Russell Regional Hospital

Summary Statement of Deficiencies 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 review of the laboratory's policy and procedure manuals, quality control documentation, patient test records and final test reports, instrument maintenance and function check documentation, transfusion records, quality assessment documentation and Allegation of Compliance (AOC) from the survey conducted on 09 September 2018 the laboratory failed to meet the immunohematology requirements by following written policies and procedures to monitor, assess and when indicated, correct problems identified in the analytic systems as specified in standard D5791. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of Quality Assurance (QA) procedures, the lack of available QA documents, and interview with General Supervisor GS#1 and Laboratory Director reveal that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems 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 -- identified in the analytic systems for 16 out of 24 months from January 2019 - December 2020. The findings include: Findings: 1. The "2018 Quality Management Plan" policy approved by the Laboratory Director on 09/18/2018 states under 3. Monthly Monitors section 3( e)" Blood Bank ( iv) Monthly review by Laboratory Director. Also the Allegation of Compliance for Survey performed on 09/11/2018 under D6079 Laboratory Director Responsibilities section 4 stated "The Laboratory Director will make monthly visits to the laboratory to review all QA activities, blood bank records, and ensure all necessary

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 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 review of the laboratory's blood gas instrument printouts and electronic medical record (EMR) final test reports, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299. Findings Include: 1. The laboratory failed to have an adequate manual or electronic system(s) in place that ensured blood gas test results and other patient-specific data were accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination. (Refer to D5801, Item 2) 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: The cumulative deficient practices identified under the specialty of Immunohematology have been determined to constitute an Immediate Jeopardy. Based on review of the laboratory's policy and procedure manuals, quality control documentation, patient test records and final test reports, temperature monitoring documentation, emergency release documentation, manufacturer's package insert Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 20 -- instructions, and interview with General Supervisor (GS) #1, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1271, and 493. 1281 through 493.1299. Findings Include: 1. The laboratory failed to ensure the written procedure for immunohematology length of crossmatch testing was followed by laboratory personnel. (Refer to D5401, Item 1) 2. The laboratory failed to ensure the written procedure for immunohematology pretransfusion testing for recipients was followed by laboratory personnel. (Refer to D5401, Item 2) 3. The laboratory failed to ensure the written procedure for immunohematology compatibility (crossmatch) testing was followed by laboratory personnel. (Refer to D5401, Item 3) 4. The laboratory failed to ensure that immunohematology testing was 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. (Refer to D5411) 5. The laboratory failed to ensure that immunohematology reagents and solutions were not used when they had exceeded their expiration date. (Refer to D5417) 6. The laboratory failed to perform quality control each day of patient testing for the immunohematology test procedures that produce graded or titered results. (Refer to D5451) 7. The laboratory failed to ensure that results of immunohematology control materials met the laboratory's test system criteria for acceptability before reporting patient test results. (Refer to D5481) 8. The laboratory failed to determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents and unknown serum with known A1 and B red cells, for confirmation of ABO group. (Refer to D5551, Item 1) 9. The laboratory failed to determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents and unknown serum with known A1 and B red cells, for confirmation of ABO group. (Refer to D5551, Item 2) 10. The laboratory failed to store immunohematology blood and blood products under appropriate conditions that include an adequate temperature alarm system. (Refer to D5555, Item 1) 11. The laboratory failed to document all immunohematology control procedures performed. (Refer to D5559) 12. The laboratory failed to have immunohematology