Delta Memorial Hospital

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Through a review of proficiency test documentation for 2022, it was determined the laboratory director or designee failed to sign attestation statements for ten of fourteen proficiency testing events in 2022. Survey findings follow: A) A review of the Attestation Statements for 1st, 2nd, and 3rd API Hematology/Coagulation Testing Events of 2022 revealed that the laboratory director or designee failed to sign the Attestation Statements. B) A review of the Attestation Statements for 1st and 2nd API Chemistry Miscellaneous Proficiency Testing Events of 2022 revealed that the laboratory director or designee failed to sign the Attestation Statements. C) A review of the Attestation Statements for 1st, 2nd, and 3rd API Immunology/ Immunohematology Proficiency Testing Events of 2022 revealed that the laboratory director or designee failed to sign the Attestation Statements. D) A review of the Attestation Statements for 1st and 2nd API Microbiology Proficiency Testing Events of 2022 revealed that the laboratory director or designee failed to sign the Attestation 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 -- Statements. E) In an interview at 2:02 p.m. on 5/30/23, laboratory employee #3 (as listed on the form CMS-209) confirmed that the laboratory director or designee failed to sign Attestation Statements for ten proficiency testing events in 2022. 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 observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature on each day of operation in one of five rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 5/30 /23 at 9:50 a.m., five separate rooms (main lab, phlebotomy blood drawing area, microbiology lab, storage room, and arterial blood gas lab) containing items with a temperature storage requirement were observed. B) During a review of the laboratory's temperature records it was noted that no temperature records were presented for the storage room. C) During a tour of the laboratory on 6/1/23 at 8:40 a. m. thirteen 2L bottles of Procell M lot # 65858301 expiration date 2024-5-31 and twelve 2L bottles of CleanCell M lot # 90122102 expiration date 2024-09-31, both products with a storage temperature requirement of 15 to 25 degrees C.,were observed in the storage room. D) Upon request, the laboratory could not present the temperature records for the storage room in which the supplies identified above were stored. E) In an interview on 5/31/23 at 3:00 p.m. , the laboratory staff member (# 4 on the CMS 209) stated " no we don't have temperatures for the storage room". 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 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 blood bank patient and quality control logbook, as well as interviews with laboratory staff, it was determined the laboratory failed to perform quality control each day of testing patient samples. Survey findings follow: A) The -- 2 of 3 -- blood bank patient and quality control logbook includes documentation of a crossmatch performed for one unit of blood on 1/26/2022 on Patient MR # 3174 and one unit of blood on 1/31/22 on Patient MR # 2671 There was no documentation in the blood bank patient and quality control log of blood bank quality control for 1/26 /2022 or 1/31/2022. B) In an interview, at 2:20 p.m. on 5/31/23, laboratory employee #3 (as listed on the form CMS-209) confirmed the lack of documented quality control on the dates listed above. -- 3 of 3 --

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 Blood Gases which include the parameters of PH, PO2 and PCO2. Survey Findings Follow: Failure to achieve a score of at least 80% of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the proficiency testing event as cited at D2087. D2087 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(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of the 2021 CMS Casper Reports 0155D and 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the Blood Gas laboratory failed to have satisfactory participation in proficiency testing for the test of PH, PO2 and PCO2. Survey Findings Follow: A. A review of the proficiency testing results revealed the Blood Gas laboratory received a sore of 20% for the test of PH, a score of 40% for the test of PO2 and a score of 0% for the test of PCO2 in the second proficiency testing event of 2021. B. A review of the proficiency testing results revealed the Blood Gas laboratory received a sore of 0% for the test of PH, a score of 20% for the test of PO2 and a score of 40% for the test of PCO2 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 Blood Gas test of PH, PO2 and PCO2. Refer to D2087 -- 2 of 2 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: . Through a review of the Casper 0096D report, proficiency testing documentation, lack of documentation and interview with staff, it was determined the Respiratory laboratory failed to report proficiency testing results to Arkansas Department of Health (ADH) for three of three proficiency testing events in 2019 and 2020. Survey Findings follow: A. A review of Casper 0096D report for Delta Memorial Hospital Respiratory Laboratory revealed no proficiency testing scores for the analytes PH Blood Gas, PO2 Blood Gas and PCO2 Blood Gas in 2019 for three of three proficiency testing events. B. A review of Casper 0096D report for Delta Memorial Hospital Respiratory Laboratory revealed no proficiency testing scores for the analytes PH Blood Gas, PO2 Blood Gas and PCO2 Blood Gas in 2020 for three of three proficiency testing events. C. A review of the College of American Pathologist (CAP) for three of three proficiency testing events in 2019 and 2020 revealed the Respiratory laboratory participated in proficiency testing and received testing scores for three of three proficiency testing events in 2019 and 2020. D. Upon request the laboratory could not provide documentation that the proficiency testing results for three of three testing events in 2019 and 2020 had been reported to ADH. E. In an interview on 05/18/2021 at 10:30, the technical consultant confirmed Respiratory Laboratory participated in proficiency for 2019-2020 and the proficiency testing results were not reported to ADH. D5445 CONTROL PROCEDURES 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): 493.1256(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 Hematology policy and procedure manual, Hematology Quality Control (QC) records for November 2019, March and July of 2020, laboratory patient log, lack of documentation as well as interview with staff it was determined the laboratory failed to document Hematology quality control when patients were tested. Survey Findings Follow: A. A review of the Hematology policy manual revealed the Quality Control policy: "Three levels of Sysmex XN-L controls will be tested once daily on the XN-550". B. A review of QC data for the month of November of 2020 (one of three months reviewed) revealed on 11/18/2020 (one of thirty days in November 2020) the laboratory had no documentation of acceptable Quality Control for Hematology. C. A review of laboratory patient log revealed on 11/18/2020, the laboratory resulted Complete Blood Counts on twenty-seven patients. D. In an interview on 05/19/2021 at 10:30, the technical consultant confirmed patients were tested and reported without acceptable QC for November 18,2020. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of ALCOR Erythrocyte Sedimentation Rate (ESR) package inserts, ESR Quality Control (QC), lack of documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to establish the criteria for acceptability of ESR control as required by the manufacturer. Survey Findings Follow: A. ALCOR Mini-Sed Auto analyzer is utilized by the laboratory to perform ESR assay. A review of package insert for Alcor ESR controls for automated Sedimentation Rate revealed: "It is recommended that an individual laboratory establish its own mean and acceptable ranges and use those provided only as a guide." -- 2 of 3 -- B. In a review of ESR quality control data, it was determined the mean and acceptable range in three of three months (January, April of 2021 and November 2020) reviewed matched the expected range as listed on the ALCOR ESR package insert. Level I control range (Lot # C138) (6-8 mm/hr) and Level II control range (Lot #C238) (40- 94 mm/hr). C. The surveyor requested documentation of established ranges for ESR quality controls. None was provided. D. In an interview on 05/19/2021 at 10:00, laboratory employee #1 (as listed on CMS-209) confirmed that the laboratory has not established their own mean and range for ESR quality controls. The laboratory uses the manufactures ranges for the ESR control. -- 3 of 3 --

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 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 Serum HCG (Human Chorionic Gonadotropin). 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 D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 2020 and 2021 CMS Casper Reports 0153D, 0155D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to achieve satisfactory performance for Serum HCG. Survey Finding Follow: A. A review of the proficiency testing results revealed the laboratory received a score of 40% for Serum HCG in the third proficiency testing event of 2020. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for Serum HCG in the first 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 2020 and 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. As cited at 6016 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 2020 and 2021 proficiency testing event , it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for Serum HCG. As cited at D2107 -- 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 temperature records for 2017 and 2018, Siemens Rapid Point instruction manual, lack of documentation, and interviews with staff, it was determined the Respiratory Laboratory failed to monitor room temperature which are essential for the proper storage of reagents and the operation of the Siemens Rapid Point 405 Respiratory analyzer. As evidenced by: A. A review of the instruction manual for the Siemens Rapid Point 405 Blood Gas analyzer revealed the Ambient Environmental requirements for the analyzer operations: operating temperature 15-35 degrees Celsius . A review room temperature logs for 2017 and 2018 revealed the Respiratory room temperature range as 15 to 35 degrees Celsius. B. A review of room temperature records for 2017 revealed the Respiratory Laboratory failed to monitor room temperatures in three of twelve months; In May 2017, two of thirty-one days; in July 2017, two of thirty-one days and in September 2017, two of thirty-one days. C. A review of room temperatures for 2018 revealed the Respiratory Laboratory failed to monitor room temperatures in two of twelve months; In May 2018, two of thirty-one days and in August 2018, two of thirty-one days. D. In an interview at 1455 on 10/10 /18, Respiratory personnel #1 (as listed on the form CMS-209) confirmed the lack of