Harper County Community Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/25,26,27,28/2025. The laboratory was found out of compliance with the following CLIA Conditions: 493.1213; D5022: Toxicology, High Complexity 493.1441; D6076: Laboratory Director, High Complexity The findings were reviewed with the chief executive officer, laboratory director, technical consultant, and testing person #3 at the conclusion of the survey. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, urine drug screen package insert and test kit box, FDA database, email correspondence with an FDA representative, and interview with the technical consultant and laboratory manager, the laboratory failed to ensure the requirements were met for the subspecialty of Toxicology for nine of nine months of patient testing. Findings include: (1) The laboratory failed to have written policy defining the method to verify the accuracy of the urine drug screen testing at least twice annually. Refer to D5401; (2) The laboratory failed to establish the performance specifications for the Accurate Urine DOA Rapid Test Dipcard test not cleared or approved by the FDA. Refer to D5423; (3) The laboratory failed to perform a negative and positive control material 14 of 14 days of patient urine drug screen testing. Refer to D5449. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with testing person #3, the laboratory failed to document competency assessments of the clinical consultant and technical consultants, based on the position responsibilities as listed in Subpart M, for one of one clinical consultant and for two of two technical consultants. Findings include: (1) On 03/25/2025 at 2:00 pm, a review of written policies identified no evidence of competency assesments for the clinical consultant and two technical consultants; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of April 2023 through the current date identified competencies, based on job responsibilities, had not been performed for one of one persons listed as clinical consultant and two of two technical consultants. (3) The findings were reviewed with testing person #3 who stated on 03/25/2025 at 2:00 pm, competency assessments had not been performed for the roles of clinical consultant and technical consultant. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures and interview with the laboratory manager, the laboratory failed to have written policy defining the method to verify the accuracy of the urine drug screen testing at least twice annually during a review period of 06/01/2023 through 12/31/2024. Findings include: (1) On 03/27 /2025 at 01:30 pm, the technical consultant stated the Alere multi-CLIN drug screen test devices had been put into use for patient testing on 04/01/2023 (refer to D5423 for specific information pertaining to the test kit not being FDA approved and defaulting to a high complexity test system); (2) A review of urine drug screen records, policies and procedures, and proficiency testing for 2024 revealed the laboratory had not enrolled and participated in a proficiency testing program and there was no evidence a policy had been written to ensure a method to verify the accuracy of the testing at least twice annually; (3) The records were reviewed with the laboratory manager who stated on 03/27/2025 at 01:30 pm the laboratory did not have a method to verify the accuracy of urine drug screen testing at least twice annually because it was believed the test kit was categorized as waived; (4) Refer to D5423 for examples of patient testing. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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 -- 2 of 7 -- applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: Based on a review of records, observation, and interview with the interim laboratory manager, the laboratory failed to ensure one of one box of QIAstat RP SARS-Co-V-2 Control materials was stored as required by the manufacturer for two of 25 days reviewed. Findings include: (1) On 03/25/2025 at 02:00 pm, observation of the contents of the chemistry freezer identified the following: (a) One box of QIAstat RP SARS-Co-V-2 Control materials, lot # M22NOV24. (2) The storage requirement, as stated on the box for the control materials was -15 degrees C (Celsius) to -25 degrees C; (3) Observation of the freezer temperature on 03/25/2025 at 2:00 pm identified the current temperature reading as -27 degrees C; (4) A review of the freezer temperature logs from March 1 to March 25, 2024 identified the following: (a) The temperatures were colder than -25 degrees C for two of 25 days reviewed. (5) The findings were reviewed with the technical consultant who stated on 03/25/2025 at 2:00 pm, the freezer temperatures were not within the manufacturer's storage requirements. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a review of records, urine drug screen package insert and test kit box, FDA database, email correspondence with FDA representative, and interview with the technical consultant and testing person #3, the laboratory failed to establish the performance specifications for the Alere multi-CLIN Drug Screen Test Device not categorized by the FDA. Findings include: (1) On 03/25/2025 at 11:00 am, the technical consultant stated urine drug screen testing was performed using the Alere multi-CLIN Drug Screen Test Device test kit, as stated on the test kit box; (2) On 03 /25/2025 a review of the urine drug screen package insert showed the name of the manufacturer as "Alcon" which did not match the name on the test kit box; (3) A review of the FDA (Food and Drug Administration) test classification database did not include a classification for the test kit (if a test is not included on the FDA site, then it did not go through the FDA approval process, which defaults the categorization of the test as high complexity). This was also confirmed during email correspondence with an FDA representative on 03/26/2025; (4) Interview with testing person #3 on 03 /27/2025 at 01:00 pm confirmed the test kit had been put into use for patient testing on or around 06/1/2024; (5) A review of records for the test system revealed no -- 3 of 7 -- evidence the performance specifications of accuracy, precision, analytical sensitivity, analytical specificity, reportable range, and reference intervals as applicable, had been established prior to putting the test into use for patient testing; (6) The findings were reviewed with the technical consultant, who stated on 03/27/2025 at 01:00 pm the laboratory did not establish the performance specifications prior to putting the test kit into use because it was believed the test kit was categorized as waived; (7) The following were examples of patient urine drug screen testing performed (number represents accession number): (a) Patient #903241790005 - Testing performed on 06 /27/2024 (b) Patient #903242010013 - Testing performed on 07/19/2024 (c) Patient #903242180027 - Testing performed on 08/05/2024 (d) Patient #903242480001 - Testing performed on 09/04/2024 (e) Patient #903242720001 - Testing performed on 09/28/2024 (f) Patient #903242800001 - Testing performed on 10/06/2024 (g) Patient #903242820022 - Testing performed on 10/08/2024 (h) Patient #903242950013 - Testing performed on 10/21/2024 (i) Patient #903243130002 - Testing performed on 11/08/2024 (j) Patient #903243190005 - Testing performed on 11/14/2024 (k) Patient #903243310041 - Testing performed on 11/26/2024 (l) Patient #903243590012 - Testing performed on 12/25/2024 (m) Patient #903243610002 - Testing performed on 12/26/2024 (n) Patient #903243610002 - Testing performed on 12/26/2024 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's maintenance checklist, and interview with technical consultant, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures during the review period of July 2023 through the current date. Findings include: (1) On 03/26/2025 at 11:15 am, the technical consultant stated Protime and Activated Partial Prothrombin Time testing were performed using the Sysmex CA-600 series analyzer; (2) A review of the the manufacturer's CA-600 maintenance Checklist required the following maintenance procedure: (a) Yearly - "Replace Rinse Filter". (3) A review of maintenance logs from July 2023 through the current date identified the yearly maintenance had not been documented as performed between 07/01/2023 and 03/26 /2025; (4) The findings were reviewed with the technical consultant who stated on 03 /26/2025 at 11:15 am the laboratory was unable to provide documentation of maintenance performed as stated above. 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 on a review of records and interview with the technical consultant and testing person #3, the laboratory failed to perform a negative and positive control material 14 of 14 days of patient urine drug screen testing. Findings include: (1) On 03/27/2025 at 01:35 pm, testing person #3 stated the Alere multi-CLIN Drug Screen Test Device had been put into use for patient testing on or around 06/01/2024 (refer to D5423 for -- 4 of 7 -- specific information pertaining to the test kit not being FDA approved and defaulting to a high complexity test system); (2) A review of QC (Quality Control) and patient testing records from June 2024 through December 2024, revealed negative and positive QC materials had not been performed each day of patient testing for 14 of 14 days of patient testing and there was no evidence an IQCP (Individualized Quality Control Program) had been developed; (3) The technical consultant stated on 03/27 /2025 at 01:35 pm negative and positive QC materials had not been performed each day of patient testing and an IQCP had not been developed because it was believed the test kit was categorized as waived; (4) The following were the days of patient testing reviewed when negative and positive QC materials had not been performed: (a) Patient #903241790005 - Testing performed on 06/27/2024 (b) Patient #903242010013 - Testing performed on 07/19/2024 (c) Patient #903242180027 - Testing performed on 08/05/2024 (d) Patient #903242480001 - Testing performed on 09/04/2024 (e) Patient #903242720001 - Testing performed on 09/28/2024 (f) Patient #903242800001 - Testing performed on 10/06/2024 (g) Patient #903242820022 - Testing performed on 10/08/2024 (h) Patient #903242950013 - Testing performed on 10/21/2024 (i) Patient #903243130002 - Testing performed on 11/08/2024 (j) Patient #903243190005 - Testing performed on 11/14/2024 (k) Patient #903243310041 - Testing performed on 11/26/2024 (l) Patient #903243590012 - Testing performed on 12/25/2024 (m) Patient #903243610002 - Testing performed on 12/26/2024 (n) Patient #903243610002 - Testing performed on 12/26/2024 D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the technical consultant, the laboratory failed to comply with 21 CFR 606.160(b)(3)(v). The laboratory failed to ensure that emergency release of blood forms had been signed by the physician for one of one emergency releases reviewed. Findings include: (1) On 03 /27/2025 at 10:00 am, the technical consultant stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for patient transfusions; (2) On 03/27/2025 a review of the form titled, "Release of uncrossmatched blood" required a Release of Uncrossmatched form be completed and stated, "Due to life- threatening condition of this patient: I hereby authorize the administration of unit #_____ to patient_______ on ______ with the knowledge that this is an uncrossmatched unit which could result in complications of a transfusion reaction. The form included a space for the attending physician signature"; (3) A review of documentation of emergency issue identified the following for one of one patient records: (a) One unit of O negative packed red blood cells had been released to a patient on 04/21/2024. The "Release of Uncrossmatched Blood" form appeared to be signed by a mid-level provider and not a physician. (4) The documentation was reviewed with the technical consultant who stated on 03/27/2025 at 10:00 am, the emergency release had not been signed by a physician. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 5 of 7 -- (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for three of nine Immunohematology, Hematology/Coagulation and Chemistry core proficiency testing events reviewed in 2024. Findings include: (1) A review of 2024 proficiency testing events identified attestation statements had been signed after the samples had been tested (after the graded evaluations were available from the proficiency testing program) for three of nine events reviewed: (a) First Hematology/Coagulation Event - The sample testing had been completed on 03/12 /2024 and the attestation statement had not been signed by the laboratory director until 05/21/2024; (b) First Immunohematology Event - The sample testing had been completed on 04/02/2024 and the attestation statement had not been signed by the laboratory director until 05/21/2024; (c) Third Chemistry Core Event - The sample testing had been completed on 08/28/2024 and the attestation statement had not been signed by the laboratory director until 10/28/2024; (2) The records were reviewed with the technical consultant who stated on 03/25/2025 at 1:45 pm the attestation statements had not been signed timely as stated above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records, urine drug screen package insert and test kit box, FDA database, email correspondence with an FDA representative, and interview with the technical consultant and laboratory manager, the laboratory director failed to provide overall management and direction for a urine drug screen test for nine of nine months of testing. Findings include: (1) The laboratory director failed to ensure the multi- CLIN Drug Screen Test Device urine drug screen test provided quality results for patient care for nine of nine months of testing. Refer to D6085. D6085 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3) (e)(3) Ensure that-- (e)(3)(i) The test methodologies selected have the capability of providing the quality of results required for patient care; This STANDARD is not met as evidenced by: Based on a review of records, urine drug screen package insert and test kit box, FDA database, email correspondence with FDA representative, and interview with the technical consultant and testing person #3, the laboratory director failed to ensure a urine drug screen test provided quality results for patient care for nine of nine months of patient testing. Findings include: (1) The laboratory director failed to ensure the -- 6 of 7 -- FDA categorization of the Multi-CLIN Drug Screen Test Device prior to using for patient testing. Refer to D5401, D5423, and D5449. -- 7 of 7 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1441; D6076: Laboratory Director, High Complexity 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 a desk review of proficiency testing records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under 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 -- CLIA The laboratory failed to achieve satisfactory performance in three of four consecutive proficiency testing events for Compatibility Testing. (Refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 a desk review of proficiency testing scores, the laboratory failed to achieve satisfactory performance for Compatibility Testing in three of four consecutive testing events. Findings include: (1) The laboratory received the following scores: (a) 60% on the first 2022 event (b) 80% on the second 2022 event (c) 0% on the first 2023 event (2) A proficiency testing desk review from API 2022 and 2023 proficiency testing records confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the American Proficiency Institute, the laboratory demonstrated non-initial unsuccessful participation for Compatibility Testing in three of four consecutive testing events. The laboratory failed to achieve a passing score of 100% for the first 2022 event, second 2022 event, and first 2023 event. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the American Proficiency Institute, the laboratory demonstrated non-initial unsuccessful participation for Compatibility Testing in three of four consecutive testing events. The laboratory failed to achieve a passing score of 100% for the first 2022 event, second 2022 event, and first 2023 event. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/31/2023. The laboratory was found out of compliance with the following CLIA Condition: 493.1409; D6033: Technical Consultant The findings were reviewed with the chief executive officer and interim laboratory manager during an exit conference performed at the conclusion of the survey. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of policies and interview with testing person #1, the laboratory failed to ensure one of three policies had been approved, signed, and dated by the current laboratory director. Findings include: (1) On 09/30/2022 at 02:50 pm, testing person #1 stated the Respiratory SARS-CoV-2 Panel Cartridge was performed using the Qiagen QIA Stat DX analyzer and an IQCP (Individualized Quality Control Plan) had been developed for the test system: (2) A review of the IQCP identified the QCP (Quality Control Plan) for the test system had not been approved, signed, and dated by the laboratory director; (3) The records were reviewed with testing person #1 who stated on 03/30/2023 at 02:06 pm, the QCP for the above test system had not been approved, signed, and dated by the laboratory director. 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 9 -- This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with testing person #1, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for two of four analyzers. Findings include: SYSMEX CA-660 (1) On 03/27/2023 at 02:57 pm, testing person #1 stated the laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing using the Sysmex CA-660 analyzer; (2) A review of the manufacturer's maintenance log showed the following required maintenance procedures: (a) Quarterly - "Clean DI Water Rinse Bottle with Alcohol" (b) Yearly - "Replace Rinse filter" (3) A review of maintenance logs from 01/01/2022 through 02/28/2023 identified maintenance had not been performed as follows: (a) Quarterly - Not documented as performed after 04/08/2022 (b) Yearly - Not documented as performed during the review period (4) The records were reviewed with testing person #1 who stated on 03/30/2023 at 01:15 pm the maintenance had not been documented as performed as shown above. QIAGEN STAT DX (1) On 03/27 /2023 at 03:00 pm, testing person #1 stated the laboratory performed testing for Adenovirus, Coronavirus 229E, Coronovirus HRU1, Coronovirus ML63, Coronovirus OC43, Human Metapnuemonovirus, Influenza A, Influenza AH1, Influenza AH1N1, Influenza H3, Infuenza B, Parainfluenza Virus 1, 2, 3 4, RSV A&B, Rhinovirus /Enterovirus, SARS-CoV2, Bordetella Pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae were performed using the Respiratory SARS-CoV-2 Panel Cartridge and the Qiagen QIA Stat DX analyzer; (2) A review of the operator's manual in section 8 "Maintenance" stated "The air filter must be changed every year to ensure the appropriate airflow rate inside the unit"; (3) A review of records from June 2021 through February 2023 identified no evidence the air filter had been changed during the review period; (4) The findings were reviewed with testing person #1 who stated on 03/30/2023 at 03:46 pm, the maintenance had not been documented as performed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly during the review period of June 2021 through the current date. Finding include: (1) On 03/29/2023 at 02:50 pm, the laboratory manager stated the following: (a) Urine sediment examinations were performed in the laboratory; (b) The specimens were processed in the Labsco Model 614V centrifuge at a speed of 1800 rpm (revolutions per minute) for 5 minutes; (2) A review of the policy titled, "Urinalysis Centrifuge RPM and Timer Check" stated the following: (a) "The time of -- 2 of 9 -- the centrifugation of the Labsco 614V centrifuge used for urinalysis must be verified once every six months and documented on the Verification and Maintenance Log Sheet"; (b) "The RPM of the Labsco 614V Centrifuge used for urinalysis must be verified once every six months and documented on the Verification and Maintenance Log Sheet". (3) A review of centrifuge records from June 2021 through the current date identified the centrifuge speed and timer had not been checked between 01/12 /2022 and 01/31/2023; (4) The records were reviewed with the interim laboratory manager who stated on 03/30/2023 at 10:15 am the laboratory had not followed their policy. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager and testing person #1, the laboratory failed to perform calibration verification procedures at least once every six months for three of three test systems. Findings include: EPOC (1) On 03/29/2023 at 02:18 pm, the interim laboratory manager stated the laboratory performed BUN, Chloride, Creatinine, CO2, Glucose, Sodium, and Potassium testing using the EPOC analyzer as a backup method to the Ortho Vitros 350 analyzer; (2) On 03/30/2023 a review of records from January 2022 through the current date identified no evidence calibration verification had been performed prior to 09/27/2022; (3) The records were reviewed with testing person #1 who stated on 03/30/2023 at 11:05 am, calibration verification procedures had not been performed every six months. TRIAGE METER PRO (1) On 03/29/2023 at 02:25 pm, the interim laboratory manager stated the laboratory performed D-dimer testing using the Biosite Triage Meter Pro analyzer; (2) On 03/30/2023 a review of records from September 2021 through the current date identified no evidence calibration verification had been performed after 02/23/2022; (3) The records were reviewed with testing person #1 who stated on 03/30/2023 at 11:14 am, calibration verification procedures had not been performed every six months. AFFINION 2 (1) On 03/29/2023 at 02:35 pm, the interim laboratory manager stated the laboratory performed Diagnostic Hemoglobin -- 3 of 9 -- A1c testing using the Affinion Hemoglobin A1c DX and the Affinion 2 analyzer; (2) On 03/30/2023 a review of records from June 2021 through the current date identified no evidence calibration verification had been performed as follows: (a) Between 06/14 /2021 and 07/20/2022 (b) After 07/20/2022 (3) The records were reviewed with testing person #1 who stated on 03/30/2023 at 11:40 am, calibration verification procedures had not been performed every six months. 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: Based on a review of records and interview with testing person #1, the laboratory failed to perform quality control as stated in the IQCP (Individualized Quality Control Plan) for one of three test systems during the review period of September 2022 through February 2023. Findings include: (1) On 03/30/2022 at 02:50 pm, testing person #1 stated the following: (a) Adenovirus, Coronavirus 229E, Coronovirus HRU1, Coronovirus ML63, Coronovirus OC43, Human Metapnuemonovirus, Influenza A, Influenza AH1, Influenza AH1N1, Influenza H3, Infuenza B, Parainfluenza Virus 1, 2, 3 4, RSV A&B, Rhinovirus/Enterovirus, SARS-CoV2, Bordetella Pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae were performed using the Respiratory SARS-CoV-2 Panel Cartridge and the Qiagen QIA Stat DX analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) A review of the QCP (Quality Control Plan) identified positive and negative quality control materials were to be tested each seven days and with new lot numbers of cartridges; (3) A review of QC records from September 2022 through February 2023 identified QC testing had not been performed as stated in the QCP as follows: (a) Between 09/28/2022 and 10/21/2022 (b) Between 10/21/2022 and 11/16/2022 (c) Between 01/13/2023 and 01/27/2023 (d) Between 02 /10/2023 and 02/27/2023 (4) The records were reviewed with testing person #1 who stated on 03/30/2023 at 02:35 pm, QC had not been performed as stated above. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the interim laboratory manager and testing person #1, the laboratory failed to follow the -- 4 of 9 -- manufacturer's specifications for the Architect BNP Controls for one of two months reviewed. Findings include: (1) On 03/31/2023 at 09:05 am, testing person #1 stated the following: (a) BNP (B-Type Natriuretic Peptide) testing was performed using the Abbott Architect Plus i1000 SR analyzer; (b) Three levels of Architect BNP Controls were performed each day of patient testing. (2) A review of the manufacturer;s instructions (package insert) for the control materials stated, "Each laboratory should establish its own concentration ranges for new control lots at each control level"; (3) A review of QC (quality control) records for one lot number of control materials used during the review period of 12/01/2022 through 01/31/2023 identified the following: (a) Control L, Control M, and Control H lot #44K18621 were in use; (b) The laboratory had used the following manufacturer's guideline ranges from 01/01/2023-01 /31/2023 instead of their established ranges: (i) Control L - 57.6-122.4 pg/ml (ii) Control M - 320-680 pg/ml (iii) Control H - 2240-4760 pg/ml (4) The records were reviewed with the interim laboratory manager and testing person #1. Both stated on 03 /31/2023 at 10:50 am the laboratory had not followed the manufacturer's instructions for the control materials. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the testing person #1, the laboratory failed to perform one sample of control material each 8 hours of patient blood gas testing using a combination of control materials that include both low and high values on each day of testing for one of 21 patients reviewed. Findings include: (1) On 03/30 /2023 at 02:40 pm, testing person #1 stated the following: (a) Blood gas testing (pH, pCO2, pO2) was performed on the EPOC analyzer; (b) Two levels of quality control (QC) material were performed each eight hours of patient testing. (2) A review of QC and patient records for testing performed from 06/06/2022-01/16/2023 identified that QC testing had not been performed each eight hours of patient testing (two levels had not been performed on the day of patient testing) for one of 21 patients reviewed: (a) The patient had been tested on 06/30/2022; (b) Two levels of QC materials had not been tested between 06/27/2022 and 07/01/2022. (3) The records were reviewed with testing person #1 who stated on 03/30/2023 at 03:35 pm, QC testing had not been performed each eight hours of patient testing. 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. -- 5 of 9 -- This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the interim laboratory manager, the laboratory failed to ensure units of blood were stored under appropriate conditions during the review period of June 2021 through December 2022. Findings include: (1) On 03/29/2023 at 02:20 pm, the interim laboratory manager stated the laboratory stored units of packed red blood cells in the Helmer blood bank refrigerator. The units were to be used for patient transfusions; (2) A review of the policy titled "Blood Bank Alarm Test" stated, "The alarm system should be tested quarterly"; (3) A review of alarm check records from June 2021 through December 2022 identified no evidence the alarm checks had been performed between: (a) 09/17/2021 and 03/30/2022 (b) 03/20/2022 and 03/21/2023 (4) The findings were reviewed with the interim laboratory manger who stated on 03/30/2023 at 09:50 am there was no documentation to prove the alarm checks had been performed as stated above. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results for Routine Chemistry testing performed using two test methods during the review period of June 2021 through January 2023. Findings include: (1) On 03/29/2023 at 02:18 pm, the interim laboratory manager stated the laboratory performed BUN, Chloride, Creatinine, CO2, Glucose, Sodium, and Potassium testing using the EPOC analyzer as a backup method to the Ortho Vitros 350 analyzer; (2) On 03/30/2023 a review of records from January 2022 through the current date identified the relationship between the two test methods had not been evaluated after 06/07/2022; (3) The records were reviewed with testing person #1 who stated on 03/30/2023 at 11:10 am, the relationship between the above test methods had not been evaluated at least twice annually during the review period. 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP (Quality Control Plan) for one of three test systems. Findings include: (1) On 03/30/2022 at 02: 50 pm, testing person #1 stated the following: (a) Adenovirus, Coronavirus 229E, -- 6 of 9 -- Coronovirus HRU1, Coronovirus ML63, Coronovirus OC43, Human Metapnuemonovirus, Influenza A, Influenza AH1, Influenza AH1N1, Influenza H3, Infuenza B, Parainfluenza Virus 1, 2, 3 4, RSV A&B, Rhinovirus/Enterovirus, SARS- CoV2, Bordetella Pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae were performed using the Respiratory SARS-CoV-2 Panel Cartridge and the Qiagen QIA Stat DX analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system, dated as approved on 02/21/2021. (2) A review of the IQCP identified that QA (Quality Assessment) reviews of the QCP (Quality Control Plans) were to be performed on an annual basis; (3) A review of records for the test system from 2021 through the current date identified no documentation an annual QA review had been performed since the implementation of the test system; (4) The records were reviewed with testing person #1 who stated on 03 /30/2023 at 02:32 pm, an annual QA review had not been documented as performed since the implementation of the IQCP. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of one patient report and interview with the interim laboratory manager and testing person #1, the laboratory failed to make appropriate reference ranges available for two of two reagent lot numbers implemented for PT (Prothrombin Time) and PTT (Partial Thromboplastin Time) testing. Findings include: (1) On 03/29 /2023 at 02:57 pm, the interim laboratory manager stated the laboratory performed PT /INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing using the Sysmex CA-660 analyzer; (2) On 03/30/2023 at 11:30 am, testing person #1 stated the following reagent lot numbers were put into use on 10/04/2022: (a) Dade Innovin lot #564616A (b) Dade Actin FSL - #562705 (3) A review of the implementation records identified the following: (a) PT - The normal reference interval had been verified as 9.7-10.9 (b) PTT - The normal reference interval had been verified as 23.8-25.3 (4) A review of a patient report with PT and PTT testing performed on 03/16/2023 showed the following normal ranges: (a) PT - 9.0-11.0 (b) PTT - 21.1-27.7 (5) The reports and implementation records were reviewed with testing person #1 who stated on 03/30/2023 at 01:30 pm, the laboratory had not updated the normal reference ranges into the laboratory's computer information system. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager, the technical consultant failed to provide technical supervision in accordance with -- 7 of 9 -- 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035; (2) The technical consultant failed to ensure competency evaluations for moderate complexity testing had been performed semiannually during the first year of testing for one of three testing persons. Refer to D6053. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for three of four competency evaluations. Findings include: (1) On 03/29/2023 a review of records for four persons performing moderate complexity testing during 2021 and to date in 2023 identified the following for three of four testing persons: (a) Testing Person #1 - The 08/17/2022 evaluation had been performed by an individual who did not meet the regulatory requirements of a technical consultant; (b) Testing Person #3 - The 08/17 /2023 evaluation had been performed by an individual who did not meet the -- 8 of 9 -- regulatory requirements of a technical consultant; (c) Testing Person #4 - The 08/19 /2022 evaluation had been performed by an individual who did not meet the regulatory requirements of a technical consultant. (2) The records were reviewed with the interim manager who stated on 03/27/2023 at 04:00 pm, the evaluations had been performed by an individual who did not meet the qualifications of a technical consultant. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager, the technical consultant failed to ensure competency evaluations for moderate complexity testing had been performed semiannually during the first year of testing for one of three testing persons. Findings include: (1) On 03/29/2023 a review of personnel records for three persons hired to perform moderate complexity testing after the previous recertification survey identified the following for one of three persons: (a) Testing Person #4 - The initial training was complete on 06/21/2021. There was no evidence a competency evaluation had been performed prior to 08/19/2022; (2) The records were reviewed with the interim laboratory manager who stated on 03/29/2023 at 04:17 pm, a semiannual competency evaluation had not been performed. -- 9 of 9 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions of Participation: 493.803; D2016: Successful Participation 493.1441; D6076: Laboratory Director, High Complexity 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from the American Proficiency Institute, the laboratory failed to successfully participate in a proficiency 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 -- testing program for the subspecialty of Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive proficiency testing events for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 a desk review of proficiency testing scores, the laboratory failed to achieve satisfactory performance for Compatibility Testing in two consecutive testing events. Findings include: (1) The laboratory received a score of 60% on the first event in 2022 and a score of 80% on the second event in 2022. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the American Proficiency Institute, the laboratory failed to achieve satisfactory performance for Compatibility Testing in two consecutive testing events. The laboratory failed to achieve a passing score of 100% for the first 2022 event and second 2022 event. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the American Proficiency Institute, the laboratory failed to achieve satisfactory performance for Compatibility Testing in two consecutive testing events. The laboratory failed to achieve a passing score of 100% for the first 2022 event and second 2022 event. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/22,23/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager at the conclusion of the survey. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for implementing coagulation reagents. Findings include: (1) On 04/22/2021 at 08:35 am, the laboratory manager stated the following to the surveyor: (a) The Sysmex CA-620 analyzer was used to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing; (b) The following reagent lot numbers were put into use on 12/11/2020: (i) PT - Innovin reagent, lot #549755B (ii) PTT - Actin reagent, lot #562628A (2) The surveyor reviewed the manufacturer's instructions contained in the "Siemens Sysmex CA-600 Installation Guide" for implementing new reagents, which stated, "The following recommendations should be used as a guideline when converting to new lots of reagents for Hemostasis analyzers. These procedures should be followed each year before new lots of reagents are put into use on the existing Hemostasis system". In addition, the manufacturer required the following: (a) Section titled, "Method Correlation" (i) "40 samples: 20 normal, 20 abnormal"; (ii) "Normal samples (Section I) may be used for the Method Correlation and Verification of Reference Range"; (iii) "Abnormal samples should span the Reportable Range of assay"; (iv) "Assay samples on current and new lot number Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- reagents simultaneously or within 1 our of each other"; (v) "Calculate Linear Regression statistics". (3) The surveyor reviewed the records for the lot changes with the following identified: (a) PT Innovin reagent (i) Method Correlation - The records showed the laboratory had used 20 abnormal samples, but they did not span the Reportable Range of the assay. The laboratory had used samples that ranged from 12.9-44.8 and the laboratory's reportable range was 8.9-138.5. (b) PTT Actin reagent (i) Method Correlation - The records showed the laboratory had used 20 abnormal samples, but they did not span the Reportable Range of the assay. The laboratory had used samples that ranged from 28.8-41.2 and the laboratory's reportable range was 22.7-224.10. (4) The surveyor reviewed the findings with the laboratory manager who stated on 04/22/2021 at 03:00 pm, the manufacturer's instructions had not been followed for the reagent lot changes as specified above. 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: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure the demonstrated reportable range was utilized for Hemoglobin A1c testing. Findings include: (1) On 04/22/2021 at 08:40 am, the laboratory manager stated to the surveyor the laboratory began performing Hemoglobin A1c testing using the Afinion 2 Hemoglobin A1c DX assay on 06/30 /2020; (2) The surveyor reviewed the performance specification records and identified the laboratory had demonstrated a reportable range of 4.99-12.26; (3) The surveyor then reviewed the records with the laboratory manager and asked for documentation to ensure the laboratory was utilizing the reportable range that had been demonstrated by the laboratory. The laboratory manager provided documentation and stated the to the surveyor on 04/22/2021 at 3:30 pm, the laboratory was using the manufacturer's reportable range of 4.0-14.1 instead of the reportable range of 4.99-12.26 that had been demonstrated by 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: Based on a review of records, policies and procedures, AABB Technical Manual, and -- 2 of 4 -- interview with the laboratory manager, the laboratory failed to ensure that blood products were stored under appropriate conditions for 2 of 9 alarm checks. Findings include: (1) On 04/22/2021 at 08:40 am, the laboratory manager stated to the surveyor units of packed red blood cells, which were stored in the blood bank refrigerator, were used for patient transfusions; (2) The surveyor reviewed the policy titled, "Blood Bank Alarm Test" which stated, "The alarm system should be tested quarterly" and provided acceptable results for the low and high alarm checks and stated: (a) "The high alarm should sound at 5.5 C +/- 1.0 C" (b) "The low alarm should sound at 1 C +/- 1.0 C" (3) Based on the policy, the surveyor documented the ranges the laboratory allowed for the alarm checks which were: (a) The laboratory defined an acceptable high alarm check as 4.5 degrees C (Centigrade) to 6.5 degrees C; (b) The laboratory defined an acceptable low alarm check as 0 degrees C to 2.0 degrees C. (4) As a reference, the surveyor reviewed the AABB (American Association of Blood Banks) Technical Manual, Fifteenth Edition on page 184 under the heading "Refrigerated Storage" which stated, "Blood must be stored only in refrigerators that, by desing and capacity, maintain the required blood storage temperatures of 1 to 6 C throughout their interior space"; (5) Based on the above, the surveyor determined the acceptable results for the alarm checks documented in the laboratory's policy titled, "Blood Bank Alarm Test" allowed for temperatures beyond the range of 1.0 to 6.0 degrees C. The surveyor then reviewed alarm checks performed during 2019 through the current date. The high alarm check results sounded at temperatures warmer than 6.0 degrees C (the warmest allowable temperature for blood products) for 2 of 9 alarm checks performed as follows: (a) 09/20/2019 - The temperature for the high alarm check sounded at 6.5 degrees C; (b) 06/05/2020 - The temperature for the high alarm check sounded at 6.2 degrees C. (6) The surveyor reviewed the records with the laboratory manger who stated the acceptable ranges for the alarm checks, as stated in the policy, were not correct; and the temperature the alarm sounded for the high alarm checks above were not acceptable. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of written policies and interview with the laboratory manager and director of nursing, the laboratory failed to ensure that written policies provided safety for individuals being transfused for 1 of 4 units of packed red blood cells. Findings include: (1) On 04/22/2021 at 08:40 am, the laboratory manager stated to the surveyor the laboratory stored units of packed red blood cells in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On 04/23/2021, the surveyor reviewed the hospital policy regarding transfusion reactions. The policy titled, "Blood Transfusion Record" stated, "Obtain vital signs immediately prior to start of -- 3 of 4 -- administration of the product, 15 minutes after start of the product, 30 minutes after the start of the product for one hour, and then hourly until discontinuation of unit"; (3) The surveyor then reviewed records for 4 units of PRBC's (Packed Red Blood Cells) that had been transfused between 07/24/2020 through 02/06/2021 for 4 patients. It was identified the vitals had not been taken hourly after the first hour until discontinuation of the unit as follows: (a) Patient #14763 - Transfused with 1 unit of PRBC's (unit #W091021110754) on 02/05,05/2021. The vitals had not been taken between: (i) 02/05/2021 at 08:30 pm and 10:09 pm; (ii) 02/05/2021 at 11:20 pm and 02 /06/2021 at 01:57 am. (4) The surveyor reviewed the findings with the laboratory manager and the director of nursing. Both stated on 04/23/2021 at 11:00 am, the vitals had not been taken hourly as specified above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/29/19 through 02/01/19. The findings were reviewed with the laboratory manager at the conclusion of the survey. The laboratory was found to be in compliance with standard-level deficiencies cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to perform a technical consultant and general supervisor competency based on the position responsibilities as listed in Subpart M. Findings include: (1) On the first day of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017 and 2018. There was no evidence competencies had been performed for the technical consultant and general supervisor, based on their job responsibilities; (2) The surveyor asked the laboratory manager if competencies had been performed for the technical consultant and general supervisor, based on job responsibilities. The laboratory manager stated the competencies had not been performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 -- This STANDARD is not met as evidenced by: Based on a review of written policies and procedures and interview with the laboratory manager, the laboratory failed to follow a written procedure for verifying donor units of packed red blood cells. Findings include: (1) On the third day of the survey, the laboratory manager stated to the surveyor that verifying ABO/Rh donor packed RBC's (red blood cells) was performed using the tube method; (2) The surveyor reviewed the Quick Retyping On Oklahoma Blood Institute Units policy which stated, "A. Follow the ABO/Rh Blood Typing -Tube Procedure (forward type only). B. Read and record all reactions in the Blood Bank Record Book."; (3) The surveyor reviewed 21 donor unit retyping records for testing performed from 08/15/18 through 12/18/18. For 6 of the 21 donor unit records there was no indication the laboratory staff followed their written procedure for retyping donor units: (a) Unit# W09101829922 - There was no documentation of results for the forward type (Anti A cells, Anti B cells, and Anti A,B cells); (b) Unit# W091018289925 - There was no documentation of results for the forward type (Anti A cells, Anti B cells, and Anti A, B cells); (c) Unit# W091018345109 - There was no documentation of results for the forward type (Anti A cells, Anti B cells, and Anti A,B cells); (d) Unit# W091018362942 - There was no documentation of results for the forward type (Anti A cells, Anti B cells, and Anti A,B cells); (e) Unit# W091018329435 - There was no documentation of result for the forward type (Anti A,B cells); (f) Unit# W091018329433 - There was no documentation of result for the forward type (Anti A, B cells). (4) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated the laboratory failed to follow their procedure for retyping donor units. 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to follow their policy for monitoring the effectiveness of their IQCP. Findings include: (1) On the second day of the survey, the laboratory manager stated the following to the surveyor: (a) The laboratory performed D-Dimer testing using the Biosite Triage Meter Plus analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP (dated as effective 05/01/16). The QA (Quality Assessment) portion of the IQCP did not include a schedule for evaluating the QCP to ensure it continued to provide accurate and reliable test results; (3) The surveyor reviewed the records with the laboratory manager and asked if there was a policy to address how the laboratory will monitor the IQCP, including the frequency of the reviews and if a QA review had been performed since 03/17/17. The laboratory manager stated a policy had not been written and a QA review had not been performed as indicated above. -- 2 of 2 --