Mountain Region Family Medicine

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Laboratory Safety procedure, and staff interview, the facility failed to ensure personnel protection from potential biohazardous materials when it stored food in the cabinet drawer directly below the analyzer's sampling apparatus on the survey date (08.15.2024). Findings include: 1. Observation of the laboratory on 08.15.2024 at 9:30 a.m. revealed the Sysmex XN- 430 (serial # 11154) Hematology analyzer used for patient testing on the counter with a biohazard label attached to it. Also observed in the cabinet drawer directly below the analyzer's sampling apparatus was food for human consumption, including candy bars, fruit, peanuts, candy, and condiments. 2. A review of the Laboratory Safety procedure revealed, "Eating, drinking, and smoking in the lab are strictly prohibited." 3. An interview with the Technical Consultant (TC), Testing Personnel 1 (TP1), and Testing Personnel 2 (TP2) during the 9:30 a.m. observation 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 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, the Centers for Medicare and Medicaid Services Form 209 Laboratory Personnel Report (CMS-209) and interview with the laboratory technical consultant, determined that PT samples were not tested by all testing personnel listed on the CMS-209 in 2022. The findings include: 1. Review of the laboratory's API proficiency testing attestation records revealed only one of two testing personnel's signature as testing PT samples (2022 Event 1, 2 and 3). 2. Review of the CMS-209 revealed two personnel who perform patient testing. 3. Interview with the technical consultant on January 5, 2023 at 11:30 a.m. confirmed that PT samples were not tested by all testing personnel listed on the CMS-209 for 3 events in 2022. ==================================== D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: 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 -- Based on review of the laboratory's "Wet Preparation" policy and procedure, observation, review of laboratory's 2022 Wet prep logsheet and interview with the laboratory technical consultant and lead testing person, determined the laboratory failed to follow policy for Wet preparations in 2022. The findings include: 1. Review of the laboratory's "Wet Preparation" policy and procedure stated, "Procedure: 1. Swab should be in glass tube with .50 ml saline." 2. Observation of water in laboratory instead of saline for "wet preparation" during laboratory tour at approximately 09:30 a.m. on January 5, 2023. 3. Review of the laboratory's 2022 Wet prep logsheet revealed nine patients reported in 2022. 4. Interview on January 5, 2023 at approximately 9:30 a.m. with the laboratory technical consultant and lead testing person confirmed the laboratory failed to follow the "Wet Preparation" policy and procedure for nine of nine patients reported in 2022. -- 2 of 2 --

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 lack of written procedures for Complete Blood Counts (CBC) and manual differentials and upon interview with the Primary Laboratory person, it was determined the laboratory failed to present written procedures on 1/7/2020 for CBC and manual differential testing for 2018- 2019. The findings include: 1. There were no written procedures available for review for CBC's and manual differential testing. 2. An interview at approximately 1:00pm on January 7, 2020, with the Primary Laboratory person, confirmed there were no written procedures available for CBC and maunal differential testing for 2018-2019. =================================== D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: =================================== Based on review of CBC (Complete Blood Count) instrument maintenance requirements, review of maintenance logs for 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 -- 2019 and interview with the Primary Laboratory person, determined the laboratory failed to document CBC instrument maintenance since installation of new CBC analyzer January 2019. The findings include: 1. Review of the CBC analyzer maintenance requires daily, weekly and PRN (as needed) maintenance to be performed. 2. No maintenance was documented for CBC analyzer since installation in January 2019. 3. Interview with Primary Laboratory person at approximately 1:00 p. m. January 7, 2020 confirmed that maintenance for the CBC analyzer had not been documented since installation of new CBC analyzer January 2019. =================================== D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: =================================== Based on review of the Laboratory's Quality Assessment (QA) for Complete Blood Counts (CBCs), CBC Calibrations, and Internal Quality Assessment Program (IQAP), lack of Laboratory Director review of QC and QA for 2019, and an interview with the Primary Laboratory Person, determined the Laboratory Director did not ensure quality of laboratory services was maintained for 2019. The findings include: 1. There was no documentation of Laboratory Director review of quality assessment which includes, CBC Quality Control, CBC Calibrations, and CBC IQAP, since implementation of the new CBC analyzer in January 2019. 2. An interview with the Primary Laboratory Person at approximately 1:00 p.m. January 7, 2020 confirmed there was no documentation of Laboratory Director review of the quality controls or quality assessment records to ensure the quality of the laboratory services were maintained since new CBC analyzer in January 2019. =================================== D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: __________________________________ Based on a review of the laboratory's employee competency evaluations and upon interview with the Primary Laboratory Person, determined the Technical Consultant failed to perform and document a semi- annual competency evaluation for testing personnel #2 who began laboratory testing December of 2018 The findings include: 1. A review of the laboratory's semi-annual competency evaluation results were not available for testing personnel # 2 who began CBC testing in December of 2018. 2. An interview with the Primary Laboratory Person at approximately 1:00p.m. on January 7, 2020 confirmed that semi-annual -- 2 of 3 -- competency evaluation was not documented for testing personnel #2 since hire date in December 2018. ___________________________________ D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: =================================== Based on a review of the laboratory's employee competency evaluations and upon interview with the Primary Laboratory Person, determined the Technical Consultant failed to perform and document annual competency evaluations for testing personnel #1 for 2018 and 2019. The findings include: 1. A review of employee competency evaluations for testing personnel #1 disclosed no annual competency evaluations documented for 2018 and 2019. 2. Interview with Primary Laboratory Person at approximately 1:00pm on January 7,2020 confirmed the Technical Consultant failed to perform and document annual competency evaluations for testing personnel #1 for the 2 year period. =================================== -- 3 of 3 --