Long Phi Dang Md Inc

Summary Statement of Deficiencies 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 observtion of the laboratory, review of laboratory documents, and interviews with the Testing Person and the Laboratory Director, it was determined that the laboratory failed to have a licensed Pathologist MD/DO as Technical Supervisor providing oversight for Grossing. Findings included: 1. The laboratory designated areas for receiving gastroenterology biopsies and for performing Grossing of the tissue sections. 2. Personnel Reports (CMS209, CLIA, 5/20/26; LAB116, 5/20 /26) failed to include any licensed Pathologist with responsibilities as Technical Supervisor in Histopathology. 3. The Testing Person affirmed (5/21/26 at 12:00 pm) there was no licensed Pathologist as Technical Supervisor. 4. The Laboratory Director affirmed (7/29/26 at 12:15pm) there was no licensed Pathologist to include as Technical Supervisor on the Personnel Reports. 5. No licensed Pathologist/Technical Supervisor supervised Grossing for 8 of 8 laboratory records reviewed from the timeframe 5/15/24 - 4/16/26, as follows:. Date Specimen ID --------------------------------------------------------- 5/15/24 LPD24-0001 A, B 8/21/24 LPD24-034 A, B, C, D, E 12/18/24 LPD24-209 A, B, C, D, E 2/05/25 LPD25-035 A 6 /26/25 LPD25-289 A 12/10/25 LPD25-496 A 2/20/26 LPD26- 097 A, B 4/16/26 LPD26-223 A . D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 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, -- 2 of 6 -- 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 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) -- 3 of 6 -- (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 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 -- 4 of 6 -- 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 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 review of laboratory documents, and interviews with the Testing Person and the Laboratory Director, the laboratory failed to have a Technical Supervisor meeting the requirements of the State and CLIA. Findings included: 1. Personnel Reports identified the Testing Person as Technical Supervisor. 2. The Testing Person affirmed (5/21/26 at 12:00 pm) not being licensed as a MD/DO, board certified in anatomic pathology as required for specialty (f) Histopathology; and thus, the Testing Person wasn't qualified. 3. The Laboratory Director affirmed (7/29/26 at 12:15pm) the laboratory didn't have a licensed Pathologist as Technical Supervisor. . D6113 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(a) (a) The technical supervisor must be accessible to the laboratory to provide on-site, telephone, or electronic consultation; and This STANDARD is not met as evidenced by: Based on the lack of laboratory records, it was determined there was no qualified Technical Supervisor to provide direct onsite supervision during Grossing, or records that Grossing test results were reviewed by the Technical Supervisor when supervision was performed remotely. Findings included: 1. For 8 out of 8 Grossing records reviewed, the laboratory failed to have records of a California-licensed Pathologist/Technical Supervisor directly overseeing Grossing or reviewing Grossing descriptions when supervision was provided remotely. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of laboratory documents, the lack of laboratory records, and interview with the Testing Person, it was determined that the laboratory failed to have a licensed Pathologist/Technical Supervisor assess and document initial training and inital evaluation records, follow up competency assessment within 6 months, and -- 5 of 6 -- annual competency assessments. Findings included: 1. Personnel Reports included one Testing Person. 2. The laboratory failed to have records for a licensed MD/DO, certified in Anatomic Pathology, assessing the Testing Person's training needs, initial evaluation, and competency assessments within six months and annually. 3. The Testing Person affirmed (5/21/26 at 12:00 pm) the aforementioned lack of records. -- 6 of 6 --

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on touring and observation of the laboratory facility, and interview with the laboratory histotech personnel, it was determined that the laboratory failed to constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the histopathology testing process. The findings included: a. The laboratory includes a histology laboratory and performs grossing, cutting, enbedding, staining, tissue processing, and reagent storage, etc. b. The space for the entire histopathology laboratory appears to be insufficient, difficuty in traffic flow, too crowded and difficult to maintain and ensure quality of tissue slide processing and staining and may be harmful for the personnel working under that environment. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of lack of the laboratory's evaluation of proficiency histopathology testing performance for the years of 2019 and 2020, and interview with the laboratory staff, it was determined that the laboratory failed to verify, at least twice annually, the accuracy of histopathology test the laboratory performed that is not included in 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 -- subpart I of 42 CFR part 493. The findings included: a. The laboratory performed biopsy tissue histopathology testing on site., which is not incliuded in subpart I of 42 CFR part 493. b. The laboratory failed to perform, at least twice annually, proficiency testing to verify the accuracy of its histopathology testing performance in the years of 2019 and 2020. c. Thge laboratory staff affirmed (12/01/2020 @ 11:10 AM) that the laboratory failed to perform, at least twice annually, the proficiecncy of histopathology testing in the years of 2019 and 2020. d. The laboratory performed histopathology testing in approximately 2,400 annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of lack of the laboratory's evaluation of proficiency histopathology testing performance for the years of 2019 and 2020, and interview with the laboratory staff, it was determined that the laboratory failed to document all proficiency testing evaluation and verification activities. The findings included: a. The laboratory performed biopsy tissue histopathology testing on site., which is not incliuded in subpart I of 42 CFR part 493. b. The laboratory failed to perform, at least twice annually, proficiency testing to verify the accuracy of its histopathology testing performance in the years of 2019 and 2020. c. The laboratory failed to document all proficiency histopathology testing evaluation and verification, see D-5217. 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 review of the laboratory's procedure manuals, and interview with the laboratory staff, it was determined that the current laboratory director failed to approve, sign and date the procedures. The findings included: a. A new laboratory director took the responsibility of the laboratory directorship in April 2019, as verified in "Director Attestation" LAB Form 183. b. There is no evidence to indicate the current laboratory director approved, signed, and dated of the laboratory policies and procedures. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on observation and touring the histology laboratory, and interview with the histotech, it was determined that the laboratory failed to label the reagents, solutions, or laboratory supplies to indicate its preparation and expiration dates, when opened, to ensure the stabilities of the reagents, solutions, or supplies. The findings included: a. The histology laboratory is located inside the laboratory. b. The laboratory uses solutions, such as xylene, reagent alcohol 95% v/v in the tissue processing procedures. c. No open dates and expiration dates were labeled for these reagents or soluttions. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, 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 observation and toruing the laboratory, review of the laboratory records, and inteview with the laborator ystaff, it was determined that the laboratory director failed to be responsible for the overall operation including the competencies of the personnel, ensurence of the proficiency testing evaluation, and assuring compliance with applicable regulations. The findings included: a. The laboratory failed to construct, to arrange, to maintain, and to ensure the space, ventilation, and utilities necessary for conducting all phases of the histology testing process, see D-3001. b. The laboratory failerd to perform and document the evaluation of histopathology testing proficiency performance for the years of 2019 and 2020, see D-5217 and D- 5221. c. The laboratory director failed to be res[posible for ensuring the procuedures aor changes in procedures to be approvesd, signed and dated, see D-5407 and failed to maintain and assure the stability of reagents or solution and to ensure quality operation of the histology laboratory, see D-5415. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Base on observation adn touring the laboratory facility, review lack of the histopathology proficiency testing records for the years of 2019 and 2020 , and interview with the laboratory staff, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for the histology test system. The dfindings included: a The laboratory failed to perform, at least twice annually, proficiency testing to verify the accuracy of -- 3 of 4 -- its histopathology testing performance in the years of 2019 and 2020, see D-5217 b. The laboratory failed to document all proficiency histopathology testing evaluation and verification, see D-5221. -- 4 of 4 --