Hemphill County Hospital Laboratory

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on October 3, 2025, the laboratory was found to be out of compliance based on the following condition level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6076 - 42 C.F.R 493.1441 Condition: Laboratory Director, High complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute 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 -- (API) Proficiency testing (PT) records, the laboratory failed to achieve successful performance in two of three consecutive testing events in 2024 and 2025, resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) Proficiency testing (PT) testing records for 2024 and 2025, the laboratory failed to achieve an overall testing event score of satisfactory performance (100%) for two of three consecutive testing events for immunohematology compatibility testing. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for immunohematology compatibility PT: Event, Analyte/Test: Score 2025 Event 2, Compatibility Testing: 0% 2024 Event 3, Compatibility Testing: 80% 2. A desk review of API proficiency testing records for 2024 and 2025 confirmed that the laboratory received an immunohematology compatibility testing score of 0% for 2025 event 2, and 80% for 2024 event 3. 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) Proficiency testing (PT) testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program in immunohematology, compatibility testing for two of three events reviewed in 2024 and 2025. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Proficiency Institute (API) Proficiency testing (PT) proficiency testing records, the laboratory director -- 2 of 3 -- failed to ensure successful participation in a HHS approved proficiency testing program for immunohematology compatibility testing for two of three reviewed in 2024 and 2025. Refer to D2181. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on March 4, 2024. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 laboratory calibration records, laboratory policy, and confirmed in interview, the laboratory failed to ensure calibration verification occurred at least every 6 months of D-Dimer testing on the Sysmex CA600 coagulation analyzer for one of two years of records reviewed in 2023 and 2024. The findings included: 1. Review of laboratory D-Dimer calibration records included the last calibration date, for D-Dimer, on 6/8/2024. Surveyor asked for the calibration records for December 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 -- 2024, and none was provided. 2. Review of the laboratory policy titled "Siemens Innovance d-Dimer", section VIII "Calibration" did not include instructions for calibration verification at least once every six months. 3. In an interview on 3/4/2025 at 13:40 hours, in the office, the general supervisor (GS) confirmed that D-Dimer calibration had not been performed every 6 months in 2024. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on a review of laboratory quality control (QC) records, laboratory reagent instructions for use (IFU), laboratory policy, patient test report, and confirmed in interview the laboratory failed to ensure negative QC reactivity for three of eight blood bank reagents use for patient red cell ABO typing, and patient undetected antibody testing, for records reviewed from June 2024 to December 2024. The findings included: 1. Review of laboratory blood bank quality control records from June 2024 to December 2024 included the following reagents without a negative QC reactivity: Reagent, test use: Anti-A, used in ABO determination of patient red cells. Anti-B, used in ABO determination of patient red cells. Screen Cell I, used in the detection of unexpected antibodies in patient serum. Screen Cell II, used in the detection of unexpected antibodies in patient serum. Surveyor asked for documentation that negative reactivity was ensured for all blood bank reagents and none could be provided. 2. Review reagent IFU included the following information: 2. a. Blood Grouping Reagent: Anti - A, section "Quality Control" "Quality control of reagents is essential and should be performed on each day of use in accordance with local, state and federal regulations. For ABO blood grouping reagents, appropriate antigen positive and negative red blood cells should be used." 2.b. Blood Grouping Reagent: Anti-B, section "Quality Control" "Quality control of reagents is essential and should be performed on each day of use in accordance with local, state and federal regulations. For ABO blood grouping reagents, appropriate antigen positive and negative red blood cells should be used." 2.c. "Reagent Red Blood Cells For the Detection of Unexpected Antibodies", section "Quality Control": "Quality control of reagents is essential and should be performed on each day of use in accordance with local, state and federal regulations." 3. Review of laboratory policy did not include instructions for to ensure negative reactivity was achieved for blood bank reagents used in patient ABO types and unexpected antibody screens. 4. Review of patient test records from June 2024 to December 2024 included the following 10 patients with ABO red cell typing and unexpected antibody testing bank testing performed: Date: Patient MRN 06/12/2024: 2151315 08/22/2024: 2166853, 2158045 10/11/2024: 2159245 10/20/2024: 2158720 11/08/2024: 2152426 11/29/2024: 2154726 12/16 /2024: 2150643 12/18/2024: 2153218, 2150643 5. In an interview on 3/4/2025 at 15: 00 hours, in the office, the general supervisor confirmed that blood bank QC did not include a negative reactivity for Anti-A, Anti-B, Antibody Screen Cell 1, and Antibody Screen Cell 2. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an unannounced complaint investigation, the laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780. Complaint TX22012215 was unsubstantiated, unrelated deficiencies cited. D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on observation, and interview, the laboratory failed to recap specimens with the original specimen cap or new cap to minimize contamination for 11 of 11 specimens observed on 12/13/2023. Findings follow. Surveyor observed testing personnel #3 on 12/13/2023 at 1010 place the caps of the tubes being analyzed onto the shelf of the analyzer in no particular order: 5 SST, 4 green top, and 2 purple top caps. Interview with testing personnel #3 on December 13, 2023 at 1010 when asked how she knows which lids belong to which tube on the analyzer stated she did not know. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Based on review of the manufacturer instructions, daily checks, and interview, the laboratory failed to retain the documentation of the daily checks on the Beckman Coulter DxH 560 for 21 out of 71 days reviewed. Findings follow. A. Review of the Beckman Coulter DxH 560 Instructions for Use (PN C48648AA, November 2020) at Chapter 4 Quality Control under Daily Checks stated, "Daily checks starts a series of quality control checks to determine whether the DxH 560 system is running properly. You can review the results of the Daily Checks on the Daily Checks screen. For additional information on performing and reviewing Daily Checks, see Daily Checks in Chapter 3, Startup and Daily Checks." At Chapter 3 Startup and Daily Checks under Viewing Daily Checks History stated, "The Daily Checks Log stores up to 50 Daily Checks results. When the log is full, the oldest daily check data is automatically removed first. The log is: Useful for troubleshooting instrument problems over time Available for reviewing, printing, and exporting." B. Review of the Daily Checks from October 3, 2023 - December 2, 2023 showed daily checks were not retained from 10/03/2023 - 10/30/2023 (21 days). C. Interview with testing personnel #2 on December 12, 2023 at 1530 acknowledged they turned off the printer for the daily checks, the backup file did not store them, and they were only able to go back to October 31, 2023 on the analyzer because it only stores the last 50. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, patient test records, and interview, the laboratory failed to update their CBC (Complete Blood Count) procedure when they changed analyzers to the Beckman Coulter DxH 560 on October 3, 2023 for 71 of 71 days. Findings follow. A. Review of the laboratory's policy and procedures showed the CBC procedure titled Quality Control Program Hematology, 05 /21/2019, was for the Sysmex XS-1000i, the last CBC analyzer. B. Review of patient testing records showed testing using the Beckman Coulter DxH 560 began on October 3, 2023 (elapsed time was 71 days). C. Interview with testing personnel #2 on December 12, 2023 at 1425 acknowledged that was on her "to do" list. 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 verification of performance specification records, patient test -- 2 of 5 -- records, interview, and LIS query, the laboratory failed to verify the performance specifications for the Complete Blood Count (CBC) on the Beckman Coulter DxH 560 for normal reference ranges for 71 of 71 days reviewed. Findings follow. A. Review of the validation for the Beckman Coulter DxH 560 showed no verification of the normal reference range. The normal range study was requested on December 12, 2023 at 1040 but not provided. B. Review of patient testing records showed testing using the Beckman Coulter DxH 560 began on October 3, 2023 (elapsed time was 71 days). C. Interview with testing personnel #2 on December 12, 2023 at 1345 confirmed the normal range study had not been performed, that they had been using the instrument for a couple of months. And added the Beckman Coulter rep mentioned he told the last manager that he needed to do that. D. Review of the LIS query showed approximately 26800 CBCs were performed annually. 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 manufacturer's instructions, laboratory's policy and procedure, quality control results, patient reports, and interview, the laboratory failed to monitor the accuracy and precision of their quality control results that fell outside 3SD (standard deviations) on two of two events reviewed in October 2023 for Carbon Dioxide (CO2) and Triglycerides tested on the Siemens Dimension EXL 200. Findings follow. A. Review of the Siemens Dimension EXL 200 Operator's Guide, 11536909 Rev 01 2021-09, in the Calibration and Quality Control chapter under Rules Field Definitions stated, "All but the first field definition listed below are 'Shewhart Rules' by which the results are examined in several ways to determine if the overall system is in control. When a new rule is selected, the Interval, In and Outs field are updated automatically to reflect the new rule selected. Rule Field Meaning High/low Interval Any result that falls outside the range listed on the QC Ranges screen for that field. any point >2 SD Any result that falls outside +/- 2 SD from the mean. This is termed a "warning" rule and requires further evaluation to judge whether the data presents a problem. any point >3 SD Any result that falls outside +/- 3 SD from the mean. A violation of this rule suggests systematic error. two consecutive >2SD Two consecutive results that fall outside +/- 2SD from the mean. A violation of this rule suggests systematic error. four consecutive >1 SD Four consecutive results that fall outside the +/- 1 SD from the mean. A violation of this rule suggests systematic error. ten consecutive Ten consecutive results above or below the mean. An above/below mean violation of this rule suggests systematic error." B. Review of the laboratory policy titled Quality Control Decisions, revised 11/26/2023, stated, "I. Accept QC/patient results if: A. All controls are within 2 SD. B. One control is less than/equal to 3SD and less than 2 SD when repeated. II. Reject QC -- 3 of 5 -- /Patient results if: A. Two controls are greater than 2 SD B. One control is greater than 3SD. C. One control is greater than 2SD when repeated. III. If QC results are rejected: A. Do not report patient results. B. Begin troubleshooting. a. Repeat analyte (s) b. Repeat analyte(s) with fresh QC material c. Repeat analyte(s) with fresh reagent d. Check for shift/trend i. shift: control is on one side of the mean for 6 consecutive days. ii. Trend: control increases/decreases for 6 consecutive days. e. Check manufacturer established range. f. Check calibration g. Notify Supervisor C. Repeat QC and patient samples." C. Review of the quality control records from October 2023 showed the laboratory routinely ran 2 levels of quality control twice per day, and showed two 3SD failures accepted with the comment "control value is within manufacturer's range": 1. CO2 Level 1 on 10/03/2023 @ 06:47 > 3 SD 2. Triglycerides Level 3 on 10/16/2023 @ 22:22 > 3SD (2SD failure on next control run on 10/17/2023 @ 06:12) The laboratory established its own mean and historical SD, and the laboratory was using two different sets of criteria to verify QC when it compared its QC values to the manufacturer's package insert. D. Patients were reported with 3SD QC failures: CO2 on 10/03/2023 @ 06:47 to 10/03/2023 @ 09:15 Date & time verified MRN 1. 10/03/2023 @ 09:07 2151149 Triglycerides on 10/16 /2023 @ 22:22 to 10/18/2023 @ 08:00 Date & time verified MRN 1. 10/16/2023 @ 10:08 2166758 2. 10/16/2023 @ 13:06 2155238 3. 10/16/2023 @ 14:47 2159425 4. 10 /16/2023 @ 20:29 2162105 5. 10/16/2023 @ 21:57 2163601 6. 10/17/2023 @ 09:14 990240 7. 10/17/2023 @ 09:18 2152199 8. 10/17/2023 @ 09:19 2151240 9. 10/17 /2023 @ 09:27 2163850 10. 10/17/2023 @ 09:41 2151052 11. 10/17/2023 @ 09:51 990478 12. 10/17/2023 @ 11:40 2164733 13. 10/17/2023 @ 16:59 2159077 14. 10/17 /2023 @ 16:59 2162250 15. 10/17/2023 @ 17:00 2159719 E. Interview with testing personnel #2 on December 13, 2023 at 1355 acknowledged the QC should have been repeated, and the comment means the control value was within the ranges on the control package insert. D5781

Summary Statement of Deficiencies D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of the facilities policies, review of patient blood transfusion records, and staff interview, the laboratory failed to ensure nursing staff identified potential transfusion reactions for five of six patients receiving blood transfusions as identified by its policies. The findings included: 1. A review of the laboratory's policy title Blood and Blood Products, Adverse Reaction ( Effective 4/20/2018) found on page one under the heading PROCEDURE: "1. Be constantly alert for the appearance of any type of reactions, which differs from those of the patient's basic disease. Possible symptoms of transfusion complications include but are not limited to: a. Temperature elevation of 1.8 above starting temperature. b. Change in Blood Pressure(BP) of 20 mmHg in systolic or 15 mmHg diastolic... 2. Should a suspected transfusion reaction occur, stop the blood transfusion immediately and change the IV tubing. (Do Not Discard Tubing). 3. Start the 0.9% Normal Saline Slowly. 4. Take Vital Signs and record. 5. Notify the physician and the laboratory. 6. Compare labels, forms and patient identification at the patient's bedside to determine if the transfused component was intended for the recipient. 7. Return the unit of blood to the Lab along with the IV tubing and all crossmatch paperwork. 8. Send first voided specimen to the Lab along with the Transfusion Reaction Report. Obtain another urine specimen 24 hours later. 9. Document all observations and actions taken on Blood Transfusion Record and Nurse's Notes." 2. A sampling of blood transfusion records from 2019, 2020 and 2021 found the following patients whose change in blood pressure (BP) met the laboratory's criteria as a possible transfusion reaction with nursing staff failing to identify it as 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 -- such: a. Patient ID: 2157209 Date: 01/20/2019 - Unit W0910 20 110769 pre initiation of transfusion Vital signs (VS) documented at 13:25 Temp = 37.6, BP 132/70 transfusion started at 13:40 PM BP at 13:40 documented as 110/68 ( Systolic change of 22 ) BP at 13:45 documented as 114/77 BP at 13:50 documented as 137/66 comments: "no problems" (systolic change of 23) BP at 14:05 documented as 156/55 increase to 150 cc BP at 14:20 documented as 137/71 (diastolic change of 16) BP at 14:35 documented as 121/51 (diastolic change of 20) BP at 15:05 documented as 133 /73 comments: "no problems, cont 150 ml/hr" Diastolic change of 22) BP at 15:35 documented as 139/87 BP at 16:05 documented as 144/79 BP at 16:35 documented as 118/61 (systolic change of 26 and diastolic change of 18) POST TRANSFUSION Reaction noted? "NO" Time Completed 16:35 VS 15 min post- trans 118/61 Unit W0910 19 277827 pre initiation of transfusion Vital signs documented at 16:45 Temp 36.9, BP 118/61 transfusion started at 16:50 BP documented as 177/69 Comments "started at 75 cc" (systolic change of 59) BP at 16:55 documented as 125/63 comments "no complications" (systolic change of 22) BP at 17:00 Documented as 149 /65 comments "increased to 125" (systolic change of 24) BP at 17:15 documented as 138/62 BP at 17:30 documented as 120/60 comments " increase to 150" BP at 17:45 documented as 140/63 BP at 18:15 documented as 127/69 BP at 18:45 documented as 154/72 (systolic change of 27) BP at 19:15 documented as 153/75 BP at 19:45 documented as 148/83 POST TRANSFUSION Reaction noted? no response Time completed: no response VS 15 min post - trans: no response b. Patient ID 216436 Date: 05/21 2021 I. Unit W0910 21 214514 pre initiation of transfusion vital signs not documented Transfusion started at 20:25 with BP documented as 151/79 BP at 20:30 documented as 162/79 BP at 20:35 documented as 166/90 BP at 20:50 documented as 153/85 BP at 21:05 documented as 168/83 BP at 21:20 documented as 120/66 (systolic change of 48 and diastolic change of 17) BP at 21:50 documented as 139/87 (diastolic change of 21) BP at 22:20 documented as 151/71 (diastolic change of 16) BP at 22:50 documented as 143/74 BP at 23:00 documented as 137/80 Transfusion completed II. Unit W0910 21 232212 pre initiation of transfusion vital signs documented at 23:00 - Temperature 99.68, BP 137/80 Transfusion start time not documented BP at 23:30 documented as 141/65 (diastolic change of 15) BP at 23:35 documented as 137/68 BP at 23:40 documented as 143/69 BP at 23:55 documented as 133/84 (diastolic change of 15) BP at 0:10 on 05/22/2021 documented as 122/68 (diastolic change of 16) BP at 0:25 documented as 103/55 BP at 0:55 documented as 122/59 BP at 1:45 documented as 119/65 Transfusion complete BP documented at 2: 45 as 111/52 ( 1 hour post transfusion) c. Patient ID 2150943 Date: 05/29/2020 Unit W091020104698 pre initiation of transfusion vital signs documented as Temp 98.6, BP 109/63 on 05/29/2020 at 14:40 BP at 14:50 documented as 116/71 BP at 14:55 documented as 116/71 BP at 15:00 documented as 104/79 BP at 15:15 documented as 109/64 (diastolic change of 15) BP at 15:30 documented as 112/70 (diastolic change of 16) BP at 15:45 documented as 119/70 BP at 16:15 documented as 107/57 BP at 16: 45 documented as 109/64 BP at 17:15 documented as 112/70 BP at 17:45 documented as 119/70 BP at 17:55 documented as 107/57 (transfusion complete) BP at 18:55 documented as 132/72 ( 1 hour post transfusion- systolic change of 25 and diastolic change of 15) d. Patient 2150287 2 units emergency release Date: 09/24/2020 I. Unit W091020161033 pre initiation of transfusion Blood pressure documented as 81/45 at 16:13 transfusion start time documented as 16:42 BP at 16:42 documented as 111/52 (systolic change of 30 BP at 16:49 documented as 105/52 BP at 16:59 documented as 122/50 BP at 17:04 documented as 114/50 II. Unit W091020347732 started at 17:07 BP at 17:10 documented as 118/54 BP at 17:17 documented as 68/56 (systolic change of 20) BP at 17:25 documented as 97/53 BP at 17:30 documented as 98/56 BP at 17: 35 documented as 88/59 BP at 17:40 documented as 97/53 (end of transfusion) e. Patient ID 2151210 Date 04/02/2021 I. Unit W091021184214 pre initiation of -- 2 of 3 -- transfusion blood pressure documented as 107/64 at 11:10 Transfusion start time documented as 12:45 PM BP at 12:45 documented as 111/68 BP at 12:50 documented as 114/66 BP at 12:55 documented as 115/68 BP at 13:10 documented as 115/67 BP at 13:25 documented as 117/69 BP at 13:40 documented as 118/66 BP at 14:10 documented as 112/63 BP at 14:40 documented as 101/58 BP at 14:50 documented as 117/70 BP at 14:55 documented as 103/52 II. Unit W091021185205 started at 15:00 BP at 15:00 documented as 116/68 BP at 15:05 documented as 107/64 BP at 15: 20 documented as 104/62 BP at 15:35 documented as 121/40 (diastolic change of 22) BP at 15:50 documented as 106/63 (diastolic change of 23) BP at 16:20 documented as 106/63 BP at 16:50 documented as 114/63 3. The laboratory was asked to provide documentation of possible transfusion reactions being identified on the listed patients. No additional documentation was provided. 4. An interview with the assistant director of nursing on August 17, 2021 at 2:12 PM after her review of the records - confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 As a result of the CLIA recertification inspection, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of American Proficiency Institute proficiency testing records and 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 -- interview with facility personnel, the laboratory failed to successfully participate in Compatibility Testing for 2 out of 3 testing events in 2017 in Immunohematology. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency test records and interview, the laboratory director failed to ensure the laboratory successfully participated in Compatibility Testing for 2 out of 3 testing events in 2017 in Immunohematology. The findings included: 1. Failure to attain an overall testing event score (in Compatibility testing) of at least 100 percent is unsatisfactory performance. Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. 2. Based on a review of American Proficiency Institute proficiency testing records, the laboratory failed to achieve a score of at least 100 percent on 2 of 3 events in 2017: 2017 - First event score - 80 percent 2017 - Third event score - 80 percent 3. In an interview at 13:20 hours on 3/5/2019 in the laboratory, the General Supervisor confirmed the scores were accurate. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Review of policies and procedures, personnel records and interview of facility personnel found that the laboratory failed to ensure that all policies and procedures had been approved , signed and dated by the current laboratory director. The findings included: 1. Review of policies and procedures in the Coagulation, Hematology and Blood Bank procedure manuals found no documentation of approval by the current laboratory director. The coagulation procedure manual contained 3 policies/ procedures not approved by the current laboratory director. The Blood Bank Manual found 15 of 15 procedures had no documentation of approval by the current laboratory director. The Hematology procedure manual contained 3 procedures without documented approval by the current laboratory director. 2. Review of personnel records found that the current laboratory director was hired November 1, 2018. 3. Interview of the general supervisor conducted on March 5, 2019 at 10:42 AM confirmed the Laboratory Director had not approved the procedures currently in use by testing personnel. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 2 of 6 -- 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 surveyor observations, manufacturer's instructions for use and interview of testing personnel, the laboratory failed to ensure 4 of 12 blood collection tubes had not exceeded the expiration date and were available for patient testing . The findings included: 1. Observations made at 3:21 PM in the phlebotomy area of the laboratory found 4 of 12 Vacuette Sodium Citrate tubes in the tray were expired. 2 Sodium Citrate tubes lot B18013EM Expiration 2019-01-16 2 Sodium Citrate tubes lot B18023HU Expiration 2019-02-07 One Patient specimen collected in Sodium Citrate tube on March 5, 2019 was not expired. 2. Review of the manufacturer's instructions for use found under the heading Vacuette Precautions/ Cautions - "Do not use the tubes after the expiration date." 3. Interview of testing person 2 on the CMS Report 209 Laboratory Personnel Report conducted on March 5, 2019 at 3:27 AM confirmed that expired tubes were available for use but had not been used today. 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: Review of Hematology quality control records, patient test records and interview of facility personnel found that the laboratory failed to test at least two levels of quality control materials on 2 of 69 days between October 11, 2017 and December 17, 2017. The findings included: 1. Review of quality control records found no documentation of quality control materials tested on Thursday, November 2, 2017 and Monday, December 4, 2017. 2. Review of patient test records found 21 patient specimens were tested without quality control materials being tested. November 2, 2017 - 15 patients tested. patient 2157080 patient 2155751 patient 2150584 patient 2150611 patient 2150983 patient 2150611 patient 2153754 patient 2155785 patient 2154741 patient 2150803 patient 2157081 patient 2152810 patient 2154307 patient 2156849 patient 2150974 December 4, 2017 patient 2150139 patient 2150332 patient 2152632 patient 2150440 patient 2156511 patient 2153826 3. Interview of the Technical Consultant conducted on March 5, 2019 at 11:08 AM confirmed the above findings. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: -- 3 of 6 -- Based on a review of the OPTI CCA-TS blood gas analyzer operator's manual, laboratory policy, quality control records, patient test records, and interview with facility personnel, the laboratory failed to test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values each day of patient testing for 5 of 5 patients tested between December 23, 2017 and December 7, 2018. The findings included: 1. Based on review of the Opti-CCA-TS blood gas analyzer operator's manual (PD7202, Rev.B), on page 4-3, the document states the following: "4.5 QC Recommendations Two standard Reference Cassettes (SRC) should be used as a control for the OPTI CCA-TS analyzer. The level 1 and level 3 SRCs represent high and low samples. The SRCs contain a stable optical sensor simulator which is measured by the device in exactly the same manner as any other cassette and provides assurance that all measured parameters by the analyzer are consistent. The results obtained should fall within limits contained in the SRC barcode. NOTE: Hospitals should develop their own policy and procedures on the number of QC samples to be run on a daily basis as mandated by the regulatory agency under which they operate. After receipt of a shipment of cassettes and at monthly intervals thereafter, validation should be performed by analysis of OPTI CHECK or OPTI CHECK PLUS Blood Gas Controls or other equivalent material as recommended by OPTI Medical Systems. These materials should provide target values for pH, PCO2, and all other measured parameters over a range of measurement values typically seen in each testing site laboratory. The results obtained should fall within limits defined by the day-to-day variability as measured in the user's laboratory facility. OPTI Medical recommends the following as a minimum testing frequency of QC materials: Control: SRC level 1 Frequency: At least 1x per day in operation Control: SRC level 3 Frequency: At least 1x per day in operation Control: Opti Check or Opti Check Plus liquid controls Frequency: 1 month intervals and each new shipment of cassettes" 2. Based on review of the laboratory procedure "OPTI CCA", the procedure states the following: "Manufacturer Standard: SRC level 1 and 3/each day of use. Three levels liquid control each month and new cassette shipment. HCH Standard Three levels SRC each day. Three levels liquid control each month and new cassette box. 2 levels SR every 8 hours as needed." This procedure is signed by the previous Lab Director on 4/21 /2015. 2. Based on review of patient records and quality control records: A patient specimen was tested on 9/3/2018. A patient specimen was tested on 5/15/2018. A patient specimen was tested on 5/9/2018. A patient specimen was tested on 5/6/2018. A patient specimen was tested on 12/23/2017. Based on review of function check records and quality control records, the liquid external quality control materials were not performed on 9/3/2018, 5/15/2018, 5/9/2018, 5/6/2018, or 12/23/2017. 3. In an interview with the Laboratory Director on 03/05/2018 at 14:12 hours in the laboratory, the Laboratory Manager stated the laboratory had not implemented an Individualized Quality Control Plan to modify the frequency of testing liquid controls at least one level every 8 hours of patient testing to include both a low and high control each day of patient testing and stated "it has always been acceptable to test the SRC's each day of patient testing." 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