Dallas County Medical Center

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the CMS-209 forms, review of proficiency test attestations for 2022 and 2023, and interviews with laboratory staff, proficiency test samples were not tested by all personnel who routinely perform patient testing. Survey findings include: A. The CMS-209 forms signed 11/14/24 included three full time testing personnel (listed as Employees #11 through #13) for blood gases. B. A review of proficiency test attestations for 2023 through 2024 revealed that only one testing personnel had signed proficiency attestation statements for all blood gas testing 2023 and 2024. C. In an interview, at 2:48 pm on 11/20/24, laboratory Employee #11 (as listed on the form CMS-209) confirmed that employees 12 and 13 (as listed on the CMS-209 form) routinely test patient samples but have not participated in proficiency testing. D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Through a review of Rules for Critical Access Hospitals in Arkansas (rev 6/17/24), blood bank records for 2023 and 2024, lack of documentation and through interviews with staff, it was determined the facility failed to comply with Arkansas state 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 -- requirements for a blood utilization committee. Survey and document all transfusion activities. Findings follow: A) The Rules for Critical Access Hospitals in Arkansas state in Chapter 19 (Laboratory) that a committee of the Medical Staff shall fulfill the following responsibilities: Establish criteria for the proper use of blood and its components; Monitor the transfusion of blood and its components to ensure the established criteria for proper use are met; Review the reports of suspected transfusion reactions; and Establish criteria for therapeutic phlebotomies. B) Review of the blood bank records contained statistical information regarding numbers of types of products and number of reported "adverse reactions" only. C) In an interview on 11/20/24 at 12: 37 pm the General Supervisor #1 (as listed on the CMS-209 form) stated that the hospital does not have a blood utilization committee, and the only report submitted by the laboratory is the monthly blood bank usage report and potential transfusion reaction workups sent to the lab director. D) In an interview on 11/20/24 at 10:46 am the Nursing Risk Management Officer (#16 as listed on the CMS-209 form) stated that the hospital does not have a blood utilization committee. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's instruction, the laboratory's procedure manual, patient test records, and interview with staff the laboratory failed to ensure 9 of 20 patient lactate samples were centrifuged within 15 minutes of collection from 1/1 /24 through 1/10/24. A) A review of the manufacturer's instructions ("Instructions for Use Vitros Chemistry Products LAC Slides" Lactate, REF 843 3880, 815 0112, ver 13.0, Pub. No. C-212_EN) for the lactate analysis performed in the laboratory, instructions stated:"centrifuge speicmens and remove the plasma from the cellular material within 15 minutes of collection time." B) The Laboratory's QC Policy manual did not contain specfic policies for lactate, but referred to "following manufacturer's instructions and/or package inserts". C) Lactate patient test records from 1/1/24 through 1/10/24 revealed: Sample ID 2400013; Collected : 1/1/24 01:04, Analyzed: 12:58 Sample ID 2400179; Collected : 1/2/24 13:24, Analyzed: 13:40 Sample ID 2400202; Collected : 1/2/24 14:47, Analyzed: 15:31 Sample ID 2400593; Collected : 1 /4/24 18:51, Analyzed: 19:26 Sample ID 2400718; Collected : 1/5/24 21:56, Analyzed: 22:24 Sample ID 2400735; Collected : 1/6/24 01:02, Analyzed: 01:39 Sample ID 2400927; Collected : 1/8/24 10:17, Analyzed: 10:55 Sample ID 2401049; Collected : 1/8/24 11:33, Analyzed: 16:05 Sample ID 2401442; Collected : 1/10/24 14: 34, Analyzed: 14:51 D) During interview, General Supervisor #1 (as listed on the CMS-209 form) confirmed that the lab documented collection times and report times; but not centrifuge times. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 2 of 3 -- 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: Through observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 11/21/24 at 12:50 pm, one (of one) unopened container of Liquid Performance Verifier I ALC, AMON, GLU (CSF only), K+ (urine only), NA+ (urine only), PROT, SALI (lot B9937, REF 846 6492, Ortho Clinical Diagnostics, Vitros Chemistry Products, expiration date 10/10/2024) was observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 11/21/24 at 12:50 pm, one (of one) unopened container of Troponin I ES Calibrators (lot 5520, REF 680 2302, Ortho Clinical Diagnostics, Vitros Chemistry Products, expiration date 8/1/2024) was observed in the laboratory, available for use beyond the expiraton date. C) During a tour of the laboratory on 11 /21/24 at 12:47 pm, two (of two) opened containers of MicroScan Innoculum Saline (lot C79790, REF C70334AA, Beckman Coulter, expiration date 2/8/24) was observed in the laboratory, available for use beyond the expiraton date. D) In an interview on 11/21/24 at 12:52 pm General Supervisor #1 (as listed on the CMS-209 form) , confirmed that the items, identified above, had exceeded the expiration date and were available in the laboratory. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the CMS-209 forms, review of proficiency test attestations for 2022 and 2023, and interviews with laboratory staff, proficiency test samples were not tested by all personnel who routinely perform patient testing. Survey findings include: A. The CMS-209 forms signed 3/27/2023 included sixteen testing personnel (listed as Employees #2 through #17). B. A review of proficiency test attestations for 2022 through 2023 revealed that one of sixteen testing personnel had not signed an attestation in 2022 or 2023. There was no documentation that Employee #4 (as listed on the form CMS-209) had participated in proficiency testing in 2022 or 2023. C. In an interview, at 10:55 a.m. on 3/30/2023, laboratory Employee #2 (as listed on the form CMS-209) confirmed that Employee #4 routinely tests patient samples but has not participated in proficiency testing. She stated that employee #4 has been testing patients since June or July 2022. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 4 -- Through review of the CMS 209 form, personnel records, and interview conducted on 3/30/2023 it was determined that the competency of the testing personnel was not assessed by the laboratory director on an annual basis. Findings follow: A) Review of personnel files for one of eight new testing personnel revealed that the initial and six month evaluation of the competency of the testing personnel (number four on the CMS 209 form) was not documented. B) Upon request, the laboratory could not provide initial and six competency evaluation of the testing personnel (number four on the CMS 209 form) dated 3/1/2023 subsequent to the evaluation identified above. C) In an interview on 3/30/2023 at 12:50 p.m. the testing personnel (number two on the CMS 209 form) said that testing personnel (number 4 on the CMS 209 form) had changed roles in May or June 2022 and no other competency evaluations were present and available. 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 laboratory "CHEMISTRY QUALITY CONTROL POLICY", review of chemistry quality control (QC) Levey-Jennings Graphs for 2022 and 2023, lack of documentation, and interviews with staff, it was determined the laboratory failed to monitor over time the accuracy of chemistry test performance. Survey findings include: A. The CHEMISTRY QUALITY CONTROL POLICY states, "Shifts and trends will be monitored through the QC log and will be investigated further to determine the cause.

Summary Statement of Deficiencies 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 2020 and 2021 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Total Bilirubin. Survey Findings Follow: Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in 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 2021 CMS Casper Reports 0155D and 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Total Bilirubin (TBILI). Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a sore of 60% for the analyte TBILI in the second proficiency testing event of 2021. B. A review of the proficiency testing results revealed the laboratory received a score of 40% for the analytes of TBILI in the third proficiency testing event of 2021. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: . Based on review of 2021 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: . Based on review of 2021 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Analyte Total Bilirubin. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: . Through a review of manufacturer's instruction, temperature records, observations made during a tour of laboratory, as well as interviews with staff, it was determined the laboratory failed to store quality control material consistent with manufacturer's recommendations to achieve accurate and reliable test results as evidenced by: A. A review of Bio-Rad Immunoassay Quality Control package inserts revealed the storage requirement for the analyte Folate as "-20 to -70 degrees Celsius." B. A review of laboratory's temperature records January-August of 2018 revealed the temperature range of freezer #2 as -10 to -20 degrees Celsius. C. During a tour of the laboratory on 8/22/2018 at 1330, the surveyor observed two vials of Bio-Rad Immunoassay controls (Level I lot # 40921 expire 10/31/2018 and Level III lot #40923 expires 10/23/2018) stored in freezer #2. D. In an interview on 8/22/2018, the general supervisor (as listed on form CMS 209) confirmed the control materials were stored in freezer #2. 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 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 -- 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: . 1. Through a review of the new instrument validation, which was performed 4/18 /2018 for the Siemens Epoch Blood Gas analyzer and interviews with staff, it was determined the laboratory failed to validate the reportable range established by the manufacturer for four of eight chemistry tests validated on the Siemens Epoch. As evidenced by: A. The manufacturer's analytic range listed on the Analytical Range Verification Summary dated 04/18/2018 includes the following analytic ranges: pCO2 5.0-250.00; pO2 5.0-750.0; Glucose 20.0-700.0 and Hematocrit 10.0-75.00. B. The Analytical Range Verification Summary dated 04/18/2018 include the following ranges validated by testing standard solutions: pCO2 17.0-141.4: pO2 26.7-595.3; Glucose 15.0-638.0 and Hematocrit 9.0-66.00.The laboratory did not validate the full analytic range claimed by the manufacturer. C. In an interview on 08/22/2018 at 1330, general supervisor (as listed on the form CMS-209) confirmed the laboratory did not validate the full reportable range claimed by the manufacturer of the Siemens Epoch. 2. Through a review of new instrument validation which was performed on 4/18/2018, lack of documentation as well as interviews with staff, it was determined the Blood Gas laboratory failed to perform method correlation for the Siemens Epoch Blood Gas Analyzer to verify that the manufacturer's reference intervals are appropriate for the laboratory's patient population. As evidenced by: A. The new instrument validation for the Siemens Epoch Blood Gas analyzer revealed the analyzer validation was performed on 4/18/2019 and revealed that no data was present to verify that the manufacturer's reference intervals (normal ranges) are appropriate for the laboratory's patient population. B. Upon request, the laboratory was unable to provide method correlation data for the validation of the Siemens Epoch Blood Gas analyzer. C. In an interview, at 1400 on 8/22/2018, the general supervisor (as listed on the form CMS- 209) confirmed that method correlation was not performed as part of the validation of the Siemens Epoch 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: . Through a review of the Sysmex CA-600 Daily Maintenance Checklist and interviews with laboratory staff, it was determined the laboratory failed to ensure function checks for the Coagulation analyzer were within manufacturer's established limits before testing patients. As evidenced by: A. A review of the Sysmex CA-600 Maintenance Checklist revealed the temperature range of the Detector as 36-38 degrees Celsius. The Sysmex CA-600 Maintenance Checklist includes the following dates when the Detector temperature was documented outside of the acceptable range: in December 2017 detector temperature was below 36 degrees Celsius on 2 of 31 -- 2 of 3 -- days; in January 2018 detector temperature was below 36.0 on 1 of 31 days; in February 2018 detector temperature was below 36.0 on 1of 28 days; in March 2018 detector temperature was below 36.0 degrees Celsius on 2 of 31 days; in April 2018 detector temperature was below 36.0 on 1 of 30 days; in May 2018 detector temperature was below 36.0 on 3 of 31 days; in June 2018 detector temperature was below 36.0 on 4 of 30 days and in July 2018 2 of 31 days. B. In an interview on 8/22 /2018 at 10:30, general supervisor (as listed on the form CMS-209) confirmed the function checks were documented outside of acceptable limits. -- 3 of 3 --