Owyhee Community Health Facility

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Chemistry quality control (QC) records and interview via telephone with the laboratory director on October 22, 2020, the laboratory failed to ensure control materials met the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. The findings included: 1. During random review of patient testing records from June 2018 through August 2020, one of the nine records reviewed, identified the QC values were outside of the laboratory's established range and patients specimens were ran and released. Date 12/19/2018 Run 1 level Test Result Test Range QC1 LIPL 102 105-125 U/L QC3 CA 1.2 2.4-13.6 U/L ALB -0.1 3.8-4.3 U/L ALPI 275 283-323 U/L ALTI 188 189-213 U/L URCA 0.0 8.8-9.8 U/L LIPL 491 570-650 U/L After repeated runs the SerumQC3 ALPI and ALTI were still not within the laboratory's established range. Repeat (2) QC3 ALPI 273 283-323 U/L ALTI 179 189- 213 U/L Repeat (3) QC3 ALPI 273 283-323 U/L ALTI 187 189-213 U/L 2. The laboratory performed and released three patient ALPI/ ALTI results on 12-19-2018, while the SerumQC3 values remained outside of the laboratory's established range. HRN# 5013 HRN# 20575 HRN# 11114 3. The laboratory technical consultant confirmed by interview via telephone conference on October 22, 2020 that the laboratory had released patients' results when chemistry QC values did not meet the laboratory's criteria for acceptability. 4. The laboratory reports performing and reporting approximately 4,265 patient chemistry results annually. D5783

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 review of laboratory instrumentation, quality control (QC) materials, patient test reports covering the period from December 29, 2016 to December 21, 2017 and interview with the laboratory director and testing personnel, it was determined that the laboratory failed to not use QC materials when they have exceeded their expiration date. The findings include: a. During examination of the laboratory's QC materials used for patient testing it was discovered that two bottles of Bio-Rad Liquichek Immunoassay Plus had expired. Reagent Lot Number Expiration 40901 2017-10-31 40903 2017-10-31 b. On June 14, 2018, the laboratory director and testing personnel affirmed that the expired QC materials have been used for patient testing. c. Based on the laboratory's annual test volume declaration the laboratory analyzed and reported approximately 5,026 chemistry procedures annually. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of laboratory equipment maintenance documentation, patient test reports covering the period from December 29, 2016 to December 21, 2017, and interview with the laboratory director and testing personnel, it was determined that the laboratory failed to establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The findings include: a. During examination of the laboratory's equipment and instrumentation used to perform laboratory testing it was discovered that the laboratory's pipettes used for prothrombin time patient testing was last serviced and calibrated 8/10/15. b. The laboratory failed to provide documentation of a maintenance protocol that ensures equipment and instrument performance necessary for accurate and reliable test results. c. On June 14, 2018, the laboratory director and testing personnel affirmed that the pipettes labeled with a service and calibration date of 8/10/15 are being used for prothrombin time testing. d. Based on the laboratory's annual test volume declaration the laboratory analyzed and reported approximately 71 prothrombin time procedures annually. 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 review of laboratory instrumentation, manufacturer package insert, quality control (QC) materials, QC records, patient test reports covering the period from December 29, 2016 to December 21, 2017 and interview with the laboratory director and testing personnel, it was determined that the laboratory failed to test a negative and positive control material at least once a day patient specimens are examined for each qualitative procedure. The findings include: a. During examination of the laboratory's QC materials and records used to perform Bio-Rad drugs of abuse testing it was discovered that negative and positive control materials were not tested each day of patient testing. b. Review of Bio-Rad's manufacturer package insert titled, "TOX /See Protocol Sheet," stated "The use of external positive and negative control material is recommended to test each new lot or shipment of product and every 30 days thereafter." c. The laboratory's QC records similarly stated, "QC(Positive and Negative controls run with new kit and monthly of use)" d. On June 14, 2018, the laboratory director and testing personnel affirmed that control materials were tested following the aforementioned manufacturer package insert protocol. e. Based on the laboratory's annual test volume declaration the laboratory analyzed and reported approximately 81 toxicology procedures annually. D5779