98-30917. Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Bloodwork Requirements  

  • [Federal Register Volume 63, Number 223 (Thursday, November 19, 1998)]
    [Proposed Rules]
    [Pages 64211-64215]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-30917]
    
    
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    Proposed Rules
                                                    Federal Register
    ________________________________________________________________________
    
    This section of the FEDERAL REGISTER contains notices to the public of 
    the proposed issuance of rules and regulations. The purpose of these 
    notices is to give interested persons an opportunity to participate in 
    the rule making prior to the adoption of the final rules.
    
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    Federal Register / Vol. 63, No. 223 / Thursday, November 19, 1998 / 
    Proposed Rules
    
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    DEPARTMENT OF AGRICULTURE
    
    Food and Nutrition Service
    
    7 CFR Part 246
    
    RIN 0584-AC30
    
    
    Special Supplemental Nutrition Program for Women, Infants, and 
    Children (WIC): Bloodwork Requirements
    
    AGENCY: Food and Nutrition Service, USDA.
    
    ACTION: Proposed rule.
    
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    SUMMARY: This proposed rule would amend regulations governing the 
    Special Supplemental Nutrition Program for Women, Infants, and Children 
    (WIC) to provide that hematological tests for anemia no longer be a 
    mandatory part of each WIC applicant's certification intake process, so 
    long as at least one nutrition risk factor is present for the 
    applicant. This proposed rule would allow the State agency the 
    discretion to obtain such tests at certification or within 90 days of 
    the date of certification. Such tests would be used for the purposes of 
    assessing nutritional status, providing nutrition education, further 
    tailoring food packages to meet nutritional needs, and referring to 
    appropriate health and social services in the community. The proposed 
    revisions to current WIC Program regulations will accommodate a 
    changing health care environment; facilitate improved coordination with 
    other health programs serving WIC applicants; minimize potentially 
    repetitive, costly, and invasive blood testing procedures; reduce 
    inconvenience to applicants, and expedite services to needy individuals 
    applying for WIC Program benefits.
    
    DATES: To be assured of consideration, comments must be postmarked on 
    or before January 19, 1999.
    
    ADDRESSES: Comments should be sent to Ronald J. Vogel, Acting Director, 
    Supplemental Food Programs Division, Food and Nutrition Service, USDA, 
    3101 Park Center Drive, Room 540, Alexandria, Virginia 22302, (703) 
    305-2730. All written comments will be available for public inspection 
    during regular business hours (8:30 a.m. to 5 p.m., Monday through 
    Friday) at the above-noted address.
    
    FOR FURTHER INFORMATION CONTACT: Barbara Hallman at (703) 305-2730 
    during regular business hours (8:30 a.m. to 5 p.m.) Monday through 
    Friday.
    
    SUPPLEMENTARY INFORMATION:
    
    Executive Order 12866
    
        This rule has been determined to be not significant for purposes of 
    Executive Order 12866 and, therefore, has not been reviewed by the 
    Office of Management and Budget.
    
    Regulatory Flexibility Act
    
        This rule has been reviewed with regard to the requirements of the 
    Regulatory Flexibility Act (5 U.S.C. 601-612). Pursuant to that review, 
    Samuel Chambers, Jr., Acting Administrator of the Food and Nutrition 
    Service, has certified that this rule will not have a significant 
    impact on a substantial number of small entities. State and local 
    agencies and participants would be most affected by this proposed rule. 
    This proposal would provide State and local agencies with increased 
    flexibility in meeting certification requirements for the Program. 
    Participants and applicants would also be affected by changes in the 
    certification process which should result in expedited receipt of 
    program services.
    
    Paperwork Reduction Act
    
        This proposed rule imposes no new reporting or recordkeeping 
    requirements which are subject to review by the Office of Management 
    and Budget (OMB) in accordance with the Paperwork Reduction Act of 
    1995.
    
    Executive Order 12372
    
        The Special Supplemental Nutrition Program for Women, Infants and 
    Children (WIC) is listed in the Catalog of Federal Domestic Assistance 
    Programs under No. 10.557. For reasons set forth in the final rule in 7 
    CFR part 3015, subpart V, and related notice (48 FR 29115), this 
    program is included in the scope of Executive Order 12372 which 
    requires intergovernmental consultation with State and local officials.
    
    Executive Order 12998
    
        This proposed rule has been reviewed under Executive Order 12998, 
    Civil Justice Reform. This rule is intended to have preemptive effect 
    with respect to any State or local laws, regulations or policies which 
    conflict with its provisions or which would otherwise impede its full 
    implementation. This rule is not intended to have retroactive effect 
    unless so specified in the EFFECTIVE DATE paragraph of this preamble. 
    Prior to any judicial challenge to the application of the provisions of 
    this rule, all applicable administrative procedures must be exhausted.
    
    Public Law 104-4
    
        Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
    L. 104-4, establishes requirements for Federal agencies to assess the 
    effects of their regulatory actions on State, local and tribal 
    governments and the private sector. Under section 202 of the UMRA, the 
    Food and Nutrition Service generally must prepare a written statement, 
    including a cost-benefit analysis, for proposed and final rules with 
    ``Federal mandates'' that may result in expenditures to State, local or 
    tribal governments, in the aggregate, or the private sector, of $100 
    million or more in any one year. When such a statement is required 
    under section 202 of the UMRA, section 205 generally requires the Food 
    and Nutrition Service to identify and consider a reasonable number of 
    regulatory alternatives and adopt the least costly, most cost-effective 
    or least burdensome alternative that achieves the objective of the 
    rule.
        This rule contains no Federal mandates (under the regulatory 
    provisions of Title II of the UMRA) for State, local and tribal 
    governments or the private sector of $100 million or more in any one 
    year. Thus, this rule is not subject to the requirements of sections 
    202 and 205 of the UMRA.
    
    Background
    
        The Department reassesses WIC Program regulations and operations on 
    an ongoing basis to ensure the continuing efficiency and effectiveness 
    of the program. The subject of blood testing requirements has 
    repeatedly been identified as warranting consideration for change based 
    on frequent expressions of concern from the WIC community, including 
    health
    
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    and medical officials at both the State and local levels. Numerous 
    concerns have been brought to the Department's attention on the WIC 
    Program's current blood test requirements, which may have the 
    consequences of delaying enrollment of WIC applicants, duplicating 
    effort, and creating unnecessary administrative expense, and hardship 
    to applicants.
        Three specific concerns regarding changes in the delivery and 
    operation of health care also compel the Department's reassessment of 
    the blood testing requirements. First, WIC blood tests coincide with 
    WIC certification periods, thus, the schedule of blood tests required 
    at WIC certification does not generally correspond with State, local, 
    and generally accepted periodicity schedules and guidelines. The 
    Department has been informed that many health programs, as cost 
    containment measures, are commonly limiting blood test screening to a 
    specified minimum seen as medically necessary, consistent with State, 
    local, and generally accepted guidelines and other auxiliary health 
    programs such as lead poisoning prevention programs or Early and 
    Periodic, Screening, Diagnosis and Treatment programs. Health care 
    providers have expressed concerns to the Department that the WIC 
    Program's certification schedule, of which blood testing is a mandatory 
    part, is creating a barrier to public health care coordination by 
    artificially dictating periodicity for hematological testing, rather 
    than conforming to standard clinical practice used by the State and 
    local health care system.
        Second, the move towards managed care programs as the primary 
    source of health care has affected the ability of WIC local agencies to 
    obtain blood test referral data in a timeframe that coincides with WIC 
    certification periods. The source of health care for WIC participants 
    and others has been shifting in many States from local health 
    department clinics, many of which collected bloodwork to meet WIC's 
    needs on site at the WIC clinic, to managed care settings in which 
    blood tests are performed off site from the WIC clinic and thus 
    provided to WIC on a referral basis.
        Third, bloodwork data obtained from referral sources is becoming 
    more frequently the norm in WIC because of Federal, State and local 
    policies limiting blood handling only to persons or laboratories with 
    specified medical credentials, thereby precluding some WIC local 
    agencies from collecting or analyzing blood samples.
    
    The Proposal
    
        In response to these major concerns, the Department is proposing 
    changes in the timing of anemia tests, extending the age of the data 
    that may be used, clarifying allowable costs for anemia tests, and 
    making corresponding changes to State Plan requirements.
        These topics are discussed in greater detail below.
    
    1. Hematological Tests for Anemia (Sec. 246.7 (e), (e)(1), and (e)(1) 
    (i)-(ii))
    
        Given the logistical difficulties of current bloodwork requirements 
    described above, the Department is proposing that hematological tests 
    for anemia no longer be a mandatory part of each WIC applicant's 
    certification intake process as long as at least one nutrition risk 
    factor is present for the applicant. However, given the importance of 
    anemia testing in the target population and WIC's long and successful 
    track record in reducing national rates of anemia, this rule proposes 
    to require such a test but would permit its completion within 90 days 
    of the date of certification, except as noted for infants as discussed 
    later in this preamble. The test data would be used for the critical 
    purposes of appropriately assessing an applicant's nutritional status, 
    providing nutrition education, tailoring food packages and referring to 
    health care or social services. Although the Department considers the 
    collection of blood test data at certification as optimal to assist 
    with performing the most timely and complete nutrition assessment and 
    providing appropriate nutrition education and referrals, this proposal 
    addresses the practical realities faced by State agencies by providing 
    flexibility to obtain this data up to 90 days after the certification 
    intake process. State agencies would, however, be required to provide 
    for blood tests at certification for income eligible applicants with no 
    other documented risk conditions (with the exception of presumptively 
    eligible pregnant women as discussed below) in order to determine if 
    they are at nutritional risk due to anemia.
    
    2. Timing of Hematological Tests (Sec. 246.7 (e), (e)(1), and (e)(1) 
    (i)-(ii))
    
    Age of Bloodwork Data
        The Department has received comments from State agencies that the 
    allowable age for bloodwork data limits local agency flexibility to 
    coordinate with other health care programs. To address the concerns 
    with the age of bloodwork data, this proposed rulemaking would expand 
    the current regulatory standard from 60 days to 90 days as the maximum 
    age of bloodwork data used to assess nutritional risk. The proposed 90-
    day limit should allow additional flexibility to coordinate referral 
    data with other health care programs, yet at the same time assure that 
    the data accurately represent the applicant's health status. This 
    rulemaking would assist in assuring this by continuing to require that 
    such data are reflective of the categorical nutritional status/risk of 
    women applicants. Thus, for a pregnant woman the test must be conducted 
    during pregnancy, and for a breastfeeding or a postpartum woman the 
    test must be conducted after the termination of their pregnancy.
        The categorical restrictions do not apply to infants and children. 
    As such, State agencies may use bloodwork data obtained from an infant 
    to certify a child applicant, provided such data is not more than 90 
    days old. For example, bloodwork data obtained when the infant was 10 
    months old may be used to certify a 13-month old child.
    Timing of Bloodwork
        This proposed rule is intended to allow sufficient flexibility to 
    States to accommodate generally accepted recommendations of maternal 
    and child health and medical experts. In April 1998, the Centers for 
    Disease Control and Prevention (CDC) issued a document titled, 
    ``Recommendations to Prevent and Control Iron Deficiency in the United 
    States.'' These recommendations are intended to guide primary health 
    care providers in preventing and controlling iron deficiency in 
    infants, preschool children, and women of childbearing age, 
    particularly pregnant women--populations served by the WIC Program 
    which are at high risk for iron-deficiency anemia. As such, the CDC 
    recommendations stipulate that blood test results should be obtained at 
    the earliest opportunity during pregnancy, from 4 to 6 weeks after 
    delivery for postpartum and breastfeeding women, between 9 and 12 
    months of age for infants, and 6 months later (15-18 months) and 
    annually from ages 2 to 5 years for children. This rule would provide 
    States with the flexibility to conform to these recommendations to 
    better assure that WIC staff have blood test data reflecting current 
    status at appropriate times during the certification period yet provide 
    that WIC participants receive timely nutrition care and referral during 
    their certification periods.
        For pregnant, breastfeeding, and postpartum women, a hematological 
    test for anemia must be performed at
    
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    certification or within 90 days of the date of certification. The test 
    may be from a referral source or may be conducted by WIC. The referral 
    data may be up to 90 days old, so long as it is reflective of women 
    applicants' categories, meaning the test must have been taken for 
    pregnant women during pregnancy and for postpartum or breastfeeding 
    women following termination of pregnancy.
        Regarding pregnant women, current regulations at 
    Sec. 246.7(e)(1)(iii), which reflect WIC legislation, provide State 
    agencies an additional flexibility by allowing them to presume that 
    income-eligible pregnant women are nutritionally at risk and thus 
    eligible to participate in the program. Presumptively eligible women 
    can be certified immediately and can receive program benefits up until 
    60 days from the date they were certified, by which time a nutrition 
    assessment must be conducted to establish nutritional risk. If the 
    subsequent assessment determines that the woman does not meet 
    nutritional risk criteria, the certification terminates on the date of 
    the determination, or 60 days after the participant was certified, 
    whichever is sooner. This proposed rule would eliminate the bloodwork 
    requirement at certification or within the 60-day presumptive 
    certification period for these women, further easing burden. However, 
    under this proposal, if the nutrition assessment performed during the 
    60-day period does not include anemia testing and does not identify any 
    other qualifying risk factor, a blood test must be performed or 
    obtained from referral sources before that 60-day period elapses to 
    permit continuity of service for women found to be anemic. This 
    requirement enables such pregnant women to have the temporary 
    presumptive certification extended to a full certification period 
    without disruption to continued receipt of WIC benefits, should they be 
    found anemic.
        Consistent with the new CDC recommendations, all infants 9 months 
    of age or older must have a hematological test for anemia between 9 and 
    12 months of age. Such test may be performed by the WIC agency or 
    obtained from referral data. A blood test taken between 6 and 9 months 
    of age may be used to meet the test requirement, however State agencies 
    are encouraged to obtain blood test data between 9 and 12 months of age 
    as recommended by CDC. In addition, recognizing that the CDC guidelines 
    state that blood tests for anemia for infants under 6 months of age may 
    be appropriate for preterm infants and low birthweight infants who were 
    not fed iron-fortified formula, this proposal would permit, but not 
    require, blood tests for such infants.
        The Department also wishes to clarify that in cases where the State 
    agency has opted to certify infants under 6 months of age up to their 
    first birthday, as permitted in Sec. 246.7(g)(1)(iv), such infants must 
    receive a blood test between 9 and 12 months of age. The extension of 
    the certification period up to the first birthday is only permitted 
    provided the quality and accessibility of health care services are not 
    diminished. A blood test for anemia is considered a critical component 
    of health care services and thus, must be performed or obtained from 
    referral services. As stated earlier in this preamble, the CDC 
    recommendations identify the period between 9 and 12 months as the 
    optimal timeframe for anemia testing for infants. Also considered as a 
    critical component of health care services during the one-year period, 
    is securing current length and weight measurements in order to assess 
    the infant's growth.
        State agencies that certify infants at 6 month intervals must 
    ensure that infants 9 months of age or older receive a blood test. A 
    blood test taken at 6 months of age may be used to meet the infant 
    blood test requirement, because such data would fall within the 90-day 
    age of bloodwork data timeframe.
        For children, current provisions at Section 246.7(e)(1) allow State 
    and local agency discretion to waive the blood test for children who 
    were determined to be within the normal range at their last 
    certification period, provided that such test is performed at least 
    once every 12 months. The new CDC guidelines recommend a blood test 
    between 9 and 12 months of age, 6 months thereafter (around 15 to 18 
    months of age), and annually thereafter for each year from ages 2 to 5 
    years of age. Thus, this rule proposes that State agencies perform a 
    blood test between 12 and 24 months of age to permit them full 
    flexibility to accommodate arrangements for bloodwork for these 
    children within the CDC recommended 6-month timeframe following their 
    infant bloodwork. While for most children, this would fall between 15 
    and 18 months of age, this proposal would expand the allowable 
    timeframe to accommodate practical logistical difficulties and 
    circumstances where, for example, there was no previous bloodwork 
    during infancy, it was taken during infancy at a time other than the 
    recommended 9 to 12 month period, or other logistical complications 
    which made bloodwork during the optimal 15 to 18 month period 
    infeasible. Nevertheless, because pediatric health authorities 
    generally recommend that children have a blood test during the most 
    vulnerable period of 15 to 18 months, when anemia is more likely to 
    become manifest, State agencies are expected to make every effort to 
    coordinate the scheduling of bloodwork for children between 12 and 24 
    months old within the recommended 15 to 18 month timeframe.
        As for women, the referral bloodwork data allowed to be used to 
    certify children and infants can be up to 90 days old. However, 
    although bloodwork data obtained when an infant was between 9 and 12 
    months old may be used to certify a 12-month old child, such data 
    cannot be used to fulfill the blood test that is required between 12 
    and 24 months of age nor can it be used to waive a blood test. Children 
    who had an inadequate iron intake during infancy are at greatest risk 
    of developing anemia between 12 and 24 months of age. Thus, it is 
    critical that children receive a blood test for anemia during the 
    period of 12-24 months of age. As such, the current provision at 
    Sec. 245.7(e) has been modified to state that for children ages two and 
    older who were determined to be within the normal range at their last 
    certification, the blood test may be waived, provided that a blood test 
    is performed at least once every 12 months.
    Other Nutrition Assessment Data
        The Department again emphasizes that this proposal provides for 
    flexibility only in the timing of the collection and age of anemia 
    blood test data: If not completed at certification (using current data, 
    or data up to 90 days old), it must be completed within 90 days of 
    certification except as noted for infants as discussed earlier in this 
    preamble. All other nutrition assessment data, e.g., height and weight, 
    and dietary and medical assessment data, must be collected as currently 
    required; namely: It must be collected at certification for 
    breastfeeding and postpartum women, infants and children, and, for 
    pregnant women unless the State agency has opted to implement 
    presumptive eligibility for pregnant women. State agencies implementing 
    presumptive eligibility must still collect height, weight and dietary 
    and medical assessment data for pregnant women within 60 days of 
    certification to determine eligibility. The Department considers the 
    effort at certification to measure and record height or length and 
    weight and collect dietary and other medical data for all applicants to 
    be minimal but necessary during the intake process, and not subject to 
    the difficulties related to bloodwork
    
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    assessment. These timely measurements and data are fundamental to the 
    assessment of nutritional risk of all categories of applicants.
    
    3. Allowable Costs for Anemia Tests (Sec. 246.14(c)(2) (i)-(iv))
    
        Current WIC Program regulations (Sec. 246.14(c)(2) (i)-(iv)) 
    stipulate that fees, equipment, salary and other costs associated with 
    the collection of hematological data to test for anemia for 
    certification purposes are allowable Program costs. This proposed rule 
    would specify that collection of hematological data is not only for 
    certification purposes, but also for health assessment and monitoring 
    purposes. This proposal would also allow State agencies to perform one 
    additional hematological test as medically necessary in follow-up to a 
    finding of anemia within a certification period. The Department 
    proposes changes in Sec. 246.14(c)(2) and (c)(2) (i)-(iv) to clarify 
    that this follow-up test for nutrition assessment purposes is an 
    allowable WIC cost when deemed necessary for health monitoring as 
    determined by the WIC competent professional authority (CPA).
        While this rule would permit WIC to pay for one follow-up test, 
    State agencies are encouraged to weigh the cost effectiveness of WIC 
    expenditures for such purposes against other competing and critical WIC 
    needs. The Department generally believes that follow up monitoring of 
    blood values of persons with anemia is largely the responsibility of 
    health care providers, and should be treated as a medical, rather than 
    solely a nutritional, concern. As such, the Department encourages State 
    agencies to explore other locally available sources for ongoing health 
    care and assessments for WIC participants with anemia.
    
    4. State Plan (Sec. 246.4(a)(11)(i))
    
        State agencies must incorporate their blood test data requirements 
    and timeframes in detail in the ``Certification Procedures'' section of 
    their State Plan Procedure Manual.
        Appropriate procedures that must be followed when blood test data 
    are obtained include: (1) Make notations in the participant's file with 
    respect to nutrition risk factors listed and priority as appropriate; 
    (2) inform the woman or parent/guardian of the outcome and meaning of 
    the blood test if the results show anemia; (3) provide follow-up 
    nutrition education, if appropriate; (4) make adjustments in the food 
    package, as appropriate; and (5) make referrals to health care or 
    social services, as appropriate.
    
    List of Subjects in 7 CFR Part 246
    
        Administrative practice and procedure, Civil rights, Food 
    assistance programs, Food and Nutrition Service, Food donations, Grant 
    programs-health, Grant programs--social programs, Indians, Infants and 
    children, Maternal and child health, Nutrition, Nutrition education, 
    Penalties, Reporting and recordkeeping requirements, Public assistance 
    programs, WIC, Women.
        For the reasons set forth in the preamble, 7 CFR part 246 is 
    proposed to be amended as follows:
    
    PART 246--SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS 
    AND CHILDREN
    
        1. The authority citation for part 246 continues to read as 
    follows:
    
        Authority: 42 U.S.C. 1786.
    
        2. In Sec. 246.4, paragraph (a)(11)(i) is revised to read as 
    follows:
    
    
    Sec. 246.4  State Plan.
    
        (a) * * *
        (11) * * *
        (i) Certification procedures, including a list of the specific 
    nutritional risk criteria by priority level which cites conditions and 
    indices to be used to determine a person's nutritional risk, 
    hematological data requirements including timeframes for the collection 
    of such data, the State agency's income guidelines for Program 
    eligibility, and any adjustments to the participant priority system 
    made pursuant to Sec. 246.7(e)(4) to accommodate high-risk postpartum 
    women or the addition of Priority VII;
    * * * * *
        2. In Sec. 246.7:
        a. The introductory text of paragraph (e) is revised;
        b. The introductory text of paragraph (e)(1) is removed;
        c. Paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(iii), and (e)(1)(iv) 
    are redesignated as paragraphs (e)(1)(iii), (e)(1)(iv), (e)(1)(v), and 
    (e)(1)(vi) respectively;
        d. New paragraphs (e)(1)(i) and (e)(1)(ii) are added;
        e. Newly redesignated paragraphs (e)(1)(iii), (e)(1)(iv) and 
    (e)(1)(vi) are amended by adding a heading; and
        f. Newly redesignated paragraphs (e)(1)(v) is revised.
        The revisions and additions read as follows:
    
    
    Sec. 246.7  Certification of participants.
    
    * * * * *
        (e) Nutritional risk. To be certified as eligible for the Program, 
    applicants who meet the Program's eligibility standards specified in 
    paragraph (c) of this section must be determined to be at nutritional 
    risk. A competent professional authority on the staff of the local 
    agency shall determine if a person is at nutritional risk through a 
    medical and/or nutritional assessment. This determination may be based 
    on referral data submitted by a competent professional authority not on 
    the staff of the local agency. Nutritional risk data shall be 
    documented in the participant's file and shall be used to assess an 
    applicant's nutritional status and risk, tailor the food package to 
    address nutritional needs, design appropriate nutrition education, and 
    make referrals to health and social services for follow-up, as 
    necessary and appropriate. Except as stated in paragraph (e)(1)(v) of 
    this section, at least one nutritional risk must be documented at the 
    time of certification in order for an income eligible applicant to 
    receive WIC benefits.
        (1) Determination of nutritional risk.--(i) Required nutritional 
    risk data. At a minimum, height or length and weight shall be measured 
    and documented in the applicant's file at the time of certification. In 
    addition, a hematological test for anemia such as a hemoglobin, 
    hematocrit, or free erythrocyte protoporphyrin test shall be performed 
    at certification or within 90 days of the date of certification. 
    However, such hematological tests are not required, but are permitted, 
    for infants under nine months of age. All infants nine months of age 
    and older (who have not already had a hematological test performed or 
    obtained, between the ages of six and nine months, by a competent 
    professional authority), shall between nine and twelve months of age 
    have a hematological test performed or obtained from referral sources. 
    This hematological test does not have to occur within 90 days of the 
    date of certification. Only one test is required for children between 
    12 and 24 months of age. At the State or local agency's discretion, the 
    hematological test is not required for children ages two and older who 
    were determined to be within the normal range at their last 
    certification. However, the hematological test shall be performed on 
    such children at least once every 12 months. Hematological test data 
    submitted by a competent professional authority not on the staff of the 
    local agency may be used to establish nutritional risk. Height or 
    length and weight measurements and, with the exceptions specified in 
    this paragraph, hematological tests, shall be obtained for all 
    participants, including those who are determined at nutritional
    
    [[Page 64215]]
    
    risk based solely on the established nutritional risk status of another 
    person, as provided in paragraphs (e)(1)(iv) and (e)(1)(v) of this 
    section.
        (ii) Timing of nutritional risk data.
        (A) Weight and height or length. Weight and height or length shall 
    be measured for program participation at the time of certification.
        (B) Hematological test for anemia. For pregnant, breastfeeding, and 
    postpartum women, and child applicants, the hematological test for 
    anemia shall be performed or obtained from referral sources at the time 
    of certification or within 90 days of the date of certification. 
    However, a State agency cannot use hematological data obtained from 
    referral sources that is taken more than 90 days prior to the date of 
    certification for program participation.
        Infants nine months of age and older (who have not already had a 
    hematological test performed, between six and nine months of age, by a 
    competent professional authority or obtained from referral sources), 
    shall between nine and twelve months of age have a hematological test 
    performed or obtained from referral sources. Such a test may be 
    performed more than 90 days after the date of certification. For 
    pregnant women, the hematological test for anemia shall be performed 
    during their pregnancy. For persons certified as postpartum or 
    breastfeeding women, the hematological test for anemia shall be 
    performed after the termination of their pregnancy. The participant or 
    parent/guardian shall be informed of the test results when there is a 
    finding of anemia, and notations reflecting the outcome of the tests 
    shall be made in the participant's file. Nutrition education, food 
    package tailoring, and referral services shall be provided to the 
    participant or parent/guardian, as necessary and appropriate.
        (iii) Breastfeeding dyads.* * *
        (iv) Infants born to WIC mothers or women who were eligible to 
    participate in WIC. * * *
        (v) Presumptive eligibility for pregnant women. A pregnant woman 
    who meets the income eligibility standards may be considered 
    presumptively eligible to participate in the program, and may be 
    certified immediately without an evaluation of nutritional risk for a 
    period up to 60 days. A nutritional risk evaluation of such woman shall 
    be completed not later than 60 days after the woman is certified for 
    participation. A hematological test for anemia is not required to be 
    performed within the 60-day period unless the nutrition risk evaluation 
    performed does not identify a risk factor. If no risk factor is 
    identified, a hematological test for anemia must be performed or 
    obtained from referral sources before the 60-day period elapses. Under 
    the subsequent determination process, if the woman does not meet any 
    nutritional risk criteria, including anemia criteria, the woman shall 
    be determined ineligible and may not participate in the program for the 
    reference pregnancy after the date of the determination, unless she 
    subsequently reapplies for program benefits and is found to be both 
    income eligible and at nutritional risk. Notification of the 
    ineligibility determination shall be given in accordance with paragraph 
    (j)(5) of this section. In addition, if the nutritional risk evaluation 
    is not completed within the 60-day timeframe, the woman's participation 
    shall end. As set forth in paragraph (j)(8) of this section, 
    notification must be given prior to expiration of the certification 
    period.
        (vi) Regression. * * *
    * * * * *
        3. In Sec. 246.14, paragraph (c)(2) is revised to read as follows:
    
    
    Sec. 246.14  Program costs.
    
    * * * * *
        (c) * * *
        (2) The cost of Program certification and nutrition assessment 
    procedures, including the following:
        (i) Laboratory fees incurred for up to two hematological tests for 
    anemia per individual per certification period conducted to assess 
    nutritional status and determine whether such individual is at 
    nutritional risk. The first test shall be to determine anemia status. 
    The second test may be performed only in follow up to a finding of 
    anemia when deemed necessary for health monitoring as determined by the 
    WIC State agency;
        (ii) Expendable medical supplies necessary to assess nutritional 
    status and to determine whether persons are at nutritional risk;
        (iii) In connection with nutrition assessment and nutritional risk 
    determinations, medical equipment used for taking anthropometric 
    measurements, such as scales, measuring boards, and skin fold calipers; 
    and for blood analysis to detect anemia, such as spectrophotometers, 
    hematofluorometers and centrifuges; and
        (iv) Salary and other costs for time spent on nutrition assessment 
    and certification.
    * * * * *
    
        Dated: October 2, 1998.
    Samuel Chambers, Jr.,
    Acting Administrator, Food and Nutrition Service.
    [FR Doc. 98-30917 Filed 11-18-98; 8:45 am]
    BILLING CODE 3410-30-U
    
    
    

Document Information

Published:
11/19/1998
Department:
Food and Nutrition Service
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
98-30917
Dates:
To be assured of consideration, comments must be postmarked on or before January 19, 1999.
Pages:
64211-64215 (5 pages)
RINs:
0584-AC30: WIC: Bloodwork Requirements
RIN Links:
https://www.federalregister.gov/regulations/0584-AC30/wic-bloodwork-requirements
PDF File:
98-30917.pdf
CFR: (5)
7 CFR 245.7(e)
7 CFR 246.7(e)(1)(iii)
7 CFR 246.4
7 CFR 246.7
7 CFR 246.14