Ouachita County Medical Center

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based upon a review of the American Proficiency Testing Institute (API) proficiency test attestation records for ten events in 2024 and 2025, lack of documentation, and interviews with laboratory staff, it was determined that required signatures to attest to the routine integration of proficiency test samples in the patient workload were not present on 3 of the ten events reviewed. Survey findings follow: A) Review of the attestation forms for API Microbiology 2024 3rd proficiency test event for Microbiology revealed that it was not signed by the laboratory director or designee. B) Review of the attestation forms for API Hematology/Coagulation 1st and 2nd event 2025 revealed they were not signed by the laboratory director or designee. C) In an interview, on 8/13/25 at 3:08 p.m., the Technical Supervisor listed on the form CMS- 209, confirmed the API proficiency testing attestation forms identified above were not signed by the required personnel. 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). 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 3 -- Based on review of laboratory policy for "Emergency Transfusion Request", Emergency Requests for Uncross matched Blood for calendar year 2024 and interview with laboratory staff, the laboratory failed to ensure the request for release of uncross matched blood in one of seventeen to release blood on an uncross matched basis during the year reviewed was signed by the requesting physician as required at 21 CFR 606.160(b)(3)(v). Findings follow: A) Review of the laboratory policy and procedure for "Emergency Transfusion Request" revealed that the ordering physician must sign the release for uncross matched emergency released blood within twenty- four hours. B) Review of Emergency Transfusion Requests for calendar year 2024 revealed that 17 units of blood were released on an uncross matched emergency release basis. C) Review of the form for the emergency release of packed red blood cell (PRBC) units W036524044288 (5) revealed that the release form was not signed by a physician. The blood was picked up for patient "Mitchell Jack" by RN or MD with unrecognized signature on 5/4/24 at 0625 and released by a person with initials "GC" at 0625. D) In an interview on 8/13/24 at 11:05 a.m., Technical Supervisor on the form CMS-209, confirmed that the request for emergency release of uncross matched blood form had not been signed by the physician who ordered the transfusion. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel files for all personnel listed on the CMS-209 form, lack of documentation, and interviews with laboratory staff, determined the laboratory director failed to authorize three of three General Supervisor (GS) personnel the responsibilities and duties to perform lead functions without direct supervision. Survey findings include: A) During a review of personnel files for all personnel GS-1, GS-2, and GS- 3 (as listed on the form CMS-209) failed to have written authorization from the laboratory director for GS/Lead responsibilities and duties without direct supervision. B) In an interview on 8/12/2025 at 1:06 pm, the Technical Supervisor (TS) TS-1on the CMS 209 form confirmed the lack of written authorization for three GS on form CMS 209. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based upon review of personnel competency records for 18 employees listed on the CMS 209 form, authorizations to perform tests, and interview the laboratory did not -- 2 of 3 -- assess the competency of six employees semiannually during the first year of employment. Findings follow: A) Review of personnel records, (General Supervisor (GS) -1, GS-2, GS-3, Testing Personnel (TP)-1, TP-3, and TP-4 on the CMS 209 form), indicated that the employees was hired in March, May and June 2024 and authorized by the laboratory director to perform moderately/high complex testing without direct supervision in March, May and June 2024. B) Upon review of personnel records (General Supervisor (GS) -1, GS-2, GS-3, Testing Personnel (TP) -1, TP-3, and TP-4 on the CMS 209 form), only one instance of competency evaluation was found dated March, May and June 2024. C) In an interview on 8/12/25 12:41 p.m., the Technical Supervisor on the CMS 209 form, confirmed that only one competency evaluation was present in the personnel file for GS -1, GS-2, GS-3, TP-1, TP-3, and TP-4 on the CMS 209 form, -- 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: Through a review of proficiency testing documentation for 2022 and 2023, as well as interviews with staff, it was determined that hematology and coagulation proficiency testing samples were not tested by all personnel who routinely perform testing. Survey Findings follow: A. A review of proficiency test attestation statements showed that testing person #5 performed the first, second, and third hematology proficiency tests for 2022 and 2023. B. A review of proficiency test attestation statements showed that testing person #5 performed the first and second cell identification proficiency tests for 2022 and 2023. C. In an interview, at 3:14 pm, 10/10/23, General Supervisor #3 (as listed on the form CMS-209) confirmed that all testing personell (#1-14 as listed on the CMS 209 form) perform testing for each specialty once fully trained. D5781

Summary Statement of Deficiencies D0000 This is the CLIA survey of the laboratory conducted on 11/30/2021 through 12/1 /2021. At the time of the survey the laboratory was not in compliance with the following conditions: 493.1217 - Immunohematology 493.1421 - Laboratory Testing Personnel 493.1441 - Laboratory Director It was determined the lack of quality control in blood bank represented an immediate jeopardy to patients. The immediate jeopardy will be removed by performing quality control on each day of testing. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Through a review of immunohematology log book for 2021 as well as interviews with laboratory staff it was determined the laboratory failed to meet the requirements in 493.1271 as evidenced by: D5551 - the laboratory failed to perform and document quality control for immunohematology testing on three of thirty days of patient testing in September 2021 and one of thirty-one days of patient testing in October 2021 D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be 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 -- tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through a review of the Laboratory Policy and Procedure Manual, immunohematology log book for 2021 and interviews with laboratory staff, it was determined the laboratory failed to perform and document quality control for immunohematology testing on three of thirty days of patient testing in September 2021 and one of thirty-one days of patient testing in October 2021. Survey findings follow: a. Through a review of the Laboratory Policy and Procedure Manual, it was revealed the Blood Bank "QC Confidence System" policy states, "The purpose of daily quality assurance in the Blood Bank is to confirm the reliability of the test system. The test system includes reagents, test procedures, and equipment. Testing known samples is an acceptable method of quality control. If expected test results are observed, procedures are being performed accurately and reagents and equipment are performing properly. If unexpected results are observed, the problem may be due to improper test performance, faulty equipment, or contamination or deterioration of reagents. The source of the problem should be determined before patient test results are reported." b. A review of the Immunohematology log book for January through November 2021 (11 months), in which quality control and patient testing is documented, revealed the laboratory failed to document immunohematology (blood bank) quality control on the following days when tests were performed on patient samples: 9/6/2021; 9/23/2021; 9/29/2021 (three of thirty days in September); and 10/9 /2021 (one of thirty-one days in October). c. A review of the Immunohematology log book revealed the patients with blood bank testing on days without blood bank quality control are as follows: on 9/6/2021 Patient AB59955 blood type and Rh, antibody screen, and crossmatched for one unit of blood and transfused, Patient AB59947 blood type and Rh, antibody screen, and crossmatched for two units and transfused one unit, Patient AB76659 blood type and Rh, antibody screen, and crossmatched with two units but was not transfused, and patient #1092164 had a type and Rh performed on cord blood; on 9/23/2021 patient AB84570 blood type and Rh, antibody screen, and crossmatched with two units of blood and had one transfused; on 9/29 /2021 patient AH51921 had a type and antibody screen performed, patient AH67065 blood type and Rh, antibody screen, and crossmatched with one unit of cells and was transfused, patient 1092394 had a type, Rh, and Direct Antiglobulin Test (DAT) performed on cord blood, patient 49924 had a type and antibody screen performed, patient AH67049 had a type and antibody screen performed, patient AH54553 blood type and Rh, antibody screen, and crossmatched with two units of packed cells and transfused both units, patient 1092397 had a type and Rh and DAT performed on cord blood, and patient AH67057 had a type and antibody screen performed; on 10/9/2021 patient AH67849 blood type and Rh, antibody screen, and crossmatched with two units of packed cells and one unit was transfused and patient AH54001 blood type and Rh, antibody screen, and crossmatched with two units of cells and both units were transfused. d. At 11:48 on 12/1/2021 laboratory employee #2 (as listed on the form CMS-209) confirmed the lack of documented quality control on days of blood bank testing. e. The laboratory had not identified the failure to perform and document quality control for immunohematology testing and had not remediated patients who were tested on days without quality control documentation. D6035 TECHNICAL CONSULTANT QUALIFICATIONS -- 2 of 5 -- CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Through a review of personnel files for fifteen of fifteen laboratory testing personnel listed on the Personnel Identification Worksheet, through a lack of documentation, and through interviews with staff, it was determined that two of fifteen laboratory testing personnel failed to meet qualification requirements as testing personnel as evidenced by: D6065 - two of fifteen laboratory testing personnel lacked documentation of appropriate education to qualify as a testing personnel -- 3 of 5 -- D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Through a review of laboratory personnel records for fifteen testing personnel, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed document that laboratory employees two of fifteen testing personnel (#16 and #17 as listed on the Personnel Identification Worksheet) met educational requirements to perform moderate complexity testing. Survey findings follow: a. In an interview, at 2:00 p.m. on 12/1/2021, employee #2 (as listed on the Personnel Identification Worksheet) confirmed employees #16 and #17 perform Activated Clotting Times (ACT) in the Cardiac Catheterization Lab using the moderate complexity I-Stat test system. b. The laboratory failed to have documentation of education that would qualify laboratory employees #16 and #17 to perform moderate complexity testing. c. In the interview, at 2:00 p.m. on 12/1/2021, laboratory employee #2 confirmed the lack of documentation of highest level of education, which would qualify employees #16 and #17 as a moderate complexity testing personnel. 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: Through a review of immunohematology log book for 2021 as well as interviews with laboratory staff, and through a review of personnel records for fifteen testing personnel, it was determined the laboratory director failed to ensure quality control programs were maintained and failed to ensure testing personnel had appropriate education, as evidenced by: D6093 - the laboratory director failed ensure that the quality control programs are maintained D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 4 of 5 -- This STANDARD is not met as evidenced by: Through a review of immunohematology log book for 2021 as well as interviews with laboratory staff, it was determined the laboratory director failed ensure that the quality control programs are maintained. Survey findings include: D5551 - the laboratory failed to perform and document quality control for immunohematology testing on three of thirty days of patient testing in September 2021 and one of thirty-one days of patient testing in October 2021 -- 5 of 5 --

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 2019 and 2020 CMS Casper Reports 0155 D, 0153 D, and the College of American Pathologist (CAP) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing in the Sub-Specialty of Endocrinology and the analyte Thyroid Stimulating Hormone (TSH) as evidence by: Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D 2099 and D 2017. D2099 ENDOCRINOLOGY 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 -- CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on review of 2019 and 2020 CMS Casper Reports 0155 D and 0153 D and CAP proficiency testing results, it was determined the Laboratory failed to have satisfactory participation in proficiency testing for the Sub-specialty of Endocrinology as evidenced by: A. The laboratory received an overall score of 50% in second proficiency testing event of 2019 for the Sub-Specialty of Endocrinology. B. The laboratory received an overall score of 60% in the first proficiency testing event of 2020 for the Sub-speciality of Endocrinology. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 2019 and 2020 CMS Casper Reports 0153 D, 0155 D and CAP proficiency testing results, it was determined the Laboratory failed to achieve satisfactory performance for Thyroid Stimulating Hormone (TSH) in two of three proficiency testing events which is unsuccessful performance as evidenced by: A. The laboratory received a score of 0% in second proficiency testing event of 2019 for the analyte TSH. D. The laboratory received a score of 60% in the first proficiency testing event of 2020 for the analyte TSH. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on review of 2019 and 2020 proficiency testing reports, it was determined the Laboratory Director failed to ensure that