Amended IN Assembly March 27, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 613Introduced by Assembly Member Nazarian(Principal coauthors: Assembly Members Cristina Garcia and Gomez)February 14, 2017An act relating to healing arts. An act to add and repeal Section 1246.7 of the Business and Professions Code, relating to clinical laboratories.LEGISLATIVE COUNSEL'S DIGESTAB 613, as amended, Nazarian. Healing arts: clinical laboratories.Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.This bill, until January 1, 2020, would authorize a person with specified qualifications to perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state if specified circumstances are met, as determined by the department. Because a violation of those provisions would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.This bill would state the intent of the Legislature to enact legislation related to authorizing a person with specified qualifications to perform a total protein refractometer test using an automatic, button-operated total protein refractometer with a digital readout in a licensed plasma collection facility in this state under specified circumstances. Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NOYES Local Program: NOYES Bill TextThe people of the State of California do enact as follows:SECTION 1. It is the intent of the Legislature to enact legislation to specify the qualifications of, and the limited circumstances in which, properly trained and supervised personnel may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state. Digital refractometers are very easy to operate; with one push of a button, the protein concentration is displayed on an LCD screen. User experience supports that the tests are simple.SEC. 2. Section 1246.7 is added to the Business and Professions Code, to read:1246.7. (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state, if the department, as part of its routine, fee-supported inspection of California Biologics facilities (plasma centers), including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all facility positions for a licensed plasma collection facility, determines that all of the following conditions are met:(1) He or she has earned a high school diploma or equivalent, as determined by the Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).(2) His or her training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor shall document, and the plasma collection facility shall maintain the documentation of, the individuals successful completion of training in the performance of the total protein test using a digital refractometer.(3) He or she performs the total protein test using a digital refractometer under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.(b) This section shall remain in effect only until January 1, 2020, and as of that date is repealed, unless a later enacted statute that is enacted before January 1, 2020, deletes or extends that date.SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.SECTION 1.It is the intent of the Legislature to enact legislation that recognizes 21st century technological advances in medical devices that are a direct outgrowth of high-technology research, development, and production capabilities in California and the United States. These advances have resulted in the creation of new, simple, one-button-operable versions of formerly complex, older equipment. It is the intent of the Legislature to enact legislation specifically relating to one such one-button advances in medical device technology to reflect the simplification of medical device operations by identifying the limited settings and circumstances in which closely supervised personnel, meeting federal CLIA-equivalent education and training standards, may use the device for nondiagnostic purposes. It is the intent of the Legislature to enact legislation to specify the qualifications of properly trained and supervised personnel and the limited circumstances in which those personnel may perform a total protein refractometer test using an automatic, button-operated total protein refractometer with a digital readout in a licensed plasma collection facility in this state.
Amended IN Assembly March 27, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 613Introduced by Assembly Member Nazarian(Principal coauthors: Assembly Members Cristina Garcia and Gomez)February 14, 2017An act relating to healing arts. An act to add and repeal Section 1246.7 of the Business and Professions Code, relating to clinical laboratories.LEGISLATIVE COUNSEL'S DIGESTAB 613, as amended, Nazarian. Healing arts: clinical laboratories.Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.This bill, until January 1, 2020, would authorize a person with specified qualifications to perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state if specified circumstances are met, as determined by the department. Because a violation of those provisions would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.This bill would state the intent of the Legislature to enact legislation related to authorizing a person with specified qualifications to perform a total protein refractometer test using an automatic, button-operated total protein refractometer with a digital readout in a licensed plasma collection facility in this state under specified circumstances. Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NOYES Local Program: NOYES
Amended IN Assembly March 27, 2017
Amended IN Assembly March 27, 2017
CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
Assembly Bill No. 613
Introduced by Assembly Member Nazarian(Principal coauthors: Assembly Members Cristina Garcia and Gomez)February 14, 2017
Introduced by Assembly Member Nazarian(Principal coauthors: Assembly Members Cristina Garcia and Gomez)
February 14, 2017
An act relating to healing arts. An act to add and repeal Section 1246.7 of the Business and Professions Code, relating to clinical laboratories.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 613, as amended, Nazarian. Healing arts: clinical laboratories.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.This bill, until January 1, 2020, would authorize a person with specified qualifications to perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state if specified circumstances are met, as determined by the department. Because a violation of those provisions would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.This bill would state the intent of the Legislature to enact legislation related to authorizing a person with specified qualifications to perform a total protein refractometer test using an automatic, button-operated total protein refractometer with a digital readout in a licensed plasma collection facility in this state under specified circumstances.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.
This bill, until January 1, 2020, would authorize a person with specified qualifications to perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state if specified circumstances are met, as determined by the department. Because a violation of those provisions would be a crime, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health, with specified exceptions. A violation of those provisions is a crime. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.
This bill would state the intent of the Legislature to enact legislation related to authorizing a person with specified qualifications to perform a total protein refractometer test using an automatic, button-operated total protein refractometer with a digital readout in a licensed plasma collection facility in this state under specified circumstances.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. It is the intent of the Legislature to enact legislation to specify the qualifications of, and the limited circumstances in which, properly trained and supervised personnel may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state. Digital refractometers are very easy to operate; with one push of a button, the protein concentration is displayed on an LCD screen. User experience supports that the tests are simple.SEC. 2. Section 1246.7 is added to the Business and Professions Code, to read:1246.7. (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state, if the department, as part of its routine, fee-supported inspection of California Biologics facilities (plasma centers), including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all facility positions for a licensed plasma collection facility, determines that all of the following conditions are met:(1) He or she has earned a high school diploma or equivalent, as determined by the Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).(2) His or her training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor shall document, and the plasma collection facility shall maintain the documentation of, the individuals successful completion of training in the performance of the total protein test using a digital refractometer.(3) He or she performs the total protein test using a digital refractometer under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.(b) This section shall remain in effect only until January 1, 2020, and as of that date is repealed, unless a later enacted statute that is enacted before January 1, 2020, deletes or extends that date.SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.SECTION 1.It is the intent of the Legislature to enact legislation that recognizes 21st century technological advances in medical devices that are a direct outgrowth of high-technology research, development, and production capabilities in California and the United States. These advances have resulted in the creation of new, simple, one-button-operable versions of formerly complex, older equipment. It is the intent of the Legislature to enact legislation specifically relating to one such one-button advances in medical device technology to reflect the simplification of medical device operations by identifying the limited settings and circumstances in which closely supervised personnel, meeting federal CLIA-equivalent education and training standards, may use the device for nondiagnostic purposes. It is the intent of the Legislature to enact legislation to specify the qualifications of properly trained and supervised personnel and the limited circumstances in which those personnel may perform a total protein refractometer test using an automatic, button-operated total protein refractometer with a digital readout in a licensed plasma collection facility in this state.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. It is the intent of the Legislature to enact legislation to specify the qualifications of, and the limited circumstances in which, properly trained and supervised personnel may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state. Digital refractometers are very easy to operate; with one push of a button, the protein concentration is displayed on an LCD screen. User experience supports that the tests are simple.
SECTION 1. It is the intent of the Legislature to enact legislation to specify the qualifications of, and the limited circumstances in which, properly trained and supervised personnel may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state. Digital refractometers are very easy to operate; with one push of a button, the protein concentration is displayed on an LCD screen. User experience supports that the tests are simple.
SECTION 1. It is the intent of the Legislature to enact legislation to specify the qualifications of, and the limited circumstances in which, properly trained and supervised personnel may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state. Digital refractometers are very easy to operate; with one push of a button, the protein concentration is displayed on an LCD screen. User experience supports that the tests are simple.
### SECTION 1.
SEC. 2. Section 1246.7 is added to the Business and Professions Code, to read:1246.7. (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state, if the department, as part of its routine, fee-supported inspection of California Biologics facilities (plasma centers), including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all facility positions for a licensed plasma collection facility, determines that all of the following conditions are met:(1) He or she has earned a high school diploma or equivalent, as determined by the Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).(2) His or her training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor shall document, and the plasma collection facility shall maintain the documentation of, the individuals successful completion of training in the performance of the total protein test using a digital refractometer.(3) He or she performs the total protein test using a digital refractometer under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.(b) This section shall remain in effect only until January 1, 2020, and as of that date is repealed, unless a later enacted statute that is enacted before January 1, 2020, deletes or extends that date.
SEC. 2. Section 1246.7 is added to the Business and Professions Code, to read:
### SEC. 2.
1246.7. (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state, if the department, as part of its routine, fee-supported inspection of California Biologics facilities (plasma centers), including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all facility positions for a licensed plasma collection facility, determines that all of the following conditions are met:(1) He or she has earned a high school diploma or equivalent, as determined by the Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).(2) His or her training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor shall document, and the plasma collection facility shall maintain the documentation of, the individuals successful completion of training in the performance of the total protein test using a digital refractometer.(3) He or she performs the total protein test using a digital refractometer under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.(b) This section shall remain in effect only until January 1, 2020, and as of that date is repealed, unless a later enacted statute that is enacted before January 1, 2020, deletes or extends that date.
1246.7. (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state, if the department, as part of its routine, fee-supported inspection of California Biologics facilities (plasma centers), including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all facility positions for a licensed plasma collection facility, determines that all of the following conditions are met:(1) He or she has earned a high school diploma or equivalent, as determined by the Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).(2) His or her training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor shall document, and the plasma collection facility shall maintain the documentation of, the individuals successful completion of training in the performance of the total protein test using a digital refractometer.(3) He or she performs the total protein test using a digital refractometer under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.(b) This section shall remain in effect only until January 1, 2020, and as of that date is repealed, unless a later enacted statute that is enacted before January 1, 2020, deletes or extends that date.
1246.7. (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state, if the department, as part of its routine, fee-supported inspection of California Biologics facilities (plasma centers), including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all facility positions for a licensed plasma collection facility, determines that all of the following conditions are met:(1) He or she has earned a high school diploma or equivalent, as determined by the Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).(2) His or her training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor shall document, and the plasma collection facility shall maintain the documentation of, the individuals successful completion of training in the performance of the total protein test using a digital refractometer.(3) He or she performs the total protein test using a digital refractometer under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.(b) This section shall remain in effect only until January 1, 2020, and as of that date is repealed, unless a later enacted statute that is enacted before January 1, 2020, deletes or extends that date.
1246.7. (a) Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection facility in this state, if the department, as part of its routine, fee-supported inspection of California Biologics facilities (plasma centers), including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all facility positions for a licensed plasma collection facility, determines that all of the following conditions are met:
(1) He or she has earned a high school diploma or equivalent, as determined by the Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).
(2) His or her training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility, or their certified, trained designate. The instructor shall document, and the plasma collection facility shall maintain the documentation of, the individuals successful completion of training in the performance of the total protein test using a digital refractometer.
(3) He or she performs the total protein test using a digital refractometer under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.
(b) This section shall remain in effect only until January 1, 2020, and as of that date is repealed, unless a later enacted statute that is enacted before January 1, 2020, deletes or extends that date.
SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
### SEC. 3.
It is the intent of the Legislature to enact legislation that recognizes 21st century technological advances in medical devices that are a direct outgrowth of high-technology research, development, and production capabilities in California and the United States. These advances have resulted in the creation of new, simple, one-button-operable versions of formerly complex, older equipment. It is the intent of the Legislature to enact legislation specifically relating to one such one-button advances in medical device technology to reflect the simplification of medical device operations by identifying the limited settings and circumstances in which closely supervised personnel, meeting federal CLIA-equivalent education and training standards, may use the device for nondiagnostic purposes. It is the intent of the Legislature to enact legislation to specify the qualifications of properly trained and supervised personnel and the limited circumstances in which those personnel may perform a total protein refractometer test using an automatic, button-operated total protein refractometer with a digital readout in a licensed plasma collection facility in this state.