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AB-613 Dentists: clinical laboratories: license examinations.(2019-2020)

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Date Published: 06/29/2020 09:00 PM
AB613:v98#DOCUMENT

Amended  IN  Senate  June 29, 2020

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Assembly Bill
No. 613

Introduced by Assembly Member Low

February 14, 2019

An act to add Section 101.1 to the Business and Professions Code, relating to professions and vocations, and making an appropriation therefor. An act to amend Sections 1209 and 1632.55 of, to amend, repeal, and add Section 1632 of, and to add and repeal Section 1632.56 of, the Business and Professions Code, relating to healing arts.


LEGISLATIVE COUNSEL'S DIGEST


AB 613, as amended, Low. Professions and vocations: regulatory fees. Dentists: clinical laboratories: license examinations.
(1) Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law requires a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) to be performed under the overall operation and administration of a laboratory director, which is defined to include certain licensees.
This bill would expand the definition of “laboratory director” to include licensed dentists.
(2) Existing law, the Dental Practice Act, provides for the licensure and regulation of the practice of dentistry by the Dental Board of California in the Department of Consumer Affairs. Existing law requires an applicant for licensure to have taken and received a passing score on either a clinical and written examination administered by the Western Regional Examining Board or a clinical and written examination developed by the American Board of Dental Examiners, Inc., subject to the Department of Consumer Affairs making a determination that the examination is compliant with specified requirements and standards. Existing law authorizes the acceptance of an American Board of Dental Examiners, Inc. examination only after the department makes that determination.
This bill would delete the provision specifying that the examination may only be accepted after that determination is made. The bill, until January 1, 2024, would specify that an applicant who received a passing score on either of the examinations specified above between January 1, 2015, to December 31, 2019, inclusive, shall be deemed to satisfy the examination requirement. The bill would make conforming changes.

Exiting law establishes the Department of Consumer Affairs, which is comprised of boards that are established for the purpose of regulating various professions and vocations, and generally authorizes a board to charge fees for the reasonable regulatory cost of administering the regulatory program for the profession or vocation. Existing law establishes the Professions and Vocations Fund in the State Treasury, which consists of specified special funds and accounts, some of which are continuously appropriated.

This bill would authorize each board within the department to increase every 4 years any fee authorized to be imposed by that board by an amount not to exceed the increase in the California Consumer Price Index for the preceding 4 years, subject to specified conditions. The bill would require the Director of Consumer Affairs to approve any fee increase proposed by a board except under specified circumstances. By authorizing an increase in the amount of fees deposited into a continuously appropriated fund, this bill would make an appropriation.

Vote: MAJORITY   Appropriation: YESNO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Section 1209 of the Business and Professions Code is amended to read:

1209.
 (a) As used in this chapter, “laboratory director” means any person who is any of the following:
(1) A duly licensed physician and surgeon.
(2) Only for purposes of a clinical laboratory test or examination classified as waived, is any of the following:
(A) A duly licensed clinical laboratory scientist.
(B) A duly licensed limited clinical laboratory scientist.
(C) A duly licensed naturopathic doctor.
(D) A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in paragraph (10) of subdivision (d) of Section 3041.
(E) A duly licensed dentist.
(3) Licensed to direct a clinical laboratory under this chapter.
(b) (1) A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.
(2) As used in this subdivision, “CLIA laboratory director” means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).
(c) The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, he or she they shall remain responsible for ensuring that all those duties and responsibilities are properly performed.
(d) (1) The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. He or she They shall be responsible for the proper performance of all laboratory work of all subordinates and shall 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 qualifications, duties, and responsibilities described in CLIA and this chapter.
(2) Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which he or she has they have been found by the laboratory director to be competent to perform and report.
(e) As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.
(f) As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:
(1) Ensure that all personnel, prior to testing biological specimens, 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. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.
(2) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.
(3) Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.
(g) The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.
(1) The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:
(A) Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.
(B) Monitoring the recording and reporting of test results.
(C) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
(D) Direct observation of performance of instrument maintenance and function checks.
(E) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
(F) Assessment of problem solving skills.
(2) Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual’s performance shall be reevaluated to include the use of the new test methodology or instrumentation.
(h) The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:
(1) If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.
(2) If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
(i) Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.
(j) A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.

SEC. 2.

 Section 1632 of the Business and Professions Code is amended to read:

1632.
 (a) The board shall require each applicant to successfully complete the written examination of the National Board Dental Examination of the Joint Commission on National Dental Examinations.
(b) The board shall require each applicant to successfully complete an examination in California law and ethics developed and administered by the board. The board shall provide a separate application for this examination. The board shall ensure that the law and ethics examination reflects current law and regulations, and ensure that the examinations are randomized. Applicants shall submit this application and required fee to the board in order to take this examination. In addition to the aforementioned application, the only other requirement for taking this examination shall be certification from the dean of the qualifying dental school or the dean’s delegate attended by the applicant that the applicant has graduated, or will graduate, or is expected to graduate. Applicants who submit completed applications and certification from the dean at least 15 days prior to a scheduled examination shall be scheduled to take the examination. Successful results of the examination shall, as established by board regulation, remain valid for two years from the date that the applicant is notified of having passed the examination.
(c) Except as otherwise provided in Section 1632.5, 1632.5 or 1632.56, the board shall require each applicant to have taken and received a passing score on one of the following:
(1) (A) A portfolio examination of the applicant’s competence to enter the practice of dentistry. This examination shall be conducted while the applicant is enrolled in a dental school program at a board-approved school located in California. This examination shall utilize uniform standards of clinical experiences and competencies, as approved by the board pursuant to Section 1632.1. The applicant shall pass a final assessment of the submitted portfolio at the end of the applicant’s dental school program. Before any portfolio assessment may be submitted to the board, the applicant shall remit the required fee to the board to be deposited into the State Dentistry Fund, and a letter of good standing signed by the dean of the applicant’s dental school or the dean’s delegate stating that the applicant has graduated or will graduate with no pending ethical issues.
(B) The board shall provide a report on how many other states have recognized licensure by portfolio examination at the time of its sunset review pursuant to subdivision (d) of Section 1601.1. The report shall be submitted in compliance with Section 9795 of the Government Code.
(2) Either one of the following examinations:
(A) A clinical and written examination administered by the Western Regional Examining Board within five years prior to the date of their application for a license under this section.
(B) The clinical and written examination developed by the American Board of Dental Examiners, Inc., within five years prior to the date of their application for a license under this section.
(d) Notwithstanding subdivision (b) of Section 1628, the board is authorized to do either of the following:
(1) Approve an application for examination from, and to examine an applicant who is enrolled in, but has not yet graduated from, a reputable dental school approved by the board.
(2) Accept the results of an examination described in paragraph (2) of subdivision (c) submitted by an applicant who was enrolled in, but had not graduated from, a reputable dental school approved by the board at the time the examination was administered.
In either case, the board shall require the dean of that school or the dean’s delegate to furnish satisfactory proof that the applicant will graduate within one year of the date the examination was administered or as provided in paragraph (1) of subdivision (c).
(e) The board may determine the testing format, as related to patients, for the examination provided pursuant to subparagraph (B) of paragraph (2) of subdivision (c).
(f) This section shall remain in effect only until January 1, 2024, and as of that date is repealed.

SEC. 3.

 Section 1632 is added to the Business and Professions Code, to read:

1632.
 (a) The board shall require each applicant to successfully complete the written examination of the National Board Dental Examination of the Joint Commission on National Dental Examinations.
(b) The board shall require each applicant to successfully complete an examination in California law and ethics developed and administered by the board. The board shall provide a separate application for this examination. The board shall ensure that the law and ethics examination reflects current law and regulations, and ensure that the examinations are randomized. Applicants shall submit this application and required fee to the board in order to take this examination. In addition to the aforementioned application, the only other requirement for taking this examination shall be certification from the dean of the qualifying dental school or the dean’s delegate attended by the applicant that the applicant has graduated, or will graduate, or is expected to graduate. Applicants who submit completed applications and certification from the dean at least 15 days prior to a scheduled examination shall be scheduled to take the examination. Successful results of the examination shall, as established by board regulation, remain valid for two years from the date that the applicant is notified of having passed the examination.
(c) Except as otherwise provided in Section 1632.5, the board shall require each applicant to have taken and received a passing score on one of the following:
(1) (A) A portfolio examination of the applicant’s competence to enter the practice of dentistry. This examination shall be conducted while the applicant is enrolled in a dental school program at a board-approved school located in California. This examination shall utilize uniform standards of clinical experiences and competencies, as approved by the board pursuant to Section 1632.1. The applicant shall pass a final assessment of the submitted portfolio at the end of the applicant’s dental school program. Before any portfolio assessment may be submitted to the board, the applicant shall remit the required fee to the board to be deposited into the State Dentistry Fund, and a letter of good standing signed by the dean of the applicant’s dental school or the dean’s delegate stating that the applicant has graduated or will graduate with no pending ethical issues.
(B) The board shall provide a report on how many other states have recognized licensure by portfolio examination at the time of its sunset review pursuant to subdivision (d) of Section 1601.1. The report shall be submitted in compliance with Section 9795 of the Government Code.
(2) Either one of the following examinations:
(A) A clinical and written examination administered by the Western Regional Examining Board within five years prior to the date of their application for a license under this section.
(B) The clinical and written examination developed by the American Board of Dental Examiners, Inc., within five years prior to the date of their application for a license under this section.
(d) Notwithstanding subdivision (b) of Section 1628, the board is authorized to do either of the following:
(1) Approve an application for examination from, and to examine an applicant who is enrolled in, but has not yet graduated from, a reputable dental school approved by the board.
(2) Accept the results of an examination described in paragraph (2) of subdivision (c) submitted by an applicant who was enrolled in, but had not graduated from, a reputable dental school approved by the board at the time the examination was administered.
In either case, the board shall require the dean of that school or the dean’s delegate to furnish satisfactory proof that the applicant will graduate within one year of the date the examination was administered or as provided in paragraph (1) of subdivision (c).
(e) The board may determine the testing format, as related to patients, for the examination provided pursuant to subparagraph (B) of paragraph (2) of subdivision (c).
(f) This section shall become operative on January 1, 2024.

SEC. 4.

 Section 1632.55 of the Business and Professions Code is amended to read:

1632.55.
 (a) Prior to implementation of subparagraph (B) of paragraph (2) of subdivision (c) of Section 1632, the department’s Office of Professional Examination Services shall review the American Board of Dental Examiners, Inc. examination to ensure compliance with the requirements of Section 139 and to certify that the examination process meets those standards, and deliver this review to the Dental Board of California. If the department determines that the examination process fails to meet those standards, does not deliver the review to the Dental Board of California, or if the American Board of Dental Examiners, Inc. fails to pay the costs and expenses the board incurs, as described in subdivision (d), subparagraph (B) of paragraph (2) of subdivision (c) of Section 1632 shall not be implemented.
(b) The American Board of Dental Examiners, Inc. examination process shall be regularly reviewed by the department pursuant to Section 139.
(c) The American Board of Dental Examiners, Inc. examination shall meet the mandates of subdivision (a) of Section 12944 of the Government Code.
(d) The American Board of Dental Examiners, Inc. shall pay all reasonable costs and expenses the board incurs for the purposes of implementing this section.

(e)The American Board of Dental Examiners, Inc. examination may only be accepted for licensure by a candidate after it is determined that the examination has met the requirements of this section. Examinations taken prior to that date may not be used for licensure.

SEC. 5.

 Section 1632.56 is added to the Business and Professions Code, immediately following Section 1632.55, to read:

1632.56.
 (a) Notwithstanding Section 1630, an applicant receiving a passing score on an American Board of Dental Examiners, Inc. examination or an examination administered by the Western Regional Examining Board from January 1, 2015, to December 31, 2019, inclusive, shall satisfy the requirement of a passing score pursuant to subdivision (c) of Section 1632 for a license to practice dentistry in this state.
(b)  This section shall remain in effect only until January 1, 2024, and as of that date is repealed.

SECTION 1.Section 101.1 is added to the Business and Professions Code, to read:
101.1.

(a)Notwithstanding any other law, no more than once every four years, any board listed in Section 101 may increase any fee authorized to be imposed by that board by an amount not to exceed the increase in the California Consumer Price Index, as determined pursuant to Section 2212 of the Revenue and Taxation Code, for the preceding four years in accordance with the following:

(1)The board shall provide its calculations and proposed fee, rounded to the nearest whole dollar, to the director and the director shall approve the fee increase unless any of the following apply:

(A)The board has unencumbered funds in an amount that is equal to more than the board’s operating budget for the next two fiscal years.

(B)The fee would exceed the reasonable regulatory costs to the board in administering the provisions for which the fee is authorized.

(C)The director determines that the fee increase would be injurious to the public health, safety, or welfare.

(2)The adjustment of fees and publication of the adjusted fee list is not subject to the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2) of the Government Code.

(b)For purposes of this section, “fee” includes any fees authorized to be imposed by a board for regulatory costs. “Fee” does not include administrative fines, civil penalties, or criminal penalties.