Dahl Memorial Clinic

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)

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of Quality Control (QC) procedures, patient test records, quality control log sheets, and interview with the laboratory director, the laboratory did not follow their written procedure to perform QC each day patients were tested for 2 of 6 patient testing days (11/19/2020 and 4/14/2022) that Abbott i-STAT PT/INR and Biosite Triage D-Dimer, Cardiac Panel, and BNP patient records were reviewed. Findings include: 1. The Quality Control Procedure states '2 controls each day a patient is tested' for the Abbott i-STAT PT/INR and the Biosite Triage D-Dimer, Cardiac Panel, and BNP assays. 2. Review of patient test and QC records revealed the laboratory performed PT/INR and Cardiac panels performed on 11/19/2020 and 4/14 /2022 (2 of 6 dates of patient record review) The QC logsheets were missing QC documentation for these dates. 3. The laboratory director confirmed these findings by interview on 8/23/22 at 14:00. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on surveyor observation of laboratory thermometers and interview with the laboratory director, the laboratory failed to verify the accuracy of 3 of 4 thermometers within the timeframe defined by the manufacturer. Findings include: 1. The Fisher Scientific digital thermometers (serial numbers 130472417 and 130472420) in use in the laboratory's refrigerator and freezer had a calibration due dates of 8/13/15. There was no documentation to indicate a verification of accuracy had been performed. The refrigerator and freezer are used to store reagents and patient samples. 2. The Fisher Scientific digital thermometer (serial number 91265965) used to monitor the laboratory's room temperature and humidity had a calibration due date of 11/30/11. There was no documentation to indicate a verification of accuracy had been performed. 3. The laboratory director confirmed these findings by interview on 8/23 /22 at 14:00. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency testing records, the laboratory unsuccessfully participated in proficiency testing (PT) for the specialty Routine Chemistry, and the Creatine Kinase Isoenzyme analyte. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, the laboratory failed to achieve satisfactory proficiency testing performance for the specialty Routine Chemistry and the Creatine Kinase Isoenzyme analyte in two of three testing events. Findings: 1. The laboratory is subscribed to the American Proficiency Institute Chemistry Core proficiency testing program. 2. The laboratory received the following scores: Routine Chemistry: 2019 Third Testing Event: 0% 2020 Second Testing Event: 60% Creatine Kinase Isoenzyme: 2019 Third Testing Event: 0% 2020 Second Testing Event: 60% -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory did not test, at a minimum, two levels of external quality control (QC) material to monitor the accuracy and precision of the Abbott i-STAT PT/INR test each day patients were tested. Findings: 1. The laboratory is performing two levels of external quality control material every 30 days and with each new lot and/or shipment of the PT/INR cartridges. 2. The laboratory performs approximately 24 PT/INRs annually. 3. During an interview on 4 /30/18 at 11:00 am, the laboratory director confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --