Endless Mountains Health Systems

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation and interview with General Supervisor (GS) #1, the laboratory director (LD)/designee failed to attest to the routine integration of samples into the patient workload for 16 of 24 PT events performed for Immunology, Immunohematology, Chemistry, Microbiology and Hematology in 2023, 2024 and 2025. Findings include: 1. On the days of survey 04/09/2025 and 04 /10/2025, review of the laboratory's API PT records revealed, the laboratory director (LD)/designee failed to document the attestation of the routine integration of samples into the patient workload for the following 16 of 24 API PT events: - API 2023 Immunology/Immunohematology 3rd Event - API 2023 Chemistry Miscellaneous 2nd Event - API 2024 Chemistry Core 1st and 3rd Events - API 2024 Chemistry Miscellaneous 1st and 2nd Events - API 2024 Immunology/Immunohematology 1st, 2nd and 3rd Events - API 2024 Microbiology 1st, 2nd and 3rd Events - API 2024 Hematology/Coagulation 1st, 2nd and 3rd Events - API 2025 Microbiology 1st Event 2. GS #1 confirmed the findings above on 04/10/2025 at 10:57 am. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel competency assessment policy, lack of documentation and interview with General Supervisor (GS) #1, the laboratory failed to follow an established competency assessment policy to assess the competency of 1 of 1 Technical Supervisor (TS) and 2 of 2 General Supervisors (GS) for their supervisory responsibilities performed in 2023 and 2024. Findings Include: 1. The laboratory's Clinical Staff Competency Assessment policy states, "Competency assessment is required for all supervisors for those duties in which they are delegated to perform. Competency is performed annually." 2. On the days of survey, 04/09/2025 and 04/10/2025, the laboratory failed to provide documentation of the annual competency assessment for the following personnel for their supervisory responsibilities performed in 2023 and 2024: - 1 of 1 TS (CMS 209 personnel #2). - 2 of 2 GS (CMS 209 personnel #2, #3). 3. GS #1 confirmed the findings above on 04/10 /2025 at 10:57 am D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing policy, lack of documentation and interview with General Supervisor (GS) #1, the laboratory failed to verify twice annually the accuracy of Direct Antiglobulin Test (DAT) (unregulated) examinations performed for 23 of 23 months from 05/17/2023 through the days of survey. Findings include: 1. The laboratory's proficiency testing policy states, "Alternative assessment procedures may be used for unregulated analytes or to investigate a failure or ongoing problem: 1. Other PT programs offered by manufacturers 2. Split samples with another laboratory (not currently PT testing) 3. Direct Observation 4. Peer consensus 5. Controls or calibrators (must be a different lot number that those used for current calibration and/or QC)." 2. On the days of survey, 04/09/2025 and 04/10/2025, the laboratory failed to provide documentation of the twice annual verification of accuracy for DAT examinations performed from 05/17/2023 to 04/10/2025. 3. The laboratory performed 1 DAT from 05/17/2023 to 04/10/2025. 4. GS #1 confirmed the findings above on 04/10/2025 at 10:57 am D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on lack of documentation and interview with General Supervisor (GS) #1, the laboratory failed to document a positive and negative control each day of patient testing for Trichomonas (wet mount) and Potassium Hydroxide (KOH) microscopic examinations performed for 23 of 23 months from 05/17/2023 to the days of survey. Findings include: 1. The laboratory's Wet Prep and KOH Testing procedure states "QC: technologist will sign off on log sheet after reviewing posted photographic QC." -- 2 of 4 -- 2. On the days of survey 04/09/2025 and 04/10/2025, the laboratory failed to provide documentation of the positive and negative control performed every day of patient testing for wet mount and KOH microscopic examinations performed from 05/17 /2023 to 04/10/2025. 3. The laboratory performed 22 wet prep procedures from 05/17 /2023 to 04/10/2025. 4. GS #1 confirmed the above findings on 04/10/2025 at 10:57 am. 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. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with General Supervisor (GS) #1, the laboratory failed to evaluate twice a year the relationship between automated white blood cell (WBC) count differentials performed on 1of 1 Beckman Coulter DxH 600 hematology analyzer and manual microscopic WBC differentials performed from 05 /17/2023 to 04/10/2025. Findings include: 1. On the days of survey, 04/09/2025 and 04 /10/2025, the laboratory failed to provide documentation of the biannual comparison of test results between the automated WBC differentials performed on 1 of 1 Beckman Coulter DxH 600 hematology analyzer and manual microscopic WBC differentials performed from 05/17/2023 to 04/10/2025. 2. The laboratory performed 2492 manual microscopic WBC differentials from 05/17/2023 to 04/10/2025. 3. GS #1 confirmed the findings above on 04/10/2025 at 10:57 am. *REPEAT DEFICIENCY D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical supervisor #1 (TS), the laboratory failed to ensure that the verifications of accuracy for serum acetone examinations were performed at least twice annually, as required for tests not included in subpart I from 04/20/2021 to the date of the survey. Findings include: 1. On the day of the survey, 05/17/2022 at 09:10 am, the laboratory could not provide documentation that the verification of accuracy for serum acetone examinations was performed at least twice annually from 04/20/2021 to 05/17/2023. 2. TS #1 confirmed the findings above on 05/17/2023 around 03:00 pm. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the Siemens Dimension EXL validation records and interview 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 -- with technical supervisor #1 (TS), the laboratory failed to provide complete validation records for the required performance specifications for 3 of 3 analytes tested on the Siemens Dimension EXL chemistry analyzer before reporting patient results from 06 /17/2022 to the date of the survey. Findings Include: 1. On the day of the survey, 05/17 /2023 at 02:15 pm, the laboratory was unable to provide complete validation records verifying the following performance specifications for 3 of 3 chemistry analytes introduced on the Siemens Dimension EXL before patient testing from 06/17/2022 to 05/17/2023:: - C-Reactive protein (CRP) performed 11/3/2022: missing acceptable criteria and reference range/ normal value study - Salicylate performed 12/16/2022: missing accuracy, acceptance criteria and reference range/normal value study - Troponin performed 06/17/2022: missing acceptance criteria and reference range /normal value study 2. The laboratory could not provide documentation that the validation studies were reviewed and evaluated by the appropriate staff before patient testing was performed. 3. TS # 1 confirmed the findings above on 05/17/2023 around 03:00 pm. 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 lack of documentation and interview with technical supervisor #1 (TS), the laboratory failed to perform calibration verification at least once every six months for 1 of 1 Siemens Dimension EXL chemistry analyzer from 04/20/2021 to the date of the survey. Findings include: 1. On the date of the survey, 05/17/2023 at 01:19 pm, the laboratory could not provide calibration verification records for the required analytes tested on 1 of 1 Siemens Dimension EXL chemistry analyzers from 04/20/2021 to 05 /17/2023. 2. TS #1 confirmed the findings above on 05/17/2023 around 03:00 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or -- 2 of 3 -- 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 lack of documentation and interview with technical supervisor #1 (TS), the laboratory failed to have a system that twice a year evaluates the relationship between automated white blood cell (WBC) count differentials performed on 1 of 1 Beckman Coulter DxH600 hematology analyzers and manual microscopic WBC differentials performed from 04/20/2021 to the day of the survey. Findings include: 1. On the day of the survey, 05/17/2023 at 12:00 pm, the laboratory could not provide documentation of the biannual comparison of test results for WBC differentials performed on the Beckman Coulter DxH600 (automated) and microscopic WBC differentials (manual) from 04/20/2021 to 05/17/2023. 3. The laboratory performed 84,344 hematology tests in 2022 (CMS-116 annual volume). 4. TS #1 confirmed the findings above on 05/17/2023 around 03:00 pm. D5785

Summary Statement of Deficiencies 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 review of the laboratory's procedures and interview with the technical supervisor (TS) #1, the laboratory failed to establish a complete competency assessment procedure from 2019 to the day of survey. Findings include: 1. On the day of survey, 04/20/2021, the laboratory's could not provide a complete competency assessment procedure in use from 04/20/2019 to 04/20/2021. 2. The TS #3 confirmed the finding above on 04/20/2021 around 2:00 pm. ** Repeat Deficiency D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (TS) #1, the laboratory failed to verify the performance specifications for the BioFire 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 -- FilmArray Torch System Respiratory 2.1 (RP2.1) Panel before reporting patient results from June 2020 to the day of survey. Findings include: 1. On the day of survey, 04/21/2021, the TS #1 was unable to provide performance specifications performed for the BioFire FilmArray Torch System Respiratory 2.1 (RP2.1) Panel before reporting patient results from June 2020 to April 20, 2021. 2. 1183 - RP2.1 panels were analyzed on the BioFire FilmArray Torch System in 2020 (01/01/2020 to 12/31/2020). 3. 1352 - RP2.1 panels were analyzed on the BioFire FilmArray Torch System in 2021 (01/01/2020 to 04/20/2021). 4. The TC confirmed the finding above on 04/20/2021 around 12:30 pm. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 the CASPER Report 155 report and performance evaluations from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Compatibility Testing which is of the specialty Immunohematology. The laboratory had unsatisfactory scores for the 1st event of 2018 and the 2nd event of 2018. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 155 report and performance evaluations from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Compatibility Testing which is in the specialty of Immunohematology in which the laboratory is certified under CLIA. The laboratory had unsatisfactory scores for the 1st event of 2018 and the 2nd event of 2018. Findings include: 1. API 2018 Event 1 for Compatibility Testing, score of 80%. 2. API 2018 Event 2 for Compatibility Testing, score of 80%. -- 2 of 2 --

Summary Statement of Deficiencies 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 of review of laboratory's Quality Assurance manual and interview with the laboratory Manager (LM), the laboratory failed to establish and follow written procedures including CLIA requirements to assess all personnel competency assessments from 2017 to the date of survey (04/20/2017 to 09/18/2018). Findings include: 1. On the day of survey, 09/18/2018, The laboratory failed to provide a written competency assessment policy that assess CLIA's 6 points of competency for laboratory personnel (11 of 11) and a policy to assess supervisory personnel (2 of 2). 2. In 2017: 241, 259 patient tests were performed in the laboratory. 3. In 2018 (01/01 /2018 to 09/18/2018) : 85,044 patient tests were performed in the laboratory 4. The LM confirmed the findings on 09/18/2018 around 9:00 am. 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. 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 observation of the Blood Gases laboratory, review of Blood Gases laboratory temperature records and interview with the Testing personnel (TP) #10, the laboratory failed to monitor and document the condition of storage for 12 of 12 boxes of OPTI Check Multi Analyte Control and OPTI CCA Cassettes from 2017 to the date of survey. Findings include: 1. OPTI Check Multi Analyte Control package insert under Storage and and Handling states, "Store unopened ampoules at room temperature 15-30 degrees Celsius (59-86 degrees Fahrenheit)". On the box of the OPTI CCA Casettes states,"store at 4-30 degrees Celsius. 2. A the day of survey, 09/18 /2018, the laboratory could not provide room temperature records where 4 of 4 boxes of OPTI Check Multi Analyte Control (Lot #7111) and 8 of 8 boxes of OPTI CCA Cassettes (Lot#815100) are stored. 3. From 04/20/2017 to 12/31/2017, 135 blood gases tests were performed. 4. From 01/01/2018 to 09/18/2018, 105 blood gases tests were performed. 5. The LM confirmed the findings above on 11:00 am. 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 laboratory tour, observation of Omega microscopes and interview with Laboratory Manager (LM), the laboratory failed to document maintenance for 1 of 1 Omega microscopes used for urine microscopic analysis from 2017 to the time of survey. Findings include: 1. On the day of survey, 09/18/2018, the laboratory failed to calibrate 1 of 1 Omega microscopes (Model #0897845) used urine microscopic analysis. Sticker on the microscope stated, "Serviced on: 8/26/2016 and Due: 08 /2017". 2. From 04/20/2017 to 12/31/2017, 950 Urine Microscopic analysis tests were performed. 3. From 01/01/2018 to 09/18/2018, 888 Urine Microscopic analysis tests were performed. 4. The LM confirmed the findings above on 09/18/2018 around 12: 00 pm. 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 the review of Urine Microscopic Analysis procedure, Bleeding Time test procedure and interview with the Laboratory Manager, the laboratory failed to document quality control (QC) for Urine Microscopic Analysis and Bleeding time test each day of patient testing in 2017 to the date of survey. (04/20/2017 to 09/18/2018). Findings Include: 1. On the day of survey 09/18/2018, the surveyor asked the Laboratory manager if the laboratory documents Urine Microscopic Analysis and -- 2 of 5 -- Bleeding time test quality control, the laboratory manager stated "the laboratory does have urine microscopic books but daily QC is not document and quality control is no performed for the Bleeding time test". 2. From 04/20/2017 to 12/31/2017, 950 Urine Microscopic analysis tests were performed. 3. From 01/01/2018 to 09/18/2018, 888 Urine Microscopic analysis tests were performed. 4. From 01/01/2018 to 09/18/2018, 1 Bleeding Time test was performed. 5. The Laboratory Manager confirmed the findings above around 01:00 pm. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS Laboratory Personnel Form (CMS Form - 209), review of laboratories personnel credentials, and interview of the Laboratory Manager, the laboratory failed to ensure that 1 of 2 Technical consultant meets the qualification requirements under 42 C.F.R. 493.1411 for blood gas testing on the OPTI CCA-TS2 Blood Gas from 2017 (04/20/2017) to the date of survey. Refer to D6035 . D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in -- 3 of 5 -- biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of the CMS Laboratory Personnel Form (CMS Form - 209), review of laboratories personnel credentials, and interview of the Laboratory Manager (LM), the laboratory failed to ensure that 1 of 2 Technical Consultants (TC) meets the qualification requirements under 42 C.F.R. 493.1411 for blood gas testing on the OPTI CCA-TS2 Blood Gas from 2017 (04/20/2017) to the date of survey. Findings Include: 1. CMS Form - 209, signed by the Laboratory Director on 08/30/2018, lists laboratory personnel #10 as a TC. 2. On the day of survey, 09/18/2018, review of blood gas records revealed that Testing Personnel (TP) #10 signs of on personnel competencies and reports. Further review of TP #10's education credentials revealed, the personnel holds an associates degree in respiratory therapy, which does not meet the minimal educational qualifications under C.F.R. 493.1411 to perform technical consultant responsibilities. 4. From 04/20/2017 to 12/31/2017, 135 blood gases tests were performed. 5. From 01/01/2018 to 09/18/2018, 105 blood gases tests were performed. 6. The LM confirmed the findings above on 09/18/2018 around 09:30 am. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require