Memorial Hospital Of Texas County Authority

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/11,12,13,14/2025. The laboratory was found out of compliance with the following CLIA Conditions: 493.1215; D5024: Hematology 493.1217; D5026: Immunohematology 493.1403; D6000 Laboratory Director, Moderate Complexity 493.1441; D6076: Laboratory Director, High Complexity The findings were reviewed with the laboratory director, interim laboratory manager, chief executive officer, respiratory manager, and chief of staff during an exit conference performed at the conclusion of the survey. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the interim laboratory manager, the laboratory failed to ensure the requirements were met for the specialty of Hematology for Coagulation testing during the review period of July 2023 through the current date. Findings include: (1) The laboratory failed to follow the manufacturer's instructions for implementing one of one coagulation reagent. Refer to D5411; (2) The laboratory failed to ensure Dade Innovin reagents had not been used beyond the expiration date; and failed to ensure expired materials were not available for use. Refers to D5417; (3) The laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures. Refer to D5429. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, policies and procedures, manufacturer's instructions, observation, and interview with the interim laboratory manager, the laboratory failed to ensure the requirements were met for the specialty of Immunohematology during the review period of April 2023 through the current date. Findings include: (1) The laboratory failed to follow their written policy for labeling blood bank specimens. Refer to D5401; (2) The laboratory failed to ensure expired Blood Bank quality control materials were not available for use. Refer to D5417; (3) The laboratory failed to define a function check protocol to ensure the blood bank pipettes were functioning properly. Refer to D5435; (3) The laboratory failed to perform a negative and positive control material each day of patient Immunohematology testing. Refer to D5449; (4) The laboratory failed to ensure one of one unit of expired fresh frozen plasma was not available for use; and failed to ensure units of blood and blood products were stored under appropriate conditions. Refer to D5555; (5) The laboratory failed to document testing on the blood bank work logbook. Refer to D5789; (6) The laboratory failed to have an ongoing mechanism for performing analytic quality assessment. Refer to D5791. 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, written policies, and interview with the interim laboratory manager, the laboratory failed to establish a written general supervisor competency assessment policy, based on the position responsibilities as listed in the Subpart M for one of one person. Findings include: (1) A review of written policies and interview with the interim laboratory manager on 03/12/2025 at 09:20 am identified no evidence of a policy for assessing the competency of the general supervisor; (2) A review of 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 no documentation competency assessments had been performed based on position responsibilities for one of one person listed as general supervisor; (3) The findings were reviewed with the interim laboratory manager on 03/12/2025 at 09:30 am, who confirmed the laboratory failed to define and perform assessments based on the specific position responsibilities. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) -- 2 of 18 -- Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the interim laboratory manager, the laboratory failed to follow the manufacturer's instructions for storing patient specimens prior to testing for six of six analytes reviewed. Findings include: (1) On 03/12/2025 at 11:50 am, the interim laboratory manager stated that thyroid stimulating hormone (TSH), Free T4 (FT4), prostate specific antigen (PSA), Vitamin B12, Ferritin, and Folate testing were performed using the Beckman Access 2 analyzer twice weekly and aliquoted serum samples (pending tests) were stored in the chemistry freezer; (2) A review of the manufacturer's product inserts, under the section "Specimen Storage" stated serum /plasma can be stored at 2 to 8 degrees Centigrade for a maximum 48 hours, if testing will be delayed, store at less than -20 C"; (3) Observation of the chemistry freezer on 03/12/2025 at 11:50 am identified patient specimens that had been collected and were awaiting testing being stored warmer than -20 C; (4) A review of temperature records for March 2025, identified that the freezer was warmer than -20 C for 12 of 12 days reviewed; (5) The findings were reviewed with the interim laboratory manager who stated on 03/12/2025 at 11:50 am, the laboratory had not followed the specimen storage requirements. 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, policy, and interview with the interim laboratory manager, the laboratory failed to follow their written policy for labeling blood bank specimens during the review period from April 2023 through the current date. Findings include: (1) A review of the blood bank policies and procedure on 03/13 /2025 identified a policy titled, "Blood Bank Transfusion Policy" which stated the following: (a) "Label specimens with Patient Name, DOB, Medical Record Number, Physician, Collector's Initials, Date, and Time." (2) Observation of the contents of the blood bank refrigerator identified a sample collected on 02/19/2025 at 3:00 pm, without the collector's initials; (3) Interview with the interim laboratory manager on 03 /13/2025 at 10:30 am, confirmed that the blood bank specimen had not been labeled according to policy. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- -- 3 of 18 -- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/10,11,12,13/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the vice president of operations and provider services, vice president of patient care, technical consultant, and general supervisor 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 the general supervisor the laboratory failed to ensure one of three policies had been approved, signed, and dated by the laboratory director. Findings include: (1) On 04/10/2023 at 02:55 pm, the general supervisor stated the following: (a) Urine drug screen testing was performed using the Med Tox Scan test system; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system effective 10/19/2021. (2) On 04/12/2023 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 until 04/11/2023; (3) The records were reviewed with the general supervisor who stated on 04/12/2023 at 09:00 am, the QCP for the above test system had not been approved, signed, and dated by the laboratory director until 04/11/2023. 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 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 -- 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 general supervisor, the laboratory failed to follow the manufacturer's implementation instructions to ensure the mean of the normal range was accurately entered into the analyzer for one of one PT reagent lot change. Findings include: (1) On 04/10/2023 at 03:00 pm, the general supervisor stated PT/INR (Prothrombin Time/International Normalized Ratio) testing was performed using the Sysmex CA-600 analyzer; (2) On 04/12/2023 at 02:57 pm, the general supervisor stated the PT reagent, Innovin lot #549775, was put into use on 06/23/2022; (3) A review of the manufacturer's instructions in section XIV "Reagent Lot Roll-Over Studies" provided instructions for calculating the geometric mean and stated, "The MNPT for INR calculation must be the geometric mean". In addition the instructions stated, "Refer to the Instrument Operator's Manual for the procedure of entering the reagent lot specific ISI value and the PT Geomean to allow INR calculation"; (4) A review of the implementation records for the reagent lot change identified the geometric mean that had been calculated by the laboratory was 9.4; (5) Observation of the geometric mean that had been programmed into the analyzer, with the assistance of the general supervisor on 04 /12/2023 at 03:15 pm, identified the value had been entered as 10.1; (6) The findings were reviewed with the laboratory manager who stated on 04/12/2023 at 03:30 pm, the geometric mean that was programmed into the analyzer was not correct and should have been entered as 9.4. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the general supervisor, the laboratory failed to ensure the humidity was maintained as required by the manufacturer of the Sysmex CA-660 analyzer for five of eight months reviewed. Findings include: (1) On 04/10/2023 at 03:00 pm, the general supervisor stated PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Sysmex CA-600 analyzer; (2) On 04/12/2023, a review of the manual for the analyzer titled, "Instructions for Use" in Section 4.2 "Installation Environment" stated "Use the instrument at a relative humidity range of 30-85%"; (3) A review of the laboratory humidity records from August 2022 through March 2023 identified the humidity readings were less than 30% for five of eight months as follows: (a) November 2022 - 15 of 30 humidity readings were documented as less than 30%; (b) December 2022 - 22 of 29 humidity readings were documented as less than 30%; (c) January 2023 - 31 of 31 humidity readings were documented as less than 30%; (d) February 2023 - 23 of 28 humidity readings -- 2 of 7 -- were documented as less than 30%; (e) March 2023 - 28 of 31 humidity readings were documented as less than 30%. (4) The records were reviewed with the general supervisor who stated on 04/13/2023 at 02:02 pm the laboratory humidity had not been maintained as required by the manufacturer as shown above. 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 general supervisor, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for three of seven analyzers. Findings include: CEPHEID GENEXPERT DX (1) On 04/10/2023 at 02:50 pm, the general supervisor stated the laboratory performed SARS CoV-2, RSV (Respiratory Syncytial Virus), Influenza A&B, and MRSA (Methicillin Resistant Staphylococcus aureus) testing using the Cepheid GeneXpert DX system; (2) On 04/11/2023 a review of the manufacturer's maintenance log showed the following required maintenance procedures: (a) Weekly (i) "Power down the GeneXpert instrument" (ii) "Power down the GeneXpert computer" (b) Monthly (i) "Archive tests" (ii) "Purge tests" (c) Quarterly (i) Clean plunger rod and cartridge bays" (ii) Clean instrument surfaces" (3) A review of maintenance logs from March 2022 through March 2023 identified the maintenance had not been documented as performed as follows: (a) Weekly (i) Between 12/02/2022 and 12/16/2022 (b) Monthly (i) Prior to 04/01/2022 (ii) Between 04/01/2022 and 07/01/2022 (iii) Between 07/22/2022 and 09/02/2022 (iv) After 09/02 /2022 (c) Quarterly (i) After 10/12/2022 (4) The records were reviewed with the general supervisor who stated on 04/11/2023 at 01:55 pm the maintenance had not been documented as performed as shown above. BECKMAN COULTER DXH 600 (1) On 04/10/2023 at 02:55 pm, the general supervisor stated CBC (Complete Blood Count) testing was performed using the Beckman Coulter DXH 600 analyzer as the primary method; (2) On 04/12/2023 a review of the manufacturer's maintenance log showed the following required maintenance procedures: (a) Each Six Months (i) "Clean the STM" (3) A review of maintenance logs from January 2022 through March 2023 identified the maintenance had not been documented as performed as follows: (a) Prior to or after 09/30/2022 (4) The records were reviewed with the general supervisor who stated on 04/12/2023 at 02:05 pm the maintenance had not been documented as performed as shown above. SYSMEX CA-600 (1) On 04/10/2023 at 03:00 pm, the general supervisor stated PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Sysmex CA-600 analyzer; (2) On 04/12/2023 a review of the manufacturer's maintenance log showed the following required maintenance procedures: (a) Quarterly (i) "Clean DI H2O Rinse Bottle w/alcohol" (ii) "Perform LED Calibration" (iii) Clean filters under front of analyzer" (b) Yearly (i) "Replace Rinse Filter" (3) A review of maintenance logs from January 2022 through March 2023 identified the maintenance had not been documented as performed as follows: (a) Quarterly (i) Between 02/14/2022 and 07/08/2022 (b) Yearly (i) Not documented as performed during the review period (4) The records were reviewed with the general supervisor who stated on 04/12/2023 at 03:22 pm the maintenance had not been documented as performed as shown above. -- 3 of 7 -- 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 general supervisor, the laboratory failed to follow their written protocol for ensuring the Blood Bank pipette was functioning properly during the review period of 11/23/2021 through the current date. Finding include: (1) On 04/10/2023 at 02:35 pm, the general supervisor stated the laboratory began performing ABO/Rh, Antibody Screen, and Compatibility testing using the Ortho ID-MTS gel system on 11/23/2021; (2) On 04/12/2023 at 09:30 am, the general supervisor stated the ID Tipmaster pipette (a multiple delivery pipette) was used for the testing as follows: (i) The 12.5 ul (microliter) setting was used to dispense patient plasma for forward ABO/Rh typing; (ii) The 25 ul setting was used to dispense commercial A1 and B cells for reverse typing and dispense patient plasma for Antibody Screen and Compatibility testing; (iii) The 50 ul setting was used to dispense commercial screen cells for Antibody Screens and donor cell suspensions for Compatibility testing. (3) A review of the policy titled, "Equipment Function Checks" included requirements for checking the pipettes used for testing and stated "The Laboratory and/or Maintenance Department will contract and/or notify the Bio- Medical service when they should perform the annual function checks"; (4) A review of records from 11/23/2021 through the current date identified the ID Tipmaster pipette had not been checked for accuracy since the laboratory began testing on 11/23 /2021; (5) The findings were reviewed with the general supervisor who stated on 04/12 /2023 at 10:35 am, the pipette had not been checked for accuracy as stated above. 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 general supervisor, the laboratory failed to perform QC (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 the current date. Findings include: (1) On 04/10/2023 at 02:50 pm, the -- 4 of 7 -- general supervisor stated the the following: (a) SARS CoV-2 was performed using the Cepheid Gene Xpert DX system and the CoV-2 plus test cartridge; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) On 04/11/2023 a review of the QCP (Quality Control Plan) identified positive and negative quality control materials were to be tested on a monthly basis; (3) A review of QC records from September 2022 through the current date identified QC testing had not been performed as stated in the QCP as follows: (a) Prior to 01/23/2023 (b) Between 01/23/2023 and 03/11/2023 (4) The records were reviewed with the general supervisor who stated on 04/11/2023 at 03:24 pm, QC had not been performed as stated above. 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 a written policy and interview with the general supervisor and director of nursing, the facility failed to ensure that written policies provided safety for individuals being transfused for two of three patients reviewed. Findings include: (1) On 03/10/2023 at 03:40 pm, the general supervisor stated the laboratory stored units of PRBC's (packed red blood cells) in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On 03/12/2023, a review of the hospital policy titled, "Blood Component Administration" stated the following: (a) "Ensure a Blood Consent is signed. One signed consent form is acceptable for the hospital stay"; (b) "Check vitals every 5 minutes x3, every 15 minutes for one hour then, every 30 minutes throughout the transfusion". (3) A review of records for three patients receiving transfusions in April 2022, October 2022, and March 2023 identified no evidence the policy had been followed for two patients for three of five units transfused as follows: (a) Patient #772302 - Transfused with two units of PRBC's on 04/11/2022 (unit #W091022174003 and unit #W091022173855). There was no evidence a signed consent had been obtained; (b) Patient #784461 - Transfused with one unit of PRBC's on 03/20/2023 (unit #W091022180845). There was no evidence the vitals had been taken as required by policy as follows: (i) Not taken every five minutes for the first 15 minutes. The vitals had not been documented between 02:35 pm and 02:50 pm; (ii) Not taken every 15 minutes for one hour. The vitals had not been documented between 02:50 pm and 03:50 pm. (iii) Not taken every 30 minutes throughout the transfusion. The vitals had not been documented between 03:50 pm and 04:55 pm. (4) The records were reviewed with the general supervisor and director of nursing. Both stated on 04/12/2023 at 12:00 pm, the policy had not been followed as stated above. D5775 COMPARISON OF TEST RESULTS -- 5 of 7 -- 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 general supervisor, 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 January 2022 through March 2023. Findings include: (1) On 04/10/2023 at 03:18 pm, the general supervisor stated the laboratory performed Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), BUN, Calcium, Chloride, CK (Creatine Kinase), Creatinine, CO2, Glucose, Sodium, Potassium, Total Bilirubin, and Total Protein testing using the Beckman Coulter DXC 600 analyzer, denoted by the laboratory as "Bonnie", as the primary method and the Beckman Coulter DXC 600 analyzer, denoted by the laboratory as "Clyde", as the backup method; (2) On 04/12/2023, a review of records from January 2022 through March 2023 identified the relationship between the two test methods had not been evaluated prior to 10/24/2022; (3) The records were reviewed with the general supervisor who stated on 04/12/2023 at 02:39 pm, the relationship between the above test methods had not been evaluated at least twice annually as stated above. 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 records and interview with the general supervisor and respiratory therapy supervisor, 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; and failed to make appropriate reference ranges available for one of one patient venous Blood Gas report. Findings include: PT AND PTT TESTING (1) On 04/10/2023 at 03:00 pm, the general supervisor stated PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Sysmex CA-600 analyzer; (1) On 04/12/2023 at 02:57 pm, the general supervisor stated the following reagent lot numbers were put into use on 06/23/2022: (a) Dade Innovin lot #549775 (b) Dade Actin FSL - #562693 (3) A review of the implementation records identified the following: (a) PT - The normal reference interval had been verified as 8.6-10.3 (b) PTT - The normal reference interval had been verified as 22.2-30.2 (4) A review of a patient report with PT and PTT testing performed on 04/11/2023 showed the following normal ranges: (a) PT - 9.6-12.5 (b) PTT - 22.5-38.0 (5) The reports and implementation records were reviewed with the general supervisor who stated on 04 /12/2023 at 04:07 pm, the laboratory had not updated the normal reference ranges into -- 6 of 7 -- the laboratory's computer information system. VENOUS BLOOD GAS TESTING (1) On 04/10/2023 at 03:18 pm, the general supervisor stated venous and arterial Blood Gas (pH, pO2, pCO2) testing were performed using the GEM 5000 analyzer; (2) On 04/13/2023, a review of two patient reports identified identical reference ranges for venous blood gas testing as follows: (a) A patient venous blood gas tested on 01/28 /2023 with the following reference intervals: (i) pH - 7.35-7.45 (ii) pO2 - 83.0-108.0 (iii) pCO2 - 35.0-45.0 (b) A patient arterial blood gas tested on 04/05/2023 with the following reference intervals: (i) pH - 7.35-7.45 (ii) pO2 - 83.0-108.0 (iii) pCO2 - 35.0-45.0 (3) The reports were reviewed with the general supervisor and respiratory therapy supervisor. Both stated on 04/13/2023 at 01:45 pm, the patient report tested on 01/28/2023 did not include reference intervals for venous Blood Gas testing. 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 general supervisor, 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 eight testing persons performing testing from June 2021 through the current date. Findings include: (1) On 04/11/2023 a review of personnel records for eight persons hired to perform moderate complexity testing after the previous recertification survey identified the following for one of eight persons: (a) Testing Person #8 - The initial training was complete on 06/21/2021. There was no evidence a competency evaluation had been performed through the current date. (2) The records were reviewed with the general supervisor who stated on 04/11/2023 at 11:01 am, a semiannual competency evaluation had not been performed. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high 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 general supervisor, the technical supervisor failed to ensure competency evaluations for high complexity testing had been performed semiannually during the first year of testing for one of one testing person. Findings include: (1) On 04/11/2023 a review of personnel records for one person hired to perform high complexity testing after the previous recertification survey identified the following for one of one person: (a) Testing Person #7 - The initial training was complete on 01/10/2022. There was no evidence a competency evaluation had been performed between 01/10/2022 and 01/18/2023. (2) The records were reviewed with the general supervisor who stated on 04/11/2023 at 11:01 am, a semiannual competency evaluation had not been performed. -- 7 of 7 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/03,04,05/2021. Immediate Jeopardy was determined during the survey due to issues identified with Coagulation testing. The laboratory voluntarily ceased patient testing, which abated the Immediate Jeopardy. The laboratory was found out of compliance with the following CLIA regulations: 493.1215; D5024: Hematology 493.1403; D6000: Laboratory Director, Moderate Complexity 493.1409; D6033: Technical Consultant The findings were reviewed with the laboratory director, technical consultant #1, technical consultant #2, and the laboratory manager during an exit conference performed at the conclusion of the survey. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the laboratory manager, technical consultant #1, and technical consultant #2, the laboratory failed to ensure the requirements were met for the specialty of Hematology for Coagulation and D-dimer testing. Findings include: (1) The laboratory failed to follow the manufacturer's instructions for implementing coagulation reagents. Refer to D5411; (2) The laboratory failed to ensure D-dimer control materials were stored as required for 11 of 11 months. Refer to D5413; (3) The laboratory failed to verify the performance specification of precision, failed to ensure the demonstrated reportable range was utilized, and failed to ensure the verification data had been evaluated prior to implementing the new test for D-Dimer testing. Refer to D5421; (4) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures on the coagulation analyzer. Refer to D5429 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- 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 have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) On 05/03/2021, the surveyor reviewed personnel records for competency assessments performed during 2019, 2020, and to date in 2021. There was no evidence competencies had been performed for technical consultant #1 and technical consultant #2 based on their job responsibilities; (2) The surveyor asked the laboratory manager if a written policy to evaluate the technical consultants, based on job responsibilities, was available and if competencies had been performed during the review period. The laboratory manager stated to the surveyor on 05/03/2021 at 12:30 pm, a policy to evaluate the technical consultants based on job responsibilities had not been written; and competencies had not been performed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to evaluate the accuracy of Ammonia and Vitamin D testing at least twice annually. Findings include: (1) On 05/03/2021 at 09:30 am, the laboratory manager stated the following to the surveyor: (a) Ammonia testing was performed on the Beckman Coulter Unicel DxC 600, denoted by the laboratory at Bonnie; (b) Vitamin D testing was performed on the Beckman Coulter Access 2 analyzer. (2) The surveyor reviewed 2020 and 2021 proficiency testing records. Since the laboratory had not enrolled and participated in proficiency testing for Ammonia and Vitamin D testing, the surveyor determined the laboratory must verify the accuracy of the testing at least twice annually; (3) The surveyor asked the laboratory manager if the accuracy of Ammonia and Vitamin D testing had been verified in 2020 and to date in 2021. The laboratory manager stated on 05/03/2021 at 01:50 pm, the accuracy had not been verified; (4) The following were examples of patient Ammonia or Vitamin D testing performed when the accuracy of the testing had not been verified: (a) Patient #746703 - Vitamin D testing performed on 02/19/2020 (b) Patient #746703 - Vitamin D testing performed on 02/20/2020 (c) Patient #746487 - Ammonia testing performed on 02/23 /2020 (d) Patient #750551 - Vitamin D testing performed on 07/14/2020 (e) Patient #750579 - Vitamin D testing performed on 07/15/2020 (f) Patient #753559 - Ammonia testing performed on 10/24/2020 (g) Patient #755078 - Vitamin D testing performed on 12/15/2020 (h) Patient #755372 - Vitamin D testing performed on 12/22 /2020 (i) Patient #756855 - Vitamin D testing performed on 02/05/2021 (j) Patient #756951 - Ammonia testing performed on 02/08/2021 (k) Patient #757128 - Vitamin D testing performed on 02/10/2021 (l) Patient #757003 - Ammonia testing performed -- 2 of 14 -- on 02/15/2021 (m) Patient #758112 - Vitamin D testing performed on 03/16/2021 (n) Patient #758269 - Vitamin D testing performed on 03/22/2021 (o) Patient #758791 - Ammonia testing performed on 04/07/2021 (p) Patient #759362 - Vitamin D testing performed on 04/23/2021 (q) Patient #759585 - Vitamin D testing performed on 04/30 /2021 D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to provide written instructions to clients collecting and referring hematology, coagulation, and urinalysis specimens. Findings include: (1) On 05/03 /2021 at 09:30 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed CBC (Complete Blood Count) testing using the Beckman Coulter Unicel DxH 600 analyzer as the primary method and the Beckman Coulter DxH 520 analyzer as the back-up method; (i) Hematology specimens were transported to the laboratory from local home health agencies, nursing homes, and clinics. (b) The laboratory performed routine urinalysis testing using the Clinitek Status + (waived test method) and microscopic urine sediment examinations; (i) Urine specimens were transported to the laboratory from local home health agencies, nursing homes, and clinics. (c) The laboratory performed coagulation testing, which consisted of PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) using the Sysmex CA-600 analyzer; (i) Coagulation specimens were transported to the laboratory from local home health agencies, nursing homes, and clinics. (2) The surveyor asked the laboratory manager if instructions (e.g., client service manual) had been written and provided to the home health agencies, nursing homes, and clinics which would explain the laboratory's specimen handling policies (e. g., collection, preservation, storage, transport, testing schedule times, and how to obtain additional assistance for unusual circumstances). The laboratory manager stated on 05/03/2021 at 09:45 am, specimen handling instructions had not been written and provided to the clients. 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, technical consultant #1, and technical consultant #2, the laboratory failed to follow the manufacturer's instructions for implementing coagulation reagents. Findings include: (1) On 05/03/2021 at 09:30 am, the laboratory manager stated the following to the surveyor: (a) The Sysmex CA-600 analyzer was -- 3 of 14 -- used to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing (the INR was calculated using the PT reference interval mean and the ISI (International Sensitivity Index) value specific for the lot number of Innovin reagent); (b) The following reagent lot numbers were put into use on 03/01/2021: (i) PT - Innovin reagent, lot #549758 (ii) PTT - Actin reagent, lot #562626 (iii) Siemens Ci-Trol control level 1 lot #564809 (iv) Siemens Ci-Trol control level 3 lot #556527A (2) On 05/04/2021, 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 "Verification of Reference Range" (i) "20 Normal Individuals * 10 males; 10 females * Medication History: no aspirin, no hormones, no herbal supplements * 20 is the minimum requirement for statistical validity"; (ii) "Assay samples on current and new lot number reagents simultaneously or within 10 minutes of each other. This data can be used in Section II"; (iii) "Calculate mean and 2 SD range"; (iv) "MNPT for INR calculation should be the geometric mean". (b) 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 reagents simultaneously or within 1 our of each other"; (v) "Calculate Linear Regression statistics". (c) Section titled, "Quality Control" (i) "Assay new lot number of QC material with the new lot of reagent in PTN and APTTN protocols"; (ii) Collect a minimum of 30 data points over multiple days and stability limits of control"; (iii) Calculate the mean, 2 SD and 3 SD range". (3) The surveyor reviewed the ISI (International Sensitivity Index) and the Normal Patient Mean that had been programmed into the analyzer, with the assistance of the laboratory manager, and reviewed the records for the lot changes. The following was identified: (a) PT - Innovin reagent, lot #549758 (i) There was no documentation to prove the normal range study had been performed, although a normal patient mean value of 10.9 had been programmed into the analyzer's memory; (ii) The package insert for the Innovin reagent showed an ISI of 1.01 and an ISI of 1.07 had been programmed into the analyzer's memory; (iii) There was no documentation to prove the method correlation had been performed using 20 normal and 20 abnormal samples with the current and new lot number of reagents simultaneously. (b) PTT - Actin reagent, lot #562626 (i) There was no documentation to prove the normal range study had been performed; (ii) There was no documentation to prove the method correlation had been performed using 20 normal and 20 abnormal samples with the current and new lot number of reagents simultaneously. (c) Siemens Ci-Trol control level 1 lot #564809 (i) The records showed the laboratory had assayed the new lot of quality control material using 20 data points instead of 30 data points as required. (d) Siemens Ci-Trol control level 3 lot #556527A (i) The records showed the laboratory had assayed the new lot of quality control material using 20 data points instead of 30 data points as required. (4) The surveyor reviewed the records and the findings with the laboratory manager, technical consultant #1, and technical consultant #2. The laboratory manager, technical consultant #1, and technical consultant #2 stated the following to the surveyor on 05/04/2021 at 03:30 pm: (a) The laboratory did not perform a normal range study for PT and PTT; (b) For the values programmed into the analyzer to calculate the INR, it could not be determined where the normal patient PT mean of 10.9 and the ISI of 1.07 came from; (c) The laboratory did not perform method correlation for PT and PTT using 20 normal and 20 abnormal samples with -- 4 of 14 -- the current and new lot number of reagents simultaneously; (d) The laboratory had utilized 20 data points to assay the new lots of quality control materials for level 1 and level 3, instead of 30 data points; (e) The laboratory had not followed the manufacturer's instructions for implementing the coagulation reagents. (5) The following were examples of patient testing performed: (a) Patient #747545 - PT testing performed on 03/02/2021 (b) Patient #753828 - PT testing performed on 03/05 /2021 (c) Patient #757834 - PT and PTT testing performed on 03/08/2021 (d) Patient #757878 - PT testing performed on 03/09/2021 (e) Patient #758043 - PT and PTT testing performed on 03/13/2021 (f) Patient #758104 - PT and PTT testing performed on 03/15/2021 (g) Patient #758376 - PT and PTT testing performed on 03/22/2021 (h) Patient #758524 - PT and PTT testing performed on 03/26/2021 (i) Patient #758602 - PT and PTT testing performed on 03/30/2021 (j) Patient #758693 - PT testing performed on 04/01/2021 (k) Patient #758886 - PT and PTT testing performed on 04 /07/2021 (l) Patient #759136 - PT and PTT testing performed on 04/15/2021 (m) Patient #759179 - PT and PTT testing performed on 04/19/2021 (n) Patient #759327 - PT and PTT testing performed on 04/22/2021 (o) Patient #759408 - PT and PTT testing performed on 04/25/2021 (p) Patient #759327 - PT and PTT testing performed on 04/27/2021 (q) Patient #759552 - PT and PTT testing performed on 04/29/2021 (r) Patient #759621 - PT and PTT testing performed on 05/01/2021 (s) Patient #759629 - PT and PTT testing performed on 05/02/2021 (t) Patient #759649 - PT and PTT testing performed on 05/03/2021 (u) Patient #759700 - PT and PTT testing performed on 05/04/2021 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in 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, manufacturer's instructions, observation, and interview with the laboratory manager, the laboratory failed to ensure materials were stored as required for 11 of 11 months. Findings include: (1) On 05/04/2021 at 03:45 pm, the surveyor observed the contents of the following freezers, which were frost-free freezers. The following control materials were being stored in the freezers, with the manufacturer's storage requirements: (a) Whirlpool Freezer - Denoted by the laboratory as "Coag Ref/Freezer" (i) Bio-Rad Liquid Assayed Multiqual controls - 6 boxes containing 12 bottles each of level 1 lot #45871 and 6 boxes containing 12 bottles each of level 3 lot #45873; the storage requirement was -20 to -70 degrees C (Centrigrade). In addition, the instructions contained in the package insert stated, "For optimum performance, avoid storing this product in a frost-free freezer". (b) Frigidaire Freezer - Denoted by the laboratory as "White Freezer" (i) Bio-Rad Liquichek Cardiac Markers Plus Control LT controls - 3 boxes containing 6 bottles each of level 1 lot #67651 and 3 boxes containing 6 bottles each of level 3 lot #67653; the storage requirement was -20 to -70 degrees C. In addition, the instructions contained in the package insert stated, "Do not store this product in a frost-free freezer". (c) Crosley Freezer - Denoted by the laboratory as "Freezer #2" (i) Bio-Rad Liquid Assayed -- 5 of 14 -- Multiqual controls - 6 boxes containing 12 bottles each of level 1 lot #45871 and 6 boxes containing 12 bottles each of level 3 lot #45873; the storage requirement was -20 to -70 degrees C (Centrigrade). In addition, the instructions contained in the package insert stated, "For optimum performance, avoid storing this product in a frost- free freezer"; (ii) Bio-Rad Liquichek Cardiac Markers Plus Control LT controls - 3 boxes containing 6 bottles each of level 1 lot #67651 and 3 boxes containing 6 bottles each of level 3 lot #67653; the storage requirement was -20 to -70 degrees C. In addition, the instructions contained in the package insert stated, "Do not store this product in a frost-free freezer"; (iii) Quidel Triage Total 5 Controls - 3 boxes containing 6 bottles each of level 2 lot #67642; the storage requirement was -20 degrees C and colder. (2) The laboratory manager explained the following to the surveyor on 05/04/2021 at 04:00 pm: (a) The Bio-Rad Liquid Assayed Multiqual controls were used to perform quality control (QC) procedures for Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Amylase, AST (Aspartate Aminotransferase), BUN (Blood Urea Nitrogen), Calcium, Chloride, Cholesterol, CK (Creatine Kinase), CO2 (Carbon Dioxide), Creatinine, Direct Bilirubin, Lipase, Magnesium, Phosphorus, and Uric Acid testing performed on the Beckman Coulter Unicel DxC analyzer, denoted by the laboratory as "Bonnie"; and to perform QC procedures for Albumin, Alkaline Phosphatase, ALT, AST, BUN, Calcium, Chloride, Cholesterol, CK, CO2, and Creatinine testing performed on the Beckman Coulter Unicel DxC analyzer, denoted by the laboratory as "Clyde"; (b) The Bio-Rad Liquichek Cardiac Markers Plus Control LT controls were used to perform QC procedures for CKMB and Troponin I testing performed on the Beckman Coulter Access 2 analyzer; (c) The Quidel Triage Total 5 Controls were used to perform QC procedures for D-dimer testing performed on the Quidel Triage Meter Pro analyzer. (3) The surveyor reviewed temperature records for 11 months (June 2020 through April 2021. In addition to the freezers being frost-free, the documented temperatures were warmer than -20 C (the warmest temperature allowed for the materials) during 11 of 11 months for the freezers as follows: (a) Coag Ref/Freezer (i) June 2020 - 30 of 30 documented temperatures were warmer than -20 degrees C (ii) July 2020 - 31 of 31 documented temperatures were warmer than -20 degrees C (iii) August 2020 - 30 of 31 documented temperatures were warmer than -20 degrees C (iv) September 2020 30 of 30 documented temperatures were warmer than -20 degrees C (v) October 2020 - 31 of 31 documented temperatures were warmer than -20 degrees C (vi) November 2020 - 30 of 30 documented temperatures were warmer than -20 degrees C (vii) December 2020 - 31 of 31 documented temperatures were warmer than -20 degrees C (viii) January 2021 - 18 of 31 documented temperatures were warmer than -20 degrees C (ix) February 2021 - 20 of 28 documented temperatures were warmer than -20 degrees C (x) March 2021 - 25 of 30 documented temperatures were warmer than -20 degrees C (xi) April 2021 - 30 of 30 documented temperatures were warmer than -20 degrees C (b) White Freezer (i) June 2020 - 9 of 30 documented temperatures were warmer than -20 degrees C (ii) July 2020 - 9 of 31 documented temperatures were warmer than -20 degrees C (iii) August 2020 - 8 of 31 documented temperatures were warmer than -20 degrees C (iv) September 2020 - 7 of 30 documented temperatures were warmer than -20 degrees C (v) October 2020 - 10 of 31 documented temperatures were warmer than -20 degrees C (vi) November 2020 - 11 of 30 documented temperatures were warmer than -20 degrees C (vii) December 2020 - 12 of 31 documented temperatures were warmer than -20 degrees C (viii) January 2021 - 3 of 30 documented temperatures were warmer than -20 degrees C (ix) February 2021 - 8 of 28 documented temperatures were warmer than -20 degrees C (x) March 2021 - 9 of 31 documented temperatures were warmer than -20 degrees C (xi) April 2021 - 5 of 30 documented temperatures were warmer than -20 degrees C (c) Freezer #2 (i) June 2020 - 28 of 30 documented temperatures were warmer than -- 6 of 14 -- -20 degrees C (ii) July 2020 - 31 of 31 documented temperatures were warmer than -20 degrees C (iii) August 2020 - 31 of 31 documented temperatures were warmer than -20 degrees C (iv) September 2020 - 30 of 30 documented temperatures were warmer than -20 degrees C (v) October 2020 - 31 of 31 documented temperatures were warmer than -20 degrees C (vi) November 2020 - 30 of 30 documented temperatures were warmer than -20 degrees C (vii) December 2020 - 31 of 31 documented temperatures were warmer than -20 degrees C (viii) January 2021 - 30 of 30 documented temperatures were warmer than -20 degrees C (ix) February 2021 - 28 of 28 documented temperatures were warmer than -20 degrees C (x) March 2021 - 31 of 31 documented temperatures were warmer than -20 degrees C (xi) April 2021 - 30 of 30 documented temperatures were warmer than -20 degrees C (3) The surveyor reviewed the records with the laboratory manager, who stated on 05/04/2021 at 04:09 pm, the laboratory was not aware the manufacturer did not allow storage of the materials in a frost-free freezer, and the freezer temperatures were unacceptable as shown 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 ranges were utilized for 2 of 3 new test methods; failed to verify the performance specification of precision for 1 of 3 new test methods; and failed to ensure the verification data had been evaluated prior to implementing the new test for 2 of 3 new test systems. Findings include: C- REACTIVE PROTEIN (1) On 05/03/2021 at 09:30 am, the laboratory manager stated to the surveyor the laboratory began performing CRP (C-Reactive Protein) on the Beckman Coulter Unicel DxC 600 analyzer, denoted by the laboratory as Bonnie, on 02/23/2021; (2) On 05/05/2021, the surveyor reviewed the performance specification records for the new test and identified the laboratory had demonstrated a reportable range of 0.8-14.8 mg/dl; (3) The surveyor reviewed the records with the laboratory manager and requested documentation to ensure the laboratory was utilizing the reportable range that had been demonstrated by the laboratory. The laboratory manager provided the reportable range that had been programmed into the analyzer, which was the manufacturer's reportable range of 0.5-20 mg/dl, instead of the reportable range of 0.8-14.8 mg/dl that had been demonstrated by the laboratory; (4) The surveyor reviewed the findings with the laboratory manager, who stated on 05/05 /2021 at 02:05 pm, the laboratory was not using the reportable range that had been demonstrated by the laboratory. D-DIMER (1) On 05/03/2021 at 09:30 am, the laboratory manager stated to the surveyor the laboratory began performing D-dimer testing using the Quidel Triage Meter Pro 01/2020 (the exact date could not be determined); (2) The surveyor reviewed the performance specification records for the new test system and identified the following: (a) There was no evidence the precision had been demonstrated; (b) The laboratory had demonstrated a reportable range of -- 7 of 14 -- 169-3320 ng/ml; (c) There was no evidence the data had been reviewed and evaluated by the laboratory until 09/30/2020. (3) The surveyor reviewed the records with the laboratory manager and asked if the precision had been demonstrated, if the laboratory was using the reportable range that had been demonstrated, and if the laboratory had reviewed and evaluated the data prior to 09/30/2020. The laboratory manager stated the following to the surveyor on 05/03/2020 at 04:05 pm: (a) The precision had not been demonstrated; (b) The laboratory was using the manufacturer's reportable range of 100-5000 ng/ml instead of the reportable range of 169-3320 that had been demonstrated by the laboratory; (c) The data had not been reviewed and evaluated by the laboratory until 09/30/2020. MRSA (1) On 05/03/2021 at 09:30, the laboratory manager stated to the surveyor the laboratory began performing MRSA (Methicillin Resistant Staphylococcus aureus) testing using the Cepheid Gene Xpert analyzer on 10/22/2020; (2) The surveyor reviewed the performance specification records for the new test system and identified that, although the laboratory demonstrated the accuracy and precision of the test system (a qualitative test), there was no evidence the data had been reviewed and evaluated by the laboratory as acceptable until 11/02/2020; (3) The surveyor reviewed the records with the laboratory manager and asked if the laboratory had reviewed and evaluated the data prior to 11/02/2020. The laboratory manager stated to the surveyor on 05/03/2020 at 04:20 pm, the data had not been reviewed and evaluated by the laboratory until 11/02 /2020. (NOTE: The interpretive guidelines at 493.1253(b)(1) state, "The laboratory is responsible for verifying the performance specifications of each nonwaived unmodified FDA-cleared or approved test system that it introduces, prior to reporting patient test results." In addition, the interpretive guidelines state, "Prior to introducing a test for routine patient testing, the laboratory must review and evaluate the verification data.") 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, technical consultant #1, and technical consultant #2, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for 2 of 2 analyzers. Findings include: SYSMEX CA-600 ANALYZER (1) On 05/03/2021 at 09:40 am, the laboratory manager stated to the surveyor PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing was performed using the System CA-600 analyzer; (2) On 05/04/2021, the surveyor reviewed reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance log for the analyzer titled, "Sysmex CA-600 Maintenance Checklist". The weekly and quarterly requirements were as follows: (a) Weekly (i) Clean Instrument Interior/Exterior (b) Quarterly (i) Clean DI H2O Rinse Bottle with Alcohol (ii) Perform LED Calibration (iii) Clean Filters Under Front of Analyzer (3) The surveyor then reviewed maintenance records from December 2019 through April 2021. Weekly and Quarterly maintenance had not been documented as performed as follows: (a) Weekly (i) Between 12/06/2019 and 01/17/2020 (ii) Between 01/31/2020 and 02/14/2020 (iii) Between 04/03/2020 and 05/07/2020 (iv) Between 05/22/2020 and 06/19/2020 (v) Between 06/19/2020 and 07/03/2020 (vi) -- 8 of 14 -- Between 12/23/2020 and 01/07/2021 (vii) Between 04/16/2021 and 04/29/2021 (b) Quarterly (i) Clean DI H2O Rinse Bottle with Alcohol not documented as performed after 12/12/2019; (ii) Perform LED Calibration not documented as performed between 03/11/2020 and after 10/27/2020; (iii) Clean Filters Under Front of Analyzer not documented as performed after 12/12/2019. (4) The surveyor reviewed the records with the laboratory manager, who stated on 05/04/2021 at 12:45 pm, the weekly and quarterly maintenance procedures had not been performed as identified above; (5) Refer to D5411 for examples of patient testing performed. BECKMAN COULTER ACCESS 2 ANALYZER (1) On 05/03/2021 at 09:30 am, the laboratory manager stated to the surveyor, the laboratory performed Vitamin B12 testing using the Beckman Coulter Access 2 analyzer; (2) On 05/05/2021, the surveyor reviewed reviewed the manufacturer's maintenance requirements as stated in the "Access 2 Instructions for Use" manual. Section 6 "Maintenance" included requirements for Daily maintenance which stated, "If you use the Access 2 system to process the Vitamin B12 assay, you should also run the Special Clean routine at the end of every day or whenever the instrument will not process samples for 8 hours or more"; (3) The surveyor reviewed patient logs and maintenance logs for testing performed from February 2020, July 2020, and January 2021 through April 2021. The Special Clean routine had not been documented as performed for 16 of 16 days of patient Vitamin B12 testing reviewed: (a) Patient #746443 - testing performed on 02/12/2020 (b) Patient #750551 - testing performed on 07/14/2020 (c) Patient #750605 - testing performed on 07/16/2020 (d) Patient #756039 - testing performed on 01/13/2021 (e) Patient #756157 - testing performed on 01/15/2021 (f) Patient #756255 - testing performed on 01/18/2021 (g) Patient #756473 - testing performed on 01/25/2021 (h) Patient #756885 - testing performed on 02/05/2021 (i) Patient #757128 - testing performed on 02/13/2021 (j) Patient #757996 - testing performed on 03/11/2021 (k) Patient #758023 - testing performed on 03/12/2021 (l) Patient #758264 - testing performed on 03/22/2021 (m) Patient #758335 - testing performed on 03/25/2021 (n) Patient #758916 - testing performed on 04/08/2021 (o) Patient #759093 - testing performed on 04/14/2021 (p) Patient #759367 - testing performed on 04/23/2021 (4) The surveyor reviewed the findings with the laboratory manager, technical consultant #1, and technical consultant #2. All stated on 05/05/2021 at 10:45 am, the Special Clean procedure had not been performed as required. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (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 perform a negative and positive control material 1 of 8 days of patient testing. Findings include: (1) On 05/03/2021 at 09:30 am, the laboratory manager stated the following to the surveyor: (a) The laboratory began performing MRSA (Methicillin Resistant Staphylococcus aureus) testing using the Cepheid Gene Xpert analyzer on 10/22/2020; (b) Negative and positive quality control (QC) materials were performed each day of patient testing. (2) The surveyor reviewed QC and patient testing records from 10/22/2020 through 03/26/2021. The review showed -- 9 of 14 -- that negative and positive QC materials had not been performed 1 of 8 days of patient testing reviewed. The specific day was 11/02/2020; 4) The surveyor reviewed the records with the laboratory manager, who stated on 05/04/2021 at 03:15 pm, negative and positive QC materials had not been performed each day of patient testing. 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, manufacturer's instructions, observation, and interview with the laboratory manager, technical consultant #1 and technical consultant #2, the laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Findings include: (1) It was determined the laboratory did not have an effective mechanism for performing analytic quality assessment because of the following issues identified during the survey: (a) The laboratory failed to follow the manufacturer's instructions for implementing coagulation reagents. Refer to D5411; (b) The laboratory failed to ensure materials were stored as required for 11 of 11 months. Refer to D5413; (c) The laboratory failed to ensure the demonstrated reportable ranges were utilized for 2 of 3 new test methods; failed to verify the performance specification of precision for 1 of 3 new test methods; and failed to ensure the verification data had been evaluated prior to implementing the new test for 2 of 3 new test systems. Refer to D5421; (d) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (e) The laboratory failed to perform a negative and positive control material 1 of 8 days of patient testing. Refer to D5449. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records manufacturer's instructions, observation, and interview with the laboratory manager, technical consultant #1, and technical consultant #2, the laboratory director failed to provide overall management and direction for moderate complexity testing. Findings include: (1) The laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Refer to D6013; (2) The laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Refer to D6014; (3) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Refer to D6020; (4) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021. -- 10 of 14 -- D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Findings include: (1) The laboratory director failed to ensure the demonstrated reportable ranges were utilized for 2 of 3 new test methods; failed to verify the performance specification of precision for 1 of 3 new test methods; and failed to ensure the verification data had been evaluated prior to implementing the new test for 2 of 3 new test systems. Refer to D5421. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the laboratory manager, technical consultant #1, and technical consultant #2, the laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Findings include: (1) The laboratory failed to ensure the laboratory followed the manufacturer's instructions for implementing coagulation reagents. Refer to D5411; (2) The laboratory director failed to ensure materials were stored as required for 11 of 11 months. Refer to D5413; (3) The laboratory director failed to ensure the manufacturer's instructions were followed for performing maintenance procedures. Refer to D5429. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and -- 11 of 14 -- maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Findings include: (1) The laboratory director failed to evaluate the accuracy of Ammonia and Vitamin D testing had been verified at least twice annually. Refer to D5217. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the laboratory manager, technical consultant #1 and technical consultant #2, the laboratory director failed to ensure a quality assessment program had been established and maintained. Findings include: (1) The laboratory director failed to ensure the laboratory had an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. 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, manufacturer's instructions, observation, and interview with the laboratory manager, technical consultant #1, and technical consultant #2, the technical consultant failed to provide technical oversight in accordance with 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 the establishment and maintenance of acceptable levels of analytic performance. Refer to D6042; (3) The technical consultant failed to evaluate personnel performing moderate complexity testing at least annually for 1 of 4 persons. Refer to D6054. 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) -- 12 of 14 -- 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 laboratory manager, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for 3 of 4 competency evaluations performed. Findings include: (1) On 05/03/2021, the surveyor reviewed records for 4 persons performing moderate complexity testing in 2020 and to date in 2021 (laboratory manager, who is also listed as testing person #1, testing person #2, testing person #3, and testing person #5). The records showed the evaluation for 3 of 4 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #2 - The 01/15/2021 and 02/16/2020 evaluations had been performed by the laboratory manager/testing person #1 (this person had earned an Associates Degree in Science); (b) Testing Person #3 - The 01/13,30/2021 evaluations had been performed by the laboratory manager/testing person #1; (c) Testing Person #5 - The 01/17/2020 and 01/17/2021 evaluation had been performed by the laboratory manager/testing person #1. (2) The surveyor reviewed the records with the laboratory laboratory manager on 05/03/2021 at 12:23 pm, and explained that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The laboratory manager -- 13 of 14 -- stated to the surveyor on 05/03/2021 at 12:25 pm, the above evaluations had been performed by an individual who did not meet the educational qualifications of a technical consultant. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the laboratory manager, technical consultant #1, and technical consultant #2, the technical consultant failed to ensure the establishment and maintenance of acceptable levels of analytic performance. Findings include: (1) The technical consultant failed to ensure the accuracy of Ammonia and Vitamin D testing had been verified at least twice annually. Refer to D5217; (2) The technical consultant failed to ensure the laboratory followed the manufacturer's instructions for implementing coagulation reagents. Refer to D5411; (3) The technical consultant failed to ensure materials were stored as required for 11 of 11 months. Refer to D5413; (4) The technical consultant failed to ensure the demonstrated reportable ranges were utilized for 2 of 3 new test methods; failed to ensure the performance specification of precision had been verified for 1 of 3 new test methods; and failed to ensure the verification data had been evaluated prior to implementing the new test for 2 of 3 new test systems. Refer to D5421; (5) The technical consultant failed to ensure the laboratory followed the manufacturer's instructions for performing maintenance procedures. Refer to D5429. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical consultant failed to evaluate personnel performing moderate complexity testing at least annually for 1 of 4 persons. Findings include: (1) On 05/03/2021, the surveyor reviewed personnel records for 4 persons who performed moderate complexity testing during 2019, 2020, and to date in 2021. For 1 of the 4 persons (laboratory manager /testing person #1), there was no evidence annual evaluations had been performed since 10/22/2018; (2) The surveyor reviewed the findings with the laboratory manager who stated on 05/03/2021 at 12:15 pm, the annual evaluations had not been performed as indicated above. -- 14 of 14 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/01/19 through 04/04/19. The findings were reviewed with laboratory director, laboratory supervisor, technical consultant #1, technical consultant #2, testing person #2, testing person #3, testing person #7, respiratory/radiology supervisor, quality risk management director, chief executive officer, chief operating officer and interim administrative chief operating officer during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1411; D6076: Laboratory Director, High Complexity 493.1271; D5026: Immunohematology D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records. The following was identified for 4 of 14 testing events: (a) Third 2017 Immunohematology Event (i) The attestation was not signed by the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- director or designee. (b) Third 2017 Chemistry Core Event (i) The attestation was not signed by the laboratory director or designee. (c) Third 2017 Microbiology Event (i) The attestation was not signed by the laboratory director or designee. (d) Third 2017 Hematology/Coagulation Event (i) The attestation was not signed by the laboratory director or designee. (2) The findings were reviewed with the laboratory supervisor who stated the attestations had not been signed as indicated above. D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) In addition, the laboratory must retain immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b) (3)(iv), (b)(3)(v), and (d). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to maintain Immunohematology records. Findings include: IMMUNOHEMATOLOGY QUALITY CONTROL RECORDS Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor that the laboratory performed the following blood bank testing: (a) Type and Screen Testing - consisted of ABO/Rh and Antibody Screen; (b) Crossmatch Testing - consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit(s)). (2) On the third day of the survey, the surveyor reviewed quality control records for blood bank testing performed during July 2017 through March 2018 and identified the following: (a) Quality control records were not available from 09/01/17 through 09/30/17 (3) The surveyor asked the laboratory supervisor if quality control records were available for review from 09/01/17 through 09/30/17. The laboratory supervisor stated the quality control records were not available; (4) The following were examples of patient testing performed when quality control records had not been maintained: (a) Patient #1 - A Type and Screen was performed on 09/02/17; (b) Patient #2- A Type and Screen was performed on 09/04 /17; (c) Patient #3 - A Type and Screen was performed on 09/05/17; (d) Patient #4 - A Type and Screen was performed on 09/06/17; (e) Patient #5 - A Type and Screen was performed on 09/07/17; (f) Patient #6 - A Type and Screen was performed on 09/08 /17; (g) Patient #7 - A Type and Screen was performed on 09/09/17; (h) Patient #8 - A Type and Screen was performed on 09/11/17; (i) Patient #9 - A Crossmatch was performed on 09/11/17; (j) Patient #10 - A Type and Screen was performed on 09/12 /17; (k) Patient #11 - A Crossmatch was performed on 09/12/17; (l) Patient #12 - A Type and Screen was performed on 09/13/17; (m) Patient #13 - A Type and Screen was performed on 09/14/17; (n) Patient #14 - A Type and Screen was performed on 09 /15/17; (o) Patient #15 - A Type and Screen was performed on 09/18/17; (p) Patient #16 - A Type and Screen was performed on 09/19/17; (q) Patient #17 - A Type and Screen was performed on 09/20/17; (r) Patient #18 - A Type and Screen was performed on 09/21/17; (s) Patient #19 - A Crossmatch was performed on 09/21/17; (t) Patient #20 - A Type and Screen was performed on 09/22/17; (u) Patient #21 - A Type and Screen was performed on 09/23/17; (v) Patient #22 - A Type and Screen was performed on 09/24/17; (w) Patient #23 - A Type and Screen was performed on 09/25/17; (x) Patient #24 - A Type and Screen was performed on 09/26/17; (y) Patient #25 - A Type and Screen was performed on 09/27/17; (z) Patient #26 - A Type and Screen was performed on 09/28/17. THERMOGRAPH TEMPERATURE CHART (1) On the second day of the survey, the surveyor observed the thermograph temperature recorder for the blood bank refrigerator. The refrigerator had a recorder -- 2 of 11 -- connected to it for continuously recording the temperature on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees Centigrade). Each chart monitored the temperature for a 7 day period; (2) The surveyor reviewed 13 refrigerator charts dated from 12/23/18 through 04/01/19. The review indicated that a chart was not available for review between 01/21/19 through 01/28/19: (3) The surveyor asked the laboratory supervisor if the Blood Bank chart between 01/21/19 through 01/28/19 was available for review. The laboratory supervisor stated the thermograph charts could not be located for the above date. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, policies and procedures, manufacturer's instructions and interview with the laboratory supervisor, the laboratory failed to ensure the requirements were met for the specialty of Immunohematology. Findings include: (1) The laboratory failed to define a function check protocol to ensure the centrifuges were functioning properly. Refer to D5435; (2) The laboratory failed to perform a negative and positive control material each day of patient Urine Drug Screening and Immunohematology testing. Refer to D5449; (3) The laboratory failed to have procedures to detect an ABO incompatibility between the donor's cell type and the recipient serum or plasma type. Refer to D5551; (4) The laboratory failed to ensure units of blood were stored under appropriate conditions. Refer to D5555; (5) The laboratory failed to have an ongoing mechanism for performing analytic quality assessment. Refer to D5791. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to review and evaluate proficiency testing results. Findings include: BIASES (1) On the first day of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2018 Chemistry Core Event (i) Calcium - 3 of 5 results exhibited a negative bias (aa) CH-11 - SDI of -2.1 (bb) CH-14 - SDI of -2.5 (cc) CH- 15 - SDI of -2.2 (b) Third 2018 Hematology Event (i) MCV (Mean Corpuscular Volume) - 4 of 5 results exhibited a positive bias (aa) CH-11 - SDI of 2.8 (bb) CH-12 - SDI of 2.5 (cc) CH-13 - SDI of 3.1 (dd) CH-15 - SDI of 2.1 (c) First 2019 Chemistry Core Event (i) Direct Bilirubin - 4 of 5 results exhibited a negative bias (aa) CH-02 - SDI of -2.8 (bb) CH-03 - SDI of -2.2 (cc) CH-04 - SDI of -2.0 (dd) CH-05 - SDI of -4.5 (2) The surveyor further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) The surveyor then -- 3 of 11 -- reviewed the records with the laboratory supervisor, and asked if the biases had been addressed. The laboratory supervisor stated the biases had not been addressed. FAILURES (1) On the first day of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records. The following failures were identified, in which