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, 2019, would authorize a person with specified qualifications to perform a total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in this state. 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, until January 1, 2019, would authorize a medical assistant, as defined, who meets specified criteria person with specified qualifications to perform a total protein refractometer test analysis using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in this state. 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 bill, until January 1, 2019, would authorize a medical assistant, as defined, who meets specified criteria to perform a total protein refractometer test analysis in a licensed plasma collection facility in this state. 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. Existing law authorizes a person who is licensed under those provisions to perform certain laboratory tests.

This bill would declare the intent of the Legislature to enact legislation to identify who, and under which circumstances he or she, may perform a total protein refractometer test analysis in a licensed plasma collection facility in this state.

GOVERNOR'S VETO

GV Bill Id:AB 757

Author:(Gomez)

As Enrolled Ver:September 2, 2015

2/3 vote

Original Committee Reference: B. & P.

SUMMARY: Authorizes a person, who meets specified criteria, to perform a total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in this state. Specifically, this bill:

1. Authorizes a person whose qualifications are at least the equivalent of those specified in Code of Federal Regulations Title 42, Section 493.1423(b)(4) to perform a total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in this state if all of the following conditions are met:

   1. The person 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 1998 (CLIA) (42 United States Code Section 263a);

   2. The person performs the total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility;

   3. The person's training in the proper procedure to be employed when performing a total protein refractometer test using an automatic, button-operated refractometer with a digital readout 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 must document, and the plasma collection facility must maintain the documentation of, the individual's successful completion of training in the performance of the total protein refractometer test using an automatic, button-operated refractometer with a digital readout;

   4. The person performs the total protein refractometer test using an automatic, button-operated refractometer with a digital readout under the direction and supervision of the physician and surgeon or licensed clinical laboratory director; and,

   5. The person submits the test results for interpretation to the physician and surgeon or licensed clinical laboratory director under whose direction and supervision he or she performed the test using an automatic, button-operated refractometer with a digital readout.

2. States that no reimbursement is required pursuant to California Constitution Article XIII B, Section 6, as specified.

The Senate amendments increase the required qualifications to perform the test (a moderate complexity test) from a medical assistant to a person qualified to perform the test under federal law.

FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.

COMMENTS:

Purpose. This bill is sponsored by Grifols, Inc. According to the author, "Plasma donation centers are critical to ensuring the availability of therapies that treat rate, chronic, and sometimes life-threatening diseases. AB 757 would authorize a medical assistant who meets specified criteria to perform a total protein refractometer test analysis – a standard, mostly automated procedure performed during donor intake and assessment to determine donor eligibility – in state licensed plasma collection facility in California. This will help promote efficiencies, where appropriate, in the biomedical industry while continuing to prioritize patient health and safety."

Background. In California, only licensed or certified individuals may perform moderate complexity tests. This bill would create an exception to the requirement under state law for a total protein refractometer test, which is a moderate complexity test. However, it will still require the person to meet the qualifications required under federal law to perform a moderate complexity test, including having earned a high school diploma or equivalent and having documentation of training appropriate for the testing performed prior to analyzing patient specimens. The training must ensure that the individual has:

1. The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens;

2. The skills required for implementing all standard laboratory procedures;

3. The skills required for performing each test method and for proper instrument use;

4. The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed;

5. A working knowledge of reagent stability and storage;

6. The skills required to implement the quality control policies and procedures of the laboratory;

7. An awareness of the factors that influence test results; and,

8. The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.

Total Protein Refractometer Test. The measurement of total protein uses an instrument called a refractometer. A refractometer is a device that shines a beam of light through a sample of liquid. The device measures the amount of light that is refracted (bent) due to the solids in the sample. In blood, protein causes light to bend. The greater the amount of protein, the more light is bent from the light path. According to the sponsors, Grifols measures a potential plasma donor's total protein levels as part of the initial screening process.

GOVERNOR'S VETO MESSAGE:

This bill would allow unlicensed personnel to perform a total protein refractometer test designed to monitor the protein level of plasma donors.

Failure to perform and report this test accurately could lead to serious health consequences for the donor. The California Department of Public Health does not believe that the standards outlined in the bill for persons to perform this test ensure the health and safety of plasma donors.

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0002450

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 757

Author:(Gomez)

As Amended Ver:June 22, 2015

Majority vote

Original Committee Reference: B. & P.

SUMMARY: Authorizes a person, who meets specified criteria, to perform a total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in this state. Specifically, this bill:

1. Authorizes a person whose qualifications are at least the equivalent of those specified in Code of Federal Regulations Title 42, Section 493.1423(b)(4) to perform a total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in this state if all of the following conditions are met:

   1. The person 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 1998 (CLIA) (42 United States Code Section 263a);

   2. The person performs the total protein refractometer test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility;

   3. The person's training in the proper procedure to be employed when performing a total protein refractometer test using an automatic, button-operated refractometer with a digital readout 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 must document, and the plasma collection facility must maintain the documentation of, the individual's successful completion of training in the performance of the total protein refractometer test using an automatic, button-operated refractometer with a digital readout;

   4. The person performs the total protein refractometer test using an automatic, button-operated refractometer with a digital readout under the direction and supervision of the physician and surgeon or licensed clinical laboratory director; and,

   5. The person submits the test results for interpretation to the physician and surgeon or licensed clinical laboratory director under whose direction and supervision he or she performed the test using an automatic, button-operated refractometer with a digital readout.

2. States that no reimbursement is required pursuant to California Constitution Article XIII B, Section 6, as specified.

The Senate amendments increase the required qualifications to perform the test (a moderate complexity test) from a medical assistant to a person qualified to perform the test under federal law.

FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs.

COMMENTS:

Purpose. This bill is sponsored by Grifols, Inc. According to the author, "Plasma donation centers are critical to ensuring the availability of therapies that treat rate, chronic, and sometimes life-threatening diseases. AB 757 would authorize a medical assistant who meets specified criteria to perform a total protein refractometer test analysis – a standard, mostly automated procedure performed during donor intake and assessment to determine donor eligibility – in state licensed plasma collection facility in California. This will help promote efficiencies, where appropriate, in the biomedical industry while continuing to prioritize patient health and safety."

Background. In California, only licensed or certified individuals may perform moderate complexity tests. This bill would create an exception to the requirement under state law for a total protein refractometer test, which is a moderate complexity test. However, it will still require the person to meet the qualifications required under federal law to perform a moderate complexity test, including having earned a high school diploma or equivalent and having documentation of training appropriate for the testing performed prior to analyzing patient specimens. The training must ensure that the individual has:

1. The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens;

2. The skills required for implementing all standard laboratory procedures;

3. The skills required for performing each test method and for proper instrument use;

4. The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed;

5. A working knowledge of reagent stability and storage;

6. The skills required to implement the quality control policies and procedures of the laboratory;

7. An awareness of the factors that influence test results; and,

8. The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.

Total Protein Refractometer Test. The measurement of total protein uses an instrument called a refractometer. A refractometer is a device that shines a beam of light through a sample of liquid. The device measures the amount of light that is refracted (bent) due to the solids in the sample. In blood, protein causes light to bend. The greater the amount of protein, the more light is bent from the light path. According to the sponsors, Grifols measures a potential plasma donor's total protein levels as part of the initial screening process.

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001303

 THIRD READING  

Bill No: AB 757

Author: Gomez (D)

Amended: 6/22/15 in Senate

Vote: 21

SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 8-0, 6/29/15

AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski

NO VOTE RECORDED: Berryhill

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 74-0, 5/22/15 (Consent) - See last page for vote

SUBJECT: Healing arts: clinical laboratories

SOURCE: Grifols, Inc.

DIGEST: This bill makes an exception to California law to allow an individual who meets standards equivalent to federally requirements to perform a particular type of total protein refractometer test (TPRT) in a licensed plasma collection facility.

ANALYSIS:

Existing federal law:

1. Establishes conditions that laboratories must meet for certification to perform testing on human specimens under CLIA. (Title 42, Code of Federal Regulations (CFR) § 493.1)

2. Classifies laboratory tests using three categories: “waived,” “moderate complexity,” or “high complexity.” (42 CFR § 493.5)

3. Requires an individual performing moderate complexity testing to have a current license issued by the state in which the laboratory is located, if such licensing is required; and meets one of the following requirements:

1. Is a physician or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution.

2. Has earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution.

3. Is a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist.

4. Has earned a high school diploma or equivalent and documentation of training appropriate for the testing performed prior to analyzing patient specimens. (42 CFR § 493.1423)

Existing state law:

1. Authorizes the following individuals to perform clinical laboratory tests or examinations classified as of moderate complexity under the Clinical Laboratory Improvement Amendments (CLIA) under the overall operation and administration of the laboratory director:

1. A licensed physician and surgeon.

2. A licensed podiatrist or a licensed dentist if the results of the tests can be lawfully utilized within his or her practice.

3. A person licensed to engage in clinical laboratory practice or to direct a clinical laboratory.

4. A licensed physician assistant if authorized by a supervising physician and surgeon.

5. A licensed nurse.

6. A perfusionist.

7. A respiratory care practitioner.

8. A person performing nuclear medicine technology.

9. A person certified or licensed as an “Emergency Medical Technician II” or paramedic, a person licensed as a psychiatric technician, as a vocational nurse, or as a midwife, or certified as a nurse assistant or a home health aide, as specified.

10. Any other person within a physician office laboratory if the test is performed under the supervision of the patient’s physician and surgeon or podiatrist who shall be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed.

11. A pharmacist. (Business and Professions Code § 1206.5)

This bill:

1. States the intent of the Legislature to enact legislation to identify who, and under which circumstances, may perform a TPRT test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in California.

2. Authorizes a person who meets standards equivalent to the federal CLIA regulations for performing a moderate complexity test to perform a TPRT using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in California if 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 pursuant to CLIA.

2. He or she performs the TPRT using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility.

3. His or her training in the proper procedure to be employed when performing a TPRT using an automatic, button-operated refractometer with a digital readout 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 individual’s successful completion of training in the performance of the total protein refractometer test using an automatic, button-operated refractometer with a digital readout.

4. He or she performs the TPRT using an automatic, button-operated refractometer with a digital readout under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.

5. He or she submits the test results to the physician and surgeon or licensed clinical laboratory director under whose direction and supervision he or she performed the test using an automatic, button-operated refractometer with a digital readout.

3. Sunsets the provisions of this bill on January 1, 2019.

Background

CLIA and California Law. The federal CLIA laws set the regulatory floor for laboratory testing; states are free to develop higher standards, and laboratories must follow whichever law is more stringent. According to the sponsor, California is one of 7 states that have developed more rigorous lab personnel requirements. California defers to CLIA in matters of determining test complexity, which dictates who and under what circumstances, may perform a test.

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. Personnel authorized to perform the tests are required to have skill and training commensurate with the test level. Diagnostic tests are categorized as waived if they are simple to use and there is little chance the test will provide wrong information or cause harm if it is performed incorrectly.

This bill would allow the source of this bill to employ a lesser skilled individual than is currently required under California law to perform TPRT, a test that screens potential plasma donors. This change would be an exception to state law, but consistent with federal law.

Total Protein Refractometer Test (TPRT). As part of donor-screening and quality-assurance procedures, some plasma donation centers perform screening tests on-site, and these screening tests are considered “waived tests,” with the exception of the TPRT. While some centers use older, analog refractometers to conduct the test, other centers use newer, digital refractometers, like the instrument described in this bill. FDA assigned TPRT to the moderate complexity category under CLIA, regardless of type.

The Plasma Protein Therapeutics Association submitted to the FDA, in an effort to get this instrument reclassified, that the experiences of one of their member centers that use digital refractometers to perform TPRTs “demonstrate that the test is a simple procedure with little health impact.”

The request for FDA reclassification of TPRT is still pending, but the sponsors believe it will likely be completed by this bill’s sunset date of 2019.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 7/14/15)

Grifols, Inc. (source)

Blood Centers of California

KEDPlasma LLC

Octapharma Plasma, Inc.

Plasma Protein Therapeutics Association

OPPOSITION: (Verified 7/14/15)

California Association for Medical Laboratory Technology

California Society of Pathologists

Engineers & Scientists of California, IFPTE Local 20

ARGUMENTS IN SUPPORT: The sponsor, Grifols, Inc., writes, “Currently, the total protein refractometer test unit is categorized by federal CLIA as a ‘moderate complexity test.’ California law authorizes 17 different categories of health care personnel, subject to varying levels of independence or supervision, to conduct a moderate complexity test. This even includes ‘any person’ if supervised in a physician’s office. In fact, a total protein refractometer test can be administered in the overwhelming majority of states by an employee trained to federal standards. ...The end goal of this measure is to help our California Department of Public Health-licensed plasma donation centers operate more efficiently by authorizing a properly-trained employ to perform this simple task as part of the donor intake process, without diverting other employees from their primary occupations.”

Plasma Protein Therapeutics Association, Blood Centers of California, KEDPlasma LLC and Octapharma Plasma are in support of this bill because it will help their operations, as well.

ARGUMENTS IN OPPOSITION: The California Association for Medical Laboratory Technology, the professional association representing clinical laboratory scientists and other laboratory personnel in California, oppose AB 757, writing, “Plasma donors are paid. They can donate every two weeks if their total protein is at least 6 g/dL.  Many plasma collection centers ‘bleed’ their donors down to 6 g/dL of protein regularly.  If the protein refractometer test and/or calibration is done incorrectly and the protein read is higher than it actually is, there is a potential to over ‘bleed’ a donor causing donor harm, such as death from untreated low protein, immune deficiency, heart and respiratory problems, bruising, insufficient blood clotting, muscle wasting and reduced energy. In short, the current personnel standard needs to be maintained.”

The California Society of Pathologists and Engineers & Scientists of California, IFPTE Local 20 also express concern about patient safety and quality control with lesser-trained individuals.

ASSEMBLY FLOOR: 74-0, 5/22/15

AYES: Achadjian, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Wilk, Williams, Wood, Atkins

NO VOTE RECORDED: Alejo, Jones, O'Donnell, Olsen, Waldron, Weber

Prepared by: Sarah Huchel / B., P. & E.D. / (916) 651-4104

7/14/15 19:27:51

**** END ****

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2015 - 2016 Regular

Bill No: AB 757 Hearing Date: June 29, 2015

Subject: Healing arts: clinical laboratories.

SUMMARY:

1. Makes an exception to California law to allow an individual who meets standards equivalent to federally requirements to perform a particular type of total protein refractometer test (TPRT) in a licensed plasma collection facility.

Existing state law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the California Department of Public Health (DPH). (Business and Professions Code (BPC) §§ 1200-1327)

2. Authorizes the following individuals to perform clinical laboratory tests or examinations classified as of moderate complexity under the Clinical Laboratory Improvement Amendments (CLIA) under the overall operation and administration of the laboratory director:

1. A licensed physician and surgeon.

2. A licensed podiatrist or a licensed dentist if the results of the tests can be lawfully utilized within his or her practice.

3. A person licensed to engage in clinical laboratory practice or to direct a clinical laboratory.

4. A licensed physician assistant if authorized by a supervising physician and surgeon.

5. A licensed nurse.

6. A perfusionist.

7. A respiratory care practitioner.

8. A person performing nuclear medicine technology.

9. A person certified or licensed as an “Emergency Medical Technician II” or paramedic while providing prehospital medical care, a person licensed as a psychiatric technician, as a vocational nurse, or as a midwife, or certified as a nurse assistant or a home health aide, who provides direct patient care, if the person is performing the test as an adjunct to the provision of direct patient care by the person, is utilizing a point-of-care laboratory testing device at a site for which a laboratory license or registration has been issued, meets the minimum clinical laboratory education, training, and experience requirements set forth in regulations adopted by the department, and has demonstrated to the satisfaction of the laboratory director that he or she is competent in the operation of the point-of-care laboratory testing device for each analyte to be reported.

10. Any other person within a physician office laboratory if the test is performed under the supervision of the patient’s physician and surgeon or podiatrist who shall be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed, and shall do both of the following:

1. Ensure that the person is performing test methods as required for accurate and reliable tests.

2. Have personal knowledge of the results of the clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory.

11. A pharmacist. (BPC § 1206.5)

3. Declares Legislative intent to sustain the integrity of California's laboratory standards, including its personnel standards, and that changes in technology to increase the efficiency of health care delivery be accommodated when the providers of laboratory services utilizing technology remain competent to provide accurate, reliable, and necessary test results. (Uncodified language from SB 113 (Maddy) Chapter 510, Statutes of 1995)

Existing federal law:

1. Establishes conditions that laboratories must meet for certification to perform testing on human specimens under CLIA. (Title 42, Code of Federal Regulations (CFR) § 493.1)

2. Classifies laboratory tests using three categories: “waived,” “moderate complexity,” or “high complexity.” (42 CFR § 493.5)

3. Requires an individual performing moderate complexity testing to have a current license issued by the state in which the laboratory is located, if such licensing is required; and meets one of the following requirements:

1. Is a physician licensed to practice medicine in the state in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or edical technology from an accredited institution.

2. Has earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution.

3. Is a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).

4. Has earned a high school diploma or equivalent and documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has:

1. Skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens.

2. Skills required for implementing all standard laboratory procedures.

3. Skills required for performing each test method and for proper instrument use.

4. Skills required for preventive maintenance, troubleshooting and calibration procedures related to each test performed.

5. A working knowledge of reagent stability and storage.

6. The skills required to implement the quality control policies and procedures of the laboratory.

7. An awareness of the factors that influence test results; and,

8. The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. (42 CFR § 493.1423)

4. Requires the laboratory director to be 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. Among other duties, the laboratory director is required to:

1. Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart;

2. Ensure that prior to testing patients' specimens, all personnel 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. (42 CFR § 493.1407)

This bill:

1. States the intent of the Legislature to enact legislation to identify who, and under which circumstances, may perform a TPRT test using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in California.

2. Authorizes a person who meets standards equivalent to the federal CLIA regulations for performing a moderate complexity test to perform a TPRT using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility in California if 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 pursuant to CLIA.

2. He or she performs the TPRT using an automatic, button-operated refractometer with a digital readout in a licensed plasma collection facility.

3. His or her training in the proper procedure to be employed when performing a TPRT using an automatic, button-operated refractometer with a digital readout 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 individual’s successful completion of training in the performance of the total protein refractometer test using an automatic, button-operated refractometer with a digital readout.

4. He or she performs the TPRT using an automatic, button-operated refractometer with a digital readout under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.

5. He or she submits the test results to the physician and surgeon or licensed clinical laboratory director under whose direction and supervision he or she performed the test using an automatic, button-operated refractometer with a digital readout.

3. Sunsets the provisions of this bill on January 1, 2019.

FISCAL EFFECT: This bill is keyed “fiscal” by the Legislative Counsel. According to the Assembly Appropriations Committee analysis dated May 13, 2015, this bill has a negligible state fiscal effect.

COMMENTS:

1. Purpose. This measure is sponsored by Grifols, Inc., a company that, among other lines of business, owns and operates 147 plasma donor centers where plasma is collected to be used in the company’s protein therapies.

This bill would allow the company to employ a lesser skilled individual than is currently required under California law to perform TPRT, a test that screens potential plasma donors. This change would be an exception to state law, but consistent with federal law.

According to the Author’s office, “California law authorizes 17 different categories of health care personnel ([including] ‘any person’ in a doctor’s office) to conduct the total protein refractometer test….

“AB 757 will authorize a fully-trained and fully-supervised employee, whose general training meets that required by federal standards, followed by specific training to operate a one-button, automated, total protein refractometer test in our licensed plasma collection centers in California. The bill allows the highly qualified physicians, laboratory directors, and other health care professionals on-site to serve more plasma donors while continuing to supervise the operation of the simple, almost entirely automated, total protein refractometer test.

“This would not only ensure efficiency and better service delivery at these licensed facilities, but would also allow highly qualified physicians and surgeons to serve more patients while continuing to supervise the administration of this simple, almost entirely automated total protein refractometer test analysis.”

2. CLIA and California Law. The federal CLIA laws set the regulatory floor for laboratory testing; states are free to develop higher standards, and laboratories must follow whichever law is more stringent. According to the sponsor, California is one of 7 states that have developed more rigorous lab personnel requirements. California defers to CLIA in matters of determining test complexity, which dictates who and under what circumstances, may perform a test.

The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. Personnel authorized to perform the tests are required to have skill and training commensurate with the test level. Diagnostic tests are categorized as waived if they are simple to use and there is little chance the test will provide wrong information or cause harm if it is performed incorrectly.

3. Total Protein Refractometer Test (TPRT). As part of donor-screening and quality-assurance procedures, some plasma donation centers perform screening tests on-site, and these screening tests are considered “waived tests,” with the exception of the TPRT. While some centers use older, analog refractometers to conduct the test, other centers use newer, digital refractometers, like the instrument described in this bill. FDA assigned TPRT to the moderate complexity category under CLIA, regardless of type.

The Plasma Protein Therapeutics Association submitted to the FDA, in an effort to get this instrument reclassified, that the experiences of one of their member centers that use digital refractometers to perform TPRTs “demonstrate that the test is a simple procedure with little health impact. The intended users of digital refractometers are donation-center employees who have prior training in blood borne pathogens, also known as universal precautions; in the hands of these test operators, the total protein test by digital refractometer is a simple procedure….

“While older, analog refractometers require water calibration … digital refractometers offer accurate, simple, electronic, water calibration at the push of a button. Digital refractometers are battery-operated, portable, and automatic and measure accurately, consistently from technician to technician, and electronically the same scale as analog refractometers. While older, analog refractometers require trained operators with experience and knowledge of proper use, simple operational software and interface-onscreen instructions guide technicians through digital-refractometer results.”

The request for FDA reclassification of TPRT is still pending, but the sponsors believe it will likely be completed by this bill’s sunset date of 2019.

4. Related Legislation. AB 940 (Ridley-Thomas) of 2015 adds the specialty of reproductive biology and the subspecialty of biochemical genetics and makes conforming changes, removes the requirement that clinical laboratory co-directors substantially comply with federal CLIA requirements, and makes other technical and conforming changes. Status: This bill is scheduled to be heard in the Senate Committee on Business, Professions, and Economic Development on June 29, 2015.

AB 599 (Bonilla) of 2015 expands the scope of practice for a licensed cytotechnologist by authorizing the performance of all tests and procedures pertaining to cytology under the supervision of a laboratory director. Status: This bill is currently in the Senate Committee on Appropriations.

5. Arguments in Support. The sponsor, Grifols, Inc., writes, “Currently, the total protein refractometer test unit is categorized by federal CLIA as a ‘moderate complexity test.’ California law authorizes 17 different categories of health care personnel, subject to varying levels of independence or supervision, to conduct a moderate complexity test. This even includes ‘any person’ if supervised in a physician’s office. In fact, a total protein refractometer test can be administered in the overwhelming majority of states by an employee trained to federal standards. However, California law does not authorize this simple, almost entirely automated test to be conducted by a highly trained and supervised employee at a licensed plasma donation center, unless they are covered by the current roster of license categories….

AB 757 (a) allows a specially trained employee, (b) in the unique and limited setting of a plasma donation facility, (c) to operate a virtually automated test with the push of one button, (d) under an array of supervisory, licensed health care personnel - including the responsible physician and surgeon and/or other licensed facility manager. The end goal of this measure is to help our California Department of Public Health-licensed plasma donation centers operate more efficiently by authorizing a properly-trained employ to perform this simple task as part of the donor intake process, without diverting other employees from their primary occupations.”

Plasma Protein Therapeutics Association, Blood Centers of California, KEDPlasma LLC and Octapharma Plasma are in support of this bill because it will help their operations, as well.

6. Arguments in Opposition. The California Association for Medical Laboratory Technology, the professional association representing clinical laboratory scientists and other laboratory personnel in California, oppose AB 757, writing, “At issue are the safety of plasma donors and the competency of personnel who test them for donor eligibility.

“AB 757 would allow lesser trained and educated persons than currently permitted by law to perform a total protein refractometer analysis, categorized as a moderately complex test by the FDA, in a licensed plasma collection facility.

The primary function of the total protein analysis is to provide an accurate and precise value in order to ensure donor safety prior to donating plasma. An erroneously performed analysis, like a false negative result, which allows the plasma center to proceed with the donation, could cause significant donor harm. As a result, the regulatory agencies have mandated that the individuals performing the total protein test must have demonstrated a higher level of education and training such as those individuals listed in BPC section 1206.5 (b).”

“Plasma donors are paid. They can donate every two weeks if their total protein is at least 6 g/dL.  Many plasma collection centers “bleed” their donors down to 6 g/dL of protein regularly.  If the protein refractometer test and/or calibration is done incorrectly and the protein read is higher than it actually is, there is a potential to over ‘bleed’ a donor causing donor harm, such as death from untreated low protein, immune deficiency, heart and respiratory problems, bruising, insufficient blood clotting, muscle wasting and reduced energy. In short, the current personnel standard needs to be maintained.”

The California Society of Pathologists and Engineers & Scientists of California, IFPTE Local 20 also express concern about patient safety and quality control with lesser-trained individuals.

7. Policy Consideration. Although TPRT is classified as a moderate complexity test under CLIA, the sponsors argue that advances in technology have made the digital refractometer, an instrument that performs the test, so simple that it should be considered “waived.” Were it classified as such, the sponsors would have much more personnel latitude according to existing California law and likely would not need this bill. However, the FDA has not yet begun a reclassification process, though there is a pending request for it to do so.

Uncodified language from the 1995 bill that incorporated CLIA into California law declared Legislative intent “to sustain the integrity of California's laboratory standards, including its personnel standards, and that [any] changes in technology to increase the efficiency of health care delivery be accommodated when the providers of laboratory services utilizing technology remain competent to provide accurate, reliable, and necessary test results,”  SB 113 (Maddy, Chapter 510, Statutes of 1995.)

This bill may be viewed as either a request to make an exception to California’s higher standards for personnel performing moderate complexity tests or a premature move in advance of FDA reclassification to streamline operator requirements. The sponsors do not indicate a lack of sufficient personnel under current law, but rather express preference to better allocate skilled resources.

SUPPORT AND OPPOSITION:

Support:

Grifols, Inc. (Sponsor)

Blood Centers of California

KEDPlasma LLC

Octapharma Plasma, Inc.

Plasma Protein Therapeutics Association

Opposition:

California Association for Medical Laboratory Technology

California Society of Pathologists

Engineers & Scientists of California, IFPTE Local 20

-- END --

Date of Hearing: May 13, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

ABPCA Bill Id:AB 757

Author:(Gomez) – As Amended Ver:April 30, 2015

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill carves out a narrow exemption from rules governing which laboratory personnel can perform moderate complexity tests, to authorize a medical assistant who meets specified criteria to perform a total protein refractometer test analysis in a licensed plasma collection facility in this state.

FISCAL EFFECT:

Negligible state fiscal effect.

COMMENTS:

1. Purpose. The author states this bill will help promote efficiencies, where appropriate, in the biomedical industry while continuing to prioritize patient health and safety. He contends the test addressed in this bill is a standard, mostly automated procedure performed during donor intake and assessment to determine donor eligibility for plasma donation.

2. Background. Federal and state law jointly govern the provision of laboratory services, and California Department of Public Health regulates laboratories on behalf of the state and federal government. The statute Clinical Laboratory Improvement Amendments (CLIA), is the federal framework for laboratory oversight. Under federal CLIA, tests are classified as either waived, moderate-complexity, or high-complexity. Waived tests are simple and low-risk, while moderate- and high-complexity tests are subject to more stringent regulation. Existing law authorizes certain exceptions from normal rules governing which professionals can conduct certain tests. Medical assistants are not licensed, although they are supervised on-site by physicians and can be certified by private agencies approved by the Medical Board of California.

3. Support. According to Grifols, Inc., the sponsor of this measure, a total protein refractometer test can be administered in 48 states by a trained healthcare professional equivalent to what California defines as a medical assistant. The Blood Centers of California are also in support.

4. Opposition. California Association for Medical Laboratory Technology, California Society of Pathologists, and Engineers & Scientists of California, IFPTE Local 20 oppose this bill, arguing exemptions undermine test result integrity and protection for patients. They explain that although the test may be simple, calibration needs to be conducted by qualified personnel.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 28, 2015

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Susan Bonilla, Chair

ABPCA Bill Id:AB 757

Author:(Gomez) – As Amended Ver:March 26, 2015

SUBJECT: Healing arts: clinical laboratories.

SUMMARY: Authorizes a medical assistant, who meets specified criteria, to perform a total protein refractometer test analysis in a licensed plasma collection facility in this state.

EXISTING FEDERAL LAW:

1. Regulates laboratory testing and requires that clinical laboratories obtain a certificate before accepting materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or the impairment of, or assessment of the health of human beings. (Clinical Laboratory Improvement Amendments (CLIA), Title 42 United States Code (USC) § 263a)

2. Classifies laboratory tests using three categories: “waived tests,” “moderate complexity,” or “high complexity.” (Title 42 Code of Federal Regulations (CFR) § 493.5)

3. Defines “waived tests” as simple laboratory examinations and procedures which: 1) are cleared by Federal Food and Drug Administration (FDA) for home use; 2) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or 3) pose no reasonable risk of harm to the patient if the test is performed incorrectly. (42 CFR § 493.15)

4. Specifies nine types of tests that are automatically categorized as waived: 1) various dipstick or tablet reagent urinalysis (non-automated), including protein; 2) fecal occult blood; 3) ovulation tests—visual color comparison tests; 4) urine pregnancy tests—visual color comparison tests; 5) erythrocyte sedimentation rate-non-automated; 6) hemoglobin-copper sulfate—non-automated; 7) blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; 8) spun microhematocrit; and 9) hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. (42 CFR § 493.15)

5. Requires laboratories to ensure that each individual performing moderate complexity testing possesses a current license issued by the state where laboratory is located, if a license is required, and meet one of the following requirements: (42 CFR § 493.1423)

   1. Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution.

   2. Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution.

   3. Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).

   4. Have earned a high school diploma or equivalent, and have documentation of training appropriate for the testing performed prior to analyzing patient specimens.

6. Defines a refractometer as a device used to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions. (21 CFR § 862.2800(a))

EXISTING STATE LAW:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health (CDPH), with specified exceptions. (BPC § 1200-1327)

2. Prohibits a person from performing a test classified as of moderate complexity test under CLIA unless the test is performed under a laboratory director, as described in BPC § 1209, the laboratory director provides documentation of the adequacy of the qualifications and competency of the personnel, and the test is performed by any of the following individuals: (BPC § 1206.5)

   1. A licensed physician and surgeon;

   2. A licensed podiatrist or a licensed dentist;

   3. A person licensed to engage in clinical laboratory practice or to direct a clinical laboratory;

   4. A certified local health officer;

   5. A licensed physician assistant if authorized by a supervising physician and surgeon;

   6. A registered nurse;

   7. A perfusionist if authorized under BPC § 2590;

   8. A respiratory care practitioner;

   9. A person certified to perform nuclear medicine technology under CDPH;

   10. Any person if performing blood gas analysis in compliance with BPC § 1245;

   11. A certified or licensed emergency medical technician II or paramedic while providing prehospital medical care; and,

   12. A person licensed as a psychiatric technician, as a vocational nurse, or as a licensed midwife, or certified by the CDPH as a nurse assistant or a home health aide, who provides direct patient care, if the person meets the following:

       1. Is performing the test as an adjunct to the provision of direct patient care by the person;

       2. Is utilizing a point-of-care laboratory testing device at a site for which a laboratory license or registration has been issued;

       3. Meets the minimum clinical laboratory education, training, and experience requirements set forth in regulations adopted by the CDPH; and,

       4. Has demonstrated to the satisfaction of the laboratory director that the person is competent in the operation of the point-of-care laboratory testing device for each analyte to be reported.

   13. Any person within a physician office laboratory if the test is performed under the supervision of the patient’s physician and surgeon or podiatrist who is accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed, and meets the following:

       1. Ensures that the person is performing test methods as required for accurate and reliable tests; and

       2. Has personal knowledge of the results of the clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory.

   14. A pharmacist, if ordering drug therapy-related laboratory.

3. Authorizes a medical assistant to do the following: (BPC § 2069)

   1. Administer medication through intradermal, subcutaneous, or intramuscular injections; and,

   2. Perform skin tests and additional technical supportive services upon the specific authorization and supervision of a licensed physician and surgeon or a licensed podiatrist. A medical assistant may also perform all these tasks and services upon the specific authorization of a physician assistant, a nurse practitioner, or a certified nurse-midwife.

4. Defines a “medical assistant” as a person who may be unlicensed who meets the following: (BPC § 2029(b)(1))

   1. Performs basic administrative, clerical, and technical supportive services for a licensed physician and surgeon, a licensed podiatrist, a medical or podiatry corporation, a physician assistant, a nurse practitioner, or a certified nurse-midwife, or a health care service plan;

   2. At least 18 years of age; and,

   3. Has had at least the minimum amount of hours of appropriate training pursuant to standards established by the Medical Board.

5. Defines “specific authorization” as a specific written order or a standing order prepared by the supervising physician and surgeon, podiatrist, physician assistant, nurse practitioner, or certified nurse-midwife, authorizing the procedures to be performed on a patient. (BPC § 2069(b)(2))

6. Defines “supervision” as the supervision of procedures authorized by this section by the following practitioners, within the scope of their respective practices, who shall be physically present in the treatment facility during the performance of those procedures: (BPC § 2069(b)(3))

   1. A licensed physician and surgeon;

   2. A licensed podiatrist; and,

   3. A physician assistant, nurse practitioner, or certified nurse-midwife as provided in subdivision (a).

7. Defines “technical supportive services” as simple routine medical tasks and procedures that may be safely performed by a medical assistant who has limited training and who functions under the supervision of a licensed physician and surgeon, a licensed podiatrist, a physician assistant, a nurse practitioner, or a certified nurse-midwife. (BPC § 2069(b)(4))

THIS BILL:

1. Authorizes a medical assistant, as defined in BPC § 2069, to perform a total protein refractometer test analysis in a licensed plasma collection facility in this state if all of the following conditions are met:

   1. The medical assistant has earned a high school diploma or equivalent, as determined by Health Care Financing Administration (HCFA) under CLIA.

   2. The medical assistant performs the total protein refractometer test analysis in a licensed plasma collection facility.

   3. The medical assistant been instructed 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 in the proper procedure to be employed when performing a total protein refractometer test analysis.

   4. The medical assistant performs the total protein refractometer test analysis under the direction and supervision of the physician and surgeon or licensed clinical laboratory director.

   5. The medical assistant submits the analysis for interpretation to the physician and surgeon or licensed clinical laboratory director under whose direction and supervision he or she performed the analysis.

2. States that no reimbursement is required pursuant to Section 6 of Article XIII B of the California Constitution, as specified.

FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

1. Purpose. This bill is sponsored by Grifols, Inc. According to the author, “Plasma donation centers are critical to ensuring the availability of therapies that treat rate, chronic, and sometimes life-threatening diseases. AB 757 would authorize a medical assistant who meets specified criteria to perform a total protein refractometer test analysis – a standard, mostly automated procedure performed during donor intake and assessment to determine donor eligibility – in state licensed plasma collection facility in California. This will help promote efficiencies, where appropriate, in the biomedical industry while continuing to prioritize patient health and safety.”

2. Background. At the federal level, laboratories that perform tests on human specimens are certified under CLIA. The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether a test system is waived, moderate or high complexity for each. In general, the more complicated the test, the more stringent the requirements under CLIA.

As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result. They include certain tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria.

Tests not classified as waived are assigned a moderate or high complexity category on the basis of seven criteria given in the CLIA regulations. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.

In California, anyone may perform a waived test in a licensed laboratory. However, only licensed or certified individuals may perform moderate complexity tests, for instance, a medical laboratory technologist (MLT) under BPC § 1260.3. There is are two exceptions for unlicensed individuals to perform a moderate complexity test in California, and that is for a blood gas analysis under BPC § 1245 and anyone in a physician’s office laboratory with a physician readily available. Because medical assistants are unlicensed and there is no exception for them, they cannot perform moderate or high complexity tests.

Total Protein Refractometer Test. According to the sponsors, Grifols measures a potential plasma donor’s total protein levels as part of the initial screening process. In general, the measurement of total protein uses an instrument called a refractometer. A refractometer is a device that shines a beam of light through a sample of liquid. The device measures the amount of light that is refracted (bent) due to the solids in the sample. In blood, protein causes light to bend. The greater the amount of protein, the more light is bent from the light path.

There are multiple types of protein refractometer devices, ranging from manual to automatic and digital. However, the FDA’s medical device database shows that the FDA has classified all total protein refractometer devices as of moderate complexity under CLIA.

There are other types of devices that can measure total protein, such as chemical analyzers using whole blood. The FDA has classified most of the whole blood chemical analyzers as waived.

CLIA Waiver by Application. The sponsor points out that the type of refractometer device it uses to perform total protein tests is very simple to use and does not require special training. However, because the device is so simple to use, it is unclear why it was not classified as waived. Further, it is unclear why the manufacturer did not try to obtain a waiver by application. The sponsor believes that there was no financial incentive.

A manufacturer may submit a CLIA waiver by application if it thinks the FDA has mistakenly categorized the test. For example, if the FDA initially categorized a test as moderately complex, but the manufacturer believes the test is simple to use, it may submit a CLIA waiver by application to request re-categorization as waived.

A CLIA waiver by application must demonstrate in clinical studies conducted at the intended use sites that the test is accurate and poses little to no risk of incorrect results. It must also include the following information:

1. A description of the device that demonstrates it is simple to use.

2. The results of risk analysis including the identification of potential sources of error for your device.

3. The results of flex studies demonstrating insensitivity of the test system to environmental and usage variations under conditions of stress.

4. The results of risk evaluation and control including a description of (1) measures you have implemented to mitigate the risk of errors, and (2) validation and/or verification studies demonstrating the ability of failure alert, fail-safe mechanisms, and other control measures that you have incorporated into your device to mitigate the risk of errors, even under conditions of stress.

5. A description of the design and results of clinical studies you conducted to demonstrate that the device has an insignificant risk of erroneous results in the hands of the intended user (hereinafter operator).

6. Proposed labeling with instructions for use consistent with a device that is "simple."

ARGUMENTS IN SUPPORT:

Grifols, Inc. (sponsor) writes in support, “a total protein refractometer test can be administered in 48 states by a trained healthcare professional equivalent to what California defines as a medical assistant. However, California law does not authorize this simple, almost entirely automated test to be conducted by a highly trained and supervised medical assistant at a licensed plasma donation center.

AB 757 represents a minor expansion in the tasks authorized for medical assistants, especially given the unique setting, virtual automation of the subject test and the array of supervisory, licensed health care personnel in the plasma collection center - including the responsible physician and surgeon and/or other licensed 'facility' manager. The end goal of this measure is to help licensed plasma donation centers operate more efficiently by authorizing a medical assistant to conduct this simple task as part of the donor intake process.”

The Blood Centers of California writes in support, “The need for source plasmas - defined as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use is growing. Source plasma is used to develop plasma based medicines and therapies which are used to treat over eighty diseases.

Assuring that eligible, trained personnel are available for this growing segment of the blood industry is necessary. We support the designation of a "donor center processor' as the staff who can perform the" simple, automated total protein refractometer". AB 757 will assure that licensed plasma centers have the appropriate staff carrying out the necessary functions to obtain and process source plasma which is converted into life sustaining medicines and therapies.”

ARGUMENTS IN OPPOSITION:

The California Association for Medical Laboratory Technology writes in opposition, “The primary function of the total protein analysis is to provide an accurate and precise value in order to ensure donor safety prior to donating plasma. An erroneously performed analysis, like a false negative result, which allows the plasma center to proceed with the donation, could cause significant donor harm. As a result, the regulatory agencies have mandated that the individuals performing the total protein test must have demonstrated a higher level of education and training such as those individuals listed in BPC section 1206.5 (b).

Plasma donors are paid. They can donate every two weeks if their total protein is at least 6 g/dL. Many plasma collection centers “bleed” their donors down to 6 g/dL of protein regularly. If the protein refractometer test and/or calibration is done incorrectly and the protein read is higher than it actually is, there is a potential to over “bleed” a donor causing donor harm, such as death from untreated low protein, immune deficiency, heart and respiratory problems, bruising, insufficient blood clotting, muscle wasting and reduced energy. In short, the current personnel standard needs to be maintained.”

The California Society of Pathologists writes in opposition, “We believe that this type of legislation that would seek to carve out certain tests from the CLIA and state personnel requirements will only lessen the quality of testing… There are existing laboratory personnel who can perform this test. We believe maintaining that standard is preferable to undoing the existing test classification system that is universal to clinical laboratory practice. That system is designed to maintain test result integrity and protection for patients.”

The Engineers & Scientists of California, IFPTE Local 20, writes in opposition, “ESC, which represents Clinical Laboratory Scientists, strongly believes that having unlicensed, untrained individuals performing these tests, even if its moderate to low complexity, isn't good for patient safety. It's going backwards to a time before phlebotomy certification.”

POLICY ISSUES FOR CONSIDERATION:

This bill seeks to carve out a narrow personnel exception for a specific device that performs a moderately complex test on human blood. According to the sponsors, the device is used in the very initial screening process, and even if there was an error in the testing, the rest of the intake process will properly screen the individual.

However, there are other waived devices that the sponsor can use without having to make a special exception in law. The sponsor has stated that it is in process switching to a waived device.

AMENDMENTS:

1. Insert a three year sunset provision to provide the sponsor an opportunity to finish switching to a waived device.

On page 2, between lines 26-27, insert subdivision (b):

(b) This section shall remain in effect only until January 1, 2019, and as of that date is repealed.

2. Narrow the class of test to ensure that only the device the sponsor wants excluded is included in the bill:

On page 2, between lines 12-13, insert:

(2) He or she performs the total protein refractometer test analysis using an automatic, button-operated refractometer with a digital readout.

3. Make conforming changes:

On page 2, line 7, before “A” insert subdivision (a):

(a)

On page 2, line 11, strike out “(a)” and insert:

(1)

On page 2, line 13, strike out “(b)” and insert:

(3)

On page 2, line 15, strike out “(c)” and insert:

(4)

On page 2, line 20, strike out “(d)” and insert:

(5)

On page 2, line 23, strike out “e” and insert:

(6)

REGISTERED SUPPORT:

Grifols, Inc. (sponsor)

Blood Centers of California

REGISTERED OPPOSITION:

California Association for Medical Laboratory Technology

California Society of Pathologists

Engineers & Scientists of California, IFPTE Local 20

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301