Title: Section 420.3 - Operating standards
420.3 Operating standards.
(a) Consistent with generally accepted standards of clinical care, the program shall provide directly onsite or through referral arrangements a full range of clinical services appropriate for the continuous care of patients. For the purposes of this Part, the provision of services through referral arrangements shall entail the establishment of linkages with qualified service providers and the development of a mechanism to track the delivery of such services.
(1) The CAHP shall provide the following core diagnostic, treatment and monitoring services onsite as clinically appropriate: Age-appropriate, confidential HIV counseling and testing, initial and annual comprehensive medical evaluation including substance use history and mental health assessments, cognitive function testing, ongoing clinical HIV disease monitoring, HIV-specific therapies and prophylactic treatments, routine gynecological care and follow-up (including reproductive counseling, pelvic examination and pap smears), case management, patient health education including HIV risk reduction, and nutrition screening and counseling.
(2) The CAHP shall provide onsite if authorized or arrange through written referral agreements with other health care providers the provision of the following services:
(i) consultations by specialists in infectious diseases. If not provided onsite, formal linkages with local resources of infectious disease expertise such as Designated AIDS Centers as defined in section 405.22(g) of this Title shall be developed to promote the timely delivery of these essential consultative services;
(ii) core diagnostic and therapeutic services: laboratory, including early diagnostic methods to establish the infection status of children; radiology, including MRI; dental services; mental health services, to include clinical social work, clinical psychology and psychiatry as clinically appropriate;
(iii) other primary care, specialty and subspecialty services: obstetrics; pediatrics, adolescent medicine and pediatric subspecialties; ophthalmology; dermatology; neurology; outpatient surgery; clinical pharmacy; sub-specialties of internal medicine including gastroenterology, hematology, pulmonology and oncology;
(iv) acute inpatient care where required; and
(v) chronic care services where required.
(b) A primary care practitioner shall be assigned principal responsibility for the continuous care and coordination of care for each patient.
(1) Program staff shall assist all patients with arrangements for all off-site medical services, facilitate receipt of those services, monitor reported results of these off-site services and integrate results into patient records.
(2) In those instances where the primary care practitioner does not have hospital admitting privileges, the CAHP shall have backup arrangements with hospitals for prompt hospital admission of patients and transfer of information between the hospital and the program.
(c) A CAHP shall provide patients prompt access on a 24-hour basis to a clinical staff member who can respond to emergencies.
(d) Comprehensive ambulatory care services for women, including gynecological specialty care, shall be provided directly onsite or through referral arrangements.
(1) Core services to be provided onsite shall include:
(i) routine gynecologic care and follow-up including pelvic examinations and PAP smears; and
(ii) routine family planning services including pregnancy testing and reproductive counseling.
(2) Services to be provided either onsite or through referral arrangements with other health care providers shall include:
(i) special diagnostic and treatment procedures for HIV-related gynecological conditions such as cervical dysplasia;
(ii) obstetrical care for pregnant women that addresses the HIV-related needs of both the mothers and their fetuses during pregnancy; and
(iii) health education for pregnant and postpartum women to include the latest generally accepted recommendations regarding breastfeeding.
(e) Consistent with generally accepted standards of medical care for these age groups, the special needs of HIV exposed infants and HIV infected infants, children and adolescents shall be addressed by the CAHP with services provided either directly onsite or through referral arrangements. Such program shall provide or arrange for comprehensive services that address the unique medical, psychosocial and developmental needs of these age groups.
(1) For children, comprehensive ambulatory health care shall combine HIV-related comprehensive evaluations and follow-up monitoring, routine pediatric care, care for acute illnesses, and continuous care for chronic conditions, incorporating the following special considerations: (i) Routine pediatric care shall be provided for HIV antibody positive infants and children in accordance with generally established standards of medical care and shall include immunizations, monitoring of growth and development, routine screening, health education and guidance to help parents anticipate normal changes and problems associated with growth and development.
(ii) For HIV infected children, the following shall be provided directly onsite or through referral arrangement as clinically indicated:
(a) comprehensive developmental assessment;
(b) early intervention services including physical, speech and occupational therapies;
(c) access to intravenous infusions; and
(d) referral to clinical trials.
(2) For adolescents, providers shall tailor individual care to puberty status, adolescent health beliefs, education level, HIV-related knowledge base, living situation and compliance patterns. Providers of care to adolescents, including HIV counselors and case managers, shall have training and/or experience regarding adolescent development and methods of effective communication with this age group.
(f) A CAHP shall provide each eligible patient, with the patient's written consent, case management services either on-site or through referral arrangements with other case management providers, including at a minimum a comprehensive age-appropriate assessment of medical, social and psychological needs and a plan for appropriate follow-up services, coordinated by a designated case manager and developed in consultation with the patient and/or patient designee or family and the patient's primary care practitioner or team. Such services shall include:
(2) coordination of services;
(3) service plan development, implementation, monitoring and periodic reassessment; and
(4) crisis intervention, which must be provided onsite.
(g) Substance use assessment and referral for treatment as clinically appropriate shall be provided and integrated into treatment planning.
(1) Comprehensive substance use assessment services to be provided onsite shall include:
(i) Substance use history and referral for laboratory screening as appropriate;
(ii) crisis intervention; and
(iii) referral to the available treatment modality appropriate to the patient's needs.
(2) Services to be provided either onsite or through referral arrangements with other qualified service providers shall include:
(i) substance use counseling;
(ii) support group programs;
(iii) inpatient drug and alcohol detoxification;
(iv) methadone maintenance treatment programs;
(v) residential drug or alcohol treatment programs;
(vi) work rehabilitation programs; and
(vii) harm reduction, recovery readiness and needle exchange services.
(h) Dental services, including preventive care, periodontics, oral surgery and pediatric dentistry shall be provided directly or through referral arrangements.
(1) Such routine services shall be provided onsite to the extent that they are currently offered to all other patients treated by the facility.
(2) Specialty services shall be readily available with referral arrangements developed to promote their timely delivery.
(i) Mental health services shall be provided directly or through referral arrangements.
(1) A mental health assessment shall be completed in conjunction with the medical and social history to establish a baseline for further care, including psychiatric diagnosis and treatment and to monitor changes in mental health status.
(2) For children, services to help them cope with progressive disease and/or the loss of a parent or other family members shall be made available.
(3) Mental health services for adolescents shall deal with issues of emerging sexuality, identity consolidation, experimentation with drugs, violence, school, family relationships and responses to authority.
(j) The CAHP shall provide onsite nutrition screening and counseling including a baseline nutritional evaluation and continuing nutrition risk assessment.
(1) Screening for specific nutrition risk conditions shall begin at the initial visit with continuing reassessment as needed.
(2) Professional nutrition counseling shall be available, either on-site or through referral arrangement, to all patients at nutritional risk.
(3) A consultant in clinical nutrition, qualified by training and experience, shall serve as an information resource to staff, patients and their families regarding the nutritional aspects of managing HIV infection. (k) A CAHP shall facilitate access to clinical research programs, including those for investigational new drugs (INDs). Programs shall have policies for managing patients on protocols, including notification of the investigator.
VOLUME C (Title 10)