Colville Tribes Health Laboratory Services

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 laboratory personnel competency records, Laboratory Personnel Initial Training and Continued Competency Assessment policy, and interview with the Testing Personnel (TP) #2 on the CMS-209, the laboratory failed to follow their own policy to assess competency of the Technical Consultant (TC) for two of two years. Findings included: 1. A review of laboratory personnel competency records revealed there were no records of annual competency assessments for the TC for the years 2023 and 2024. 2. A review of the Laboratory Personnel Initial Training and Continued Competency Assessment policy revealed the statement, "The purpose of this policy and procedure is to define how all new laboratory staff, both employees and contractors, will be trained, as well as define how continued assessment will be monitored for all laboratory staff, including both laboratory testing personnel and Laboratory Supervisor/Technical Consultant (as defined in the QA/QI laboratory policy and procedure)." 3. In an interview on March 26, 2025, at 10:15 AM, the TP #2 confirmed annual competency assessments for the Technical Consultant were not completed for the years 2023 and 2024. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage 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 -- requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the GeneXpert Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG) and the GeneXpert Xpress SARs-CoV-2 (COV-2) /Influenza (FLU)/Respiratory Syncytial Virus (RSV) Plus test kit labels and package inserts, review of the laboratory Daily Temperature Check log sheets, and interview with the Testing Personnel (TP) #2 on the CMS-209, the laboratory failed to ensure the room temperature ranges were within the manufacturer's test kit storage specifications for five of five CT/NG test kits and two of two COV-2/FLU/RSV Plus test kits from March 2023 to March 2025. Findings included: 1. Laboratory observation on March 26, 2025 at 2:30 pm revealed five CT/NG test kits (Lot # 1001429812) with 10 tests cartridges per kit and two COV-2/FLU/RSV test kits (Lot # 1001465028) with 10 tests cartridges per kit stored in the cupboard above the Cepheid GeneXpert Xpress instrument in the laboratory. 2. A COV-2/FLU/RSV test kit package insert and test kit labels for both COV-2/FLU/RSV and CT/NG stated storage temperature requirement of 2-28C. 3. A review of Daily Temperature Check log sheets from March 2023 to March 2025, revealed an acceptable Room Temperature Range of 18-30C. 4. In an interview on March 26, 2025, at 2:35 PM, the TP #2 confirmed the room temperature range set by the laboratory was 2-28C on the Daily Temperature Check log sheets from March 2023 to March 2025. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 the Operator Manual for the Cepheid GeneXpert Xpress instrument, a review of the GeneXpert Xpress System Maintenance Log sheets, and interview with the Testing Personnel (TP) #2 on the CMS-209, the laboratory failed to document the monthly maintenance of archiving tests, purging tests, and replacing the fan filters as specified by the manufacturer for nine out of twenty-four months of use. Findings included: 1. A review of the Operator Manual and the GeneXpert Xpress System Maintenance Log sheets for the Cepheid GeneXpert Xpress instrument, serial number 907628, revealed monthly maintenance tasks of Archive Tests, Purge Tests, and Replace fan filters. 2. A review of the GeneXpert Xpress System Maintenance Log sheets from March 2023 to February 2025 revealed no recording of monthly maintenance being completed for the following nine out of twenty-four months: August 2023 November 2023 December 2023 January 2024 February 2024 June 2024 August 2024 Sept 2024 December 2024 3. In an interview on March 26, 2025, at 2:45 PM, the TP #2 confirmed that the laboratory failed to document completion of the monthly maintenance for the Cepheid GeneXpert instrument, serial number 907628, for nine of twenty-four months from March 2023 to February 2025. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each -- 2 of 5 -- 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. This STANDARD is not met as evidenced by: Based on review of the Laboratory Directors Job Description, Laboratory Personnel Initial Training and Continued Competency Assessment policy, and interview with the Testing Personnel (TP) #2 on the CMS-209, the Laboratory Director failed to specify, in writing, the responsibilities and duties for two of two consultants, the Clinical Consultant (CC) and the Technical Consultant (TC). Findings included: 1. A review of the Laboratory Directors job description revealed the following statement, "Duty: The responsibilities and duties of each consultant and each person engaged in the testing process are specified in writing ..." 2. A review of the Laboratory Personnel Initial Training and Continued Competency Assessment policy revealed the following statement, "The Laboratory Director must specify, in writing, the responsibilities and duties of each consultant ..." 3. In an interview on March 26, 2025, at 1:55 PM, the TP #2 confirmed there were no written responsibilities and duties available for the CC and TC. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY 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 laboratory personnel records and interview with the Testing Personnel (TP) #2 on the Centers for Medicare and Medicaid Services (CMS)-209, the laboratory failed to provide personnel records for one of one Technical Consultant (TC) for technical oversight of the moderate complexity laboratory. Findings: 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 (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 1 year of laboratory training or experience, or both, in nonwaived 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 -- 3 of 5 -- technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with the Testing Personnel (TP) #2 on the CMS-209, the laboratory failed to provide personnel records for one of one Technical Consultant (TC) for technical oversight of the moderate complexity laboratory. Findings included: 1. Review of the laboratory personnel records revealed the laboratory failed to provide personnel records with credentials for TC of the moderate complexity laboratory. 2. In an interview on March 26, 2025, at 10:15 AM, the TP #2 confirmed the laboratory did not have personnel records and credentials of the TC and the laboratory was not able to produce the records by the survey exit time. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 review of laboratory personnel competency records, Laboratory Personnel Initial Training and Continued Competency Assessment policy, and interview with the Testing Personnel (TP) #2 on the CMS-209, the Technical Consultant (TC) failed to complete and document one of one initial competency assessment for Testing Personnel # 3 on the CMS-209 form, during the first year of moderate complexity testing. Findings included: 1. A review of laboratory personnel competency records -- 4 of 5 -- revealed an initial competency assessment was completed and documented for TP #3 by TP #2. 2. A review of the Laboratory Personnel Initial Training and Continued Competency Assessment policy revealed the statement, "A. New staff: prior to being assigned any laboratory duties in the Coleville Service Unit and prior to obtaining or testing patient specimens, all new laboratory staff will: Have present in the laboratory under the care of the Laboratory Supervisor/Technical Consultant, a file for each staff member that contains ... evidence of competency ..." 3. In an interview on March 26, 2025, at 10:15 AM, the TP #2 confirmed the initial competency was completed in December 2024 by TP# 2 who is not qualified, and not by the Technical Consultant. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of laboratory personnel competency records, Laboratory Personnel Initial Training and Continued Competency Assessment policy, and interview with the Testing Personnel (TP) #2 on the CMS-209, the Technical Consultant (TC) failed to complete and document five of five annual competency assessments for three testing personnel. Findings included: 1. Review of three testing personnel competency records revealed the following: Testing personnel number based on the sequence on the CMS-209 form a. TP# 1: Annual competency assessment not completed by TC for the years 2023 and 2024. b. TP# 2: Annual competency assessment not completed by TC for the year 2024. c. TP# 4: Annual competency assessment not completed by TC for the years 2023 and 2024. 2. A review of the Laboratory Personnel Initial Training and Continued Competency Assessment policy revealed the statement, "D. Testing Personnel: each laboratory employee requires yearly direct observation by the Laboratory Supervisor of proficiency in each test performed in the CSU laboratory and documented as proficient in each test independently." 3. In an interview on March 26, 2025, at 10:15 AM, the TP #2 confirmed that the TC did not complete and document annual competency assessments for TP#1 (2023 and 2024), TP#2 (2024) and TP# 4 (2023 and 2024). -- 5 of 5 --

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 record review of American Proficiency Institute (API) proficiency testing (PT) documents, and interview with the acting laboratory manager, the laboratory failed to ensure that the individual testing or examining the samples and the laboratory director signed the attestation documents regarding the routine integration of the PT samples into the laboratory's routine workloads. Findings include: 1. Review of the 2020 API PT records revealed that the testing personnel (TP) and laboratory director (LD) did not sign the PT attestation form, attesting to the integration of PT samples into the laboratory's routine workload for six (6) of fifteen (15) PT testing events,. Event (1)-Hematology/Coagulation No signature-TP, LD Event (1)-Chemistry No signature-TP, LD Event (2)-Hematology/Coagulation No signature-TP, LD Event (2)- Microbiology No signature-TP, LD Event (2)-Chemistry No signature-TP, LD Event (3)-SARS CoV2 No signature-LD 2. Interviews with the acting laboratory manager and laboratory director on 4/28/2021 at 09:51 a.m., confirmed that the laboratory director and testing personnel did not attest to the integration of PT samples with patient testing on the API PT forms. 3. The laboratory reports performing 6210 patient tests annually. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- 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 -- (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 record review for SARS CoV2 testing and interview with the acting laboratory manager, the laboratory failed to perform control procedures using the number and frequency specified by the manufacturer. Findings include: 1. The laboratory performs SARS CoV2 testing on an Abbott ID Now and Cepheid GeneXpert platforms. The manufacturers Emergency Use Authorization for both platforms requires controls to be ran for each new lot number, each shipment and each new testing personnel. 2. The laboratory has implemented non-laboratory personnel to perform SARS CoV2 testing at an ancillary location outside the laboratory on both analyzers. 3. The laboratory has no documentation of controls being performed by the non-laboratory testing personnel for three of four testing personnel who have been performing SARS CoV2 testing. 4. Interviews with the acting laboratory manager and the laboratory director on 4/28/2021 at 2:45 p.m. confirmed that the non-laboratory SARS CoV2 testing personnel have not performed control testing on the Abbott ID Now and Cepheid GeneXpert platforms. 5. The laboratory records indicate that the laboratory has performed 1440 SARS CoV2 tests since April 13, 2020 to 4/28/2021on the two testing systems D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review of the laboratory's test menu, personnel education and competency records and interview with the acting laboratory manager, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. Findings include: 1. The laboratory implemented SARS CoV2 testing on three waived Emergency Use Authorized (EUA) platforms utilizing laboratory and non-laboratory staff to perform the testing in April 13, 2020 (Abbott ID Now), November 2020 (Binax antigen test kit), and January 2021 (Cepheid GeneXpert Fourplex). 2. The laboratory did not have documentation of education for three (3) of five (5) of the testing personnel performing SARS CoV2 testing. 3. The laboratory did not have documentation of competency for five (5) of five (5) of laboratory testing personnel performing SARS CoV2 testing prior to testing and reporting patient result. 4. The acting laboratory -- 2 of 3 -- manager and laboratory director confirmed by interview on 4/28/2021 at 2:45 p.m., the laboratory did not have documentation of education for 3 of 5 testing personnel and that the laboratory director did not perform competency assessment's for 5 of 5 testing personnel prior to testing and reporting patient SARS CoV2 results. 5. The laboratory reports performing and resulting 1,812 SARS CoV2 patient tests since April 13, 2020 to the date of survey 4/28/2021. 6. *This is a repeat dificiency identified in the previous recertification survey conducted on 05/15/2019. (Laboratory Director failed to ensure that traveling testing personnel had met the minimal education requirement to qualify as moderate complexity testing personnel). 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. This STANDARD is not met as evidenced by: Based on record review of personnel training, and competency records, and interview with the acting laboratory manager, the laboratory director failed to specify, in writing, the responsibilities and duties of each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, and failed to identify 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. Findings include: 1. For two (2) of two (2) laboratory personnel performing patient testing, the laboratory had no documentation identifying and authorizing the responsibilities and testing each individual were allowed to perform. 2. The laboratory initiated SARS CoV2 testing and crossed trained non-laboratory administrative personnel to perform the patient testing. The laboratory director did not specify in writing the responsibilities and duties of three (3) of three (3) non-laboratory individuals, or whether supervision is required. 3. The laboratory acting manager and laboratory director confirmed by interview on 4/28/2021 at 2:45 p.m., the failure of the laboratory director to specify in writing the responsibilities and duties of each individual authorized to perform patient testing and whether supervision is required. 4. The laboratory reports performing and reporting 6210 patient tests annually. 5. *This is a repeat dificiency identified in the last survey conducted on 05/15/2019. Based upon review of proficiency testing, quality control, quality assurance and maintenance records and an interview with the Laboratory Supervisor, the Laboratory Director (LD) failed to assign in writing, the responsibilities of the Technical Consultant (TC) and testing personnel (TP) in all phases of the testing process. -- 3 of 3 --

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 record review of the laboratory's general policies and procedures, personnel training and competency records and an interview with the laboratory staff it was determined that there was not a written policy that defined how training was performed or how competency was assessed for the testing personnel and the technical consultant. Finding include: 1. The laboratory was unable to provide a policy that explained how training or competency of testing personnel is assessed. The turnover of testing personnel is every 13 weeks and a robust training and competency program is essential. 2. An interview on 5/15/19 at approximately 11:30am, in the laboratory, with the laboratory supervisor confirmed that the laboratory did not have a written policy. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of laboratory procedures and an interview with the laboratory supervisor, the newly appointed Laboratory Director (LD) failed to approve the laboratory policies. Finding include: 1. A review of two(2) binders with the general 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 -- laboratory and procedural policies revealed that none of the current polices were approved by the newly appointed Laboratory Director. 2. An interview on 5/15/19 in the laboratory, with the laboratory supervisor at approximately 9:10 confirmed the findings. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on a review of the critical values policy and an interview with laboratory personnel, the laboratory was unable to provide documentation that critical values are reported in accordance with the laboratory's policy. Findings include: 1. A review of the laboratory's critical value policy indicated that the laboratory is responsible to document the date/time and name of the individual being notified of a critical value. 2. During an interview on 5/15/19 at approximately 10:17 am, in the laboratory, with the laboratory supervisor a request was made to retrieve a critical value report. 3. The laboratory supervisor and testing personnel were unable to provide documented evidence that critical values are reported as required. D6003 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1405 AND 493.1406 The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director 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 had laboratory training or experience consisting of: (b)(2)(ii)(A) At least one year directing or supervising non- waived laboratory testing; or (b)(2)(ii)(B) Beginning September 1, 1993, have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 493.1407; or (b)(2)(ii)(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of this section obtained during medical residency. (For example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and (b)(3)(i) Be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or the American Board of Medical Laboratory Immunology; or (b)(3)(ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (b)(4)(i) Have earned a master's degree in -- 2 of 5 -- a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (b)(4)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and (b)(4)(iii) In addition, have at least one year of supervisory laboratory experience in non-waived testing; or (b)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (b)(5)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and (b)(5)(iii) In addition, have at least 2 years of supervisory laboratory experience in non-waived testing; (b)(6) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under 493.1406; or (b)(7) On or before February 28, 1992, qualified under State law to direct a laboratory in the State in which the laboratory is located. Laboratory director qualifications on or before February 28, 1992 The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. (a) The laboratory director must possess a current license as a laboratory director issued by the State, if such licensing exists; and (b) The laboratory director must: (b)(1) Be a physician certified in anatomical 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; (b)(2) Be a physician who: (b)(2)(i) Is certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties; or (b)(2)(ii) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board in one of the laboratory specialties; or (b)(2)(iii) Is certified by the American Society of Cytology to practice cytopathology or possesses qualifications that are equivalent to those required for such certification; or (b)(2)(iv) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(3) For the subspecialty of oral pathology only, be certified by the American Board of Oral Pathology, American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications that are equivalent to those required for certification; (b)(4) Hold an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject and (b)(4)(i) Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to HHS in one of the laboratory specialties; or (b)(4)(ii) Subsequent to graduation, has had 4 or more years of full-time general laboratory training and experience of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties; (b)(5) With respect to individuals first qualifying before July 1, 1971, have been responsible for the direction of a laboratory for 12 months between July 1, 1961, and January 1, 1968, and, in addition, either: (b)(5)(i) Was a physician and subsequent to graduation had at least 4 years of pertinent full-time laboratory experience; (b)(5)(ii) Held a master's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 4 years of pertinent full- time laboratory experience; (b)(5)(iii) Held a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject and subsequent to graduation had at least 6 years of pertinent full-time laboratory experience; or (b)(5)(iv) Achieved a satisfactory grade through an examination conducted by or under the sponsorship of the U.S. Public Health Service on or before July 1, 1970; or (b)(6) Qualify under State law to direct the laboratory in the State in which the laboratory is located. Note: The January 1, 1968 date for meeting the 12 months' laboratory direction requirement in paragraph (b)(5) of this section may be extended 1 year for each year of full-time laboratory experience obtained before -- 3 of 5 -- January 1, 1958 required by State law for a laboratory director license. An exception to the July 1, 1971 qualifying date in paragraph (b)(5) of this section was made provided that the individual requested qualification approval by October 21, 1975 and had been employed in a laboratory for at least 3 years of the 5 years preceding the date of submission of his qualifications. This STANDARD is not met as evidenced by: Based on an interview with the Laboratory Supervisor and the newly appointed Laboratory Director (LD) it was determined that the newly appointed LD does not meet the qualifications to manage and direct a moderate complexity laboratory Findings include: 1. There was no documentation available at the time of the survey that could be used to qualify the newly appointed LD. 2. An interview on 5/15/19 at approximately 9:05 am, in the laboratory, with the laboratory supervisor confirmed that there was a new LD appointed approximately six (6) months ago. 3. An interview on 5/15/19 at approximately 11:56 am, in the laboratory, with the newly appointed Laboratory Director confirmed that he does not qualify to manage or direct a moderate complexity laboratory. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based upon review of personnel records and an interview with the Laboratory Supervisor, the Laboratory Director failed to ensure that traveling testing personnel had met the minimal education requirement to qualify as moderate complexity testing personnel. Findings include: 1. A review of personnel records did not include documentation of education for five (5) of eight (8) "travel" testing personnel for the type and complexity of the services offered. 2. An interview on 5/15/19 at approximately 10:40 am, in the laboratory, with the laboratory supervisor confirmed that diplomas or transcripts were not available. 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 -- 4 of 5 -- processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based upon review of proficiency testing, quality control, quality assurance and maintenance records and an interview with the Laboratory Supervisor, the Laboratory Director (LD) failed to assign in writing, the responsibilities of the Technical Consultant (TC) and testing personnel (TP) in all phases of the testing process. Findings include: 1. A review of the last six (6) Hematology and six (6) Chemistry) proficiency testing events revealed that all attestation statement and PT result reviews has been signed by the TC. 2. An interview on 5/15/19 at approximately 11:15 am , in the laboratory, with the laboratory supervisor who also serves as the TC revealed that there was not a written delegation of authority signed by the LD. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on a review of the critical values policy and an interview with laboratory personnel, the laboratory was unable to provide documentation that critical values are addressed in accordance with the laboratory's policy. Findings include: 1. A review of the critical value policy, which states "A critical value report will be printed and reviewed by the department supervisor at the beginning of each month". 2 An interview at approximately 10:14 am, in the laboratory, with the laboratory supervisor confirmed that monthly critical value reports were not printed and reviewed. -- 5 of 5 --