Mackinac Straits Health System

Summary Statement of Deficiencies 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: . A. Based on record review and interview with Technical Consultant, the laboratory failed to follow its competency assessment policy for 6 of 9 testing personnel listed on Form CMS-209 for the Sysmex XN-550 installed in March 2023. Findings include: 1. Review of the laboratory's "Competency Assessment" policy, Page 1, Paragraph 3, "Schedule," states, "New employees (or current employees performing new test procedures) will be evaluated initially, at six months and annually thereafter." 2. Record review of Sysmex Analyzer XN-550 Training Checklists and Competency Assessments revealed that 6-month competency assessments were not conducted for 6 of 9 testing personnel: a. Testing Personnel #1 completed initial training on 3/28/2023 and one competency assessment performed on 12/22/23. b. Testing Personnel #2 completed initial training on 3/03/2023 and one competency assessment performed on 12/11/23. c. Testing Personnel #4 completed initial training on 3/01/2023 and one competency assessment performed on 12/11/23. d. Testing Personnel #6 completed initial training on 3/10/2023 and one competency assessment performed on 12/11/23. e. Testing Personnel #7 completed initial training on 7/05/2023 and one competency assessment performed on 7/05/23. f. Testing Personnel #8 completed initial training on 3/03/2023 and competency assessments on 12/05/23 and 11/04/24. 3. An interview with the Technical Consultant on 10/01/2024 at 11:30 am confirmed the 6-month competency assessments for testing personnel using the Sysmex Analyzer XN-550 had not been performed in accordance with the laboratory's policy.. B. Based on record review and interview with Technical Consultant, the laboratory failed to follow its competency assessment policy for its immunohematology Ortho Diagnostic Gel 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 -- Card testing for 4 of 5 testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's "Competency Assessment" policy revealed a section stating, "New employees (or current employees performing new test procedures) will be evaluated initially, at six months and annually thereafter." 2. A record review of the Blood Bank Gel Card Training Checklists and competency assessments revealed that a 6-month competency assessment was not conducted for the following testing personnel: a. Testing Personnel #1 completed initial training on 1/11/2024 with no documented competency assessment. b. Testing Personnel #2 completed initial training on 1/17/2024 with no documented competency assessment. c. Testing Personnel #4 completed initial training on 10/27/2023 with no documented competency assessment. d. Testing Personnel #6 completed initial training on 10/24 /2023 with no documented competency assessment. e. Testing Personnel #8 completed initial training on 1/8/2024 with no documented competency assessment. 3. An interview with the Technical Consultant on 10/01/2024 at 11:30 am confirmed the 6-month competency assessment for gel card testing had not been performed in accordance with the laboratory's 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, record review and interview with Technical Consultant (TC) the laboratory failed to ensure reagents and supplies were not used beyond expiration dates for five (one bottle of Direct Coombs Control, two bottles of Contrad70 Access Reagent, and two bottles of Internal Reference Solution (ISE)) reagents observed. Findings include: 1. The surveyor observed on 10/01/2024 at 9:15 am 1 of 1 bottle of Direct Coombs Control (expired 08/13/2024) in Blood Bank available for use. 2. A review of the Blood Bank patient log revealed that 1 patient was tested with expired reagent on 08/28/2024. 3. An interview with TC on 10/01/2024 at 10:30 am confirmed the reagent was expired. 4. The surveyor observed on 10/02/2024 at 9:30 am 2 of 2 bottles of CONTRAD70 reagent (expired 06/27/2024) for the Beckman Coulter Access 2 Immunoassay Analyzer. 5. An interview with the TC on 10/02/2024 at 9:30 am confirmed that the reagents were expired and available for use. 6. The surveyor observed on 10/02/2024 at 8:15 am 2 of 2 boxes of ISE Internal Reference Solution reagent (lot # 2534, expired 5/24/2024) was available for use. 7. An interview with the TC on 10/02/2024 at 9:30 am confirmed that the reagents were expired and available for use. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #2, the laboratory failed to perform control procedures for its Complete Blood Count (CBC) testing using the Sysmex XN-550 analyzer after it had changed reagents for 38 patients tested between the reagent change and the next run of controls. Findings include: 1. A review of the laboratory's CBC analyzer, Sysmex XN-550, reagent change history revealed both the Lysercell WDF and the Fluorocell WDF reagents were change on 9 /30/23 at 12:58 pm and 12:56 pm respectively. 2. A review of the laboratory's control results revealed the controls performed on 9/30/24 were performed at 00:26 am and 12:28 pm with the next control run performed on 10/1/24 at 00:29 am. 3. A review of the patients receiving CBC testing using the Sysmex XN-550 between 9/30/24 at 12: 58 pm and 10/1/24 at 00:29 am revealed 38 patients had been tested. 4. A review of the laboratory's "CBC (XN-550)" procedure revealed a lack of process for performing control procedures after a change in reagents. 5. A review of the laboratory's "Sysmex Automated Hematology Analyzer XN-L Series XN-550 Basic Operation" manufacturer's instructions revealed a section titled "3.2.2 When QC analysis is performed" stating, "QC is performed at the following times. a. Before sample analysis b. After replacement/replenishment of reagents c. After instrument maintenance d. When there is a concern about the accuracy of analysis values." 6. An interview on 10/1/24 at 11:08 am with Testing Personnel #2 confirmed controls had not been performed after the replacement of both the Lysercell WDF and the Fluorocell WDF reagents when changed on 9/30/24 before patients were tested. D5785

Summary Statement of Deficiencies D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with General Supervisor #2, the laboratory failed to use control materials of a similar matrix for its serum ketone testing using the AimTab Ketone Tablets for 2 (January 2021 to January 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's "QC log for Ictotest and Acetest" from 1/5/21 to 12/29/22 revealed the laboratory used urine controls to determine if the serum ketone AimTab Ketone test was acceptable. 2. An interview on 1/24/23 at 8:15 am with General Supervisor #2 confirmed the laboratory had been using urine controls for its serum ketone testing, not testing control materials in the same manner as patient specimens. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. 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 2 -- . Based on observation and interviews, the laboratory failed to test its peripheral blood smear staining materials for predictable staining characteristics at least each day of patient testing for 2 (January 2021 to January 2023) of 2 years reviewed. Findings include: 1. The surveyor observed peripheral blood smear staining materials while touring the laboratory on 1/23/23 at 2:44 pm. 2. An interview on 1/23/23 at 3:45 pm with Testing Personnel #1 revealed the laboratory had not been documenting its peripheral blood smear staining materials for predictable staining characteristics at least each day of patient testing. 3. An interview on 1/23/22 at 3:50 pm with General Supervisor #2 confirmed the laboratory had not established a practice of documenting its peripheral blood smear staining materials for predictable staining characteristics and no documentation was present. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and interview with Technical Consultant (TC) #2, the laboratory failed to ensure test results were accurately transferred from the patient log to the laboratory information system (LIS) for 1 (#26) of 34 patient test reports reviewed. Findings include: 1. A review of the "Mackinac Straits Health System Serology Log" revealed on 12/30/2019 the results for patient #26 recorded on the log for helicobacter pylori (HPYL) was "positive". 2. A review of the final test report in the LIS system for patient #26 reported out on 12/30/2019 at 8:40 am was resulted out as "negative". 3. An interview on 3/24/2021 at 9:00 am, TC2 confirmed patient #26 final test report had a incorrect result reported. 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 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 review of the "Gram Stain" log and interview with the Technical Supervisor #1 (TS1), the laboratory failed to retain the microbiology quality control documents for two years. Findings include: 1. Record review of the daily "Gram Stain" quality control log revealed a lack of documentation of quality control on the day of testing (3/8/2019) for patient specimen number 622822. 2. Record review revealed quality control from February 22, 2019 to March 19, 2019 was not retained. 3. During the interview on April 11, 2019 at 11:00 am, the TS1 confirmed the quality control data was not available to the surveyor. ***Repeat Deficiency from 10/8/14*** . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 surveyor review of the "Blood Bank Incubator Temperature Log", review of procedures, and an interview with the Technical Supervisor #2 (TS2), the laboratory did not have a defined acceptable temperature range for the Blood Bank Incubator for two (April 2017 to April 2019) of two years. Findings include: 1. Review of "Blood Bank Incubator Temperature Log" revealed acceptable temperature ranges were missing from the logs. 2. The laboratory did not have a policy with an acceptable temperature range for the Blood Bank Incubator. 3. Interview with the TS2 on 4/11/19 at 10:00 am confirmed an acceptable temperature range was absent from the log and a policy. 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 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 surveyor review of records and an interview with the Technical Supervisor #2 (TS2), the laboratory failed to perform calibration verifications for Total Bilirubin and Direct Bilirubin assays for at least once every six months for one of two events in 2018. Findings include: 1. Record review revealed the laboratory lacked documentation of the calibration verification for one event (September 2018) for Total Bilirubin and Direct Bilirubin assays. 2. Interview with the TS2 on 4/10/19 at 3:18 pm confirmed there was no valid calibration verification performed for Total Bilirubin or Direct Bilirubin for the September 2018 event. ***Repeat Deficiency from 10/8/14 and 10/23/12*** D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) -- 2 of 3 -- The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . A. Based on surveyor review of quality control records, review of procedures, and an interview with the Technical Supervisor #2 (TS2), the laboratory failed to perform negative controls for 9 of 9 forward, reverse, screening, and compatibility tests in blood bank in 2017. Findings include: 1. Review of quality control records revealed a lack of documentation for negative control values for the following blood banking daily control testing: a. Anti-A b. Anti-B c. Anti-D d. A1 Cells e. B Cells f. Anti- Human Globulin g. Screening Cells I and II 2. Review of the laboratory's "Blood Bank Quality Control" procedure did not contain instructions for negative control testing. 3. Interview with TS on 4/11/19 at 9:07 am confirmed the negative controls were not performed and documented each day of patient testing. B. Based on surveyor review of the patient testing log book, review of procedures, and interview with the Technical Supervisor #2 (TS2), the laboratory failed to perform Rh controls in parallel with patient testing according to laboratory procedure for 50 of the 53 patients reviewed. Findings include: 1. Review of patient testing log from 1/2/19 to 4/10/19 showed Rh control testing was not performed on 50 of the 53 patients tested. 2. Review of the laboratory's "Rh Typing" procedure stated, "An Rh control serum should be performed in parallel with each test." 3. Interview with TS2 on 4/11/19 at 9: 07 am confirmed Rh control was not performed with each patient. -- 3 of 3 --