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<regulation prefix="Regulation" num=".04" citation="COMAR 10.28.12.04" title_num="10" subtitle_num="28" chapter_num="12" heading="Standards of Quality for Therapeutically Certified Optometrists and Optometric Care.">
  <paragraph num="A.">
    <text>The therapeutically certified optometrist shall provide clinical therapeutic eye care consistent with published, universally accepted practice or clinical guidelines and standards of care.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The therapeutically certified optometrist shall adhere to the additional guidelines and standards of care given in §§C—T of this regulation.</text>
  </paragraph>
  <paragraph num="C.">
    <text>The therapeutically certified optometrist shall ensure that:</text>
    <paragraph num="(1)">
      <text>TPA records are consistent with the Subjective, Objective, Assessment, and Plan (SOAP) format;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Assessment and plans are consistent with the patient's subjective and clinical findings; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>TPA records are complete and legible.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The therapeutically certified optometrist shall document the following data, if applicable, for each TPA patient visit or communication:</text>
    <paragraph num="(1)">
      <text>Date of service;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Current Procedural Terminology (CPT) Code, most recent edition;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>International Classification of Diseases (ICD) Code, most recent edition;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Medication/treatment provided; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Follow-up recommendation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The therapeutically certified optometrist shall document the following data as part of the patient's permanent file:</text>
    <paragraph num="(1)">
      <text>Name;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Date of birth;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Name of the doctor to whom the patient is referred, appointment date, and documentation that the patient or guardian preferred to schedule the referral appointment on their own;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Record of tests administered and the results of the tests;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Written reports of other consultations, referrals received, or both; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Documentation of the occurrence of any adverse reaction.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>The therapeutically certified optometrist shall provide for 24-hour emergency coverage.</text>
  </paragraph>
  <paragraph num="G.">
    <text>The therapeutically certified optometrist shall have a medical kit for treating anaphylactic emergencies available at each location where patients are seen.</text>
  </paragraph>
  <paragraph num="H.">
    <text>The therapeutically certified optometrist shall be certified in CPR.</text>
  </paragraph>
  <paragraph num="I.">
    <text>The therapeutically certified optometrist shall have a written plan for responding to emergencies, including specific plans for referral to hospital emergency rooms, emergency ambulatory centers, ophthalmologists, or other appropriate medical doctors when necessary at each location where patients are seen.</text>
  </paragraph>
  <paragraph num="J.">
    <text>The therapeutically certified optometrist shall comply with:</text>
    <paragraph num="(1)">
      <text>Applicable national and State standards of infection control at each office; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Principles of universal precautions as defined in COMAR 10.06.01.02B(10).</text>
    </paragraph>
  </paragraph>
  <paragraph num="K.">
    <text>The therapeutically certified optometrist shall maintain a written tracking system to identify patients who are being followed or referred for emergency sight or life-threatening conditions and who fail to keep appointments.</text>
  </paragraph>
  <paragraph num="L.">
    <text>The therapeutically certified optometrist shall document that a patient who fails to keep an appointment for an emergency sight or life-threatening condition was contacted by:</text>
    <paragraph num="(1)">
      <text>Telephone;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Electronic mail or other electronic means;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Text message; or</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Mail.</text>
    </paragraph>
  </paragraph>
  <paragraph num="M.">
    <text>The therapeutically certified optometrist shall report all adverse reactions to the Board. An adverse drug reaction may be indicated by symptoms which include, but are not limited to, painful eye, pruritus, urticarial lesions, wheals, skin rash of periorbital tissues, nausea, vomiting, fainting, confusion, cessation of respiration, wheezing, clinically significant change in heart rate, or chest pain.</text>
  </paragraph>
  <paragraph num="N.">
    <text>The therapeutically certified optometrist shall prescribe and administer all therapeutic pharmaceutical agents in accordance with the applicable standards of care established under Health Occupations Article, Title 11, Annotated Code of Maryland.</text>
  </paragraph>
  <paragraph num="O.">
    <text>The therapeutically certified optometrist shall remove superficial foreign bodies from the eye in accordance with the applicable standards of care established under Health Occupations Article, Title 11, Annotated Code of Maryland.</text>
  </paragraph>
  <paragraph num="P.">
    <text>A therapeutically certified optometrist may not prescribe or administer a therapeutic pharmaceutical agent unless specifically authorized by law or these regulations.</text>
  </paragraph>
  <paragraph num="Q.">
    <text>The therapeutically certified optometrist shall report to the Board, on the form provided by the Board, within 10 working days of the occurrence, an adverse reaction. The therapeutically certified optometrist shall include in the report, at a minimum, the following:</text>
    <paragraph num="(1)">
      <text>The optometrist's name, address, and license number;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Patient information including:</text>
      <paragraph num="(a)">
        <text>Presenting problem;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Diagnosis;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Agent administered; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Method of administration;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>The adverse reaction; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Subsequent action taken.</text>
    </paragraph>
  </paragraph>
  <paragraph num="R.">
    <text>Glaucoma Management.</text>
    <paragraph num="(1)">
      <text>In accordance with Health Occupations Article, §11-404.2, Annotated Code of Maryland, a therapeutically certified optometrist shall perform the procedures and tests necessary to diagnose primary open angle glaucoma appropriately.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A therapeutically certified optometrist may administer and prescribe topical pharmaceutical agents for glaucoma only as authorized by law.</text>
    </paragraph>
  </paragraph>
  <paragraph num="S.">
    <text>In developing a glaucoma treatment plan that ensures the maximum effectiveness for the patient, the therapeutically certified optometrist shall consider the following:</text>
    <paragraph num="(1)">
      <text>Types of agents to be administered and potential side effects;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Status of the optic nerve structure, function, and its relationship to intraocular pressure;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Identification of a target intraocular pressure at or below the target level in which further optic nerve damage is unlikely to occur;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Maintenance of intraocular pressure at or below the target level by initiating appropriate therapeutic intervention;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Monitoring of the optic nerve and resetting the target intraocular pressure if deterioration occurs;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Minimization of the side effects of treatment and their impact on the patient's vision, general health, and quality of life;</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Education of the patient in the management of primary open angle glaucoma disease;</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Reference to accepted clinical guidelines for glaucoma follow-up management; and</text>
    </paragraph>
    <paragraph num="(9)">
      <text>Criteria for surgical intervention.</text>
    </paragraph>
  </paragraph>
  <paragraph num="T.">
    <text>Laboratory Tests. Laboratory tests shall be ordered by a therapeutically certified optometrist only as provided by law.</text>
  </paragraph>
</regulation>