Shamrock Community Hospital, Inc

Summary Statement of Deficiencies D0000 During a recertification survey completed on January 21, 2026, the laboratory was found out of compliance with the following conditions: 493.1210 Condition: Routine chemistry. 493.1217 Condition: Immunohematology. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on laboratory observation, a review of the manufacturer's package inserts, a review of test validation records, a review of the laboratory's quality control records, a review of the laboratory procedure manual, final patient test reports, electronic mail communications, and staff interview, the laboratory failed to ensure the procedure for the Abbott i-STAT High Sensitivity Troponin I (i-STAT hs-TnI) included the normal (reference) range (Refer to D5403 Citation One), failed to verify the normal/reference range for the i-STAT hs-TnI (Refer to D5421), failed to perform quality control (QC) for the creatinine analyte at least every eight hours according to the manufacturer's requirements (Refer to D5445), and the laboratory failed to follow the procedure for calculation of QC ranges for the albumin analyte (Refer to D5469). 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- This CONDITION is not met as evidenced by: Based on a review of the laboratory's procedure manual, a review of the laboratory's form for recording transfusion medicine testing and patient test records, the laboratory's quality assessment documents for transfusion medicine, a review of the laboratory's Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (FORM CMS-116)and staff interview, the laboratory failed to have a procedure that required a second verification of patient ABO group/Rh type (ABO /Rh) prior to the transfusion of blood products for patients without an established history (Refer to D5403 Citation Two), and the laboratory failed to identify and correct problems with transfusion medicine testing, including recording of results, failed quality control, undocumented quality control, and missing documentation of function checks in 2024 and 2025 (Refer to D5793 Citation One). 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: CITATION ONE: Based on a review of the laboratory procedure manual, lack of documentation, staff interview, and review of an electronic mail communication, annual urine microscopy competency assessment was not performed in 2024 for three of three established testing personnel reviewed. This was cited on the previous survey, and compliance was not maintained. The findings include: 1. The laboratory policy titled "Competency Evaluation" stated the following: "A skill competency assessment must be performed twice during the employee's initial year of employment of all technical staff and annually thereafter to ensure staff have adequate training and orientation to perform skills/procedures and test competently." 2. Urine microscopy competency assessment was not documented in 2024 for three of the three established testing personnel reviewed (testing personnel numbers one, four, and six). 3. During an interview on 01/20/26 at 10:45 a.m., the general supervisor/technical consultant stated that she accidentally left urine microscopy off the 2024 competency assessment forms when making changes. This confirmed the survey findings. 4. In an electronic mail communication received on 01/26/26 at 10:40 a.m., the general supervisor /technical consultant stated that approximately 948 urine microscopics were performed in 2024 during the time when competency assessments were not performed. CITATION TWO: Based on observation of the laboratory, a review of the laboratory's competency assessment records, and staff interview, the laboratory failed to have a process in place to document separate testing personnel competencies for the ABO group, Rh type, and compatibility testing performed using the tube method and the Ortho Gel method used for performing antibody screening. The findings include: 1. Observation of the transfusion medicine testing area of the laboratory on 01/20/26 at 8:40 a.m. revealed the laboratory performed ABO group, Rh type, and compatibility testing using the tube method, and antibody screening using the Ortho gel method. 2. A review of the laboratory's 2024 and 2025 testing personnel competency assessment records and forms revealed that separate competencies were not documented for the ABO group, Rh type, and compatibility testing performed using the tube method, and the antibody screen performed using the Ortho gel method. 3. The general supervisor/technical consultant confirmed the survey findings -- 2 of 9 -- during an interview on 01/20/26 at 10:45 a.m. CITATION THREE: Based on a review of the laboratory's personnel records, a review of the laboratory procedure manual, and staff interview, the laboratory policy for competency assessment was not in compliance with Subpart M when it did not require competency assessments for duties delegated by the laboratory director. The findings include: 1. A review of the laboratory's personnel records revealed the following: Technical consultant duties were delegated to two persons. General supervisor duties were delegated to one person. Competency assessment was not documented in 2024, 2025, or 2026 for either of the two persons to whom duties were delegated. 2. The laboratory policy titled "Competency Evaluation" did not include a requirement for competency assessment for delegated laboratory director duties (technical consultant, general supervisor). 3. The general supervisor confirmed the survey findings during an interview on 01/20/26 at 1:30 p.m. 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 laboratory observation, review of the laboratory procedure manual, review of calibration verification documents, review of patient activity reports, and staff interview, the laboratory failed to follow the procedure for performing calibration verification at least every six months in 2024 and 2025 for chemistry and toxicology analytes performed on the Beckman Coulter DxC 700 AU. The findings include: 1. Laboratory observation on 01/20/26 at 8:40 a.m. revealed the Beckman Coulter DxC 700 AU used for patient testing for chemistry and toxicology analytes. 2. The laboratory's procedure titled "Calibration Verification" stated that calibration verification would be performed for analytes on the Beckman Coulter DxC 700 AU for tests with less than three calibration points at least every six months. 3. A review of the laboratory's calibration verification records revealed the following: The calibration verification, due 03/08/24, was not performed until 09/24/24 for the Triglyceride analyte. The calibration verification for the Ethyl Alcohol and Ammonia analytes, due 09/05/24, was not performed until 03/28/25. The calibration verification, due 09/18/24, was not performed until 09/08/25, for the High-Density Lipoprotein Cholesterol analyte. The calibration verification, due 03/24/25, was not performed until 09/8/25, for the Carbon Dioxide, Creatinine, Direct Bilirubin, Total Bilirubin, and Total Protein analytes. The calibration verification, due 03/24/25, was not performed until 06/09/25, for the Albumin, Blood Urea Nitrogen, Calcium, Carbon Dioxide, Chloride, Cholesterol, Glucose, Lactic Acid, Magnesium, Phosphorus, Potassium, Sodium and Triglyceride analytes. 4. A random review of patient activity reports revealed the following: During the calibration verification gap from 03/08/24 to 09/24/24, approximately 23 Triglyceride results were reported. During the calibration verification gap from 09/05/2024 to 03/28/25, approximately 38 Ammonia results were reported. During the calibration verification gap from 03/24/25 to 06/09 /25, approximately 714 Albumin results were reported. During the calibration verification gap from 03/24/25 to 09/8/25, approximately 1,845 creatinine and 1,786 Total Protein results were reported. 5. The general supervisor/technical consultant confirmed the survey findings during an interview on 01/21/26 at 5:00 p.m. -- 3 of 9 -- 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- 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 During an initial survey the laboratory was found out of compliance with the following condition: 493.1250 Condition: Analytic systems 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 review of the laboratory procedure manual, the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), lack of documentation, and staff interview, the laboratory failed to follow its' own policies for testing personnel training and evaluation of competency for eight of eight testing personnel in 2023. The findings include: 1. Review of the laboratory's policy titled "QUALITY ASSURANCE (QA) FOR THE LABORATORY under the section for new employees revealed that new employees would be trained for each section they work, and that performance would be review at 90 days, six months and then annually. The policy titled "Competency Evaluation" revealed that "each individual's performance in the laboratory will be evaluated at orientation, at 6 months, and yearly thereafter." "Prior to implementation of new equipment or procedures - orientation, inservice and competency must be performed prior to test performance by technical staff." 2. Review of the FORM CMS 209 revealed eight testing personnel who perform patient testing. 3. There was no documentation of laboratory training /assessment of competency for testing personnel as follows: Testing person number one: Urine microscopic, manual differential, ABO, Rh, Antibody Screen, Compatibility testing, mono test, wet prep. Testing person number two: Beckman Coulter AU and Beckman Coulter Access chemistry instruments, urine microscopic, testing performed on the Abbott i-STAT instrument (blood gas and troponin I), and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- wet prep. Testing person number three: Triage meter for performance of D-Dimer, urine microscopic, manual differential, Beckman Coulter DxH complete blood count instrument, wet prep, and Sysmex CA 600 for performance of Prothrombin Time (PT) and activated Partial Thromboplastin Time (PTT). Testing person number four: Triage meter for performance of D-Dimer, urine microscopic, Beckman Coulter DxH complete blood count instrument, manual differential, Abbott i-STAT for performance of arterial blood gas and troponin I, mono test, Sysmex CA 600 for performance of PT and PTT, and serum pregnancy test on the ICON test kit. Testing person number five: Beckman Coulter DxH complete blood count instrument, urine microscopic, manual differential, Abbott i-STAT instrument for performance of blood gas and troponin I, mono test, wet prep, serum pregnancy test on the ICON test kit. Testing person number six: Triage meter for performance of D-Dimer, urine microscopic, Beckman Coulter DxH complete blood count instrument, manual differential, transfusion medicine testing to include ABO, Rh, antibody screen and compatibility testing, Abbott i-STAT for performance of arterial blood gas and troponin I, wet prep, and Sysmex CA 600 for performance of PT and PTT. Testing person number seven: Triage meter for performance of D-Dimer, Beckman Coulter AU and Access 2 chemistry instruments, Beckman Coulter DxH complete blood count instrument, urine microscopic, manual differential, Abbott i-STAT instrument for performance of blood gas and troponin I, wet prep, and Sysmex CA 600 for performance of PT and PTT. Testing person number eight: Beckman Coulter AU and Access 2 chemistry instruments, Beckman Coulter DxH complete blood count instrument, Abbott i-STAT instrument for performance of blood gas and troponin I and wet prep. 4. Interview with the general supervisor on 12/11/23 at 4 pm confirmed the laboratory failed to follow its' own policy for testing personnel training and competency assessment for all eight personnel who perform patient testing. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on laboratory observations, review of laboratory procedures, patient test reports, manufacturer instructions for use, quality control records, patient test logs, lack of documentation, staff interview and electronic communications, the laboratory failed to maintain compliance with analytic systems when it failed to have a complete procedure manual for performance of hematology testing on the Beckman Coulter DxH 690T (Refer to D5403), failed to ensure the procedure for the Beckman Coulter DxH 690T hematology instrument was approved by the laboratory director before use (Refer to D5407), failed to perform Mean Normal Patient Prothrombin Time for the current lot of Innovin (Refer to D5411), failed to verify the performance of the moderately complex Respiratory Syncytial Virus (RSV) performed on the Quidel Sophia 2 (Refer to D5421-Citation One), failed to verify the performance specifications of the cardiac Troponin I performed on the i-STAT instrument (Refer to D5421-Citation Two), failed to establish performance specifications for RSV test performed on patients outside the manufacturer specified age groups (Refer to -- 2 of 10 -- D5423), failed to ensure at two levels of controls were performed each day of patient testing for the cardiac Troponin I performed on the i-STAT instrument (Refer to D5447), failed to ensure two levels of quality control were performed for the qualitative serum pregnancy test for the ICON test kit (Refer to D5449-Citation number one), failed to ensure two levels of quality control were performed each day of patient testing for the non-waived RSV test performed on the Quidel Sophia 2 (Refer to D5449-Citation number two), failed to verify the quality control (QC) ranges that were in use for the Thyroid Stimulating Hormone (Refer to D5469), and failed to ensure an anti-human globulin (AHG) crossmatch was performed when the patient had a positive antibody screen (Refer to D5551). 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)