Izard Regional Hospital

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations made during a tour of the laboratory, laboratory policy, and interviews with staff, the laboratory failed to label staining reagents to indicate expiration date and preparation date. Survey findings include: A. During a tour of the laboratory at 2:57 p.m. on 4/2/2025 the surveyor observed three containers of liquid in the lab. They were labelled "Fixative", "Solution 1", and "Solution 2." No other information was on the containers. B. Laboratory policy stated that all reagents will be labelled with expiration dates and storage requirements. C. In an interview, at 3:01 p. m. on 4/2/2025, the Technical Supervisor confirmed the lack of expiration date and storage requirement labels on the staining reagents. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (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. (d)(10)(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. (d)(10)(iii) Statistical parameters for unassayed control materials 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 -- must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on a review of quality control documentation for February 2024, November 2024, and January 2025 chemistry controls, lack of documentation, laboratory policy and interviews with laboratory staff, it was determined the laboratory failed to document criteria for acceptable quality control for Hematology. Survey findings include: A. Laboratory policy "Quality Control Range Establishment" (effective date 9 /16/2021) states "When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch or lot number of control materials must be defined and available." B. The surveyor reviewed chemistry quality control documentation for February 2024, November 2024, and January 2025. The surveyor requested data used for calculating the changes in means for quality control evaluation that occurred in Januray 2025. Initial calculation of the means for all controls of Biorad multiqual controls lots 56761/56763 was available, but the changes in means utilized for Glucose Level 3 (356.63 to 359.63), Albumin Level 1 (2.13 to 2.22), Lactic Acid Level 1 (1.37 to 1.51) and 2 (5.97 to 5.77), Lipase level 2 (139.0 to 139.5), Phosphate Level 1 (2.05 to 1.99), and Aspartate Amino Transferase level 2 (242.46 to 247.24) that occurred mid January had no documented calculations or justification. C. In an interview, at 12:38 p.m. on 4/2/2025, the General Supervisor stated that the documentation of above changes in means for quality control ranges was not available. -- 2 of 2 --

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: Review of the 2024 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute (API) proficiency testing results, showed the laboratory failed to have initial successful participation in proficiency testing for the analyte partial pressure of carbon dioxide(pCO2). Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the 2024 CMS Casper Reports 096D, 0153D and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte pCO2. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte pCO2 in the second proficiency testing event of 2024. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte pCO2 in the third proficiency testing event of 2024. 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: Review of 2024 proficiency testing results, showed 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: Review of the 2024 proficiency testing event, showed the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Hematology test pCO2. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Through 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 two rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 7/11 /23 at 12:50 p.m. two separate rooms (main lab, phlebotomy blood drawing room) 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 phlebotomy blood drawing area. C) During a tour of the laboratory on 7/13/23 at 9:10 a.m. 24 five ml. Vacuette heparin blood collection tubes lot # 822113QY expiration date 2024-05-05, 195 two ml. Vacuette EDTA blood collection tubes lot # 82211328 expiration date 2024-03-06 , 91 two ml. Vacuette Na Citrate blood collection tubes lot # 82302359 expiration date 2024-02-01 , 64 eight ml. BD Serum Separation blood collection tubes lot # 8109767 expiration date 2024- 04-30 , all with a storage temperature requirement of 4 degrees C. to 25 degrees C. were observed in the phlebotomy blood collection room. D) Upon request, the laboratory could not present the temperature records for the storage room in which the 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 -- supplies identified above were stored. E) In an interview on 7/13/23 at 8:30 a.m. , the laboratory staff member (# 3 on the CMS 209) stated " no we don't have temperatures for the phlebotomy blood drawing room". D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (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 blood bank refrigerator temperature recording chart, lack of documentation and interview it was determined that the laboratory did not document proper storage temperature requirements were maintained on one of one occasions when the storage temperature for blood and blood components could not be confirmed on the temperature recording charts. Findings follow: A) Review of the temperature recording chart for the blood storage refrigerator revealed that temperature records were not recorded on 5/11/22 12:00 p.m. until 5/12/22 09:00 a.m. with no notation explaining the lack of recording. B) Upon request, the laboratory was unable to provide documentation of hourly temperature recordings for 5/11/22 at 12:00 PM until 5/12/22 at 09:00 a.m.for the blood storage refrigerator. C) In an interview on 7/12 /23 at 03:03 p.m. the laboratory staff members, (# 3 on the CMS 209 form) , confirmed that the laboratory did not document proper storage temperatures for the blood storage refrigerator for the twenty-one hour period identified above. D5783

Summary Statement of Deficiencies 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 validation documentation for the Opti CCA TS 2 blood gas analyzer, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to verify the normal range of the new test system. Survey findings follow: A. The laboratory documented validation of a new Opti CCA TS 2 blood gas analyzer. The validation documentation was signed by the laboratory director on 3/18/2021. B. A review of the Opti CCA TS 2 new instrument validation data revealed the laboratory failed to verify the normal range for the blood gas tests. C. In an interview at 1:22 p.m. on 7/21/2021, laboratory employee #3 (as listed on the form CMS-209) confirmed the laboratory failed to validate the new instrument normal range for blood gases. 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 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 -- 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 the HORIBA Minotrol-16 Hematology Control assay sheets and instructions for use, a review of the documented establishment of mean and range for hematology controls, and interviews with laboratory staff, it was determined the laboratory failed to establish the statistical parameters for acceptable quality control. Survey findings include: A. The HORIBA Minotrol-16 Hematology Control instructions for use state, "Upon receipt of a new lot of hematology control, each laboratory should establish its own mean value and range." B. Through a review of the HORIBA Minotrol-16 Hematology Control assay sheets for Lot # MX429 (put in use 5/5/2021) and the laboratory's established ranges for hematology controls, it was determined the established ranges were the same values as the assay sheet ranges (not established by the laboratory). Examples are as follows: Low WBC package insert range 0.4 (established lower/upper limits 2.0 +/-0.4); Low Hemoglobin package insert range 0.4 (established lower/upper limits 6 +/- 0.4); Low Platelet package insert range 20 (established lower/upper limits 69.5 +/- 20); Normal WBC package insert range 0.8 (established lower/upper limits 7.8 +/- 0.8); Normal Hemoglobin package insert range 0.6 (established lower/upper limits 13.4 +/- 0.6); Normal Platelet package insert range 40 (established lower/upper limits 250.7 +/- 40); High WBC package insert range 1.6 (established lower/upper limits 20.3 +/- 1.6); and High Hemoglobin package insert range 0.7 (established lower/upper limits 18.2 +/- 0.7). C. In an interview at 10: 06 on 7/21/2021, laboratory employee #3 confirmed the laboratory calculates a target mean for new lots of hematology controls but uses the package insert range as it's acceptable range limits instead of calculating its acceptable range based on statistical parameters. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) 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, a review of the operators manual for the Hemochron Signature Elite coagulation analyzer, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to perform quality control each 8 hours of testing for D-dimer, and the laboratory failed to document two levels of control each 8 hours for Protime and PTT testing. Survey findings include: 1. The laboratory failed to perform quality control each 8 hours of testing for D-dimer. A. A review of the laboratory policies and procedures revealed the written policy for D-dimer states that quality control will be -- 2 of 3 -- performed every 30 days. B. The laboratory had no documentation of D-dimer quality control every 8 hours of testing. C. In an interview, at 1:53 p.m. on 7/20/2021, laboratory employee #3 (as listed on the form CMS-209) stated the D-dimer quality control is performed monthly and she confirmed the laboratory did not have an IQCP for D-dimer. 2. The laboratory failed to document two levels of control each 8 hours of testing for Protime and PTT. A. The IQCP for Protime and PTT, using the Hemochron Signature Elite, states that liquid controls are run once per month or whenever a new lot of cuvettes is opened. It further stated that two levels of electronic quality control will be performed every 8 hours. B. At 9:00 a.m. on 7/21/2021, the surveyor requested electronic quality control documentation. Laboratory employee #3 (as listed on the form CMS-209) stated that the electronic quality control was not printed or saved into the laboratory information system. She further stated that there may be a way to retrieve the quality control data from the instrument. C. A review of the Hemochron Signature Elite operator's manual revealed that the instrument will only hold 600 results. (The laboratory performs 2 levels of electronic quality control on two different tests every 8 hours which would add up to 600 results in 50 days) D. In the interview at 9:00 a.m. on 7/21/2021, laboratory employee #3 confirmed that the instrument would not store two years of quality control data. D5783

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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: Through a review of the proficiency test attestation records for 2018, lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to attest to the routine integration of proficiency test samples in the patient workload on eleven of fourteen proficiency testing events and the individual testing the sample failed to attest the routine integration of proficiency test samples in the patient workload in one of three Immunohematology events. Survey findings follow: A. Review of proficiency testing attestation forms showed the attestation forms for the following proficiency test events were not signed by the laboratory director: First, second and third Chemistry events 2018; First, second and third Hematology Events 2018, Second and third Microbiology Events 2018, First, second and third Immunohematology Events 2018 Chemistry Event 2015. B. Review of proficiency testing attestation forms showed that the individual performing the testing on samples SER-14 and SER-15 on the third Immunohemtology Event in 2018 did not sign the attestation form. C. In an interview, at 02:30 PM on 1/15/19, the technical consultant (as listed on the form CMS-209) confirmed the director failed to sign attestation forms for eleven proficiency testing events in 2018 and further confirmed the attestation form was not signed by the testing individual for samples SER-14 and SER-15 on the third Immunohematology event of 2018. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Through a review of , manufacturer's quality control package inserts, laboratory policy and procedure, laboratory's "QC Statistics", laboratory's Levy Jennings Charts, and interview with laboratory staff, it was determined the laboratory failed to meet applicable analytic systems requirements as evidenced by: D5445- The laboratory failed to identify the external quality control materials intended for use in the laboratory's individualized quality control plan (IQCP). D5469- the laboratory failed to establish quality control acceptable range for Complete Blood Cell analyses as required according to the manufacturer's package insert recommendation . 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 review of the Procedure for "Prothrombin Time (PT)", "Partial Prothrombin Time (APTT)", the laboratory's Individualized Quality Control Plan (IQCP) for Hemochron Signature Elite coagulation analyzer and interview it was determined that the laboratory failed to identify the external controls used for quality control of PT and PTT testing. Findings follow: A. Review of the procedures for "Prothrombin Time (PT)", "Partial Prothrombin Time (APTT)", showed that "external liquid controls" are to be performed once per month and for different lot numbers or shipment of reagent. B. Review of the"type of quality control" section of the IQCP for the Hemochron Signature Elite states "External Quality Control - 2 Levels" but does not identify the external quality control material to be used. C. In an interview on 1/17 /19 at approximately 11:15 AM the technical consultant, as identified on the CMS 209 form, confirmed that the IQCP for the Hemochron Signature Elite coagulation testing system did not specify what external quality control materials would be used. 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 -- 2 of 5 -- 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 review of the manufacturer's package insert for Horiba Mintrol 16 Hematology controls, the laboratory's "Quality Control Protocol", the laboratory's quality control records for 2018, and interview it was determined that the laboratory failed to determine the acceptable range for quality control of Complete Blood Cell (CBC) procedure as required by the manufacturer. Findings follow: A. Review of the manufacturer's package insert for Horiba Mintrol 16 hematology controls showed that "each laboratory should establish its own mean value and range". B. The laboratory's "Quality Control Protocol" defines an acceptable range of plus or minus 2 SD (standard deviations). C. Review of the laboratory's "QC Statistics" for 2018 revealed that the laboratory developed its own target mean but all acceptable ranges matched those published ranges for the Horiba Mintrol 16 package insert. As an example, Mintrol 16 lot # MX413H utilized by the laboratory during the month of October 2018 has a published range of 65 for platelet count which was used by the laboratory as one standard deviation (SD)) to establish its acceptable range. In October of 2018 the laboratory was actually experiencing a SD for platelet count of 24.07 which, according to manufacturer's recommendations and laboratory policy and procedure, should be used to establish an acceptable range. D. In an interview on 1/16/19 at approximately 01:15 PM the technical consultant, identified on the CMS 209 form, confirmed that the laboratory was using twice the values of the ranges published on the manufacturer's package insert for Horiba Mintrol 16 quality control material to establish the acceptable range for the laboratory. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (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 for "Blood Bank Alarm", review of documentation of "Blood Bank Alarm Checks" and interview it was determined that the laboratory was required to perform Blood Bank refrigerator temperature checks on a quarterly basis and performed the checks twice during 2017 and three times in 2018 and only checked high temperature alarming from March 2017 to the date of the survey. Findings follow: A. Review of the laboratory procedure for "Blood Bank Alarm" revealed that "The blood bank alarm will be checked at least four times a year as stated by the Arkansas Rules and Regulations for -- 3 of 5 -- Hospitals and Related Institutions" and the alarm will be checked for temperatures too cold as well as temperatures too warm. B. Review of the documentation of the "Blood Bank Alarm Check" revealed that the alarm was checked on 6/2/17, 3/1/18, 8/9/18 and 11/3/18 and the alarm was checked for only high temperature alarm on those occasions. No other temperature alarm checks were available. C. In an interview on 1 /16/19 at approximately 10:15 AM the technical consultant, as identified on the CMS 209 form, confirmed that the Blood Bank refrigerator temperature alarm checks were not accomplished with the required frequency and lacked the cold temperature checks. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of