Cedar County Memorial Hospital

Summary Statement of Deficiencies 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 D0000 A recertification survey was completed on September 19, 2022. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1441 Condition: Laboratory Director 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 review of the Bio-Rad Liquichek Immunoassay Plus Control package insert, review of the Bio-Rad Liquichek Cardiac Markers Plus Control LT package insert, review of the Bio-Rad Liquid Unassayed Multiqual Control package insert, review of laboratory temperature logs, observation of chemistry refrigerator, review of the performance verification procedures for the Sysmex XN-350 hematology analyzer, review of calibration records for the Ortho Diagnostics Vitros 5600 chemistry analyzer and iStat blood gas analyzer, review of Sysmex XN-350 hematology analyzer quality control (QC), review of Sysmex XN-L check hematology QC package insert, review of blood gas individualized quality control plan (IQCP), review of 2021/2022 blood gas quality control (QC), review of Ortho Diagnostics Vitros 5600 chemistry analyzer quality control (QC), review of Meditech LIS for blood bank, review of patient history with prior antibodies, review of blood bank procedures, review of blood bank quality control (QC) logs, review of blood bank alarm test logs, lack of blood bank alarm test logs for 2021, review of patient results, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to follow manufacturer's instructions for reagent storage for 38 of 44 days in 2022 (Refer to D5411); the laboratory failed to discard expired chemistry reagents (Refer to D5417); the laboratory failed to verify performance specifications prior to reporting patient test results (Refer to D5421); the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range (Refer to D5439); the laboratory failed to ensure hematology QC detects immediate errors that occur (Refer to D5441); the laboratory failed to ensure the IQCP was followed for 11 of 21 months (Refer to D5445); the laboratory failed to include two control materials of different concentrations for alkaline phosphatase, cholesterol and alanine transaminase (ALT) for 20 of 135 patient testing days (Refer to D5447); the laboratory failed to establish criteria for acceptability of control materials providing quantitative results (Refer to D5469); the laboratory failed to ensure patients with prior antibodies were checked before compatibility testing occurred and failed to document quality control for three patient testing days in 2022 (Refer to D5551); and the laboratory failed to perform refrigerator alarm checks according to the laboratory's established procedure (Refer to D5555). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation of chemistry freezer, review of the Bio-Rad Liquichek Immunoassay Plus Control package insert, Bio-Rad Liquichek Cardiac Markers Plus Control LT package insert, Bio-Rad Liquid Unassayed Multiqual Control package insert, laboratory temperature logs, and interview with the general supervisor (GS) #1, the laboratory failed to follow manufacturer's instructions for reagent storage for 38 of 44 days in 2022. Findings: 1. Observation of the chemistry freezer showed Bio-Rad Liquichek Immunoassay Plus controls, Bio-Rad Liquichek Cardiac Markers Plus controls and Bio-Rad Liquid Unassayed Multiqual controls stored in freezer. 2. Review of the Bio-Rad Liquichek Immunoassay Plus Control package insert states, "Storage and stability: This product will be stable until the expiration date when stored unopened at -20C to -70C." 3. Review of the Bio-Rad Liquichek Cardiac Markers Plus Control LT package insert states, "Storage and stability: This product will be stable until the expiration date when stored unopened at -20C to -70C." 4. Review of the Bio-Rad Liquid Unassayed Multiqual Control package insert states, "Storage and stability: This product will be stable until the expiration date when stored unopened at -20C to -70C." 5. Review of laboratory temperature logs for August to date September 2022 showed the laboratory freezer digital temperature was not within acceptable range for 14 for 44 days and the inside freezer temperature was not within acceptable range for 38 of 44 days. 6. Interview with the GS #1 on September 13, 2022 at 2:30 PM, confirmed the laboratory failed to follow manufacturer's instructions for reagent storage. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 2 of 10 -- CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the chemistry refrigerator and interview with the general supervisor (GS) #1, the laboratory failed to discard expired chemistry reagents. Findings: 1. Observation of the chemistry refrigerator showed: Two boxes of Vitros NT-proBNP range verifier lot #1780, expiration date August 11, 2022 still in use. One box of Vitros CKMB range verifier lot # 0438, expiration date August 6, 2022 still in use. 2. Interview with the GS #1 on September 13, 2022 at 1:15 PM confirmed the laboratory failed to discard expired chemistry reagents. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the performance verification procedures for the Sysmex XN-350 hematology analyzer and interview with the general supervisor (GS) #1, the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance specifications for the Sysmex XN-350 hematology analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: red blood cell (RBC), hemoglobin, hematocrit, platelet, white blood cell (WBC) and differential prior to the beginning of patient testing in February 2022. 2. Review of patient results from February 2022 to date September 13, 2022 showed 2637 complete blood count (CBC) patient results were reported. 3. Interview with the GS #1 on September 13, 2022 at 2:30 PM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. 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 -- 3 of 10 -- 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 2021 to date September 13, 2022 calibration records for the Ortho Diagnostics Vitros 5600 chemistry analyzer, iStat blood gas analyzer and interview with the general supervisor (GS) #1, the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range. Findings: 1. Review of the Vitros 5600 calibration records for 2021 through February 2022 showed no calibration every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for the analytes: sodium, potassium and chloride. 2. Review of the iStat blood gas calibration records for June 2021 showed no calibration that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for the analytes: pH, pCO2 and pO2. 3. Interview with the GS #1 on September 13, 2022 at 2:00 PM confirmed the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for sodium, potassium, chloride, pH, pCO2 and pO2. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Sysmex XN350 hematology analyzer quality control (QC), Sysmex XN-L check hematology QC package insert, and interview with the general supervisor (GS) #1, the laboratory failed to ensure hematology QC detects immediate errors that occur. Findings: 1. Review of Sysmex XN350 showed a new lot # of QC started on September 12, 2022 with ranges that do not match the package insert. -- 4 of 10 -- Review of Sysmex XN350 QC ranges showed: Level 1 WBC 0..00-4.80 RBC 0.00- 4.45 HGB 0.0-10.8 HCT 0.0-31.6 MCV 0.0-138.6 PLT 0-90 Level 2 WBC 0.00-13.76 RBC 0.00-8.62 HGB 0.0-25.6 HCT 0.0-72 MCV 0.0-167.0 PLT 0-472 Level 3 WBC 0.00-32.82 RBC 0.00-10.44 HGB 0.0-33.6 HCT 0.0-92.0 MCV 0.0-176.2 PLT 0-1200 2. Review of Sysmex XN-L Check hematology control package insert showed: Level 1; WBC 2.07-2.80 RBC 2.18-2.41 HGB 5.2-5.7 HCT 14.7-16.9 MCV 64.9-73.2 PLT 35-82 Level 2: WBC 6.40-7.82 RBC 4,21-4.56 HGB 12.5-13.6 HCT 34.3-38.6 MCV 78.1-88.1 PLT 202-285 Level 3: WBC 15.30-18.32 RBC 5.11-5.54 HGB 16.3-17.7 HCT 43.6-49.2 MCV 82.0-92.4 PLT 511-650 3. Interview with GS #1 on September 13, 2022 at 11:00 AM, confirmed the laboratory failed to ensure hematology QC detects immediate errors that occur. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the blood gas individualized quality control plan (IQCP), review of 2021/2022 blood gas quality control (QC), and interview with the general supervisor (GS) #1, the laboratory failed to ensure the IQCP was followed for 11 of 21 months. Findings: 1. Review of the blood gas IQCP states "Two levels of QC will be analyzed monthly." 2. Review of 2021 blood gas QC showed no monthly QC was performed in January, February, March, April, May, June, July, September, October, November and December for the analytes PH, PO2, and PCO2. 3. Interview with the GS #1 on September 13, 2022 at 11:00 AM confirmed the laboratory failed to perform monthly QC for blood gases. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Ortho Diagnostics Vitros 5600 chemistry analyzer quality control (QC) from May 1, 2022 to date September 13, 2022, patient results, and interview with the general supervisor (GS) #1, the laboratory failed to include two control materials of different concentrations for alkaline phosphatase (ALP), cholesterol, and alanine transaminase (ALT) for 20 of 135 patient testing days. Findings: 1. Review of Ortho Diagnostics Vitros 5600 chemistry analyzer QC results -- 5 of 10 -- from May 1, 2022 to date September 13, 2022 showed two acceptable levels of ALP QC were not performed on August 8, 2022, August 22, 2022, July 3, 2022, July 2, 2022, June 19, 2022, June 13, 2022, June 4, 2022, May 14, 2022, May 5, 2022 and May 3, 2022. 2. Review of patient results showed the laboratory reported 80 ALP patients while QC was not acceptable. 3. Review of Ortho Diagnostics Vitros 5600 chemistry analyzer QC results from May 1, 2022 to date September 13, 2022 showed two acceptable levels of cholesterol QC were not performed on May 19, 2022, May 18, 2022, May 14, 2022 and May 1, 2022. 4. Review of patient results showed the laboratory reported 5 cholesterol patients while QC was not acceptable. 5. Review of Ortho Diagnostics Vitros 5600 chemistry analyzer QC results from May 1, 2022 to date September 13, 2022 showed two acceptable levels of ALT QC were not performed on August 29, 2022, June 27, 2022, June 26, 2022, June 25, 2022, June 20, 2022, and May 8, 2022. 6. Review of patient results showed the laboratory reported 52 ALT patients while QC was not acceptable. 7. Interview with the GS #1 on September 13, 2022 at 2:30 PM confirmed the laboratory failed to include two control materials each day of patient testing for ALP, cholesterol and ALT each day of patient testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on interview with testing personnel (TP) #2, review of Ortho Diagnostics Vitros 5600 quality control (QC) records, and interview with the general supervisor (GS) #1, the laboratory failed to establish criteria for acceptability of control materials providing quantitative results for 43 of 43 analytes. Findings: 1. Interview with TP #2 confirmed the laboratory uses Bio-Rad unassayed multiqual quality control (QC), Bio- Rad Liquichek Cardiac Markers Plus Control LT QC, and Bio-Rad Liquichek Diabetes Control QC for their Vitros 5600. The laboratory did not have copies of QC package inserts. TP #2 and GS #2 did not know how Vitros 5600 QC ranges were established. 2. Review of the Ortho Diagnostics Vitros 5600 QC records showed the laboratory did not establish and define statistical parameter criteria (mean and standard deviations) for acceptability of quantitative QC results reported on the chemistry analyzer for the analytes: aspartate aminotransferase, alanine aminotransferase, albumin, alkaline phosphate, alcohol, acetaminophen, amylase, beta HCG quantitative, calcium, carbamazepine, cholesterol, chloride, creatinine, creatinine kinase, creatinine kinase MB, digixon, direct bilirubin, direct high density lipoprotein, enzymatic CO2, free thyroxine, gentamicin, glucose, lactate, lipase, low density lipoprotein, magnesium, myoglobin, NT-proB-type natriuretic peptide, -- 6 of 10 -- phosphorus, potassium, prostate specific antigen, phenytoin, salicylate, sodium, thyroid stimulating hormone, total bilirubin, total protein, triglyceride, troponin, urea, uric acid, vancomycin and valproic acid. From January 2021 to date September 13, 2022, the laboratory performed 371,500 patient chemistry tests. 3.Interview with the GS #1 on September 13, 2022 at 1:00 PM, confirmed the laboratory failed to establish criteria for acceptability of chemistry control materials providing quantitative results. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (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 interview with testing personnel (TP) #4, review of Meditech LIS for blood bank, patient history with prior antibodies files, and interview with the general supervisor (GS) #1, the laboratory failed to ensure patients with prior antibodies were checked before compatibility testing was performed. Findings: 1. Interview with TP #4 stated before compatibility testing is performed patient history is checked in Meditech LIS system. 2. Review of the Meditech LIS system showed laboratory starting using the Meditech LIS system in 2018. 3. Review of the patient history in a paper file located in blood bank showed four patients with prior antibodies from 2014 to present September 13, 2022. No patient history could be provided previous to July 30, 2014. From January 2021 to date September 13, 2022 the laboratory performed 148 blood bank patients. 4. Review of the Community Blood Center of the Ozarks antibody consultation report showed one of four patient's were not entered into the Meditech LIS system. The patient from "7-13-14" had a "Warm auto-immune antibody" and was not entered into the Meditech LIS system. 5. Interview with the TP #4 and GS #1 on August 13, 2022 at 10:30 AM confirmed the laboratory failed to ensure patients with prior antibodies were checked before compatibility testing was performed. 44735 Based on review of blood bank procedures, blood bank patient logs, blood bank quality control (QC) logs, and interview with the general supervisor (GS) #1, the laboratory failed to document quality control (QC) for three patient testing days in 2022. Findings: 1. Review of the laboratory's blood bank policy "Quality Control Policies" states, "QC- Reagent QC must be performed on each day of use." 2. Review of 2022 blood bank patient testing logs showed patient testing was performed on January 22, 2022, May 7, 2022 and July 9, 2022. 3. Review of 2022 blood bank QC logs show no documented QC on January 22, 2022, May 7, 2022 and July 9, 2022. 4. Review of blood bank patient logs showed three units of blood were transfused to patients while blood bank QC was not documented. 5. Interview with the GS #1 on September 13, 2022 at 2:30 PM, confirmed the laboratory failed to document quality control for three patient testing days in 2022. D5555 IMMUNOHEMATOLOGY -- 7 of 10 -- 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 expected refrigerator temperature range, blood bank refrigerator continuous temperature monitoring by a recording thermograph, and interview with the general supervisor (GS) #1, the laboratory failed to accurately monitor the blood bank refrigerator temperature for 14 of 21 months. Findings: 1. Review of blood bank refrigerator acceptable temperature ranges showed acceptable ranges as 2 degrees Celsius to 6 degrees Celsius. 2. Review of blood bank refrigerator continuous temperature monitoring by a recording thermograph showed a continuous temperature reading of "10" for August 2021 to date September 13, 2022. 3. Interview with the GS #1 on September 13, 2022 at 11:00 AM confirmed the laboratory failed to accurately monitor the blood bank refrigerator. 44735 Based on review of the blood bank procedures, blood bank alarm test log, lack of blood bank alarm test logs for 2021, and interview with the general supervisor (GS) #1, the laboratory failed to perform refrigerator alarm checks according to the laboratory's established procedure. Findings: 1. Review of blood bank procedure "Blood Bank Refrigerator Alarm Testing" states, "To check the high activation temperature: (5.5 degree Celsius)." 2. Review of blood bank alarm test log showed in quarter 1 of 2022 on January 22, 2022, the refrigerator starting temperature was 6 degrees Celsius and the refrigerator high alarm when it sounded at the nurse's station was 5.5 degrees Celsius. 3. Review of blood bank procedure "Blood Bank Refrigerator Alarm Testing" states, "Both the high and low activation temperatures are checked and documented at least on a quarterly basis using the Blood Bank Refrigerator Alarm Verification Form." 4. The laboratory did not have documentation for quarterly refrigerator alarm inspections during 2021. 5. Interview with the GS #1 on September 13, 2022 at 2:30 PM confirmed, the laboratory failed to perform blood bank refrigerator alarm inspections according to the laboratory's established procedure. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of blood bank quality control (QC), blood bank antibody history check, Vitros 5600 chemistry analyzer QC, iSTAT blood gas analyzer QC, Sysmex XN-350 hematology QC, freezer temperatures, observation of reagents, Sysmex XN- 350 performance verification, chemistry and blood gas calibration verification, blood bank alarm checks, blood bank refrigerator temperature and interviews, the laboratory director (LD) failed to provide overall management and direction of the laboratory. The LD failed to ensure the overall operation of the laboratory was appropriate for -- 8 of 10 -- reporting accurate results (Refer to D6079); the LD failed to ensure the laboratory maintained acceptable levels of analytical performance (Refer to D6095). D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of blood bank quality control (QC), blood bank antibody history check, Vitros 5600 chemistry analyzer QC, iSTAT blood gas analyzer QC, Sysmex XN-350 hematology QC, freezer temperatures, observation of reagents, Sysmex XN- 350 performance verification, chemistry and blood gas calibration verification, blood bank alarm checks, blood bank refrigerator temperature and interview with the general supervisor (GS) #1, the laboratory director (LD) failed to ensure the overall operation of the laboratory was appropriate for reporting accurate results. Findings: 1. Review laboratory QC showed the LD failed to ensure QC was performed appropriately for blood bank, chemistry, blood gases and hematology (Refer to D5551, D5469, D5447, D5445 and D5441). 2. Review of temperatures logs and reagents showed the LD failed to ensure freezer temperatures were within acceptable limits and reagents were not used past expiration (Refer to D5411 and D5417). 3. Review of Sysmex XN-350 showed the LD failed to ensure performance verification was acceptable before patient testing started (Refer to D5421). 4. Review of chemistry and blood gas calibration verification showed the LD failed to ensure calibration verification was performed every six months (Refer to D5439). 5. Review of blood bank alarm checks and temperature logs showed the LD failed to ensure blood bank refrigerator alarm checks and temperature were documented appropriately (Refer to D5555). 6. Interview with GS #1 on September 13, 2022 at 2:30 PM confirmed the laboratory director (LD) failed to ensure the overall operation of the laboratory was appropriate for reporting accurate results. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on review of blood bank quality control (QC), blood bank antibody history check, Vitros 5600 chemistry analyzer QC, iSTAT blood gas analyzer QC, Sysmex XN-350 hematology QC and interview with the general supervisor (GS) #1, the laboratory director (LD) failed to ensure the laboratory maintained acceptable levels -- 9 of 10 -- of analytical performance. Findings: 1. Review of blood bank patient logs showed three units of blood were transfused to patients while blood bank QC was not documented on January 22, 2022, May 7, 2022 and July 9, 2022 (Refer to D5551). 2. Review blood bank history check and Community Blood Center of the Ozarks antibody consultation report showed one of four patient's were not entered into the medi-tech LIS system. The patient from "7-13-14" had a "Warm auto-immune antibody" and was not entered into the medi-tech LIS system. No patient history could be provided previous to July 30, 2014. From January 2021 to date September 13, 2022 the laboratory performed 148 blood bank patients (Refer to D5551). 3. Review of Ortho Diagnostics Vitros 5600 quality control (QC) record showed the laboratory failed to establish criteria for acceptability of control materials providing quantitative results for 43 of 43 analytes (Refer to D5469). 4. Review of Ortho Diagnostics Vitros 5600 quality control (QC) record showed the laboratory failed to include two control materials of different concentrations for alkaline phosphatase, cholesterol and alanine transaminase (ALT) for 20 of 135 patient testing days (Refer to D5447). 5. Review of 2021 blood gas QC showed no monthly QC was performed in January, February, March, April, May, June, July, September, October, November and December for the analytes PH, PO2 and PCO2 (Refer to D5445). 6. Review of Sysmex XN-350 hematology analyzer QC showed hematology ranges failed to ensure hematology QC detects immediate errors that occur. (Refer to D5441) 7. Interview with GS #1 on September 13, 2022 at 11:00 AM confirmed the LD failed to ensure the laboratory maintained acceptable levels of analytical performance.. -- 10 of 10 --

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 review of 2018, 2019 and 2020 blood gas quality control (QC) records and interview with testing personnel #6, the laboratory failed to retain blood gas QC for at least 2 years. Findings: 1. Review of blood gas QC showed no documentation of blood gas QC from January 2018 to November 2018. 2. Interview with testing personnel #6 on October 14, 2020 at 11:00 AM confirmed the laboratory failed to retain blood gas QC for at least 2 years. 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 review of ACL Elite analyzer, Vitros 5600 chemistry analyzer and the i-Stat blood gas analyzer, the laboratory failed to verify normal patient range (Refer to D5411), failed to follow manufacturer's instructions (Refer to D5415), failed to 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 -- perform preventative maintenance (Refer to D5429), failed to perform calibration (Refer to D5439) and failed to perform instrument comparisons (Refer to D5775). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 product insert, lack of documentation of normal patient Protime mean study and interview with testing personal (TP) #1 the laboratory failed to verify normal patient Protime mean study. Findings: 1. Review of manufacturer's product insert for HemosiL reagent states "each laboratory should verify its own normal range for Protime, international normailized ratio (INR) results." 2. No documentation was available to show the laboratory performed a normal patient Protime mean study. 3. Interview with TP #1 on October 14, 2020 at 0930 AM confirmed the laboratory did not have documentation proving they verified the normal patient Protime result used in conjunction with the international standard index to calculate INR. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of manufacturer's product insert, procedure manual and interview with testing personal (TP) #1, the laboratory failed to follow manufacturer's storage requirements for HemosIL controls. Findings: 1. Review of manufacturer's product insert stated "HemosIL controls after reconstitution, are stable for 8 hours at 2-8 degrees Celsius in the original vial." 2. Procedure manual stated "reconstituted controls in original vials are stable for 8 hours when stored at 2-8 degrees Celsius." Observation revealed two controls aliquoted and stored in the freezer. 3. Interview with TP #1 October 14, 2020 at 9:30 AM confirmed the laboratory was aliquoting controls after reconstitution and freezing for later use. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on manufacturer's preventive maintenance (PM) procedure, lack of PM documentation and interview with the general supervisor (GS) the laboratory failed to perform PM procedures for blood bank cell washer for years 2018, 2019 and 2020. Findings: 1. Review of manufacturer's PM procedure checks included, "daily inspect tubing and conections, inspect interior bowl, check saline fill volume, weekly flush tubing with a 1:10 solution of household bleach, clean the rotor and solenoid plunger and three months check motor speed.". 2. No documentation was available for PM checks for years 2018, 2019 and 2020, 3. Interview with the GS October 14, 2020 at 9: 40 AM the laboratory failed to follow manufacturer's PM procedures for daily, weekly, and three month intervals in 2018, 2019 and 2020. 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 calibration records for the Vitros 5600 analyzer, i-Stat analyzer and interview with the general supervisor #1, the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value and a maximum value near the upper limit to verify the laboratory's reportable range. Findings: 1. Review of the Vitros 5600 calibration records for 2018 and to date October 14, 2020 for the analyte hemoglobin A1C showed the laboratory failed to perform calibration verification which included at least a minimal value, a mid-point value and a maximum value near the upper limit at least once every six months. 2. Review of the i-Stat blood gas analyzer calibration records for 2018 to date October 14, 2020 for the analytes: pH, pCO2 and pO2 showed the laboratory failed to perform calibration verification which included at least a minimal value, a mid-point value and a maximum value near the upper limit at least once every six months. 2. Interview with general supervisor #1 on October 14, 2020 at 11:30 AM confirmed the laboratory failed to perform calibration verification procedure for hemoglobin A1C and blood gases at least once every six months. -- 3 of 6 -- D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of lack of i-Stat instrument comparison's in 2018, 2019 and interview with the general supervisor #1, the laboratory failed to evaluate and define the relationship between analyzers performing blood gases twice a year. Findings: 1. Review of 2018 and 2019 i-Stat instrument comparison's for analytes: pH, pCO2 and pO2 showed the laboratory failed to evaluate and define the relationship between two i-Stat analyzers twice a year. 2. Interview with the general supervisor #1 on October 14, 2020 at 12:15 PM confirmed, the laboratory failed to evaluate and define the relationship between two i-Stat analyzers twice a year. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of i-Stat blood gas analyzer, Immunohematology the laboratory director failed to verify i-stat verification (Refer to D6086), failed to review proficiency testing results (Refer to D6091), failed to ensure blood bank quality control (Refer to D6093) and failed to ensure i-Stat competencies (Refer to D6103). D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of blood gas i-Stat verification and interview with general supervisor (GS) #1, the laboratory director failed to perform reportable range of the test results for i-Stat blood gases and failed to verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. Findings: 1. Review of the i-Stat verification from June 2018 showed no verification of reportable range of the test results for the i-Stat and no verification of the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population for analytes; pH, pCO2 and pO2. 2. Interview with the GS #1 on October 14, 2020 at 11:30 AM confirmed the laboratory director failed to ensure verification procedures were adequate for the i-Stat blood gas analyzer. -- 4 of 6 -- D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and patient records for 2017 and interview with the general supervisor, the laboratory failed to verify the accuracy of the Leuko-EZ Vue test at least twice annually. Findings: 1. Review of PT records for 2017 revealed the laboratory did not verify the accuracy of the moderately complex Leuko-EZ Vue test (a marker for fecal leukocytes and indicator of intestinal inflammation) at least twice annually for 2017. 2. Review of patient records for 2017 revealed the laboratory performed the Leuko-EZ Vue test on seven patients. 3. Interview with the general supervisor on May 1, 2018 at 2:00 PM confirmed the laboratory failed to verify the accuracy of the Leuko-EZ Vue test at least twice annually during 2017. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, documentation of freezer temperatures and observation of quality control (QC) material stored in the freezer revealed, and interview with the general supervisor, the laboratory failed to follow the manufacturer's instructions for storage of control material for 6 of 121 testing days since January 1, 2018 through May 1, 2018. Findings: 1. Review of the manufacturer's instructions for Bio-Rad liquid unassayed Multiqual control showed controls must be stored at minus 20 degrees Celsius (C) to minus 70 degrees C. 2. Review of the laboratory's temperature chart showed a defined acceptable range of minus 18 degree C or below. 6 of 121 testing days failed to meet the manufacturer's required minus 20 to minus 70 degree C range. 3. Observation of the laboratory freezer showed 2 boxes of Bio-Rad Multiqual unassayed control level I(lot# 47971)control currently in use in the laboratory. 4. Interview with the general supervisor on May 1, 2018 at 11:00 AM confirmed the laboratory failed to properly monitor the freezer and store QC materials per manufacturer's instructions. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of coagulation plasma calibration materials on May 1, 2018 and interview with the general supervisor, the laboratory failed to ensure four of four boxes of calibration materials did not exceed the expiration date. Findings: 1. Observation of four boxes of Hemosil (coagulation) plasma calibration materials, lot number N0154106, revealed an expiration date of January 2018 and were available for use. 2. Interview with the general supervisor on May 1, 2018 at 10:00 AM confirmed the calibration materials expired and were available for coagulation calibration procedures. 38475 Based on observation of chemistry calibration reagents and interview with the general supervisor the laboratory failed to ensure that all calibrators in use had not exceeded their expiration date. Findings: 1. Observation of Vitros chemistry liquid performance verifier showed level 1 lot # 170929 expired 9/29 /17 and level 11 lot # 170930 expired 9/29/17 and were still available for use. 2. Interview with the general supervisor on May 1, 2018 at 11:30 AM confirmed the laboratory failed to ensure that all calibrators in use had not exceeded their expiration date. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient test reports, laboratory procedure manuals and interview with the general supervisor, the laboratory failed to ensure pertinent normal values as determined by the laboratory were available for interpretation. Three of three selected -- 2 of 3 -- patient test reports generated by the laboratory information system on May 1, 2018 revealed differences between normal values for BUN and urine microscopic white blood cells (WBC) included on test reports and those stated in the approved procedure manual Findings: 1. The differences between BUN and urine microscopic (WBC) normal values included on patient test reports and those included in the procedure manual approved by the director are as follows: Normal values included on patient test reports: Blood Urea Nitrogen (BUN) 7-25 mg/dl (male/female) Urine Microscopic : 3-5 WBC / HPF Normal values included in the approved chemistry and urinalysis procedure manual: BUN 9-20 mg/dl (male) BUN 7-17 mg/dl (female) Urine Microscopic : 0-5 WBC / HPF 2. Interview with the general supervisor on May 1, 2018 at 2:00 PM confirmed the normal values determined by the laboratory and approved by the laboratory director differed from those included on the test reports. -- 3 of 3 --