These regulations are promulgated to specify the selection and the responsibilities of a local agency, and the rate of payment to a local agency in the administration of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC Program or Program), operated by the Maryland Department of Health with funding substantially provided by the U.S. Department of Agriculture under §17 of the Child Nutrition Act of 1966, 42 U.S.C. §1786. The terms defined in COMAR 10.54.01.04 also apply to this chapter. The State agency shall select a local agency in accordance with the following priorities: First consideration shall be given to a public or a private nonprofit health agency that will provide ongoing, routine pediatric and obstetric care and administrative services; Second consideration shall be given to a public or private nonprofit health or human service agency that will enter into a written agreement with another agency for either ongoing, routine pediatric and obstetric care or administrative services; Third consideration shall be given to a public or private nonprofit health agency that will enter into a written agreement with private physicians licensed by the State in order to provide ongoing, routine pediatric and obstetric care to a specific category of participants (women, infants, or children); Fourth consideration shall be given to a public or private nonprofit human service agency that will enter into a written agreement with private physicians licensed by the State to provide ongoing, routine pediatric and obstetric care; and Fifth consideration shall be given to a public or private nonprofit health or human service agency that will provide ongoing, routine pediatric and obstetric care through referral to a health care provider. To participate in the Program, a local agency shall: Comply with the fiscal and operational requirements prescribed by the State agency or the federal government in: This chapter; COMAR 10.54.01; 7 CFR Part 3015; 7 CFR Part 3016; and 7 CFR Part 246; Maintain the caseload within the prescribed performance standards of the State-assigned level over a prescribed time period as specified in the written agreement between the State agency and the local agency; Inform the State agency on a timely basis of clinic sites and hours of operation; Make available, contract to make available, or provide by referral, appropriate health services to participants and inform applicants of the health services which are available; Devise and implement a plan to make health services available to participants at the clinic or through written agreements with health care providers when health services are provided through referral; Provide Program benefits to the participant at no cost; Perform the certification procedure at no cost to the applicant; Have on its staff a competent professional authority as defined at COMAR 10.54.01.04; Maintain on file and have available for review, audit, and evaluation all criteria used for certification, including information on the: Area served; Income standards used; and Specific criteria used to determine nutritional risk; Provide nutrition education services to participants, in compliance with all State and federal statutes and regulations including: Regulation .06 of this chapter; 7 CFR 246; and COMAR 10.54.01; Implement and operate a food delivery system prescribed by the State agency pursuant to these regulations and approved by the Food and Nutrition Service of the U.S. Department of Agriculture; Maintain complete, accurate, documented, and current accounting of all Program funds received and expended; Establish an internal monitoring system to review local agency operations and its associated clinics or contractors; Provide orientation and ongoing in-service training for staff; Inform the State agency of the content and schedule of training activities; Make staff available to attend training sessions offered by the State agency; and Compile data, maintain records, and submit reports as required to permit effective enforcement of nondiscrimination laws and regulations. A local agency shall: Certify an applicant as eligible for the Program according to the policies and procedures prescribed in COMAR 10.54.01; Inform an applicant or participant, or a parent or caretaker, of the participant’s rights and responsibilities and the Program benefits as prescribed in COMAR 10.54.01.16 and .18; and Maintain historical participant case files which shall include at least the following information obtained at each certification: Information regarding income documentation as required by COMAR 10.54.01.07; Anthropometric measurements of height and weight; A hematological test result as required by COMAR 10.54.01.08E; The local agency copy of the form developed by the Department outlining the rights and responsibilities of the applicant or participant and the form signed by the: Applicant; Parent; or Caretaker; and Documentation of the nutrition education contacts, including the: Date; and Nutrition education content. A local agency shall provide nutrition education or a local agency shall enter into an agreement with another agency to provide nutrition education. If nutrition education is provided by another agency, then the local agency shall: Acknowledge the nutrition education agreement in the nutrition education plan to the State agency; Ensure proper training to the individual or individuals rendering the services; and Monitor the services rendered. A local agency shall ensure that nutrition education is: Made available at no cost to the participant; Practical and relevant to the participant's individual needs; and Integrated into: Participant health care plans; The delivery of supplemental foods; and Other Program operations. To carry out the nutrition education responsibilities, a local agency shall: Develop and submit for State agency approval an annual nutrition education plan; Make available at reasonable times and locations during each 1-year certification period at least four opportunities for nutrition education for the: Adult participant; Parent or caretaker of an infant or child participant; and Child participant whenever possible; Document in each participant’s file, at the time of certification or recertification, all nutrition education sessions given to the participant, parent, caretaker, or child; Document the participant’s, parent’s, caretaker’s, or child’s refusal or inability to attend or participate in nutrition education for purposes of further education efforts and monitoring as specified by the State agency; and Provide an individual care plan for a participant when the need for a plan is determined by a competent professional authority or when a participant, parent, or caretaker requests an individual care plan. General Provisions. A local agency shall: Implement and operate a food delivery system according to the local agency's agreement with the State agency; Ensure that the food delivery system's operation is compatible with the delivery of health and nutrition education services; Inform a participant or the parent or caretaker of an infant or child participant of the authorized vendors within the local agency service area; Issue food instruments to participants or the participant's parent, caretaker, or proxy in accordance with COMAR 10.54.01; and Ensure that a participant or the participant’s parent, caretaker, or proxy signs for receipt of food instruments. Vendor Authorization. The State agency, in conjunction with a local agency, shall: Determine the appropriate number and distribution of vendors needed to serve the participants within the area served by the local agency; and Conduct and provide documentation of on-site visits to an applicant vendor. Vendor Agreements. A local agency shall abide by the vendor agreement or agreements authorized for use in the local agency by the State agency. Vendor Training. A local agency shall provide training to a vendor when required by the State agency. Vendor Monitoring. A local agency, in conjunction with the State agency, shall: Conduct on-site monitoring visits to at least 10 percent of the authorized vendors per year, selected on a representative basis, and submit to the State agency a summary of the results; Identify and monitor vendors who present the potential for abuse of the Program and submit to the State agency a summary of the results; Ensure investigation of suspected fraud and abuse and of complaints against participants as well as complaints by participants; and Recommend sanctioning of vendors as prescribed at COMAR 10.54.03.16. Food Instruments Accountability. A local agency shall control and provide accountability for the receipt and issuance of food instruments. Conflict of Interest. A local agency shall notify the State agency if any conflict of interest appears to exist between the local agency or a member of its staff and a vendor within its jurisdiction. A local agency shall: Maintain records that identify the source and use of funds expended for Program activities and which contain information pertaining to: Authorization; Receipt of funds; Obligations; Unobligated balances; Assets; Liabilities; Outlays; and Income; and Implement procedures which ensure prompt and accurate payment of allowable costs. A local agency may have the following administrative and program services costs: Direct costs, as allowed under 7 CFR Part 3016, which are identifiable costs incurred exclusively for the purpose of the Program; and Indirect costs, as allowed by 7 CFR Part 3016, which are those costs incurred for a common purpose benefitting more than one program. Expenditures for Nutrition Education. During each federal fiscal year, a local agency shall use for nutrition education an amount equal to at least 20 percent of the administrative award set forth in §B of this regulation. A local agency may not apply the cost of dietary assessments for purposes of certification and the cost of prescribing and issuing supplemental foods to the 20 percent minimum amount required to be spent on nutrition education. A local agency may apply the following to the 20 percent minimum amount required to be spent on nutrition education: Salary and other costs for time spent on nutrition education consultation, whether with an individual or group; The cost of procuring, producing, and distributing nutrition education materials including the cost of: Handouts; Flip charts; Videos; Food models or other teaching aids; and Mailing nutrition education material to participants; Salary and other costs incurred in developing the local agency's annual nutrition education plan; and Other costs that can be justified by the local agency to the State agency as related to nutrition education. Expenditures for Administrative Costs. A local agency may incur costs for the following administrative services: Outreach; Interpreters; Translators; and Fair hearings including the cost of an independent medical assessment of an appellant, when ordered by an administrative law judge. The Cost of Program Certification Procedures. A local agency may incur the following program certification costs: Laboratory fees for tests conducted to determine whether an individual is at nutritional risk; The cost of expendable medical supplies necessary to determine whether an individual is at nutritional risk; The cost of medical equipment used in connection with a nutritional risk determination to take anthropometric measurements, such as scales, measuring boards, and medical equipment used for analysis to detect anemia; and Salary and other costs for time spent on certification. Prior Approved Costs. A local agency may incur the following allowable costs only with prior approval from the State agency: Data processing costs which are required by the local agency, except for those used in general management and payroll, including acquisition of automatic data processing hardware or software whether by outright purchase, retail purchase agreement, or other method of acquisition; Capital expenditures over $5,000, such as the cost of facilities, equipment, including medical equipment, other capital assets, and any repairs that materially increase the value or useful life of capital assets; and Management studies performed by an agency, or department other than the local agency, or those performed by an outside consultant under contract with the local agency. Management Evaluation and Reviews. Every 2 years the State agency shall conduct a monitoring review of each local agency, including an on-site review of a minimum of 20 percent of the clinics in a local agency or one clinic, whichever is greater. This review shall encompass, but not be limited to, the evaluation of: Management; Certification; Nutrition education; Civil rights compliance; Accountability; Financial management systems; and Food delivery systems. Periodic Review of a Local Agency's Qualifications. The State agency may conduct periodic reviews of the qualifications of an authorized local agency. Based upon the results of the reviews in §B(1) of this regulation, the State agency may take appropriate action, including the disqualification of a local agency. Investigations. The State agency shall investigate any allegation of a local agency's noncompliance with State and federal Program statutes and regulations. Local Agency Audits. The Department may arrange for an audit by an entity independent from the Department. The audit in §D(1) of this regulation may go beyond the management evaluation of the financial operation of a local agency. The State agency may disqualify a local agency when the: State agency determines a local agency's noncompliance with Program regulations; State's Program funds are insufficient to support the continued operation of the Program's existing local agencies at the agencies' current participation level; or State agency determines, following a review of local agency credentials in accordance with Regulation .11B of this chapter, that another local agency can operate the Program more effectively and efficiently. If the State agency determines through a review of a local agency's reports, program or financial analysis, monitoring, audit, or other means, that Program funds provided to a local agency for administrative and program services purposes were, through the local agency's negligence or fraud, misused or otherwise diverted from Program purposes, the State agency shall make a claim against the local agency. The local agency shall pay the State agency a sum equal to the amount of misused or diverted administrative and program services funds and the face value of food misused or diverted instruments, or both. A local agency shall: Maintain full and complete records concerning Program operations; Establish and maintain records concerning: Financial operations; Food delivery systems; Food instrument issuance; Equipment purchases; Inventory; Certification; Nutrition education; Civil rights; Fair hearing procedures; and Other information as specified by the State agency; Retain all records for a minimum of 4 years following the date of submission of the final expenditure report for the period to which the report pertains; Except for medical case records of individual participants, unless they are the only source of certification data, make available for review, audit, or copying during normal business hours, records for: Representatives of the Comptroller General of the United States, U.S. Department of Agriculture's Office of the Inspector General, Food and Consumer Service (FCS) of the U.S. Department of Agriculture; and State-authorized personnel; Submit a quarterly expenditure report on a form specified by the Department within 30 days after the end of the quarter being reported; Ensure that, for the purposes of an audit, the quarterly expenditure report is documented so that it can be traced to its source; and Designate a person who shall certify the quarterly expenditure report as to its completeness and accuracy. A local agency may not divulge individual names in any report issued. The State agency or a local agency shall: Forward Program records to the Food and Nutrition Service of the U.S. Department of Agriculture whenever either agency is disposing of them, if the Food and Nutrition Service of the U.S. Department of Agriculture considers any of the records to be of historical interest; and Retain a record for nonexpendable property acquired in whole or in part with Program funds for 3 years after final disposition of the property. If any litigation, claim, negotiation, audit, or other action involving the records specified in §A(2) of this regulation has been started before the end of the 3-year period, a local agency shall keep the records until all issues are resolved, or until the end of the regular 3-year period, whichever is later. A local agency filing an appeal from an administrative decision made in connection with these regulations shall do so in accordance with COMAR 10.01.06. If a provision of this chapter conflicts with a federal statute or regulation, the federal statute or regulation prevails. The Food and Nutrition Service of the U.S. Department of Agriculture and the State agency reserve the right to use information obtained under the Program in a summary, statistical, or other form which does not identify an individual client. The Food and Nutrition Service of the U.S. Department of Agriculture and the State agency may require the local agency to supply medical data and other information collected under the Program, in a form that does not identify individual clients, to enable the United States Department of Agriculture or the State agency to evaluate the effect of food intervention upon low income individuals determined to be at nutritional risk. A local agency shall protect the confidentiality of information obtained from a Program applicant or participant and shall disclose this information only to: An individual directly connected with the administration or enforcement of the Program, including an individual investigating or prosecuting violations in the WIC Program under federal, State, or local authority; A representative of a public organization with whom the State agency has executed a written agreement pursuant to 7 CFR §246.26; and The Comptroller General of the United States for audit and examination authorized by law. The funds awarded by the Department to a local agency are based on the caseload to be served and are subject to the availability of federal funds. Funding rates will be updated annually and available from the Department. Health-General Article, §§18-107(a) and 18-108, Annotated Code of Maryland Effective date: March 30, 1992 (19:6 Md. R. 674) Regulation .01 amended as an emergency provision effective July 8, 1993 (20:15 Md. R. 1219); amended permanently effective January 9, 1994 (20:20 Md. R. 1572) Regulation .02 amended as an emergency provision effective February 22, 1996 (23:6 Md. R. 473); amended permanently effective June 3, 1996 (23:11 Md. R. 810) Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 519) Regulations .04, .10, .14, .17, and .18 amended as an emergency provision effective June 29, 1996 (23:15 Md. R. 1083); amended permanently effective October 21, 1996 (23:21 Md. R. 1468) Regulation .05B, C amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .06 amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 519) Regulations .07F, .10A, .14A, and .18C amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1183); amended permanently effective October 5, 1998 (25:20 Md. R. 1532) Regulation .08A amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .09 repealed and new Regulation .09 adopted effective April 16, 2012 (39:7 Md. R. 494) Regulation .10A amended effective April 16, 2012 (39:7 Md. R. 494) Regulation .10A, C amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .11D amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .14A amended effective April 16, 2012 (39:7 Md. R. 494) Regulation .14C amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .17A, B amended effective May 18, 2020 (47:10 Md. R. 519) Regulation .18 adopted as an emergency provision effective July 8, 1993 (20:15 Md. R. 1219); adopted permanently effective January 9, 1994 (20:20 Md. R. 1572) Regulation .18 amended as an emergency provision effective February 22, 1996 (23:6 Md. R. 473); amended permanently effective June 3, 1996 (23:11 Md. R. 810) Regulation .18 amended as an emergency provision effective August 26, 1999 (26:19 Md. R. 1446); amended permanently effective November 15, 1999 (26:23 Md. R. 1777) Regulation .18 amended effective November 13, 2000 (27:22 Md. R. 2060) Regulation .18 amended as an emergency provision effective July 1, 2001 (28:15 Md. R. 1395); amended permanently effective October 1, 2001 (28:19 Md. R. 1685) Regulation .18 amended as an emergency provision effective July 1, 2010 (37:16 Md. R. 1058); amended permanently effective October 4, 2010 (37:20 Md. R. 1394) Regulation .18 amended as an emergency provision effective July 1, 2012 (39:17 Md. R. 1145); amended permanently effective October 15, 2012 (39:20 Md. R. 1306) Regulation .18 amended as an emergency provision effective July 19, 2013 (40:17 Md. R. 1418); emergency status extended to February 3, 2014 (41:2 Md. R. 89); amended permanently effective January 6, 2014 (40:26 Md. R. 2164) Regulation .18 amended as an emergency provision effective August 28, 2014 (41:19 Md. R. 1075); amended permanently effective November 10, 2014 (41:22 Md. R. 1319); December 8, 2016 (43:24 Md. R. 1350) Regulation .18 amended effective March 26, 2018 (45:6 Md. R. 321) Regulation .18B amended as an emergency provision effective July 1, 1994 (21:16 Md. R. 1380); amended permanently effective October 24, 1994 (21:21 Md. R. 1814) Regulation .18B amended as an emergency provision effective July 1, 1997 (24:15 Md. R. 1060); amended permanently effective October 20, 1997 (24:21 Md. R. 1451) Regulation .18B, C amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1116); amended permanently effective October 9, 1995 (22:20 Md. R. 1543) Regulation .18B, C amended as an emergency provision effective July 1, 2002 (29:16 Md. R. 1285); amended permanently effective October 28, 2002 (29:21 Md. R. 1646) Regulation .18B, C amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective December 22, 2003 (30:25 Md. R. 1848) Regulation .18B, C amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1252); amended permanently effective October 11, 2004 (31:20 Md. R. 1485) Regulation .18B, C amended as an emergency provision effective July 1, 2005 (32:15 Md. R. 1314); amended permanently effective October 10, 2005 (32:20 Md. R. 1656) Regulation .18B, C amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1275); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) Regulation .18B, C amended as an emergency provision effective July 1, 2007 (34:13 Md. R. 1150); amended permanently effective August 27, 2007 (34:17 Md. R. 1509) Regulation .18B, C amended as an emergency provision effective June 26, 2008 (35:15 Md. R. 1345); amended permanently effective October 6, 2008 (35:20 Md. R. 1776) Regulation .18B, C amended as an emergency provision effective July 1, 2009 (36:15 Md. R. 1164); amended permanently effective September 7, 2009 (36:18 Md. R. 1382) Regulation .18B, C amended as an emergency provision effective July 1, 2011 (38:19 Md. R. 1146); amended permanently effective October 17, 2011 (38:21 Md. R. 1279) Regulation .18B, C amended as an emergency provision effective August 6, 2015 (42:18 Md. R. 1173); amended permanently effective October 26, 2015 (42:21 Md. R. 1302) Regulation .18E adopted as an emergency provision effective August 6, 2015 (42:18 Md. R. 1173); adopted permanently effective October 26, 2015 (42:21 Md. R. 1302)