BILL ANALYSIS Ó AB 757 Page 1 Date of Hearing: April 28, 2015 ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS Susan Bonilla, Chair AB 757 (Gomez) - As Amended March 26, 2015 SUBJECT: Healing arts: clinical laboratories. SUMMARY: Authorizes a medical assistant, who meets specified criteria, to perform a total protein refractometer test analysis in a licensed plasma collection facility in this state. EXISTING FEDERAL LAW: 1)Regulates laboratory testing and requires that clinical laboratories obtain a certificate before accepting materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or the impairment of, or assessment of the health of human beings. (Clinical Laboratory Improvement Amendments (CLIA), Title 42 United States Code (USC) § 263a) 2)Classifies laboratory tests using three categories: "waived tests," "moderate complexity," or "high complexity." (Title 42 Code of Federal Regulations (CFR) § 493.5) 3)Defines "waived tests" as simple laboratory examinations and AB 757 Page 2 procedures which: 1) are cleared by Federal Food and Drug Administration (FDA) for home use; 2) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or 3) pose no reasonable risk of harm to the patient if the test is performed incorrectly. (42 CFR § 493.15) 4)Specifies nine types of tests that are automatically categorized as waived: 1) various dipstick or tablet reagent urinalysis (non-automated), including protein; 2) fecal occult blood; 3) ovulation tests-visual color comparison tests; 4) urine pregnancy tests-visual color comparison tests; 5) erythrocyte sedimentation rate-non-automated; 6) hemoglobin-copper sulfate-non-automated; 7) blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; 8) spun microhematocrit; and 9) hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. (42 CFR § 493.15) 5)Requires laboratories to ensure that each individual performing moderate complexity testing possesses a current license issued by the state where laboratory is located, if a license is required, and meet one of the following requirements: (42 CFR § 493.1423) a) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution. b) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution. AB 757 Page 3 c) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). d) Have earned a high school diploma or equivalent, and have documentation of training appropriate for the testing performed prior to analyzing patient specimens. 6)Defines a refractometer as a device used to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions. (21 CFR § 862.2800(a)) EXISTING STATE LAW: 7)Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health (CDPH), with specified exceptions. (BPC § 1200-1327) 8)Prohibits a person from performing a test classified as of moderate complexity test under CLIA unless the test is performed under a laboratory director, as described in BPC § 1209, the laboratory director provides documentation of the adequacy of the qualifications and competency of the personnel, and the test is performed by any of the following individuals: (BPC § 1206.5) AB 757 Page 4 a) A licensed physician and surgeon; b) A licensed podiatrist or a licensed dentist; c) A person licensed to engage in clinical laboratory practice or to direct a clinical laboratory; d) A certified local health officer; e) A licensed physician assistant if authorized by a supervising physician and surgeon; f) A registered nurse; g) A perfusionist if authorized under BPC § 2590; h) A respiratory care practitioner; i) A person certified to perform nuclear medicine technology under CDPH; j) Any person if performing blood gas analysis in compliance with BPC § 1245; aa)A certified or licensed emergency medical technician II or paramedic while providing prehospital medical care; and, bb)A person licensed as a psychiatric technician, as a vocational nurse, or as a licensed midwife, or certified by AB 757 Page 5 the CDPH as a nurse assistant or a home health aide, who provides direct patient care, if the person meets the following: i) Is performing the test as an adjunct to the provision of direct patient care by the person; ii)Is utilizing a point-of-care laboratory testing device at a site for which a laboratory license or registration has been issued; iii)Meets the minimum clinical laboratory education, training, and experience requirements set forth in regulations adopted by the CDPH; and, iv)Has demonstrated to the satisfaction of the laboratory director that the person is competent in the operation of the point-of-care laboratory testing device for each analyte to be reported. cc)Any person within a physician office laboratory if the test is performed under the supervision of the patient's physician and surgeon or podiatrist who is accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed, and meets the following: i) Ensures that the person is performing test methods as required for accurate and reliable tests; and ii)Has personal knowledge of the results of the clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory. dd)A pharmacist, if ordering drug therapy-related laboratory. 9)Authorizes a medical assistant to do the following: (BPC § 2069) AB 757 Page 6 a) Administer medication through intradermal, subcutaneous, or intramuscular injections; and, b) Perform skin tests and additional technical supportive services upon the specific authorization and supervision of a licensed physician and surgeon or a licensed podiatrist. A medical assistant may also perform all these tasks and services upon the specific authorization of a physician assistant, a nurse practitioner, or a certified nurse-midwife. 10) Defines a "medical assistant" as a person who may be unlicensed who meets the following: (BPC § 2029(b)(1)) a) Performs basic administrative, clerical, and technical supportive services for a licensed physician and surgeon, a licensed podiatrist, a medical or podiatry corporation, a physician assistant, a nurse practitioner, or a certified nurse-midwife, or a health care service plan; b) At least 18 years of age; and, c) Has had at least the minimum amount of hours of appropriate training pursuant to standards established by the Medical Board. 11) Defines "specific authorization" as a specific written order or a standing order prepared by the supervising physician and surgeon, podiatrist, physician assistant, nurse practitioner, or certified nurse-midwife, authorizing the procedures to be performed on a patient. (BPC § 2069(b)(2)) 12) Defines "supervision" as the supervision of procedures authorized by this section by the following practitioners, within the scope of their respective practices, who shall be physically present in the treatment facility during the performance of those procedures: (BPC § 2069(b)(3)) AB 757 Page 7 a) A licensed physician and surgeon; b) A licensed podiatrist; and, c) A physician assistant, nurse practitioner, or certified nurse-midwife as provided in subdivision (a). 13) Defines "technical supportive services" as simple routine medical tasks and procedures that may be safely performed by a medical assistant who has limited training and who functions under the supervision of a licensed physician and surgeon, a licensed podiatrist, a physician assistant, a nurse practitioner, or a certified nurse-midwife. (BPC § 2069(b)(4)) THIS BILL: 14) Authorizes a medical assistant, as defined in BPC § 2069, to perform a total protein refractometer test analysis in a licensed plasma collection facility in this state if all of the following conditions are met: a) The medical assistant has earned a high school diploma or equivalent, as determined by Health Care Financing Administration (HCFA) under CLIA. b) The medical assistant performs the total protein refractometer test analysis in a licensed plasma collection facility. c) The medical assistant been instructed by a physician and surgeon licensed in this state or by a licensed clinical laboratory director who is in charge of the licensed plasma collection facility in the proper procedure to be employed AB 757 Page 8 when performing a total protein refractometer test analysis. d) The medical assistant performs the total protein refractometer test analysis under the direction and supervision of the physician and surgeon or licensed clinical laboratory director. e) The medical assistant submits the analysis for interpretation to the physician and surgeon or licensed clinical laboratory director under whose direction and supervision he or she performed the analysis. 15) States that no reimbursement is required pursuant to Section 6 of Article XIII B of the California Constitution, as specified. FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel. COMMENTS: 16)Purpose. This bill is sponsored by Grifols, Inc . According to the author, "Plasma donation centers are critical to ensuring the availability of therapies that treat rate, chronic, and sometimes life-threatening diseases. AB 757 would authorize a medical assistant who meets specified criteria to perform a total protein refractometer test analysis - a standard, mostly automated procedure performed during donor intake and assessment to determine donor eligibility - in state licensed plasma collection facility in California. This will help promote efficiencies, where appropriate, in the biomedical industry while continuing to prioritize patient health and safety." AB 757 Page 9 17)Background. At the federal level, laboratories that perform tests on human specimens are certified under CLIA. The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether a test system is waived, moderate or high complexity for each. In general, the more complicated the test, the more stringent the requirements under CLIA. As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result. They include certain tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category on the basis of seven criteria given in the CLIA regulations. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. In California, anyone may perform a waived test in a licensed laboratory. However, only licensed or certified individuals may perform moderate complexity tests, for instance, a medical laboratory technologist (MLT) under BPC § 1260.3. There is are two exceptions for unlicensed individuals to perform a moderate complexity test in California, and that is for a blood gas analysis under BPC § 1245 and anyone in a physician's office laboratory with a physician readily available. Because medical assistants are unlicensed and there is no exception for them, they cannot perform moderate or high complexity tests. Total Protein Refractometer Test. According to the sponsors, Grifols measures a potential plasma donor's total protein levels as part of the initial screening process. In general, the measurement of total protein uses an instrument called a AB 757 Page 10 refractometer. A refractometer is a device that shines a beam of light through a sample of liquid. The device measures the amount of light that is refracted (bent) due to the solids in the sample. In blood, protein causes light to bend. The greater the amount of protein, the more light is bent from the light path. There are multiple types of protein refractometer devices, ranging from manual to automatic and digital. However, the FDA's medical device database shows that the FDA has classified all total protein refractometer devices as of moderate complexity under CLIA. There are other types of devices that can measure total protein, such as chemical analyzers using whole blood. The FDA has classified most of the whole blood chemical analyzers as waived. CLIA Waiver by Application. The sponsor points out that the type of refractometer device it uses to perform total protein tests is very simple to use and does not require special training. However, because the device is so simple to use, it is unclear why it was not classified as waived. Further, it is unclear why the manufacturer did not try to obtain a waiver by application. The sponsor believes that there was no financial incentive. A manufacturer may submit a CLIA waiver by application if it thinks the FDA has mistakenly categorized the test. For example, if the FDA initially categorized a test as moderately complex, but the manufacturer believes the test is simple to use, it may submit a CLIA waiver by application to request re-categorization as waived. AB 757 Page 11 A CLIA waiver by application must demonstrate in clinical studies conducted at the intended use sites that the test is accurate and poses little to no risk of incorrect results. It must also include the following information: a) A description of the device that demonstrates it is simple to use. b) The results of risk analysis including the identification of potential sources of error for your device. c) The results of flex studies demonstrating insensitivity of the test system to environmental and usage variations under conditions of stress. d) The results of risk evaluation and control including a description of (1) measures you have implemented to mitigate the risk of errors, and (2) validation and/or verification studies demonstrating the ability of failure alert, fail-safe mechanisms, and other control measures that you have incorporated into your device to mitigate the risk of errors, even under conditions of stress. e) A description of the design and results of clinical studies you conducted to demonstrate that the device has an insignificant risk of erroneous results in the hands of the intended user (hereinafter operator). f) Proposed labeling with instructions for use consistent with a device that is "simple." ARGUMENTS IN SUPPORT: AB 757 Page 12 Grifols, Inc. (sponsor) writes in support, "a total protein refractometer test can be administered in 48 states by a trained healthcare professional equivalent to what California defines as a medical assistant. However, California law does not authorize this simple, almost entirely automated test to be conducted by a highly trained and supervised medical assistant at a licensed plasma donation center. AB 757 represents a minor expansion in the tasks authorized for medical assistants, especially given the unique setting, virtual automation of the subject test and the array of supervisory, licensed health care personnel in the plasma collection center - including the responsible physician and surgeon and/or other licensed 'facility' manager. The end goal of this measure is to help licensed plasma donation centers operate more efficiently by authorizing a medical assistant to conduct this simple task as part of the donor intake process." The Blood Centers of California writes in support, "The need for source plasmas - defined as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use is growing. Source plasma is used to develop plasma based medicines and therapies which are used to treat over eighty diseases. Assuring that eligible, trained personnel are available for this growing segment of the blood industry is necessary. We support the designation of a "donor center processor' as the staff who can perform the" simple, automated total protein refractometer". AB 757 will assure that licensed plasma centers have the appropriate staff carrying out the necessary functions to obtain and process source plasma which is converted into life sustaining medicines and therapies." AB 757 Page 13 ARGUMENTS IN OPPOSITION: The California Association for Medical Laboratory Technology writes in opposition, "The primary function of the total protein analysis is to provide an accurate and precise value in order to ensure donor safety prior to donating plasma. An erroneously performed analysis, like a false negative result, which allows the plasma center to proceed with the donation, could cause significant donor harm. As a result, the regulatory agencies have mandated that the individuals performing the total protein test must have demonstrated a higher level of education and training such as those individuals listed in BPC section 1206.5 (b). Plasma donors are paid. They can donate every two weeks if their total protein is at least 6 g/dL. Many plasma collection centers "bleed" their donors down to 6 g/dL of protein regularly. If the protein refractometer test and/or calibration is done incorrectly and the protein read is higher than it actually is, there is a potential to over "bleed" a donor causing donor harm, such as death from untreated low protein, immune deficiency, heart and respiratory problems, bruising, insufficient blood clotting, muscle wasting and reduced energy. In short, the current personnel standard needs to be maintained." The California Society of Pathologists writes in opposition, "We believe that this type of legislation that would seek to carve out certain tests from the CLIA and state personnel requirements will only lessen the quality of testing? There are existing laboratory personnel who can perform this test. We believe maintaining that standard is preferable to undoing the existing test classification system that is universal to clinical laboratory practice. That system is designed to maintain test result integrity and protection for patients." AB 757 Page 14 The Engineers & Scientists of California, IFPTE Local 20 , writes in opposition, "ESC, which represents Clinical Laboratory Scientists, strongly believes that having unlicensed, untrained individuals performing these tests, even if its moderate to low complexity, isn't good for patient safety. It's going backwards to a time before phlebotomy certification." POLICY ISSUES FOR CONSIDERATION: This bill seeks to carve out a narrow personnel exception for a specific device that performs a moderately complex test on human blood. According to the sponsors, the device is used in the very initial screening process, and even if there was an error in the testing, the rest of the intake process will properly screen the individual. However, there are other waived devices that the sponsor can use without having to make a special exception in law. The sponsor has stated that it is in process switching to a waived device. AMENDMENTS: 18)Insert a three year sunset provision to provide the sponsor an opportunity to finish switching to a waived device. On page 2, between lines 26-27, insert subdivision (b): (b) This section shall remain in effect only until January 1, 2019, and as of that date is repealed. 19)Narrow the class of test to ensure that only the device the sponsor wants excluded is included in the bill: AB 757 Page 15 On page 2, between lines 12-13, insert: (2) He or she performs the total protein refractometer test analysis using an automatic, button-operated refractometer with a digital readout. 20)Make conforming changes: On page 2, line 7, before "A" insert subdivision (a): (a) On page 2, line 11, strike out "(a)" and insert: (1) On page 2, line 13, strike out "(b)" and insert: (3) On page 2, line 15, strike out "(c)" and insert: (4) On page 2, line 20, strike out "(d)" and insert: AB 757 Page 16 (5) On page 2, line 23, strike out "e" and insert: (6) REGISTERED SUPPORT: Grifols, Inc. (sponsor) Blood Centers of California REGISTERED OPPOSITION: California Association for Medical Laboratory Technology California Society of Pathologists Engineers & Scientists of California, IFPTE Local 20 Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301 AB 757 Page 17