-HEM-PRO-110.03) pages 4-5, revealed "Specimen Requirements ...Storage: Unopened (whole blood) tubes are stable for at least 24 hours at room temperature 15-25C." The laboratory's procedure was not consistent with the manufacturer's instructions. d. A review of the LabCorp Test Menu Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) Test 020321 revealed "Storage Instructions: Specimens are stable at room temperature for 24 hours. If testing cannot be completed within 24 hours, specimens should be centrifuged for at least 10 minutes at 1500xg. Plasma should then be transferred to a LabCorp PP transpak frozen purple tube with screw cap (LabCorp N). Freeze immediately and maintain frozen until tested." e. A review of final reports from April 2022 revealed the laboratory tested and reported 14 of 15 PTT patient samples beyond the manufacturer's defined stability (greater than or equal to 4 hours stored as whole -- 4 of 21 -- blood). 1. Sample Number 1179700792, Collected April 27, 2022, at 3:27 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 28, 2022, at 2:42 AM, Reported April 28, 2022, at 08:07 AM, Elapsed Time 11 hours, 15 minutes from the time of collection to the time of analysis. 2. Sample Number 1179700770, Collected April 27, 2022, at 2: 59 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022, at 11:47 PM, Reported April 28, 2022, at 08:07 AM, Elapsed Time 8 hours, 48 minutes from the time of collection to the time of analysis. 3. Sample Number 1179700767, Collected April 27, 2022, at 3:06 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022, at 11:46 PM, Reported April 28, 2022, at 08:07 AM, Elapsed Time 8 hours, 40 minutes from the time of collection to the time of analysis. 4. Sample Number 1179700773, Collected April 27, 2022, at 2:32 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022, at 11:51 PM, Reported April 28, 2022, at 07:05 AM, Elapsed Time 9 hours, 19 minutes from the time of collection to the time of analysis. 5. Sample Number 1179700769, Collected April 27, 2022, at 2:27 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022, at 11:52 PM, Reported April 28, 2022, at 08:07 AM, Elapsed Time 9 hours, 25 minutes from the time of collection to the time of analysis. 6. Sample Number 1179700768, Collected April 27, 2022, at 3:30 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022, at 11:50 PM, Reported April 28, 2022, at 08:07 AM, Elapsed Time 8 hours, 20 minutes from the time of collection to the time of analysis. 7. Sample Number 1179700796, Collected April 27, 2022, at 4:42 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 28, 2022, at 2:33 AM, Reported April 28, 2022, at 8:07 AM, Elapsed Time 21 hours, 51 minutes from the time of collection to the time of analysis. 8. Sample Number 1179701350, Collected April 27, 2022, at 4:38 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 28, 2022, at 2:41 AM, Reported April 28, 2022, at 08:07 AM, Elapsed Time 22 hours, 3 minutes from the time of collection to the time of analysis. 9. Sample Number 1179700759, Collected April 27, 2022, at 4: 20 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022, at 11:09 PM, Reported April 28, 2022, at 08:07 AM, Elapsed Time 6 hours, 49 minutes from the time of collection to the time of analysis. 10. Sample Number 1179700761, Collected April 27, 2022, at 4:13 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022 at 11:08 PM, Reported April 28, 2022 at 8:07 AM, Elapsed Time 6 hours, 55 minutes from the time of collection to the time of analysis. 11. Sample Number 1179700772, Collected April 27, 2022, at 3:09 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022, at 11:48 PM, Reported April 28, 2022, at 8:07 AM, Elapsed Time 8 hours, 39 minutes from the time of collection to the time of analysis. 12. Sample Number 1179700774, Collected April 27, 2022, at 2:00 PM, Received April 27, 2022, at 7:39 PM, Analyzed April 27, 2022, at 10:54 PM, Reported April 28, 2022, at 8:07 AM, Elapsed Time 8 hours, 54 minutes from the time of collection to the time of analysis. 13. Sample Number 1179700723, Collected April 27, 2022, at 10:28 AM, Received April 27, 2022, at 7:22 PM, Analyzed April 27, 2022, at 11:11 PM, Reported April 28, 2022, at 7:05 AM, Elapsed Time 12 hours, 43 minutes from the time of collection to the time of analysis. 14. Sample Number 1179701047, Collected April 27, 2022, at 11:47 AM, Received April 27, 2022, at 7:22 PM, Analyzed April 28, 2022, at 1:00 AM, Reported April 28, 2022, at 7:05 AM, Elapsed Time 13 hours, 13 minutes from the time of collection to the time of analysis. f. An interview with General Supervisor #2, as listed on the CMS Form 209, on April 28, 2022, at 2:46 PM in their office confirmed these findings. *Word Key: C=degrees Celsius; g=gravity IV. Based on a review of the manufacturer's instructions, the laboratory's policy and procedures, patient reports, and interviews with staff, the laboratory failed to follow their own written procedure and reject four of four visibly hemolyzed prothrombin time and activated partial thromboplastin time patient samples on April 27, 2022. a. A review of Sysmex Automated Blood Coagulation -- 5 of 21 -- Analyzer CS-2500 Instructions for Use (Revised February 2018), revealed "Chapter 8 Troubleshooting ...8.5.3 Displaying sample information ...The [Joblist] screen and the [Detail] dialog box display the result of the inhibitor check in the sample (normal mode only) ...Code: 1000.1000.0000 ...Display/Message [Detail] dialog box: [Hemolyzed Sample] ...Possible cause: Sample suspected of hemolysis ...