Tyler County Hospital Laboratory

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted 8/27/2024 and 08/28/2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 laboratory verification studies, laboratory reference ranges, and confirmed in interview, the laboratory failed to verify reference ranges for two of two new analyzers put into use in January 2023, the Sysmex XN-10 hematology analyzer and the Vitros 5600 Chemistry analyzer, before reporting patient test results. The findings included: 1. Review of the laboratory test and instrument menu listed the following two new analyzers and their implementation dates: A. The Vitros 5600 Chemistry analyzer, put into use January 2023 B. The Sysmex XN-10 Hematology analyzer, put into use January 2023 A. 1. Review of the "Vitros System Verification", signed by the laboratory director January 22, 2023, binder did not include a reference range verification for patient testing. A. 2. Review of laboratory policy and patient final reports included the following reference range (RR) for the chemistry analytes glucose, potassium, sodium, Carbon dioxide (CO2), calcium, chloride, alkaline phosphatase (ALP), and aspartate aminotransferase (AST): Analyte: Policy RR [Final Report RR] Glucose: 74 - 106 [75 - 115] md/dL Potassium: 3.5 - 5.1 [ 3.5 - 5.0] mmol /L Sodium: 137 - 145 [135 - 147] mmol/L CO2: 22 - 30 [24 - 32] mmol/L Calcium: 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 -- 8.4 - 10.2 [8.4 - 10.7] mg/dL Chloride: 98 - 107 [95 - 108] mmol/L ALP: 38 - 126 [40 - 170] U/L AST: 15 - 46 [9 - 34] U/L B 1. Review of the Application Manual for the Sysmex XN-10 hematology analyzer introductions included the following instruction: "It is the customer's responsibility to perform additional studies, following the requirements of their accrediting agency: The following protocols are provided: ... Reference Range Verification." B 2. Review of the laboratory verification studies did not include a reference range verification. Surveyor asked for the study to verify that the laboratory's reference was appropriate on the new Sysmex XN-10 hematology analyzer and none was provided. B 3. Review of patient final reports included the following reference range on the patient final report: Analyte [Reference range] WBC [5.0-10.0 K/uL] RBC [4.20 - 6.20 M/uL] Hemoglobin [12.0 - 16.0 g/dL] Hematocrit [37.0 - 47.0%] MCV [82.0 - 92.0 fL] MCH [27.0 - 31.0 pg] MCHC [32.0 - 40.0g/dL] Platelets [140 - 440 K/uL] RDW [11.5 - 14.5 %] %Neutrophils [37.0 - 90%] % Lymphocytes [10 - 50%] %Monocytes [0.0 - 12.0%] %Eosinophils [0.0 - 3.0%] % Basophils [0.0 - 2.0%] %Immature Granulocytes [0 -5%] 2. Surveyor asked for a laboratory policy to outline new instrument implementation procedures, and none was provided. 3. In an interview on 8/27/2024 at 14:15 hours, in the office, the general supervisor confirmed that a reference range verification had not been performed on the Vitros 5600 chemistry analyzer or the Sysmex XN-10 hematology analyzer. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the instrument maintenance activities list, maintenance records, and confirmed in interview, the laboratory failed to perform monthly maintenance on the Vitros 5600 chemistry analyzer for two of seven months reviewed from January 2024 to July 2024. The findings included: 1. Review of the periodic maintenance activity list on the Vitros 5600 chemistry system included the following 11 tasks to be performed monthly: M1: Clean VersaTip Supply M2: Inspect/Clean Supply 3 Pack Opener M3: Inspect/Clean uIA Reagent Supply Top Cover M4: Clean Cuvette Arm M5: Clean Cuvette Incubator M6: Clean PM Discard Chute M7: Clean PM Incubator Slot and Insert Blade Channels M8: Clean/Replace PM Evaporation Caps M9: Clean MicroSensor Cover and Ring Area M10: Inspect/Clean Reagent Cooler filter M11: Perform System Backup 2. Review of the "Periodic Maintenance - Review Log" for January to July 2024 included the following two months where monthly maintenance was not performed: May 2024 July 2024 3. In an interview on 8/28/2024 at 16:20 hours, in the laboratory, the general supervisor confirmed that the monthly maintenance for May and July 2024 had not been performed. 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) -- 2 of 3 -- The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, blood bank quality control (QC) records, laboratory policy, patient test worksheets, and confirmed in interview, the laboratory failed to include a negative control for nine of nine reagents used in patient ABORh blood grouping and indirect Coombs antibody detection for records reviewed from January 2024 to July 2024. The findings included: 1. Review of the laboratory policy titled "Blood Bank Policy #1121"; section "Quality Control" stated the following: "1. Each day of testing a known positive and negative must be tested. For indirect coombs use a known positive and negative antibody samples with appropriate red cells. Reactivity must be present only in the positive sample." 2. Review of the blood bank worksheets titled "ORTHO Confidence System Blood Bank Quality Control Record" from January to July 2024 included the following nine reagents used in ABORh blood grouping and antibody detection without a negative control: Ortho A/B/D and Reverse Grouping Card containing wells with Anti-A, Anti-B, Anti-D A1 Cell and B Cell suspension for reverse ABO grouping Screen cell 1 (SC1) and screen cell 2 (SC2) for indirect Coombs antibody detection 3. Review of patient test records included the following 39 patients with ABORh blood grouping and antibody detection tested on days where a negative QC was not performed: Date Patient MRN 01/01/2024 10122284-17427 01/02/2024 10122314-2092 01/13/2024 10122754-36494 01/16 /2024 10122754-36494 01/20/2024 10122961-72840 01/26/2024 10123167-11918 01 /27/2024 10123169-71416, 10123201-13382 02/02/2024 10123410-813 02/06/2024 10123410-813 02/07/2024 10123561-75866 03/01/2024 10124332-9681 03/04/2024 10124442-18248 03/06/2024 10124519-2092 03/10/2024 10124639-24207, 10124645-26731 03/25/2024 10125115-3585 04/01/2024 10125338-2092, 10125368- 813 04/07/2024 10125574-25834 04/08/2024 10125586-36494 04/16/2024 10125887- 26826 04/28/2024 10126307-56231 05/07/2024 10126555-2092 05/08/2024 10126608-11228 05/22/2024 10127042-84977 05/23/2024 10127090-82544 06/05 /2024 10127469-85051 06/07/2024 10127514-43969 06/08/2024 10127567-85064 06 /12/2024 10127627-67434 06/19/2024 10127958-813 06/25/2024 10128138-85169 07 /18/2024 10128860-30112 07/22/2024 10128952-75800 07/25/2024 10129099-82315, 10129068-813 07/28/2024 10129164-36494 07/29/2024 10129161-85343 4. In an interview on 8/28/2024 at 10:35 AM, in the office, the general supervisor confirmed that a negative QC had not been performed for ABORh blood grouping and antibody detection. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An onsite survey conducted October 4th and 5th, 2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on a review of hospital policy, patient transfusion records, and confirmed in interview, the laboratory failed to have a system in place to identify and document communication breakdowns for the identification and notification of suspected transfusion reactions for three of five random patients selected that met hospital transfusion reaction signs and symptoms from May to September 2022. The findings include: 1. Review of the Tyler County Hospital Policy/Procedure titled "Blood Administration", page three, had the following signs and symptoms (s/s) of a transfusion reaction a patient may exhibit while receiving blood product: "7. Watch for s/s of transfusion reactions which may include: 1. Elevation of temperature more than 2 degrees above baseline 2. Flank pain (pain in the lumbar area) 3. Nausea /vomiting 4. Unexplained oozing of blood at operative site 5. Unexplained blood in urine 6. Tachycardia or bracycardia (change in 10-15% from baseline) 7. Unexplained fall in blood pressure or rise in blood pressure (change in 10-15% from baseline) 8. Chills 9. Itching of skin 10. Hives 11. Edematous of skin vesicles 12. Edema of larynx 13. Shortness of breath, wheezing 14. Cyanosis 15. Symptoms of shock 2. A complete list of 29 patients transfused with blood products from May to September 2022 was provided and five random patient records were selected for review. The following three patients met the criteria for a transfusion reaction with no documentation of notification. Patient 10102345 Transfused 6/16/2022 Unit Number: W036522047214 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Pre-Transfusion (baseline) Blood Pressure (BP) at 21:25: 106/65 BP at 23:55: 134/62 Percent change from baseline: 26.4% increase decrease in systolic pressure Patient 10102797 Transfused: 6/24/2022 Unit Number: W036522038441 Pre-transfusion BP at 17:25: 159/65 BP at 20:45: 135/50 Percent change from baseline: 15.1% / 23.1% decrease in systolic/diastolic pressure Transfused: 6/25/2022 Unit Number: W036522037870 Pre -transfusion BP at 09:20: 147/56 BP at 12:50: 124/54 Percent change from baseline: 15.6% decrease in systolic pressure Patient 10104521 Transfused 8/14/2022 Unit Number: W036522073188 Pre-transfusion BP at 20:35: 170/84 BP at 8/15/2022, 00:09: 124/76 Percent change from baseline of 27% decrease in systolic pressure Transfused 8/16/2022 Unit Number: W036522060630 Pre- transfusion Blood Pressure (BP) at 10:15: 149/79 BP at 13:55: 100/61 Percent change from baseline: 32.8% / 22.8% decrease in systolic/diastolic pressure Surveyor queried on 10/4/2022 at 16:00, in the office, as to why the above instances weren't marked as a potential transfusion reaction by the observing nurse, and the laboratory or provider wasn't notified. The hospital nursing administrator stated that all the values above were normal patient values and wouldn't trigger an investigation. 3. In an interview on 10/4/2022 at 16:05, in the office, the laboratory manager stated that the laboratory had not participated in the transfusion record review of patients to identify and clarify communication issues for the identification and notification of suspected transfusion reactions Calculation: Percent Change: ((V2 - V1) / |V1|) x100 V2: Value 2 V1: Value 1 |V1|: Absolute value of V1 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 a review of laboratory policy, laboratory records, the Center for Medicare and Medicaid Services (CMS) form 116, and confirmed in an interview, the laboratory failed to perform calibration verification of three of three chemistry electrolytes on the Beckman Coulter DXc chemistry analyzer every six since it was last performed on November 2, 2021. The findings include: 1. Review of the laboratory policy titled "Chemistry Quality Control Program", section XVI "Linearity -- 2 of 4 -- Protocol" stated: "Analyzer Measurement Range verification is validated by three point calibration. This must be done every six months using analyte specific calibrators." 2. Review of the linearity documents had the following three chemistry electrolyte ranges confirmed by calibration verification on November 2nd, 2021. NA - Sodium CL - Chloride K -Potassium Surveyor queried for the calibration verification documents for May 2022, six months after the November 2021 calibration verification, and none was provided. 3. Review of the CMS form 116, section VII. "Non-Waived Testing" listed an estimated annual volume for the specialty Chemistry at 77,021. 4. In an interview on 10/5/2022 at 11:40 hours, in the office, the laboratory manager confirmed that calibration verification had not been performed for the above chemistry electrolytes since November 2021. 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: I. Based on a review of laboratory policy and procedure, laboratory documents, and confirmed in interview, the laboratory failed to perform and document monthly blood bank alarm checks for nine of nine months reviewed from January to September 2022. The findings include: 1. Review of the laboratory procedure titled "Blood Bank Alarm System, Temperature Check, Blood Bank Refrigerator Failure", stated: "Monthly, an alarm check will be performed, checking for low alarm, below 1.5*C and a high alarm above 5.6*C Documentation of this check is also on the monthly log, ER personnel will respond and it must be documented." 2. Review of the "Daily Blood Bank Temperature Charts" from January 2022 to September 2022 did not include the documentation for the alarm check at the bottom of the form. 3. In an interview on 10 /5/2022 at 10:50 hours, in the office, the laboratory manager confirmed that the alarm checks had not been performed, or documented, from January to September 2022. II. Based on a review of laboratory policy, blood bank temperature charts, and confirmed in interview, the laboratory failed to change the seven-day temperature monitoring chart every seven days for four out of twelve weeks reviewed in November 2021, April 2022, and September 2022. The findings include" 1. Review of the laboratory procedure titled "Blood Bank Alarm System, Temperature Check, Blood Bank Refrigerator Failure", stated: "A seven-day temperature monitor system is connected to the refrigerator, maintaining a temperature between 2* - 6*C (Celsius)." In an interview with the laboratory manager, it was clarified that the wheel charts were changed weekly by the night shift tech. 2. Review of the blood bank seven-day temperature monitoring wheels for November 2021, April 2022, and September 2022 had the following time frames where there was an overlap of seven days of continuous monitoring. "On 11/18/2021 at 0200 - Off 12/2/2021 at 0200" - Elapsed time 14 days. "On 04/07/2022 at 0200 - Off 04/15/2022 at 0200" - Elapsed time 8 days. "On 9/08 /2022 at 0200 - Off 09/15/2022 at 0200" - Elapsed time 8 days. "On 9/22/2022 at 0200 - Off 10/1/2022" - Elapsed time 9 days. 3. In an interview on 10/5/2022 at 11:20 -- 3 of 4 -- hours, in the office, the laboratory manager confirmed that the blood bank continuous monitoring wheel charts had not been changed after the seven-day period for the above instances. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the laboratory American Proficiency Institute (API) proficiency testing records from 2020 and 2021, and confirmed in interview, the laboratory failed to document remedial action for PT failures for the analytes: Total Bilirubin for 2 of 5 testing events and CKMB for 1 of 5 testing events reviewed. Findings were: 1. Review of the 2020 and 2021 API proficiency testing records revealed the laboratory failed to attain an 80% for the the following analytes: Total Bilirubin and CKMB. 2020 Chemistry Core 3rd event Total Bilirubin 20% CKMB 60% 2021 Chemistry Core 3rd event Total Bilirubin 40% 2. Review of the laboratory

Summary Statement of Deficiencies D2109 TOXICOLOGY CFR(s): 493.845(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2019 during a desk review subsequent to the survey on 03-20- 2019, confirmed by staff interview, the laboratory failed to attain a score of at least 80 percent acceptable analyte responses for toxicology testing. Findings: 1. An individual laboratory profile update run on 03-28-2019 revealed PT scores of 60 percent for analytes digoxin and acetaminophen in the first testing event of 2019. 2. An API performance summary was retrieved for the event showing the following: Analyte: digoxin Sample Reported Expected Score CH-01 1.0 0.6-1.1 Acceptable CH-02 2.9 9.6-16.1 Acceptable CH-03 2.3 1.4-2.2 Unacceptable CH-04 0.9 0.4-0.9 Acceptable CH-05 1.7 1.0-1.6 Unacceptable Analyte: acetaminophen Sample Reported Expected Score CH-01 6.5 0.0-6.3 Unaceptable CH-02 158.9 126.9-165.9 Acceptable CH-03 93.9 76.6-100.8 Acceptable CH-04 6.0 2.1-10.8 Acceptable CH-05 60.9 39.2-54.9 Unacceptable 3. In a telephone interview from the site on 04-09-2019 at 0900 CDT, the general supervisor (CMS form 209) confirmed the API scores. 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 --