Arkansas Heart Hospital Llc-Encore

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based upon review of the laboratory's records for establishing the Normal Patient Mean Prothrombin Time (MNPT), the user's manual for the Stago Compact Max coagulation analyzer, confirmation of the MNPT set in the Stago Compact Max instrument for calculating the International Normalized Ratio (INR) and interview, the laboratory was using the incorrect MNPT value in the Stago Compact Max coagulation analyzer for the Neoplastine CL Plus reagent Lot # 271563 used fron 6/27 /25 until date of survey . Findings follow: A) Review of the user's manual for the Stago Compact Max coagulation analyzer revealed that the MNPT must be determined specifically for each lot of Neoplastine CL Plus and entered into the instrument settings. B) Review of records used to establish the MNPT for Neoplastine CL Plus lot # 271563 dated 1/25/25 revealed that the geometric mean of the 20 samples used to establish the MNPT was determined to be 13.1 seconds. C) In an interview on 8/19/25 at 01:38 p.m., the laboratory staff member ( #2 on the form CMS 209) stated the MNPT set in the Stago Compact Max coagulation analyzer was 14.4 instead of 13.1, as reported on the records for establishment of the MNPT, which would have caused an error in the calculation of the INR affecting all patient INR tests reported since Neoplastine CL Plus reagent lot # 271635 was placed into use on 6 /27/25 (56 days). D) In an interview on 8/19/25 at 02:15, the laboratory staff member (#2 on the form CMS 209) confirmed that the correct MNPT determined for Neoplastine CL Plus lot # 271563 was 13.1 seconds and the MNPT set in the Stago Compact Max coagulation instrument was 14.4. The MNPT of 14.4 was the MNPT 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 -- value of the previous lot number of Neoplastine CL Plus reagent and was not changed when the lot 271563 was implemented on 6/27/25. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on policy, lack of documentation and an interview, the laboratory failed to follow established written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in analytic systems. Findings include: A. Policy titled "Chemistry Calibrations and QC Policy" (5161.71 version 3.0 Effective Date 8/20/2019) states "4. On-going review of quality control data is performed by all technologists with particular attention to patterns of shifts or trends in the method. Shifts or trends are to be addressed immediately and be accompanied by documentation of remedial actions." B. For C-reactive protein chemistry testing, level I quality control results for lot 10031110 Biorad Cardiac Markers Plus LT were above the mean for 59 of 61 days from 6/20/25 to 8/19/25. C. Upon request, no documentation showing how the shift was addressed was available. D. At 3:43 on 8/20 /25 Technical Consultant #1 (as listed on the CMS-209 form) confirmed that documentation addressing the above shift was not available. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of CFR 606.151, the laboratory policy and procedure for emergency release of un-crossmatched blood, emergency release forms for 2022 and 2023, and interviews with hospital staff, it was determined that the laboratory failed to have the physician in charge sign the authorization for the emergency release of un- crossmatched blood in 4 of 13 cases reviewed. Findings follow: A) Review of CFR 606.151 reveals that for procedures to expedite transfusions in life-threatening emergencies "records of all such incidents shall be maintained, including complete documentation justifying the emergency action, which shall be signed by a physician". B) Review of the laboratory policy for the emergency release of un-crossmatched blood revealed under the heading of 'procedure' "the physician in charge must authorize the use of un-crossmatched blood" and under the heading of "final documentation", "the emergency release authorization form signed by the physician". C) Review of the emergency release authorization forms for thirteen emergency release of un-crossmatched blood for 2022 and 2023 revealed that 4 were signed by personnel identifying with the credentials "APRN"as the authorizing physician D) In a 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 -- telephone interview on 9/20/23 ay 09:57 a.m. the hospital risk management staff member (identified on a separate staff identification form) confirmed that there were no privileges granted or official documentation of delegation of authority to order the emergency release of un-crossmatched blood in emergency situations to non- physician personnel. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as 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 result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Through a review of personnel records of fifteen testing personnel performing moderately complex laboratory assays and interviews with laboratory staff, it was determined the laboratory director failed to give written authorization for seven of fifteen testing personnel to perform moderately complex procedures without direct supervision. Survey findings follow: A) A review of personnel records of fifteen randomly selected testing peronnel, who have completed training for performing moderately complex procedures, revealed that seven (#17, #18, #23, #26, #28, #33, #36 as listed on the form CMS-209) failed to have the laboratory director's written authorization to perform moderately complex testing without supervision. B) In an interview, at 10:40 a.m. on 9/19/23, laboratory employee (#2 as listed on the form CMS-209) confirmed the lack of written authorizations for the seven personnel identified above and that they performed moderately complex testing for Arterial Blood Gas and/or Activated Clotting time Determinations. -- 2 of 2 --

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 Respiratory Therapy policy, proficiency testing documentation for 2021, as well as interviews with staff, it was determined that proficiency testing samples were not tested by all personnel who routinely perform Blood Gas patient testing. Survey Findings follow: A. A review of the Respiratory Therapy Policy revealed the procedure for proficiency testing:" Follow the same procedure as patient testing." B. A review of Respiratory Therapy proficiency test attestation statements for three of three events in 2021 revealed that Respiratory personnel #2, #3, #4 and #5 (as listed on form CMS 209) had not participated in proficiency testing. C. In an interview, at 10:23 a.m. on 10/13/2021, laboratory personnel #1 (as listed on the form CMS-209) confirmed that Respiratory personnel who routinely test patient sample for Blood Gas Analysis did not participate in proficiency testing for three of three events in 2021. 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 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 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . Through observation, review of manufacturer's user's manual, lack of documentation and interviews with laboratory and hospital staff it was determined that the laboratory failed to monitor room humidity level in one of one room in which instruments with an operating humidity level were utilized for patient testing. Findings follow: A) During a tour of the laboratory on 10/12/21 at 09:55 AM two Dimension EXL 200 instruments were observed in operation performing patient testing. B) Review of the manufacturer's manual for the Dimension EXL 200 analyzer revealed an operating humidity requirement of 20% to 80%. C) Review of the laboratory's policy and procedure for laboratory environmental requirements revealed an acceptable humidity range of 10% to 85% which does not conform to the requirement specified for the Dimension EXL 200 analyzer. D) Upon request, the laboratory could not provide record of room humidity level for the room in which the Dimension EXL 200 analyzers were in operation. E) In an interview on 10/13/21 at 10:40 AM the laboratory staff member, identified as number one on the CMS 209 form, said the laboratory had no record of room humidity level but stated that hospital engineering services might have computerized records of room humidity. F) In an interview on 10 /13/21 at 01:00 PM, the hospital engineering staff member, identified as number one on a separate staff member list, said that no parameters have been set for acceptable humidity levels and there is no system for notification of laboratory staff if levels are outside of acceptable range and records of humidity maintained are for "return air" and do not accurately represent the ambient room humidity in the laboratory. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Through a review of the new instrument verification documentation for the Siemens Dimension Exl 200 dated 12/7/2020 and interviews with laboratory staff, it was determined the laboratory failed to verify the reportable range of Cholesterol and Aspartate Aminotransferase (AST) and failed to verify the manufacturer's normal values for five of thirty-five chemistry tests (HDL Cholesterol, Triglyceride, Cholesterol, C Reactive Protein, and AST) are appropriate for the laboratory's patient population. Survey findings include: A. Through a review of the Analytic Range Verification for Cholesterol on the Dimension Exl 200 (serial number 272830) it was determined the analytical range listed on the documentation is 50 - 600 but the laboratory only documented verification to 426.667. Although the laboratory only validated to 426.667 they continue to use the analytic range of 50 - 600. This was confirmed with laboratory employee #1 (as listed on the form CMS-209) in an interview at 1:45 p.m. on 10/12/2021. B. Through a review of the Analytic Range Verification for AST on the Dimension Exl 200 (serial number 272845) it was -- 2 of 5 -- determined the analytical range listed on the documentation is 0 - 1000 but the laboratory only documented verification to 823.667. Although the laboratory only validated to 823.667 they continue to use the analytic range of 0 - 1000. This was confirmed with laboratory employee #1 (as listed on the form CMS-209) in an interview at 1:45 p.m. on 10/12/2021. C. During a review of the Normal Reference Range Verification documentation, it was revealed that the laboratory tested five laboratory employees who were used to represent the normal population. Normal ranges for the following tests are not verified due to the employees results for these tests being reported outside of the normal range: HDL Cholesterol (2 of 5 outside of normal range); Triglyceride (3 of 5 outside of normal range); Cholesterol (4 of 5 outside of normal range); C-Reactive Protein (3 of 5 outside of normal range) and AST (4 of 5 outside of normal range). In an interview, at 1:50 p.m. on 10/12/2021, laboratory employee #1 confirmed the five employees tested did not validate the normal ranges in use and further confirmed that there was no other validation performed. 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: . Through a review of the Chemistry Calibration and QC Policy, a review of chemistry Levey-Jennings Charts, and interviews with laboratory staff, it was determined the laboratory failed to monitor over time the accuracy on four of twelve tests reviewed. Survey findings include: A. The Chemistry Calibration and QC Policy states, "The mean must fall within the reference range set by the manufacturer guidelines. The range is then set by using the mean of the reference and the historical SD. These values are reviewed weekly by Chemistry Supervisor or designee and monthly by Administrative Laboratory Director and are adjusted as needed. Shifts and Trends will be documented... Guidelines for acceptance or rejection of quality control run are programmed internally to the analyzer. The following Westgard rules are activated: R1 (2s) and R10x. Any data point flagged by the analyzer will require a decision from the technologist to accept or reject the data. The technologist will monitor the data for shifts and trends." The policy further states, "Shifts or trends are to be addressed immediately and be accompanied by documentation of remedial actions." B. Through a review of quality control Levey-Jennings Charts for Bio-Rad Multiqual Control (lot #45870) it was revealed that the graph for Lipase Level 2 Control included a shift below the mean, starting on 2/5/2021 and continuing through the date of the survey (10/13/2021). The shift included 272 consecutive points below the mean. The quality control documentation failed to include R10 flags (10 consecutive points on one side of the mean) and failed to have documentation that the shift was addressed as required by the QC policy. C. During the review of quality control Levey-Jennings Charts for -- 3 of 5 -- Bio-Rad Multiqual Control (lot #45870) the following additional shifts without R10 flags were noted by the surveyor: Alkaline Phosphatase Level 2 shifted below the mean 29 consecutive points from 9/6/2021 through 10/13/2021; Calcium Level 2 shifted above the mean 17 points from 9/17/2021 through 10/13/2021, and Glucose Level 2 shifted below the mean 23 consecutive points from 9/21/2021 through 10/12 /2021. D. In an interview, at 9:37 a.m. on 10/13/2021, employee #1 (as listed on the form CMS-209) stated that the R10 flag (used to identify shifts) was not turned on and confirmed the shifts noted by the surveyor had no documented actions. 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 Individualized Quality Control Plan (IQCP) for the Hemochron Signature Elite-ACT, Quality Control (QC) documentation, Quality Control (QC) records for March and August 2021, patient testing log, lack of documentation as well as interview with staff it was determined that Cath-Lab #2 (E-CL 2) laboratory failed to document QC according to the frequency establish in their IQCP policy. Survey Findings Follow: A. A review of the IQCP for Hemochron Signature Elite for performing Activating Clotting Times (ACT) revealed the Quality Control Plan "Two levels of Liquid Quality Control (LQC) will be performed every thirty-days that the instrument is in use." B. A review of the ACT Quality Control documentation for March and July 2021 (two of ten months) revealed on March 24,2021 LQC level 2 (lot #G0DCA0062) was analyzed with a result of 451. There was no documentation that E-CL 2 laboratory had analyzed LQC level 1 on March 24, 2021. C. The surveyor requested ACT Quality Control documentation for Level 1 on March 24, 2021. None was provided. D. A review of the ACT patient logs revealed patient #941997 had an ACT ran on April 2, 2021 @ 10:13 am. E. In an interview on 10/13/2021 at 10:40, laboratory personnel #1(as listed on form CMS 209) confirmed patient was tested and reported with only one level of acceptable ACT QC on March 24, 2021. D5783