BILL ANALYSIS                                                                                                                                                                                                    �







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        |Hearing Date:April 22, 2013        |Bill No:SB                         |
        |                                   |492                                |
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                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                          Senator Curren D. Price, Jr., Chair
                                           

                        Bill No:        SB 492Author:Hernandez
                     As Amended:April 16, 2013          Fiscal:Yes

        
        SUBJECT:   Optometrist:  practice:  licensure.

        SUMMARY:  Permits an optometrist to diagnose, treat and manage  
        additional conditions with ocular manifestations; directs the  
        California Board of Optometry to establish educational and examination  
        requirements and permits optometrists to perform vaccinations and  
        surgical and non-surgical primary care procedures. 

        Existing law:
        
        1)Establishes the California Board of Optometry (Board), within the  
          Department of consumer Affairs, which licenses optometrists and  
          regulates the practice of optometry.  (BPC � 3010.5)

        2)Authorizes the Board to establish educational and examination  
          requirements for licensure.  (BPC � 3041.2)

        3)Defines the practice of optometry as follows:  (BPC � 3041)

           a)   The prevention and diagnosis of disorders and dysfunctions of  
             the visual system;
           b)   Treatment and management of certain disorders and dysfunctions  
             of the visual systems;
           c)   Provision of rehabilitative optometric services;
           d)   Examination of the human eyes;
           e)   Determination of the powers or range of human vision; 
           f)   The prescribing or directing the use of any optical device in  
             connection with ocular exercises, visual training, vision  
             training or orthoptics;
           g)   Prescribing of contact lenses and glasses; and





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           h)   The use of topical pharmaceutical agents for the purpose of  
             the examination of the human eye or eyes for any disease or  
             pathological condition. 

        4)Specifies that an optometrist who is certified to use therapeutic  
          pharmaceutical agents may also diagnose and treat the human eye or  
          eyes or any of its appendages for the following conditions:   (BPC �  
          3041(b)(1))

           a)   Infections;
           b)   Ocular allergies;
           c)   Ocular inflammation, non-surgical in cause except when  
             co-managed with the treating physician and surgeon;
           d)   Traumatic or recurrent conjunctival or corneal abrasions and  
             erosions;
           e)   Corneal surface disease and dry eyes;
           f)   Ocular pain, non-surgical in cause except when co-managed with  
             the treating physician and surgeon; and 
           g)   Glaucoma in patients over the age of 18. 

        5)Permits optometrists to use the following therapeutic pharmaceutical  
          agents:  (BPC � 3041(c))

           a)   Topical miotics;
           b)   Topical lubricants;
           c)   Anti-allergy agents;
           d)   Topical and oral anti-inflammatories;
           e)   Topical antibiotic agents;
           f)   Topical hyperosmotics;
           g)   Topical and oral anti-glaucoma agents;
           h)   Non-prescription medications;
           i)   Oral antihistamines;
           j)   Prescription oral non-steroidal anti-inflammatory agents;
           aa)  Oral antibiotics for treatment of ocular disease;
           bb)  Topical and oral antiviral medication for treatment of:
             i)     Herpes.
             ii)    Viral Keratitis.
             iii)   Herpes Simplex Viral conjunctivitis.
             iv)    Periocular herpes simplex viral dermatitis.
             v)     Varicella zoster viral keratitis.
             vi)    Varicella zoster viral conjunctivitis.
             vii)   Periocular varicella zoster viral dermatitis.
           cc)  Oral analgesics that are not controlled substances; and
           dd)  Codeine with compounds and hydrocodone with compounds with  
             specific restrictions regarding usage timeframe. 






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        6)Specifies that an optometrist who is certified to use therapeutic  
          pharmaceutical agents may also perform the following: 

           a)   Corneal scraping with cultures;
           b)   Debridement of corneal epithelia;
           c)   Mechanical epilation;
           d)   Venipuncture for testing patients suspected of having  
             diabetes;
           e)   Suture removal, with prior consultation with the treating  
             physician and surgeon;
           f)   Treatment or removal of sebaceous cysts by expression;
           g)   Administration of oral fluorescein to patients suspected as  
             having diabetic retinopathy;
           h)   Use of an auto-injector to counter anaphylaxis;
           i)   Ordering of smears, cultures, sensitivities, complete blood  
             count, mycobacterial culture, acid fast stain, urinalysis, tear  
             fluid analysis and X-rays necessary for the diagnosis of  
             conditions or diseases of the eye or adnexa;
           j)   A clinical laboratory test or examination classified as waived  
             under CLIA necessary for the diagnosis of conditions and diseases  
             of the eye or adnexa;
           aa)  Punctal occlusion by plugs, excluding laser, diathermy,  
             cryotherapy or other means constituting surgery;
           bb)  The prescription of therapeutic contact lenses, including  
             lenses or devices that incorporate a medication or therapy the  
             optometrist is certified to prescribe or provide;
           cc)  Removal of foreign bodies from the cornea, eyelid and  
             conjunctiva with any appropriate instrument other than a scalpel  
             or needle; and
           dd)  Lacrimal irrigation and dilation, excluding probing of the  
             nasal lacrimal tract for patients over 12 years of age.

        This bill:

        1)Authorizes an optometrist to do the following:

           a)   Examine, prevent, diagnose and treat and disease, condition or  
             disorder of the visual system, the human eye and adjacent and  
             related structures;
           b)   Prescribe appropriate drugs including narcotic substances;
           c)   Perform minor surgical and non-surgical primary care  
             procedures consistent with an optometrist's education and  
             training;
           d)   Prescribe visual therapy, ocular exercises and rehabilitation  
             services;
           e)   Order laboratory and diagnostic imaging tests;





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           f)   Administer immunizations;
           g)   Diagnose other common primary care conditions which have  
             ocular manifestations; and
           h)   Allow an optometrist, who is working under a protocol with a  
             physician and surgeon, health care facility, medical home,  
             accountable care organization or other system of care to initiate  
             treatment and manage medications for conditions or disorders of  
             the visual system. 

        2)Specifies that the California Board of Optometry shall establish  
          regulations for educational and examination requirements for  
          licensure to ensure optometrists are practicing competently. 

        3)Requires the California Board of Optometry, on or after January 1,  
          2014, to require applicants for licensure as an optometrist to  
          complete Part I-III of the National Board of Examiners in Optometry.

        4)Requires the California Board of Optometry, on or after January 1,  
          2014, to require applicants for licensure as an optometrist to  
          complete an examination on California law and ethics.

        5)Allows the California Board of Optometry, on or after January 1,  
          2014, to require additional examinations to ensure optometrists will  
          be competent in utilizing diagnostic and therapeutic pharmaceutical  
          agents. 

        FISCAL EFFECT:  Unknown.  This bill has been keyed "fiscal" by  
        Legislative Counsel. 

        COMMENTS:
        
        1.Purpose.  This bill is sponsored by the Author.  According to the  
          Author, SB 492 is intended to allow optometrists to practice to the  
          full extent of their education and training in order to expand  
          access to the health care delivery system for the millions of  
          Californians who will have new access to coverage through the  
          implementation of the federal Patient Protection and Affordable Care  
          Act (ACA).  The bill will allow optometrists to diagnose, treat and  
          manage conditions with ocular manifestations.  To ensure public  
          safety is of the highest priority, SB 492 will direct the California  
          Board of Optometry to establish educational and examination  
          requirements of optometrists including, but not limited to,  
          completion of the National Board of Examiners in Optometry  
          examination.  Finally, the bill will permit optometrists to perform  
          vaccinations and allow them to perform surgical and non-surgical  
          primary care procedures requiring no more than topical or local  





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          anesthetic.

        2.Background.  

           a)   The Patient Protections and Affordable Care Act.  On March 23,  
             2010, President Obama signed the Patient Protection and  
             Affordable Care Act (ACA) into federal statute.  The ACA, which  
             states will begin implementing in 2014, represents one of the  
             most significant government expansions and regulatory overhauls  
             of the United States health care system since the passage of  
             Medicare and Medicaid in 1965.  The ACA is aimed at increasing  
             the rate of health insurance coverage for Americans and reducing  
             the overall costs of health care.  It provides a number of  
             mechanisms including mandates, subsidies and tax credits to  
             employers and individuals in order to increase the coverage rate.  
              Additional reforms aim to improve health care outcomes and  
             streamline the delivery of health care.   One salient provision  
             is the requirement for insurance companies to cover all  
             applicants and offer the same rates regardless of pre-existing  
             medical conditions.  

             Opponents of the ACA turned to the federal courts to challenge  
             its constitutionality.  On June 28, 2012, the United States  
             Supreme Court upheld the constitutionality of most of ACA in the  
             case of National Federation of Independent Business vs. Sebelius.  
              Specifically, the Supreme Court upheld the mandate for  
             individuals to purchase health insurance if not covered by their  
             employers on the basis that it is a tax rather than protection  
             under the Commerce Clause.  However, the Supreme Court determined  
             that states could not be forced to participate in the expansion  
             of Medicaid.  As such, all provisions of the ACA will continue in  
             effect or will take effect as scheduled subject to states  
             determination on Medicaid expansion.  In California, efforts are  
             well underway to implement the ACA including Medicaid expansion,  
             also referred to as "Medi-Cal" in California, by 2014. 

           b)   Primary Care Workforce Shortage.   As a result of  
             implementation of the ACA, about 4.7 million additional  
             Californians will be eligible for health insurance beginning in  
             2014.  It is anticipated that the newly insured will increase  
             demand for health care on an already strained system.  For  
             example, according to estimates obtained from the Council on  
             Graduate Medical Education (CGME), the number of primary care  
             physicians actively practicing in California is far below the  
             state's need.  The distribution of these primary care physicians  
             is also poor.  In 2008, there were 69,460 actively practicing  





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             primary care physicians in California, of which only 35 percent  
             reported they actually practiced primary care.  This equates to  
             63 active primary care physicians per 100,000 persons.  However,  
             according to the CGME, 60 to 80 primary care physicians are  
             needed per 100,000 persons in order to adequately meet the needs  
             of the population.  When the same metric is applied regionally,  
             only 16 of California's 58 counties fall within the needed supply  
             range for primary care physicians.  In other words, less than one  
             third of Californians live in a community where they have access  
             to adequate health care services.

           c)   Shortage of Optometrists.  According to a report prepared by  
             the Center for the Health Professions at the University of  
             California San Francisco, the number of optometrist licenses in  
             California has declined, but the number of licensees with a  
             secondary practice location has increased.  According to the  
             California Board of Optometry, there are approximately 9000  
             optometrists in California, the largest population of  
             optometrists in the United States.  These optometrists are  
             generally concentrated in coastal counties, the Bay Area and  
             counties in the Sacramento region.  Several counties have no  
             licensed optometrists with an address of record in those  
             counties, and a number of other counties have ratios that  
             indicate there is approximately one optometrist for every 10,000  
             people.  

           d)   Optometry and Ophthalmology.  This bill would expand the types  
             of procedures an optometrist is authorized to execute.  This  
             would include some tasks that have been traditionally performed  
             by ophthalmologists.  This bill would also require optometrists  
             to consult with ophthalmologists as needed.  As such, the current  
             education, training and scope of each profession is outlined  
             below.  

              i)     Optometrist Education, Training and Scope.   After  
               completion of an undergraduate degree, optometrists complete  
               four years of and accredited optometry college after which they  
               are awarded the Doctor of Optometry degree. Some optometrists  
               also undertake an optional one year non-surgical residency  
               program to enhance their experience in a particular area.   
               Students graduate with 2500-3000 patient encounters; these  
               include a mix of post-surgical, medical and routine visits. 

               Optometrists are trained to diagnose mild to severe eye  
               problems such as serious eye infections, inflammations of the  
               eye, trauma, foreign bodies and glaucoma.  They also examine  





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               the eye for vision prescription and corrective lenses.   
               Optometrists may apply for certification to administer  
               therapeutic pharmaceutical agents (TPA); to perform lacrimal  
               irrigation and dilation (TPL); and to diagnose and treat  
               primary open angle glaucoma (TLG).

              ii)    Ophthalmologist Education, Training and Scope.   After  
               obtaining an undergraduate degree, ophthalmologists complete  
               four years at an accredited medical school and earn a Medical  
               Degree.  This is followed by a one year internship and a three  
               or four year surgical residency.  Many ophthalmologists pursue  
               additional fellowship training in specialized areas such as  
               retina, glaucoma or cornea.  Ophthalmologists may become  
               certified by the American Board of Ophthalmology, which  
               requires, serving as primary surgeon or first assistant to the  
               primary surgeon on a minimum of 364 eye surgeries. 

               The central focus of ophthalmology is surgery and management of  
               complex eye diseases.  An ophthalmologist specializes in the  
               refractive, medical and surgical care of the eyes and visual  
               system and in the prevention of disease and injury. 

           e)   Current and Proposed Scope of Practice for Optometrists.  This  
             bill would expand the scope of practice for optometrists.  The  
             following chart on the next page illustrates some of the salient  
             changes that would be made to the current scope of practice for  
             optometrists. 



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          f)  Other States.  Since 1997, there have been over 45 attempts in  
            over 20 states by optometry associations to legislate surgery  
            privileges for optometrists.  However, with the exception of  
            Oklahoma and West Virginia, most states continue to prohibit  
            optometrists from performing surgery, and their statutes specify  
            that the license to practice optometry does not include the right  
            to practice medicine.  States such as Colorado and North Carolina  
            specifically exclude surgery from their definition of the practice  
            of optometry.  Other states have statutes that delineate between  
            laser and non-laser surgery.  

       3.Arguments in Support.   Blue Shield of California  supports the bill.   
         In their letter they state, "Expanding the range of services that  
         these practitioners are able to provide will improve access and  
         quality of care as they are well trained and highly educated  





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         professionals that are already providing integral health services."

         The  Bay Area Council  also supports the bill.  They note that the bill  
         would expand the range of services optometrists can perform to help  
         ensure that the citizens of our state have access to high-quality  
         primary care.

          Californians for Patient Care  also supports the bill.  In their  
         letter they note, "It is widely noted that there are not enough  
         trained medical professionals to appropriately care for the influx of  
         new patients.  We believe it is important that qualified, educated  
         and trained optometrists be allowed to practice to the extent of  
         their licenses to best serve California's patient population  
         throughout the state."

         The  California Pharmacists Association  wrote a joint letter with the  
          California Society of Health-System Pharmacists.   They write, "CSHP  
         and CPhA believe that it is vital to better utilize all health care  
         providers consistent with their training and education to address  
         current workforce shortages.  By empowering nurse practitioners to  
         provide additional services with greater flexibility, SB 492 is an  
         important part of the equation to meet health system demand."

         The  California Optometric Association  believes that this legislation,  
         "?addresses the health care provider gap by expanding the scope of  
         practice of optometry.  Optometrists are positioned and prepared to  
         be part of the solution to meeting the additional health care needs  
         upon enactment of the ACA in 2014."

         The  United Nurses Associations of California/ Union of Health Care  
         Professionals  supports the bill.  In their letter they indicate, "SB  
         492 would allow optometrists to practice to the full extent of their  
         education and training in order to expand access to the health care  
         delivery system for the millions of Californians who will have new  
         access to coverage through implementation of the federal ACA."

       4.Support if Amended.  The  California Association of Physician Groups   
         supports the bill if it is amended.  They propose the following  
         amendments:

                   Section 3041(a)(2) is overbroad and should be amended to  
               state: "drugs for the treatment of ocular problems including  
               narcotic pain medications for the treatment of pain related to  
               ocular problems." 

                   Section 3041(a)(3) is problematic because most eye surgery  





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               is performed with topical or local anesthetic.  Cataract  
               surgery, for instance, is done with topical/local anesthesia.   
               Perhaps this section can be better defined, such as, "?primary  
               care procedures on the lids, and conjunctiva and cornea that  
               only require topical or local anesthesia." 

                   Section (5)(b).  Because there can be complications from  
               the administration of certain vaccines, notably live vaccines,  
               we suggest that this scope expansion requires an optometrist to  
               have more knowledge of the patient than is reasonable given the  
               limited access to patient records under independent practice,  
               when outside of an integrated, coordinated care system.  We  
               recommend against this section under independent practice.

                   Section (5)(c)(a).  As written, this would allow for the  
               treatment of diabetes; not the ocular manifestations of  
               diabetes, but the illness itself.  Temporal Arteritis is  
               another very serious illness, for example, with ocular  
               manifestations.  We suggest a similar limitation as outlined in  
               the preceding section.  

       1.Arguments in Opposition.  The  California Medical Association  opposes  
         the bill.  They outline several concerns in their letter.  Included  
         is the provision of primary care services that optometrists would be  
         permitted to do if the bill passed.  CMA believes that this is  
         "?beyond the existing scope of practice related to visual disorders  
         and could result in serious harm to patients."  They also note that  
         optometrists "?do not have the training and experience necessary to  
         provide comprehensive primary care.  In addition, "SB 492 would allow  
         optometrists to practice medicine without being subject to the  
         Medical Practice Act.  Currently, optometrists are licensed by the  
         Board of Optometry.  Under SB 492, the scope of practice for  
         optometrists would be expanded to the point where they would be  
         practicing as ophthalmologists, who are required to have a medical  
         license, without being subject to the controls and oversight of the  
         Medical Practice Act."

         The  California Association for Medical Laboratory Technology  also  
         opposes the bill.  They note in their letter, "While we recognize the  
         ability of optometrists to perform certain waived tests limited to  
         their scope of practice, we have concerns about the broad range of  
         testing contained in this bill.  Of greater concern is whether or not  
         optometrists receive the proper education and training to perform as  
         a laboratory director." 

         The  California Academy of Eye Physicians & Surgeons  is concerned  





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         about the expanded scope of practice for optometrists permitted by SB  
         492.  Specifically, they are concerned about the provisions that  
         would allow optometrists to conduct eye surgeries and prescribe  
         medications by all routes with no additional training."

         The  Union of American Physicians and Dentists  shares the Author's  
         concerns regarding expanding health care access to residents of the  
         State of California.  However, SB 492 is a questionable solution.  SB  
         492 rolls out an uncertain health care delivery system with patients  
                                                                        subject to unintended consequences of the bill.  Medical supervision  
         over optometrists is critical to safe patient outcomes.  SB 492  
         raises serious patient safety concerns in allowing optometrists to  
         prescribe medication and perform surgical procedures without and  
         medical supervision." 

         The  Blind Children's Center  notes, "While we support some increased  
         role for optometrists in helping to provide health care, we question  
         whether optometrists, with only a 4-year optometry school education,  
         have the training, education and experience to perform the procedures  
         authorized by the bill.  Many of these procedures should only be  
         performed by experts with many more years of training and  
         experience." 

         The  Lighthouse for Christ Mission Eye Center  and the  Canvasback  
         Missions, Inc.  oppose the bill and state in their letters, "The bill  
         would give optometrists greatly increased privileges, including the  
         ability to treat any disease that might have a "manifestation" in the  
         eye without additional specific training requirements.  The Board of  
         Optometry, whose members have no experience doing surgery or treating  
         the added diseases would be allowed to decide those training  
         requirements." 

          Here4Them Inc.  , provides aid to children and adults who have been  
         abandoned, orphaned, disadvantaged, threatened or are in high risk  
         situations.  They oppose the bill and note, "Since we have organized  
         cataract surgery projects, we are well aware of the importance of  
         skilled professionals for eye surgeries.  When one is used to highly  
         qualified medical ophthalmologists with 100% success rates in  
         surgery, how could the possibility of less trained professionals even  
         be a consideration?  It is important to provide more access to health  
         care, but not at the cost of the best possible care."

         The  California Society of Anesthesiologists  also opposes SB 492.  In  
         their letter they argue, 
         "SB 492 would allow the diagnosis and initiation of treatment of any  
         condition with ocular manifestation.  This is a broad and unclear  





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         authorization that has not attained scientific consensus.  It is not  
         a sufficient basis to authorize comprehensive primary care.  Also, by  
         granting full drug prescribing authority to optometrists, the bill  
         would add a new category of authorized controlled substance  
         prescribers at a time when more controls are being sought over  
         excessive prescribing."

       2.Oppose Unless Amended.  The  Osteopathic Physicians & Surgeons of  
         California  (OPSC) have taken an oppose unless amended position on SB  
         492.  They state, "While optometrists play an important role in the  
         provision of health care to patients in California, their current  
         education and training requirements fall far short of the knowledge  
         base necessary to safely and appropriately treat the complete health  
         of patients.  OPSC finds it unconscionable that a health care  
         provider with education and training limited to a specific area of  
         the body be given broad authority to provide treatment that has  
         implications for health of the entire body." 

         The  California Academy of Family Physicians  also has an oppose unless  
         amended position.  
         They note, "Physicians see many benefits from working collaboratively  
         with other health care professionals to meet patient care demand, but  
         the framework of care delivery should be within the scope of practice  
         that each health care professional is qualified to perform.   
         Arbitrarily allowing allied health care professionals to  
         independently practice medicine or to render services that are beyond  
         a providers scope can lead to increased costs through over  
         utilization of tests, over prescribing of medications and excess  
         referrals to specialists." 

       3.Current Related Legislation.   SB 491  (Hernandez, 2013) deletes the  
         requirement that Nurse Practitioners perform certain tasks pursuant  
         to standardized procedures and/or consultation with a physician or  
         surgeon and authorizes a Nurse Practitioner to perform those tasks  
         independently.  Also requires, after July 1, 2016, that Nurse  
         Practitioners possess a certificate from a national certifying body  
         in order to practice.  (  Note  : The bill is up for consideration before  
         the BP&ED Committee today)

        SB 493  (Hernandez, 2013) authorizes a pharmacist to administer drugs  
         and biological products that have been ordered by a prescriber.   
         Expands other functions pharmacists are authorized to perform, and  
         authorizes pharmacists to order and interpret tests for the purpose  
         of monitoring and managing the efficacy and toxicity of drug  
         therapies and to independently initiate and 






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       administer routine vaccinations.  Also establishes board recognition  
         for an advanced practice pharmacist.  (  Note  : The bill is up for  
         consideration before the BP&ED Committee today)

       4.Prior Related Legislation.   SB 668  (Polanco, Chapter 13, Statutes of  
         1996) expanded the scope of practice of optometrists to provide for  
         the diagnosis and treatment of specified conditions or diseases of  
         the human eye or its appendages, and to use other therapeutic  
         pharmaceutical agents.

          SB 929  (Polanco, Chapter 676, Statutes of 2000) expanded the scope of  
        lawful practice for  
         optometrists by specifying additional diseases and conditions that  
         optometrists may treat (in particular certain types of glaucoma) with  
         specified medications, and  by specifying the extent of physician  
         involvement that is required under various circumstances.

          SB 1406  (Correa, Chapter 352, Statutes of 2008) specified permissible  
         procedures for certified optometrists, and created the Glaucoma  
         Diagnosis and Treatment Advisory Committee to establish glaucoma  
         certification requirements. 


        SUPPORT AND OPPOSITION:
        
         Support:  

        Bay Area Council
        Blue Shield of California
        California Optometric Association
        California Pharmacists Association/ California Society of  
        Health-System Pharmacists
        Californians for Patient Care
        United Nurses Associations of California/Union of Health Care  
        Professionals
        Western University of Health Sciences
        2 individuals

         Support if Amended:

         California Association of Physician Groups

         Opposition:
         
        California Medical Association
        Blind Children's Center





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        California Academy of Eye Physicians & Surgeons
        California Association for Medical Laboratory Technology
        California Society of Anesthesiologists
        Canvasback Missions Inc.
        Here4Them
        Lighthouse for Christ Mission Eye Center
        Union of American Physicians and Dentists
        Over 100 letters from employees and parents of children of the Blind  
        Children's Center
        Hundreds of individuals
         
        Oppose Unless Amended:

         California Academy of Family Physicians
        Osteopathic Physicians & Surgeons of California



        Consultant: Le Ondra Clark, Ph.D.