Billings Clinic Broadwater

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. This STANDARD is not met as evidenced by: Based on a record review, and interview with the Technical Supervisor (TS) #1, the laboratory failed to follow their policy and procedure and retain two years of quality control (QC) records for the ABL80 FLEX CO-OX blood gas analyzer from May 15, 2022, to July 23, 2023. Findings: 1. A review of the "Record Retention" policy and procedure and request for quality control records revealed the laboratory failed to follow their procedure to retain two years of ABL80 FLEX CO-OX quality control records from May 15, 2022, to July 23, 2023. 2. Based off the test volume sheet, 24 blood gas patient tests were performed from April 30, 2023, to April 30, 2024 (12 months). 3. An interview with TS #1 on May 15, 2024, at 3:35 PM confirmed that the laboratory did not retain two years of blood gas QC records from May 15, 2022, to July 23, 2023. D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) In addition, the laboratory must retain immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b) (3)(iv), (b)(3)(v), and (d). This STANDARD is not met as evidenced by: Based on a record review and interview with Technical Supervisor (TS) #1, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- laboratory failed to follow their procedures and retain ten years of blood bank temperature records and visual checks of blood bank inventory from January 1, 2023, to March 31, 2023. Findings: 1. A review of the policy and procedure for "Record Retention" and "Blood Bank Quality Assurance" revealed the laboratory failed to follow their procedures to retain ten years of their "Daily Checklist/Temperature Log" containing blood bank-related temperature logs and visual checks of blood bank inventory from January 1, 2023, to March 31, 2023. 2. An interview with TS #1 on May 15, 2024, at 12:34 PM confirmed two units of O-negative were maintained in inventory. 3. An interview with TS #1 on May 15, 2024, at 12:35 PM confirmed that the laboratory was missing Daily Checklist/Temperature Logs for the months of January, February, and March of 2023. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a record review of immunohematology and the laboratory's policy and procedure, the laboratory failed to have a step-by-step procedure for the review of historical blood bank patient data (refer to D5401); failed to complete their blood bank quality control (QC) records in their entirety for three out of four records (refer D5551); and failed to perform and document quarterly alarm checks for two of the four quarters in 2023, as well as record high and low temperature alarm activation in 2022 (refer to D5555). D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a record review of chemistry and hematology, and the laboratory's policy and procedure, the laboratory failed to include in their policy and procedure the reference intervals (normal values) for complete blood counts (refer to D5403); failed to follow the manufacturer's instructions to update the coagulation instrument with the new lot of Dade Innovin Reagent's International Sensitivity Index (ISI) value and the new calculated mean normal prothrombin time (refer to D5411); and failed to verify lipase and C-reactive protein (CRP) normal reference ranges (refer to D5421). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the -- 2 of 6 -- 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 blood bank logs, the laboratory's policy and procedure, and an interview with the technical supervisor (TS) #1, the laboratory failed to have a step-by- step procedure for the review of historical blood bank patient data from May 15, 2022, to May 15, 2024. Findings: 1. No policy and procedure for checking historical blood bank patient data was available for review at the time of the survey. 2. An interview with TS #1 on May 15, 2024, at 1:05 PM confirmed the laboratory failed to have a step-by-step procedure for the review of historical blood bank testing results from May 15, 2022, to May 15, 2024. 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 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 review of Immunohematology records, procedure, and interview with Technical Supervisor (TS) #1, the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood products and of returned/reissued blood products not used for transfusion from January 1, 2020 to May 18, 2022. Findings: 1. Review of Blood Product Receiving and Distribution Log revealed "Date Rec'd; Rec'd Temp" column with no temperature recorded. 2. Immunohematology records lacked documentation of temperatures of blood products reissued to the laboratory from January 1, 2020 to May 18, 2022. 3. Review of Manual Blood Bank Procedures revealed, "To ensure that all regional hospital blood banks receive blood products that are of the highest quality and safe for transfusion, the American Red Cross requires all of its Blood Centers to monitor the temperature of blood products shipped to participating hospitals". 4. Interview with TS #1 on May 18, 2022 at 12:30 PM, confirmed the laboratory failed to ensure the temperature is documented upon receipt of new shipments of blood products and returned/reissued blood products not used for transfusion from January 1, 2020 to May 18, 2022 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) 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 -- 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 coagulation record review, procedure, and interview with Technical Supervisor (TS) #1 and #2, the laboratory failed to establish and follow written policies and procedures for accessioning of prothrombin time (PT) and international normalized ratio (INR) test requests and collection of the appropriate specimen for 8 out of 27 patients in June, July, and August of 2021. Findings: 1. Review of Coagulation (Sysmex CA 600) patient results report (#21-208-0580) revealed PT/INR results were verified and released on 7/27/2021 at 6:25AM 2. Review of the Sysmex CA-600 Operator's Maintenance checklist revealed no testing was performed on 7/27 /2021. 3. Review of CoaguCheck Patient Log revealed the following patients' orders for the Sysmex CA 600 were incorrectly performed on the CoaguCheck: a. On 6/16 /2021 patient accession #21-167-1958 and #21-167-1910 b. On 7/27/2021 patient accession #21-208-2164 and #21-208-0580 c. On 7/25/2021 patient accession #21- 206-0465 d. On 7/23/2021 patient accession #21-204-2956 and #21-204-0632 e. On 8 /7/2021 patient accession #21-219-0600 4. Review of Sysmex Instructions for use CA 600 series revealed, "5.10 Prepare Plasma. 1) Add 1 part of 3.8%, 3.2% or 3.13% sodium citrate solution as anticoagulant to 9 parts of venous blood , and mix the contents thoroughly." 5. Review of CoaguCheck XS PT Test package insert revealed, "Limitations of procedure: The CoaguChek XS PT Test uses only fresh capillary or non-anticoagulated venous whole blood. Plasma or serum cannot be used." 6. No policy and procedure for coagulation ordering instructions was available for review at the time of the survey. 7. Interview with the TS #1 and TS #2 on May 18, 2022, at 3: 40 PM confirmed these findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review, procedures, and interview with Technical Supervisor (TS) # 1 and # 2, the laboratory failed to establish and follow written policies and procedures for its review of its quality assurance program from January 1, 2021 to May 18, 2022. Findings: 1. Review of Quality Assurance Program procedure revealed, "Quality Control Assessment, a) Problems identified during evaluation of calibration and control data for each test method." 2. Review of CoaguCheck Patient log lacked quality control assessment review by technical supervisor or laboratory director for June, July, August, November and December of 2021. 3. Review of Coagulation Worksheet PT PTT lacked quality control assessment review by technical supervisor or laboratory director for October, November and December of 2021. 4. No

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 4/23/18, deficiencies were cited for Broadwater Health Center in Townsend, MT. D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory technical supervisor failed to evaluate and document annual competency assessments of two of three testing personnel. The findings include: 1. A review on 4/23/18 at 10:30 a.m. of the Broadwater Health Center Laboratory competency assessments for staff members A and B lacked assessments for 2016 and 2017. 2. A review on 4/23/18 at 3:25 p.m. of the Broadwater Health Center Laboratory Competency Assessment policy included that "all staff performing CLIA moderate and complex testing must be evaluated for knowledge, skills and behaviors of performance after initial orientation training. Evaluation is done semi-annually in the first year, annually after the first year and any time a method or instrument changes prior to reporting results." 3. On 4/23/18 at 3:25 p.m., staff member A stated the competency assessments were not kept up. 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 --