Drew County Laboratory

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 the 2025 CMS Casper Reports 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 Aspartate Amino Transferase (AST). 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 -- (f) 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 the 2025 CMS Casper Reports 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 AST. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 20% for the analyte AST in the first proficiency testing event of 2025. B. A review of the proficiency testing results revealed the laboratory received a score of 20% for the analyte AST in the second proficiency testing event of 2025. 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 2025 proficiency testing results, 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) (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 the 2025 proficiency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test AST. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) In an interview on 5 /22/25 at 10:05 a.m., the laboratory staff member (# 3 on CMS form 209) stated the laboratory staff does not collect inpatient blood samples for testing, that all samples for inpatient testing are collected by nursing personnel. B) During a tour of the Medical/Surgical nursing unit supply closet on 5/22/25 at 10:15 a.m. the surveyor observed one bin containing 100 BD 6.0 ml. K2 EDTA blood collection tubes, lot # 3318891, with an expiration date of 2025-04-30. C) In an interview on 5/22/25 at 10: 05 a.m., the laboratory staff member (# 3 on CMS form 209) confirmed that the blood collection tubes identified above were expired and available for use. D5783

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Through a review of Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016, Blood Transfusion/Utilization Committee Meeting Minutes, Drew Memorial Hospital transfusion statistics, review of the

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 the 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 Lactate Dehydrogenase (LDH). 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 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 -- CFR(s): 493.841(f) 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 the 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 Lactate Dehydrogenase (LDH). Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a sore of 0% for the analyte LDH and in the second proficiency testing event of 2021. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analytes of LDH 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 the 2021 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Analyte Lactate Dehydrogenase. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies 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 and Regulations for Hospitals and Related Institutions in Arkansas 2016, "Monthly Blood Bank Totals" reports for the first five months of 2021, lack of documentation and through interviews with staff, it was determined the facility failed to comply with Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016 requirements for blood utilization committee. Survey and document all transfusion activities. Findings follow: A) The Rules and Regulations for Hospitals and Related Institutions in Arkansas 2016 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 "Monthly Blood Bank Totals" reports for the months of January though May of 2021 revealed in 2021 the laboratory reported 257 transfusions and that the reports contained statistical information regarding numbers of types of products and number of reported "adverse reactions" only. C) In an interview on 7/8/21 at 11:35 a.m. the laboratory staff member , identified as number one on the CMS 209 form, stated that the hospital does not have a blood utilization committee or any medical staff criteria governing the administration of blood products or any related committee, to her knowledge, and the only report submitted by the laboratory is the "Monthly Blood Bank Totals" report that is submitted to the hospital's Chief Nursing Officer. D) In an interview on 7/9/21 at 09:35 a.m. the hospital's Chief Nursing Officer/Quality Assurance Director, identified as number one on a separate staff identification list, stated that the hospital's 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 -- Medical Staff Bylaws have no criteria for the admistration of blood products, that there is no blood utilization committee in the hospital, there is no current quality assurance activity analyzing the administration of blood products and the only blood bank information reported to the Medical Executive Committee is the statistical report identified above. 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 Respiratory policy and procedures, temperature logs for 2020, lack of documentation and interviews with staff, it was determined the Respiratory laboratory failed to monitor and document room and refrigerator temperatures that are essential for the storage of reagents and supplies. Survey findings follow: A. A review of Respiratory policy and procedure revealed: "Respiratory Temperature will be checked daily and recorded on the temperature logs. Refrigerator range 2-8 degrees Celsius: Room Temperature Range 15-28 degrees Celsius." B. A review of the refrigerator temperatures for January- December 2020 (twelve of twelve months) revealed the Respiratory laboratory failed to monitor and document refrigerator temperatures on one of thirty-one days in January; one of thirty-one days in March; one of thirty days in April; five of thirty-one days in May; one of thirty days in June; one of thirty-one days in July; three of thirty-one days in August; one of thirty-one days in October; one of thirty days in November and one of thirty-one days in December. C. A review of the room temperatures for January-December of 2020 (twelve of twelve months) revealed the Respiratory laboratory failed to monitor and document room temperatures on one of thirty-one days in March; one of thirty days in April; four of thirty-one days in May; one of thirty days in June; one of thirty-one days in July; two of thirty-one days in August; two of thirty days in September; one of thirty days in November and one of thirty-one days in December. D. In an interview with Respiratory testing personnel #1 (as listed on form CMS 209) confirmed the Respiratory laboratory failed to monitor or document room and refrigerator temperatures on the days mentioned. 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 -- 2 of 6 -- 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: . Through a review of policy and procedure manual, quality control(QC) data for 2020 and 2021, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to monitor the accuracy and precision of the quality control process and failed to monitor over time the accuracy and precision of test performance. As evidenced by: A. Through a review of the policy and procedure manual it was determined the laboratory failed to have a policy to monitor shifts and trends for the evaluation of accuracy and precision over time to meet the laboratory's established criteria for the Vitros 7600 Chemistry analyzer. B. A review of Levy Jennings charts for May 2021 (one of three months reviewed) revealed: Level 1 Cardiac Control Lot #87811, Myoglobin (MYO) results were below the assayed mean of 81.1 ( 22 points): Level III Cardiac Control Lot #87813, Myoglobin (MYO) results were below the assayed mean of 505.4 (18 points): Level I Control Lot #67634, Troponin results were below the assayed mean of 0.29 (15 points): Level I Control Lot #85211 Thyroid Stimulating Hormone (TSH) results were above the assayed mean of 0.62 (20 points). C. A review of Levy Jennings charts for June 2021 (two of three months reviewed) revealed Level I Control Lot #45891, Glucose results were below the assayed mean of 57.7 (25 points) and Level II Control Lot #45983, Glucose results were below the assayed mean of 370.0 (20 points). D. There was no documentation that the laboratory had identified the shifts or trends in test performance, or any actions performed to address the shifts or trends. E. In an interview on 7/8/2021 at 10:00 a.m., laboratory personnel #1 (as listed on form CMS- 209) confirmed the laboratory did not evaluate the accuracy and precision over time to meet established criteria of acceptability. 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: . Through a review of Chemistry policy and procedure manual, Chemistry Quality Control (QC) records for June 2021 laboratory patient log, lack of documentation as well as interview with staff it was determined the laboratory failed to document Chemistry QC when patients were tested. Survey Findings Follow: A. A review of the Chemistry policy manual revealed the Quality Control policy: "Two levels of Chemistry QC will be tested daily. " B. A review of Chemistry QC data for the analyte Blood Urea Nitrogen (BUN) in the month of June 2021(one of three months reviewed) revealed on June 8, 2021 (one of thirty days in June 2021) Level I QC (Lot #45891) was out of range (more than -3SD) with no repeated analysis. There was no documentation the laboratory had two levels of acceptable QC for the analyte BUN. -- 3 of 6 -- C. A review of laboratory patient log revealed on 06/08/2021, the laboratory tested and resulted BUN on 105 patients. D. In an interview on 07/7/2021 at 10:30, laboratory personnel #1(as listed on form CMS 209) confirmed patients were tested and reported without acceptable Chemistry QC on June 8,2021. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through review of the laboratory policy and procedure (Reference # 30-1027 "Emergency Release of Blood Products"), the Blood Bank log, lack of documentation and interview it was determined that the laboratory failed to complete compatibility testing for two of six instances of the emergency release of blood as required by CFR 606.160 (b) (3) (v). Findings follow: A) Review of laboratory policy and procedure (Reference # 30-1027 "Emergency Release of Blood Products") revealed in paragraph 6 "keep two segments of each unit of blood and label it with the unit number so that the crossmatch can be later completed" and , in paragraph 9, "set up cross-matches as soon as possible, the cross-matches must be carried through the coombs phase even if the blood has been transfused when time allows". B) Review of the Blood Bank Log of six most recent occasions of the emergency release of blood products revealed that on 12/28/20 unit # WO 265 20 956434 was released on an emergency basis to patient 1048745 with no follow-up cross-match result being recorded and on 1/26/21 unit # WO 265 20 001799 was released on an emergency release basis to patient 1052885 with no follow-up cross-match result being recorded. C) Upon request, the laboratory was unable to provide documentation of cross-matches being completed for the cases identified above or to provide documentation of the reasons that cross-matches were unable to be completed. D) In an interviw with laboratory staff member, identified as number one on the CMS 209 form, confirmed that the units identified above were released and administered to patients without follow-up cross-matches being performed or reasons for the lack of cross-matches documented. D5783

Summary Statement of Deficiencies D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: . Through lack of documentation as well as interview with staff, it was determined the laboratory failed to provide written instructions to the laboratory clients (four of four medical clinics) for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transport, and specimen acceptability and rejection criteria. As evidenced by: A. In an interview on 01/24/2019 at 1000, laboratory personnel #1 (as listed on CMS form 209) stated the laboratory accepted specimens from Monticello Medical Clinic/Star City, Monticello Medical Clinic/Crossett, Monticello Medical Clinic/Monticello and one Obstetrics/Gynecology (OB/GYN Clinic). B. Upon request, the laboratory was unable to produce written instructions provided to the referring clinics for proper specimen collection, handling, storage and transport. C. In an interview on 01/24/2019 at 1000, laboratory personnel #1 ( as listed on form CMS 209) confirmed that the laboratory failed to provide a Client Service Manual to the laboratory's clients. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: . Through a review of the Oncology Clinic policy and procedure manual, quality control (QC) records for six of twelve months of 2018, patient medical records, as well as interviews with staff, it was determined that patients were reported when results of QC material failed to meet the Oncology laboratory's criteria for acceptability. As evidenced by: A. The Oncology Clinic utilizes the Abbott Emerald Hematology analyzer to perform Complete Blood Counts (CBC). A review of the Oncology laboratory policy and procedure manual revealed the QC policy: " Three levels of QC will be ran each day of use of the Hematology analyzer. At least 2 of the 3 levels must be within assigned 2SD range for all parameters tested for the control run to be acceptable. The laboratory will not release any patient results until acceptable QC results have been obtained." B. A review of Hematology quality control results for March, April, June, August, September and December of 2018 ( six of twelve months) revealed on 9/19/2018 Hematology Normal Control for Red Blood Cell Count (RBC) was reported as 3.60 ( with an acceptable range of 3.82 to 4.32). Hematology High Control for Red Blood Cell Count was reported as 4.83 ( with an acceptable range of 4.85 to 5.45). C. A review of patient medical records revealed on 9 /19/2018 eighteen patients had RBC counts reported with only one level of acceptable quality control results: patient # 717898, patient #718155, patient #717429, patient #718148, patient #717965, patient #717916, patient #718145, patient #718143, patient #71841, patient #717903, patient #717890, patient #717895, patient #718133, patient #717909, patient #717880, patient #717888, patient #717883 and patient #717889. D. In an interview on 01/23/2019 at 10:00, laboratory personnel #1 (as listed on the form CMS-209) confirmed that patients were reported when the quality control results were outside of acceptable range. D5785