Northwest Mississippi Regional Medical Center

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: Based on review of manufacturer's instructions for ASI Rapid Plasma Reagin (RPR) test for syphilis, RPR Worklists from 1/2/2025 through 4/7/2025, and observation of the RPR carbon antigen stored in a dropping bottle on 5/8/2025 at 1:45 p.m., the laboratory failed to follow manufacturer's instructions for RPR testing for 41 of 41 testing days, when needle cleaning was not documented and the 30-day expiration date of carbon antigen, stored in a dropping bottle, was not recorded. Findings include: 1. Manufacturer's instructions for ASI Rapid Plasma Reagin (RPR) test for syphilis state, "Carbon Antigen may be stored for up to one month in the dropping bottle at 2 - 8 degrees Celsius. In this case, the needle must be cleaned at the end of each shift, using a syringe or pipet." 2. Review of RPR Worklists from 1/2/2025 through 4/7/2025 revealed 135 patient RPR tests were performed on 41 days during this time frame, with no documentation of needle cleaning after each day of use. 3. Observation of the RPR carbon antigen stored in a dropping bottle in the laboratory refrigerator on 5/8/2025 at 1:45 p.m. revealed no documentation of when the carbon antigen was placed in the dropping bottle, to determine if the 30-day stability of the carbon antigen was exceeded. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using 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 -- 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 the Radiometer ABL 80 Flex blood gas analyzer records including quality control, maintenance, and calibration verification records from 5/3/2023 through 5/4/2025 and confirmation with the Laboratory Manager and Testing Personnel #3 (as listed on the Centers for Medicare and Medicaid Services 209 Personnel form) the laboratory failed to document as performed one of three calibration verification/linearity on the Radiometer ABL 80 blood gas analyzer every six months for pCO2, pH, pO2, HbsO2, O2Hb, CoHb and MetHb. Findings include: 1. Calibration verification is required every six months on any assay which is calibrated with less than 3 levels of calibration material. 2. Review of the calibration verification/linearity performed since 5/3/23, revealed calibration verification/linearity had been performed on the Radiometer ABL 80 Flex blood gas analyzer (SN-316393) on 10/29/2023 and on 11/9/2024. 3. In an interview with the Lab Manager and TP #3 on 5/8/2025 at 1:00 p.m., it was confirmed when the 2nd Radiometer ABL 80 was taken out of commission, the calibration verification on the remaining blood gas analyzer (SN-316393) was overlooked. One of three calibration verification/linearity were not performed on the Radiometer ABL 80 (SN-316393) since the last survey. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for Drugs of Abuse testing from 3/27 /2023 until 5/3/2023, test counts from the electronic medical record (EMR) system, and interview with TP#1 and TP#3 as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form on 5/3/2023 at 11:00 a.m., the laboratory failed to include a positive and negative control on 34 of 38 days of patient testing for the Bio-Rad TOX/See Drug Screen test cassette kit. Findings include: 1. Review of the QC logs for Drugs of Abuse testing revealed positive and negative external quality control samples were performed monthly on the moderate complexity Bio-Rad TOX/See Drug Screen or with each new lot number of the test kit. 2. Testing categorized as moderate complexity requires two levels of QC on each day of patient testing in the absence of an Individualized Quality Control Plan (IQCP). 3. There was no IQCP for the Bio-Rad TOX/See Drug Screen available for review on the day of survey. 4. TP #1 and #3 confirmed in an interview at 11:00 a.m. on 5/3/2023 that testing personnel were not performing two levels of external QC (positive and negative) each day of patient testing for drugs of abuse with the moderate complexity Bio-Rad TOX/See Drug Screen kit. 5. Review of the Bio-Rad TOX/See Drug Screen QC log from 3/27/2023 through 5/3/2023 revealed QC was not performed on 34 of 38 days when patients were tested and reported for drugs of abuse. 6. A review of the test counts from the EMR indicated 118 patient results were reported on the days when no QC was performed. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 review of Emergency Blood Release Forms from 4/18/21 through 10/11/21, the Blood Bank Procedure Manual, and the patient's electronic medical record, the laboratory failed to follow its policy for notifying the patient's physician when incompatibility was detected for a unit of PRBC after transfusion to Patient #0000072647. Findings Include: Review of the Blood Bank Procedure Manual revealed the "Emergency Transfusion" policy states after a unit is released for emergency transfusion, "Begin compatibility tests and complete them promptly. If incompatibility is detected, the patient's physician should be notified." Review of Emergency Blood Release Forms from 4/18/21 through 10/11/21 revealed Unit #W2024-21-243815-00 was released for Patient #0000072647 for emergency transfusion on 5/13/21. Review of the patient's electronic medical record revealed the unit of PRBC was transfused to Patient #0000072647 on 5/13/21. Review of the compatibility testing for Unit #W2024-21-243815-00 in the electronic medical record of Patient #0000072647 revealed this unit was reported as incompatible when compatibility testing was completed. There was no documentation available to indicate the patient's physician was notified of the incompatibility of this unit of PRBC. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: I. Based on review of blood bank maintenance logs from 3/1/21 through 10/26/21 and confirmation by Testing Personnel #1 listed on the Center for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to document as performed the Quarterly Alarm and Calibration check and the 9 volt battery check for the Helmer Platelet Incubator from 3/1/21 through 10/26/21. Findings include: Review of blood bank maintenance logs from 3/1/21 through 10/26/21 revealed the maintenance log form for the Helmer Platelet Incubator included a quarterly alarm and calibration check and 9 volt battery check. There was no documentation of performance of this quarterly maintenance available for review on 10/27/21, the day of the survey. Testing Personnel #1 confirmed the quarterly maintenance was not documented as performed. 38948 II. Based on surveyor review of chemistry preventative maintenance records from 3-1-21 through 10-28-21 and interview with the General Supervisor and Testing Personnel # 6 listed on the Center for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to document as performed the daily, monthly and as needed maintenance for the Advanced Instruments Osmometer Model 3250 with the frequency specified by the manufacturer. Findings include: Review of the Advanced Instruments Osmometer Model 3250 maintenance logs revealed the following maintenance procedures were not documented as performed from 3-1-21 through 10-28-21: Daily 1. Perform reading on Clinitrol 290 standard 2. Check heat- transfer fluid reservoir Monthly 1. Clean air filters 2. Check air vents As Needed 1. Wipe exterior of analyzer 2. Replace fuse The General Supervisor and Testing Personnel # 6 confirmed the preventative maintenance was not documented as performed. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: 1. Based on review of blood bank maintenance records from 3/1/21 through 10/26/21, the Blood Bank Procedure manual, and confirmation by Testing Personnel #5 listed on the CMS 209 personnel form, the laboratory failed to perform blood distribution in accordance with 21 CFR Part 640.11(b). The laboratory failed to document a visual inspection of the inventory of units of packed red blood cells (PRBC) during storage from 3/1/21 through 10/26/21. Findings include: Review of blood bank maintenance records from 3/1/21 through 10/26/21 revealed no documentation of a visual inspection of the laboratory's inventory of units of PRBC during storage from 3/1/21 through 10/26/21. Testing Personnel #5 confirmed there was no documentation of a visual inspection of units of PRBC during storage during this time frame. Review of the Blood Bank Procedure Manual revealed the "Inspection of Blood Prior to Transfusion" policy states, "All units shall be inspected daily and the notation made -- 2 of 3 -- on the donor card." 2. Based on review of Emergency Blood Release Forms from 4/18 /21 through 10/11/21 and the patient's electronic medical record, the laboratory failed to perform blood distribution in accordance with 21 CFR Part 606.160(b)(3)(v). The laboratory failed to obtain the signature of the requesting physician on the Emergency Blood Release Forms for 2 units of PRBC transfused to Patient #0000179077 on 9/4 /21. Findings include: Review of Emergency Blood Release Forms from 4/18/21 through 10/11/21 revealed the Emergency Blood Release Forms for PRBC Units #W2040-21-287409-00 and #W2024-21-257640-00 did not include the signature of the requesting physician. Review of the patient's electronic medical record revealed these two units were transfused to Patient #0000179077 on 9/4/21. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of