[Federal Register Volume 64, Number 97 (Thursday, May 20, 1999)]
[Notices]
[Pages 27554-27557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12708]


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GENERAL SERVICES ADMINISTRATION


Interagency Committee for Medical Records (ICMR); Automation of 
Medical Standard Form 559

AGENCY: General Services Administration.

ACTION: Guideline on automating medical standard forms.

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BACKGROUND: The Interagency Committee on Medical Records (ICMR) is 
aware of numerous activities using computer-generated medical forms, 
many of which are not mirror-like images of the genuine paper Standard/
Optional Form. With GSA's approval the ICMR eliminated the requirement 
that every electronic version of a medical Standard/Optional form be 
reviewed and granted an exception. The committee proposes to set 
required fields standards and that activities developing computer-
generated versions adhere to the required fields but not necessarily to 
the image. The ICMR plans to review medical Standard/Optional forms 
which are commonly used and/or commonly computer-generated. We will 
identify those fields which are required, those (if any) which are 
optional, and the required format (if necessary). Activities may not 
add data elements that would change the meaning of the form. This would 
require written approval from the ICMR. Using the process by which 
overprints are

[[Page 27555]]

approved for paper Standard/Optional forms, activities may add other 
data entry elements to those required by the committee. With this 
decision, activities at the local or headquarters level should be able 
to develop electronic versions which meet the committee's requirements. 
This guideline controls the ``image'' or required fields but not the 
actual data entered into the field.

SUMMARY: With GSA's approval, the Interagency Committee on Medical 
Records (ICMR) eliminated the requirement that every electronic version 
of a medical Standard/Optional form be reviewed and granted an 
exception. The following fields must appear on the electronic version 
of the following form:

                                         Electronic Elements for SF 559
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                                    Item                                                 Placement *
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Text:
    Title: Allergen Extract Prescription New and Refill....................  Top of form.
    Form ID: Standard Form 559 (Rev. 4-94).................................  Bottom right corner of form.
    The total of individual antigens and diluent must add up to 10 ml. The   Under ``Final Concentration * * *
     total vial volume is 10 ml.                                              '' entry.
    This prescription may be refilled for a period not to exceed 4 years,    Under ``Please list * * * '' entry.
     after which a new prescription must be issued by an authorized
     prescriber.
    Complete Items 5 (Vials Requested) Through 9 (Strength) for Refills      Before ``Item 5 Through 9'' appear
     Only.                                                                    on form.
    Specific Instructions:
        A. PHYSICIAN MUST ALWAYS BE IMMEDIATELY AVAILABLE IN THE CLINIC
         AREA.
        B. ALL PATIENTS MUST REMAIN IN THE CLINIC AT LEAST 30 MINUTES AFTER
         AN INJECTION.
        C. Use a 26-28 gauge needle and give the subcutaneous injection
         into the lower deltoid area.
        D. Record date, dosage, and any reaction on a separate
         immunotherapy form.
        E. GRADING AND MANAGEMENT OF REACTIONS:
            (1) Negative (swelling up to 15 mm; i.e., dime size)--progress
             according to schedule.
            (2) ``A'' (swelling 15-20 mm; i.e., dime to nickel size)--
             repeat the same dosage.
            (3) ``B'' (swelling 20-25 mm; i.e., nickel to quarter size)--
             return to the last dosage which caused no reaction.
            (4) ``C'' (swelling persisting more than 12 hours or over 25
             mm; i.e., quarter size or larger)--decrease dosage by 50%.
            (5) Systemic reactions (hives, sneezing, generalized itching,
             asthma, difficulty breathing, or shock) may be controlled by
             immediately placing a tourniquet above the injection site, and
             giving up to 0.01 ml/kg of 1:1000 epinephrine up to 0.50 ml
             every 10-20 minutes subcutaneously. NOTIFY THE PHYSICIAN! For
             the average adult give 0.10 ml 1:1000 epinephrine
             subcutaneously in the injection site and 0.20 ml of 1:100
             epinephrine in the other arm. Generally the allergen extract
             dose is reduced to \1/3\ the last dosage that caused no
             systemic reaction and repeated 3 times before increasing dose.
             If the injections cause repeated reactions or are suspected of
             causing delayed symptoms repeatedly, or if reactions prevent
             progression of treatment, please contact the medical facility
             below for further instructions.
        F. IF THE PATIENT MISSES THE SCHEDULED INJECTION BY:
            Up to 7 days late, increase according to schedule.
                8 to 14 days late, repeat the last dose.
                15 to 21 days late, reduce dose by 25%.
                22 to 28 days late, reduce dose by 50%.
                29 to 42 days late, reduce dose by 75%.
                43 to 56 days late, reduce dose by 90%.
        In a patient with a history of previous shot reactions, severe
         asthma or severe cardiac disease, the dose may need to be
         decreased even more. If in doubt, contact the medical facility
         below.
        If patient misses his/her scheduled injection by over 8 weeks,
         contact the medical facility below!
        G. If newly informed that patient is pregnant or on beta blockers,
         notify medical facility below for instructions.
        H. REFILL EXTRACT PRESCRIPTIONS: When starting a new treatment
         vial, recommend a minimum of 40% reduction in initial dose.
        RECOMMENDED TREATMENT INSTRUCTIONS:
            Progress treatment using one vial at a time starting with the    Before items 13-13D.
             lowest numbered vial. When the schedule for each vial is
             completed, go to the next higher vial.
            SCHEDULE A.....................................................  Near Items 13-13C.
                0.05 ml....................................................      Do.
                0.10 ml....................................................      Do.
                0.25 ml....................................................      Do.
                0.60 ml....................................................      Do.
            SCHEDULE B
                0.05 ml....................................................      Do.
                0.10 ml....................................................      Do.
                0.20 ml....................................................      Do.
                0.40 ml....................................................      Do.
                0.60 ml....................................................      Do.
            SCHEDULE C
                0.05 ml....................................................      Do.
                0.10 ml....................................................      Do.

[[Page 27556]]

 
                0.20 ml....................................................      Do.
                0.30 ml....................................................      Do.
                0.40 ml....................................................      Do.
                0.50 ml....................................................      Do.
            SCHEDULE D
                0.05 ml....................................................      Do.
                0.10 ml....................................................      Do.
                0.15 ml....................................................      Do.
                0.20 ml....................................................      Do.
                0.30 ml....................................................      Do.
                0.40 ml....................................................      Do.
                0.50 ml....................................................      Do.
            SCHEDULE E
                0.05 ml....................................................      Do.
                0.07 ml....................................................      Do.
                0.10 ml....................................................      Do.
                0.15 ml....................................................      Do.
                0.20 ml....................................................      Do.
                0.25 ml....................................................      Do.
                0.30 ml....................................................      Do.
                0.35 ml....................................................      Do.
                0.40 ml....................................................      Do.
                0.45 ml....................................................      Do.
                0.50 ml....................................................      Do.
            SCHEDULE F (Custom Schedule)
Data Entry Fields:
    New (check box).
    Refill (check box).
    Revision (check box).
    Aqueous (check box).
    Alum Precipitate (check box).
    Final Concentration Below Stated In--
        Protein Nitrogen Unit (PNU/ml) (check box).
        Weight/Volume (WT/VOL) (check box).
        Allergen Unit (AU)/ml is: (check box and entry).
    Please list the most dilute vial as the lowest numbered vial.
    Vial no. XXX is the most concentrated.
    Previous Treatment Programs Will Be Discounted--Yes.
    Previous Treatment Programs Will Be Discounted--No.
    Explain.
    Allergen Contents (allow for at least 33 entries).
    ML Extract (allow for at least 33 entries).
    Conc (allow for at least 33 entries) Diluent.
    Vials Requested (List vial number and strength).
    Asthma Symptoms--Yes or No.
    Prescription Number.
    Systemic Reaction History--Yes or No.
    Date of Last Dose (Mo. Day, Yr.).
    Current Interval (Weeks).
    Amount (e.g., 0.1 ml).
    Vial Number.
    Strength--PNU/ML.
    Strength--Wt/Vol.
    Strength--AU/ML.
    Patient's Address.
    Patient's Telephone--Home.
    Patient's Telephone--Work.
    Send Extract To.
    Date Ordered.
    Requested Treatment--Vial No. (allow for at least 7 entries).
    Requested Treatment--PNU/ml., WT/VOL, Au/ml Content (allows for at
     least 7 entries).
    Requested Treatment--Days Betw. Shots (allow for at least 7 entries).
    Requested Treatment--Schedule (allow for at least 7 entries).
    When the maximum tolerated dose or a dose of ml (no.) of vial (no.) has
     been achieved, injections should be administered every weeks (no.).
    An exception to this is during the period (describe).
    When injections should be administered every weeks (no.).
    Custom Extract Label or Remarks.
    The Prescription Must Be Signed By The Ordering Physician--Signature.
    The Prescription Must Be Signed By The Ordering Physician--Rank.
    The Prescription Must Be Signed By The Ordering Physician--Degree.
    Name of Medical Facility.

[[Page 27557]]

 
    Telephone Number (Medical Facility).
    Patient's Name--last, first, middle.
    Patient's ID No. or SSN................................................  Bottom left corner of form.
    Patient's Sex..........................................................      Do.
    Patient's Date of Birth................................................      Do.
    Patient's Sex..........................................................      Do.
    Patient's Treating Facility............................................      Do.
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* If no placement indicated, items can appear anywhere on the form.

FOR FURTHER INFORMATION CONTACT: CDR Steven S. Kerrick, USN National 
Naval Medical Center, Department of Ophthalmology, Bethesda, MD 20889-
5000 or E-Mail at StevenK[email protected].

    Dated: May 12, 1999.
Steven S. Kerrick,
Chairperson, Interagency Committee on Medical Records.
[FR Doc. 99-12708 Filed 5-19-99; 8:45 am]
BILLING CODE 6820-34-M