Harney District Hospital Lab

Summary Statement of Deficiencies D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) (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 review of American Proficiency Institute (API) Proficiency Testing (PT) for Blood Bank (BB) in 2024, it was revealed that the laboratory failed to attain a total score of 100% for Compatibility Testing for BB event #3. Interview with the Technical Supervisor (TS) confirmed the unsatisfactory score for API BB event #3 Compatibility testing. Findings include: 1. Upon review of the scores for the specialty BB, the laboratory failed to attain a score of 100% for Compatibility testing for event #3 in 2024. 2. Upon request for written documentation of a complete

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: This STANDARD is not met as evidenced by: Based on the Coagulation instrument data review, Dade Innovin reagent package insert review and testing personnel interview on 05/21/2025 at 1300, the laboratory failed to verify the Dade Innovin reagent lot number in use was current in the instrument. Findings include: a. Upon review of the Sysmex CA-600 coagulation analyzer, the Dade Innovin reagent lot number in the analyzer was Lot 564615A expiration 03/03/2025, with an International Sensitivity Index (ISI) of 1.04. b. Upon review of the Dade Innovin reagent package insert currently in use on the analyzer, the lot number is 564640 expiration 12/01 /2025, with an International Sensitivity Index (ISI) of 1.09. c. Interview with testing personnel (TP3) confirmed the laboratory was using Dade Innovin reagent lot number 564640 expiration 12/01/2025. d. The laboratory performs approximately 489 prothrombin time tests annually. 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 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 personnel interview and document review on December 13, 2023 at 10:10 am, the laboratory failed to establish and follow written policies and procedures for personnel competency assessments, including remedial training or continuing education needs, that included all the elements listed at 42 CFR 493.1451(b)(8). Findings included: a. It was the practice of the laboratory to include quizzes in initial testing personnel competency assessments. A review of initial testing personnel competency assessments indicated the following: i. Testing Personnel 3's (TP-3's) Cepheid quiz was upgraded. ii. TP-5's "moderate complexity" initial quiz was scored as "failed." iii. Only 1 of 5 TP had a "moderate complexity" quiz. b. Interview with the Technical supervisor (TS) confirmed that the laboratory did not have written policies and procedures for conducting laboratory personnel competency assessments. c. According to laboratory records, the laboratory performed approximately 171,000 tests annually. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Based on interview with the laboratory director (LD) and document review on December 13, 2023 at 3:00 pm, at least twice annually, the laboratory failed to verify the accuracy of C-Reactive Protein (CRP) and measured total iron-binding capacity (TIBC), tests or procedures it performed that is not included in subpart I of this part, in 2023. Findings include: a. It is the laboratory's practice to enroll in CRP and TIBC proficiency testing (PT) to meet the requirement at 42 CFR 493.1236(c)(1). b. A review of the laboratory's 2023 PT records showed that the laboratory received unsatisfactory CRP and TIBC PT test scores (i.e., obtain a minimum proficiency test score of 80%) in two consecutive proficiency testing events or two out of three consecutive proficiency testing events. Year Event Score Analyte 2023 1st 50% CRP 2023 2nd 50% CRP 2023 1st 60% TIBC 2023 2nd 40% TIBC c. Interview with the LD confirmed these findings. d. The laboratory performed and reported approximately 900 patient CRP and TIBC test results annually. 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. This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and postanalytic systems quality assessment policies and procedures record review on December 13, 2023 at 10:30 am, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the general laboratory systems specified in 493.1231 through 493.1236. Findings included: a. As confirmed by laboratory personnel, the laboratory maintained no written policies and procedures detailing the laboratory's quality assessment mechanisms to monitor, assess and, when indicated, correct problems identified in the laboratory's general laboratory systems. b. According to laboratory records, the laboratory performed approximately 171,000 tests on patient blood specimens annually D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on testing personnel interview and specimen collection policies and procedures record review on December 13, 2023 at 10:00 am, the laboratory failed to establish written policies and procedures for the collection of blood specimens. Findings included: a. It was the practice of the laboratory to collect patient blood specimens using routine phlebotomy procedures. b. As confirmed by testing personnel, the -- 2 of 7 -- laboratory maintained no written policies and procedures detailing the laboratory's phlebotomy protocols. c. According to laboratory records, the laboratory performed approximately 171,000 tests on patient blood specimens annually. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on laboratory personnel interviews and analytic systems quality assessment policies and procedures record review on December 13, 2023 at 10:15 am, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the preanalytic systems specified in 493.1241 through 493.1242. Findings included: a. As confirmed by laboratory personnel, the laboratory maintained no written policies and procedures detailing the laboratory's quality assessment mechanisms to monitor, assess and, when indicated, correct problems identified in the laboratory's preanalytic systems. b. For example, the laboratory maintained no written policies and procedures establishing the laboratory's preanalytic systems quality assessment protocol to ensure written policies and procedures for the collection of blood specimens were established. See D5311. c. According to laboratory records, the laboratory performed approximately 171,000 tests on patient blood specimens annually. 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 An onsite revisit complaint survey was completed on 9/1/2022. The facility is not in compliance with all of the Conditions required for certification in the CLIA program. The following Condition was not met: 42 C.F.R. 493.1250 Condition: Analytic Systems 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: No deficiency details available. 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: No deficiency details available. 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 -- D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: No deficiency details available. 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: No deficiency details available. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: No deficiency details available. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: No deficiency details available. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: No deficiency details available. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: No deficiency details available. -- 3 of 3 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory's policies and procedures and discussion with staff the laboratory failed to ensure that complaint investigations, discrepant patients results, quality control and calibration issues were monitored and evaluated and rectified. Refer to D5205, D5211, D5291 and D5293. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of laboratory's policies and procedures and interview with the Laboratory Director (LD) and Laboratory Manager (LM) on 06/03/2022 @ 10:30 AM the laboratory failed to implement their complaint investigation protocol. Findings include: 1. There were twenty seven (27) management and adverse events reported using the Patient Incident Form that was reviewed from 12/21/2021 to 05/13/2022. 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 -- The specialties involved were 10 in Chemistry, 3 in Urinalysis, 2 in Hematology, 1 in Coagulation, and 3 in Bacteriology. 2. Nineteen (19) of the adverse events were from testing personnel who lacked training and oversight, that resulted in the test not being perform, delayed in testing, or incorrect patients results. There were no follow through to determine root cause and what actions were taken to rectify the lack of training and oversight for testing personnel. 3 The Lab Director and staff concurred with these findings on 06/03/2022 @ 10:30. 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 review of proficiency testing records from the American Association of Bioanalyst (AAB) the laboratory failed to achieve acceptable test scores for the sub- specialties in Bacteriology, Endocrinology and Routine Chemistry for the 1st event 2022.. Findings include: 1. AAB 1st event 2022 Virology - 60% 2. AAB 1st event 2022 Free TY - 60% 3. AAB 1st event 2022 Routine Chemistry a) Amylase - 60% b) Total Cholesterol - 0% c) Cholesterol HDL - 60% d) Creatinine kinase total- 60% e) CK Isoenzyme - 60% f) Iron total - 60% g) LDH total - 60% h) Magnesium - 60% i) Triglyceride - 0% j) Uric Acid - 0% 4. Documentation for failure was cited as clerical errors both in running the specimens and entering results in the AAB system. 5. Lab Director and staff concurred with these findings 06/03/2022 @ 10:30. 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with the Laboratory Director and Laboratory Manager on 06/03/2022 @ 10:30AM the laboratory failed to document

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on record review and discussion with staff the laboratory failed to provide a written procedure that provided a step by step process that ensures positive patient identification from specimen collection through reporting of results. Findings include: 1. There was no written procedure available for review that describes how the surgeon submits a tissue specimen removed surgically by Mohs micrographic surgery technique, how the tissue specimen is labeled and submitted to laboratory with Mohs map work sheet for processing. 2. Random review of microscope slides with frosted end for labeling was labeled with limited patient identification. The slides were labeled with the following: Mohs case number; initials for the patient's first and last name, Diagnosis, encounter date, and primary number of stages and slides. The selected slide was clearly labeled with OW-19-10 NC BCC 5/20/10 I2-A 3. Comparison with the other six slides from the same slide holder for Mohs case number OW-19-10 and the review of the final report, revealed the encounter date 05 /20/10 was incorrect on the randomly selected slide. 4. Comparison with the Mohs map, patient log sheet for the Mohs surgery day and the final report reveal the Mohs map is blank for location and patient log sheet and final report indicate "Right Lateral arm". 5. Discussion with laboratory manager on 06/04/2019 approximately at 11:00 am confirmed that there was no written procedure to describe the step by step process of special handling of tissue specimens to ensure positive patient identification is 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 -- maintained through the testing process, which includes labeling of slides with at least two unique identifiers and assuring pertinent information will be a match on the slide, on the Mohs map, and final report. 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)