Quest Diagnostics Mary Bird Perkins Cancer Center

Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 26, 2025 at Quest Diagnostics Mary Bird Perkins Cancer Center, CLIA ID # 19D2226722. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records as well as interview with personnel, the laboratory failed to document quality control mean adjustments for Blood Urea Nitrogen (BUN) testing. Findings: 1. Review of the laboratory's quality control records revealed the laboratory established the following means and standard deviations (SD) for QC Serum Chemistry Control Lot 77950 for Blood Urea Nitrogen (BUN): a) June 5, 2024 *Level 1 - Mean 15.76, SD 0.50 *Level 2 - Mean: 30.08, SD: 0.68 *Level 3 - Mean: 79.32, SD 1.78 b) February 3, 2025 *Level 1 - Mean 15.21, SD 0.50 *Level 2 - Mean: 30.11, SD: 0.68 *Level 3 - Mean: 79.53, SD 1.79 2. In interview on June 6, 2025 at 2:45 p.m., Testing Personnel 1 stated new means were established February 3, 2025 because the laboratory used a new lot of calibrator and laboratory policy required the laboratory to establish new means. 3. Review of the current means and standard deviations in use for lot 77950 in the laboratory information system (LIS) revealed the following means and standard deviations for BUN: *Level 1 - Mean 15.4, SD 0.5 *Level 2 - Mean: 29.5, SD: 0.7 4. Further review of the BUN QC records in the LIS for lot 77950 revealed a comment stating an adjustment was made to BUN on February 26, 2025, but the laboratory did not document the reason for the adjustment and failed to provide raw data to support 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 -- the adjustment. 5. In interview on June 26, 2025 at 3:02 p.m., Testing Personnel 1 confirmed the laboratory did not document why and/or how the means were adjusted for BUN between February 3, 2025 and June 26, 2025. D5785

Summary Statement of Deficiencies D0000 A Certification survey was performed on September 12, 2023 at Quest Diagnostics Mary Bird Perkins Cancer Center, CLIA ID # 19D2226722. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on review of the CASPER 155D report, proficiency testing records, and interview with personnel, the laboratory failed to report the proficiency testing results to the state of Louisiana's CLIA program for four (4) of four (4) events reviewed. Findings: 1. Review of the CASPER 155D report revealed the laboratory's proficiency testing results were not accessible. 2. Review of the laboratory's 2022 and 2023 proficiency testing records revealed the laboratory was enrolled and participated in the College of American Pathologists (CAP) proficiency testing program for Chemistry and Hematology; however, the results were not released/reported to the CMS CLIA program for the state of Louisiana. 3. In interview on September 12, 2023 at 12:23 pm, the Technical Consultant confirmed the laboratory did not release their proficiency testing results to the state of Louisiana's CLIA program. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- 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 the laboratory's policies and interview with personnel, the laboratory failed to establish a complete written competency assessment policy for Technical Consultants. Findings: 1. Review of the laboratory's "Policy for Delegation of Responsibilities" revealed the laboratory not include frequency of performance of competency assessments for the Technical Consultants. 2. In interview on September 12, 2023 at 4:35 pm, the Technical Consultant confirmed the laboratory's policy did not include the frequency of performance of competency assessments for Technical Consultants. 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's policies and interview with personnel, the laboratory failed to have Chemistry quality control range establishment policies approved and signed by the Laboratory Director. Findings: 1. Review of the laboratory's policy for quality control range establishment for Chemistry testing revealed the Laboratory Director did not approve/sign the policy. 2. In interview on September 12, 2023 at 3:50 pm, the Technical Consultant confirmed the Laboratory Director did not approve/sign the identified policy. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory personnel, the laboratory failed to ensure blood collection supplies were not used beyond their expiration date. Findings: 1. Observation by surveyors on September 12, 2023 at 9:52 a.m. revealed the following expired blood collection tubes in the phlebotomy room: - BD Vacutainer Sodium heparin; reference 367871; Lot 2109090; Expiration date: August 31, 2023; Quantity: nine (9) tubes 2. In interview on September 12, 2023 at 10:12 a.m., Testing Personnel 1 confirmed the items identified above were expired. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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 -- 2 of 5 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of laboratory records, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5417. 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's CASPER 155D report, proficiency testing records, and interview with personnel, the Laboratory Director failed to ensure proficiency testing results were reported as required. Refer to D2005. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(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 review of the laboratory's personnel records and interview with personnel, the Laboratory Director failed to ensure two (2) of two (2) Testing Personnel had appropriate training documentation prior to patient testing. Findings: 1. Review of personnel records for Testing Personnel 1 and Testing Personnel 2 revealed the Laboratory Director did not sign off on the initial Beckman Coulter AU 480 Chemistry analyzer training documents approving the identified personnel for patient testing. 2. In interview on September 12, 2023 at 2:00 pm, the Technical Consultant confirmed the Laboratory Director did not sign the training documents for Testing Personnel 1 and Testing Personnel 2. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) -- 3 of 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of personnel records and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were established. Refer to D5209. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5407. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on observation by surveyors, record review, and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Refer to D5417. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's CASPER 155D report, proficiency testing records, and interview with personnel, the Technical Consultants failed to ensure proficiency testing results were reported as required. Refer to D2005. -- 5 of 5 --

Summary Statement of Deficiencies D0000 An Initial survey was performed on February 14, 2022 at Quest Diagnostics Mary Bird Perkins Cancer Center, CLIA ID # 19D2226722. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: I. Based on observation by surveyor, review of the laboratory's performance verification studies, test menu, and interview with personnel, the laboratory failed to include raw data that matched the values utilized for precision studies for Complete Blood Count (CBC) testing. Findings: 1. Observation by surveyor during the laboratory tour on February 14, 2022 at 9:39 am revealed the laboratory utilizes the Sysmex XN-100 for CBC testing. 2. Review of the laboratory's performance verification (validation) studies for the Sysmex XN-100 revealed the instrument had a "Implementation Date of 10/07/21." 3. Review of the laboratory's precision studies and raw data revealed the White Blood Cell (WBC) raw data did not correspond to the values utilized in their studies. 4. Further review of the laboratory's "WBC Precision " form revealed three (3) levels of XN Check controls were run over the course of the following dates and times: Level 1: "08/26/21, 08/27/21. 09/13/21, 9/14/2021 a, 9/14 /2021 p" Level 2: "8/23/21 a, 8/23/21 p, 8/26/21 a, 8/26/21 p, 08/27/21" Level 3: "08 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 -- /19/21, 8/20/21 a, 8/20/21 p, 8/23/21 a, 8/23/21 p" 5. In interview on February 14, 2022 at 1:03 pm Technical Consultant 1 and Technical Consultant 2 initially stated the white blood count reported for patients are the "WBC-D" values. Technical Consultant 2 later stated the "WBC" values are reported for patients. Technical Consultant 2 stated the WBC values utilized for the precision studies should have been from the "WBC" column not "WBC-D." 6. Review of the corresponding precision raw data revealed the laboratory utilized values from the "WBC-D" column not the "WBC" column for the following dates: Level 1: 9/13/21 Run 1: WBC-D value 3.16 Run 2: WBC-D value 3.10 Run 3: WBC-D value 3.10 Run 4: WBC-D value 3.16 Run 5: WBC-D value 3.11 Level 1: 9/14/21 a Run 1: WBC-D value 3.07 Run 2: WBC-D value 3.07 Run 3: WBC-D value 3.05 Run 4: WBC-D value 3.09 Run 5: WBC-D value 3.08 Level 1: 9/14/21 p Run 1: WBC-D value 3.17 Run 2: WBC-D value 3.16 Run 3: WBC-D value 3.09 Run 4: WBC-D value 3.06 Run 5: WBC-D value 3.13 7. Further review of the corresponding raw data for the precision studies revealed the Level 2 control data for August 27, 2021 utilized on the summary page did not match the WBC raw instrument data. 8. In further interview on February 14, 2022 at 1:03 pm, Technical Consultant 1 stated she was unsure where the WBC values for Level 2 on August 27, 2021 came from. Technical Consultant 1 stated she thinks the wrong date was utilized on the summary page as the values match for August 20, 2021, not August 27, 2021. 9. Review of the laboratory's test menu revealed the laboratory performs 45,648 CBC tests annually. II. Based on observation by surveyor, review of the laboratory's performance verification studies, policies, test menu, and interview with personnel, the laboratory failed to verify reference ranges in use to ensure appropriate for the laboratory's patient population. Findings: 1. Observation by surveyor during the laboratory tour on February 14, 2022 at 9:39 am revealed the laboratory utilizes the Sysmex XN-100 for CBC testing. 2. Review of the laboratory's "RRL Inspection Checklist" under "Section 7-Method Validation /Analytic Performance" revealed "129. Are reference intervals established or verified by the RRL?" 3. Review of the laboratory's "BPT Verification of a Hematology System" forms revealed under the "Reference IntervalStudies [sic]" section "The reference intervals for the hematology assays has been determined at the corporate level for all Quest Diagnostics Laboratories." 4. In interview on February 14, 2022 at 1:03 pm, Testing Personnel 1 initially stated the laboratory verified reference ranges with normal patients. Technical Consultant 1 stated the laboratory did not perform reference range studies as they are using the nationwide reference ranges utilized by the company. " 5. Review of the laboratory's test menu revealed the laboratory performs 45,648 CBC tests annually. 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 review of patient laboratory reports and interview with personnel, the -- 2 of 5 -- laboratory failed to include the name and address of the reference laboratory where testing was performed for one (1) of five (5) patients reviewed. Findings: 1. In interview on February 14, 2022 at 9:48 am, Testing Personnel 1 stated manual differentials are sent to a reference laboratory for testing. 2. Review of the laboratory's patient final reports revealed the name and addresses of the reference laboratory that performed the testing was not included for the following patient: Collection date: October 18, 2021, Patient DL512640Q 3. Further review of the identified patient final reports revealed a cover sheet that stated "Form for Secondary Review or Manual Diff QLS-Manual Diff/Slide Review Deliver to Hematology ASAP!!! Please place Lav top, slide & copy of CBC results from instrument into a transport bag, Send to your main lab. Reason to Review: Moderate Complexity (X) Manual Differential" 4. In interview on February 14, 2022 at 1:52 pm, Technical Consultant 1 stated the manual differential for the identified patient was performed at a reference laboratory, not their laboratory as listed on the report. Technical Consultant 1 confirmed the name and address of the reference laboratory that performed the manual differential was not included on the patient final report. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure performance verification studies were complete. Refer to D5421 I and D5421 II. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure patient final reports included required pertinent information. Refer to D5805. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) -- 3 of 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Findings: 1. The Technical Consultant(s) failed to include testing of external proficiency test samples, previously analyzed sample or internal blind sample as part of semi-annual competency assessment for one (1) of two (2) testing personnel reviewed. Refer to D6051. 2. The Technical Consultant(s) failed to perform the semi- annual competency assessment for one (1) of two (2) testing personnel reviewed. Refer to D6053. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Technical Consultant(s) failed to ensure performance specification verification studies were complete. Refer to D5421 I and D5421 II. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with personnel, the Technical Consultant(s) failed to include testing of external proficiency test samples, previously analyzed sample or internal blind sample as part of the semi-annual competency assessment for one (1) of two (2) testing personnel reviewed. Findings: 1. Review of personnel records for Testing Personnel 1 revealed a "SNX Sysmex XN Series Operation for CBC Sysmex XN 6 Month Assessment Direct Observation/Record Review" form completed February 7, 2022. 2. Further review of the identified form revealed assessment of previously analyzed sample, internal blind sample, or external proficiency test sample was not included as part of the semi-annual competency. 3. In -- 4 of 5 -- interview on February 14, 2022 at 12:33 pm Testing Personnel 1 stated Testing Personnel 2 performed her assessment. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the personnel records and interview with personnel, the Technical Consultant(s) failed to perform the semi-annual competency assessment for one (1) of two (2) testing personnel reviewed. Findings: 1. Review of personnel records for Testing Personnel 1 revealed a "SNX Sysmex XN Series Operation for CBC Sysmex XN 6 Month Assessment Direct Observation/Record Review" form completed February 7, 2022. 2. Further review of the semi-annual competency assessment form for Testing Personnel 1 revealed Testing Personnel 2 performed the assessment not the Technical Consultant(s). 3. In interview on February 14, 2022 at 12:33 pm Testing Personnel 1 stated Testing Personnel 2 performed her assessment. -- 5 of 5 --