Labcorp At St Vincent Cancer & Wellness

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on record review and staff interview with the General Supervisor (GS) and the Laboratory Supervisor (LS), the laboratory director failed to ensure testing personnel (TP) received documented training prior to reporting results on patient samples in the specialty of Hematology. Findings include: 1. Record review on 1/14/2026 of the laboratory's TP records revealed 2 of 2 new TP did not have documented training prior to testing patient samples. 2. Record review on 1/14/2026 of the laboratory's 'Training and Competency Assessment Policy,' revealed: a. Section 1.0 Purpose: "Staff must be trained on their assigned duties and responsibilities and demonstrate that they are competent in their assigned work processes. The training program provides staff with the information needed to perform their daily tasks and processes." b. Section 2.0 Scope: "All laboratories must be able to demonstrate documentation of training." c. Section 6.1.1 Policy Training: "An employee who is new to the job function must receive training before being allowed to test independently." d. Section 6.1.5 Policy Training: "There must be documentation of training." 3. Staff interview on 1/14/2026 at 10:00 AM with the GS and LS confirmed the above TP did not have documented training records and are reporting out patient test results. The LS stated, "We were told by our QA department that we could use the same form we use for competency." 4. The laboratory performs 31,078 Hematology tests annually. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) record review and interview with the laboratory consultant (LC) and testing personnel #1 (TP1), the laboratory failed to maintain a copy of PT attestation sheets in the specialty of Hematology. Findings include: 1. Record review on 3/4/2024 of the laboratory's 2023 API Hematology PT records revealed, the laboratory did not have a copy of the attestation sheet signed by the analyst and laboratory director for 2023 Events 1 and 2. 2. Interview with the LC and TP1 on 3/4/2024 at 11:00 AM confirmed the above findings. 3. The laboratory performs 46,800 tests annually in the specialty of Hematology. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 surveyor observation, record review, and interview with the the laboratory consultant (LC) and testing personnel #1 (TP1), the laboratory failed to follow the procedure manual as written in the specialty of Hematology. Findings include: 1. Surveyor observation of the laboratory on 3/4/2024 at 11:00 AM revealed: a. A strip of black and yellow tape running across the laboratory, sectioning off an area that includes the entry door. b. Side 1 of the tape is the laboratory specimen and reagent refrigerators, laboratory processing area and Hematology testing equipment. c. Side 2 of the tape is a refrigerator marked, 'Refrigerator for food only," containing 2 cups of yogurt, 2 bottles of water, a bottle of creamy Caesar salad dressing and 4 plastic containers of food. Beside this refrigerator is a paper bag containing a plastic bag with bread in it. Hanging on the wall approximately 2 feet from this refrigerator is a rack with 3 laboratory coats hanging on it. The laboratory door is on this side of the tape. 2. Record review on 3/13/2024 of the laboratory's, 'Engineering and Work Practice Controls' procedure, section 7.0, Work Control Practice, item 7.2 revealed, "Food, beverages, medication and food handling containers or equipment may not be stored in refrigerator, drawers, cabinets etc. in laboratory areas and other areas where specimens or specimen waste is processed or stored." 3. Staff interview with the LC and TP1 on 3/4/2024 at 11:30 AM confirmed the findings in 1a, b, and c above. TP1 stated, "We don't have anywhere else to store our lunch." 4. The laboratory performs 46,800 tests annually in the specialty of Hematology. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory consultant (LC) and testing personnel #1 (TP1), the laboratory failed to document centrifuge function checks every 6 months to ensure platelet poor plasma (PPP) for accurate and reliable test results for the Prothrombin Time (PT) test in the specialty of Hematology. Findings include: 1. Record review on 3/4/2024 of the laboratory's centrifuge maintenance and function checks records for the centrifuge used to spin blood collection tubes for coagulation studies, revealed a lack of documentation for PPP studies in 2022, 2023 and 2024 to date. 2. Staff interview with the LC and TP1 on 3/4/2024 at 12:30 PM confirmed that PPP performance checks were not performed in 2022, 2023 and 2024 to date. TP1 stated, "We draw blue top tubes for the PT test and if there is a delay in pick-up, we will spin and aliquot the plasma to be sent to the main laboratory for testing." "It doesn't happen often that there is a delay. It is mostly at the end of the day." D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an -- 2 of 4 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with the laboratory consultant (LC) and Testing personnel #1 (TP1)the laboratory failed to monitor QC results over time to detect shifts and trends in the specialty of Hematology. Findings include: 1. Record review on 3/4/2024 of the laboratory's 2023 Hematology Insight QC records for the Sysmex XS-1000i revealed, the laboratory did not send QC results to the Insight program to monitor QC shifts and trends from January 2023 through October 2023, (10 of 12 months). 2. Record review on 3/4/2024 of the laboratory's, 'Sysmex XS1000i CLSI Procedure: Complete Blood Count of Whole Blood on the Sysmex XS-1000i' revealed: a. Section V: Quality Control, Item J: Insight Quality Assurance Program (QAP). "The Technical Supervisor is responsible for saving the data to a USB flash drive and uploading the data to the Sysmex Insight on the Sysmex website. Data must be submitted no later than 3 days after the due date on the Sysmex e-Check/ e-check(XS) assay sheet." 3. Staff interview on 3/4/2024 with the LC and TP1 confirmed the above findings. TP1 stated, "We did not have a supervisor at the time, so the laboratory director had to take on that role. When we found out about it, we generated a quality assurance event." 4. The laboratory performs 46,800 tests annually in the specialty of Hematology. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory consultant (LC) and testing personnel #1 (TP1) the laboratory failed to ensure the reference ranges on the Male (M) and Female (F) final patient test report (FPTR) matched the reference ranges in the procedure manual (PM) in the specialty of Hematology. Findings include: 1. Record review on 3/4/2024 of a male and female FPTR compared to the procedure manual revealed the following differences for white blood cell count (WBC), red blood cell count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red Cell Distribution Width (RDW), Neutrophil Percent (N%), Lymphocyte Percent (L%), Monocyte Percent (M%), Eosinophil Percent (E%), Basophil Percent (B%), Neutrophils Absolute (NA), Lymphocytes Absolute (LA), Monocytes Absolute (MA), Eosoinophils Absolute (EA), and Basohpils Absolute (BA) . Note: NE = Not established is written on the FPTR NL = Not listed on the FPTR Male Test FPTRM PM WBC 3.4-10.8 3.9-11 RBC 4.14-5.8 4.3-5.8 HGB 13.0-17.7 12.5-17.0 HCT 37.5-51.0 36.0-50.0 MCV 79- 97 80-100 MCH 26.6-33.0 27-33 MCHC 31.5-35.7 31-36 RDW 11.6-15.4 11.4-14.4 N% NE 15-35 L% NE 15-60 M% NE 0-9 E% NE 0-7 B% NE 0-3 NA 1.4-7.0 NL LA 0.7-3.1 NL MA 0.1-0.9 NL EA 0.0-0.4 NL BA 0.0-0.2 NL Female Test FPTR PM WBC 3.4-10.8 3.9-11 RBC 3.77-5.28 3.70-5.10 HGB 11.1-15.9 11.5-15.0 HCT 34.0- 46.6 34.0-44.0 MCV 79-97 80-100 MCH 26.6-33.0 27-33 MCHC 31.5-35.7 31-36 -- 3 of 4 -- RDW 11.6-15.4 11.4-14.4 N% NE 15-35 L% NE 15-60 M% NE 0-9 E% NE 0-7 B% NE 0-3 NA 1.4-7.0 NL LA 0.7-3.1 NL MA 0.1-0.9 NL EA 0.0-0.4 NL BA 0.0-0.2 NL 2. Interview with the LC and TP1 on 3/4/2024 at 12:30 PM confirmed the above findings. 3. The laboratory performs 46,800 tests annually in the specialty of Hematology. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the LabCorp at Saint Vincent Wellness & Cancer Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on record review and interview, the technical supervisor failed to fulfill the responsibility of verifying that the competency of the staff was evaluated through review of quality control records as evidenced by the following: a) A review of hematology quality control records from 11/20/19 to 10/17/21 (approximately two years of quality control) was performed. The review revealed that the technical supervisor had not documented a review of quality control records. In addition, the laboratory director had designated a person not qualified under 493.1449 - Standard: Technical supervisor qualifications to review the quality control records. b) The laboratory director confirmed in an interview on 11/9/21 at 10:55 AM that quality control records were not being reviewed by the designated technical supervisor. c) The laboratory performs 57,288 hematology tests annually, . 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 A CLIA recertification survey was conducted for the Labcorp at Saint Vincent Wellness & Cancer Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to accurately indicate the name and address of the laboratory on the test report as evidenced by the following: a) On 9/25/19 twelve (12) patient final reports were reviewed in for hematology testing performed between 9/10/18 and 8/13/19. The review revealed that the name of the laboratory where testing was performed was not accurately indicated for all twelve (12) reports reviewed (accession numbers - B44754396, B45253048, B46026657, B46098780, B46907891, B47051434, B47707470, B47926988, B48826286, B48973602, B49330136, and B49943596). In each case the report footer indicated the laboratory name as "LabCorp Worcester", whereas the laboratory is officially CLIA certified under "LabCorp at Saint Vincent Wellness and Cancer Center". b) Interview with the laboratory general supervisor on 9/25/19 at 10:35 a.m. confirmed that the name of the laboratory on the final reports did not match what the laboratory is CLIA certified under. . 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 -- D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to: 1) promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors; and 2) issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results as evidenced by the following: a) On 9/25/19 twelve (12) patient final reports were reviewed in for hematology testing performed between 9/10/18 and 8/13/19. The review revealed that one (1) of the twelve (12) reports (accession number B48973602 reported out on 7/3/19) was a corrected report for the manual differential portion of the complete blood count (CBC) analysis. The error had been discovered during a quality assessment review of reports in August of 2019. b) Review of the laboratory's information system revealed that the erroneous result (under lymphocytes "25 bands" was corrected to read "25 atypical lymphs"). However, there was no indication that the report indicated it was a corrected report. Furthermore a telephone contact by the laboratory technologist on 9/25/19 at 10:49 AM to the physician practice receiving the results revealed that a revised CBC report was not available in the patient's medical record. c) The laboratory had policies and procedures titled "Clinical Corrected Reports" indicating that the laboratory, "Upon discovery of an incorrect result must issue a corrected report....The client is notified of the error and is given the corrected report." In this case these procedures were not followed. d) The laboratory performs 56,862 CBC tests annually. -- 2 of 2 --