Warm Springs Health & Wellness Center

Summary Statement of Deficiencies D0000 During a routine recertification onsite survey conducted on 06/22/2021, a random sampling review of laboratory's records found the laboratory to be in substantial compliance with federal regulations at 42 C.F.R. 493, Clinical Laboratory Requirements for SARS CoV-2 reporting. 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 record review of the laboratory's testing personnel competency records and interview with the laboratory general supervisor (GS) the laboratory failed to follow written policies and procedures to assess one of three employee competency in accordance with CLIA regulations and the laboratory's policy and procedures. Findings include: 1. The laboratory CMS-209 personnel report indicated that the labortory had one new testing personnel since the last surey with a start date of 06/08 /2020. 2. The laboratory had no documentation of annual competency performed for the testing of SARS CoV-2 for the new Medical Laboratory Technician (MLT) testing personnel. 3. The laboratory general supervisor confirmed by interview on 06/22/2021 that the annual competency for the MLT had not been performed. 4. The laboratory records indicate the laboratory has performed 11,591 SARS CoV-2 tests from 11/20 /2020 to survey date 06/22/2021. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's chemistry quality control (QC) records, personnel training and competency records and interview with the laboratory general supervisor (GS) the laboratory failed to have a policy and procedure for reviewing and documenting general laboratory systems quality assessment activities which includes a review of the effectiveness of

Summary Statement of Deficiencies D0000 During a routine recertification onsite survey conducted on 06/22/2021, a random sampling review of laboratory's records found the laboratory to be in substantial compliance with federal regulations at 42 C.F.R. 493, Clinical Laboratory Requirements for SARS CoV-2 reporting. 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 record review of the laboratory's testing personnel competency records and interview with the laboratory general supervisor (GS) the laboratory failed to follow written policies and procedures to assess one of three employee competency in accordance with CLIA regulations and the laboratory's policy and procedures. Findings include: 1. The laboratory CMS-209 personnel report indicated that the labortory had one new testing personnel since the last surey with a start date of 06/08 /2020. 2. The laboratory had no documentation of annual competency performed for the testing of SARS CoV-2 for the new Medical Laboratory Technician (MLT) testing personnel. 3. The laboratory general supervisor confirmed by interview on 06/22/2021 that the annual competency for the MLT had not been performed. 4. The laboratory records indicate the laboratory has performed 11,591 SARS CoV-2 tests from 11/20 /2020 to survey date 06/22/2021. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's chemistry quality control (QC) records, personnel training and competency records and interview with the laboratory general supervisor (GS) the laboratory failed to have a policy and procedure for reviewing and documenting general laboratory systems quality assessment activities which includes a review of the effectiveness of

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of available quality control records and an interview with the laboratory supervisor the laboratory failed to retain all quality control records for two years. Findings: 1. A review of quality control (QC) records for Erythrocyte Sedimentation Rate (ESR) revealed no records for 2018 were available for review at the time of the survey. 2. An interview of the laboratory supervisor at 1:15 PM confirmed that the laboratory was unable to find the 2018 ESR QC records. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 on an observation of freezer storage, a review of freezer temperature records, and an interview of the laboratory supervisor the laboratory failed to define the correct Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- acceptable range for Freezer Unit #2 for proper storage of all controls stored in the freezer. Findings: 1. Observation of Freezer Unit #2 at 11:20 AM revealed the storage of the following two controls: a. BioRad Liquid Assayed Multiqual with a manufacturer required storage temperature range of -20 to -70 degrees Celsius. b. BioRad Liquichek Immunoassay Plus Control with a manufacturer required storage temperature range of -20 to -70 degrees Celsius. 2. A review of temperature charts for the Freezer Unit #2 revealed a documented acceptable temperature range of -15 degrees Celsius or colder. 3. An interview of the laboratory supervisor on 07/10 /20119 at 11:30 AM confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of calibration records and an interview with the laboratory supervisor the laboratory failed to perform calibration verification every six (6) months, as required for multiple analytes tested on the Dimension EXL 200 chemistry analyzer. Findings: 1. A review of calibration and calibration verification records for the Dimension chemistry analyzer revealed that the laboratory failed to perform calibration verification for Sodium, Potassium, Chloride, Triglyceride and Hemoglobin A1C every six (6) months as required. 2. A review of the calibration and calibration verification records for the Dimension chemistry analyzer, also revealed that the laboratory failed to perform calibration verifications on the analytes AST, ALT, ALKP, and GGT from August 28, 2017 through February 28, 2019. 3. An interview with the laboratory supervisor on July 10, 2019 at 1:10 PM confirmed that the laboratory failed to perform calibration verification for Sodium, Potassium, Chloride Triglyceride, Hemoglobin, A1C, AST, ALT, ALKP and GGT every six (6) months. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 2 of 3 -- 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records and an interview with the laboratory supervisor, the laboratory failed to test at least 2 levels of quality control materials for the Medtox Verdict II Oxycodone test each day of patient testing since March 20, 2019. Findings: 1. A review of the quality control records for the Medtox Verdict II Oxycodone revealed the laboratory failed to test at least 2 levels of quality control material each day of patient testing between March 20, 2019 and the date of the survey. 2. A review of patients test logs revealed that 88 patient samples had been tested between March 20, 2019 and July 10, 2019. 3. An interview with the laboratory supervisor on July 10, 2019 at 1:30 PM, confirmed the laboratory failed to test at least 2 levels of quality control material prior to testing patients on each day of use. D5781