Comprehensive Rheumatology Center

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) evaluation records from American Proficiency Institute (API), and interview with the laboratory staff on October 28, 2025, at 12:30 p.m., the laboratory failed to attain a score of at least 80% of acceptable responses for antinuclear antibody and rheumamatoid factor. The findings include: 1. The laboratory received 40% score for antinuclear antibody at the 2nd event in 2024, and 0% at the 2nd event in 2025. It also scored 0% for rheumamatoid factor at the 2nd event in 2025. The score resulted in an unsatisfactory analyte performance for the events. Therefore, the accuracy of the laboratory's antinuclear antibody and rheumamatoid factor results reported to the patients cannot be assured and may have potentially harmed patients. 2. The laboratory staff on October 28, 2025, at 12:30 p.m., affirmed that it received an unsatisfactory analyte performance for the events. 3. The laboratory's testing declaration form signed by the laboratory director on 10/24/2025, stated that the laboratory performed approximately 250 tests, annually. 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 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 -- 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 Surveyor review of laboratory's PT and personnel records, and interview with the laboratory staff on October 28, 2025, at 12:30 p.m., the laboratory director failed to employ qualified competent personnel to perform the test and ensure compliance with the applicable regulations. The findings include: See D2075, D6109, D6168 and D6171. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's PT records and interview with the laboratory staff on October 28, 2025, at 12:30 p.m., the laboratory director failed to ensure that the laboratory maintained an acceptable levels of analytical performance for immunology tests. The findings include: The laboratory received an unsatisfactory performance score from the proficiency testing organization in the year 2024 and 2025. See D2075. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) (e)(11) 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 Surveyor review of laboratory's personnel records and interview with the staff on October 28, 2025, at 12:30 p.m., the laboratory director failed to employ qualified laboratory personnel for supervision and performing the high complexity test in immunology. The findings include: See D6109, D6168 and D6171. 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 -- 2 of 4 -- the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's personnel records and interview with the staff on October 28, 2025, at 12:30 p.m., the laboratory failed to have qualified technical supervisor for immunology to provide technical supervision. The findings include: The laboratory did not have any one to function as technical supervisor for the immunology test. 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: Based on Surveyor review of laboratory's personnel records and interview with the staff on October 28, 2025, at 12:30 p.m., the laboratory failed to have testing person to perform testing. The findings include: The laboratory did not have any testing person. Therefore, the laboratory was not performing test. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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; or (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified -- 3 of 4 -- laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b) (6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's personnel records and interview with the staff on October 28, 2025, at 12:30 p.m., the laboratory failed to have testing person who is qualified to perform testing. The findings include: The laboratory did not have any qualified testing person to perform high complexity test in Immunology. -- 4 of 4 --