Neuroscience Associates Inc

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Neuroscience Associates INC from May 27, 2026 to June 9, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6108 493.1447 Condition: Laboratory Technical Supervisor 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 personnel record review, review of license verification website, review of competency assessments records, and interview with the Quality Assurance consultant, the laboratory failed to verify the qualifications for the Technical Supervisor position for the Histology laboratory from January 2026 to May 2026. Refer to D6111 D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is 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)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American 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 -- Osteopathic Board of Pathology. (c) Bacteriology, Mycobacteriology, Mycology, Parasitology or Virology- If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, mycobacteriology, mycology, parasitology, or virology, the individual functioning as the technical supervisor must- (c)(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 (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (c)(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 (c)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable microbiology subspecialty; or (c)(3)(i)(A) Have an earned doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (c)(3)(i)(B) Meet the requirements in 493.1443(b)(3) (i)(B); and(c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty; or (c)(4)(i) (A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (c)(4)(i) (B)(1) Meet bachelor's degree equivalency; and (c)(4)(i)(B)(2) Have at least 16 semester hours of additional graduate level coursework in chemical, biological, clinical or medical laboratory science, or medical technology; or (c)(4)(i)(C)(1) Meet bachelor's degree equivalency; and (c)(4)(i)(C)(2) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, or clinical or medical laboratory science coursework and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty; or (c)(5)(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 (c)(5)(i)(B) Have at least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either- (c)(5)(i)(B)(1) 48 semester hours of medical laboratory technology courses; or (c)(5)(i)(B)(2) 48 semester hours of science courses that include- (c)(5)(i)(B)(2)(i) 12 semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry; (c)(5)(i) (B)(2)(ii) 12 semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and (c)(5)(i)(B)(2)(iii) 24 semester hours of chemistry, biology, or medical laboratory science or technology in any combination; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty. (d) Diagnostic Immunology, Chemistry, Hematology, Radiobioassay, or Immunohematology - If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, chemistry, hematology, radiobioassay, or immunohematology, the individual functioning as the technical supervisor must- (d)(1)(i) Be a doctor of medicine or a -- 2 of 5 -- doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (d) (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 (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the applicable specialty; or (d)(3)(i) (A) Have an earned doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (d)(3)(i) (B) Meet the education requirement at 493.1443(b)(3)(i)(B); and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the applicable specialty; or (d)(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (d)(4)(i)(B) Meet the education requirement at paragraphs (c)(4)(i)(B) or (C) of this section; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the applicable specialty; or (d)(5)(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 (d)(5)(i)(B) Meet the education requirement at paragraph (c) (5)(i)(B) of this section; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the applicable specialty. (e) Cytology- If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must- (e)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (e) (2) An individual qualified under paragraph (b) or (e)(1) of this section may delegate some of the cytology technical supervisor responsibilities to an individual who is in the final year of full-time training leading to certification specified in paragraph (b) or (e)(1)(ii) of this section provided the technical supervisor qualified under paragraph (b) or (e)(1) of this section remains ultimately responsible for ensuring that all of the responsibilities of the cytology technical supervisor are met. (f) Histopathology - If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must- (f)(1) Meet one of the following requirements: (f)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (f)(1)(ii) An individual qualified under paragraph (b) or (f)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (f)(2) For tests in dermatopathology, meet one of the following requirements: (f)(2)(i)(A) 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 (f) (2)(i)(B) Meet one of the following requirements: (f)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (f)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology; or (f) (2)(i)(B)(3) Be certified in dermatology by the American Board of Dermatology; or (f) (2)(ii) An individual qualified under paragraph (b) or (f)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to -- 3 of 5 -- certification specified in paragraph (b) or (f)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (f)(3) For tests in ophthalmic pathology, meet one of the following requirements: (f)(3)(i)(A) 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 (f)(3)(i)(B) Must meet one of the following requirements: (f)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (f) (3)(i)(B)(2) Be certified by the American Board of Ophthalmology and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (f)(3)(ii) An individual qualified under paragraph (b) or (f) (3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (g) Oral Pathology- If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (g)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g) (1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or (g)(2) Be certified in oral pathology by the American Board of Oral Pathology; or (g)(3) An individual qualified under paragraph (b) or (g)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (g) (1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (h) Histocompatibility - If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either- (h)(1)(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 (h)(1)(ii) Have training or experience that meets one of the following requirements: (h)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (h)(1)(ii) (B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (h)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (h)(2)(i) Have an earned doctoral degree in a biological, clinical or medical laboratory science, or medical technology from an accredited institution; or meet the education requirement at 493.1443(b)(3)(i)(B); and (h)(2)(ii) Have training or experience that meets one of the following requirements: (h)(2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (h)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (h)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (i) Clinical cytogenetics- If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must- (i)(1)(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 (i)(1)(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (i)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, clinical or medical laboratory science, or medical technology from an accredited institution; or meet the education requirement at 493.1443(b)(3)(i) (B); and (i)(2)(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (j) Notwithstanding any other provision of this section, an individual is considered qualified as a technical -- 4 of 5 -- supervisor under this section if they were qualified and serving as a technical supervisor for high 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 records reviewed and interview with the Quality Assurance (QA) consultant, the laboratory failed to ensure a qualified Technical Supervisor (TS) was in place from January 2026 to May 2026. Findings included: 1. Record review of the CMS 209 signed by the Laboratory Director (LD) 06/04/2026 showed that the LD was listed as the TS for Histology. The laboratory also had Testing Personnel TP-A (Mohs surgeon), and three Histology Technicians TP-B, TP-C, TP-D. 2. Review of the competency assessments revealed that the LD had signed the initial competency assessments for TP-A on 01/12/2026, TP-B on 4-20-2026, TP-C on 01/26/2026, and TP-D 01/12/2026. 3. Record review of education and certification for the LD revealed an Educational Council for Foreign Medical Graduates Certificate and an American Board of Psychiatry and Neurology Certificate in Neurology. 4. A review of the CMS 116 application for Certification signed by the Laboratory Director on 05/05/2026 revealed that the laboratory had the non-waived testing for Histology Hematoxylin and Eosin (H&E) stain with an annual testing volume of 200. 5. Review of the Mohs log revealed that the laboratory performed testing on 59 patients between 01/12/2026 to 04/22/2026. Count for patients tested in May was requested and not provided as of 06/15/2026. 6. During a Teams meeting call on 06/09/2026 at 3:00 PM, the Laboratory's Quality Assurance consultant admitted listed the LD as TS role in error. -- 5 of 5 --