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Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, manufacturer's package insert, and interview with testing personnel (TP) #1; the laboratory failed to perform Rhesus (Rh) factor testing as outlined in the laboratory's procedure or as outlined in the manufacturer's package insert for the specialty of immunohematology. Findings include: 1. Review of the laboratory's policy and procedure manual revealed the procedure, "Point-of-Care Rh Factor Testing", which stated, under "Tube Technique - Immediate Spin", " ....4. Mix the contents of the test tube and centrifuge at [approximately] 3400 [rotations per minute] rpm for 10-15 seconds." 2. Review of the manufacturer's package insert revealed, under "Tube Technique - Immediate Spin", " ....4. Mix the contents of the test tube and centrifuge. NOTE: Suggested centrifugation: [approximately 3400 rpm] for 10 seconds ...." 3. Interview with TP #1 on 09/05/2024, at 1:48 PM, during a demonstration of Rh factor testing technique stated that the contents of the test tube were spun for 30 seconds. D6076 LABORATORY DIRECTOR Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, manufacturer's package insert, laboratory records, American Proficiency Institute (API) proficiency testing (PT) records, the Food and Drug Administration (FDA)'s laboratory test complexity database, the CMS-209 (Laboratory Personnel Report), laboratory personnel records, lack of documentation, and interviews with the laboratory director (LD), laboratory representative, and testing personnel (TP) #1; the laboratory director (LD) failed to provide overall management and direction to the laboratory performing high complexity Rhesus (Rh) factor testing in the specialty of immunohematology. Findings include: 1. The LD failed to meet the qualification requirements as a high complexity LD. See D6078. 2. The LD failed to ensure one of one TP was competent to perform high complexity Rhesus (Rh) factor testing. See D6079. 3. The LD failed to ensure that one of one TP was performing Rhesus (Rh) factor testing as outlined in the laboratory's procedure or as outlined in the manufacturer's package insert. See D6087. 4. The LD failed to ensure no inter-laboratory communications pertaining to the results of PT samples took place for five of six PT events reviewed. See D6089. 5. The LD failed to ensure TP had the appropriate education and received the appropriate training for performing high complexity Rhesus (Rh) factor testing. See D6102. D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (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) Be a doctor of medicine, a 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)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; 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 and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory -- 2 of 7 -- director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, the Food and Drug Administration (FDA)'s laboratory test complexity database, laboratory personnel records, and interviews with the laboratory director (LD) and laboratory representative; the LD failed to meet the qualifications for a high complexity laboratory testing Rhesus (Rh) factor in the specialty of immunohematology. Findings include: 1. Review of the laboratory's policy and procedure manual found the laboratory used "ALBAclone Anti-D Blood Grouping Reagent" for typing the patient's Rh factor in the specialty of immunohematology. 2. Review of the FDA's laboratory test complexity database found that the use of "ALBAclone Anti-D Blood Grouping Reagent" is categorized as a high complexity testing methodology. 3. Review of the laboratory's personnel records found that the LD failed to qualify as a high complexity laboratory director. 4. Interviews with the LD, via telephone, and the laboratory representative at 10:15 am, on 09/05/2024, confirmed that the LD did not qualify as a high complexity laboratory director. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, the CMS-209 (Laboratory Personnel Report), laboratory personnel records, lack of documentation, and interview with the laboratory representative; the laboratory director failed to ensure one of one testing personnel (TP) performing Rhesus (Rh) factor testing in the specialty of immunohematology was competent to perform the testing prior to reporting patient results. Findings include: 1. Review of the laboratory's policy and procedure manual revealed the procedure entitled, "Personnel", which stated, under "Position: Laboratory Director", "Personnel Duties ....Ensure that prior to testing patient specimens, all personnel have the appropriate education and experience, and receive the appropriate training for the type and complexity of services offered, and have demonstrated that they can perform all testing operations reliably to provide and -- 3 of 7 -- report accurate results". 2. Review of the CMS-209 (Laboratory Personnel Report) revealed one TP performing Rh factor testing in the specialty of immunohematology. 3. Review of laboratory personnel records revealed a lack of documentation of training and competency records, as required above, for one of one TP (TP #1) performing Rh factor testing. 4. Interview with the laboratory representative at 12:35 pm, on 09/05/2024, confirmed no training or competency documentation was available for one of one TP performing immunohematology testing. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, manufacturer's package insert, and interview with testing personnel (TP) #1; the laboratory director failed to ensure that laboratory TP are performing Rhesus (Rh) factor testing as outlined in the laboratory's procedure or as outlined in the manufacturer's package insert for the specialty of immunohematology. See D5551. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory policies and procedures, laboratory records, American Proficiency Institute (API) proficiency testing (PT) records, and interviews with the laboratory representative and testing personnel (TP) #1; the laboratory director failed to ensure no inter-laboratory communications pertaining to the results of PT samples took place for five of six PT events reviewed for the years of 2022 through 2024. See D2011. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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 review of laboratory policies and procedures, the CMS-209 (Laboratory Personnel Report), laboratory personnel records, lack of documentation, and interview with the laboratory representative; the laboratory director failed to ensure one of one testing personnel (TP) had the appropriate education and received the appropriate training for performing Rhesus (Rh) factor testing in the specialty of -- 4 of 7 -- immunohematology prior to reporting patient results. Findings include: 1. Review of the laboratory's policy and procedure manual revealed the procedure entitled, "Personnel", which stated, under "Position: Laboratory Director", "Personnel Duties .... Ensure that prior to testing patient specimens, all personnel have the appropriate education and experience, and receive the appropriate training for the type and complexity of services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results". 2. Review of the CMS-209 (Laboratory Personnel Report) revealed one TP performing Rh factor testing in the specialty of immunohematology. 3. Review of laboratory personnel records revealed TP #1 lacked the qualifications to perform high complexity testing. See D6170. 4. Review of laboratory personnel records revealed a lack of documentation of training records for one of one TP performing Rh factor testing. See D6079. 5. Interview with the laboratory representative at 12:35 pm, on 09/05/2024, confirmed no training documentation was available for one of one TP (TP #1) performing immunohematology testing. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, the Food and Drug Administration (FDA)'s laboratory test complexity database, laboratory personnel records, and interviews with the laboratory director (LD) and laboratory representative; one of one technical supervisor (TS) failed to meet the qualifications for a high complexity laboratory testing Rhesus (Rh) factor in the specialty of immunohematology. See D6109. D6109 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. The director of a laboratory performing high complexity testing may function as the technical supervisor provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, the Food and Drug Administration (FDA)'s laboratory test complexity database, laboratory personnel records, and interviews with the laboratory director (LD) and laboratory representative; one of one technical supervisor (TS) failed to meet the qualifications for a high complexity laboratory testing Rhesus (Rh) factor in the specialty of immunohematology. Findings include: 1. Review of the laboratory's policy and procedure manual and the FDA's laboratory test complexity database, the laboratory was found to be performing high complexity Rh factor testing. See D6078. 2. Review of the laboratory's personnel records found that one of one TS (TS #1) failed to -- 5 of 7 -- qualify as a high complexity laboratory TS for the specialty of immunohematology. 3. Interviews with the LD, via telephone, and the laboratory representative at 10:15 am, on 09/05/2024, confirmed that TS #1 did not qualify for a high complexity laboratory. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, the Food and Drug Administration (FDA)'s laboratory test complexity database, laboratory personnel records, and interviews with the laboratory director (LD) and laboratory representative; one of one general supervisor (GS) failed to meet the qualifications for a high complexity laboratory testing Rhesus (Rh) factor in the specialty of immunohematology. See D6142. D6142 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 The laboratory must have one or more general supervisors who, under the direction of the laboratory director and supervision of the technical supervisor, provides day-to- day supervision of testing personnel and reporting of test results. In the absence of the director and technical supervisor, the general supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, the Food and Drug Administration (FDA)'s laboratory test complexity database, laboratory personnel records, and interviews with the laboratory director (LD) and laboratory representative; one of one general supervisor (GS) failed to meet the qualifications for a high complexity laboratory testing Rhesus (Rh) factor in the specialty of immunohematology. Findings include: 1. Review of the laboratory's policy and procedure manual and the FDA's laboratory test complexity database, the laboratory was found to be performing high complexity Rh factor testing. See D6078. 2. Review of the laboratory's personnel records found that one of one GS (GS #1) failed to qualify as a high complexity laboratory GS for the specialty of immunohematology. 3. Interviews with the LD, via telephone, and the laboratory representative at 10:15 am, on 09/05/2024, confirmed that GS #1 did not qualify for a high complexity laboratory. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: -- 6 of 7 -- Based on review of laboratory policies and procedures, the Food and Drug Administration (FDA)'s laboratory test complexity database, laboratory personnel records, and interviews with the laboratory director (LD) and laboratory representative; one of one testing personnel (TP) failed to meet the qualifications for a high complexity laboratory testing Rhesus (Rh) factor in the specialty of immunohematology. See D6170. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, the Food and Drug Administration (FDA)'s laboratory test complexity database, laboratory personnel records, and interviews with the laboratory director (LD) and laboratory representative; one of one testing personnel (TP) failed to meet the qualifications for a high complexity laboratory testing Rhesus (Rh) factor in the specialty of immunohematology. Findings include: 1. Review of the laboratory's policy and procedure manual and the FDA's laboratory test complexity database, the laboratory was found to be performing high complexity Rh factor testing. See D6078. 2. Review of the laboratory's personnel records found that one of one TP (TP #1) failed to qualify as a high complexity laboratory TP for the specialty of immunohematology. 3. Interviews with the LD, via telephone, and the laboratory representative at 10:15 am, on 09/05/2024, confirmed that TP #1 did not qualify for high complexity testing. -- 7 of 7 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report - CLIA (CMS FORM 209), proficiency testing (PT) records, patient testing logs and interview with the laboratory director (LD); personnel who routinely perform the testing in the laboratory failed to examine PT samples with the laboratory's regular patient workload. Findings: 1. Review of CMS FORM 209 revealed that there are 2 persons (TP1 and TP2) performing rh testing in the laboratory. 2. Review of PT records revealed TP2 performed PT on 04/12/18 and 12/08/18 for the 1st and 3rd PT events of 2018. 3. Review of patient rh testing logs dated 04/12/18 and 12/08/18 revealed that there was no documentation to show that TP2 performed patient rh testing on either of those dates. All documentation shows that TP1 performed all patient rh testing both days. 4. During survey date at 11:30 AM on September 26, 2019, the LD confirmed the surveyor's findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION 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 5 -- Based on record review and interview with the laboratory director; the laboratory failed to have a director who meets the qualification requirments of 493.1405 of this subpart. Findings: 1. There was no documentation to show that the laboratory has a qualified laboratory director. See D tag 6003. 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 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 -- 2 of 5 -- 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 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 review Laboratory Personnel Report - CLIA (CMS FORM 209), personnel records and interview with the laboratory director (LD); the laboratory director failed to be qualified and eligible to manage and direct moderate complexity tests. Findings include: 1. Review of CMS FORM 209 revealed who the current laboratory director is. 2. Review of personnel records revealed that there is no documentation to show the qualifications of the current LD. 3. During survey date at 10:30 AM on September 26, 2019, the LD confirmed the surveyor's findings. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 -- 3 of 5 -- 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 personnel records and interview with the laboratory director, the laboratory failed to have a qualified technical consultant. Findings: 1. There is no documentation to show that the laboratory has a qualified Technical Consultant. See D tag 6035. 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 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 Laboratory Personnel Report - CLIA (CMS FORM 209), personnel records and interview with the laboratory director (LD); the laboratory failed to have a qualified technical consultant (TC). Findings include: 1. Review of CMS FORM 209 revealed that the laboratory director is also listed as the technical consultant of the laboratory. 2. Review of personnel records revealed that there is no documentation to -- 4 of 5 -- show the qualifications of the current TC. 3. During survey date at 10:30 AM on September 26, 2019, the LD confirmed the surveyor's findings. -- 5 of 5 --