Noxubee General Critical Access Hospital

Summary Statement of Deficiencies 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: Based on review of chemistry laboratory records from 03/01/2022 through 11/30/2022 and confirmation with the laboratory manager/technical consultant LM/TC and testing personnel (TP) #6 at 1:00 p.m. on 11/30/2022, the laboratory failed to perform calibration verification on the Ortho Vitros 5600 chemistry analyzer every 6 months for LDL (low density lipoprotein), TIBC (total iron binding capacity), Vitamin B12 and Vitamin D. Findings include: 1. Review of Ortho Vitros 5600 calibration 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 -- verification records revealed that LDL, TIBC, Vitamin B12 and Vitamin D assays are calibrated with a 2 point calibrator. 2. Calibration verification is required on any assay which is calibrated with less than 3 calibration materials. 3. No documentation of calibration verification was available for review since 11/17/2021. 4. The LM/TC and TP #6 confirmed in an interview at 1:00 p.m. on 11/30/2022 that LDL, TIBC, Vitamin B12 and Vitamin D calibration verifications were not performed every 6 months in 2022. The last calibration was performed on 11/17/2021. -- 2 of 2 --

Summary Statement of Deficiencies D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of moderate and high complexity laboratory testing records from 7/2 /18 through 1/13/21, the technical consultant failed to document review of the records listed below. Findings Include: 1. Review of the laboratory records from 7/2/20 through 1/13/21 revealed the following records were not documented as reviewed by the technical consultant: a. Sysmex CA 600 coagulation quality control (QC) and calibration records b. Vitros 5600 QC, calibration, calibration verification and maintenance records c. Temperature records (room, refrigerators, freezers) d. Sysmex KN 430 hematology QC, calibration and maintenance records e. OSOM HCG serum pregnancy test kit QC records. 2. Interview with the technical consultant at 5:30 pm on 1/13/21 confirmed there was no documented review of the records. 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 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: Based on review of blood bank refrigerator continuous-monitoring temperature recorder graphs, blood bank refrigerator temperature logs, and blood bank transfusion records from 10-6-16 through 8-9-18, the laboratory failed to ensure blood was stored under appropriate conditions from 9-12-17 through 11-13-17, when blood was stored for transfusion. Findings include: Review of blood bank refrigerator continuous- monitoring temperature recorder graphs from 10-10-16 through 9-24-18 revealed no temperature recorder graphs from 9-12-17 through 11-13-17. Review of blood bank refrigerator temperature logs from 9-12-17 through 11-13-17 revealed the temperature of the blood bank refrigerator was manually recorded on the logs only once per day, which does not ensure continuous storage under appropriate conditions. Review of blood bank transfusion records revealed blood was stored for transfusion during this time frame. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in 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 -- facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the Transfusion Service Testing Record and blood bank reagent quality control (QC) records from 10-6-16 through 8-9-18, the laboratory failed to document performance of quality control for the reagents used for ABO grouping, Rh typing, antibody detection, and compatibility testing for two days during this time frame, when testing was performed on three patients with a total of four units of packed red blood cells (PRBC) issued for transfusion. Findings include: Review of the Transfusion Service Testing Record and blood bank reagent QC records from 10-6-16 through 8-9-18 revealed that quality control for the blood bank reagents was not documented, as performed, on the following days when ABO grouping, Rh typing, antibody detection (Ab screen), and compatibility testing was performed on three patients: 4-6-18--ABO/Rh, Ab screen, and compatibility testing performed on Patient #8667 for one unit of PRBC transfused on 4-6-18; ABO/Rh, Ab screen, and compatibility testing performed on Patient #6610 for one unit of PRBC transfused on 4-6-18. 4-11-18--ABO/Rh, Ab screen, and compatibility testing performed on Patient #6610 for two units of PRBC transfused on 4-11-18. -- 2 of 2 --