Corewell Health Dearborn Hospital Hem & Oncology

Summary Statement of Deficiencies 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 the Technical Consultant, the laboratory failed to ensure sodium citrate blood collection tubes were not used beyond their expiration dates for 84 of 84 sodium citrate tubes observed. Findings include: 1. The surveyor observed a flat of 84 blue-top sodium citrate tubes in the clinic infusion area with other phlebotomy supplies on 4/10/24 at 10:06 am. The tubes had expired on 3/31 /24. 2. An interview on 4/10/24 at 10:15 am with the Technical Consultant confirmed the sodium citrate tubes had exceeded their expiration dates. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless 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 -- the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to perform calibrations for the Beckman Coulter DxH 520 analyzer at least every 6 months in 2023 (1/20/23 to 11/3/23). Findings include: 1. A review of the laboratory's "Calibration of Hematology Analyzer" procedure revealed a section stating, "All automated analyzers are to be calibrated under the following conditions (including but not limited too) a. Replacement of a major part b. Unacceptable quality control results c. Every 6 months or sooner if needed." 2. A review of the laboratory's Beckman Coulter DxH 520 hematology analyzer's calibration documentation revealed a lack of calibration performed between the 1/20/23 and 11/2/23 calibration dates. 3. An interview on 4/10/24 at 12:05 pm with the Technical Consultant confirmed the laboratory had not performed a calibration between the 1/20/23 and 11/2/23 calibration dates. -- 2 of 2 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure function checks were within established limits before testing and reporting patient Complete Blood Count (CBC) test results from the Beckman Coulter DxH 520 hematology analyzer for 1 (Patient 251573637) of 1 patient CBC test run observed. Findings include: 1. The surveyor observed Testing Personnel #3 (TP3) on 6/1/22 at 9:06 am perform a CBC on Patient 251573637. After sampling the specimen, the analyzer gave an error code stating, "Count Vacuum Error". TP3 requested assistance from TP1. TP1 advised TP3 to use the results from the patient run if they thought it was normal for that patient. 2. A review of the manufacturer's troubleshooting "Event Messages" revealed a section stating, "Count Vacuum Error. Cause: Vacuum Failure occurred during the counting phase in the analysis cycle OR vacuum stability check failed during the counting vacuum. Consequence: Emergency stop occurs. 1. Perform Diluter Reset from the Diagnostics screen. 2. If the problem recurs, contact your Beckman Coulter Representative." 3. A review of the laboratory's "Procedure when CBC Machine is Not Working" policy, established on 9/12/19, revealed a section stating, "At no time should specimen results be given until problem is corrected and machinery and controls are running properly." 4. An interview on 6/1/22 at 9:21 am confirmed the results for Patient 251573637 obtained from the run with the "Count Vacuum Error" were entered into the patient's chart. 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 -- D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 record review and interview with the Technical Consultant (TC), the laboratory failed to ensure quality control results met laboratory-established criteria prior to reporting patient Complete Blood Count (CBC) results for 3 days (1/28/21, 2/1 /21, and 2/2/21) of 10 months of quality control documentation reviewed. Findings include: 1. A review of the laboratory's "Quality Control Data Interpretive Procedure" revealed a section stating, "Do two consecutive results exceed the same limit (either X + 2SD or X-2SD)? Rejection Rule." 2. A review of the laboratory's "Laboratory Quality Control" policy established on 9/12/19 revealed a section stating, "All controls must be within 2 STD." 3. A review of the laboratory's Beckman Coulter DxH 520 hematology analyzer quality control records revealed the following dates when quality control was out of range: a. The low abnormal control for Mean Platelet Volume (MPV) was out of range for three runs on 1/28/21 performed at 7:44 am, 7:47 am, and 7:49 am. b. The low abnormal control for Mean Platelet Volume (MPV) was out of two standard deviations for three runs on 2/1/21 performed at 7:37 am, 7:43 am, and 7:49 am. c. The low abnormal control for Mean Platelet Volume (MPV) was out of two standard deviations for two runs on 2/2/21 performed at 7:36 am and 7:51 am. 4. An interview on 6/1/22 at 12:27 am with the TC revealed 48 patients were tested on the dates listed above and confirmed the laboratory did not ensure quality control was within established acceptability criteria before reporting patient test results. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure Testing Personnel #1, performing the duties of a Technical Consultant had met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure personnel performing the Technical Consultant duty of peforming personnel competency assessments was qualified. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or -- 2 of 4 -- both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure personnel performing the Technical Consultant duty of performing personnel competency assessments was qualified for 1 (Testing Personnel #1) of 2 personnel performing competency assessments. Findings include: 1. A review of the laboratory's personnel competency records revealed Testing Personnel #1 had performed competency assessment for Testing Personnel #2-#12 in 2021 and 2022. 2. A review of the qualifications for Testing Personnel #1 revealed a lack of documentation required to meet the educational requirements of a Technical Consultant. 3. An interview on 6/1/22 at 9:37 am with the Technical Consultant revealed Testing Personnel #1 was not qualified to perform the duties of a Technical Consultant. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on record review and a lack of documentation, the laboratory failed to ensure testing personnel met the qualification requirements at 493.1423. Findings include: 1. The laboratory failed to ensure testing personnel were qualified. Refer to D6065. -- 3 of 4 -- D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on a lack of documentation and record review, the laboratory failed to ensure testing personnel were qualified for 1 (Testing Personnel #11) of 12 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel records revealed a lack of qualification documentation for Testing Personnel #11 listed on the CMS-209 form performing moderate complexity testing. 2. The surveyor requested qualification documentation for Testing Personnel #11 showing they were qualified to perform moderate complexity testing on 6/1/22 at 10: 03 am and it was not made available. 3. The laboratory was provided 7 days to supply documentation and it was not made available. -- 4 of 4 --

Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC) and Testing Personnel (TP) #1, the laboratory failed to 1) retain patient test requisitions and/or electronic orders for 3 (#10-#12) of 13 patient charts audited and 2) retain the final test report for 5 (#8 - #12) of 13 patient charts audited from January 14, 2019 to January 14, 2021. Findings include: 1. A record review revealed a lack of documentation for 13 patient charts audited for the patient test requisition and/or electronic orders and the final test reports as follows: a. 3 (#10 - #12) of 13 patient test requisitions and/or electronic orders not available b. 5 (#8- #12) of 13 patient final test results not available 2. When queried on 1/14/2021 at 12:34 pm, TC and TP1 were unable to provide the surveyor the requested documentation due to the information being stored in an old hard drive not connected to a interface or a laboratory information system. 3. A interview on 1/14/2021 at 12:34 pm, TC and TP1 confirmed the patient test requisition and final test reports were not retrievable from the old hard drive. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to rotate the American Association of Bioanalysts (AAB) hematology proficiency testing (PT) samples among all testing personnel who routinely perform patient testing for five (event 3 in 2016, events 1 - 3 in 2017, and event 1 in 2018) of six events reviewed. Findings include: 1. Review of the CMS-209 signed by the laboratory director on May 16, 2018 listed seven testing personnel performing moderately complex hematology testing. 2. On May 17, 2018 at 9:58 AM, review of the final graded AAB hematology proficiency testing documents revealed for five (event 3 in 2016, events 1 - 3 in 2017, and event 1 in 2018) of six events reviewed the same testing personnel (#1) performed and documented all testing. 3. During the interview on May 17, 2018 at 12:45 PM, testing personnel #1 as listed on the CMS-209 confirmed the proficiency testing events were not rotated. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the testing personnel failed to attest to the routine integration of the hematology proficiency testing samples into the patient workload for four (events 1-3 in 2017 and event 1 in 2018) of six testing events reviewed. Findings include: 1. On May 17, 2018 at 9:55 AM, record review of the American Association of Bioanalysts (AAB) hematology proficiency testing documents revealed for four (events 1-3 in 2017 and event 1 in 2018) of six testing events the testing personnel did not sign the attestation statement sheets. 2. During the interview on May 17, 2018 at 12:45 PM, testing personnel #1 as listed on the CMS- 209 confirmed the attestation statement sheets were not signed by the testing personnel. 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: . Based on record review and interview, the laboratory failed to retain 1) the monthly quality control records for the hematology Beckman Coulter AcT 5diff CP analyzer for two (#4 and #6) of nine patient charts audited and 2) the daily background counts for one (#8) of nine patient charts audited for two years. Findings include: 1. On May 17, 2018 at 12:37 PM, record review for two of nine and three of nine patient charts audited revealed the laboratory did not retain the following documentation for two years: a. two of nine patient charts audited (#4 and #6) - did not retain the monthly quality control records for the hematology complete blood cell count testing on the Beckman Coulter AcT 5diff CP analyzer b. one of nine patient charts audited (#8) - did not retain the daily background count for the Beckman Coulter AcT 5diff CP analyzer 2. During the interview on May 17, 2018 at 12:45 PM, testing personnel #1 as listed on the CMS-209 confirmed the above documentation was not retained for two years. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform the Beckman Coulter Act 5diff CP hematology analyzer calibration procedures at least every 6 -- 2 of 3 -- months for one (1st half in 2017) of four every six months reviewed in 2nd half in 2016, 2017, and the 1st half in 2018. Findings include: 1. On May 17, 2018 at 12:30 PM, record review of the calibration data for the hematology Beckman Coulter AcT 5diff CP hematology analyzer revealed the laboratory did not perform and document the calibration procedure every six months for one (1st half in 2017) of four every six months reviewed. 2. On May 17, 2018 at 12:30 PM when requested, testing personnel #1 as listed on the CMS-209 was not able to provide the surveyor with the documentation to demonstrate the calibrations had been performed every six months. 3. During the interview on May 17, 2018 at 12:45 PM, testing personnel #1 confirmed the calibrations procedures was not performed and documented every six months in 2017. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require