Holdenville General Hospital

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/10,11,12,13/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #2, laboratory manager, and testing person #2 at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory manager, the laboratory failed to follow manufacturer's directions to ensure Nova StatStrip glucose test strips had not exceeded their room temperature expiration date; and failed to follow manufacturer's directions for ensuring Fentanyl testing cassettes were not compromised prior to patient testing. Findings include: I. NOVA STATSTRIPS (1) On 06/10/2025 at 12:28 pm, the laboratory manager stated glucose testing was performed on the Nova Stat Meter in the emergency department and on the nursing floor; (2) Observation of the emergency department on 06/10/2025 at 12:28 pm identified one open bottle (Lot #0325027249, expiration 01/27/2027) of Novastat test strips stored at room temperature, without documentation of when they were put in use; (3) Review of the manufacturer's storage requirements stated the following: (a) "Write the discard date on the bottle label. The test strips are stable for six months after opening or until the expiration date on the bottle label, whichever comes first". (4) Interview with the laboratory manager on 06/10/2025 at 12:28 pm confirmed the bottle had been opened without a method to monitor if they exceeded the manufacturer's modified expiration date. II. FENTANYL RAPID TEST CASSETTES (1) On 06/10/2025 at 12:38 pm, the laboratory manager stated Fentanyl testing was 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 -- performed using Discover Fentanyl Rapid Test Cassettes; (2) Observation of the laboratory on 06/10/2025 at 12:38 pm identified one open cassette (Lot #FYL23110008U, expiration 11/23/2025) without documentation of when it was opened, stored in a biohazard bag; (3) Review of the manufacturer's warnings and precautions stated the following: (a) "Do not use the test if foil pouch is torn or damaged, The test device should remain in the sealed pouch until use". (4) Interview with the laboratory manager on 06/10/2025 at 12:38 pm confirmed the cassette had not been kept inside the sealed pouch until ready for use. 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 policies and procedures, interview with the laboratory manager and technical consultant #2, the laboratory failed to have a written procedure that explained the current practice and procedure being performed in the laboratory for processing specimens for Chemistry and Immunoassay testing using two of two centrifuges; and failed to follow their policy for ensuring the health status of the donors for the Coagulation lot rollover studies. Findings include: I. CHEMISTRY AND IMMUNOASSAY (1) On 06/10/2025 at 11:00 am, the laboratory manager stated the following: (a) Routine Chemistry and Immunoassay testing were performed using the Siemens Dimension EXL 200 analyzer; (b) The specimens were processed using the Silencer #67943 centrifuge at a speed of 4000 rpm (revolutions per minute) for five minutes, and the Benchtop 6F centrifuge at a speed of 3365 rpm for eight minutes. (2) A review of the procedure titled, "Platelet Poor Plasma and Serum" identified the following: (a) Under the heading "Clinical Application" it stated, "It is also necessary for all chemistry and immunoassay plasma and/or serum samples to be platelet poor per the laboratory best practices"; (b) Under the heading "Specimen Collection and Handling" it stated, "Specimens will be evaluated on the appropriate centrifuges annually"; (c) Under the heading "Procedure" it stated, "Each tube will be centrifuged for the appropriate time in the appropriate centrifuge. For example, a Li heparin tube for chemistry will be centrifuged in the Silencer #67943 for 5 minutes at 4000 rpms and The Benchtop 6F centrifuge for 8 minutes at 3365 rpms. A platelet count will then be performed before testing on that tube to ensure platelet poor plasma". (3) Interview with technical consultant #2 during a phone call following the survey on 06/17/2025 at 11:25 am confirmed the laboratory did not perform platelet poor plasma using Lithium Heparin tubes and the procedure did not reflect the laboratory's current practice for the two centrifuges. II. NORMAL PATIENTS FOR PT/PTT LOT ROLLOVER (1) On 06/10/2025 at 11:00 am, the laboratory manager stated the following: (a) The laboratory performed Coagulation (PT/INR and PTT) testing using the ACL Elite analyzer; (b) During the coagulation lot rollover studies, the laboratory utilized ten healthy adult males and ten healthy adult female donors. (2) A review of the procedure titled, "Protime and PTT Lot Roll-Over Procedures" identified the following: (a) Under the heading "Normal Reference Range" section b, it stated, "Need at least 20 patients for a rollover-use the questionnaire; it needs to include age, gender, name or identifier, healthy patients (status= no pathological conditions like diabetes, lupus, auto-immune disease, nothing affecting coagulation); -- 2 of 6 -- (3) A review of the "Hemostasis Roll-Over Normal Patient Worksheet" identified no documentation to verify the health status of the donors; (4) Interview with technical consultant #2 and the laboratory manager on 06/12/2025 at 02:55 pm confirmed the laboratory failed to include questionnaires for ensuring the health status of the donors for the coagulation lot rollover studies. 48517 Based on review of policy, direct observation, and interview with technical consultant #2, the laboratory failed to follow their policy for blood bank specimen labeling for two of two patients observered. Findings include: 1. On 06/11/2025 at 1:00 pm a review of the procedure, "Specimen Identification and Integrity" stated, "All samples must be labeled with the patient's first and last names, patient's date of birth, date and time of collection, and the phlebotomist's initials."; 2. Direct observation of the lab on 06/11/2025 at 1:00 pm, revealed two Ortho MTS blood bank gel testing cards labeled with a patient's first and last name only; 3. Interview with technical consultant #2 at 1:00 pm on 06/11/2025, confirmed the laboratory failed to follow their policy for specimen identification and integrity. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 laboratory procedures and interview with technical consultant #2 and laboratory manager, the laboratory failed to ensure one of six procedures had been approved, signed, and dated by the laboratory director. Findings include: (1) A review of laboratory procedures identified no evidence the procedure titled "Platelet Poor Plasma and Serum" had been signed and dated as approved by the laboratory director; (2) The procedure was reviewed with technical consultant #2 and laboratory manager. Both stated on 06/13/2025 at 09:30 am, the procedure had not been signed and dated as approved by the laboratory director. 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 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 observation and interview with technical consultant #2, the laboratory failed to ensure three of three types of blood collection tubes were stored as required by the manufacturer at the emergency room nurse's station. Findings include: (1) Observation of the emergency room nurse's station and interview with technical consultant #2 on 06/11/2025 at 2:00 pm, identified the following: (a) Eight Vacuette Gel and Lithium Heparin tubes, lot # B241134X, storage temperature of 4-25 degrees -- 3 of 6 -- (C) centigrade; (b) Ten Vacuette K2 EDTA 7.2 mg tubes, lot # B241134W, storage temperature of 4-25 degrees C; (c) Seven Vacuette Sodium Citrate Collection tubes, lot # B240833V, storage temperature of 4-25 degrees C. (2) Interview with technical consultant #2 on 06/11/2025 at 02:00 pm confirmed the laboratory was not monitoring the temperature of the emergency room nurse's station. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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. (b)(2)(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 technical consultant #2 and the laboratory manager, the laboratory failed to have a written function check protocol to ensure urine and coagulation centrifuges were functioning properly during the review period of June 2023 through the current date. Findings include: I. URINE CENTRIFUGE (1) On 06/10/2025 at 10:19 am, technical consultant #2 and the laboratory manager stated the following: (a) The laboratory performed urine sediment examinations; (b) The urine specimens were processed at a speed of 1800 rpms (revolutions per minute) for 5 minutes using the Drucker Diagnostics Horizon 642 VES centrifuge. (2) Although the speed and time function checks had been performed at least twice annually for the urine centrifuge, a function check protocol that defined the frequency of the speed and timer checks and limits of acceptability could not be located; (3) The findings were reviewed with technical consultant #2 and the laboratory manager who confirmed on 06/11/2025 at 02:30 pm, there was no written protocol that defined the centrifuge speed and timer function check. COAGULATION CENTRIFUGE (1) On 06/10/2025 at 10:19 am, technical consultant #2 and the laboratory manager stated the following: (a) The laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing using the ACL Elite analyzer; (b) The specimens were processed using the Hamilton Bell Vanguard V6500 centrifuge at a speed of 3600 rpm for 15 minutes. (2) Although the speed and time function checks had been performed annually for the centrifuge, a function check protocol that defined the frequency of the speed and timer checks and limits of acceptability could not be located; (3) The findings were reviewed with technical consultant #2 and laboratory manager who confirmed on 06 /11/2025 at 02:30 pm, there was no written protocol that defined the centrifuge speed and timer function check. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 -- 4 of 6 -- 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 technical consultant #2, the laboratory failed to perform calibration verification procedures at least once every six months for the Triage D-Dimer test system during the review period of 12/29/2023 through the current date. Findings include: (1) On 06/12/2025 at 10:45 am, technical consultant #2 stated the laboratory performed D-Dimer testing using the Triage meter pro analyzer; (2) A review of records from 12/29/2023 through the current date identified no evidence the calibration verification procedures had been performed for D-dimer between 06/12/2024 and 05/22/2025. (3) The findings were reviewed with technical consultant #2, who stated on 06/12/2025 at 10:45 am, the calibration verification procedures had not been performed every six months as stated above. 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 technical consultant #2, 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 six of 13 emergency releases reviewed. Findings include: (1) On 06/12 /2025 at 10:00 am, technical consultant #2 stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for patient transfusions; (2) On 06/12/2025 a review of the form titled, "Emergency transfusion request for uncrossmatched blood or for universal donor blood" required a Release of Uncrossmatched form be completed and stated, "I believe the life of this patient ________ will be in jeopardy without an emergency transfusion. I therefore accept responsibility for any adverse reactions, which my occur from this transfusion."; (3) A review of documentation of emergency issues identified the following for six of 13 patient records: (a) Three units of O negative packed red blood cells had been released to a patient on 04/20/2025. The "Release of Uncrossmatched Blood" form appeared to be signed by a mid-level provider and not a physician; (b) One unit of O negative packed red blood cells had been released to a patient on 07/16/2024. The "Release of Uncrossmatched Blood" form appeared to be signed by a mid-level provider and not a physician; (c) Two units of O negative packed red blood cells had been released to a patient on 07/04/2024. The "Release of Uncrossmatched Blood" form appeared to be signed by a mid-level provider and not a physician; (d) One unit of O negative packed -- 5 of 6 -- red blood cells had been released to a patient on 06/21/2024. The "Release of Uncrossmatched Blood" form appeared to be signed by a mid-level provider and not a physician; (e) Two units of O negative packed red blood cells had been released to a patient on 06/24/2024. The "Release of Uncrossmatched Blood" form appeared to be signed by a mid-level provider and not a physician; (f) One unit of O Positive packed red blood cells had been released to a patient on 07/14/2024. 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 technical consultant #2, who stated on 06/12/2025 at 10:00 am, the emergency releases had not been signed by a physician. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (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 technical consultant #2, 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 20 proficiency testing events reviewed in 2024 and 2025. Findings include: (1) On 06/10/2025, a review of 2024 and 2025 proficiency testing events identified attestation statements had not been signed before the graded evaluation was completed by the proficiency testing program for three of 20 events reviewed: (a) First Chemistry Miscellaneous Event 2025 - The graded evaluation was completed on 05/30/2025 and the attestation statement had not been signed by the laboratory director; (b) Second Hematology/Coagulation Event 2024 - The grade evaluation was completed on 09/16/2024 and the attestation was signed 09/16/2024; (c) Second Chemistry Core Event 2024 - The graded evaluation was completed on 07 /22/2024 and the attestation was signed on 07/22/2024. (2) The records were reviewed with technical consultant #2, who stated on 06/10/2025 at 01:10 pm the attestation statements had not been signed timely as stated above. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/08/2021 and 07/09/2021. The findings were reviewed with the chief executive officer, general supervisor/technical consultant #2, the laboratory manager, testing person #3, testing person #4, testing person #5, and the phlebotomist during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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. 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 performing maintenance procedures for the Dimension EXL 200 analyzer. Findings include: (1) On 07/08/2021 at 10:05 am, the laboratory manager stated to surveyor #1 *CMP, *Lipid Profile, Amylase, Pro-BNP (B-Type Natriuretic Peptide), CK (Creatine Kinase), CKMB, Direct Bilirubin, Lactic Acid, Hemoglobin A1c, Magnesium, Phosphorus, PSA (Prostate Specific Antigen), Uric Acid, and Troponin I testing were performed on the Siemens Dimension EXL 200 analyzer; (2) On 07/09/2021, surveyor #1 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's weekly maintenance log titled, "Dimension EXL Weekly and Monthly Maintenance". The weekly requirements were as follows: (a) Clean Outside of R2 Probe (b) Clean Outside of HM Wash Probes (3) Surveyor #1 then reviewed maintenance records from February 2020 through June 2021. The weekly maintenance had not been documented as performed between: (a) 04/23/2020 and 05 /08/2020 (b) 03/25/2021 and 04/06/2021 (4) Surveyor #1 reviewed the findings with 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 -- the laboratory manager who stated on 07/09/2021 at 12:45 the weekly maintenance had not been documented as performed as identified above. *Comprehensive Metabolic Panel (CMP) - Albumin, Alkaline Phosphatase, ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), BUN (Blood Urea Nitrogen), Calcium, Chloride, CO2, Creatinine, Glucose, Potassium, Sodium, Total Bilirubin and Total Protein *Lipid Profile - Total Cholesterol, HDL Cholesterol, Triglyceride 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 the laboratory manager, the laboratory failed to ensure IQCP's included the required components. Findings include: (1) On 07/08/2021 at 10:00 am, the laboratory manager stated to the following to surveyor #1: (a) The following testing was performed using 2 iSTAT 1 analyzers (Serial Numbers 390874 and 418361): (i) pH, pCO2, pO2, and Lactate testing using the CG4+ test cartridge; (ii) Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, Creatinine, Hemoglobin, and Hematocrit testing using the Chem 8+ test cartridge; (iii) Troponin I testing using the CTnI test cartridge. (b) An IQCP had been developed for the test systems. (2) Surveyor #1 reviewed the IQCP for the test systems and identified a QA plan had not been included in the IQCP (it consisted of a Risk Assessment and QCP only); (3) Surveyor #1 reviewed the records with the laboratory manager who stated on 07/08/2021 at 12:30 pm, a QA plan had not been included in the IQCP. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the general supervisor/technical consultant #2 and testing person #1, the laboratory failed -- 2 of 4 -- to have procedures to detect an ABO incompatibility between the donor's cell type and the recipient serum or plasma type for 41 of 41 patients. Findings include: (1) On 07/08/2021 at 09:50 am, testing person #1 stated to surveyor #1 the Ortho MTS Anti- IgG gel card was used to perform patient antibody screen and compatibility testing; (2) On 07/09/2021, surveyor #2 reviewed the manufacturer's instructions contained in the package insert for the MTS Anti-IgG gel cards. The instructions stated, "The MTS Anti-IgG Gel Test System can be used in both direct and indirect antiglobulin test systems to detect the presence or absence of IgG on human red blood cells"; (3) Surveyor #2 then reviewed the blood bank log book for patient compatibility testing performed from 01/04/2021 through 07/07/2021. For 41 of 41 patients reviewed (76 of 76 units), the records indicated the laboratory only used the Anti-IgG gel cards to perform patient compatibility testing, and therefore, did not include a method to detect ABO incompatibilities based on IgM antibodies (in order to achieve this, an immediate spin crossmatch, containing the donor's red blood cells and the recipient's serum or plasma, or an electronic crossmatch must be performed in conjunction with the IgG crossmatch); (4) The findings were reviewed on 07/09/2021 with the general supervisor/technical consultant #2 and testing person #2. Both stated on 07/09/2021 at 12:35 pm they were not aware that an immediate spin crossmatch must be performed to detect IgM antibodies; (5) Days of patients in which an immediate spin crossmatch had not been performed were: (a) 01/04/2021 - 2 units crossmatched (b) 01/12/2021 - 2 units crossmatched (c) 01/13/2021 - 2 units crossmatched (d) 01/18/2021 - 2 units crossmatched (e) 01/23/2021 - 2 units crossmatched (f) 01/24/2021 - 2 units crossmatched (g) 02/12/2021 - 2 units crossmatched (h) 02/19/2021 - 2 units crossmatched (i) 02/24/2021 - 2 units crossmatched (j) 02/26/2021 - 1 unit crossmatched (k) 03/05/2021 - 2 units crossmatched (l) 03/08/2021 - 2 units crossmatched (m) 03/09/2021 - 2 units crossmatched (n) 03/13/2021 - 2 units crossmatched (o) 03/15/2021 - 2 units crossmatched (p) 03/17/2021 - 2 units crossmatched (r) 03/20/2021 - 1 unit crossmatched (s) 03/22/2021 - 2 units crossmatched (t) 03/23/2021 - 2 units crossmatched (u) 03/25/2021 - 2 units crossmatched (v) 03/28/2021 - 2 units crossmatched (w) 04/05/2021 - 2 units crossmatched (x) 04/06/2021 - 2 units crossmatched (y) 04/07/2021 - 2 units crossmatched (z) 04/14/2021 - 2 units crossmatched (aa) 04/16/2021 - 2 units crossmatched (bb) 04/19/2021 - 2 units crossmatched (cc) 04/28/2021 - 2 units crossmatched (dd) 05/04/2021 - 2 units crossmatched (ee) 05/10/2021 - 2 units crossmatched (ff) 05/20/2021 - 2 units crossmatched (gg) 05/24/2021 - 1 unit crossmatched (hh) 05/25/2021 - 2 units crossmatched (ii) 06/02/2021 - 1 unit crossmatched (jj) 06/14/2021 - 2 units crossmatched (kk) 06/15/2021 - 2 units crossmatched (ll) 06/17/2021 - 2 units crossmatched (mm) 06/18/2021 - 2 units crossmatched (nn) 06/19/2021 - 2 units crossmatched (oo) 07/07/2021 - 2 units crossmatched NOTE: The following reference was published in the CLIA Network Newsletter dated July-August 2009: "The gel card only detects incompatibility based on IgG antibodies. It does not detect incompatibility based on IgM antibodies, which is important in determining ABO compatibility. Therefore, the use of the gel card alone is not adequate to demonstrate incompatibility between the donor's cell type and the recipient's serum type, and the laboratory must also perform an immediate spin or electronic crossmatch to determine ABO compatibility." NOTE: The Interpretive Guidelines at 493.1271 requires standard operating procedures for compatibility testing: "Procedures to demonstrate incompatibility between the donor's cell type and the recipients's serum or plasma type. These procedures may consist of a serologic crossmatch, or a computer crossmatch." D5807 TEST REPORT CFR(s): 493.1291(d) -- 3 of 4 -- 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 a patient report and interview with the general supervisor /technical consultant #2 and testing person #1, the laboratory failed to provide normal reference intervals for 1 of 1 Wet Prep test reports. Findings include: (1) On 07/08 /2021 at 09:5 am, testing person #1 stated to surveyor #1 Wet Prep testing was performed in the laboratory; (2) Surveyor #2 reviewed one Wet Prep report for a patient tested on 07/07/2021 at 12:14 pm. The report did not include a normal reference range for Clue Cells and Trichomonas; (3) Surveyor #2 reviewed the report with testing person #1, who stated on 07/08/2021 at 01:10 pm, Wet Prep reports did not include a normal reference range for Clue Cells and Trichomonas as indicated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for the analyte Total Cholesterol. Refer to D2094 and D2096. 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 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve a successful performance for the analyte Total Cholesterol. Findings include: (1) The laboratory failed to achieve satisfactory performance on the First 2020 event and the Third 2020 event. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed 04/16/19 - 04/18/19. The laboratory was found to in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager, the technical consultant, testing person #1, and testing person #2 at the conclusion of the survey. 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. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and the technical consultant, the laboratory failed to perform maintenance procedures as required by the manufacturers of the analyzers used for patient testing. Findings include: SYSMEX XS-1000i (1) On the first day of the survey, the laboratory manager stated to the surveyor, the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XS-1000i analyzer; (2) On the third day of the survey, the surveyor identified the manufacturer's required weekly maintenance procedure as documented on the manufacturer's maintenance log, which was "power down the IPU (Internal Processor Unit);" (3) The surveyor then reviewed the maintenance records from 21 months (July 2017 through March 2019) and identified during 4 of the 21 months reviewed, the weekly maintenance had not been documented as performed: (a) Between 08/22/17 and 09/05/17 (b) Between 05/22/18 and 06/05/18 (4) The surveyor reviewed the findings with the laboratory manager and the technical consultant, who stated to the surveyor the weekly maintenance had not been documented as performed, as listed above. DIMENSION EXL (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory performed the following testing on the Dimension EXL 200 analyzer: (a) CMP*, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Amylase, CK (Creatinine Kinase), CK-Isoenzyme, Direct Bilirubin, High Density Lipoprotein, Magnesium, Total Cholesterol, Triglycerides, Troponin I, and Uric Acid (b) Therapeutic Drug testing: Acetaminophen, Alcohol, Digoxin, Dilantin, Salicylate, Valproic Acid, and Vancomycin (c) Immunoassay testing: TSH (Thyroid Stimulating Hormone), PSA (Prostate Specific Antigen), Serum Quantitative pregnancy, and Free T4 (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The manufacturer required the follow procedures be performed on a monthly basis: (a) Replace IMT Pump Tubing (b) Clean IMT System (c) Replace/Clean Air Filters (d) Stylette HM Wash Probes (e) Replace HM Pump Heads (f) Clean R2 Drain (3) The surveyor then reviewed maintenance records for the analyzer from January 2018 through March 2019. The surveyor identified during the 15 months reviewed, the laboratory failed to perform the Replace IMT Pump Tubing, Clean IMT System, Replace/Clean Air Filters, Stylette HM Wash Probes, and Replace HM Pump Heads procedures between 05/31/18 and 07/03/18; (4) The surveyor reviewed the records with the laboratory manager and the technical consultant who stated to the surveyor the above required maintenance procedures had not been documented as being performed as listed above. ID-MTS DILUENT DISPENSER (1) On the first day of the survey, the laboratory manager stated to the surveyor the laboratory performed Compatibility (i.e. ABO/Rh Type, Antibody Screen, Crossmatch) testing on units of Packed Red Blood Cells for transfusion purposes. In addition, the laboratory manager stated the testing was performed using the ID-Micro Typing System; (2) The surveyor reviewed the manufacturer's instructions for the test system and identified the manufacturer required the ID-MTS diluent dispenser (used to aliquot the MTS Diluent 2Plus during the testing), be cleaned on a weekly basis; (3) The surveyor then reviewed the maintenance records from 6 months (January, March, July, and December 2018; and January and March 2019). There was no documentation the weekly cleaning had been performed as required between 03/03/18 and 03/14/18; (4) The surveyor reviewed the findings with the laboratory manager and the technical consultant, who stated to the surveyor, there was no documentation which proved the required weekly cleaning of the MTS diluent dispenser had been performed as listed above. *CMP: BUN (Blood Urea Nitrogen), Calcium, Creatinine, Glucose, Chloride, CO2, Potassium, Sodium, Albumin, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Alkaline Phosphatase, Total Bilirubin, and Total Protein NOTE: D5429 had been cited at the previous recertification survey performed 06/20/17- 06/21/17. 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, policy and procedure, and interview with the laboratory manager, the laboratory failed to ensure that blood products were stored under appropriate conditions. Findings include: (1) On the first day of the survey, the laboratory manager stated to the surveyor units of Packed Red Blood Cells to be used -- 2 of 3 -- for patient transfusions were stored in the blood bank refrigerator; (2) The surveyor reviewed the blood bank alarm check policy and procedure. The policy stated the warm temperature of activation should cause the alarm to sound at 5.8 degrees C (Centigrade). (Note: units of packed cells must be stored between 1-6 degrees C, therefore, the low temperature of activation should be no lower than 1 degree C and the high temperature of activation should be no higher than 6 degrees C): (3) The surveyor then reviewed quarterly alarm check records from October 2017 through March 2019. The surveyor identified that, although the alarm checks had been performed quarterly, 1 of the 7 high temperature activation alarm checks performed during the time period reviewed was unacceptable: (a) 03/05/19: The warm temperature alarm sounded at 6.4 C, which was warmer than the acceptable limit. (4) The surveyor reviewed the records with the laboratory manager and the technical consultant and explained the high temperature of activation must be 6.0 C or less to ensure units of packed red blood cells were stored at the appropriate temperature; (5) The laboratory manager stated to the surveyor the records showed the laboratory did not ensure the blood bank refrigerator alarm sounded before the refrigerator reached an unacceptable temperature for storage of units of packed red blood cells. -- 3 of 3 --