Under existing law, the State Department of Public Health licenses, registers, and regulates clinical laboratories and various clinical laboratory personnel. Existing law prohibits a person from performing a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 unless the test or examination is performed under the overall operation and administration of a laboratory director and the test or examination is performed by any one of specified professionals and others, including a licensed physician and surgeon or pharmacist. Existing law establishes the Office of AIDS in the department and defines human immunodeficiency virus (HIV) as the etiologic agent of acquired immunodeficiency syndrome (AIDS). Existing law authorizes an HIV counselor who receives specified training and works in specified counseling and testing sites to perform HIV, hepatitis C virus (HCV), or combined HIV/HCV tests, including performing skin punctures for purposes of withdrawing blood for purposes of these tests, as specified.

This bill would authorize a hepatitis C counselor who meets specified requirements to perform an HCV test and to order and report HCV test results. The bill would authorize the State Department of Public Health to implement and administer these provisions by means of a bulletin or similar instructions. The bill would also add hepatitis C counselors performing an HCV test to the list of professionals authorized to perform a test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988, as specified.

Under existing law, the State Department of Public Health licenses, registers, and regulates clinical laboratories and various clinical laboratory personnel. Existing law prohibits a person from performing a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 unless the test or examination is performed under the overall operation and administration of a laboratory director and the test or examination is performed by any one of specified professionals and others, including a licensed physician and surgeon or pharmacist. Existing law establishes the Office of AIDS in the department and defines human immunodeficiency virus (HIV) as the etiologic agent of acquired immunodeficiency syndrome (AIDS). Existing law authorizes an HIV counselor who receives specified training and works in specified counseling and testing sites to perform HIV, hepatitis C virus (HCV), or combined HIV/HCV tests, including performing skin punctures for purposes of withdrawing blood for purposes of these tests, as specified.

This bill would authorize a hepatitis C counselor who receives specified training and works in described counseling and testing sites to perform HCV tests, and meets specified requirements to perform an HCV test and to order and report HCV test results. The bill would authorize the State Department of Public Health to implement and administer these provisions by means of a bulletin or similar instructions. The bill would also add hepatitis C counselors performing those tests to the specified professionals and others referred to above. an HCV test to the list of professionals authorized to perform a test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988, as specified.

Under existing law, the State Department of Public Health licenses, registers, and regulates clinical laboratories and various clinical laboratory personnel. Existing law prohibits a person from performing a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 unless the test or examination is performed under the overall operation and administration of a laboratory director and the test or examination is performed by any one of specified professionals and others, including a licensed physician and surgeon or pharmacist. Existing law establishes the Office of AIDS in the department and defines human immunodeficiency virus (HIV) as the etiologic agent of acquired immunodeficiency syndrome (AIDS). Existing law authorizes an HIV counselor who receives specified training and works in specified counseling and testing sites to perform HIV, hepatitis C virus (HCV), or combined HIV/HCV tests, including performing skin punctures for purposes of withdrawing blood for purposes of these tests, as specified.

This bill would authorize a hepatitis C counselor who receives specified training and works in described counseling and testing sites to perform HCV tests, and add hepatitis C counselors performing those tests to the specified professionals and others referred to above.

Under existing law, the State Department of Public Health licenses, registers, and regulates clinical laboratories and various clinical laboratory personnel. Existing law prohibits a person from performing a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 unless the test or examination is performed under the overall operation and administration of a laboratory director and the test or examination is performed by any one of specified professionals and others, including a licensed physician and surgeon or pharmacist. Existing law establishes the Office of AIDS in the State Department of Public Health department and defines human immunodeficiency virus (HIV) as the etiologic agent of acquired immunodeficiency syndrome (AIDS). Existing law authorizes an HIV counselor who receives specified training and works in specified counseling and testing sites to perform HIV, hepatitis C virus (HCV), or combined HIV/HCV tests, including performing skin punctures for purposes of withdrawing blood for purposes of these tests, as specified.

This bill would authorize a hepatitis C counselor who receives specified training and works in described counseling and testing sites to perform HCV tests. tests, and add hepatitis C counselors performing those tests to the specified professionals and others referred to above.

Existing law establishes the Office of AIDS in the State Department of Public Health and defines human immunodeficiency virus (HIV) as the etiologic agent of acquired immunodeficiency syndrome (AIDS). Existing law authorizes an HIV counselor who receives specified training and works in specified counseling and testing sites to perform HIV, hepatitis C virus (HCV), or combined HIV/HCV tests, including performing skin punctures for purposes of withdrawing blood for purposes of these tests, as specified.

This bill would authorize a hepatis C counselor, who meets specified requirements comparable to the requirements specified for an HIV counselor, to perform HCV tests in the manner described above with respect to HCV testing by an HIV counselor. hepatitis C counselor who receives specified training and works in described counseling and testing sites to perform HCV tests.

Existing law establishes the Office of AIDS in the State Department of Public Health and defines human immunodeficiency virus (HIV) as the etiologic agent of acquired immunodeficiency syndrome (AIDS). Existing law authorizes an HIV counselor who receives specified training and works in specified counseling and testing sites to perform HIV, hepatitis C virus (HCV), or combined HIV/HCV tests, including performing skin punctures for purposes of withdrawing blood for purposes of these tests, as specified.

This bill would authorize a hepatis C counselor, who meets specified requirements comparable to the requirements specified for an HIV counselor, to perform HCV tests in the manner described above with respect to HCV testing by an HIV counselor.

Existing law establishes the Office of AIDS in the State Department of Public Health and defines human immunodeficiency virus (HIV) as the etiologic agent of acquired immunodeficiency syndrome (AIDS). Existing law authorizes an HIV counselor who receives specified training and works in specified counseling and testing sites to perform HIV, hepatitis C virus (HCV), or combined HIV/HCV tests, including performing skin punctures for purposes of withdrawing blood for purposes of these tests, as specified.

This bill would authorize a hepatis C counselor, who meets specified requirements comparable to the requirements specified for an HIV counselor, to perform HCV tests in the manner described above with respect to HCV testing by an HIV counselor.

GOVERNOR'S VETO

GV Bill Id:AB 2179

Author:(Gipson)

As Enrolled Ver:August 31, 2016

2/3 vote

Original Committee Reference: B. & P.

SUMMARY: Authorizes a hepatitis C counselor, who meets specified training requirements and works in specified testing sites, to perform hepatitis C virus (HCV) tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Specifically, this bill:

1. Authorizes a hepatitis C counselor to perform a HCV test that is classified as waived under CLIA if the following conditions exist:
   1. The performance of the HCV test meets the requirements of CLIA and California's clinical laboratory requirements;
   2. The counselor i) is trained as a Human Immunodeficiency Virus (HIV) counselor to perform a HCV test or ii) is working in a HCV counseling and testing site that meets specified criteria;
   3. The HCV test is performed under the overall operation and administration of a laboratory director;
   4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional, more specific test, or, if approved by the Center for Disease Control and Prevention (CDC) for that purpose, a second, different rapid HCV test; and,
   5. If performing a skin punctures for the purpose of withdrawing blood for HCV testing, the counselor meets the following requirements:
      1. Works under the direction of a licensed physician and surgeon;
      2. Has specific authorization from a licensed physician and surgeon; and,
      3. Is trained to perform rapid test proficiency either for skin puncture blood tests or oral swab tests in universal infection control precautions, as specified.
2. Authorizes the counselor to order and report the results from the HCV tests performed to a patient without authorization from a licensed health care practitioner or the patient's authorized representative.
3. Requires the counselor to refer a patient who has an indeterminate or positive test result to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation.
4. Provides that a hepatitis C counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test, including those requiring certifications in phlebotomy.

The Senate amendments delete the requirement that a HCV counselor must also be trained in HIV testing and made technical and clarifying changes.

FISCAL EFFECT: According to the Senate Appropriations Committee:

1. One-time costs of about $150,000 for the development and adoption of regulations by the Department of Health Care Services.
2. Minor ongoing costs to train hepatitis C counselors and provide technical assistance to local health jurisdictions.
3. Unknown additional costs to the Medi-Cal program to provide treatment for newly diagnosed hepatitis C cases. By making it easier for hepatitis C counselors working in certain situations to perform hepatitis C tests, the bill is likely to result in additional testing and additional diagnoses of hepatitis C. For those individuals who are eligible for Medi-Cal, there would likely be increased costs to provide treatment for newly diagnosed hepatitis C cases. The costs to provide such treatment are unknown and would depend on the number of new diagnoses amongst the Medi-Cal population. New hepatitis C drugs on the market have very high upfront costs (in the tens of thousands per course of treatment), but are very effective at curing hepatitis C. In the long-run, early diagnosis and treatment for some patients, may actually save money. However, a very low percentage of hepatitis C patients will ever receive a costly liver transplant. Therefore, it is not known whether widespread use of these very expensive drugs will actually save money for the Medi-Cal program in the long-run.

COMMENTS:

Purpose. This bill is sponsored by Project Inform. According to the author, "The unchecked spread of HCV threatens the public health and economic welfare of California. It is necessary that California reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. [This bill] will give local health departments greater flexibility to respond to HCV in their communities and reduce costs related to training non-medical personnel to administer the rapid test."

Background. Hepatitis means inflammation of the liver. Hepatitis C is an infection of the liver caused by HCV, one of several contagious viruses that can cause hepatitis. HCV is spread by blood-to-blood contact and common ways people become infected are through needle sharing, inadequate sterilization of medical equipment, and unscreened blood transfusions.

The CDC estimates that there are 3.5 million people in the United States have chronic HCV infection. Between 1994 and 2011, the California Department of Public Health (CDPH) had received 501,664 newly reported chronic HCV cases in California. As a result, the World Health Organization, the CDC, and the CDPH suggest policies that promote prevention and education among high-risk populations. This bill seeks to do so by authorizing HCV counselors to perform a HCV screening test if it is classified as waived under CLIA. The author states that doing so will increase access to HCV counselors, who will promote prevention by providing screening and education services at a community level.

Federal and State Laboratory Requirements. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services (CMS). The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. The three complexities are waived, moderate, and high complexity. In general, the more complicated the test, the more stringent the requirements under CLIA. Waived tests are simple, consumer-level tests with a low risk for an incorrect result. However, California law only allows specified personnel to perform waived tests on others.

HIV and HCV Counselors. Existing law allows HIV counselors to perform HIV, HCV, and combination HIV/HCV tests as long as the tests are classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and CDPH approval, and the HIV counselor has attended a Counseling and Testing (C&T) training specific to each type of test.

Currently, the OA either establishes or approves federally-funded HIV C&T training programs for a local health jurisdiction's (LHJ) HIV counselors. However, not all LHJs are able to access the trainings. Access to the trainings is determined by incidence of HIV, but some LHJs have a high incidence of HCV but not a high incidence of HIV. The LHJs that cannot meet the HIV thresholds must pay for the trainings.

The sponsor notes that having to pay out of pocket for the C&T training means that if the LHJ does not have the funds or the offered training is full, its counselors will not be able to provide necessary HCV testing and screenings. This bill seeks to remedy this issue by establishing training and workplace pathways for HCV counselors.

GOVERNOR'S VETO MESSAGE:

I am returning Assembly Bill 2179 without my signature.

This bill creates a hepatitis C counselor classification allowing a person who is trained to perform hepatitis C virus rapid tests to do so.

The Department of Public Health works with local health agencies to train HIV counselors who test for both HIV and hepatitis C. National health guidelines recommend people at risk for either of these diseases be tested for both. As such, I believe the existing counselor classification is more protective of public health.

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0005087

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2179

Author:(Gipson)

As Amended Ver:August 16, 2016

Majority vote

Original Committee Reference: B. & P.

SUMMARY: Authorizes a hepatitis C counselor, who meets specified training requirements and works in specified testing sites, to perform hepatitis C virus (HCV) tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Specifically, this bill:

1. Authorizes a hepatitis C counselor to perform a HCV test that is classified as waived under CLIA if the following conditions exist:
   1. The performance of the HCV test meets the requirements of CLIA and California's clinical laboratory requirements;
   2. The counselor 1) is trained as a Human Immunodeficiency Virus (HIV) counselor to perform a HCV test or 2) is working in a HCV counseling and testing site that meets specified criteria;
   3. The HCV test is performed under the overall operation and administration of a laboratory director;
   4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional, more specific test, or, if approved by the Center for Disease Control and Prevention (CDC) for that purpose, a second, different rapid HCV test; and,
   5. If performing a skin punctures for the purpose of withdrawing blood for HCV testing, the counselor meets the following requirements:
      1. Works under the direction of a licensed physician and surgeon;
      2. Has specific authorization from a licensed physician and surgeon; and,
      3. Is trained to perform rapid test proficiency either for skin puncture blood tests or oral swab tests in universal infection control precautions, as specified.
2. Authorizes the counselor to order and report the results from the HCV tests performed to a patient without authorization from a licensed health care practitioner or the patient's authorized representative.
3. Requires the counselor to refer a patient who has an indeterminate or positive test result to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation.
4. Provides that a hepatitis C counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test, including those requiring certifications in phlebotomy.

The Senate amendments delete the requirement that a HCV counselor must also be trained in HIV testing and made technical and clarifying changes.

FISCAL EFFECT: According to the Senate Appropriations Committee:

1. One-time costs of about $150,000 for the development and adoption of regulations by the Department of Health Care Services.
2. Minor ongoing costs to train hepatitis C counselors and provide technical assistance to local health jurisdictions.
3. Unknown additional costs to the Medi-Cal program to provide treatment for newly diagnosed hepatitis C cases. By making it easier for hepatitis C counselors working in certain situations to perform hepatitis C tests, the bill is likely to result in additional testing and additional diagnoses of hepatitis C. For those individuals who are eligible for Medi-Cal, there would likely be increased costs to provide treatment for newly diagnosed hepatitis C cases. The costs to provide such treatment are unknown and would depend on the number of new diagnoses amongst the Medi-Cal population. New hepatitis C drugs on the market have very high upfront costs (in the tens of thousands per course of treatment), but are very effective at curing hepatitis C. In the long-run, early diagnosis and treatment for some patients, may actually save money. However, a very low percentage of hepatitis C patients will ever receive a costly liver transplant. Therefore, it is not known whether widespread use of these very expensive drugs will actually save money for the Medi-Cal program in the long-run.

COMMENTS:

Purpose. This bill is sponsored by Project Inform. According to the author, "The unchecked spread of HCV threatens the public health and economic welfare of California. It is necessary that California reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. [This bill] will give local health departments greater flexibility to respond to HCV in their communities and reduce costs related to training non-medical personnel to administer the rapid test."

Background. Hepatitis means inflammation of the liver. Hepatitis C is an infection of the liver caused by HCV, one of several contagious viruses that can cause hepatitis. HCV is spread by blood-to-blood contact and common ways people become infected are through needle sharing, inadequate sterilization of medical equipment, and unscreened blood transfusions.

The CDC estimates that there are 3.5 million people in the United States have chronic HCV infection. Between 1994 and 2011, the CDPH had received 501,664 newly reported chronic HCV cases in California. As a result, the World Health Organization, the CDC, and the CDPH suggest policies that promote prevention and education among high-risk populations. This bill seeks to do so by authorizing HCV counselors to perform a HCV screening test if it is classified as waived under CLIA. The author states that doing so will increase access to HCV counselors, who will promote prevention by providing screening and education services at a community level.

Federal and State Laboratory Requirements. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services (CMS). The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. The three complexities are waived, moderate, and high complexity. In general, the more complicated the test, the more stringent the requirements under CLIA. Waived tests are simple, consumer-level tests with a low risk for an incorrect result. However, California law only allows specified personnel to perform waived tests on others.

HIV and HCV Counselors. Existing law allows HIV counselors to perform HIV, HCV, and combination HIV/HCV tests as long as the tests are classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and CDPH approval, and the HIV counselor has attended a Counseling and Testing (C&T) training specific to each type of test.

Currently, the OA either establishes or approves federally-funded HIV C&T training programs for a local health jurisdiction's(LHJ) HIV counselors. However, not all LHJs are able to access the trainings. Access to the trainings is determined by incidence of HIV, but some LHJs have a high incidence of HCV but not a high incidence of HIV. The LHJs that cannot meet the HIV thresholds must pay for the trainings.

The sponsor notes that having to pay out of pocket for the C&T training means that if the LHJ does not have the funds or the offered training is full, its counselors will not be able to provide necessary HCV testing and screenings. This bill seeks to remedy this issue by establishing training and workplace pathways for HCV counselors.

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0004748

 THIRD READING  

Bill No: AB 2179

Author:

:

Vote:

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 6/20/16

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

SENATE HEALTH COMMITTEE: 8-0, 6/29/16

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth

NO VOTE RECORDED: Wolk

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16

AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen

ASSEMBLY FLOOR: 80-0, 5/31/16 - See last page for vote

SUBJECT:

SOURCE: Project Inform

DIGEST: This bill authorizes a hepatitis C counselor to perform any hepatitis C virus (HCV) test that is classified as waived under the federal Clinical Laboratory Improvement Act (CLIA), as specified.

ANALYSIS:

Existing 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. Requires an individual who draws blood to be certified by the DPH as a certified phlebotomy technician. (BPC § 1246)
3. Authorizes an HIV counselor who meets specified requirements to perform any HIV, HCV, or combination HIV/HCV test that is classified as waived under CLIA as specified, and is authorized to perform skin punctures for the purpose of withdrawing blood for a test without being certified as a phlebotomy technician or a limited phlebotomy technician. (Health & Safety Code § 120917)
4. 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)
5. Classifies laboratory tests using three categories: “waived,” “moderate complexity,” or “high complexity.” (42 CFR § 493.5)
6. Requires tests for certificate of waiver to be simple laboratory examinations and procedures which:
   1. Are cleared by 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)

This bill:

1. Authorizes a hepatitis C counselor to perform a HCV test under the overall operation and administration of a laboratory director, as specified.
2. Requires a hepatitis C counselor to meet one of the following criteria:
   1. Is authorized to perform an HCV test as a HIV counselor, as specified.
   2. Is working in a hepatitis C counseling and testing site that meets both of the following criteria:
      1. Utilizes hepatitis C counselors who are trained by DPH or its agents to provide testing and hepatitis C counseling and testing. States that a training agent may include, but is not limited to, a local health department or its designee, an academic medical center, or a community-based organization.
      2. Has and retains a quality assurance plan and has hepatitis C counseling and testing staff who comply with the quality assurance protocols and guidelines made available by DPH, as specified.
3. Authorizes a hepatitis C counselor to do all of the following:
   1. Perform any HCV test that is classified as waived under CLIA if all of the following conditions exist:
      1. The performance of the HCV test meets the requirements of state and federal law regarding clinical labs.
      2. Perform skin punctures for the purpose of withdrawing blood for waived HCV testing without a certificate as a certified phlebotomy technician, upon specific authorization from a licensed physician and surgeon, provided that the person meets both of the following requirements:
         1. He or she works under the direction of a licensed physician and surgeon.
         2. He or she has been trained in rapid test proficiency for skin puncture blood tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health in the Department of Industrial Relations and the federal Centers for Disease Control and Prevention (CDC).
      3. The person performing the HCV test meets the requirements for the performance of waived laboratory testing, as specified.
      4. The patient is informed that the preliminary result of the HCV test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the federal CDC for that purpose, a second, different rapid HCV test. This does not allow a hepatitis C counselor to perform any HCV test that is not classified as waived under CLIA.
   2. Order and report HCV test results to patients without authorization from a licensed health care practitioner or his or her authorized representative. A patient who has an indeterminate or positive test result shall be referred to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation.
4. Prohibits a hepatitis C counselor who meets the requirements of this section from performing any other test unless that person meets the statutory and regulatory requirements for performing that other test.
5. States that compliance with this bill does not fulfill any requirements for certification as a phlebotomy technician or a limited phlebotomy technician, unless the hepatitis C counselor has otherwise satisfied the certification requirements.

Background

Hepatitis C. Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with HCV, which is spread primarily through contact with the blood of an infected person. While infection rates are high among baby boomers who were exposed to the virus prior to effective blood screenings, most individuals become infected currently by sharing injection equipment.

Hepatitis C’s effects can be mitigated through early detection and treatment, which can also reduce new infections. This is especially important in California, as the CDC reports that between 2009 and 2013, reported rates of acute hepatitis C increased by 100 percent in this state.

HIV Counselors. Existing law allows HIV counselors to perform HIV, HCV, and combination HIV/HCV tests that are classified, as waived under CLIA, if the facility or clinic has obtained a certificate of waiver from Center for Medicaid Services and DPH approval, and the HIV counselor has attended trainings specific to each type of test. Currently, the Office of AIDS (OA) establishes or approves a local healthcare jurisdiction’s (LHJ’s) HIV Counseling and Testing training programs, which are conducted by community-based, non-profit HIV organizations for HIV testing. However, not all LHJs are able to access the trainings.

According to the Office of AIDS Integrated HIV Surveillance, Prevention, and Care Plan, budget cuts during fiscal year 2009-10 reduced the OA’s funding for many of its AIDS programs. Since 2012, the majority of the OA’s HIV prevention activities have been funded solely through a five-year funding opportunity from the CDC. The program established three funding areas in California: Los Angeles and San Francisco Metropolitan Statistical Areas and the California Project Area (CPA). The CPA includes a limited number of local health jurisdictions that have demonstrated a high incidence of HIV. Local health jurisdictions within the CPA receive counseling and testing training as a part of the CDC’s program, but the remaining local health jurisdictions must pay for the counseling and testing training out of their own funds, and spaces within those trainings are limited.

AB 2179’s sponsor and supporters note that having to pay out of pocket for the counseling and testing training is a burden for the local health jurisdictions that have not met the HIV-incidence thresholds but may still have a high incidence of HCV. Currently, the counselors working in local health jurisdictions outside of the CPA cannot attend the HCV counseling and testing training without attending the HIV counseling and testing training. If the LHJ does not have the funds or the offered training is full, the counselor will be unable to provide HCV testing and screening at the testing site. This bill seeks to remedy this situation by expanding the entities allowed to train hepatitis C counselors separately from HIV counseling and establishing parameters for hepatitis C testing and practice.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

According to the Senate Appropriations Committee:

• Minor ongoing costs to train hepatitis C counselors and provide technical assistance to local health jurisdictions (General Fund).
• Unknown additional costs to the Medi-Cal program to provide treatment for newly diagnosed hepatitis C cases (General Fund and federal funds). By making it easier for hepatitis C counselors working in certain situations to perform hepatitis C tests, the bill is likely to result in additional testing and additional diagnoses of hepatitis C. For those individuals who are eligible for Medi-Cal, there would likely be increased costs to provide treatment for newly diagnosed hepatitis C cases. The costs to provide such treatment are unknown and would depend on the number of new diagnoses amongst the Medi-Cal population. New hepatitis C drugs on the market have very high upfront costs (in the tens of thousands per course of treatment), but are very effective at curing hepatitis C. In the long-run, early diagnosis and treatment for some patients, may actually save money. However, a very low percentage of hepatitis C patients will ever receive a costly liver transplant. Therefore, it is not known whether widespread use of these very expensive drugs will actually save money for the Medi-Cal program in the long-run.

SUPPORT: (Verified 8/15/16)

Project Inform (source)

Access Support Network

AIDS Community Research Consortium

Asian Pacific Health Foundation

Bay Area Black Nurses Association

California Black Health Network

California Chronic Care Coalition

California Hepatitis Alliance

California Life Sciences Association

Comprehensive Opiate Recovery Experience Medical Clinic, Inc.

Desert AIDS Project

Drug Policy Alliance

Harm Reduction Coalition

Health Officers Association of California

HIV Education and Prevention Project of Alameda County

Mendocino County AIDs/Viral Hepatitis Network

Sacramento Area Task Force for the Outreach and Prevention of Hepatitis

San Francisco Hepatitis C Task Force

The Wall Las Memorias Project

One individual

OPPOSITION: (Verified 8/15/16)

None received

ARGUMENTS IN SUPPORT: Project Inform writes, “California must reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic.”

ASSEMBLY FLOOR: 80-0, 5/31/16

AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, 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, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon

Prepared by:

8/17/16 9:19:41

**** END ****

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 2179 (Gipson) - Hepatitis C testing

*********** ANALYSIS ADDENDUM – SUSPENSE FILE ***********

The following information is revised to reflect amendments

adopted by the committee on August 11, 2016

Bill Summary:

AB 2179 would authorize a hepatitis C counselor who meets specific requirements to perform certain hepatitis C tests.

Fiscal Impact:

• One-time costs of about $150,000 for the development and adoption of regulations by the Department of Health Care Services (General Fund).
• Minor ongoing costs to train hepatitis C counselors and provide technical assistance to local health jurisdictions (General Fund).
• Unknown additional costs to the Medi-Cal program to provide treatment for newly diagnosed hepatitis C cases (General Fund and federal funds). By making it easier for hepatitis C counselors working in certain situations to perform hepatitis C tests, the bill is likely to result in additional testing and additional diagnoses of hepatitis C. For those individuals who are eligible for Medi-Cal, there would likely be increased costs to provide treatment for newly diagnosed hepatitis C cases. The costs to provide such treatment are unknown and would depend on the number of new diagnoses amongst the Medi-Cal population. New hepatitis C drugs on the market have very high upfront costs (in the tens of thousands per course of treatment), but are very effective at curing hepatitis C. In the long-run, early diagnosis and treatment for some patients, may actually save money. However, a very low percentage of hepatitis C patients will ever receive a costly liver transplant. Therefore, it is not known whether widespread use of these very expensive drugs will actually save money for the Medi-Cal program in the long-run.

Author Amendments:

Simplify the requirements for hepatitis C counselors.

-- END --

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 2179 (Gipson) - Hepatitis C testing

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

AB 2179 would authorize a hepatitis C counsellor who meets specific requirements to perform certain hepatitis C tests.

Fiscal Impact:

• One-time costs of about $150,000 for the development and adoption of regulations by the Department of Health Care Services (General Fund).
• Ongoing costs of about $500,000 per year to develop training curricula, train hepatitis C counselors, and provide technical assistance to local health jurisdictions (General Fund).
• Unknown additional costs to the Medi-Cal program to provide treatment for newly diagnosed hepatitis C cases (General Fund and federal funds). By making it easier for hepatitis C counsellors working in certain situations to perform hepatitis C tests, the bill is likely to result in additional testing and additional diagnoses of hepatitis C. For those individuals who are eligible for Medi-Cal, there would likely be increased costs to provide treatment for newly diagnosed hepatitis C cases. The costs to provide such treatment are unknown and would depend on the number of new diagnoses amongst the Medi-Cal population. New hepatitis C drugs on the market have very high upfront costs (in the tens of thousands per course of treatment), but are very effective at curing hepatitis C. In the long-run, early diagnosis and treatment for some patients, may actually save money. However, a very low percentage of hepatitis C patients will ever receive a costly liver transplant. Therefore, it is not known whether widespread use of these very expensive drugs will actually save money for the Medi-Cal program in the long-run.

Background:

Under current federal and state law, clinical laboratory tests are classified by their complexity. The level of clinical complexity determines the qualifications needed to perform those laboratory tests. The least complex laboratory tests are referred to as “waived”. Under current state law, HIV counsellors are authorized to perform HIV, hepatitis C, or a combined test that is categorized as “waived” provided that specified conditions are met.

Proposed Law:

AB 2179 would authorize a hepatitis C counsellor who meets specific requirements to perform certain hepatitis C tests.

Specific provisions of the bill would:

• Require hepatitis C counselors to meet specified criteria – such as having been trained by the Department of Public Health, working in an HIV counselling and testing site, or work at a site approved by a local health jurisdiction to provide hepatitis C testing and counselling;
• Permit hepatitis C counsellors who meet one of the above criteria to perform hepatitis C tests that are waived, if certain conditions are met;
• Impose other restrictions on hepatitis C counsellors acting under the authority of the bill.

Staff Comments:

The bill does not specifically require the Department of Public Health to develop a training curriculum or train hepatitis C counsellors. However, the Department indicates that it anticipates a demand for such training.

The supporters of the bill indicate that there is unmet demand for hepatitis C screening, particularly in the rural areas of the state where there is not the same level of HIV-related public health infrastructure.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 2179

SUBJECT: Hepatitis C testing

SUMMARY:

Authorizes a hepatitis C counselor who meets specific requirements to perform any hepatitis C virus (HCV) test that is classified as waived under the federal Clinical Laboratory Improvement Act.

Existing federal law:

1. Defines “laboratory” or “clinical laboratory” (lab or clinical lab) as a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment or health assessment of human beings.
2. Requires labs to obtain a certificate, meet quality standards, and undergo inspections, among other things, before accepting materials derived from the human body. Exempts laboratories with a certificate of waiver from the Clinical Laboratory Improvement Amendments (CLIA), provided that the laboratory follows the manufacturer’s instructions.
3. Provides that a lab is eligible for a certificate of waiver if it only performs “waived tests,” which are simple examinations and procedures that:
   1. Have been approved by the Food and Drug Administration (FDA) for home use;
   2. The FDA has determined are so simple and accurate that there is a negligible chance of erroneous results; or,
   3. Pose no unreasonable risk of harm to the patient if performed incorrectly.
4. Authorizes a state to enact and enforce laws relating to CLIA to the extent that the state laws are not inconsistent with the CLIA laws and regulations.

Existing state law:

1. Provides for the licensure, registration, and regulation of clinical labs and various clinical lab personnel by the Department of Public Health (DPH).
2. Prohibits a person from performing a clinical lab test or examination classified as waived under CLIA unless the clinical lab test or examination is performed under the overall operation and administration of the lab director, as specified, and the test is performed by one the following persons if within the person’s scope of practice:
   1. A licensed physician and surgeon holding a M.D. or D.O. degree;
   2. A licensed podiatrist, a licensed dentist, or a licensed naturopathic doctor;
   3. A person licensed in California to engage in clinical laboratory practice or to direct a clinical laboratory;
   4. A person authorized by a local health laboratory to perform tests pursuant to a certificate issued by the DPH;
   5. A licensed physician assistant;
   6. A licensed nurse;
   7. A licensed vocational nurse;
   8. A certified perfusionist (a specialized healthcare professional who uses the heart-lung machine during cardiac surgery and other surgeries that require cardiopulmonary bypass to manage the patient's physiological status);
   9. A licensed respiratory care practitioner;
   10. A medical assistant;
   11. A pharmacist;
   12. A naturopathic assistant;
   13. A licensed optometrist;
   14. Other health care personnel providing direct patient care; or,
   15. Any other person performing non-diagnostic testing.
3. Establishes the Office of AIDS (OA) within DPH as the lead agency within the state, responsible for coordinating state programs, services, and activities relating to HIV/AIDS, and AIDS-related conditions (ARC).
4. Requires DPH to authorize the establishment of training programs throughout the state for counselors for publicly funded HIV testing programs.
5. Permits a HIV counselor to perform a HIV, HCV, or combination HIV/HCV test that is classified as waived under CLIA if the following conditions exist:
   1. The performance of the HIV, HCV, or combination HIV/HCV test meets the requirements of CLIA and the California clinical lab requirements.
   2. The HIV counselor meets one of the following criteria:
      1. Is trained by the OA and working in a HIV counseling and testing site funded by the DPH through a local health jurisdiction, or its agents;
      2. Is working in a HIV counseling and testing site that utilizes HIV counseling staff who are trained by the OA or its agents; or, has a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by DPH.
   3. The HIV, HCV, or combination HIV/HCV test is performed under the overall operation and administration of a lab director;
   4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HIV infection or HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the federal Centers for Disease Control and Prevention (CDC) for that purpose, a second different rapid HIV, HCV, or combination HIV/HCV test; and,
   5. If performing skin punctures for the purpose of withdrawing blood for HIV, HCV, or combination HIV/HCV testing, the counselor must:
      1. Work under the direction of a licensed physician and surgeon;
      2. Have specific authorization from a licensed physician and surgeon; and,
      3. Be trained in both rapid HIV, HCV, or combination HIV/HCV test proficiency for skin puncture blood tests and oral swab tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health (DOSH) in the Department of Industrial Relations (DIR) and the CDC.
6. Permits a HIV counselor to order and report the results from the HIV, HCV, or combination HIV/HCV test to a patient without authorization from a licensed health care professional or the patient’s authorized representative.
7. Requires patients with indeterminate or positive results from the HIV, HCV, or combination HIV/HCV test be referred to a licensed health care provider whose scope of practice includes the authority to refer patients for laboratory testing for further evaluation.
8. Provides that a HIV counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test.

This bill:

1. Requires HCV counselors to meet one of the following criteria:
   1. Be trained by the OA and work in a HIV counseling and testing site funded by DPH through a LHJ, or its agents.
   2. Work in a HIV counseling and testing site that:
   3. Utilize HIV counseling staff who are trained by OA or its agents to provide both HIV counseling and testing and hepatitis C counseling and testing;
   4. Have and retain a quality assurance plan approved by the local health department (LHD) in the jurisdiction where the site is located and have HIV counseling and testing staff who comply with the quality assurance requirements as specified by DPH; and,
   5. Work at a site approved by the LHD to provide HCV rapid testing and counseling, and has been trained using a curriculum approved by the LHD, and retained by the site, or approved by DPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of HCV rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of HCV transmission.
2. Permits HCV counselors who meet these requirements to:
   1. Perform any HCV test that is classified as waived under CLIA if:
      1. The performance of the HCV test meets the requirements of CLIA and state law.
      2. In the case of performing skin punctures for the purpose of withdrawing blood for waived HCV testing, specific authorization from a licensed physician is obtained and the person:
         1. Works under the direction of a licensed physician and surgeon.
         2. Has been trained in rapid test proficiency for skin puncture blood tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health in the Department of Industrial Relations and the CDC.
      3. The person performing the HCV test meets the requirements for the performance of waived laboratory testing pursuant to existing state law 2) above.
      4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the CDC for that purpose, a second, different rapid HCV test.
   2. Order and report HCV test results from tests to patients without authorization from a licensed health care practitioner or his or her authorized representative. Requires a patient who has an indeterminate or positive test result to be referred to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation.
3. Prohibits a HIV counselor who meets the requirements of this bill with respect to performing any CLIA-waived HCV from performing any other test unless that person meets the statutory and regulatory requirements for performing that other test.
4. Specifies that compliance with this bill does not fulfill any requirements for certification as a phlebotomy technician or a limited phlebotomy technician, unless the HCV counselor has otherwise satisfied the certification requirements imposed pursuant to existing state law.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, uncertain, potential cost pressure to the DPH. This bill does not place direct requirements on the department, but is intended to allow local health jurisdictions (LHJs) flexibility to approve and implemented their own training programs. However, DPH indicates cost pressure in the hundreds of thousands of dollars to promulgate and implement regulations, provide technical assistance, and review, approve, and potentially implement Hepatitis C counselor trainings.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, the hepatitis C virus (HCV) is a communicable disease that is spread by blood-to-blood contact. If untreated, HCV can lead to liver cancer, liver disease, cirrhosis, and death. Early detection reduces the likelihood of disease progression, reduces costs of treatment, and prevents new infections in the community. It is necessary that California reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. AB 2179 would allow local health jurisdictions (LHJs) as well as CDPH, to certify training standards for hepatitis C test counselors to administer low-risk, easy-to-use, finger-stick rapid tests that meet the standards for “waiver” under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). The bill would remove the prerequisite that personnel be trained to administer an HIV rapid test before be trained to administer the hepatitis C rapid test. Only persons working in sites authorized by LHJs to offer HCV rapid testing would be allowed to administer CLIA-compliant tests.

Background. According to DPH, hepatitis C is a liver disease caused by HCV and usually spread through blood. People can become infected through sharing needles, needle-stick injuries in health care settings, or being born to a mother who has hepatitis C. Less commonly, a person can also get HCV infection through sharing personal care items that may have come in contact with another person’s blood (like razors or toothbrushes), or having sexual contact with a person infected with the virus. Hepatitis C can be either “acute” or “chronic,” and can range in severity from a mild illness lasting a few weeks to a lifelong illness. According to the CDC, millions of Americans have hepatitis C, but most don’t know it, because people often have no symptoms and can live with an infection for decades without SB 1303 | Page 3 feeling sick. About 80 percent who have HCV infection develop a chronic, or lifelong, infection. Hepatitis C is a leading cause of liver cancer and the leading cause of liver transplants. According to data from 1999 to 2008, about three-fourths of U.S. patients with HCV infection were born between 1945 and 1965. The most important risk factor for HCV infection is past or current IDU, with most studies reporting a prevalence of 50 percent or more. The incidence of HCV infection was more than 200,000 cases per year in the 1980s but decreased to 25,000 cases per year by 2001. According to the CDC, there were an estimated 16,000 new cases of HCV infection in 2009 and an estimated 15,000 deaths in 2007. 

USPSTF recommendations. Released in June 2013, the USPSTF recommendations for HCV infection screening apply to all asymptomatic adults without known liver disease or functional abnormalities. Persons born between 1945 and 1965 are more likely to be diagnosed with HCV infection, possibly because they received blood transfusions before the introduction of screening in 1992 or have a history of other risk factors for exposure decades earlier. The recommendations state that a risk-based approach may miss detection of a substantial proportion of HCV-infected persons in the birth cohort because of a lack of patient disclosure or knowledge about prior risk status. As a result, one-time screening for HCV infection in the birth cohort may identify infected patients at earlier stages of disease who could benefit from treatment before developing complications from liver damage. ​

Federal and state lab requirements. Under the federal CLIA law, labs that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services (CMS). The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. The three complexities are waived, moderate, and high complexity. 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. Waived tests include 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. In order for the FDA to approve a test device as waived, the manufacturer must show that the test is accurate and consistent when performed by untrained individuals. This includes performing studies conducted using participants without laboratory training, no prior experience of the test, and no verbal instruction. The study participants must be able to generate accurate results using only the product label and included instructions.

Because waived tests are essentially consumer-level products, facilities that use only waived tests are eligible for a certificate of waiver. Those with a certificate of waiver are not subject to the CLIA requirements as long as the tests are performed according to the manufacturer’s instructions. However, CLIA still requires that all laboratories meet individual state personnel license requirements.

Under California law, all laboratory tests classified under CLIA must be performed by personnel specified in statute under the overall operation and administration of a laboratory director, with limited exceptions. As of 2014, California is one of 15 other states that regulate laboratories in addition to the CLIA standards.

HIV and HCV counselors. Existing law allows HIV counselors to perform a HIV, HCV, and combination HIV/HCV test as long as it is classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and DPH approval, and the HIV counselor has attended trainings specific to each type of test. Currently, the OA establishes or approves a local health jurisdiction’s (LHJ’s) HIV Counseling and Testing (C&T) training programs, which are conducted by community-based, non-profit HIV organizations for HIV testing. However, not all LHJs are able to access the trainings.

According to the OA’s Integrated HIV Surveillance, Prevention, and Care Plan (Integrated Plan), budget cuts during fiscal year 2009-10 reduced the OA’s funding for many of its AIDS programs. Since 2012, the majority of the OA’s HIV prevention activities have been funded solely through a five-year funding opportunity from the CDC. The program established three funding areas in California: the Los Angeles and San Francisco Metropolitan Statistical Areas (which receive funds directly from the CDC), and the California Project Area (CPA). The CPA includes a limited number of LHJs that have demonstrated a high incidence of HIV. LHJs within the CPA receive the C&T training as a part of the CDC’s program, but the remaining LHJs must pay for the C&T training out of their own funds and spaces within the C&T trainings are limited.

The sponsor notes that having to pay out of pocket for the C&T training burdens the LHJs that have not met the HIV-incidence thresholds but may still have a high incidence of HCV. Currently, the counselors working in LHJs outside of the CPA cannot attend the HCV C&T training without attending the HIV C&T training. If the LHJ does not have the funds or the offered training is full, the counselor will be unable to provide HCV testing and screening at the testing site. This bill seeks to remedy this issue in two ways: 1) authorizing a LHJ to approve a HCV C&T training program and 2) authorizing a HCV counselor who works at a testing site approved by the LHJ to perform a CLIA-waived HCV test after attending the training program.

Double referral. This bill was heard in the Senate Business and Professions Committee on June 21, 2016, and passed with a 9-0 vote.

Previous legislation. AB 761(Roger Hernández, Chapter 714, Statutes of 2012), provides that a laboratory director may include a licensed optometrist and authorizes an optometrist to perform certain clinical laboratory tests or examinations classified as waived under CLIA.

SB 1481(Negrete McLeod Chapter 874, Statutes of 2012), allows pharmacists to perform specific CLIA waived tests without the supervision of a laboratory director.

AB 1382 (Roger Hernández, Chapter 643, Statutes of 2011), authorized HIV test counselors to perform HCV or combined HIV/HCV tests in addition to HIV tests.

AB 221 (Portantino, Chapter 421, Statutes of 2009), among other things, removed the HIV counselor training equivalency credit towards a limited phlebotomy technician certification and instead exempted an HIV counselor who works under a licensed physician and surgeon, and who is trained in rapid HIV test proficiency and universal infection control precautions, from the requirement that he or she hold a valid certification as a phlebotomist technician.

AB 685 (Leno, Chapter 2, Statutes of 2004), provided that HIV counselors that completed HIV counselor training were deemed to have met the requirements for certification as a limited phlebotomy technician.

AB 1263 (Migden, Chapter 324, Statutes of 2001), among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA.

Support. Project Inform is the sponsor of this bill and states current state law allows non-medical personnel to administer HCV rapid tests in compliance with CLIA standards, but only if personnel are working at a DPH-OA funded site, or authorized by a LHJ; have been trained to administer an HIV testing and counseling using a DPH-OA approved curriculum; and have completed an additional HCV test counseling and testing module approved by DPH-OA. The sponsor notes this bill will give local governments greater flexibility and reduce costs related to training non-medical personnel to administer the rapid test to screen for HCV in community settings by allowing LHJs as well as DPH to certify training standards for HCV rapid test counselors.

Mendocino County AIDs/Viral Hepatitis Network (MCAVNH) supports this bill stating that they are the only HIV/IDS/HCV service-oriented, community based harm reduction organization in all of Mendocino County. MCAVNH notes that they have adapted their services to assist those with multiple co-morbid conditions, and within Mendocino County persons who inject drugs have a projected HCV positive rate of 85%, and that early detection reduces the likelihood of disease progression, reduces costs of treatment, and prevents new infections in the community. MCAVNH concludes that California must reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic.

SUPPORT AND OPPOSITION:

Support: Project Inform (sponsor)

Access Support Network

AIDS Community Research Consortium

Asian Pacific Health Foundation

Bay Area Black Nurses Association

California Black Health Network

California Chronic Care Coalition

California Hepatitis Alliance

California Life Sciences Association

C.O.R.E. Medical Clinic, Inc.

Desert AIDS Project

Drug Policy Alliance

Harm Reduction Coalition

Health Officers Association of California

HIV Education and Prevention Project of Alameda County

Mendocino County AIDS/Viral Hepatitis Network

San Francisco Hepatitis C Task Force

S.T.O.P. Hepatitis Task Force

Wall Las Memorias Project

Oppose: None received

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2015 - 2016 Regular

Bill No: AB 2179 Hearing Date: June 20, 2016

Subject: Hepatitis C testing

SUMMARY:

Authorizes a hepatitis C counselor to perform any hepatitis C virus (HCV) test that is classified as waived under the federal Clinical Laboratory Improvement Act (CLIA), as specified.

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. Defines a “clinical laboratory test or examination” as the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual. (BPC § 1206)
3. Requires an individual who draws blood to be certified by the DPH as a certified phlebotomy technician. (BPC § 1246)
4. Allows any person to request, and any licensed clinical laboratory or public health laboratory to perform, the following laboratory tests if the test is waived under CLIA and the laboratory has registered with the DPH: pregnancy, glucose level, cholesterol, occult blood, and any other test for which there is a test for a particular analyte approved by the federal Food and Drug Administration (FDA) for sale to the public without a prescription in the form of an over-the-counter test kit. A test approved only as an over-the-counter collection device may not be conducted pursuant to this section. (BPC § 1246.5)
5. Authorizes an HIV counselor who meets specified requirements to perform any HIV, HCV, or combination HIV/HCV test that is classified as waived under CLIA as specified, and is authorized to perform skin punctures for the purpose of withdrawing blood for a test without being certified as a phlebotomy technician or a limited phlebotomy technician. (Health & Safety Code § 120917)
6. Defines a “local health jurisdiction” (LHJ) as a county health department or combined health department in the case of counties acting jointly or city health department, as specified. (HSC § 124030)

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 tests for certificate of waiver to be simple laboratory examinations and procedures which:
   1. Are cleared by 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)

This bill:

1. Authorizes a hepatitis C counselor to perform a HCV test under the overall operation and administration of a laboratory director, as specified.
2. Requires a hepatitis C counselor to meet one of the following criteria:
   1. Is trained by the Office of AIDS and working in an HIV counseling and testing site funded by the DPH through a LHJ, or its agents.
   2. Is working in an HIV counseling and testing site that meets both of the following criteria:
      1. Utilizes HIV counseling staff who are trained by the Office of AIDS or its agents to provide both HIV counseling and testing and hepatitis C counseling and testing.
      2. Has and retains a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by the DPH.
   3. Is working at a site approved by the local health department to provide hepatitis C rapid testing and counseling, and has been trained using a curriculum approved by the local health department, and retained by the site, or approved by the DPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of hepatitis C rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of hepatitis C transmission.
3. Authorizes a hepatitis C counselor to do all of the following:
   1. Perform any HCV test that is classified as waived under CLIA if all of the following conditions exist:
      1. The performance of the HCV test meets the requirements of state and federal law regarding clinical labs.
      2. Perform skin punctures for the purpose of withdrawing blood for waived HCV testing without a certificate as a certified phlebotomy technician, upon specific authorization from a licensed physician and surgeon, provided that the person meets both of the following requirements:
         1. He or she works under the direction of a licensed physician and surgeon.
         2. He or she has been trained in rapid test proficiency for skin puncture blood tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health in the Department of Industrial Relations and the federal Centers for Disease Control and Prevention (CDC).
      3. The person performing the HCV test meets the requirements for the performance of waived laboratory testing, as specified.
      4. The patient is informed that the preliminary result of the HCV test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the federal CDC for that purpose, a second, different rapid HCV test. This does not allow a hepatitis C counselor to perform any HCV test that is not classified as waived under CLIA.
   2. Order and report HCV test results to patients without authorization from a licensed health care practitioner or his or her authorized representative. A patient who has an indeterminate or positive test result shall be referred to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation.
4. Prohibits a hepatitis C counselor who meets the requirements of this section from performing any other test unless that person meets the statutory and regulatory requirements for performing that other test.
5. States that compliance with bill does not fulfill any requirements for certification as a phlebotomy technician or a limited phlebotomy technician, unless the hepatitis C counselor has otherwise satisfied the certification requirements.

FISCAL EFFECT:

This bill is keyed “fiscal” by the Legislative Counsel. According to the Assembly Committee on Appropriations analysis dated April 27, 2016, this bill has uncertain, potential cost pressures to the DPH. The analysis notes that this bill does not place direct requirements on the department, but is intended to allow LHJs flexibility to approve and implemented their own training programs. According to the analysis, DPH indicates cost pressure in the hundreds of thousands of dollars to promulgate and implement regulations, provide technical assistance, and review, approve, and potentially implement hepatitis C counselor trainings.

COMMENTS:

1. Purpose. This bill is sponsored by Project Inform. According to the Author’s office,

“AB 2179 would allow LHJs as well as DPH, to certify training standards for hepatitis C test counselors to administer low-risk, easy-to-use, finger-stick rapid tests that meet the standards for “waiver” under the CLIA. The bill would remove the prerequisite that personnel be trained to administer an HIV rapid test before be trained to administer the hepatitis C rapid test. Only persons working in sites authorized by LHJs to offer HCV rapid testing would be allowed to administer CLIA-compliant tests.

“The California Hepatitis Alliance did a series of interviews with community based programs in California in 2015 and 2016 and identified significant barriers to screening at-risk population, even when local resources existed to provide the tests. Even if tests were available and staff was available – either the training was not available or was too distant or too expensive for small community-based programs to access.

“Current state statute mandates that a person must complete an HIV rapid test counseling training as a prerequisite, even if the local conditions call for deployment of HCV screening.

“The State Office of AIDS currently pays contractors to provide HIV and HCV rapid test training, but only offers it to persons from 18 local health jurisdictions that have been prioritized due to high rates of HIV. The prioritization is based on HIV rates, not HCV rates, which is very high in many rural counties. 40 other counties (total of 60 LHJs) may ask for a seat in the trainings, but are wait-listed to see if there will be any availability.

“The trainings generally take place in San Francisco and Los Angeles, far from programs. A small community based program, with very tight budgets, assumes the high cost of travel, accommodations, and the loss of staff for 4 days to complete a training that, if the law were changed, could be provided locally in half the time.

“AB 2179 will trust local health officers and local health departments to certify a training for a test has been judged by the federal government to be easy-to-use, and very low-risk.”

1. CLIA waived tests. Federal law, CLIA, establishes conditions that laboratories must meet for certification to perform testing on human specimens. This law classifies laboratory tests and establishes corresponding regulatory parameters using three categories: “waived,” “moderate complexity,” and “high complexity.” “Waived” tests constitute the lowest category, and may be granted for those exams and procedures which are cleared by the FDA for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.

This bill establishes criteria under which a hepatitis counselor may perform a waived HCV test after training, using a curriculum approved by the local health department, or the DPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of hepatitis C rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of hepatitis C transmission.

1. Hepatitis C. Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with HCV, which is spread primarily through contact with the blood of an infected person. While infection rates are high among baby boomers who were exposed to the virus prior to effective blood screenings, most individuals become infected currently by sharing injection equipment.

Hepatitis C’s effects can be mitigated through early detection and treatment, which can also reduce new infections. This is especially important in California, as the CDC reports that between 2009 and 2013, reported rates of acute hepatitis C increased by 100 percent in this state.

1. HIV Counselors. Existing law allows HIV counselors to perform HIV, HCV, and combination HIV/HCV tests that are classified, as waived under CLIA, if the facility or clinic has obtained a certificate of waiver from Center for Medicaid Services and DPH approval, and the HIV counselor has attended trainings specific to each type of test. Currently, the Office of AIDS (OA) establishes or approves a LHJ’s HIV Counseling and Testing training programs, which are conducted by community-based, non-profit HIV organizations for HIV testing. However, not all LHJs are able to access the trainings.

According to the Office of AIDS Integrated HIV Surveillance, Prevention, and Care Plan (Integrated Plan), budget cuts during fiscal year 2009-10 reduced the OA’s funding for many of its AIDS programs. Since 2012, the majority of the OA’s HIV prevention activities have been funded solely through a five-year funding opportunity from the CDC. The program established three funding areas in California: the Los Angeles and San Francisco Metropolitan Statistical Areas (which receive funds directly from the CDC), and the California Project Area (CPA). The CPA includes a limited number of LHJs that have demonstrated a high incidence of HIV. LHJs within the CPA receive the Counseling and Testing training as a part of the CDC’s program, but the remaining LHJs must pay for the Counseling and Testing training out of their own funds, and spaces within the C&T trainings are limited.

AB 2179’s sponsor and supporters note that having to pay out of pocket for the Counseling and Testing training burdens the LHJs that have not met the HIV-incidence thresholds but may still have a high incidence of HCV. Currently, the counselors working in LHJs outside of the CPA cannot attend the HCV Counseling and Testing training without attending the HIV Counseling and Testing training. If the LHJ does not have the funds or the offered training is full, the counselor will be unable to provide HCV testing and screening at the testing site. This bill seeks to remedy by authorizing a LHJ to approve an independent HCV Counseling and Testing training program and authorizing a hepatitis C counselor who works at a testing site approved by the LHJ to perform a CLIA-waived HCV test after attending the training program.

1. Prior Related Legislation. AB 1382 (R. Hernandez, Chapter 643, Statutes of 2011) authorized HCV training for HIV test counselors.

AB 221 (Portantino, Chapter 421, Statutes of 2009) among other things, removed the HIV counselor training equivalency credit towards a limited phlebotomy technician certification and instead exempted an HIV counselor who works under a licensed physician and surgeon, and who is trained in rapid HIV test proficiency and universal infection control precautions, from the requirement that he or she hold a valid certification as a phlebotomist technician.

AB 685 (Leno, Chapter 2, Statutes of 2004) provided that HIV counselors that completed HIV counselor training were deemed to have met the requirements for certification as a limited phlebotomy technician.

AB 1263 (Migden, Chapter 324, Statutes of 2001) among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA.

1. Arguments in Support. Project Inform writes, “California must reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. Current state law allows non-medical personnel to administer HCV rapid tests in compliance with federal standards under CLIA, but only if personnel are working at a DPH Office of AIDS (OA)-funded site, or authorized by a local health jurisdiction (LHJ); have been trained in HIV testing and counseling using a DPH-OA approved curriculum; and have completed an additional HCV test counseling and testing module approved by DPH-OA.

“AB 2179 would allow LHJs, as well as DPH, to certify training standards for HCV rapid test counselors, and remove the prerequisite that personnel be trained to administer an HIV rapid test before learning to administer the HCV rapid test. Further, only those persons working in sites authorized by LHJs to offer HCV rapid testing would be allowed to administer CLIA-compliant tests.”

Access Support Network writes that they were recently able to train 16 local individuals to become HIV/HCV Test Counselors. “The training was a four day training that came at a cost of nearly $40,000 to our agency. We were fortunate to have one time funding to facilitate this training, but, not normally being funded by the State Office of AIDS HIV testing, this training will not be available again for our agency. A more simplified training for HCV test counselors is greatly needed.”

Mendocino County AIDS/Viral Hepatitis Network (MCAVHN) writes that they are the “only HIV/AIDS/HCV service-oriented, community based harm reduction organization in all of Mendocino County…. MCAVHN began outreach efforts in the mid-nineties, notably building bridges within the Native-American communities who were significantly under-represented. Our services have adapted to assist those with multiple co-morbid conditions, and within Mendocino County our persons who inject drugs have a projected HCV+ rate of 85%. We are the only community-based organization delivering HCV testing to persons within our syringe exchange services delivery, both in-house and in the field, and have just been informed that we can no longer provide this service due to the conditions of the SAPTBG funding stream, which for the past two years has been our only source of funding for this testing....

“AB 2179 would allow LHJs to certify training standards for HCV rapid test counselors and remove the prerequisite that personnel be trained to administer an HIV rapid test before learning to administer the HCV rapid test. Further, only those persons working in sites authorized by LHJs to offer HCV rapid testing would be allowed to administer CLIA-compliant tests. These trainings need to be available and low-cost so that communities can deliver these services even in resource-poor, rural areas.”

1. Technical Amendment. The following are suggested technical amendments to strike code that was amended by the inclusion of text explicitly authorizing a hepatitis C counselor to perform a HCV test under the overall operation and administration of a laboratory director, as specified.

On page 7, line 36, delete everything after “Code.”

On page 7, delete lines 37-39.

On page 8, delete lines 1-2

NOTE:

Double-referral to Senate Committee on Health , second.

SUPPORT AND OPPOSITION:

Support:

Project Inform (Sponsor)

Access Support Network

AIDS Community Research Consortium

Asian Pacific Health Foundation

Bay Area Black Nurses Association

California Black Health Network

California Chronic Care Coalition

California Hepatitis Alliance

California Life Sciences Association

Comprehensive Opiate Recovery Experience Medical Clinic, Inc.

Desert AIDS Project

Drug Policy Alliance

Harm Reduction Coalition

Health Officers Association of California

HIV Education and Prevention Project of Alameda County

Mendocino County AIDs/Viral Hepatitis Network

Sacramento Area Task Force for the Outreach and Prevention of Hepatitis

San Francisco Hepatitis C Task Force

The Wall Las Memorias Project

One individual

Opposition:

None on file as of June 14, 2016.

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 2179

Author:(Gipson)

As Amended Ver:April 14, 2016

Majority vote

SUMMARY: Authorizes a hepatitis C counselor, who meets specified training requirements and works in specified testing sites, to perform hepatitis C virus (HCV) tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Specifically, this bill:

1. Authorizes a hepatitis C counselor to perform a HCV test that is classified as waived under CLIA if the following conditions exist:
   1. The performance of the HCV test meets the requirements of CLIA and California's clinical laboratory requirements;
   2. The counselor meets one of the following training and workplace requirements:
      1. Is trained by the California Department of Public Health's (CDPH's) Office of Aids (OA) and is working in a HIV counseling and testing site funded by the CDPH through a local health jurisdiction (LHJ), or its agents; or,
      2. Is working in a HIV counseling and testing site that meets both of the following criteria:
         1. Utilizes HIV counseling staff trained by the OA or its agents to provide both HIV counseling and testing and hepatitis C counseling and testing; and,
         2. Has a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by the CDPH; or,
      3. Is working at a site approved by the local health department to provide hepatitis C rapid testing and counseling, and has been trained using a curriculum approved by the local health department or the CDPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of hepatitis C rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of hepatitis C transmission;
   3. The HCV test is performed under the overall operation and administration of a laboratory director. Defines, for purposes of this requirement, an HIV counselor who meets the specified requirements as "other health care personnel providing direct patient care" under California's clinical laboratory requirements;
   4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional, more specific test, or, if approved by the Center for Disease Control and Prevention (CDC) for that purpose, a second, different rapid HCV test; and,
   5. If performing a skin punctures for the purpose of withdrawing blood for HCV testing, the counselor must meet the following additional requirements:
      1. Work under the direction of a licensed physician and surgeon;
      2. Obtain specific authorization from a licensed physician and surgeon; and,
      3. Be trained in rapid test proficiency either for skin puncture blood tests or oral swab tests in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health (DOSH) in the Department of Industrial Relations (DIR) and the CDC.
2. Authorizes the counselor to order and report the results from the HCV tests performed to a patient without authorization from a licensed health care practitioner or the patient's authorized representative.
3. Requires the counselor to refer a patient who has an indeterminate or positive test result to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation.
4. Provides that a hepatitis C counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test, including those requiring certifications in phlebotomy.

FISCAL EFFECT: According to the Assembly Appropriations Committee, uncertain, potential cost pressure to the CDPH. This bill does not place direct requirements on the department, but is intended to allow local health jurisdictions (LHJs) flexibility to approve and implemented their own training programs. However, CDPH indicates cost pressure in the hundreds of thousands of dollars to promulgate and implement regulations, provide technical assistance, and review, approve, and potentially implement Hepatitis C counselor trainings.

COMMENTS:

Purpose. This bill is sponsored by Project Inform. According to the author, "The unchecked spread of HCV threatens the public health and economic welfare of California. It is necessary that California reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. [This bill] will give local health departments greater flexibility to respond to HCV in their communities and reduce costs related to training non-medical personnel to administer the rapid test."

Background. Hepatitis means inflammation of the liver. Hepatitis C is an infection of the liver caused by HCV, one of several contagious viruses that can cause hepatitis. HCV is spread by blood-to-blood contact and common ways people become infected are through needle sharing, inadequate sterilization of medical equipment, and unscreened blood transfusions.

The CDC estimates that there are 3.5 million people in the US have chronic HCV infection. Between 1994 and 2011, the CDPH had received 501,664 newly reported chronic HCV cases in California. As a result, the World Health Organization, the CDC, and the CDPH suggest policies that promote prevention and education among high-risk populations. This bill seeks to do so by authorizing HCV counselors to perform a HCV screening test if it is classified as waived under CLIA. The author states that doing so will increase access to HCV counselors, who will promote prevention by providing screening and education services at a community level.

Federal and State Laboratory Requirements. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services (CMS). The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. The three complexities are waived, moderate, and high complexity. In general, the more complicated the test, the more stringent the requirements under CLIA. Waived tests are simple, consumer-level tests with a low risk for an incorrect result. However, California law only allows specified personnel to perform waived tests on others.

HIV and HCV Counselors. Existing law allows HIV counselors to perform HIV, HCV, and combination HIV/HCV tests as long as the tests are classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and CDPH approval, and the HIV counselor has attended a Counseling and Testing (C&T) training specific to each type of test.

Currently, the OA either establishes or approves federally-funded HIV C&T training programs for a LHJ's HIV counselors. However, not all LHJs are able to access the trainings. Access to the trainings is determined by incidence of HIV, but some LHJs have a high incidence of HCV but not a high incidence of HIV. The LHJs that cannot meet the HIV thresholds must pay for the trainings.

The sponsor notes that having to pay out of pocket for the C&T training means that if the LHJ does not have the funds or the offered training is full, its counselors will not be able to provide necessary HCV testing and screenings. This bill seeks to remedy this issue in two ways: 1) authorizing a LHJ to approve a HCV C&T training program and 2) authorizing a HCV counselor who works at a testing site approved by the LHJ to perform a CLIA-waived HCV test after attending the training program.

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0003188

Date of Hearing: April 27, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 2179

Author:(Gipson) – As Amended Ver:April 14, 2016

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

SUMMARY:

This bill allows a new category of personnel, Hepatitis C counselors, to perform simple, easy-to-use rapid tests for Hepatitis C virus (HCV) when they are working under specified supervision, training, and work site conditions.

FISCAL EFFECT:

Uncertain, potential cost pressure to the California Department of Public Health (CDPH). This bill does not place direct requirements on the department, but is intended to allow local health jurisdictions (LHJs) flexibility to approve and implemented their own training programs. However, CDPH indicates cost pressure in the hundreds of thousands of dollars to promulgate and implement regulations, provide technical assistance, and review, approve, and potentially implement Hepatitis C counselor trainings.  

COMMENTS:

1. Purpose. This bill is intended to streamline training requirements for non-medical personnel to perform rapid Hepatitis C tests, to allow local health departments to respond in a safe and appropriate manner to the urgency of the Hepatitis C epidemic. This bill is sponsored by Project Inform, a statewide HIV and Hepatitis C advocacy group based in the Bay Area. It has no opposition.
2. Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. As a leading cause of liver disease, liver cancer, and liver transplants, chronic viral hepatitis is an important public health problem in California and nationwide. Since 2007, the annual number of deaths due to Hepatitis C nationwide has surpassed those due to Human Immunodeficiency Virus (HIV). It is estimated 3.5 million in the United States have chronic Hepatitis C. Current law allows HIV counselors who meet certain training requirements to perform HIV, HCV, or combined HIV/HCV.
3. Clinical Laboratory Improvement Act (CLIA)-waived tests. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services. The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed—waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements under CLIA. Waived tests are simple tests with a low risk for an incorrect result, which can be performed by participants without laboratory training, no prior experience of the test, and no verbal instruction.
4. Impact of this bill. Although HIV/HCV counselor training is available, limited availability of state-sponsored training in recent years has led to delays in certifying counselors and rendered local health jurisdictions unable to afford required trainings. This bill creates a new "Hepatitis C counselor" authorization to perform waived HCV tests under prescribed circumstances, which will allow LHJs to train and deploy the workforce more rapidly and at a lower cost.
5. Prior legislation.
   1. AB 1382 (Roger Hernández), Chapter 643, Statutes of 2011 authorized HIV test counselors to perform HCV or combined HIV/HCV tests in addition to HIV tests.
   2. AB 1263 (Migden), Chapter 324, Statutes of 2001, among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA.
6. Staff Comments. The intent of the bill appears to be to empower LHJs to more rapidly train and deploy Hepatitis C counselors in order to address the Hepatitis C epidemic. However, if CDPH interprets the bill to require promulgation of regulations through a multi-year process as well as state approval and delivery of training, it could negate the intent of the bill and put additional cost pressure on the state. At the same time, there may be some role for the state to ensure quality control and proper oversight. The author may wish to clarify the role of CDPH and LHJs to ensure this bill delivers on its intent and does not result in undue state administrative and cost pressure.

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

Date of Hearing: April 12, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2179

Author:(Gipson) – As Amended Ver:March 30, 2016

SUBJECT: Hepatitis C testing

SUMMARY: Authorizes a hepatitis C counselor who meets specific requirements to perform any hepatitis C virus (HCV) test that is classified as waived under the federal Clinical Laboratory Improvement Act (CLIA). Specifically, this bill:

1. Requires a hepatitis C counselor to meet one of the following criteria:
   1. To be trained by the Office of AIDS (OA) and working in an human immunodeficiency virus (HIV) counseling and testing site funded by the Department of Public Health (DPH) through a local health jurisdiction, or its agents;
   2. To be working in an HIV counseling and testing site that meets both of the following criteria:
      1. Utilizes HIV counselling staff that is trained by the OA or its agent to provide both HIV counseling and testing and hepatitis C counseling and testing; and,
      2. Has a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by DPH; or,
   3. To be working at a site approved by the local health department to provide hepatitis C rapid testing and counseling, and has been trained using a curriculum approved by the local health department or DPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of hepatitis C rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of hepatitis C transmission.
2. Authorizes a hepatitis C counselor who meets the criteria in 1) above to do all of the following:
   1. Perform any HCV test that is classified as waived under CLIA if all of the following conditions exist:
      1. The performance of the HCV test meets the requirements of CLIA and state law.
      2. Perform skin punctures for the purpose of withdrawing blood for HCV testing upon authorization from a licensed physician provided that the person meets both of the following requirements:
         1. He or she works under the direction of a licensed physician; and,
         2. He or she has been trained in rapid test proficiency for skin puncture blood tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health in the Department of Industrial Relations and the federal Centers for Disease Control and Prevention (CDC).
      3. The person performing the HCV tests meet the requirements for the performance of waived laboratory testing pursuant to existing state law as described in existing law in 2) below. For purposes of these provisions a hepatitis C counsel is "other health care personnel provide direct patient care," per existing law.
      4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the CDC, a second, different rapid HCV test.
   2. Order and report HCV test results to patients without authorization from a licensed health care practitioner or his or her authorized representative. Requires a patient who has an indeterminate or positive test result to be referred to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further revaluations.
3. Prohibits a hepatitis C counselor as defined in these provisions from performing any other test unless they meet the statutory and regulatory requirements for performing that other test.
4. Specifies that compliance with these provisions does not fulfill any requirements for certification as a phlebotomy technician or a limited phlebotomy technician.

EXISTING FEDERAL LAW:

1. Defines “laboratory” or “clinical laboratory” as a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment or health assessment of human beings.
2. Requires that laboratories obtain a certificate, meet quality standards, and undergo inspections, among other things, before accepting materials derived from the human body. Exempts laboratories with a certificate of waiver from the CLIA, provided that the laboratory follows the manufacturer’s instructions.
3. Provides that a laboratory is eligible for a certificate of waiver if the laboratory only performs “waived tests,” which are simple examinations and procedures that:
   1. Have been approved by the Food and Drug Administration (FDA) for home use;
   2. The FDA has determined are so simple and accurate that there is a negligible chance of erroneous results; or,
   3. Pose no unreasonable risk of harm to the patient if performed incorrectly.
4. Authorizes a state to enact and enforce laws relating to CLIA to the extent that the state laws are not inconsistent with the CLIA laws and regulations.

EXISTING STATE LAW:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by DPH.
2. Prohibits a person from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as specified, and the test is performed by one the following persons if within the person’s scope of practice:
   1. A licensed physician and surgeon holding a M.D. or D.O. degree;
   2. A licensed podiatrist, a licensed dentist, or a licensed naturopathic doctor;
   3. A person licensed in California to engage in clinical laboratory practice or to direct a clinical laboratory;
   4. A person authorized by a local health laboratory to perform tests pursuant to a certificate issued by the DPH;
   5. A licensed physician assistant;
   6. A licensed nurse;
   7. A licensed vocational nurse;
   8. A certified perfusionist (a specialized healthcare professional who uses the heart-lung machine during cardiac surgery and other surgeries that require cardiopulmonary bypass to manage the patient's physiological status);
   9. A licensed respiratory care practitioner;
   10. A medical assistant;
   11. A pharmacist;
   12. A naturopathic assistant;
   13. A licensed optometrist;
   14. Other health care personnel providing direct patient care; or,
   15. Any other person performing non-diagnostic testing.
3. Establishes the OA within DPH as the lead agency within the state, responsible for coordinating state programs, services, and activities relating to HIV, acquired immune deficiency syndrome (AIDS), and AIDS related conditions (ARC).
4. Requires DPH to authorize the establishment of training programs throughout the state for counselors for publicly funded HIV testing programs.
5. Authorizes an HIV counselor to perform a HIV, HCV, or combination HIV/HCV test that is classified as waived under CLIA if the following conditions exist:
   1. The performance of the HIV, HCV, or combination HIV/HCV test meets the requirements of CLIA and the California clinical laboratory requirements.
   2. The HIV counselor meets one of the following criteria:
      1. Is trained by the OA and working in a HIV counseling and testing site funded by the DPH through a local health jurisdiction, or its agents;
      2. Is working in a HIV counseling and testing site that meets both of the following criteria:
         1. Utilizes HIV counseling staff who are trained by the OA or its agents; or,
         2. Has a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by DPH.
   3. The HIV, HCV, or combination HIV/HCV test is performed under the overall operation and administration of a laboratory director. Defines, for purposes of this requirement, a HIV counselor who meets the specified requirements as “other health care personnel providing direct patient care” under the California clinical laboratory requirements.
   4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HIV infection or HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the federal Centers for Disease Control and Prevention (CDC) for that purpose, a second different rapid HIV, HCV, or combination HIV/HCV test.
   5. If performing skin punctures for the purpose of withdrawing blood for HIV, HCV, or combination HIV/HCV testing, the counselor must meet the following additional requirements:
      1. The counselor works under the direction of a licensed physician and surgeon.
      2. The counselor has specific authorization from a licensed physician and surgeon.
      3. The counselor has been trained in both rapid HIV, HCV, or combination HIV/HCV test proficiency for skin puncture blood tests and oral swab tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health (DOSH) in the Department of Industrial Relations (DIR) and the CDC.
6. Authorizes the HIV counselor to order and report the results from the HIV, HCV, or combination HIV/HCV test to a patient without authorization from a licensed health care professional or the patient’s authorized representative.
7. Requires that patients with indeterminate or positive results from the HIV, HCV, or combination HIV/HCV test be referred to a licensed health care provider whose scope of practice includes the authority to refer patients for laboratory testing for further evaluation.
8. Provides that a HIV counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test.

FISCAL EFFECT: This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, the unchecked spread of HCV threatens the public health and economic welfare of California. The author states that there are an estimated 750,000 Californians living with HCV, and most do not know it, and between 2002 and 2011 there were over 400,000 hepatitis B and HCV-related hospitalizations in California, costing $26 billion. The author contends that the burden of HCV is expected to grow, and early detection reduces the likelihood of disease progression, reduces treatment costs, and prevents new infections. The author also states that community-based programs are best positioned to serve low-income communities, including the homeless, reaching those who are currently not enrolled in Medi-Cal or other health insurance, or who are disconnected from primary care services. The author asserts that it is necessary for California reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. The author states that this bill will give local health departments greater flexibility to respond to HCV in their communities and reduce costs related to training non-medical personnel to administer the rapid test. The author concludes that the current statutory requirement that a person must complete training in HIV test counseling before receiving HCV test counseling, and that the training must be approved by a state health official rather than a county health official is outdated and a barrier to cost-effective disease control and prevention.
   
   
   
2. BACKGROUND.
   1. HCV. Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with the HCV, which is spread primarily through contact with the blood of an infected person. Hepatitis C can be either “acute” or “chronic.” Acute HCV infection is a short-term illness that occurs within the first six months after someone is exposed to the HCV. For most people, acute infection leads to chronic infection. Chronic Hepatitis C virus infection is a long-term illness that occurs when HCV remains in a person’s body. HCV infection can last a lifetime and lead to serious liver problems, including cirrhosis (scarring of the liver) or liver cancer. According to the CDC, most people become infected with HCV by sharing needles or other equipment to inject drugs.
      
      The CDC estimates that there are 3.5 million people in the U.S. who have chronic HCV infection. Between 1994 and 2011, DPH had received 501,664 newly reported chronic HCV cases in California. As a result, the World Health Organization, the CDC, and DPH suggest policies that promote prevention and education among high-risk populations. This bill seeks to do so by authorizing HCV counselors to perform a HCV screening test if it is classified as waived under CLIA. The author states that doing so will increase access to HCV counselors, who will promote prevention by providing screening and education services at a community level.
   2. Federal and State Laboratory Requirements. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services (CMS). The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. The three complexities are waived, moderate, and high complexity. 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. Waived tests include 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. In order for the FDA to approve a test device as waived, the manufacturer must show that the test is accurate and consistent when performed by untrained individuals. This includes performing studies conducted using participants without laboratory training, no prior experience of the test, and no verbal instruction. The study participants must be able to generate accurate results using only the product label and included instructions.

Because waived tests are essentially consumer-level products, facilities that use only waived tests are eligible for a certificate of waiver. Those with a certificate of waiver are not subject to the CLIA requirements as long as the tests are performed according to the manufacturer’s instructions. However, CLIA still requires that all laboratories meet individual state personnel license requirements.

Under California law, all laboratory tests classified under CLIA must be performed by personnel specified in statute under the overall operation and administration of a laboratory director, with limited exceptions. As of 2014, California is one of 15 other states that regulate laboratories in addition to the CLIA standards.

• 1. HIV and HCV Counselors. Existing law allows HIV counselors to perform a HIV, HCV, and combination HIV/HCV test as long as it is classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and DPH approval, and the HIV counselor has attended trainings specific to each type of test. Currently, the OA establishes or approves a local health jurisdiction’s (LHJ’s) HIV Counseling and Testing (C&T) training programs, which are conducted by community-based, non-profit HIV organizations for HIV testing. However, not all LHJs are able to access the trainings.

According to the OA’s Integrated HIV Surveillance, Prevention, and Care Plan (Integrated Plan), budget cuts during fiscal year 2009-10 reduced the OA’s funding for many of its AIDS programs. Since 2012, the majority of the OA’s HIV prevention activities have been funded solely through a five-year funding opportunity from the CDC. The program established three funding areas in California: the Los Angeles and San Francisco Metropolitan Statistical Areas (which receive funds directly from the CDC), and the California Project Area (CPA). The CPA includes a limited number of LHJs that have demonstrated a high incidence of HIV. LHJs within the CPA receive the C&T training as a part of the CDC’s program, but the remaining LHJs must pay for the C&T training out of their own funds and spaces within the C&T trainings are limited.

The sponsor notes that having to pay out of pocket for the C&T training burdens the LHJs that have not met the HIV-incidence thresholds but may still have a high incidence of HCV. Currently, the counselors working in LHJs outside of the CPA cannot attend the HCV C&T training without attending the HIV C&T training. If the LHJ does not have the funds or the offered training is full, the counselor will be unable to provide HCV testing and screening at the testing site. This bill seeks to remedy this issue in two ways: 1) authorizing a LHJ to approve a HCV C&T training program and 2) authorizing a HCV counselor who works at a testing site approved by the LHJ to perform a CLIA-waived HCV test after attending the training program.

1. SUPPORT. Project Inform is the sponsor of this bill and states current state law allows non-medical personnel to administer HCV rapid tests in compliance with CLIA standards, but only if personnel are working at a DPH-OA funded site, or authorized by a LHJ; have been trained to administer an HIV testing and counseling using a DPH-OA approved curriculum; and have completed an additional HCV test counseling and testing module approved by DPH-OA. The sponsor notes this bill will give local governments greater flexibility and reduce costs related to training non-medical personnel to administer the rapid test to screen for HCV in community settings by allowing LHJs as well as DPH to certify training standards for HCV rapid test counselors.
   
   Mendocino County AIDs/Viral Hepatitis Network (MCAVNH) supports this bill stating that they are the only HIV/IDS/HCV service-oriented, community based harm reduction organization in all of Mendocino County. MCAVNH notes that they have adapted their services to assist those with multiple co-morbid conditions, and within Mendocino County persons who inject drugs have a projected HCV positive rate of 85%, and that early detection reduces the likelihood of disease progression, reduces costs of treatment, and prevents new infections in the community. MCAVNH concludes that California must reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic.
2. PREVIOUS LEGISLATION.
   1. AB 761(Roger Hernández) Chapter 714, Statutes of 2012 provides that a laboratory director may include a licensed optometrist and authorizes an optometrist to perform certain clinical laboratory tests or examinations classified as waived under CLIA.
      
   2. SB 1481(Negrete McLeod) Chapter 874, Statutes of 2012 allows pharmacists to perform specific CLIA waived tests without the supervision of a laboratory director.
      
   3. AB 1382 (Roger Hernández), Chapter 643, Statutes of 2011 authorized HIV test counselors to perform HCV or combined HIV/HCV tests in addition to HIV tests.
      
   4. AB 221 (Portantino), Chapter 421, Statutes of 2009, among other things, removed the HIV counselor training equivalency credit towards a limited phlebotomy technician certification and instead exempted an HIV counselor who works under a licensed physician and surgeon, and who is trained in rapid HIV test proficiency and universal infection control precautions, from the requirement that he or she hold a valid certification as a phlebotomist technician.
   5. AB 685 (Leno), Chapter 2, Statutes of 2004, provided that HIV counselors that completed HIV counselor training were deemed to have met the requirements for certification as a limited phlebotomy technician.
   6. AB 1263 (Migden), Chapter 324, Statutes of 2001, among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA.
3. DOUBLE REFERRAL. This bill has been double referred. It passed the Assembly Committee on Business and Professions with a vote of 16-0 on March 29, 2016.
4. TECHNICAL AMENDMENTS. This bill is attempting to improve access to training for persons who are providing HCV screening by creating HCV tester training programs at the local level, similar to the HIV training program provided at the state level. In order to more closely align the training and supervision requirements for persons performing HPV tests with those for persons performing HIV tests, the bill should be amended as follows:
   1. Clarify that skin punctures are only allowed to be performed for waived tests;
   2. Require local testing sites to maintain copies of LHJ approved training documents; and,
   3. Add language to the Business & Professions code to clarify that waived HCV tests do not have to be performed in a clinical laboratory.
5. POLICY COMMENT. Given that DPH has extensive experience in providing and approving training programs, as this bill moves forward, the author should consider adding in language that would require DPH and LHJs to consult on developing the HCV training programs.

REGISTERED SUPPORT / OPPOSITION:

Support

Project Inform (sponsor)
C.O.R.E. Medical Clinic, Inc.
Desert AIDS Project
Harm Reduction Coalition
Mendocino County AIDs/Viral Hepatitis Network
San Francisco Hepatitis C Task Force
STOP Hepatitis Task-Force
The Wall Las Memorias Project
One individual

Opposition

None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097

Date of Hearing:

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Rudy Salas, Chair

ABPCA Bill Id:AB 2179

Author:(Gipson) – As Amended Ver:March 28, 2016

NOTE: This bill is double-referred, if passed by this Committee it will be referred to the Assembly Committee on Health.

SUBJECT: Hepatitis C testing.

SUMMARY: Authorizes a hepatitis C counselor, who meets specified training requirements and works in specified testing sites, to perform hepatitis C virus (HCV) tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA).

EXISTING FEDERAL LAW:

1. Requires that laboratories obtain a certificate, meet quality standards, and undergo inspections, among other things, before accepting materials derived from the human body. (CLIA, 42 USC §§ 263a - 263a–7)
2. Defines “laboratory” or “clinical laboratory” as a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment or health assessment of human beings. (Title 42 United States Code (USC) § 263a(a))
3. Exempts laboratories with a certificate of waiver from the CLIA, provided that the laboratory follows the manufacturer’s instructions. (42 USC § 263a(d)(2)(C); Title 42 Code of Federal Regulations (CFR) § 493.15)
4. Provides that a laboratory is eligible for a certificate of waiver if the laboratory only performs “waived tests,” which are simple examinations and procedures that:
   1. Have been approved by the Food and Drug Administration (FDA) for home use;
   2. The FDA has determined are so simple and accurate that there is a negligible chance of erroneous results; or,
   3. Pose no unreasonable risk of harm to the patient if performed incorrectly. (42 USC § 263a(d)(3); 42 CFR § 493.15; 69 Federal Register (FR) 22849)
5. Authorizes a state to enact and enforce laws relating to CLIA to the extent that the state laws are not inconsistent with the CLIA laws and regulations. (45 USC § 263a(p))

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). (Business and Professions Code (BPC) §§ 1200-1327)
2. Defines “clinical laboratory test or examination” as the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual. (BPC § 1206(a)(5))
3. Prohibits a person from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as specified, and the test is performed by one the following persons if within the person’s scope of practice: (BPC § 1206.5)
   1. A licensed physician and surgeon holding a M.D. or D.O. degree.
   2. A licensed podiatrist, a licensed dentist, or a licensed naturopathic doctor.
   3. A person licensed in California to engage in clinical laboratory practice or to direct a clinical laboratory.
   4. A person authorized by a local health laboratory to perform tests pursuant to a certificate issued by the CDPH.
   5. A licensed physician assistant.
   6. A licensed nurse.
   7. A licensed vocational nurse.
   8. A certified perfusionist.
   9. A licensed respiratory care practitioner.
   10. A medical assistant.
   11. A pharmacist.
   12. A naturopathic assistant.
   13. A licensed optometrist.
   14. Other health care personnel providing direct patient care.
   15. Any other person performing nondiagnostic testing, as specified.
4. Establishes the Office of AIDS (OA) within the CDPH as the lead agency within the state, responsible for coordinating state programs, services, and activities relating to the human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), and AIDS related conditions (ARC). (Health and Safety Code (HSC) § 131019)
5. Defines “human immunodeficiency virus” or “HIV” as the etiologic virus of AIDS. (HSC § 120775(b))
6. Defines “HIV test” as any clinical test, laboratory or otherwise, used to identify HIV, a component of HIV, or antibodies or antigens to HIV. (HSC § 120775(c))
7. Requires the CDPH to authorize the establishment of training programs throughout the state for counselors for publicly funded HIV testing programs. (HSC § 120871)
8. Authorizes a HIV counselor to perform a HIV, HCV, or combination HIV/HCV test that is classified as waived under CLIA if the following conditions exist: (HSC § 120917)
   1. The performance of the HIV, HCV, or combination HIV/HCV test meets the requirements of CLIA and the California clinical laboratory requirements (BPC §§ 1200 – 1327).
   2. The HIV counselor meets one of the following criteria:
      1. Is trained by the OA and working in a HIV counseling and testing site funded by the CDPH through a local health jurisdiction, or its agents.
      2. Is working in a HIV counseling and testing site that meets both of the following criteria:
         1. Utilizes HIV counseling staff who are trained by the OA or its agents.
         2. Has a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by the CDPH (Title 17 California Code of Regulations (CCR) §1230).
   3. The HIV, HCV, or combination HIV/HCV test is performed under the overall operation and administration of a laboratory director. Defines, for purposes of this requirement, a HIV counselor who meets the specified requirements as “other health care personnel providing direct patient care” under the California clinical laboratory requirements (BPC § 1206.5).
   4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HIV infection or HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the federal Centers for Disease Control and Prevention (CDC) for that purpose, a second different rapid HIV, HCV, or combination HIV/HCV test.
   5. If performing skin punctures for the purpose of withdrawing blood for HIV, HCV, or combination HIV/HCV testing, the counselor must meet the following additional requirements:
      1. The counselor works under the direction of a licensed physician and surgeon.
      2. The counselor has specific authorization from a licensed physician and surgeon.
      3. The counselor has been trained in both rapid HIV, HCV, or combination HIV/HCV test proficiency for skin puncture blood tests and oral swab tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health (DOSH) in the Department of Industrial Relations (DIR) and the CDC.
9. Authorizes the HIV counselor to order and report the results from the HIV, HCV, or combination HIV/HCV test to a patient without authorization from a licensed health care professional or the patient’s authorized representative. (HSC § 120917(a)(2))
10. Requires that patients with indeterminate or positive results from the HIV, HCV, or combination HIV/HCV test be referred to a licensed health care provider whose scope of practice includes the authority to refer patients for laboratory testing for further evaluation. (HSC § 120917(a)(2))
11. Provides that a HIV counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test.

THIS BILL:

1. Authorizes a hepatitis C counselor to perform a HCV test that is classified as waived under CLIA if the following conditions exist:
   1. The performance of the HCV test meets the requirements of CLIA and the California clinical laboratory requirements (BPC § 1200 – 1327).
   2. The counselor meets one of the following training and workplace requirements:
      1. Is trained by the OA and is working in a HIV counseling and testing site funded by the CDPH through a local health jurisdiction, or its agents.
      2. Is working in a HIV counseling and testing site that meets both of the following criteria:
         1. Utilizes HIV counseling staff trained by the OA or its agents to provide both HIV counseling and testing and hepatitis C counseling and testing.
         2. Has a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by the CDPH (17 CCR §1230).
      3. Is working at a site approved by the local health department to provide hepatitis C rapid testing and counseling, and has been trained using a curriculum approved by the local health department or the CDPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of hepatitis C rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of hepatitis C transmission.
   3. The HCV test is performed under the overall operation and administration of a laboratory director. Defines, for purposes of this requirement, a HIV counselor who meets the specified requirements as “other health care personnel providing direct patient care” under the California clinical laboratory requirements (BPC § 1206.5).
   4. The patient is informed that the preliminary result of the test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional, more specific test, or, if approved by the CDC for that purpose, a second, different rapid HCV test.
   5. If performing a skin punctures for the purpose of withdrawing blood for HCV testing, the counselor must meet the following additional requirements:
      1. Work under the direction of a licensed physician and surgeon.
      2. Obtain specific authorization from a licensed physician and surgeon.
      3. Be trained in rapid test proficiency either for skin puncture blood tests or oral swab tests in universal infection control precautions, consistent with best infection control practices established by the DOSH in the DIR and the CDC.
2. Authorizes the counselor to order and report the results from the HCV tests performed to a patient without authorization from a licensed health care practitioner or the patient’s authorized representative.
3. Requires the counselor to refer a patient who has an indeterminate or positive test result to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation.
4. Provides that a hepatitis C counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test.

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

COMMENTS:

Purpose. This bill is sponsored by Project Inform. According to the author, “The unchecked spread of HCV threatens the public health and economic welfare of California. It is necessary that California reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. [This bill] will give local health departments greater flexibility to respond to HCV in their communities and reduce costs related to training non-medical personnel to administer the rapid test.”

Background. Hepatitis is a condition characterized by inflammation of the liver (CDC Hepatitis C Fact Sheet, 2015). Hepatitis C is an infection of the liver caused by HCV, one of several viruses that can cause hepatitis. HCV is spread by blood-to-blood contact and common ways people become infected are through needle sharing, inadequate sterilization of medical equipment, and unscreened blood transfusions.

Acute infections (short-term) are treatable with antiviral medications. However, the World Health Organization (WHO) notes that early detection can be difficult, medications can be costly, and there is currently no vaccine (WHO Hepatitis C Fact Sheet, 2015). Acute infections left untreated become chronic, and can result in liver disease, liver failure, and liver cancer.

The CDC estimates that there are 3.5 million people in the US have chronic HCV infection. Between 1994 and 2011, the CDPH had received 501,664 newly reported chronic HCV cases in California (CDPH Chronic Hepatitis B and Hepatitis C Infections in California: Cases Newly Reported through 2011, November 2013).

As a result, the WHO, the CDC, and the CDPH suggest policies that promote prevention and education among high-risk populations. This bill seeks to do so by authorizing HCV counselors to perform a HCV screening test if it is classified as waived under CLIA. The author states that doing so will increase access to HCV counselors, who will promote prevention by providing screening and education services at a community level.

Federal and State Laboratory Requirements. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services (CMS). The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. The three complexities are waived, moderate, and high complexity. 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. Waived tests include 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. In order for the FDA to approve a test device as waived, the manufacturer must show that the test is accurate and consistent when performed by untrained individuals. This includes performing studies conducted using participants without laboratory training, no prior experience of the test, and no verbal instruction. The study participants must be able to generate accurate results using only the product label and included instructions.

Because waived tests are essentially consumer-level products, facilities that use only waived tests are eligible for a certificate of waiver. Those with a certificate of waiver are not subject to the CLIA requirements as long as the tests are performed according to the manufacturer’s instructions. However, CLIA still requires that all laboratories meet individual state personnel license requirements.

Under California law, all laboratory tests classified under CLIA must be performed by personnel specified in statute under the overall operation and administration of a laboratory director, with limited exceptions. As of 2014, California is one of 15 other states that regulate laboratories in addition to the CLIA standards.

HIV and HCV Counselors. Existing law allows HIV counselors to perform a HIV, HCV, and combination HIV/HCV test as long as it is classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and CDPH approval, and the HIV counselor has attended trainings specific to each type of test. Currently, the OA establishes or approves a LHJ’s HIV Counseling and Testing (C&T) training programs, which are conducted by community-based, non-profit HIV organizations for HIV testing. However, not all local health jurisdictions (LHJs) are able to access the trainings.

According to the OA’s Integrated HIV Surveillance, Prevention, and Care Plan (Integrated Plan), budget cuts during fiscal year 2009-10 reduced the OA’s funding for many of its AIDS programs. Since 2012, the majority of the OA’s HIV prevention activities have been funded solely through a five-year funding opportunity from the CDC (CDC PS12-1201 Comprehensive HIV Prevention Programs for Health Departments). The program established three funding areas in California: the Los Angeles and San Francisco Metropolitan Statistical Areas (which receive funds directly from the CDC), and the California Project Area (CPA). The CPA includes a limited number of LHJs that have demonstrated a high incidence of HIV. LHJs within the CPA receive the C&T training as a part of the CDC’s program, but the remaining LHJs must pay for the C&T training out of their own funds and spaces within the C&T trainings are limited.

The sponsor notes that having to pay out of pocket for the C&T training burdens the LHJs that have not met the HIV-incidence thresholds but may still have a high incidence of HCV. Currently, the counselors working in LHJs outside of the CPA cannot attend the HCV C&T training without attending the HIV C&T training. If the LHJ does not have the funds or the offered training is full, the counselor will be unable to provide HCV testing and screening at the testing site. This bill seeks to remedy this issue in two ways: 1) authorizing a LHJ to approve a HCV C&T training program and 2) authorizing a HCV counselor who works at a testing site approved by the LHJ to perform a CLIA-waived HCV test after attending the training program.

Existing HCV Counselor Training Programs. Because counselors (and others) are prohibited from performing a HCV test classified as waived under CLIA, there is no existing standalone training program or provider. However, there is currently only one CLIA-waived HCV test, the OraQuick HCV Rapid Antibody Test.

The OraQuick HCV Rapid test is manufactured by OraSure Technologies Inc. and is a qualitative immunoassay to detect antibodies to HCV in fingerstick whole blood and venipuncture whole blood specimens (see CLIA Currently Waived Analytes database under Hepatitis C, FDA premarket approval number (PMA) P080027). OraSure has stated that it is able to provide technical training and assistance in the use of its products, which include:

1. Dedicated account managers responsible for the Public Health and Hospital markets in California.
2. Live and webinar product training.
3. Quality Assurance Program development/support.
4. Technical assistance with test implementation.
5. Troubleshooting on product complaints in the field.
6. Marketing and PR support for special event days.
7. Free promotional support for organizations in the form of "palm cards."

In addition to the technical device and fingerstick and venipuncture procedural trainings, non-CPA LHJs will also need to develop the public health and community health modules that are specific to HCV. The sponsor has stated that the process would be the same as when the HCV-specific module was developed for the OA’s HIV training.

Prior Related Legislation. AB 1382 (Roger Hernández), Chapter 643, Statutes of 2011 authorized HIV test counselors to perform HCV or combined HIV/HCV tests in addition to HIV tests.

AB 221 (Portantino), Chapter 421, Statutes of 2009, among other things, removed the HIV counselor training equivalency credit towards a limited phlebotomy technician certification and instead exempted an HIV counselor who works under a licensed physician and surgeon, and who is trained in rapid HIV test proficiency and universal infection control precautions, as specified, from the requirement that he or she hold a valid certification as a phlebotomist technician.

AB 685 (Leno), Chapter 2, Statutes of 2004 provided that HIV counselors that completed HIV counselor training were deemed to have met the requirements for certification as a limited phlebotomy technician.

AB 1263 (Migden), Chapter 324, Statutes of 2001, among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA , as specified.

AMENDMENT(S):

The author should make the following technical amendments:

1. Page 2, line 2, strike “A” and after “(a)” insert:

Notwithstanding any other law, a

1. Page 2, line 8, strike “and, subject to subparagraph (B),” and insert:

and

1. Page 2, line 17, strike:

both

1. Page 2, line 18, strike:

and oral swab tests

1. Page 3, lines 18-19, strike:

This section does not certify a hepatitis C counselor as a phlebotomy technician or a limited phlebotomy technician.

REGISTERED SUPPORT:

Project Inform (sponsor)
Aids Community Research Consortium
Asian Pacific Health Foundation
California Hepatitis Alliance
HIV Education and Prevention Project of Alameda

REGISTERED OPPOSITION:

None on file.

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