Huron Regional Medical Center

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 5/2/24. Huron Regional Medical Center laboratory was found not in compliance with the following requirements: D6107. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to specify in writing the duties delegated to two of two technical supervisors (A, B), and one previous technical supervisor (C), including the performing of competency assessment for testing personnel. Findings include: 1. Review of the 2024 laboratory competency assessments revealed the following competencies had been completed and signed by technical supervisor A for: *Technical supervisor B on 4/6/24 *Testing personnel D on 2/7/24 *Testing personnel E on 2/7/24 *Testing personnel F on 2/7/24 *Testing personnel G on 2/14/24 Review of the 2024 laboratory competency assessments revealed the competency for technical supervisor A had been completed and signed by technical supervisor C on 2/7/24. On 5/1/24 the surveyor requested a copy from the laboratory supervisor of the laboratory director's designation of duties for technical supervisor A, B and C. No documentation was provided during the survey. Interview on 5/1/24 at 1:30 p.m. with the laboratory supervisor revealed she confirmed the laboratory did not have a written delegation of duties for technical supervisor A, B or 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 -- C. She was unaware this delegation of duties was needed for these supervisors to perform employee competencies. The laboratory director was unavailable for interview at the time of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 11/29/22. Huron Regional Medical Center laboratory was found not in compliance with the following requirements: D5215 and D5407. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to review proficiency testing (PT) results to ensure the accuracy of results not graded as acceptable and whether this issue could have affected the accuracy of patient care results, in 6 of 18 American Proficiency Institute (API) PT testing events reviewed (2022 Hematology /Coagulation second event; 2022 Immunology/Immunohematology first and second events; and 2022 Microbiology first, second, and third events). Findings include: 1. Review on 11/29/22 at 8:30 am of the API PT records revealed: * The evaluation and

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/9/21 through 8/10/21. The Huron Regional Medical Center laboratory was found not in compliance with the following requirement: D5471. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the potassium hydroxide (KOH) reagent, review of the annual test volume form, quality control (QC) records, and interview with testing personnel A, the laboratory failed to check each lot number or shipment of the KOH reagent for its positive reaction for 32 of 32 months reviewed (1/1/19 to 8/10/21). Findings include: 1. Review of available records revealed no documentation of quality control (QC) had been completed on KOH reagents during 2019, 2020 or to date in 2021. There was no documentation indicating QC had been performed on the current lot number in use before being used on patient specimens. Review of the annual test volume form revealed KOH testing had been performed on three patient specimens during 2020 without reagent QC to ensure accurate patient test results. Observation of open bottle of KOH reagent at 12:30 p.m. on 8/10/21 revealed the reagent was available for use on patient specimens. Interview at 12:10 p.m. on 8/10/21 with testing personnel A revealed: *She confirmed QC had not been verified before the KOH 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 -- reagent had been placed into use for testing patient samples. *They had not performed QC verification on KOH reagent as long as she had worked there. She had worked there approximately 4 years. -- 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 proficiency testing (PT) record review and interview with the laboratory supervisor, the laboratory failed to achieve successful participation for the subspecialty of Endocrinology. Unsatisfactory results had been received in two of three PT events (2019 Chemistry Core first and second events) resulting in unsuccessful PT participation. Refer to D2108. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) 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 an overall testing event score of satisfactory performance for two 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 American Proficiency Institute (API) and CASPER reports, and interview with the laboratory manager, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the subspecialty of Endocrinology in two out of three events (2019 Chemistry Core first and second events), resulting in unsuccessful performance. Findings include: 1. Review of CASPER reports 153D and 155D revealed the API PT scores for the subspecialty of Endocrinology were less than the 80% required per CLIA requirements found at CFR 493.86 (a): a. 2019 Chemistry Core first event- Endocrinology score = 30%. - Free thyroxine score = 0%. - Thyroid stimulating hormone (TSH) score = 20%. - Thyroxine score = 0%. b. 2019 Chemistry Core second event- Endocrinology score = 75%. - HCG quantitative score = 20%. - TSH score = 80%. Interview with the laboratory manager on 10/4/19 revealed: *She was aware of the scores and had conducted an investigation into the unacceptable PT results. a. The 2019 first PT event unacceptable PT results were due to technician error. The laboratory staff member processed the same PT sample multiple times instead of running all 5 PT samples for the affected test methods. b. The 2019 second PT event HCG unacceptable PT results were due to technician error. The laboratory staff member failed to investigate multiple samples with similar results. c. The 2019 second PT event TSH unacceptable PT result was due to clerical error. -- 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 proficiency testing (PT) record review and interview with the laboratory manager, the laboratory failed to achieve successful participation for the mycology identification test method. Unsatisfactory results had been received in two of three PT events (College of American Pathologists F-C 2018 and American Proficiency Institute 2019 Microbiology 1st event) resulting in unsuccessful PT participation. Refer to D2046. D2046 MYCOLOGY CFR(s): 493.827(e) 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 an overall testing event score of satisfactory performance for two 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 the federal proficiency testing (PT) reports 155D and 153D and interview with the laboratory manager, the laboratory failed to achieve a satisfactory score of 80% or above for the mycology identification test method for two of three events (College of American Pathologists [CAP] J-C 2018 and American Proficiency Institute [API] 2019 Microbiology 1st event). Findings include: 1. Review of the laboratory's CASPER Reports 153D and 155D revealed the laboratory had received unsatisfactory scores (less than 80%) for the mycology identification test method in each of the two events identified above. Review of the individual PT reports revealed: a. CAP J-C 2018 mycology identification score = 70%. *F-13 was reported as Candida albicans acremonium species. The acceptable results were Candida albicans, Candida albicans/dubliniensis, Candida species, or yeast, referred for ID. *F-16 was reported as Mucor species. The acceptable results were Rhizopus species, Mucorales presumptive identification, or mold recognized referred. b. API 2019 Microbiology 1st Event mycology idendification score = 60%. *MY-04 was reported as Acremonium species. The acceptable response was Pseudallescheria boydii. *MY-05 was reported as Curvularia species. The acceptable response was Alternaria species. Interview on 5/1/2019 with the laboratory manager confirmed the failure. She stated the laboratory had recently replaced their microbiology analyzer and had experienced staffing issues in microbiology. She had been reviewing patient reports to ensure no patients had been affected. The laboratory was considering referral of fungal isolates for identification in the future. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 4/24/18. The Huron Regional Medical Center laboratory was found not in compliance with the following requirements: D2007, D5413, D5471, and D6127. 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 review of proficiency testing (PT) attestation statements, the Laboratory Personnel Report form 209, review of the External Assessment policy, and interview with laboratory employee A, the laboratory failed to ensure all testing personnel routinely testing patient samples participated in PT testing during 12 of 12 months (January through December 2017). The laboratory did not implement their established policy regarding staff participation in PT. Findings include: 1. Review of the College of American Pathologist (CAP) PT attestation statements for 2017 revealed the following: a. Laboratory employee B participated in three of three general chemistry testing events, two of two cardiac marker testing events, two of two urine chemistry testing events, and three of three special chemistry testing events. Laboratory personnel C participated in one of three general chemisty events. No other laboratory employee who routinely tested patient samples participated in any of the events. b. Laboratory employee D participated in three of three hematology testing events, two of two body fluid cell count testing events, two of two coagulation testing events, and two of two clinical microscopy testing events. c. Laboratory employee E participated in three of three blood bank testing events. d. Laboratory employee F participated in three of three plasma cardiac marker testing events. e. Laboratory employee G also 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 -- performs patient testing in all areas of the laboratory and did not participate in PT events during this time period. Review of the External Assessment policy revealed "the proficiency test should be rotated and assigned among the various lab personnel assigned to the section to assess individual proficiency and competency." Interview with laboratory employee A at 3:30 p.m. on 4/23/18 revealed all personnel are proficient to work in all areas of the laboratory. He stated there is no set schedule for PT assignments among the testing personnel. He left it up to the individual department heads to assign PT testing within their individual areas. 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. This STANDARD is not met as evidenced by: Based on observation, review of maintenance logs and instrument manuals, and interview with laboratory employee A and maintenance employee B, the lab failed to maintain humidity levels within the optimal humidity ranges for instruments used to test patient specimens for 9 of 15 months (January, February, March, April, May, October, November and December 2017 and January through March 2018 ) reviewed in the main laboratory and histology areas. Findings include: 1. Review of 2017 and 2018 maintenance logs revealed the accetable humidity range to be LL (below lower limit) - 50 percent. Review of the package insert accompanying the hygrometer /thermometer indicated the lower limit of humidity measurement was 25 percent. The recorded humidity within the main laboratory area was below 25 percent for the following in 2017: * 30 of 31 days in January 2017 * 24 of 28 days in February 2017 * 26 of 31 days in March 2017 * 10 of 30 days in April 2017 * 5 of 31 days in May 2017 * 14 of 31 days in October 2017 * 28 of 30 days in November 2017 Review of the Sysmex CA-560 operators manual revealed the performance specifications required optimal performance of the instrument required 30 to 85 percent humidity. Interview with laboratory employee D on 4/24/18 at 12:10 p.m. revealed that the concentrated stain in the automatic stainer was evaporating sooner due tolow humidity leading to poor quality hematology slides. The recorded humidity in the histology area was below 30 percent for the following in 2017: * 31 of 31 days in January 2017 * 28 of 28 days in February 2017 * 31 of 31 days in March 2017 * 30 of 30 days in April 2017 * 31 of 31 days in October 2017* 30 of 30 days in November 2017 * 31 of 31 days in December 2017 * 31 of 31 days in January 2018 * 28 of 28 days in February 2018 * 31 of 31 days in March 2018 Review of the Tissue Tek Stainer operators manual revealed the performance specifications required optimal perforance of the instrument required 30-85 percent humidity. Interview on 4/24/18 at 1:40 p.m. with maintenance employee A revealed he had been aware of the low room humidity levels. He stated the building was old and due to the steam heating system it was difficult to maintain acceptable humidity levels especially in the winter months. They tried to maintain humidity levels at a minimum of 20 percent by pulling in outside air -- 2 of 4 -- to mix with the heated air. Interview with laboratory employee A at the same time revealed he did not think the laboratory was experiencing any analyzer issues due to the low humidity. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the package insert for 0.8% Resolve Panel A, review of the annual test volume form, and interview with laboratory employee A, the laboratory failed to check each lot number or shipment of 0.8% Resolve Panel A cells for their positive and negative reactivity prior to patient testing for 15 of 15 patients tested during 2017. Findings include: 1. Review of available records revealed no documentation of quality control (QC) having been done on the 0.8% Resolve Panel A cells in 2016, 2017, or 2018. Review of the package insert for 0.8% Resolve Panel A (last revised October 2015) revealed the manufacturer stated: "for quality assurance 0.8% Resolve Panel A should be tested with a known weak antibody." Review of the annual testing volume form indicated fifteen patient antibody identification procedures had been performed using 0.8% Resolve Panel A during 2017. Interview on 4/2/8/18 at 2:05 p.m. with laboratory employee A revealed he was unaware QC was required of a new lot number or shipment before use on patient samples. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high 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 personnel records, review of the Competency Assessment Program policy, and interview with laboratory personnel A, the technical supervisor failed to ensure employee competencies had been performed semi-annually during the first year for 1 of 1 laboratory employees (laboratory employee G). Findings include: 1. Review of personnel records revealed laboratory employee G had no competency assessments recorded. Laboratory employee G had been hired on 1/23/17. This individual had not had a competency performed in the 15 months of her employment. Review of the Competency Assessment Program policy revealed in section 5- Evaluations: "Each new employee will be evaluated biannually the first year of employment and annually thereafter." Interview with laboratory employee A on 4/23 /18 at 4:25 p.m. indicated a six month human resources evaluation had been -- 3 of 4 -- performed, but no competency assessment had been performed to date for laboratory employee G. The human resources evaluation had been an employment evaluation and did not address the competency assessment. -- 4 of 4 --