Morrison Community Hospital

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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of laboratory documents, lack of documentation, and interviews with the general supervisor (GS) and the laboratory director (LD); the laboratory failed to ensure patient testing records and activities were documented and retained in the subspecialty of histopathology from the beginning of 2024 through the date of survey, 04/09/2025, affecting 25 patients. Findings include: 1. Review of laboratory records revealed the document titled, "Pathologist Visit Log", which indicated, on the following dates, that Frozen Section Tissue Biopsies were performed: Date: "On-Site Activity or Items Addressed": 01/30/2024 "Frozen Section" 02/27/2024 "Frozen Sections x2" 03/26/2024 "Frozen x3" 05/28/2024 "Frozen x4" 07/23/2024 "Frozen x4" 08/27/2024 "Frozen x3" 09/24/2024 "Frozen x2" 11/26/2024 "Frozen Section" 02 /11/2025 "Frozen Section x1" 03/25/2025 "4 frozens" 2. Interview with LD via telephone on 04/09/2024, at 1:10 pm, revealed that the laboratory did not document which patients had Frozen Section Tissue Biopsies performed on each day of patient testing. 3. Interview with the GS on 04/09/2025, at 12:24 pm, confirmed the laboratory failed to ensure patient testing records and activities were documented and retained in the subspecialty of histopathology from the beginning of 2024 through the date of survey, 04/09/2025, affecting 25 patients. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of laboratory records, lack of documentation, and interviews with the general supervisor and testing personnel #3; the laboratory failed to ensure accuracy of five of five analytes not evaluated by the PT provider (See D5213), failed to test one sample of control material each eight hours of testing using a combination of control materials that include both low and high values on each day of patient testing for four of four blood gas testing patients reviewed (See D5537), and failed to have a system in place that twice annually evaluates the relationship between testing on two of two Siemens Epoc analyzers and one of one Siemens Atellica analyzer (See D5775). D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, laboratory test reports, the CMS-209 (Laboratory Personnel Report), lack of documentation, and interviews with the laboratory director, general supervisor, and testing personnel #3; the laboratory failed to perform bi-annual method accuracy verifications (proficiency testing/peer reviewed histopathology interpretations) twice a year for frozen section biopsy testing (See D5217), failed to outline all components of the test procedures for Frozen Section Tissue Biopsy testing (See D5403), failed to have one of one procedure reviewed, approved, signed, and dated by the current laboratory director (See D5407), failed to ensure 22 of 22 provided histopathology reports were signed by a qualified individual (See D5607), and failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic system by ensuring the Cryostat temperature was recorded for two of ten days of patient testing reviewed (See D5791) in the subspecialty of histopathology. 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 CMS-209 (Laboratory Personnel Form), laboratory policies and procedures, lack of documentation, and interview with the general supervisor (GS); the laboratory failed to have a competency assessment policy and procedure in place to assess employee competency for one of one general supervisor. Findings -- 2 of 12 -- include: 1. Review of the CMS-209 (Laboratory Personnel Form) revealed one general supervisor. 2. Review of the laboratory policies and procedures revealed the laboratory lacked a competency assessment policy and procedure to assess the competency of one of one GS. 3. Interview with GS #1 on 04/08/2025, at 12:18 pm, confirmed the laboratory failed to have a competency policy and procedure in place to assess competency for one of one GS. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records, laboratory records, lack of documentation, and interviews with the general supervisor (GS) and testing personnel (TP) #3; the laboratory failed to ensure accuracy of five of five analytes not evaluated by the PT provider in the specialties of chemistry and immunohematology in 2023 and 2024. Findings include: 1. Review of API comparative evaluation summaries for the following PT events of 2023 and 2024 revealed the following un-graded PT samples: PT Event: Analyte: Sample: 2023 Event 1 - Chemistry ALT* CH-01 2023 Event 3 - Immunohematology Compatibility SER-12 2024 Event 1 - Chemistry Total Bilirubin CH-02 2024 Event 1 - Chemistry Total Bilirubin CH-03 2024 Event 1 - Chemistry Total Bilirubin CH-05 *ALT = alanine aminotransferase 2. Review of laboratory records found no documented review of the ungraded PT analytes in the specialties of chemistry and immunohematology in 2023 and 2024. 3. Interviews with the GS and TP #3 on 04/09 /2025, at 2:22 pm, confirmed the laboratory failed to ensure accuracy of five of five analytes not evaluated by the PT provider in the specialties of chemistry and immunohematology in 2023 and 2024. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to perform bi-annual method accuracy verifications (proficiency testing/peer reviewed histopathology interpretations) twice a year for frozen section biopsy testing in the subspecialty of histopathology from the beginning of 2024 through the date of survey, 04/09/2025, affecting 25 patient test results. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Frozen Sections", which stated, under "7. Competency: Each of the pathologists will review one frozen section per year which has been performed at [this laboratory] ...." 2. Review of laboratory records revealed no documentation of bi-annual method accuracy verifications for histopathology frozen section biopsies tested from the beginning of 2024 through the date of survey, 04/09/2025, affecting 25 patients. Date: # of frozen section biopsies -- 3 of 12 -- performed: 01/30/2024 "Frozen Section" 02/27/2024 "Frozen Sections x2" 03/26 /2024 "Frozen x3" 05/28/2024 "Frozen x4" 07/23/2024 "Frozen x4" 08/27/2024 "Frozen x3" 09/24/2024 "Frozen x2" 11/26/2024 "Frozen Section" 02/11/2025 "Frozen Section x1" 03/25/2025 "4 frozens" 3. Interview with the LD via telephone on 04/09/2025, at 2:25 pm, confirmed the laboratory failed to perform bi-annual method accuracy verifications (proficiency testing/peer reviewed histopathology interpretations) twice a year for frozen section biopsy testing in the subspecialty of histopathology from the beginning of 2024 through the date of survey, 04/09/2025. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on record review, manuals, and interview, the laboratory failed to ensure the laboratory director (LD) attested to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods for nine out of nine Pt events in 2021 during the year of 2021. Findings include: 1. The laboratory procedures manual and American Proficiency Institute (API) PT documents for 2019 through 2021 were reviewed. 2. The PT policy and procedure and API-PT program instructions required the signature of the LD or technical supervisor (TS) to attest to the treatment and testing of PT samples when submitting any PT results to the PT program, as a condition of participation, for each PT event. 3. The PT documents of 2021 revealed nine out of nine attestation statements were not signed by the LD or TS for tests performed in the specialties of Hematology, Chemistry and Immunochemistry. 4. On a Recertification survey conducted on 12/22/2021 at 2:30 PM, the TS confirmed the above findings. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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. 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 laboratory director (LD) failed to ensure prior to testing patients' specimens, all personnel had the appropriate education to perform all testing operations reliably to provide and report accurate results, affecting three out of five testing personnel (TP). Findings include: 1. The laboratory personnel documents, the Laboratory Personnel Report (CMS 209), and patients' test logs were reviewed. 2. The LD failed to ensure three new laboratory employees met education requirements to perform high complexity testing. See D6168 and D6171. 3. The personnel training and competency records and test logs revealed all three employees were performing patient testing in laboratory 4. On a Recertification survey conducted on 12/22/2021 at 2:30 PM, the TS confirmed the above findings. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS 209), and interview, the laboratory failed to employ individuals who meet the qualification requirements of 493.1489 to perform the functions of highly complex testing in the laboratory for three out of five testing personnel (TP), prior to testing patients. Findings: 1. The laboratory failed to ensure new laboratory staff meet the education criteria specified in 493.1489(b) (1-3) for highly complex testing. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could -- 2 of 3 -- have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS-209), and interview, the laboratory failed to ensure laboratory employees meet the qualification requirements for performing highly complex testing for three out of five testing personnel (TP). Findings: 1. The CMS 209 list three new hires (TP1, TP2, and TP3) to performing moderately and highly complex testing in the laboratory. 2. Review of the employee files revealed the three new TP failed to include education credentials. 3. On a Recertification survey conducted on 12/22/2021 at 2:30 PM, the TS confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of API (American Proficiency Institute) proficiency testing (PT) records and an interview with the general supervisor (GS), the laboratory failed to attain an overall testing event score of at least 100 percent for testing in the specialty of Immunohematology, during the year of 2017. Findings: 1. The API Immunohematology results for 2017 and 2018 were reviewed. 2. The laboratory failed to score 100% for the immunohematology PT tests performed in 2017. The unsatisfactory performance was for the following tests: a). Compatibility testing received a score of 80% for Event #1 of 2017; and b). Unexpected Antibody Detection received a score of 80% for Event #1 of 2017. 3. On a recertification survey conducted on 04/02/2019 at 2:30 PM, the GS confirmed the above findings. 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 record review and an interview with the general supervisor (GS), the laboratory failed to follow written procedures to assess employees performing moderately and highly complex testing for 6 out of 6 testing personnel (TP). Findings 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 -- include: 1. The procedures manual and personnel records were reviewed. 2. The laboratory failed to follow the written competency procedure established by the laboratory director. 3. The laboratory begin to used a revised competency procedure to evaluate TP on 04/25/2017, a review of the changed competency revealed the following:; *a). The procedure no longer indicated whether the TP being assessed is evaluated as "Satisfactory or Unsatisfactory" *b). The procedure no longer indicated whether the TP is authorized to perform the test for which they were evaluated, and *c). The procedure no longer indicated whether the TP required supervision or not. 4. On a recertification survey conducted on 04/02/2019 at 2:30 PM, the GS confirmed the above findings and stated they were unaware the changes would lead to noncompliance. -- 2 of 2 --