Dewitt Hospital And Nursing Home

Summary Statement of Deficiencies 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 upon observation, review of temperature records, lack of documentation and interview the laboratory failed to monitor the temperature on each day of operation in one of three rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 4/9/26 at 1:23pm one room (the micro room) was observed separated by a closable door containing laboratory items with a temperature storage requirement . B) A review of the laboratory's temperature records revealed that no room temperatures were recorded for the micro room for the year of 2025. C) During a tour of the laboratory on 4/9/26 at 1: 23pm one (of one) Micro Sars Antigen test Quickvue (REF 20387, temperature requirements of 15C-30C) and one (of one) ParaPak C+S (REF 900612, temperature requirements of 2C-30C) were observed in the micro room. D) Upon request, the laboratory could not present the temperature records for the micro room in which the supplies identified above were stored. E) In an interview on 4/9/26 at 1:24pm, the laboratory staff member (GS# 2 on form CMS 209) confirmed that temperature records for the micro room were not available. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 4/9/26 at 1:32pm, one unopened bottle of EDM3 solution Immersion Oil (lot: 2349, expiration date 9/8/24) was observed in the laboratory, available for use beyond the expiration date. B) In an interview on 4/9/26 at 1:32pm laboratory staff (GS#2 as listed on the CMS-209 form) confirmed that the item, identified above, had exceeded the expiration date and was available for use in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's instruction, the laboratory's procedure manual, patient test records, and interview with staff the laboratory failed to ensure 6 of 8 patient lactate samples were centrifuged within 15 minutes of collection from January to April 2023. A) A review of the manufacturer's instructions ("Flex Reagent Cartridge" from Siemens, Lactic Acid, REF DF16, rev.-2019/04/01) for the lactate analysis performed in the laboratory, instructions stated:"centrifuge within 15 minutes of collecting specimen." B) The Laboratory's QC Policy manual did not contain specfic policies for lactate, but referred to "following manufacturer's instructions and /or package inserts". C) Lactate patient test records from January 2023-April 2023 revealed: Sample ID 6595; Collected : 01/10/23 05:31, Analyzed: 01/10/23 06:50 Sample ID 2849; Collected : 01/10/23 16:11, Analyzed: 01/10/23 16:48 Sample ID 12371; Collected : 01/18/23 21:15, Analyzed: 01/18/23 22:07 Sample ID 12376; Collected : 01/22/23 19:29, Analyzed: 01/22/23 20:30 Sample ID 11544; Collected : 02/08/23 06:52, Analyzed: 02/08/23 07:50 Sample ID 8999; Collected : 03/02/23 15: 43, Analyzed: 03/02/23 16:28 D) During interview, General Supervisor #2 (as listed on the CMS-209 form) confirmed that the lab documented collection times and report times; but not centrifuge times. D5401 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of laboratory policies and procedures for chemistry, a review of the chemistry Quality Control (QC) records, and interviews with laboratory staff, the laboratory failed to follow written procedures for Chemistry QC. Survey findings include: A. The laboratory chemistry QC policy states: "Run abnormal high level controls before low level controls to check for instrument carryover." B. A review of the chemistry QC records for January 2024 showed that the abnormal high level control IMMU-II was not ran before the normal level control for IMMU-I on 6/16 days of testing and the CARD-III abnormal high control was not ran before the normal level CARD-I control on 27/30 days of testing. A review of the chemistry QC records for April 2024 showed that the abnormal high level control IMMU-II was not ran before the normal level control for IMMU-I on 8/13 days of testing and the CARD-III abnormal high control was not ran before the normal level CARD-I control on 25/30 days of testing. C. In an interview, at 10:14 on 6/12/24, the technical consultant confirmed that abnormal high controls were not always ran before normal controls in chemistry. -- 2 of 2 --

Summary Statement of Deficiencies 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: Through a review of blood transfusion procedures, a review of patient transfusion records, and interviews with laboratory staff, it was determined nursing personnel failed to follow procedures to detect transfusion reactions so that the reactions may be investigated by the laboratory. Survey findings include: A. The procedure titled "DeWitt Hospital Blood and Blood Products Transfusions" states, "Take and record vital signs immediately preceding transfusion, 15 minutes after initiation, 30 minutes after initiation, 60 minutes into the transfusion, and immediately post transfusion." B. During a review of thirty-two patient Blood Transfusion Records it was determined that three of thirty-two records were missing vital signs documentation. Patient #805940 was transfused on 8/7/2022. The required post transfusion blood pressure was not documented. Patient #10344 was transfused on 6/28/2022. There were no post transfusion vitals documented. Patient #11893 was transfused on 1/25/2022. Fifteen minute and sixty minute vitals were not documented. C. In an interview at 1:40 p.m. 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 -- on 11/17/2022, employee #3 (as listed on the form CMS-209) confirmed that vital signs required to monitor for a transfusion reaction were not documented on the three patients listed above. D5783

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)