Grand River Medical Center

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director, the laboratory failed to achieve satisfactory performance scores for the College of American Pathologists (CAP) PT for Toxicology for two out of three PT events, (event 2 in 2023 and event 3 in 2023), Gentamicin for two out of three PT events, (event 2 in 2023 and event 3 in 2023), and Phenytoin for two out of three PT events, (event 2 in 2023 and event 3 in 2023). See D2110. D2110 TOXICOLOGY 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 -- CFR(s): 493.845(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT), College of American Pathologists (CAP) reports, and email communication with the laboratory director, the laboratory failed to achieve a satisfactory score for Toxicology for event 2 in 2023 and event 3 in 2023, Gentamicin for event 2 in 2023 and event 3 in 2023 and failed to achieve a satisfactory score for Phenytoin for event 2 in 2023 and event 3 in 2023. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 12/27/2023, at 10:20 AM, revealed the CAP PT results for Toxicology testing scores for event 2 in 2023 was 57%, and 57% for event 3 in 2023. 2. A review of the CMS-155 Individual Laboratory Profile on 12/27/2023, at 10:20 AM, revealed the CAP PT results for Gentamicin testing scores for event 2 in 2023 was 0%, and 0% for event 3 in 2023. 3. A review of the CMS-155 Individual Laboratory Profile on 12/27 /2023, at 10:20 AM, revealed the CAP PT results for Phenytoin testing scores for event 2 in 2023 was 0%, and 0% for event 3 in 2023. 4. An email with the laboratory's director on 12/27/2023, at 03:35 PM, confirmed the laboratory failed to achieve satisfactory test performance for Toxicology, Gentamicin, and Phenytoin. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a routine desk review of the CMS-155 report for proficiency testing performance and an interview with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for compatibility testing for two consecutive events (Events 1 and 2 in 2022). See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing scores from the College of American Pathologists (CAP) and an interview with the laboratory manager, the laboratory failed to achieve a score of 80% for PO2 Blood Gas for Events 1 and 2 in 2022. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 10/11/2022, at 1:00 PM, revealed the PO2 Blood Gas scores for Event 1 in 2022 was 60% and Event 2 in 2022 was 40%. 2. An interview with laboratory manager on 10/13/2022, at 9:15 AM, confirmed two consecutive unsuccessful proficiency scores for compatibility testing due to clerical and laboratory testing personnel errors. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on routine desk audit of CMS-153 and CMS-155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for Partial Thromboplastin Time (PTT) and Prothrombin Time (PT) for two consecutive events (2020 event 1 and 2020 event 2), resulting in unsuccessful proficiency testing performance. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for Partial Thromboplastin Time (PTT) and Prothrombin Time (PT) in two consecutive events in 2020, resulting in unsatisfactory performance. The findings include: 1. During a review on 7-31-20 of the CMS-153 Unsuccessful Proficiency Testing Report included the Grand River Medical Center with unsatisfactory proficiency testing scores for PTT and PT. 2. During a review on 7-31- 20 of the CMS-155 report, the PTT score for event 1 of 2020 was 60%. During a review on 7-31-20 of the CMS-155 report, the PT score for event 1 of 2020 was 60%. 3. During a review on 7-31-20 of the CMS-155 report, the PTT score for event 2 of 2020 was 60%. During a review on 7-31-20 of the CMS-155 report, the PT score for event 2 of 2020 was 40%. 4. On 7-31-20, the laboratory manager stated that the results were due to transcription errors and that review and

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: Based on review of the quality assessment (QA) plan, personnel competency assessment records and staff interview, the laboratory failed in 2019 to follow their written policy to assess competency of all testing personnel who performed patient testing in the specialty of Hematology and Immunohematology after a change in instrumentation occurred. Findings include: a. The QA plan states that all lab staff will be assessed initially, at 6 months after hire, at 12 months and then annually thereafter. b. No documentation existed to show 10 of 10 established testing personnel were assessed in 2019 prior to changes in instrumentation in the specialties of Hematology in December 2019 and in the specialty of Immunohematology in April 2019. c. The laboratory director and laboratory manager confirmed that competency assessements were not performed on testing personnel prior to reporting patient test results in the specialty of Hematology and Immunohematology after implementation of new testing instrumentation. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: Based on review of the quality assessment (QA) plan, personnel competency assessment records and staff interview, the laboratory failed to follow the establish QA plan and monitor that competency assessment was performed on 10 of 10 testing personnel who perform testing in the specialty of Hematology and Immunohematology prior to reporting patient test result after implementation of new instrumentation in 2019. Findings include: a. The QA plan states that all laboratory staff will be assessed initially, at 6 months after hire, at 12 months and then annually thereafter. b. No documentation existed to show 10 of 10 testing personnel were assessed in 2019 in the specialties of Hematology and Immunohematology. c. The general supervisor stated that personnel competency assessments of testing personnel were not completed prior to reporting patient test results. d. The laboratory director and general supervisor confirmed the laboratory failed to follow their QA plan and did not perform competency assessments on testing personnel prior to reporting patient test results in the specialties of Hematology and Immunohematology after implementation of new instrumentation in 2019. 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)