Faulkton Area Medical Center

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 7/14/21. The Faulkton Area Medical Center laboratory was found not in compliance with the following requirement: D5447. 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 observation, record review, and interview, the laboratory failed to perform two levels of controls or establish an equivalent quality control (QC) method to verify the accuracy of six of six non-waived test methods (D-Dimer, urine microalbumin, urine creatinine, pH, PCO2, and PO2) each day patient testing was performed. Findings include: 1. Review of the laboratory's records revealed: a. The laboratory performed patient D-Dimer testing on the Alere Triage analyzer. *QC results had not been documented 6/5/21. Patient D-Dimer test results had been reported to the provider on that date. *The laboratory's D-Dimer Procedure (last reviewed by the laboratory director on 1/18/21) stated, "Quality Control Policy- Perform external quality checks on test device with each new lot or shipment and at least monthly. Assay two levels of control (normal and abnormal) to ensure reagent integrity and performance." *Review of the manufacturer's Alere Triage D-Dimer Product Insert revealed, "Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by your laboratory's standard quality control procedures." *The laboratory had not developed an individual quality control plan (IQCP) which would have 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 -- allowed the laboratory to process QC specimens at the minimum number and frequency required by the manufacturer. *Review of the laboratory's annual test volume form revealed 208 patient specimens had been reported between 6/30/20 and 7 /1/21 without QC having been performed to ensure the accuracy of the test results.. b. The laboratory performed patient urine microalbumin/creatinine ratio testing on the DCA Vantage analyzer. *QC results had not been documented 6/22/21. Patient urine microalbumin/creatinine ratio test results had been reported to the provider on that date. *The laboratory's Microalbumin Creatinine Procedure (written 9/14/18, last reviewed by the laboratory director on 2/22/21) stated, "Quality Control Policy: Assay two levels of control (normal and abnormal) to ensure reagent integrity and performance. Perform with each reagent shipment, every new lot or at least once a month." *Review of the Siemens DCA systems Microalbumin/Creatinine Reagent Kit manufacturer's package insert revealed, "Run quality control specimens under the following conditions: -At regular intervals determined by the laboratory procedures. - With each new lot of reagents. -Each time a calibration card is scanned. -To train and confirm performance acceptability for new analysts. -When results do not match the patient's clinical condition or symptoms." *The laboratory had not developed an individual quality control plan (IQCP) which would have allowed the laboratory to process QC at the minimum number and frequency required by the manufacturer. *Review of the laboratory's annual test volume form revealed 86 urine microalbumin and creatinine patient specimens had been reported between 6/30/20 and 7/1/21 without QC having been performed to ensure the accuracy of the test results. c. The laboratory performed patient blood gas (pH, PCO2, and PO2) testing on the Epoc analyzer. *QC results had not been documented on 2/3/21. Patient blood gas results had been reported to the provider on that date. *The laboratory's Epoc System Operating Procedure (written 3/23/15 and last reviewed by the laboratory director on 6 /4/21) stated, "Quality control: Three levels of Eurotrol Epoc control. Frequency: Performed with each new lot number of test cards or every month." *Review of the Epoc System Manual revealed "From each lot in each shipment of cards, analyze at least two (2) levels of fluid controls in duplicate using any verified Reader(s)." *The laboratory had not developed an individual quality control plan (IQCP) which would have allowed the laboratory to process QC at the minimum number and frequency required by the manufacturer. *Review of the laboratory's annual test volume form revealed 99 patient blood gas specimens had been reported between 6/30/20 and 7/1 /21 without QC having been performed to ensure the accuracy of the test results. Interview on 7/14/21 at 11:15 a.m. with the laboratory manager revealed: *She confirmed QC was performed on a monthly basis, with new shipments, and changes of lot numbers for the above named testing methods. *She confirmed the laboratory had not developed an IQCP for the D-Dimer, urine microalbumin creatinine ratios, or blood gas testing (pH, PCO2 and PO2). *She was not aware QC was required each day of patient testing was performed unless an IQCP had been established. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 7/26/18. The Faulkton Area Medical Center laboratory was found not in compliance with the following requirements: D2009, D5775, and D6149. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) events, quality assurance (QA) activities review, and interview with testing personnel A and B, the laboratory failed to ensure the director and/or testing personnel had signed 4 of 29 attestation forms (College of American Pathology [CAP] CM-A 2017 clinical microscopy and BNP-A 2017 first event, C-B 2017 general chemistry and therapeutic drugs second event, and C-C2017 general chemistry and therapeutic drugs third event) that attested PT samples had been tested in the same manner as patient specimens for 2017. Findings include: 1. Review of PT events for 2017 revealed four of four attestation statements had not been signed by the laboratory director or designee and or testing personnel (tow of four attestation statements had not been signed by the laboratory director or designee, one of four attestation statements had not been signed by testing personnel, and one of four surveys lacked a signed attestation statement signed by the laboratory director or designee and testing personnel) for the following: %CAP C-C 2017 general chemistry and therapeutic drugs third event and CAP BNP-A 2018 BNP lacked a laboratory director or designee signature. %CAP C-B 2017 general chemistry and therapeutic drugs second event lacked a testing personnel signature. %CAP CM-A 2017 clinical microscopy first event lacked a signed attestation statement 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 2 -- director or designee and testing personnel. Review of the QA reports revealed PT review was not included in the laboratory's QA plan. Interview on 7/26/18 at 12:30 p. m. with testing personnel A and B revealed they were unaware the PT attestation forms had not been signed. D5775 COMPARISON OF TEST RESULTS 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 quality assessment (QA) activities review and interview with testing personnel B, the laboratory failed to monitor the differences between five of five tests (sodium, potassium, chloride, creatinine, and glucose) performed by multiple instruments (Siemens EPOC versus Dimension Expand). Those methods or instruments had not been evaluated twice a year in 2017 or to date in 2018 to determine if their differences had been acceptable. Findings include: 1. Review of the laboratory's 2017 and 2018 QA reports revealed comparison testing had not been completed twice a year for sodium, potassium, chloride, creatinine, or glucose between the Siemens EPOC and the Dimension Expand. Interview on 7/26/18 at 11: 40 a.m. with testing personnel B revealed: %The lab used the Siemens EPOC as a back-up analyzer for the Dimension Expand. %She was not aware comparison testing between the two analyzers was required. D6149 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(1) The director or technical supervisor may delegate to the general supervisor the responsibility for assuring that all remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, Levy Jennings graphs, and interview the general supervisor failed to review QC records to ensure they had stayed within performance specifications for each chemistry analyte for three of three months reviewed (January 2018 through March 2018). Findings include: 1. Review of the laboratory's 2018 monthly QC reports and Levy-Jennings graphs revealed the following out of range controls: %Troponin I, 1/22/18. %Creatinine Kinase, 1/30/18. %Vancomycin, 1/7/18. %C-Reactive Protein, 1/31/18. %Free Thyroxine, 1/19/18. % Chloride, 1/13/18, 2/3/18. %Potassium, 2/3/18 and 2/26/18. %Amylase, 2/8/18. % Sodium, 2/12/18 and 3/31/18. Further review of the laboratory's Quality and