Seiling Municipal Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/03,4,5,6/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant, chief operating officer, and administrator at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure a proficiency testing attestation statement had been dated by the laboratory director or designee for one of five Hematology events reviewed from 2023 through 2024. Findings include: (1) A review of the first, second, and third 2023; and first and second 2024 Hematology proficiency testing records identified the following for one of five events: (a) Second 2024 Event - The attestation statement had been signed but not dated by the laboratory director or designee. (2) The findings were reviewed with the technical consultant who stated on 12/03/2024 at 1:04 pm, the attestation statement had been signed but not dated by the laboratory director or designee. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant, the laboratory failed to ensure 13 of 13 bottles of Thermo Scientific GlucoCrush glucose tolerance beverages were stored to minimize contamination. Findings include: (1) On 12/04 /2024 at 10:15 am, observation of the contents of the laboratory refrigerator identified the following materials: (a) Type "O" uncrossmatched units of blood for emergency release; (b) 13 bottles of Thermo Scientific GlucoCrush glucose tolerance beverages for patient consumption. (2) Interview with the technical consultant on 12/04/2024 at 10:20 am confirmed the laboratory failed to minimize contamination by storing patient beverages for consumption with biohazard materials. D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and testing person #1, the laboratory failed to ensure blood products were stored under appropriate conditions in the blood bank refrigerator for three of 34 thermograph charts reviewed between March and November 2024. Findings Include: (1) On 12/03 /2024 at 3:45 pm, testing person #1 stated the laboratory maintained two units of O positive and two units of O negative packed red blood cells in the blood bank refrigerator. The units were available for emergency patient transfusions; (2) Observation of the blood bank refrigerator on 12/03/2024 at 3:45 pm identified the refrigerator was connected to an analog temperature recorder which continuously recorded the temperatures for a 7-day period on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees Centigrade); (3) A review of the 34 temperature charts from 03/01/2024 through 11/15/2024 identified no evidence three of 34 charts had been changed by the 7th day of usage as follows: (a) Between 05/09 /2024 and 05/17/2024 (b) Between 08/19/2024 and 08/27/2024 (c) Between 09/17 /2024 and 09/19/2024 (4) The findings were reviewed with the technical consultant who stated on 12/06/2024 at 10:15 am, the charts had not been changed by the 7th day of usage as shown above. 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. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the technical consultant, the laboratory failed to assess the competency of the technical consultant based on the position responsibilities as listed in subpart M, and the policy failed to define the frequency the assessments were to be performed. Findings include: (1) A review of the laboratory policy and procedure manual identified a written policy for assessing the competency of the technical consultant based on the position responsibilities. The policy did not define the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of March 2023 through the current date identified competencies based on the position responsibilities, had not been performed for the technical consultant listed on the CMS-209; (3) The findings were reviewed with the technical consultant who stated on 12/03/2024 at 02: 28 pm, competency assessments had not been performed for the technical consultant during the review period, and the policy failed to define the frequency of assessments as stated above. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results to identify biases for one of five Hematology proficiency testing events reviewed in 2023 and 2024. Findings include: (1) On 12/03/2024, a review of Hematology proficiency testing records for 2023 (first, second, and third events) and 2024 (first and second events) identified the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) for one of five events: (a) First 2024 Event: (i) Hematocrit (Hem-5S) - five of five results exhibited positive biases: (aa) Sample XE-01 - SDI of -0.7 (bb) Sample XE-02 - SDI of -2.0 (cc) Sample XE-03 - SDI of -2.0 (dd) Sample XE-04 - SDI of -1.3 (ee) Sample XE-05 - SDI of -1.2 (2) There was no evidence in the records to prove the biases had been identified and addressed; (3) The records were reviewed with the technical consultant who stated on 12/03/2024 at 01:40 pm, the biases had not been addressed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the technical consultant, the laboratory failed to follow the written policy to ensure that emergency -- 3 of 8 -- release of blood forms had been signed by the physician for one of three emergency releases reviewed; and failed to follow written policy for compatibility testing as soon as possible after emergency release for one of two units given. Findings include: Emergency Release Forms (1) On 12/06/2024 at 11:00 am, the technical consultant stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for emergency transfusions; (2) A review of the policy titled, "Emergency Release of uncrossmatched units" required an Emergency Release form be completed (OBI_CL_Form 257). The form included a space for the medical provider's signature. The policy also stated "If a PA or APRN signs OBI_CL_Form 257, accepting responsibility for the transfusion, the form must be returned to the facility and additionally signed by a hospital physician"; (3) A review of documentation of emergency issue identified the following for one of three patient records: (a) One unit of O positive packed red blood cells had been released to a patient on 10/25/2024. The "Emergency Blood Transfusion Request" form appeared to be signed by a mid-level provider and not a physician; (4) The documentation was reviewed with the technical consultant who stated on 12/06/2024 at 11:00 am, the emergency releases had not been signed by a physician. Emergency Release Compatibility Testing (1) On 12/06/2024 at 11:00 am, the technical consultant stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for emergency transfusions; (2) A review of the policy titled, "Emergency Release of uncrossmatched units" stated, "This procedure provides instructions when emergency transfusion is medically necessary before compatibility testing can be performed by the reference laboratory". The policy also stated "When the appropriately labeled specimen is received in the reference laboratory, the standard compatibility testing procedure will be completed with a stat priority status"; (3) A review of documentation of emergency releases identified the following for one of two patient records: (a) Unit # W091024203484 - O positive packed red blood cells had been emergency released to a patient on 5/1/2024, with no documentation of compatibility testing performed after release. (4) The documentation was reviewed with the technical consultant who stated on 12/06/2024 at 11:00 am, the sample had not been sent to the reference laboratory for compatibility testing after the emergency release. 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)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/13,14/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant, laboratory manager, and chief executive officer during an exit conference performed at the conclusion of the survey. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the technical consultant and laboratory manager, the laboratory failed to define a written function check protocol to ensure the urine centrifuge was functioning properly for three of three function checks performed from December 2021 through November 2022. Findings include: (1) On 03/13/2023 at 10:55 am, the laboratory manager stated the following: (a) The laboratory performed urine microscopic testing; (b) The urine specimens were processed at a speed of 1500 rpm (revolutions per minute) for 5 minutes using the Select Medical Product PSS 602 centrifuge. (2) A function check protocol that defined the frequency of the urine centrifuge speed and timer checks and the acceptable limits for the checks could not be located; (3) During an interview on 03/14/2023 01:20 pm, the laboratory manager stated the laboratory did not have a written function check protocol but the centrifuge was checked by an outside 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 -- biomedical company at least annually; (4) A review of the centrifuge maintenance records from December 2021 through November 2022 identified the following for three of three function checks: (a) 12/21/2021 - Although the timer had been checked, there was no documentation of the actual time obtained and the documenation stated, "pass"; (b) 05/06/2022 - There was no documentation the timer had been checked for accuracy; (c) 11/04/2022 - Although the timer had been checked, there was no documentation of the actual time obtained and the documenation stated, "acceptable". (5) The findings were reviewed with the technical consultant and laboratory manager. Both stated on 03/13/2023 at 01:50 pm, the laboratory did not have a written function check protocol for the urine centrifuge and the laboratory did not ensure the urine centrifuge was functioning properly as shown above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/07,08,09/2021. The laboratory was found out of compliance with the following CLIA regulations: 493.1409; D6033: Technical Consultant 493.1447; D6108: Technical Supervisor The findings were reviewed with the technical consultant and laboratory manager during an exit conference performed at the conclusion of the survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review proficiency testing results for 1 of 21 events. Findings include: (1) On 04/07/2021, surveyor #2 reviewed 2019 and 2020 proficiency testing records and identified the following failure: (a) Third 2019 Chemistry Core Event (i) Creatine Kinase - The laboratory failed the results for 1 of 5 samples (CH-11); (2) Surveyor #2 could not locate evidence in the records proving the failure had been addressed; (3) Surveyor #2 reviewed the records with technical consultant, and asked if

Summary Statement of Deficiencies D0000 The recertification survey was performed 12/10/2018 - 12/12/2018. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and the hospital administrator at the conclusion of the survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed the 2017 and 2018 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program): (a) First 2017 Hematology Event (i) WBC (White Blood Count): 5 of 5 results exhibited a Negative bias (aa) XE-01: SDI -1.3 (bb) XE-02: SDI -1.9 (cc) XE-03: SDI -1.6 (dd) XE-04: SDI -2.6 (ee) XE-05: SDI -2.8 (b) Third 2017 Chemistry Event: (i) pH: 4 of 5 results exhibited a Negative bias (aa) BG-12: SDI -2.4 (bb) BG-13: SDI -2.8 (cc) BG-14: SDI -2.3 (dd) BG-15: SDI -2.2 (c) Second 2018 Chemistry Event: (i) Amylase: 4 of 5 results exhibited a Positive bias (aa) CH-06: SDI 3.8 (bb) CH-07: SDI 1.3 (cc) CH-08: SDI 1.5 (dd) CH-10: SDI 2.4 (ii) AST (Aspartate Aminotransferase): 4 of 5 results exhibited a Positive bias (aa) CH-06: SDI 2.0 (bb) CH-07: SDI 2.6 (cc) CH-09: SDI 2.2 (dd) CH-10: SDI 2.5 (iii) BUN: 4 of 5 results exhibited a Positive bias (aa) CH-06: SDI 2.7 (bb) CH-08: SDI 1.0 (cc) CH-09: SDI 1.4 (dd) CH-10: SDI 3.5 (iv) Calcium: 4 of 5 results exhibited a Positive bias (aa) CH-06: SDI 3.9 (bb) CH-07: SDI 4.3 (cc) CH-09: SDI 3.2 (dd) CH-10: SDI 3.1 (v) Uric Acid: 4 of 5 results exhibited a Positive bias (aa) CH-06: SDI 3.9 (bb) CH-07: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- SDI 2.9 (cc) CH-09: SDI 2.3 (dd) CH-10: SDI 2.8 (d) Third 2018 Chemistry Event (i) Albumin: 3 of 5 results exhibited a Positive bias (aa) CH-13: SDI 2.9 (bb) CH-14: SDI 2.0 (cc) CH-15: SDI 2.6 (ii) Chloride: 4 of 5 results exhibited a Positive bias (aa) CH-11: SDI 2.7 (bb) CH-13: SDI 2.6 (cc) CH-14: SDI 3.1 (dd) CH-15: SDI 3.3 (iii) Potassium: 3 of 5 results exhibited a Positive bias (aa) CH-11: SDI 1.8 (bb) CH-13: SDI 2.0 (cc) CH-15: SDI 2.4 (iv) Sodium: 4 of 5 results exhibited a Positive bias (aa) CH-11: SDI 2.2 (bb) CH-13: SDI 2.1 (cc) CH-14: SDI 2.3 (dd) CH-15: SDI 2.4 (2) There was no documentation found in the records the laboratory identified and evaluated the biases to determine if a systematic failure had occurred, and there was no documentation the laboratory took

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. The laboratory was found out of compliance with the following CLIA regulations: 1. 493.803; D2016: Successful Participation 2. 493.807; D2017: Reinstatement of Nonwaived Laboratories 3. 493.1441; D6076: Laboratory Director, High Complexity 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 desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Compatibility Testing. Findings include: (1) The laboratory failed to achieve 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 -- satisfactory performance for three consecutive testing events for Compatbility Testing. Refer to D2181. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for Compatibility Testing. Findings include: (1) The laboratory failed to successfully participate in proficiency testing for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 a desk review of proficiency testing scores, the laboratory failed to achieve satisfactory performance for Compatibility Testing in three consecutive testing events. Findings include: (1) The laboratory received a score of 80% on the second event in 2017, a score of 80% on the third event in 2017 and a score of 80% on the first event in 2018. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory demonstrated initial and non-initial unsuccessful participation for Compatibility Testing. The -- 2 of 3 -- laboratory failed to achieve a passing score (100%) for the second 2017 event, the third 2017 event, the first 2018 event. It is the responsibility of the laboratory director to 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

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for Compatbility Testing. Refer to D2179 and D2181. 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 -- D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the second event in 2017 and the third event in 2017. Refer to D2181. NOTE: The only acceptable