Bristow Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/12/2021 and 04/13/2021. The findings were reviewed with the laboratory director, laboratory manager, and testing person #1 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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, policies and procedures, obseration, and interview with the laboratory manager and testing person #1, the laboratory failed to ensure an adequate alarm system was in place for the blood bank refrigerator; and failed to ensure blood products were stored under appropriate conditions in the blood bank refrigerator for 3 of 25 thermograph charts. Findings include: ALARM CHECKS (1) On 04/12/2021 at 09:25 am, testing person #1 stated to the surveyor the laboratory routinely maintained 2 units of O negative packed red blood cells and 2 units O positive packed red blood cells of in the Helmer blood bank refrigerator. The units were available for emergency patient transfusions (packed red blood cells must be stored at 1-6 degrees Centigrade-C); (2) The surveyor reviewed the laboratory's written policy for performing alarm checks on the refrigerator. The policy required the alarm checks be performed on a quarterly basis; (3) The surveyor then reviewed the alarm check records for 2019, 2020, and 2021. It was identified that alarm checks were not performed as follows: (a) Between 04/20/2019 and 07/22/2020 (b) Between 07/22/2020 and 02/10/2021 (4) The surveyor reviewed the records with the laboratory manager and testing person #1. Testing person #1 stated on 04/12/2021 at 12:40 pm, 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 alarm checks had not been performed as indicated above. THERMOGRAPH CHARTS (1) On 04/12/2021 at 09:25 am, testing person #1 stated to the surveyor the laboratory routinely maintained 2 units of O negative packed red blood cells and 2 units O positive packed red blood cells of in the Helmer blood bank refrigerator. The units were available for emergency patient transfusions (packed red blood cells must be stored at 1-6 degrees Centigrade-C); (2) On 04/12/2021 at 09:30 am, the surveyor observed the thermograph temperature recorder for the blood bank refrigerator. The refrigerator had a recorder connected to it for continuously recording the temperature on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees Centigrade). Each chart monitored the temperature for a 7 day period; (3) The surveyor reviewed 25 refrigerator charts dated from 04/02/2019 through 08/23/2019 and 12/02/2020 through 01/14/2021. The review indicated that 3 of 25 charts had not been changed by the 7th day of usage. The findings include: (a) Chart #7 - The chart was put into use on 05/14/19 and removed on 05/22/19 (8 days); (b) Chart #18 - The chart was put into use on 07/31/2019 and removed 08/08/2021(8 days); (c) Chart #20 - The chart was put into use on 08/15/2021 and removed 08/23/2021 (8 days). (4) The surveyor reviewed the charts with the laboratory manager and technical consultant #2. Testing person #1 stated on 04/12/2021 at 12:30 pm the charts had not been changed by the 7th day of usage as indicated 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 laboratory manager and testing person #1, the laboratory failed to review and evaluate proficiency testing results for 2 of 11 events. Findings include: FAILURES (1) On 04/12/2021, the surveyor reviewed 2019, 2020, and 2021 proficiency testing records and identified the following failure: (a) Second 2019 Hematology Event (i) Blood Cell Identification - The laboratory failed the results for 1 of 5 samples (BCI-10); (2) The surveyor could not locate evidence in the records proving the failure had been addressed; (3) The surveyor reviewed the records with the laboratory manager and testing person #1, and asked if

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 specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for the analyte Prothrombin Time (PT) Refer to D2128 and D2130. 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 -- D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or 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 unacceptable analyte or 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 the analyte Prothrombin Time (PT). Findings include: (1) The laboratory failed to achieve satisfactory performance on the second event in 2018 and the third event in 2018. Refer to D2130. NOTE: The only acceptable