Laboratory Corporation Of America

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) result reports and interviews with the laboratory's laboratory director (LD), technical supervisor (TS), and laboratory's testing personnel (TP); it was determined that the laboratory failed to enroll and participate in a proficiency testing (PT) program that meets the criteria in subpart H of 42 CFR part 493 and is approved by HHS. The findings included: 1. The laboratory performed mycology and parasitology procedures and failed to show evidence of enrollment in a PT program for both subspecialties using a CMS approved PT program for the years 2022 and 2023 when the laboratory started testing for mycology procedures (potassium hydroxide- KOH) and parasitology procedures (pinworm, Giardia and Cryptococcus). The laboratory analyzed and reported tests for both mycology and parasitology patient test results during the time of non-enrollment in a proficiency testing (PT) program. 2. The laboratory staff confirmed on January 11, 2024, at approximately 12:00 p. m. that patient test results for mycology and parasitology were reported, yet the laboratory had not enrolled in an accredited PT program for KOH, Giardia, pinworm, and Cryptococcus for the years 2022 and 2023. 3. The laboratory annual testing declaration signed by the LD estimated total volume of mycology to be 66 and parasitology 1,135 tests respectively. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of proficiency testing results, quality control, and verification of accuracy results and interview with the laboratory's director (LD) and testing personnel (TP) on January 11, 2024 at approximately 12:00 pm, for those tests performed by the laboratory that are not included in subpart I of this part, the laboratory failed to establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). Findings include: 1. The laboratory could not provide documentation of verification of accuracy and quality control for potassium hydroxide (KOH), for the years 2022 and 2023. 2. The laboratory could not provide documentation of verification of accuracy for Giardia, Cryptococcus and pinworm testing for the years 2022 and 2023. 3. This deficient practice was verified by interview with the LD and TP on the day of the survey on January 11, 2024. 4. The laboratory reports approximately 1,200 tests annually for KOH, Giardia, Cryptococcus and pinworm. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) of the laboratory's proficiency testing (PT) result reports for the third Immunohematology event of 2022 and interview with the laboratory's technical supervisor (TS), it was determined that the laboratory failed to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event was unsatisfactory analyte performance for the testing event. The findings included: 1. CAP reported a score of 80 % for ABO group and Rh (D) type for the 2022 third event (Q3-2022) which was unsatisfactory analyte performance for the testing event. 2. The laboratory TS affirmed that the laboratory attained a score of 80 % for ABO group and Rh (D) type for Q3-2022 event which was unsatisfactory analyte performance for the testing event. 3. The laboratory performed ABO group and Rh (D) type in approximately 871 patient samples monthly. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's proficiency testing records, policies and procedures, patients' test results records, quality control documentation, and interviews with the laboratory's technical supervisor and testing personnel on January 11, 2024; it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of the laboratory testing were monitored. See D2000, D2003, and D2153. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on the deficiency cited (See D2000 and D2003), the laboratory director is herein cited for deficient practice in overall administration to ensure the laboratory is enrolled in proficiency testing for all the analytes patients samples are tested and results reported. -- 3 of 3 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, observation and interviews it was determined the laboratory failed to establish written policies and procedures to ensure positive patient identification during gynecologic specimen processing and staining. The laboratory failed to label four of four specimen slides with a unique identifier during gynecologic specimen processing and staining on November 16, 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure positive patient identification during gynecologic specimen processing and staining. 2. During observation of gynecologic specimen processing and staining on November 16, 2021 at 9:15 AM, Laboratory Assistant B failed to label four of four gynecologic specimen slides with the complete patient identifier accession number. Specimens include: Accession #: # Written on Specimen Slide: -C21-33163 33163 -C21-33164 33164 -C21-33165 33165 -C21- 33171 33171 3. During further observation of gynecologic specimen processing and interview with Laboratory Assistant B and the Cytology Supervisor on November 16, 2021 at 9:30 AM, it was confirmed it was the laboratory's practice to not write the complete patient identifier accession number on gynecologic specimen slides during processing. The Cytology Supervisor stated that a label with the complete patient identifier accession number was not applied to the specimen slides until after staining of the specimen slides. 4. During an interview on November 16, 2021 at 3:30 PM, the Laboratory Director/Technical Supervisor A and Cytology Supervisor confirmed these findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 review of laboratory policies and procedures, lack of laboratory records and interview it was determined the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors. The laboratory failed to assess the competency of two of two Technical Supervisors in 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for two of two Technical Supervisors in 2020 and to the date of the survey in 2021. Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B 3. During an interview on November 15, 2021 at 1:50 PM, the Laboratory Director /Technical Supervisor A confirmed these findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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: Based on Surveyor review of laboratory's policy & procedure and test records of random patients' samples for the years of 2019, 2020 and 2021, and interview with the laboratory technical supervisor on September 20, 2021 at 3:15 pm, the laboratory failed to follow written policies and procedures to reject the heparinized blood sample for QuantiFERON-TB Gold test. The findings include: 1. The laboratory did QuantiFERON-TB Gold test on blood samples collected in tubes containing heparin. The laboratory procedure describes the sample stability at room temperature for 12 hours after collection. However, the laboratory never recorded or tracked the sample collection and receiving times, and when interviewed the processing staff #1 was unaware of this timing requirement. Therefore, the laboratory might had performed test on compromised blood samples and rendered inaccurate patient test results causing potential harm to the patients. 2. The laboratory technical supervisor on September 20, 2021 at 3:15 pm, affirmed that the laboratory never recorded or tracked the sample collection and receiving times. 3. The laboratory's testing declaration form, signed by the laboratory Director on 9/22/2021, stated that the laboratory performs 26,211 tests in mycobacteriology, annually. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure and test records of random patients' samples for the years of 2019, 2020 and 2021, and interview with the laboratory technical supervisor on September 20, 2021 at 2:05 pm, the laboratory failed to establish a procedure for an ongoing mechanism to monitor, identify and correct problems regarding missing samples. The findings include: 1. The laboratory's problem resolution and investigation forms showed that samples # 20073554 and 20039366 were missing lavender specimen. The laboratory did investigations to find the missing samples but was unable to locate the samples. However, it resolved the problem by re-collecting the samples. The laboratory's investigation could not identify the reason of missing samples. The laboratory must establish policies or procedures to ensure proper accountability or tracking of patient specimens from time of collection to receipt by the laboratory and throughout the accessioning, testing, and reporting processes. When the laboratory discovers an error or identifies a potential problem, actions must be taken to correct the situation. This correction process involves identification and resolution of the problem, and development of policies that will prevent recurrence. A missing sample might have serious negative outcome in patient care. 2. The laboratory technical supervisor on September 20, 2021 at 2:05 pm, affirmed that the laboratory could not identify the cause of the missing samples. 3. The laboratory's testing declaration form, signed by the laboratory Director on 9/21 /2021, stated that the laboratory performs 225,147 tests in hematology, annually. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, patients' test records for the years of 2019, 2020 and 2021, and interview with the laboratory technical supervisor and sample processing staff #1 on September 20, 2021 at 3:15 pm, the laboratory director failed to ensure laboratory staffs are performing the test methods as required for accurate and reliable results. The findings include: See D5311. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, patients' test records for the years of 2019, 2020 and 2021, and interview with the laboratory technical -- 2 of 3 -- supervisor on September 20, 2021 at 2:05 pm, the laboratory director failed to assure the quality of laboratory services provided in the pre-analytic phase of testing. The findings include: See D5391. -- 3 of 3 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's evaluation of proficiency test performance documents, and interview with the laboratory testing personnel, it was determined that the laboratory failed to attained a score of at least 80 % of acceptable response for each analyze in each testing event was unsatisfactory analyte performance for the test event. The findings included: a. The laboratory performed immunoglobulins (Ig) using Roche-Cobas 8000 Line instrument. b. To evaluate the proficiency test performance for the IgA, IgG, and IgM testing systems, the laboratory enrolled its proficiency testing with CAP (College of American pathologists) PT programs. c. The laboratory attained scores of 0% for IgA, IgG, and IgM, respectively in the 1st 2018 PT event, which was unsatisfactory performance. d. The laboratory performed IgA, IgG, and IgM in approximately 3,333 patient samples monthly. e. the laboratory personnel affirmed (4/2/2019) that the laboratory attained scores of 0% for IgA, IgG, and IgM, respectively in the 1st 2018 PT event, which was unsatisfactory performance. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 5 -- Based on review of the laboratory's evaluation of proficiency test performance documents, and interview with the laboratory testing personnel, it was determined that the laboratory failed to attained a score of at least 80 % of acceptable response for each analyze in each testing event was unsatisfactory analyte performance for the test event. The findings included: a. The laboratory performed immunoglobulins (Ig) using Roche-Cobas 8000 Line instrument. b. To evaluate the proficiency test performance for the testing system, the laboratory enrolled its NA proficiency testing with CAP (College of American pathologists) PT program. c. The laboratory attained a score of 60% for serum Sodium (NA) in the 1st 2018 PT event, which was unsatisfactory performance. d. The laboratory performed NA in approximately 19,011 patient samples monthly. e. The laboratory personnel affirmed (4/2/2019) that the laboratory attained a scores of 60% for NA in the 1st 2018 PT event, which was unsatisfactory performance. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's evaluation of proficiency test performance documents, and interview with the laboratory testing personnel, it was determined that the laboratory failed to verify, at least twice annually, the accuracy of the test or any procedure which is not listed in the subpart I of 42 CFR part 493. The findings included: a. The laboratory performed Prothrombin Time (PrT) by Stago Compact Max analyzer and reported PrT in second with INR. b. To evaluate the proficiency test performance and ensure the accuracy for INR results, the laboratory elected to enroll with CAP to ensure the accuracy of the testing system. c. The laboratory attained a score of 0 % for INR in the 1st 2018 PT event, which was unsatisfactory performance for that event. d. The laboratory performed PrT with INR in approximately 145 patient samples monthly. e. The laboratory personnel affirmed (4/2/2019) that the laboratory attained a scores of 0% for INR in the 1st 2018 PT event, which was unsatisfactory performance. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory records including but not limited to the followings: the test requisition forms, patient test reports, laboratory worksheets, and interview with the laboratory personnel, it was determined that the current new laboratory director failed to ensure and approve the changes of the laboratory's documents, forms, worksheets, or policies and procedures accordingly due to the changes of the ownership and the name of the laboratory before use. The findings included: a. The laboratory has been acquired by the new owners in January 2018 and a new laboratory director was hired to lead the laboratory operations. b. The current laboratory director failed to ensure and approve accordingly due to the changes of the laboratory -- 2 of 5 -- operation team and the name of the laboratory. c. Review of the cytology report of ID #19176353 CYT19-02768), collected date of 02/28/2019 with reported date of 03/03 /2019, an e-REQ with name of Physician's Automated Laboratory, Inc. d. Review of a Cytology report with ID #19192231 , collected date of 03/07/2019 with reported date of 03/08/2019 on a paper requisition form name West Pacific Medical Laboratory. e. "West Pacific Medical Laboratory" name was noted in the procedure manual of "Title: Stago Compact Max D-Dimer Liatest" "page 9 of 11". f. Review of the laboratory's records including various testing procedures, requisition form (eREQ) and worksheet documents were noted unchanged or incorrect laboratory name. g. The laboratory must use consistent laboratory names appeared in its various internal and external documents or records. 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: Based on review of the laboratory records and documents, and interview with the testing personnel, it was determined that the laboratory failed to follow the manufacture's instructions and in a manner that provides test result within the laboratory stated performance specifications for each test system. The findings included: a. The laboratory used Hologic Panther System to perform CT/GC with APTIMA Combo 2 Assay, and Trich with APTIMA Trichomonas vaginalis Assay. b. The laboratory failed to follow the manufacturer's instructions for "Lab Contamination Monitoring Protocol for the PANTHER System" c. No evidences for decontamination procedure documents were available at the time of the survey (4/2 /2019 @ 11 AM). D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory records, and interview with the laboratory personnel, it was determined that the laboratory failed to have accurate electronic systems in place to ensure the test results and other patient-specific data were accurate and reliably sent from the point of data entry to final report destinations. The findings included: a. A bacteriology patient results were pulled, wound culture ID #19251242 sample received date was 3/29/2019, a reported date of 3/30/2017@ 17:40 with a -- 3 of 5 -- "Final" (indicated a final report) appeared after "Isolate 1: Staphylococcus aureus. b. A computerized worksheet (printed on 4/2/2019 11:1) indicated that the 1 Day, 2 Days, and 3 Days, a clinical laboratory scientist (CLS) had worked on the culture and processed records to conclude a final isolation of the organism, Staphylococcus aureus on 4/2/2019. c. That report was retrieved and printed with a "Final" appeared in the report for Isolate 1: Staphylococcus aureus. d. The patient test result report showed a reported date on 03/30/2019 17:40, which was inconsistent with the culturing dates the CLS proceeded. The timing of dates was inconsistent with the worksheet and the final report. e. In addition, one urine culture final report with ID #19250454 had Collected: 03/26/2019 12:35, and Received: 03/28/2019 12:36. f. The receiving date should be the time received by the laboratory location rather than from the Patient Service Center (PSC). g. The laboratory has its IT (Information System) in house and affirmed (03/22/2019) that inconsistencies of these two reports. 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 patient test result reports records including but not limited to the followings: the test requisition forms, patient test reports, laboratory worksheets, and interview with the laboratory personnel, it was determined that the laboratory failed to follow its written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified. The findings included: See D-5407, and D-5801 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing (PT) records and documents, and interview with the testing personnel, it was determined that the laboratory director failed to ensure that the evaluation of proficiency test performance were performed. The findings included: See- D-2075, D-2087, D-5217 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 4 of 5 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory records and documents, and interview with the testing personnel, it was determined that the laboratory director failed to ensure that the quality control and quality assessment programs were established and maintained to assess the quality of the laboratory services provided. The findings included: See D- 5407, D-5411, and D-5801 -- 5 of 5 --