Existing law provides for the regulation and licensure of clinical laboratories and clinical laboratory personnel by the State Department of Public Health and makes a violation of a provision under this law a misdemeanor. Existing law authorizes a person to request, and a licensed clinical laboratory or public health laboratory to perform specified clinical laboratory tests, including pregnancy, glucose level, cholesterol, and occult blood tests. Existing law authorizes a registered clinical laboratory to perform these tests if the test is subject to a certificate of waiver under the Clinical Laboratory Improvement Amendments of 1988 and the laboratory has registered with the State Department of Public Health.

Existing law authorizes the results of the test to be provided directly to the person requesting the test if the test is on or for his or her own body. Existing law requires that those test results be provided in a manner that presents clear information and that identifies results indicating the need for referral to a physician.

This bill would repeal those provisions and instead allow a person to request, and a licensed clinical laboratory or public health laboratory to perform, any laboratory test that the laboratory offers to the public on a direct access basis without a health care providers request. healing arts licensees order. If a laboratory test of a person is conducted by or under the supervision of a person other than a health care provider and not at the request or with the written authorization of a health care provider, without an order from a healing arts licensee, the bill would require any report of the test results to be provided by the person conducting the test to the person who was the subject of the test. The bill would require the report to state in bold type that it is the responsibility of the person who was tested to arrange with the persons his or her health care provider for consultation and interpretation of the test results. The bill would make additional conforming changes. By changing the definition of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law provides for the regulation and licensure of clinical laboratories and clinical laboratory personnel by the State Department of Public Health and makes a violation of a provision under this law a misdemeanor. Existing law authorizes a person to request, and a licensed clinical laboratory or public health laboratory to perform, perform specified clinical laboratory tests, including pregnancy, glucose level, cholesterol, and occult blood, and other specified blood tests. Existing law authorizes a registered clinical laboratory to perform these tests, as specified. tests if the test is subject to a certificate of waiver under the Clinical Laboratory Improvement Amendments of 1988 and the laboratory has registered with the State Department of Public Health.

Existing law authorizes the results of the test to be provided directly to the person requesting the test if the test is on or for his or her own body. Existing law requires that those test results be provided in a manner that presents clear information and that identifies results indicating the need for referral to a physician.

This bill would make technical, nonsubstantive changes to these provisions. repeal those provisions and instead allow a person to request, and a licensed clinical laboratory or public health laboratory to perform, any laboratory test that the laboratory offers to the public on a direct access basis without a health care providers request. If a laboratory test of a person is conducted by or under the supervision of a person other than a health care provider and not at the request or with the written authorization of a health care provider, the bill would require any report of the test results to be provided by the person conducting the test to the person who was the subject of the test. The bill would require the report to state in bold type that it is the responsibility of the person who was tested to arrange with the persons health care provider for consultation and interpretation of the test results. By changing the definition of an existing crime, this bill would impose a state-mandated local program.

Existing law provides for the regulation and licensure of clinical laboratories and clinical laboratory personnel by the State Department of Public Health and makes a violation of a provision under this law a misdemeanor. Existing law authorizes a person to request, and a licensed clinical laboratory or public health laboratory to perform, pregnancy, glucose level, cholesterol, occult blood, and other specified tests. Existing law authorizes a registered clinical laboratory to perform these tests, as specified.

Existing law authorizes the results of the test to be provided directly to the person requesting the test if the test is on or for his or her own body. Existing law requires that those test results be provided in a manner that presents clear information and that identifies results indicating the need for referral to a physician.

This bill would make technical, nonsubstantive changes to these provisions.

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2015 - 2016 Regular

Bill No: SB 1418 Hearing Date: April 18, 2016

Subject: Clinical laboratory testing

SUMMARY:

Allows direct access laboratory (lab) testing and does not require a healing arts licensee to review the results of a lab test he or she did not order.

Existing state law:

1. Provides for the licensure, registration, and regulation of clinical laboratories and various clinical lab personnel, including cytotechnologists, by the California Department of Public Health. (Business and Professions Code (BPC) §§ 1200-1327)
2. States that the chapter regulating clinical labs does not authorize any person to practice medicine and surgery or to furnish the services of physicians for the practice of medicine and surgery. Current law further emphasizes that the chapter does not repeal or in any manner affect any provision of this code relating to the practice of medicine. (BPC § 1240)
3. Defines “diagnose” or “diagnosis” for the purposes of regulating the practice of medicine to include any undertaking by any method, device, or procedure whatsoever, and whether gratuitous or not, to ascertain or establish whether a person is suffering from any physical or mental disorder. Such terms shall also include the taking of a person’s blood pressure and the use of mechanical devices or machines for the purpose of making a diagnosis and representing to such person any conclusion regarding his or her physical or mental condition. (BPC § 2038)
4. States that any person may request, and any registered lab may perform, the following waived lab tests: pregnancy, glucose level, cholesterol, occult blood, and any other test for which there is a test 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. The results from any test may be provided directly to the person requesting the test if the test is on or for his or her own body. These test results shall be provided in a manner that presents clear information and that identifies results indicating the need for referral to a physician and surgeon. (BPC § 1246.5)
5. Requires a person conducting or operating a clinical lab to accept assignments for tests only from and make reports only to persons licensed under the provisions of law relating to the healing arts or their representatives. A report of results issuing from a clinical lab shall show clearly the name and address of the lab and the name of the director. (BPC § 1288)

Existing federal law:

1. Establishes conditions that laboratories must meet for certification to perform testing on human specimens under Clinical Laboratory Improvement Amendments (CLIA). (Title 42, Code of Federal Regulations (CFR) § 493.1)
2. Establishes standard requirements for information presented on clinical lab test reports. (42 CFR § 493.1291)

This bill:

1. Authorizes a person to request, and a licensed clinical lab or public health lab to perform, any lab test that the laboratory offers to the public without an order from a healing arts licensee or their representative.
2. States that if a lab test of a person is conducted without an order from a healing arts licensee or their representative, the test results shall be provided to the person who was the subject of the test.
3. Requires the test results report to state in bold type that it is the responsibility of the person who was tested to arrange with his or her health care provider for consultation and interpretation of the test results.
4. States that a healing arts licensee is not required to review or act on a lab test result if the healing arts licensee or their representative did not order the lab test. States that a healing arts licensee shall not be subject to liability or disciplinary actions for failure to review or act on the results of a lab test of any person if the healing arts licensee or their representative did not order the lab test.
5. States that it does not require that any lab test be covered by a health care service plan contract or health insurance policy.
6. Deletes provisions of law requiring assignments for tests only from and to make reports only to persons licensed under the provisions of law relating to the healing arts or their representatives.

FISCAL EFFECT:

This bill is keyed “fiscal” by the Legislative Counsel.

COMMENTS:

1. Purpose. This bill is Author sponsored. According to the Author’s office, “this bill would remove barriers in existing law regarding individuals ordering their own laboratory tests. It would open the market for Californians to all laboratory tests, with [sic] having to be symptomatic in order to get a doctor to order the test and insurance to pay for it.

“The current restrictions ultimately result in costly outcomes for patients and the health system itself, and inhibit[s] individuals from accessing tests that will help them prevent disease and illness, leading the State to be at the forefront of a nationwide movement towards increased patient engagement, autonomy, and personal ownership of health outcomes.”

1. Background. The traditional gatekeeper model of healthcare requires a licensed healthcare provider to order lab testing for his or her patient. The patient is tested by a lab, which then provides the results to the provider who interprets the results and consults with the patient. However, deviations in this model began to appear in the 1950s, according to a 2012 policy paper by the American Society for Clinical Laboratory Science, when certain over-the-counter (OTC) urine tests became available. This progression accelerated with home diabetes testing, increasing availability of other OTC tests, and now the marketplace is opening further to accommodate direct access testing for those tests a lab makes available to the public.
2. State access laws. California currently allows individuals to obtain pregnancy, glucose, cholesterol, occult blood, and any other OTC tests approved by the FDA without an order from a healthcare licensee.

According to information provided by Theranos, a company that provides direct access testing, nine states allow consumers to order some tests directly from a lab. Last year, Arizona passed HB 2645, which made it the first state to explicitly allow consumers to order any publicly available test directly.

1. Regulation of laboratory developed tests (LDTs). As direct access testing gathers momentum and companies develop new technologies and business strategies to adapt, concerns have been raised about the regulation of laboratory developed tests (LDT).

FDA defines a LDT as an in vitro diagnostic test that is intended for clinical use and designed, manufactured, and used within a single lab. LDTs are a significant part of the direct access test market. While LDTs were explicitly included in the 1976 Medical Device Amendments to the Food, Drug and Cosmetic (FD&C) Act, by its own admission, FDA has generally not enforced those provisions.

The Centers for Medicare & Medicaid Services (CMS) regulates laboratories, including those that develop LDTs, under CLIA. CLIA governs the accreditation, inspection and certification process for laboratories, but they do not assess the clinical validity of a LDT (i.e., the accuracy with which the test identifies, measures, or predicts the presence or absence of a clinical condition or predisposition in a patient).

The Office of Public Health Strategy and Analysis Office within the FDA issued a report on November 16, 2015 that argued for increased FDA oversight of LDTs titled “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies of the Commissioner Food and Drug Administration.”

The report states, “As technology and science have advanced, LDTs have increased in complexity and availability and are now used to diagnose common, serious medical conditions, including cancer and heart disease. Others guide therapy for these and other conditions, while still others predict one’s personal risk of developing a particular disease. Some individual laboratories that initially developed LDTs have now morphed into separate businesses that market complex tests nationwide. These activities take place in much larger populations than the local or limited patient populations who may have used these products four decades ago. As the field of medicine evolves, the need for accurate, reliable, and clinically meaningful tests is essential. …But inaccurate or unreliable LDTs and unsupported or disproven claims can undermine progress in Precision Medicine and other fields.”

In addition to the lack of clinical validation, the report notes the following concerns about LDTs:

• Deficient adverse event reporting.
• No premarket review of performance data.
• Unsupported manufacturer claims.
• Inadequate product labeling.
• Lack of transparency.
• Threats to the scientific integrity of clinical trials.
• No comprehensive listing of all LDTs currently being used.

Thus, while CLIA oversight is important, it alone does not ensure that LDTs are properly designed, consistently manufactured, and are safe and effective for patients.

FDA released a Draft Guidance for Regulatory Oversight of LDTs (Guidance) on July 31, 2014 and intends to finalize it this year. The Guidance describes a risk-based framework for regulating LDTs based on the existing medical device classification system. According to the Guidance, “In determining the risk an LDT poses to the patient and/or the user, FDA will consider several factors including whether the device is intended for use in high risk disease/conditions or patient populations, whether the device is used for screening or diagnosis, the nature of the clinical decision that will be made based on the test result, whether a physician/pathologist would have other information about the patient to assist in making a clinical decision (in addition to the LDT result), alternative diagnostic and treatment options available to the patient, the potential consequences/impact of erroneous results, [and] number and type of adverse events associated with the device, etc.“ Tests will be divided into three classes, on which FDA intends to issue specific information within 18 months of the Guidance’s finalization.

This Guidance is timely because Theranos, an innovator in the direct access space, has been recently highlighted in the media about concerns with its LDT testing and clinical practices. CMS issued a letter in January 2016 indicating Theranos’ facility was not in compliance with certification standards for CLIA and that their “deficient practices” pose “immediate jeopardy to patient health and safety.” The following month, The Journal of Clinical Investigation published a report questioning Theranos’ lab results. The Journal published a study that tested 60 healthy adults using Theranos’ proprietary finger prick method (in which a smaller volume of blood is drawn from a patient’s finger) and a traditional blood draw from two other major clinical testing services, Quest and LabCorp, to compare the respective accuracy in 22 common clinical lab tests. The analysis indicated concerns with Theranos’ testing system because the samples were rejected at a higher rate than the other companies,’ and there were significant variations in results between the testing services.

The report concluded that, “While laboratory practice standards exist to control this variability [in testing services, sample collection times, and subjects that influenced the lab results], the disparities between the testing services we observed could potentially alter clinical interpretation and health care utilization. Greater transparency and evaluation of testing technologies would increase their utility in personalized health management.” Essentially, broad use of LDT may not be in the best interests of consumers until better regulation of the quality of the testing and results are available.

1. Test results interpretation California law restricts the ability to diagnose to certain licensed healthcare providers. “Diagnose,” as defined in law, includes the use of mechanical devices for the purpose of representing any conclusion regarding a person’s medical condition. Giving consumers direct access to lab results places labs in a delicate position of informing results without implying disease.

This bill will require test results reports to state in bold type that it is the responsibility of the person who was tested to arrange with his or her health care provider for consultation and interpretation of the test results. Healthcare providers are also exempt from liability for failing to review or act on a lab report that he or she did not order.

1. Policy considerations. Current law restricts the authority for broad lab testing to licensed healthcare providers who are in a better position than most consumers to understand the possibilities and limitations of various lab tests. Acknowledging the market deficiencies raised by the FDA and its planned regulatory intervention, policymakers should consider whether California should allow consumers direct access to lab tests in advance of federal regulation, given the potential significant health impacts of false positives and negatives.
2. Author’s amendments. The Author is accepting the following amendments to ensure greater quality for laboratory processes and testing:

On page 2, line 6, after “a,” insert “laboratory certified by CLIA or a CLIA authorized accreditor to perform high complexity tests”

On page 2, line 6, delete “licensed clinical laboratory or public health”

On page 2, line 7 delete the first “laboratory” and after “any,” insert “FDA-approved”

On page 2, line 8, after “public,” insert “on a direct access basis”

SUPPORT AND OPPOSITION:

Support: None on file.

Opposition: None on file.

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