Hardeman County Memorial Hospital

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based upon review of manufacturer's instructions, policies and procedures, quality control records patient test records and interview of facility personnel the laboratory failed to test a positive and negative control with each test run when testing 81 patient specimens for Rheumatoid Factor (RF) in 2024. The findings included: 1. Review of the manufacturer's instructions for use of the Arlington Scientific RF Direct Slide Test found on page 3 under the heading QUALITY CONTROL: "REACTIVE and NONREACTIVE CONTROLS should be included in each test run to confirm optimal reactivity of the LATEX REAGENT. If controls do not yield the expected response, the assay should be considered invalid and the assay repeated." 2. Review of the laboratory's own written procedure dated 02/09/2024 found under the heading QUALITY CONTROL: "REACTIVE and NONREACTIVE CONTROLS should be included in each test run to confirm optimal reactivity of the LATEX REAGENT. If controls do not yield the expected response, the assay should be considered invalid and the assay repeated." 3. Review of RF Quality control records found the laboratory tested reactive and nonreactive controls on the following dates in 2024: 01/31/2024 - lot 2J29D3 expiration 04/30/2024 02/29/2024 - lot 2J29D3 expiration 04/30/2024 04 /01/2024 - lot 3P12D3 expiration 09/30/2025 05/01/2024 - lot 3P12D3 expiration 09 /30/2025 05/31/2024 - lot 3P12D3 expiration 09/30/2025 07/01/2024 - lot 3P12D3 expiration 09/30/2025 08/01/2024 - lot 3P12D3 expiration 09/30/2025 08/31/2024 - lot 3P12D3 expiration 09/30/2025 09/24/2024 - lot 3P12D3 expiration 09/30/2025 10 /01/2024 - lot 3P12D3 expiration 09/30/2025 11/01/2024 - lot 3P12D3 expiration 09 /30/2025 11/08/2024 - lot L3L31DC expiration 10/31/2025 12/02/2024 - lot L3L31DC expiration 10/31/2025 4. Review of patient test records found the laboratory tested 81 patients without testing quality control materials with each test 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 -- run as follows: 01/02/2024 - patient 10071050 01/15/2024 - patient 10071422 01/23 /2024 - patient 10071676 01/25/2024 - patient 10071748 01/31/2024 - patient 10071943 02/01/2024 - patient 10071982 02/05/2024 - patient 10072196 02/06/2024 - patient 10072201 02/08/2024 - patient 10072266 02/13/2024 - patient 10072369 02/20 /2024 - patient 10072519 02/21/2024 - patient 10072557 02/26/2024 - patient 10072668 02/27/2024 - patients 10072691 and 10072696 03/04/2024 - patient 10072917 03/08/2024 - patient 10073040 03/15/2024 - patient 10073199 03/21/2024 - patient 10073343 03/22/2024 - patient 10073396 03/28/2024 - 5 proficiency samples 04/05/2024 - patient 10073776 04/08/2024 - patients 10073856, 10073860 and 10073870 04/16/2024 - patient 10074030 04/23/2024 - patient 10074113 04/26/2024 - patient 10074289 04/29/2024 - patient 10074302 04/30/2024 - patients 10074339 and 10074352 05/15/2024 - patient 10074771 06/04/2024 - patient 10075253 06/07/2024 - patient 10075346 06/12/2024 - patient 10075417 06/19/2024 - patients 10075546 and 10075539 06/20/2024 - patient 10075571 06/26/2024 - patient 10075698 07/02/2024 - patients 10075904, 10075896 and 10075908 07/10/2024 - patient 10076079 07/18 /2024 - patient 10076215 08/06/2024 - patient 10076796 08/08/2024 - patient 10076832 08/15/2024 - patient 10076979 08/23/2024 - patient 10077199 09/05/2024 - patients 10077590 and 10077600 09/17/2024 - patient 10077893 09/19/2024 - patient 10077923 09/24/2024 - patient 10078062 09/25/2024 - patients 10078073, 10078082 and 10078088 10/04/2024 - patient 10078390 10/10/2024 - patients 10078524 and 10078519 10/19/2024 - patient 10078581 10/23/2024 - patient 10078845 10/28/2024 - patients 10078931, 10078946 and 10078947 10/31/2024 - patient 10079056 11/07 /2024 - patient 10079329 11/08/2024 - patient 10079372 11/18/2024 - patient 10079568 11/20/2024 - 5 proficiency samples 11/25/2024 - patients 10079754 and 10079781 5. During interview of the Technical Consultant conducted February 5, 2025 at 1:27 PM, she confirmed the laboratory did not test a reactive and nonreactive control with each test run when testing patient samples for RF. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Review of policies and procedures, quality control records and interview of facility personnel found the technical consultant failed review and document the review of Hematology quality control (QC) reports monthly for 24 of 24 months as defined in their own policy. The findings included: 1. Review of the laboratory policy titled SYSMEX XN 550 (dated 05/23/2022) found on page 6 under the heading Frequency of Control Use and Review: "The supervisor reviews the following QC reports at the following intervals: Exception Report every month Summary Report every month Continuous Calibration Verification Certificate every month Detailed Daily Verification Report every month Parameter Report every month Traceability Report every month." 2. Review of quality control records for 2023 and 2024 found no monthly review of the six reports defined in the procedure. 3. During interview of the technical consultant conducted February 5, 2025 at 10:37 AM, she confirmed that she did not have documentation of the monthly reviews for 2023 and 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey conducted 03/20/2023 found the facility in substantial compliance with CLIA regulations (42 CFR Part 493). Standard level deficiencies were cited. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of the facility blood/blood product transfusion policies, a random review of patient transfusion records (01/2022-12/2022), and confirmed in staff interview, it was revealed the facility failed to ensure possible transfusion reactions were promptly identified, investigated, and documented for 3 of 12 patients that received blood products in 2022. Findings Included: 1. Review of facility policy, "Blood Transfusion Policy" (Effective: 03/01/2010) revealed the following: "Management of Suspected Transfusion Reaction 1. If a reaction occurs, it usually manifests with in the first fifteen minutes of the transfusion. However, transfusion related adverse events can occur hour after the transfusion is complete. 2. Some common signs and symptoms associated with transfusion reactions are: Fever (increase in temperature (100.4) from baseline) Skin manifestations - Urticaria Hemoglobinuria Oliguria- decreased urine output Anuria- absence of urine output Nausea/Vomiting- sweating, weakness, increase saliva, urge to vomit Pain- back, muscle, flank Chills/rigors with or without fever Abnormal bleeding- any new onset or unsuspected bleeding occurrence. Oozing blood at IV site. Respiratory distress /Shortness of breath Hypotension- clinically significant decrease in blood pressure (30 mmHg fall in systolic) Hypertension- clinically significant decrease in blood pressure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- (30 mmHg rise in systolic) TRALI (Transfusion Related Lung Injury) TACO (Transfusion Associated Circulatory Overload) 3. Stop transfusion 4. Two licensed nursing staff, one must be an RN, will check the blood bag identification against the patient identification. 5. Notify physician and Lab. Lab will provide a transfusion reaction investigation form to the RN to fill out. The Lab will notify the blood bank. 6. Get order for UA- Collect urine specimen for examination, send blood bag with completed transfusion reaction investigation for to the Lab. 7. Take any measurements to stabilize/support the patient throughout the event." 2. Random review of patient transfusion records in 2022, revealed the following 3 of 12 patients in which the facility did not follow its own policy to ensure transfusion reactions were promptly identified, investigated, and documented for all blood products: a. 02/20/2022-02/21 /2023 Patient ID: 54659 Product: Unit Number W091022129966; Packed Red Blood Cells Transfusion start time: 23:30 Blood Pressure at 23:30: 108/60 mmHg Blood Pressure at 01:55: 161/87 mmHg The rise in systolic pressure was 53 mmHg. Per facility policy, an increase in blood pressure by 30 mmHg indicated a transfusion reaction. No documentation of a transfusion reaction investigation was provided. b. 03 /12/2022 Patient ID: 6892 Product: Unit Number W091022128672; Packed Red Blood Cells Transfusion start time: 16:00 Blood Pressure at 16:00: 118/67 mmHg Blood Pressure at 18:00: 169/69 mmHg Review of laboratory transfusion form completeted by nursing staff revealed the following: "Transfusion reaction: No" The rise in systolic pressure was 51 mmHg. Per facility policy, an increase in blood pressure by 30 mmHg indicated a transfusion reaction. No documentation of a transfusion reaction investigation was provided. c. 04/02/2022 Patient ID: 7138 Product: Unit Number W091022146646; Packed Red Blood Cells Transfusion start time: 21:20 Blood Pressure at 21:05 (baseline): 121/62mmHg Blood Pressure at 18: 00: 159/85 mmHg Review of laboratory transfusion form completeted by nursing staff revealed the following: "Transfusion reaction: No" The rise in systolic pressure was 38 mmHg from baseline. Per facility policy, an increase in blood pressure by 30 mmHg indicated a transfusion reaction. No documentation of a transfusion reaction investigation was provided. 3. During an interview with the general supervisor (GS-1) on 03/20/2023, at 12:35 p.m. in the laboratory, GS-1 stated the laboratory performed audits and discovered the above possible transfusion reactions. These transfusion reactions were not communicated to the laboratory by the facility. This confirmed the facility failed to ensure possible transfusion reactions were promptly identified, investigated, and documented for 3 of 12 patients that received blood products in 2022. Word Key RN- Registered Nurse mmHg-millimeter of mercury D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on review of the laboratory policy, patient test requisitions, and confirmed in interview, the laboratory failed to ensure patient test requisitions solicited date and/or time of specimen collection for Complete Blood Count (CBC) specimens collected from outside facilities for 12 of 12 patients from March 2023 (random sampling). The findings include: 1. Review of the laboratory policy for pre-analytic systems revealed: "PREANALYSIS Preanalysis refers to all complex steps that must take place before a sample can be analyzed. Preanalytic factors include patient related variable such as diet, age, sex, specimen collection and labeling techniques, specimen preservatives and anticoagulants, specimen transport and processing and storage. Specimen Collection a. The Test Order In order for the laboratory personnel to begin the process, a written order from the doctor or an electronic request through the laboratory information system is needed. Verbal orders are accepted in emergency situations and are documented on a standard form. However, an official laboratory request or computerized order should be received within 72 hours of verbal order. b. Time of Collection Specimen collected and submitted to the laboratory must have time of collection at all times. c. Specimen Rejection All Specimens must be collected, labeled, transported and processed according to established procedures. The following are the criteria for rejecting specimens: i. Unlabeled or mislabeled ii. Discrepancies between requisition and specimen label iii. Specimen type unsuitable for the test ordered iv. Hemolyzed and lipemic specimens v. Clots present in anticoagulated sample vi. Nonfasting specimen when the test requires fasting vii. Short draws, wrong volume viii. Improper blood collection tube ix. Inadequate specimen-anticoagulant ratio x. Improper transport conditions xi. Specimen too old for testing xii. Contaminated specimen/leaking container" The policy did not specify date of collection as a required element for test requisitions. 2. A random review of patient test requisitions revealed the following 12 patients whose requisitions did not include a collection date and/or time: Patient IDs: 10063734, 10063735, 10063927, 10063937, 10063954, 10063984, 10064064, 10064096, 10064117, 10064131, 10064183, 10064208 3. During the exit conference on 03/20/2023 at 6:00 p.m., the Laboratory Manager confirmed the above findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on review of laboratory policy, manufacturer's instructions, patient test records, and confirmed in interview, the laboratory failed to ensure patient complete blood count (CBC) specimens were not analyzed beyond the manufacturers stability requirements prior to testing on the Sysmex XN-L 550 hematology analyzer for 3 of 11 specimens in March 2023 (random sampling). The findings include: 1. Review of the laboratory policy titled "COMPLETE BLOOD COUNT USING SYSMEX XN 550" revealed: "Specimen Collection, Preservation, and Transport: Unhemolysed [sic] -- 3 of 6 -- whole blood collected on a lavender top K2 EDTA. Sample is stable for 24 hours after collection at room temperature." 2. Review of the Sysmex Basic Operation guide revealed: "Chapter 4 Analyzing Samples ... 4.3 Preparing Samples ... Handling whole blood Mix the venous blood with an anticoagulant (EDTA-2K or EDTA-3K). Draw the amount of venous blood that is specified for the amount of EDTA anticoagulant. The sample should be analyzed within 4 hours after collection. If it is not possible to analyze the sample within 4 hours, store it in a refrigerator at 2 to 8C until it can be analyzed ..." 3. Review of the Sysmex Method Verification Manual revealed: "Section 3 Method Verification Protocols ... It is the customer's responsibility to perform additional studies, following the requirements of their accrediting agency. The following protocols are provided: Correlation Studies (CAS assists) Sensitivity Studies (See Resource Manual) Reference Range Verification (See Resource Manual) Stability Study (See Resource Manual) Mixing Study (See Resource Manual) Typically, method verification studies are performed on new analyzers to verify and document satisfactory analyzer performance according to the manufacturer's specifications. It is up to the laboratory to perform more extensive studies if they deem it necessary to satisfy requirements over and above what is contained in these protocols." 4. During an interview on 03/20/2023 at 12:44 p.m., the surveyor asked the Laboratory Manager if stability studies were performed for the Sysmex XN-L 550 hematology analyzer. The Laboratory Manager stated that the laboratory did not perform any stability studies. 5. A random review of patient test records from March 2023 revealed the following patients whose CBCs were performed beyond the manufacturer's 4-hour stability requirement: Patient ID: 10063734 Collection date /time: 03/01/2023 at 10:50 hours Analysis date/time: 03/01/2023 at 16:47 hours Elapsed time from collection to analysis: 5 hours and 57 minutes Patient ID: 10063927 Collection date/time: 03/06/2023 at 10:30 hours Analysis date/time: 03/06 /2023 at 15:17 hours Elapsed time from collection to analysis: 4 hours and 47 minutes Patient ID: 10064131 Collection date/time: 03/15/2023 at 09:00 hours Analysis date /time: 03/15/2023 at 13:04 hours Elapsed time from collection to analysis: 4 hours and 4 minutes The laboratory did not ensure their written preanalytical requirements were consistent with manufacturer's preanalytical requirements. The laboratory extended the specimen stability beyond manufacturer's instructions for the above CBC specimens and could not provide studies to support the extended stability. 6. During an exit conference on 03/20/2023 at 06:00 p.m., the Laboratory Manager confirmed the above findings. II. Based on laboratory policy, patient test records, and confirmed in interview, the laboratory failed to ensure patient slides for manual differentials were labeled with at least 2 unique patient identifiers for 5 of 7 slides in March of 2023 (random sampling). The findings include: 1. Review of the laboratory policy titled "BLOOD SMEAR PREPARTION" revealed: "Procedure: 1. Prepare a thing film of blood from EDTA tube. 2. Label slide in pensil [sic] with patients last name /date and order number (at least 2 patient identifier) ..." The laboratory policy did not include labeling instructions to reliably identify patients using at least 2 unique patient identifiers to distinguish between specimens. 2. A random review of patient slides from March 2023 revealed 5 of 7 slides labeled with only a patient last name and order number. The laboratory failed to ensure patient slides for manual differentials were labeled with at least 2 unique patient identifiers. 3. During an interview on 03/20 /2023 at 1:37 p.m., the Laboratory Manager confirmed the above findings. D5781

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observations and interview with facility personnel, the laboratory failed to ensure 6 of 6 royal blue top blood collection tubes and 2 of 3 grey top Sodium Fluoride tubes were available for use in collecting patient specimens on February 20, 2019. The findings included: 1. Based on surveyor observations on Wednesday, February 20, 2019 in the phlebotomy room, the surveyor observed the following blood collection tubes in the rack beside the phlebotomy chair available for collecting patient specimens: 6 of 6 royal blue blood collection tubes Manufacturer: Becton Dickinson Lot: 8011601 Expiration: 2019-01-31 Elapsed time: the tubes were expired by 20 days 2 of 3 grey top Sodium Fluoride blood collection tubes Manufacturer: Becton Dickinson Lot: 7180569 Expiration: 12-31-2018 Elapsed time: the tubes were expired by 51 days 2. In an interview at 16:51 hours on 2/20/2019 in the phlebotomy room, the Laboratory Manager confirmed the blood collection tubes were available for use beyond the expiration date printed on the tubes. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of the MTS diluent dispenser instructions for use, laboratory maintenance records, and interview with facility personnel, the laboratory failed to perform required weekly maintenance procedures for 1 of 1 repetitive dispenser for 38 of 52 weekly cleaning events in 2018. The findings included: 1. Based on review of the Ortho MTS Dispenser Repetitive Dispenser of 0.5 or 1.0 mL Instructions for Use (Pub. No. J33098_EN), on page 3 of 5, the document states the following: "Cleaning: The dispenser should be cleaned on a weekly basis as follows: 1. Remove the dispenser from the diluent bottle. Dispense diluent until the outlet line is empty. 2. Rise and decant the inside of the cap with 70 percent Isopropyl Alcohol. 3. Rinse and decant the inside of the cap with copious amounts of deionized or distilled water. 4. Aspirate with 70 percent Isopropyl Alcohol a minimum of 15 times through the dispenser into a waste receptacle. 5. Remove the dispenser from the 70 percent Isopropyl Alcohol solution. 6. Dispense into the waste receptacle the remained 70 percent Isopropyl Alcohol that is left in the tubing until the outlet line is empty. 7. Wipe the inlet tubing with a soft cloth so as not to contaminate the deionized or distilled water with the 70 percent Isopropyl Alcohol solution. 8. Flush the dispenser with freshly drawn deionized or distilled water a minimum of 20 dispenses into a waste receptacle. 9. Remove the dispenser from the deionized or distilled water. 10. Dispense into a waste receptacle the remained water that is left in the tubing until the outlet line is empty. 11. Wipe dry the inlet tubing wand outer dispenser surface with a soft, clean cloth. 12. If ready for use, prime line a minimum of one time, with appropriate diluent to be dispensed. If the dispenser will not be used for a while, store dry." This document was laminated and stored in the blood bank area of the laboratory. 2. Based on review of laboratory maintenance records "Quality Control Record", MTS Dispenser Weekly Cleaning was documented as being performed on the following 14 dates in 2018: 1/4/2018 1/11/2018 2/5/2018 2/28/2018 3/8/2018 4/9 /2018 5/17/2018 6/26/2018 7/16/2018 8/23/2018 9/6/2018 10/19/2018 11/21/2018 12 /28/2018 There are 52 weeks per calendar year. The laboratory documented the weekly maintenance 14 times. Weekly maintenance was not performed for 38 of 52 weeks. The laboratory reported an annual volume of 259 tests annually for immunohematology on the CMS-116 collected the day of the survey. 3. In an interview at 15:06 hours on 2/20/2019 in the laboratory, when asked to describe how weekly maintenance was performed on the MTS diluent dispensers, the Laboratory Manager stated the frequency had been changed from weekly to monthly before she had assumed the responsibilities as Laboratory Manager in October of 2018 and that it was the Lab Manager's understanding there was a product notification or similar document that initiated the change in maintenance frequency. 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. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on review of hematology control instructions for use, surveyor observations, quality control record review, and interview with facility personnel, the laboratory failed to follow manufacturer instructions for setting acceptability criteria for 2 of 2 lots of control materials currently in use to detect immediate error in hematology analyzer performance. The findings included: 1. Based on review of the Sysmex E CHECK (XS) control instructions for use, under Performance characteristics and limitations, the document states the following: "The mean assay values for each parameter of e-CHECKS(XS) are derived from replicate analysis on whole blood calibrated instrumentation. The mean values obtained on e-CHECKS(XS) should be within the expected ranges. The expected ranges listed on the assay sheet represent estimates of inter-laboratory variation for each parameter. These expected ranges should not be used as QC file limits." And; "e-CHECKS(XS) is intended for use only on Sysmex XS-Series analyzers with Sysmex reagents. E-CHECKS(XS) assay targets and limits are model specific. 2. Based on review of the Sysmex Product Notification "Sysmex Evidence Based Control Limits" (07/2017), under Action, states the following: "1. Enter model specific control limits from the table attached. 2. Auto-set the control target value and limit for each parameter using minimum of 10 analyses. 3. Verify target values are within published assay ranges. 4. Analyze QC according to your laboratory's established protocols." 3. Based on surveyor observations at 16:42 hours on 2/20/2019, the Limit Range percent for each analyte was set at 100 percent control lots 83520805 and 83520806. For example, Control Level 3, Lot 83520806, the analyte mean platelet volume (MPV) had a target of 9.9 and the Limit Range percent was set at 100 percent. According to the "Sysmex Evidence Based Control Limits" (07/2017), the Limit Range Percent should have been 6.3 percent. Another example: Control Level 2, Lot 83520805, the analyte Hemoglobin was had a target of 11.6 and a Limit Range percent of 100 percent. According to the "Sysmex Evidence Based Control Limits" (07/2017), the Limit Range Percent should have been 4.3 percent. The ranges of control acceptability were too wide for the laboratory to detect immediate error. 4. In an interview at 16:45 hours on 2/20/2019, the Laboratory Manager stated the laboratory had been unaware of the product notification "Sysmex Evidence Based Control Limits" (07/2017) and had not known how to set acceptability criteria on the Sysmex XS-1000i hematology analyzer. 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: -- 3 of 7 -- Based on a review of laboratory policy, quality control records, quality control peer review records, and interview with laboratory personnel, the laboratory failed to establish a step by step procedure for establishing quality control acceptability criteria for 1 of 1 lot of control material reviewed on February 20, 2019. The findings included: 1. Based on review of the procedure "Laboratory Policies", last reviewed by the laboratory director on 10/22/2018, the procedure states the following on page 12: "8. The mean and standard deviation will be established "in-house" with results being compared to other laboratories using the same instrument and reagent. At least ten comparisons will be run on each new lot of controls." 2. Based on review of the Bio- Rad Immunoassay Plus instructions for use, under Assignment of Values, states the following: "It The mean values and corresponding plus/minus 3SD ranges in the Assignment of Values Data Charts were derived from replicate analysis and are specific for this lot of product. Data from Unity Interlaboratory Program are included in the determination of some ranges. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacture test method modifications." 3. Based on review of quality control records, the laboratory was using a target mean of 0.8 and a target one standard deviation of 0.07 for Level 1 Free T4, Lot: 40961. The plus/minus two (2) standard deviation range was 0.66 - 0.94. This information differed from other sources. The ranges provided from Bio-Rad, to be used only as guides were as follows: Target: 0.829 1 SD: 0.053 The cumulative statistics for the laboratory: Cumulative mean: 0.788 Cumulative 1 SD: 0.044 With a sample size of 255 points, contributed by this laboratory on this analyzer. The cumulative statistics from a peer group of other laboratories using an Access II chemistry analyzer and this method of Free T4: Peer cumulative mean: 0.781 Peer cumulative 1 SD: 0.046 With a sample size of 38,939 points, contributed by this laboratory and other laboratories using the Free T4 reagent on an Access II chemistry analyzer. The 1SD target used by the laboratory was 27.6 percent larger than the 1 SD target provided as guide by the Bio-Rad instructions for use, 39 percent greater than the peer cumulative 1 SD, 45.6 percent larger than the lot-to-date cumulative statistics generated by the laboratory. 4. In an interview with the laboratory manager at 15:45 hours on 2/202/2019 in the laboratory, when asked to describe the laboratory policy for establishing acceptability criteria, the Laboratory Manager stated the laboratory used the peer review data to guide QC limit decisions, but did not have an evidence based policy on how to establish QC limits. D5783