Byu - Idaho Student Health Center

Summary Statement of Deficiencies D0000 During an offsite paper revisit the laboratory was found to be in compliance with CLIA regulations (42 CFR Part 493 effective April 24, 2003.), all previous deficiencies found were corrected. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of proficiency testing (PT) documents, facility PT policy, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory manager on 10/30/2025, the laboratory failed to have PT samples tested by the testing personnel (TP) that routinely test patient samples since the last inspection on 10/26/2023. The findings include: 1. A review of hematology PT attestation records for 2023 event three, 2024 events one, two and three and 2025 events one and two identified that the laboratory manager and the technical consultant, who is not a TP, performed all the of the PT sample testing. 2. A review of the laboratories policy "BUYI Policy for Proficiency Testing" established as evidence of correction from the 10/26/2023 inspection identified that the facility failed to follow their policy and treat samples the same as patient samples. 3. A review of the CMS 209 listed ten TP performing patient testing identifying that the laboratory failed to have nine of ten TP perform PT testing in 2023, 2024 and 2025. 4. An interview with the laboratory manager on 10/30/2025 at 10:33 am confirmed that the regular TP that performed patient testing did not perform PT. 4. The laboratory reports performing 10,032 hematology tests annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 -- 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 a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory policies, competency assessment records and an interview with the laboratory manager on 10/30/2025, the laboratory failed to follow written policies and procedures to assess testing personnel and technical consultant in 2024 and 2025. The findings include: 1. A review of the CMS 209 form identified ten testing personnel (TP) and one technical consultant. 2. The laboratory policy "BYUI Policy on Competency and Training" which was implemented as evidence of correction from the 10/26/2023 inspection, states that there will be an initial training, six month competency, one year after the start date then annual competency each year after. 3. A review of competency assessment and training records identified the laboratory failed to have initial training for eight of eight TP hired after the last inspection on 10/26/2023. 4. A review of competency assessment records identified the laboratory failed to have six month competency assessments for eight of eight TP. 5. A review of competency assessment records identified the laboratory failed to have annual competency assessments for two of two TP in 2024 and six of six TP in 2025. 6. A review of competency assessment records identified that the laboratory director failed to perform competencies for the technical consultant (TC) for their TC responsibilities in 2024 and 2025. 7. An interview with the laboratory manager on 10 /30/2025 at 10:00 am confirmed that the laboratory failed to follow their policy and perform initial training and competencies in 2024 and 2025. 8. The laboratory reports performing 10,032 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory quality assessment (QA) plan, QA documents and an interview with the laboratory manager on 10/26/2023, the laboratory failed to follow the established QA plan. The findings include: 1. A review of "Quality Assessment Plan- Student Health Center Lab" identified 15 quality indicators to be review and the timeline for reviews. 2. A review of Quality Assessment Review Forms, competency assessments and proficiency testing documents identified that the laboratory failed to review 11 of 15 quality indicators in 2022. 3. An interview with the laboratory manager on 10/26/2023 at 2:52 pm confirmed that the laboratory failed to follow their QA plan in 2022. 4. The laboratory reports performing 7,460 tests annually. 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: 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 a review of the procedure manual and an interview with the laboratory manager on 10/26/23, the laboratory failed to establish a policy for performance of proficiency testing (PT). The findings include: 1. A review of the laboratory procedure manual identified that the laboratory failed to have a policy for PT performance that included enrollment, testing, attestation, results review and

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 a review of Proficiency Testing (PT) results from the American Association of Bioanalysts (AAB), the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and an interview with the laboratory manger on 3/24/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 for the subspecialty of hematology. See D2123 and D2131 D2123 HEMATOLOGY CFR(s): 493.851(c) 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 participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) results from the American Association of Bioanalysts (AAB), the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and an interview with the laboratory manager on 3/24/2022, the laboratory failed to participate in two (2) of three (3) testing events in 2021 for the specialty of hematology. The findings include: 1. A review of Report 155D and graded PT results from AAB identified that the laboratory failed to participate in testing for events one (1) and three (3) in 2021 for the specialty of hematology for the analytes white blood cell differential, erythrocyte count, hematocrit, hemoglobin, leukocyte count and platelet count resulting in scores of zero (0). 2. An interview with the laboratory manager on 3/24/2022 at 1:32 pm confirmed the above findings. 3. The laboratory reports performing 5,500 hematology tests annually. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance 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 a review of Proficiency Testing (PT) results from the American Association of Bioanalysts (AAB), the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and an interview with the laboratory manager on 3/24/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2021 for the specialty of hematology. The findings include: 1. A review of graded PT results from AAB and Report 155D identified that the laboratory failed to participate and achieve a satisfactory score for events one (1) and three (3) in 2021 for the specialty of hematology. Specialty Year Event Score hematology 2021 1 0% hematology 2021 3 0% 2. An interview with the laboratory manager on 3/24/2022 at 1:32 pm confirmed the above findings. 3. The laboratory reports performing 5,500 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies 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 an American Association of Bioanalysts (AAB) proficiency test (PT) record review from 2018 to 2020 and an interview with the laboratory supervisor on November 4, 2020, the laboratory director failed to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Findings: 1. A PT record review revealed that the AAB Hematology 2019 event 3 attestation was not signed by the laboratory director. 2. A PT record review revealed that the AAB Hematology 2020 event 1 and event 2 attestation were signed by the technical consultant not the laboratory director. There was no delegation of authority for the technical consultant to act as a designee for the laboratory director for the attestation of PT . 3. An interview with the laboratory supervisor on November 4, 2020 at 3:30 pm, confirmed that the 2019 event 3 attestation had not been signed and the 2020 events 1 and 2 had been signed by the technical consultant. It was also confirmed that there was no delegation of authority for the technical consultant to act as a designee for the laboratory director for the attestation of PT. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on policy and procedure review and an interview with the laboratory supervisor on November 4, 2020, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the laboratory. Findings: 1. Based on policy and procedure review the laboratory did not have a quality assurance procedure to monitor, assess and correct problems identified in the laboratory. The laboratory has an instrument error/action log used for the Medonic hematology analyzer but no procedure for when to fill it out and what to do when a problem can not be resolved. 2. The instrument Error/Action log for February 20, 2020 had documented that the high quality control (QC) had been performed four times and the low QC was repeated for complete blood count (CBC) testing. The instrument Error/Action log for February 24, 2020 had documented that the high QC had been performed six times for CBC testing. The instrument Error/Action log for February 25, 2020 had documented that the high QC had been performed four times for CBC testing 3. An interview with the laboratory supervisor on November 4, 2020 at 4:07, confirmed that the laboratory did not have a policy or procedure to monitor, assess, and, correct problems identified in the laboratory. It was confirmed that they have an instrument Error/Action log for the Medonic hematology analyzer but not everyone documents analyzer errors and or issues and that they do not monitor the log. 4. The laboratory reports performing 1200 patient CBC specimens annually. 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 the Medonic hematology maintenance log review and an interview with the laboratory supervisor on November 4, 2020, the laboratory failed to perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. Findings: 1. The laboratory performs complete blood counts (CBC) on the Medonic hematology analyzer. A random review the Medonic hematology maintenance log from April 2018 to November 2020, revealed that the monthly maintenance of monthly cleaning and clot prevention maintenance were not documented in May, August, September of 2020 and these logs were all reviewed and signed by the technical consultant on October 29, 2020. 2. A random review the Medonic hematology maintenance log from April 2018 to November 2020, revealed that monthly clot prevention maintenance was not documented in June, and July of 2020 and these logs were reviewed and signed by the technical consultant on October 29, 2020. 3. A random review the Medonic hematology maintenance log from April 2018 to November 2020, revealed that the daily maintenance was not documented on 7 /30/20, 8/18/20, 9/17/20, 9/18/20, 9/21/20-9/25/20, 10/26/20-1030/20 and 11/2/20. 3. An interview with the laboratory supervisor confirmed that the Medonic monthly maintenance had not been completed in May, June, July, August and September of 2020 and the logs were reviewed and signed by the technical consultant on October 29, 2020. 4. The laboratory reports performing 1200 patient CBC specimens annually. -- 2 of 6 -- D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based record review of the laboratory's Medonic quality control (QC) logs and interview with the laboratory supervisor on November 4, 2020, the laboratory failed to monitor over time the accuracy and precision of test performance for hematology testing that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. Findings: 1. A Medonic QC log record review revealed that the laboratory failed to monitor shifts and trends of their hematology complete blood count (CBC) testing over time to ensure proper testing performance. 2. An interview with the laboratory supervisor on November 4, 2020 at 3:40 pm, confirmed that the laboratory failed to monitor shifts and trends of their hematology CBC QC using a Levy- Jennings chart or by any other method. 3. The laboratory reports performing 1200 patient CBC specimens annually. 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 record review of the laboratory's quality control (QC) logs for the Medonic hematology analyzer and an interview on November 4, 2020, with the laboratory supervisor, the laboratory failed to perform 2 levels of controls for each day of patient testing. Findings: 1. A record review of the laboratory's quality control (QC) logs for the Medonic hematology analyzer for October of 2020 and the first four days in November of 2020, the laboratory failed to document QC on six of the patient testing days. 11/ 2/ 2020 no QC documented 3 patients analyzed 10/30/2020 no QC documented no patients analyzed 10/29/2020 no QC documented no patients analyzed 10/28/2020 no QC documented 2 patients analyzed 10/27/2020 no QC documented 6 patients analyzed. 10/26/2020 no QC documented no patients analyzed 2. Based on the record review of the laboratory's quality control (QC) logs for the Medonic hematology analyzer for October it was determined that the technical consultant had reviewed and signed the documents on October 29, 2020 despite having no QC documented for the dates listed above and no documentation that the analyzer was out -- 3 of 6 -- of service. 3. An interview with the laboratory supervisor on November 4, 2020 at 2: 50 pm, confirmed that QC had not been perform, and patients samples had been analyzed on the above mentioned dates and the technical consultant had signed off on the Medonic analyzer QC log for October . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a random review of patient test reports and an interview with the laboratory supervisor on November 4, 2020, the laboratory failed to indicate the name and address of the laboratory where the test was performed on the test report for those patient specimens that are performed at a different laboratory or location for testing. Findings: 1. A review of a patient test report from 6/29/2020 in which the specimen was sent to Express Laboratory for testing indicated that the testing was performed at BYU. 2. A review of a patient test report from 10/30/2020 in which the specimen was sent to LabCorp for testing indicated that the testing was performed at BYU. 3. An interview with the laboratory supervisor on November 4, 2020 at 4:36 pm confirmed that the testing on reports were performed at Express Laboratory and LabCorp and that the reports in the patient charts did not identify the referring laboratory's name and location for those patient tests that had been performed by the referred laboratory. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on record review of personnel education documents and an interview with the laboratory supervisor on November 4, 2020, the laboratory director failed to employ laboratory personnel with the appropriate education and either experience or training to accurately perform tests and report test results in accordance with the personnel responsibilities described in the state operations manual subpart M. Findings: 1. A review of personnel education documents revealed that 2 out of 13 testing personnel listed on the CMS-209 Personnel Report Form did not have educational -- 4 of 6 -- documentation. 2. An interview with the laboratory supervisor on November 4, 2020 at 1:30 pm, confirmed that the laboratory failed to have the educational documentation for 2 of 13 testing personnel. 3. The laboratory reports performing 13,200 moderate and waived patient tests annually. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a document review of the laboratories personnel competency assessments and an interview with the laboratory supervisor on November 4, 2020, the technical consultant failed to establish and follow a written procedure for evaluating the competency of all testing personnel and assure that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. Findings: 1. The laboratory testing personnel report (CMS-209) identifies 13 testing personnel performing moderate and waived testing. 2. A document review of personnel competency assessments revealed that 4 of 13 testing personnel had missing or incomplete initial training and were performing patient testing. 3. A document review of personnel competency assessments revealed that 2 of 13 testing personnel did not have a semi-annual competency. 4. A document review of personnel competency assessments revealed that 6 of 13 testing personnel did not have an annual competency for 2019. 5. A document review of personnel competency assessments revealed that 2 of 13 testing personnel did not have an annual competency for 2020. 6. The laboratory records revealed gaps in compliance with daily and monthly maintenance and quality control for the Medonic hematology analyzer. See D5429, D5447 7. An interview with the laboratory supervisor on November 4, 2020 at 1:50 pm, confirmed that the testing personnel did not have all required competency assessments performed. 8. The laboratory reports performing 13,200 moderate and waived patient tests annually. 9. The laboratory was cited on previous survey, 3/13/2018, for the deficient practice of not evaluating the competency of all testing personnel and at the time of the current survey the laboratory did not have evidence of correction as stated in the previous surveys

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 a proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the analytes cell identification, red blood cells, hematocrit, hemoglobin, white blood count, and platelet. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 -- This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review and the laboratory's graded PT results from the American Association of Bioanalysts (AAB), the laboratory failed to achieve satisfactory performance for two out of three consecutive testing events for cell identification, white blood cell, red blood cell, platelet, hemoglobin, and hematocrit. Findings: 1. A review of the AAB PT results from 2018 event 3 revealed the laboratory received a score of '0 No Results' for the analytes: cell identification, white blood cell, red blood cell, platelet, hemoglobin, and hematocrit. 2. A review of the AAB PT results from 2019 event 1 revealed the laboratory received a score of 73 for cell identification and a score of 60 for the analytes: white blood cell, red blood cell, platelet, hemoglobin, and hematocrit. -- 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 on an interview with the laboratory manager and a record review of personnel documents, the laboratory failed to establish and follow procedures to assess the technical consultant competency since the last survey on April 13, 2016. Findings: 1. A review of personnel documents and laboratory procedures and policies revealed the laboratory failed to establish in writing and assess the competency for the technical consultant listed on the CMS-209 Personnel Report form. 2. An interview on March 13, 2018 at 10:05 AM, with the laboratory manager, confirmed the laboratory failed to establish and assess the competency for the technical consultant. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. 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 an interview with the laboratory manager and a record review, the laboratory director failed to specify in writing, the responsibilities and duties of the technical consultant engaged in the preanalytic, analytic, and postanalytic phases of testing since the last survey on April 13, 2016. Findings: 1. A review of the laboratory documents revealed the laboratory failed to specify in writing the responsibilities and duties of the technical consultant listed on the CMS-209 Personnel Report form. 2. An interview on March 13, 2018 at 10:10 AM, with the laboratory manager, confirmed the laboratory director failed to specify in writing the responsibilities for the technical consultant. 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 an interview with the laboratory manager and record review, the technical consultant failed to meet the qualifications and provide technical oversight. Refer to D6035, D6046, and D6053. 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 -- 2 of 4 -- "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 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 an interview with the laboratory manager and a record review of personnel documents, the laboratory failed to ensure the technical consultant was qualified prior to providing technical consultation for the laboratory in the specialty of hematology since the last survey on April 13, 2016. Findings: 1. A review of personnel education documents revealed that the laboratory failed to qualify the 1 technical consultant listed on the CMS-209 Personnel Report form prior to providing technical consultation to laboratory. 2. An interview on March 13, 2018 at 9:45 AM, with the laboratory manager, confirmed the laboratory failed to qualify the technical consultant who provides technical consultation for the laboratory. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on an interview with the laboratory supervisor and personnel records review, the laboratory failed to have a qualified individual perform competency assessments on the 10 testing personnel performing complete blood counts since the last survey on April 13, 2016. Findings: 1. A review of personnel records revealed the laboratory allowed testing personnel that do not qualify perform competency assessments on the 10 personnel listed on the CMS-209 Personnel Report form. 2. An interview on March 13, 2018 at 12:30 PM, with the laboratory supervisor, confirmed the laboratory failed to have a qualified individual perform competency assessments. 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 an interview with the laboratory manager and a record review of personnel documents, the laboratory failed to establish and follow a written procedure for assessing employee competency at least semiannually during the first year of patient testing on the Medonic analyzer used to test complete blood counts since the last survey on April 13, 2016. Findings: 1. A record review of personnel documents revealed 8 out of 14 testing personnel listed on the CMS-209 Personnel Report form, -- 3 of 4 -- failed to have competency assessments performed at least semiannually during the first year of patient testing. 2. An interview on March 13, 2018 at 9:30 AM, with the laboratory manager, confirmed the laboratory failed to perform competency at least semiannually on 8 testing personnel. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager and a record review of personnel documents, the laboratory failed to ensure all the testing personnel are qualified to perform testing on the Medonic complete blood count analyzer since the last survey on April 13, 2016. Findings: 1. A review of personnel education documents revealed that 1 out of 10 personnel listed on the CMS-209 Personnel Report form, from Peru, failed to have their foreign education equivalency evaluated before testing patient specimens. 2. An interview on March 13, 2018 at 9:45 AM, with the laboratory manager, confirmed the laboratory failed to have the foreign education equivalency evaluated prior to testing patient specimens. -- 4 of 4 --