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NY-AD-02.ASC
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/* New York Administrative Code, part 2 of 4. */
(v) The hospital shall adopt and uniformly apply donor
selection criteria and establish policies and procedures to
ensure the medical suitability of organs and tissues to be
transplanted, the donor selection criteria shall:
(a) be specific for each type of organ and tissue;
(b) describe those medical conditions, confirmed through
the donor's medical history and appropriate clinical
laboratory testing, which would make the potential donor
ineligible under any circumstances, including at a minimum:
(1) For donation of kidneys, heart and liver:
(i) serologic evidence of human immunodeficiency virus
(H.I.V.) or clinical history of acquired immune deficiency
syndrome (AIDS);
(ii) history or evidence of a disseminated malignancy; or
(iii) evidence of a transmissible disease or infection.
(2) For bone donation:
(i) serologic evidence of H.I.V., or clinical history of
AIDS;
(ii) donor death preceded availability for tissue
procurement by a period exceeding 24 hours;
(iii) the presence of systemic sepsis;
(iv) evidence of a transmissible disease or infection;
(v) history or evidence of any malignancy; or
(vi) history of metabolic bone disease.
(3) For eye donation:
(i) serologic evidence of H.I.V. or clinical history of
AIDS;
(ii) donor death preceded availability for tissue
procurement by a period exceeding a predetermined time limit
which is specified in the policies and procedures of the
transplantation service;
(iii) the presence of systemic sepsis; or
(iv) evidence of a transmissible disease or infection
including, but not limited to, rabies, Jacob-Creutzfeld
disease, and viral hepatitis.
(4) For skin donation:
(i) serologic evidence of H.I.V. or clinical history of
AIDS;
(ii) donor death preceded availability for tissue
procurement by a period exceeding a predetermined time limit
which is specified in the policies and procedures of the
transplantation service.
(iii) the presence of systemic sepsis;
(iv) evidence of a transmissible disease or infection;
(v) the presence of diffuse dermatitis or any diseases
associated with the skin;
(vi) history of any hepatic disease; or
(vii) history or evidence of any malignancy.
(5) For heart valve donation:
(I) serologic evidence of H.I.V. or clinical history of
AIDS;
(ii) history or evidence of any malignancy;
(iii) the presence of systemic sepsis;
(iv) evidence of a transmissible disease or infection,
including myocarditis; or
(v) the presence of congenital valve abnormalities,
excluding fenestrations.
(c) describe those medical conditions, confirmed through
the donor's medical history and appropriate clinical
laboratory testing, for which discretion, with specified
limits on that discretion, may be exercised regarding
suitability, including at a minimum:
(1) unknown cause of death;
(2) history or evidence of localized malignancies not
involving organ or tissues to be transplanted with the
exception of bone, skin and heart valve donation for which
any malignancies are absolute contraindications;
(3) localized infections not involving the organ or tissue
to be transplanted;
(4) cardiovascular instability and prolonged ischemia;
(5) history of a disease of unknown etiology such as
multiple sclerosis, amyothrophic lateral scerlosis or cystic
fibrosis;
(6) history of any trauma, disease process or pathology
potentially compromising organ function, including but not
limited to alcoholism, diabetes mellitus, longstanding
hypertension, cardiovascular or peripheral vascular disease;
(7) history of prolonged drug therapy potentially affecting
organ or tissue function;
(8) history or evidence of intravenous drug abuse; or
(9) history of viral hepatitis;
(d) for bone marrow donation, meet the pertinent
requirements of Subpart 58-5 of this Title.
(e) be made available to the public; and
(f) be communicated to organ procurement agencies and
tissue banks.
(vi) The hospital shall ensure that the transplantation
service is under the direction of a qualified specialist
with previous experience and training in transplantation
services, The hospital shall also assure that:
(a) a staff person is designated to coordinate the
procurement and transplant program including patient follow-
up after discharge;
(b) nursing staff for transplantation services are
commensurate with the assessed needs of the patients;
(c) supportive care, including psychiatric and social
services, are made available to living donors, organ
recipients and the families of these patients;
(d) all staff providing care to transplantation patients
are prepared for their responsibilities through experience,
demonstrated competence and completion of inservice
education programs as needed;
(e) patient care evaluation, management and planning are
performed by the professional health care team involved with
the care of the patient, from admission to discharge,
including plans for follow-up of the patient into the
community;
(f) any necessary specialized facilities and equipment are
available to meet the needs of the patients;
(g) clinical laboratory services are available from
laboratories possessing permits issued under article 5,
title 5 of the Public Health Law, in the categories of
virology, diagnostic immunology, diagnostic
immunohematology, bacteriology, mycology, mycobacteriology,
parasitology, cytogenetics, cellular immunology and
histocompatibility;
(h) infection control policies and procedures specific to
transplantation services are developed and implemented as an
integral part of the hospital's infection control program;
(i) there shall be an organized follow-up program for
transplant patients following discharge including data
management resources to maintain records on the long-term
survival of transplant patients; and
(j) as part of the hospital's quality assurance program,
the hospital shall implement a system for evaluating the
quality and appropriateness of patient care and patient
outcomes including survival rates and any complications.
Reports summarizing the outcomes from the quality assurance
program for transplantation services shall be submitted to
the department on an annual basis.
(2) Bone marrow transplantation service. The hospital
shall:
(i) ensure that the physician director is a qualified
specialist with training in immunology or hematology and
advanced training and previous experience in bone marrow
transplantation services;
(ii) ensure that physicians providing care in the bone
marrow transplantation program have extensive experience and
demonstrate expertise in the medical or surgical treatment
of oncologic/ hematologic/ immunologic disease;
(iii) provide a multidisciplinary team to include qualified
specialists in chemotherapy, radiation therapy, nursing,
social work, infectious disease control, immunology,
oncology, hematology and expertise in intensive
cardiopulmonary medicine;
(iv) have clinical services with staff specialized in the
care and management of bone marrow transplantation patients
to include but not be limited to: pathology, immunology,
anesthesiology, laboratory, radiology, renal dialysis,
respiratory therapy, nutrition and pharmacology;
(v) ensure that the program is supported by a blood bank
with a capacity to support four to six patients a day, and
ensure the availability of a blood separator, a central
blood repository, and an irradiator for blood products; and
(vi) provide or make arrangements for the harvesting of bone
marrow.
(3) Liver transplantation service, The hospital shall:
(i) perform at least 20 transplants per year when fully
operational to ensure quality of care and cost
effectiveness;
(ii) ensure that the liver transplantation surgeon(s) is
board-certified in general surgery or has equivalent
training and experience and demonstrates the ability to
successfully perform liver transplantation as evidenced by
clinical experience in existing liver transplantation
programs;
(iii) ensure that all physicians providing care in the
liver transplantation program have extensive experience and
demonstrate expertise in the medical and surgical treatment
of hepatic disease including the immunosuppressive
management of transplant recipients;
(iv) have a qualified transplantation team to include
physician specialists in gastroenterology, hepatology,
infectious disease, nephrology, pulmonary medicine,
pediatrics, neurology, neurosurgery, immunology and
hematology; and
(v) have clinical services with staff specialized in the
care of liver transplant patients to include, but not be
limited to: pathology, immunology, anesthesiology,
laboratory, radiology, renal dialysis, respiratory therapy,
nutrition and pharmacology.
(4) Renal transplantation services. The hospital shall:
(i) ensure that renal transplantation services are provided
in a renal transplantation center which is a unit of a
hospital approved by the department to provide
transplantation and other medical and surgical services
required for renal transplant patients;
(ii) ensure that the services are provided under the
direction of a transplantation surgeon with previous
training and experience in renal transplantation services or
a physician-director who shall be responsible for planning,
organizing, conducting and directing the clinical aspects of
renal transplantation services and participating in the
selection of a suitable treatment modality for each patient.
For the purposes of this subparagraph, physician-director is
defined as a licensed and currently registered physician who
is board-certified in internal medicine or pediatrics or has
equivalent training and experience and has at least 12
months of experience or training in the care of patients
with chronic renal disease;
(iii) ensure that the surgeons performing renal
transplantation are certified in general surgery or urology
or have equivalent training and experience with at least 12
months of advanced experience or training in renal
transplantation;
(iv have a qualified transplantation team to include an
internist with subspecialty training in nephrology and
dialysis and documented experience in the management of
renal transplantation patients; a physician with experience
in postoperative management of transplant patients who
shall be designated to ensure the availability and
appropriateness of postoperative care and services; as
necessary, the consultative services of physician
specialists in immunology and infectious disease; and for
those programs providing pediatric renal transplantation, a
pediatrician whose role is specifically identified and who
is trained in the subspecialty of pediatric nephrology with
documented experience in the management of pediatric
transplantation;
(v) have clinical services with staff specialized in the
care of renal transplant patients to include, but not be
limited to: radiology (including radioisotopic services),
laboratory (including tissue typing), anesthesiology,
nutrition, psychiatric and social services, pharmacology and
renal dialysis;
(vi) provide onsite or through a formal agreement with
another renal transplantation center, renal dialysis and
home dialysis training. A renal transplantation center may
also be a renal dialysis center; and
(vii) perform at least 20 transplants a year when fully
operational to ensure quality of care and cost
effectiveness.
(5) Heart transplantation service. The hospital shall:
(i) ensure compliance with all provisions of a cardiac
surgery center;
(ii) develop and implement medical staff and nursing service
policies and procedures which include, but are not limited
to:
(a) operative procedure protocols including donor
maintenance, heart removal and cardioplegia;
(b) posttransplantation treatment protocols including
coordination, cardiology and infection disease/isolation
protocols;
(c) Postdischarge follow-up protocols including
immunosuppression and social services;
(d) commitment of appropriate support services and
staffing, including but not limited to anesthesiology,
cardiology, operating suite, immunology, pathology,
endomycardial biopsy, dietary, nursing, social services,
central supply, cardiac surgery, neurology, neurosurgery and
psychiatry; and
(e) patient data collection and reporting protocols for
long-term patient follow. up; and
(iii) perform at least 14 human heart transplants per year.
(c) Burn unit/center. (1) Personnel and staffing.
(it A burn unit/center shall designate a director who is a
board-certified or board-admissible general or plastic
surgeon with one additional year of Specialized training in
burn therapy or equivalent experience in burn patient care.
[) Staff for the burn unit/center shall include:
(a) a head nurse of the facility who is a registered
professional nurse, with two years intensive care unit or
equivalent training and a minimum of six months burn
experience;
b) one registered professional nurse for every two
intensive care patients at times;
(c) one registered professional nurse for every three
nonintensive care patients at all times;
(d) on staff, or through formal arrangement, a physical
therapist and occupational therapist with a minimum of three
months training or six months experience in burn treatment
available as needed;
(e) staff or through formal arrangement a registered
dietician available as needed;
(f) on staff, or through formal arrangement, a medical
social worker responsible for referral and follow-up care
and individual and group counseling available as needed; and
(g) a psychologist and/or psychiatrist available as needed.
(iii) The burn unit/center shall be responsible for
training facility staff and other personnel within the
service area on emergency treatment procedures, assessment
of total body surface area affected, and the classification
of burns and triage protocols.
(2) Operation and service delivery. (i) Each burn
unit/center shall have a minimum of six beds.
(ii) Each burn unit/center shall treat a minimum of 50
patients with major burn injury to moderate uncomplicated
burn injury per year.
(iii) The burn unit/center shall refer patients for whom
there are no available beds to another burn unit/center
which can provide the care needed.
(iv) Each burn unit/center shall have available, either
through direct control or through a network of clearly
identified relationships, a system of land and/or air
transport which will bring severe burn victims to the
unit/center.
(v) Each burn unit/center shall have a designated area for
providing specialized intensive care and an operating room
easily accessible within the hospital.
(vi) Reviews of each patient with major burn injury or
moderate uncomplicated burn injury shall be undertaken on a
weekly basis by the burn care team.
(d) Cardiac surgical centers. The hospital shall not admit
patients for cardiac surgery unless the facility is an
approved cardiac surgical center nor shall the hospital
admit patients for heart transplantation unless the facility
is a cardiac surgical center approved for heart
transplantation. Cardiac surgical centers shall provide both
diagnostic and surgical services and shall be approved only
as such a combined center.
(1) Direction. The center shall be under the direction of a
qualified specialist in thoracic surgery with adequate
training and concentration of practice in cardiovascular
surgery.
(2) Staff. All personnel shall be prepared for their
responsibilities through appropriate training and
educational programs.
(i) Physicians shall all be qualified specialists in their
respective specialty, and the medical staff shall at a
minimum include:
(a) a pediatric cardiologist to care for patients in the
pediatric age group herein defined as less than age 21;
(b) a cardiologist to care for adults;
(c) in centers doing surgery for coronary artery disease, a
cardiac arteriographer with basic medical training in
internal medicine or in radiology. Supplemental
qualifications shall include at least two years of training
or experience, including but not limited to the areas of
cardiac radiology, clinical and laboratory cardiology, basic
and/or clinical cardiac physiology and catheter techniques;
(d) a thoracic surgeon or surgeons whose training
emphasized cardiovascular surgery;
(e) a radiologist with additional training in the
cardiovascular field;
(f) an anesthesiologist with experience with cardiovascular
surgical patients and open chest anesthesia;
(g) a pathologist familiar with cardiac abnormalities of
all types;
(h) residents, resident fellows, physician's assistants or
specialist's assistants on a full-time basis, capable of
dealing with all problems that arise before, during and
after surgery;
(i) consultants, readily available for consultation in
additional specialties, including hematology, neurology,
renal physiology and clinical pharmacology; and
(j) in centers performing transplants, the director of this
service and other surgeons performing heart transplants
shall be a qualified specialist in thoracic surgery and
shall demonstrate adequate training and experience in
performing human heart transplants.
(ii) Nursing personnel shall include:
(a) a registered professional nurse supervisor;
(b) a registered professional nurse in charge and on the
unit at all times; and
(c) such registered professional nurses, licensed practical
nurses, and nursing aides in such ratios that are
commensurate with the type and amount of nursing needs of
the patients.
(iii) Heart-lung machine (pump) operators shall have
special training and experience in an active program of open
heart surgery, including a thorough background in sterile
techniques, perfusion physiology, and the use of monitoring
equipment. The operator may be a specially trained
physician, nurse, or technician, at the discretion of the
director of the center.
(3) Diagnostic and surgical services. All services shall be
integrated and available on an inpatient basis, but there
shall also be adequately and appropriately organize
outpatient services to preclude unnecessary hospitalization
and ensure continuity of care. Diagnostic and surgical
services shall consist of the following:
(i) a full range of diagnostic services, including but not
limited to diagnostic radiology, clinical laboratory and
noninvasive cardiac diagnostic capability;
(ii) medical social workers shall be available to the
medical staff of the unit to assist with social problems of
the patient and the family as they arise, regardless of the
economic status of patient and family;
(iii) all essential therapeutic procedures, including but
not limited to open and closed heart surgery;
(iv) a blood bank, that meets the requirements of Subpart
58-2 of this Title under the direction of qualified
specialists in this field;
(v) intensive care, in specific units, available on a 24-
hour basis to provide the special and constant care required
by cardiac surgical patients. The unit shall be staffed by
personnel trained in the use of monitoring devices,
respirators, pacemakers, defibrillators and other necessary
equipment for cardiac resuscitation:
(vi) preoperative and postoperative care as indicated;
(vii) patient and family education, preoperative and
postoperative care; and
(viii) a system of adequate patient follow-up.
(4) State Cardiac Advisory Committee. The State Cardiac
Advisory Committee shall, at the request of the
commissioner, consider any matter relating to cardiac
surgical centers and shall advise the commissioner thereon.
(5) Approval and review, Site visits to existing and
prospective new centers by members of the State Cardiac
Advisory Committee, or other designees of the commissioner,
shall be made as indicated, as an adjunct to initial
approval and/or for maintaining approval. The public need
for cardiac transplantation services shall be evaluated in
accordance with section 709.9 of this Title. There shall be
sufficient utilization of a cardiac surgical center or heart
transplant service to insure both quality and economy of
services, as determined by the commissioner. An institution
seeking to maintain approval, or in applying for initial
approval, shall present evidence that the annual minimum
workload standards can be achieved and maintained, The fol
lowing annual minimum workload standards shall be achieved
within two years following initiation of the service to
ensure both quality and economy of services:
(i) surgical centers performing only adult open heart
surgery shall maintain an annual minimum of 100 procedures;
(ii) surgical centers performing only pediatric open heart
surgery shall maintain an annual minimum of 50 procedures;
and
(iii) surgical centers performing both adult and pediatric
open heart procedures shall maintain an annual minimum of
100 adult and 50 pediatric open heart procedures,
(6) Waiver of minimum workload standards, The commissioner
or his designee may waive the workload requirements upon a
satisfactory showing by the operator and a determination by
the commissioner that the quality of the service is adequate
and:
(i) there are extenuating circumstances temporarily
precluding compliance with the workload requirements; and/or
(ii) there is a documented unmet need in the center's
geographical service area.
(e) Cardiac diagnostic centers, Cardiac diagnostic centers
shall provide coronary arteriography and/or other cardiac
invasive diagnostic procedures.
(1) For purposes of this subdivision, the following terms
shall have the following meanings:
(i) Combined center shall mean an adult or pediatric
cardiac diagnostic center located in the same facility as a
corresponding adult or pediatric cardiac surgical center,
(ii) Free-standing center shall mean an adult cardiac
diagnostic center located in a separate facility from an
adult cardiac surgical center,
(iii) Center shall mean an approved cardiac diagnostic
facility under the direction of a qualified specialist in
internal medicine (cardiovascular disease) and/or pediatrics
(cardiology), depending on the age group(s) served, A center
may operate more than one adult or pediatric catheterization
laboratory. Each of adult and each of the pediatric
catheterization laboratories must meet the card diagnostic
requirements for specialized facilities, equipment, support
staffing and work-load pursuant to this subdivision and
section 712.11 of this Title.
(iv) Laboratory shall mean an independent unit consisting
of a separate room or rooms in a facility with specialized
cardiac diagnostic equipment and facilities primarily for
the performance of invasive cardiovascular diagnostic
procedures as referenced in paragraph (12) of this
subdivision. Such laboratories shall function under the
supervision of a qualified medical specialist, operate in
compliance with this subdivision, and meet the construction
provisions of section 712.11 of this Title.
(2) Cardiac diagnostic services may be provided at
hospitals independent of cardiac surgical centers only when
the following conditions have been met:
(i) these services are limited to adult cardiac diagnostic
service; and
(ii) there is a written affiliation agreement, acceptable to
the commissioner, between the approved cardiac diagnostic
center and an approved cardiac surgical center, which
provides for:
(a) the management of cardiac surgical emergencies; and
(b) regular conferences held at least once per month or
more frequently if required by caseload between
representatives of the cardiac surgical center and the
cardiac diagnostic center in which a significant percentage
of preoperative and postoperative cardiac cases of the free-
standing cardiac diagnostic center are reviewed. Some of the
joint conferences shall take place at the cardiac diagnostic
center.
(3) Periodic cardiology conferences shall be. held at which
the staff reviews the appropriate diagnostic studies of a
statistically significant number of cases. Records of these
conferences indicating attendance, cases reviewed and
decisions on patient management shall be maintained.
(4) Records of the disposition of the adult cases studied
shall be maintained. The number of patients referred for
surgery and the center(s) to which they are referred shall
be part of these records.
(5) Criteria adopted by the cardiac diagnostic center to be
used as indications for coronary arteriography and/or other
cardiac invasive diagnostic procedures shall be available
for review during site visits. The criteria may be developed
by the center or the center may use the criteria promulgated
by recognized specialty organizations, such as the American
Heart Association, the Inter-Society Commission on Heart Dis
ease, a professional standards review organization or the
Society for Cardiac Angiographers.
(6) Statistics shall be kept on the number of normal
invasive cardiac diagnostic studies performed, and written
criteria shall be available for determining when study is to
be considered abnormal.
(7) Direction. Patient services shall be under the
direction of a qualified specialist internal medicine
(cardiovascular disease) and/or pediatrics (cardiology),
depending upon the age group(s) served.
(8) Staff. The staff of such center shall consist of the
following:
(i) an internist and/or pediatrician, depending upon the
age group(s) served, with special training and experience in
cardiovascular diseases;
(ii) a cardiac arteriographer whose basic medical training
may be in internal medicine or in radiology. Supplemental
qualification shall include at least two years of training
or experience, including but not limited to the areas of
cardiac radiology, clinical and laboratory cardiology, basic
and/or clinical cardiac physiology and catheter techniques;
(iii) anesthesiologists experienced in the management of
cardiac patients shall be available to the center;
(iv) nurses or medical technicians with appropriate
education and training who shall be regularly assigned to
the center; and
(v) a surgeon or surgeons trained and experienced in
vascular surgery shall be available to the center for
consultation and management of complications.
(9) Services. All services shall be integrated and
available on an inpatient basis, but there shall also be
adequately and appropriately organized outpatient services,
to include unnecessary hospitalization and ensure continuity
of care. The following services shall be provided as a
minimum:
(i) a full range of diagnostic services, including but not
limited to diagnostic radiology, clinical laboratory and
noninvasive cardiac diagnostic capability;
(ii) patient and family education; and
(iii) a system of adequate follow-up.
(10) State Cardiac Advisory Committee. The State Cardiac
Advisory Committee shall, at the request of the
commissioner, consider any matter relating to cardiac
diagnostic centers and shall advise the commissioner
thereon.
(11) Approval and review. Site visits to existing and
prospective new centers by members of the State Cardiac
Advisory Committee, or other designees of the commissioner,
shall be made as indicated, as an adjunct to initial
approval, and/or for maintaining approval. There shall be
sufficient utilization of a center to ensure both quality
and economy of services, as determined by the commissioner.
Any institution seeking to maintain approval, or in applying
for initial approval, shall present evidence that the annual
minimum workload standards can be achieved and maintained.
The following minimum workload standards shall be achieved
within two years following initiation of the service to
ensure both quality and economy of services:
(i) diagnostic centers performing only adult invasive
cardiovascular procedures shall maintain an annual minimum
of 200 adult procedures;
(ii) a pediatric diagnostic center located in a facility
approved for pediatric cardiac surgery shall maintain an
annual minimum workload of 100 invasive cardiovascular
procedures; and
(iii) diagnostic centers performing both adult and
pediatric procedures shall maintain an annual minimum of 200
adult and 100 pediatric invasive cardiac diagnostic
procedures.
(12) Waiver of minimum workload standards. The commissioner
may waive the workload requirements upon a satisfactory
showing by the cardiac diagnostic center that the quality of
the service is adequate and:
(i) there are extenuating circumstances temporarily
precluding compliance with the workload requirements; and/or
(ii) there is a documented unmet need in the center's
geographical service area.
(13) Annual workload reporting. For annual reporting
purposes, an invasive cardiovascular diagnostic procedure
shall include left and/or right heart catheterization with
or without the use of contrast visualization and with or
without coronary arteriograms, excluding:
(i) placement of permanent or temporary pacemaker;
(ii) any floating type catheter;
(iii) his bundle study;
(iv) balloon septostomy;
(v) radionuclide study; and
(vi) right heart catheterization without contrast
visualization in adults.
(f) Alternate level of care. (1) Organization and
staffing.
(i) Patients on each service of the hospital who have been
assigned alternate level of care status shall be congregated
on a single care unit when there are 10 or more such persons
on the service. Patients for whom discharge is anticipated
with: 14 days and patients whose identified needs cannot be
safely and effectively met on this unit need not be
transferred to the congregate unit and shall not be counted
in the 10-patient threshold.
(ii) If the hospital can demonstrate to the department that
it can fully meet the needs of patients assigned alternate
level of care status without congregating sue patients, it
may provide such services in accordance with a plan approved
by the department in lieu of meeting the requirements of
subparagraph (i) of this paragraph.
(iii) The hospital shall appoint a staff person who has
administrative responsibility for the delivery of patient
care services to patients assigned alternate level of care
status and for the supervision of the services whether or
not they are provide by congregate care units.
(iv) The appointed staff person shall monitor and evaluate
the quality and appropriateness of care provided to
alternate level of care patients and shall ensure that
identified problems are resolved and are reported, as
appropriate, to the hospital-wide quality assurance program.
(2) Delivery of services. (i) The hospital shall provide
each patient assigned to alternate level of care status care
and services in accordance with a multidisciplinary
assessment of needs in order to promote the patient's
independence and health.
(a) A written individualized, comprehensive care plan based
upon the patient' assessed needs shall include, but not be
limited to:
(1) medical and nursing care;
(2) assistance and/or supervision, when required, with
activities of daily living, such as toileting, feeding,
ambulation, bathing including routine skin care, care of
hair and nails, and oral hygiene;
(3) rehabilitation therapy services as the patient's needs
indicate;
(4) an activities program appropriate to the needs and
interests of each patient to sustain physical and
psychosocial functioning; and
(5) other clinical care and supportive services to meet the
needs of patients.
(b) The written individualized comprehensive care plan
shall be developed and implemented by all of the qualified
professionals whose services are required by the patient
under the supervision and coordination of the patient's
attending physician and with the involvement of the patient
and the family to the extent possible, in accordance with
the patient's wishes.
(c) The comprehensive care plan shall establish realistic
and measurable goals for short- and long-term care needs,
and shall identify the type, amount and frequency of care
and services needed to maintain, restore and/or promote the
patient's functioning and health within stated time frames
for achievement.
(g) Acquired immune deficiency syndrome (AIDS) centers.
(1) Definition. An AIDS center shall mean a hospital
approved by the commissioner pursuant to Part 710 of this
Title as a provider of designated, comprehensive and
coordinated services for AIDS patients in accordance with
the requirements of this section. These services shall
include inpatient, outpatient, community and support
services for the screening, diagnosis, treatment, care and
follow-up of patients with AIDS.
(2) Administrative requirements. The hospital shall ensure
that:
(i) integrated and comprehensive services are provided
onsite to include, as a minimum, the following:
(o) a designated patient care unit for AIDS patients,
except that the commissioner may waive this requirement,
under a plan acceptable to the commissioner for placing
patients in other than a designated unit, if the AIDS center
meets all other requirements of this section and the
hospital can demonstrate:
(1) that it is unable, due to structural or space
limitations, to place the AIDS patients in a designated
unit; or
(2) specific programmatic or operational reasons why it is
preferable not to use a designated unit or not practicable
to have a designated unit for AIDS patients;
(b) an outpatient clinic program for screening, diagnostic
and treatment services for AIDS patients: and
(c) emergency services, available 24 hours a day, for
treatment of AIDS patients;
(ii) other health care services, as appropriate, are
provided directly or through contract for AIDS patients, to
include at least the following:
(a) home health care, provided through a home care services
agency licensed or certified under article 36 of the Public
Health Law, made available 24 hours a day, 7 days a week;
and
(b) personal care services;
(iii) all reasonable efforts are made to provide or arrange
for the following services and programs to meet the needs of
the AIDS patients:
(a) residential health care;
(b) hospice services provided through a hospice certified
under article 40 of the Public Health Law; and
(c) residential living programs;
(iv) diagnostic and therapeutic radiology services and
other specialized services are made available to meet the
needs of AIDS patients;
(v) inservice education programs which address the medical,
psychological and social needs specific to AIDS patients are
conducted for all hospital personnel caring for AIDS
inpatients;
vi) infection control policies and procedures pertinent to
AIDS are developed and implemented as an integral part of
the hospital-wide infection control program;
(vii) a quality assurance program, which includes a review
of the appropriateness of care for patients with AIDS, is
developed and implemented as an integral part of the overall
quality assurance program;
(viii) at the request of the department, it shall
participate in clinical research programs approved by the
hospital's institutional review board/human research review
committee;
(ix) resource information about AIDS shall be available to
the public, and educational programs are provided for
particular high-risk populations in their service area; and
(x) a crisis intervention program shall be made available
in coordination wit other existing community services,
(3) Patient referral, admission and discharge. The hospital
shall ensure that:
(i) policies and procedures are developed and implemented
which address a( mission criteria for AIDS patients,
referral mechanisms and coordinated discharge planning;
(ii) only patients who meet the admission criteria for AIDS
are admitted to the designated patient care unit;
(iii) services which the center provide are available to
all persons regardless of age, race, color, creed, sex,
sexual orientation, disability, national origin or ability
to pay;
(iv) there are transfer agreements in effect with other
hospitals in accordance with section 400.9 of this Title for
the acceptance of referrals or the transfer of AID patients
in need of specialized services available at the center; and
(v) professional staff responsible for planning patient
discharges, referrals or transfers shall have available
current information regarding home care programs,
institutional health care providers and other support
services within the hospital's primary service area.
(4) Patient management plan. The hospital shall ensure
that:
(i) a multidisciplinary team, whose composition reflects
inpatient and outpatient care services, operating in
conjunction with the attending physician:
(a) shall be responsible for each AIDS patient;
(b) shall include, as appropriate to the needs of the AIDS
patient, health car professionals from nursing, nutritional,
mental health and social work services and
(c) whenever practicable, the AIDS patient is assigned to
the same multidisciplinary team;
(ii) a comprehensive patient management plan is developed by
the multidisciplinary professional team, the patient, and
when appropriate, home health care or other nonacute long-
term care representatives, in consultation with the patient'
family and other individuals with significant personal ties
to the patients, which:
(a) shall reflect the ongoing psychological, social,
functional and financial needs of the patient and is
oriented to posthospital, ambulatory care and community
support services;
(b) shall be based on the patient's illness, prescribed
treatments and the individual patient's needs and choices;
(c) shall be reviewed and updated to reflect the patient's
changing needs and current status;
(d) shall include transfer or discharge and follow-up plans
coordinated by the multidisciplinary team or the case
manager;
(e) shall be forwarded with the patient upon discharge or
transfer for post-hospital care; and
(f) shall evaluate the extent to which the patient or
patient's personal support system can provide or arrange to
provide for identified care needs of that patient in the
home situation;
(iii) a case manager shall he designated from the
multidisciplinary team to be responsible for coordinating
the health care services and plan for each AIDS patient; and
(iv) a mechanism shall he established to assure periodic
reviews and updates of the patient management plan in
conjunction with other agencies involved with, or
responsible for, the care of the AIDS patient;
(5) Medical director. The hospital shall appoint a
physician who:
(i) shall be a qualified physician with special training in
infectious diseases, oncology or other appropriate
subspecialty;
(ii) shall direct and coordinate all medical services
provided in the AIDS center;
(iii) shall ensure the implementation of the quality
assurance program specified in subparagraph (2)(vii) of this
subdivision;
(iv) shall ensure that all members of the health care team
participate in the quality assurance program;
(v) shall ensure that interdisciplinary rounds that include
the health care professionals responsible for the patient's
total care are made on a timely and sufficiently frequent
basis as determined by each patient's needs;
(vi) shall ensure that other qualified physician
specialists are available for consultation as indicated by
the patient's condition; and
(vii) shall ensure that routine dental services are
available for AIDS patients.
(6) Quality assurance monitoring. (i) The commissioner
shall monitor and evaluate the quality and appropriateness
of care provided to AIDS patients by the AIDS center through
mechanisms which include, but are not limited to, the
monitoring and evaluation of patient management plans,
utilization reviews and quality assurance programs.
(ii) The department and its AIDS Institute shall develop
criteria for assessing the effectiveness of AIDS centers in
providing care that meets the special needs of AIDS
patients.
(7) Construction requirements. The designated patient care
unit shall be a discrete unit which complies with the
requirements of section 712.2 of this Title, except as
modified by the following:
(i) maximum patient room capacity shall be two beds, except
that more than two beds per room may be allowed under a
protocol based on patient diagnosis and approved by the
commissioner;
(Ii) patient room temperature shall be capable of being
maintained between 70 and 80 degrees F. Individual room air-
conditioning units may be used; and
(iii) each patient care unit shall have at least one
functional dayroom with space commensurate with the needs of
the patients.
(h) Comprehensive and extended screening and monitoring
services for epilepsy. (1) Definition. Comprehensive and
extended screening and monitoring services for epilepsy
shall mean a planned combination of services including
inpatient/ outpatient care which shall include, but not be
limited to: electroencephalographic monitoring, selection of
appropriate anticonvulsant medication through
neuropharmacological monitoring, surgical interventions, if
indicated, and management of a patient's psychological and
social needs through a coordinated interdisciplinary team
approach. For purposes of this section, extended screening
and monitoring services are considered rehabilitative care.
(2) Comprehensive and extended screening and monitoring
services for epilepsy shall be provided in a hospital
approved by the commissioner pursuant to Part 710 of this
Title as a provider of such services.
The purpose of these services is to treat and rehabilitate
patients with uncontrolled seizures in order to restore and
promote them to their optimal level of functioning.
(3) Administrative requirements. The hospital shall ensure
that:
(i) policies and procedures be developed and implemented
which address provision and coordination of care between the
inpatient unit and the outpatient unit for comprehensive and
extended screening and monitoring services for patients with
epilepsy;
(ii) a physician is appointed to direct the service, who is
a qualified neurologist and who has demonstrated competence
in the services and care provided to patients with epilepsy;
(iii) an interdisciplinary team of health care professionals
with training and experience in the treatment of epilepsy
shall be responsible for assessing patients and planning,
providing and coordinating care. The interdisciplinary team
shall include as a minimum the following types of health
care professionals: neurologist, neurosurgeon, registered
professional nurse, pharmacist, psychiatrist with training
in neuropsychiatry, psychologist with training in
neuropsychology, social worker, dietician, physical therapy,
occupational therapist, and dentist;
(iv) consultative services of a neurologist with experience
in pediatrics shall be made available as needed;
(v) the service shall provide or make formal arrangement
for vocational rehabilitation services and special education
services for patients who can benefit from such services;
(vi) comprehensive and extended screening and monitoring
services for epilepsy shall include clinical services with
staff specialized in electroencephalography, cable telemetry
and neuropharmacological monitoring of anticonvulsant drugs;
and
(vii) as part of the hospital's quality assurance program,
the comprehensive epilepsy service shall implement a system
for evaluating the quality and appropriateness of patient
care and patient outcomes. Reports summarizing the outcomes
from the quality assurance program for these services shall
be submitted to the department on an annual basis.
(i) Pediatric and maternal human immunodeficiency virus
(HIV) services.
(1) Applicability. (i) AIDS centers designated in
accordance with subdivision (g) of this section which have
pediatric and/or maternity services shall provide
specialized services for infants, children, adolescents, and
pregnant women who are infected with human immunodeficiency
virus (HIV) or who are HIV antibody positive and comply with
the pertinent provisions of this subdivision as well as
those in subdivision (g).
(ii) Hospitals not designated as AIDS centers in accordance
with subdivision (g) may be approved to provide specialized
services for infants, children, adolescents and pregnant
women who are infected with human immunodeficiency virus or
who are antibody positive, if the hospital:
(a) is in an area of high prevalence of HIV infection in
children and women as evidenced by the hospital's newborn
HIV seropositivity rate and the hospital's discharge rate
for pediatric and maternal HIV related disorders;
(b) provided care in the past to pediatric and maternal HIV
patients;
(c) demonstrates that it is unable to meet the requirements
for full designation under subdivision (g) of this section;
and
(d) complies with the requirements of this subdivision and
subdivision (g) of this section, except for the definition
of AIDS center in paragraph (g)(1) and except for the
administrative requirement regarding designated patient care
units in clause (g)(2)(l)(a).
(iii) A patient shall be eligible for services if the
patient is an infant, child, adolescent or a pregnant woman
who is infected with HIV or is HIV antibody positive,
whether or not the patient has progressed to symptomatic HIV
related illness.
(iv) For purposes of these regulations, family shall include
the patient's immediate kin, legal guardian or anyone with
significant personal ties to and who resides with the
patient.
(2) Organization of services. The hospital shall ensure
that:
(i) patients who require HIV related services are
identified and referred for care by the pediatric and
maternal HIV services;
(ii) obstetrical, pediatric and medical services develop and
implement procedures to coordinate the clinical care of
pediatric and maternal HIV patients to ensure the voluntary
identification of potentially affected patients and family
members and the delivery of appropriate services;
(iii) an organizational plan and policies and procedures
are developed and implemented which address
interdepartmental relationships and communications between
the pediatric and maternal HIV services;
(iv) patient care services are provided through a
coordinated interdisciplinary team approach, Inpatient and
outpatient services shall be organized to preclude
unnecessary hospitalization and to ensure continuity of
care. A member of the interdisciplinary team managing the
patient shall be designated as the individual patient's and
family's case manager and shall be responsible for serving
as a liaison among patient, family, staff and resources in
the community and responsible for coordinating the
comprehensive family management plan;
(v) services are family-centered and, in addition to the
inpatient services, include the following ambulatory care
and community support services: dental, substance abuse
treatment, family planning, infusion therapy, mental health,
neurodevelopmental evaluation, nutrition, rehabilitation
therapies, prenatal care and primary care services;
(vi) other health and related human services are provided
or arranged for as appropriate to meet the personal, social,
educational, developmental and financial needs of these
patients, including as a minimum:
(a) personal services such as caregiver support, day care,
homemaker, housekeeper, transitional residential living
programs, respite and transportation to and from needed
services;
(b) referral for legal services as appropriate to the needs
of the patient;
(c) identification and referral of children and adolescents
in need of foster care and adoption services;
(d) financial services such as emergency support, food
stamps, housing assistance, medical assistance, public
assistance, Social Security Disability, Supplemental
Security Income and Special Supplemental Food Program for
Women, Infants and Children; and
(e) education and developmental services such as early
intervention and therapeutic day care services.
(vii) a comprehensive family management plan is developed
and implemented to address the medical, nursing,
nutritional, functional, developmental, educational,
psychological, social and financial needs of the patient and
family, which plan:
(a) integrates the patient management plans as specified in
subdivision (g) of this section with plans addressing the
needs of the family; and
(b) documents the assessment and the monitoring of the
patient's and family's needs with reassessment as necessary.
(3) Patient referral, admission and discharge. The hospital
shall ensure that:
(i) services begin at the home of the patient's entry into
the pediatric and maternal HIV service program and continue
until the patient chooses not to participate in the
pediatric and maternal HIV service; or relocates outside the
pediatric and maternal HIV service catchment area; or
transfers to another AIDS center for pediatric and maternal
HIV service; or expires;
(ii) admission criteria include provisions for the
assignment of pediatric and adolescent patients to a unit
appropriate for the developmental needs of the patient; and
(iii) written policies and procedures are established and
implemented for the pediatric and maternal HIV service to
include voluntary HIV counseling and testing.
(j) Secure units for tuberculosis patients including
detainees. (1) Definition. Secure unit for tuberculosis
patients including detainees shall mean a designated patient
care unit specifically designed to accommodate patients who
have been diagnosed with active tuberculosis patients
eligible for admission to such units shall include
(i) patients who have been found to be noncompliant with
medical regimens and legally remanded to such unit shall
receive priority admission to and retention in such unit;
and
(ii) other patients requiring acute care for active
tuberculosis but not legally remanded for treatment.
Hospitals shall provide such patients with safe and adequate
care within such secure unit in accordance with procedures
approved by he commissioner.
(2) Staffing and operation. A secure unit for tuberculosis
patients including detainees shall:
(i) maintain staff that are adequate in number and trained,
including continuing education and inservice training, to
perform all necessary activities related to the care of such
patients with tuberculosis;
(ii) implement procedures to identify, diagnose and treat
patients who exhibit signs and symptoms of infectious
disease including the use of appropriate isolation
practices;
(iii) consist of an environmentally sound physical plant in
accordance with current, generally accepted standards of
infection control practices specifically relating to
tuberculosis, Such practices shall address ventilation, air
dilution, and the provision of adequate and appropriate
isolation facilities; and
(iv) provide adequate and effective personal protective
devices to any persons at risk of exposure to an infectious
tuberculosis patient. Such protective devices shall be
utilized and monitored through a respiratory program which
shall ensure training, proper use and/or fit of such
appropriate devices in accordance with generally accepted
standards of practice.
(3) Approval. Hospitals wishing to operate secure units for
tuberculosis patients including detainees, for which
construction approval pursuant to Part 710 of this Title is
not otherwise required, shall apply to the Commissioner of
Health for approval to operate such units pursuant to such
Part.
NEW YORK ADMINISTRATIVE CODE, part 6
CHAPTER V MEDICAL FACILITIES
PART 422
HEALTH-RELATED FACILITIES FOR PERSONS WITH ACQUIRED IMMUNE
DEFICIENCY SYNDROME (AIDS)
Section 422.1 Applicability. (a) This Part shall apply to a
free-standing health-related facility (HRF) of 40 beds or
less, approved by the commissioner pursuant to Part 710 of
this Title, which is designated solely for the care and
management of persons with AIDS.
(b) For purposes of this Part, AIDS shall mean acquired
immune deficiency syndrome and other human immunodeficiency
virus (HIV) related illness.
422.2 Administrative requirements. The operator shall
ensure that:
(a) a health-related facility for persons with AIDS shall
comply with the rules and regulations set forth in Parts
400, 401 and 414 of this Title, and other regulations
specified in this Part, unless a contrary requirement is
stated;
(b) only persons diagnosed by a physician as having AIDS,
who are ambulant and who would benefit from the support and
clinical services provided in the HRF, shall be admitted;
(c) a written agreement exists between the HRF and at least
one designated AIDS center for the provision of case
management services for each resident. The commissioner may
waive the requirement that case management services be
provided by a designated AIDS center if the facility
presents an alternative plan to the department which
adequately meets the case management of its residents;
(d) outpatient, emergency and acute inpatient health-care
services are to be provided by a designated AIDS center or
other hospital. The facility shall provide directly or make
formal arrangements for special services to residents in
need thereof. These services must include, as a minimum,
medical, substance abuse, mental health, dental, rehabili
tative and pastoral counseling;
(e) a written transfer agreement exists with the designated
AIDS center or other hospital for the transfer of residents
requiring emergency care and acute inpatient care services;
(f) all resident transfers and discharges are coordinated
with the resident's case manager and the resident, or the
resident's legal representative, and the attending
physician. Such persons shall be informed of the transfer or
discharge at least five days before the transfer or
discharge occurs, except in an emergency;
(g) in-service and continuing educational programs which
address the medical, psychological, social problems and care
needs specific to persons with AIDS are conducted for all
staff on a regular basis, but no less than every three
months. A record of programs attended shall be maintained
for each employee;
(h) staff counseling and supportive services are made
available to staff to address problems related to the care
of patients with AIDS;
(i) infection control policies and procedures specific to
AIDS are developed and implemented;
(j) written policies and procedures, including admission
and discharge criteria, are developed and implemented. The
HRF shall admit and retain only persons with AIDS whose
needs can be met by this type of facility;
(k) written policies and related procedures that govern
each service furnish onsite by the facility are developed
and implemented. The policies and procedures must be avail
able to the staff, residents, members of the family and
legal representatives of the residents, and the public; and
(1) security services sufficient to safeguard staff and
residents are provided 24 hours a day.
422.3 Physician services. The operator shall ensure
that:
(a) the health care of each resident is under the
continuing supervision of an attending physician;
(b) the attending physician sees and evaluates the resident
whenever necessary, but at least once every 30 days, and
participates in interdisciplinary resident care planning;
and
(c) a physician experienced in the care and clinical
management of persons with AIDS is designated as medical
director. This individual shall provide medical consultation
as needed to the attending physicians and assist with the
development of policies and procedures for the facility.
422.4 Administrative and health-care staff. There shall
be sufficient numbers of qualified staff on duty 24 hours a
day to carry out the responsibilities and the programs of
the HRF to include, as a minimum:
(a) a currently licensed nursing home administrator full-
time or part-time depending on the number of beds and the
type of program in accordance with section 420.2(a) through
(d) of this Title;
(b) a resident services director, who may be the
administrator or a licensed or certified health
professional, and who is responsible for coordinating and
monitoring the resident's plan of care;
(c) a registered professional nurse who is responsible for
the supervision of the HRF's health services and nursing
care seven days a week for at least one shift each day;
(d) nurse aids employed on each shift, seven days a week,
in sufficient numbers to meet the health-care needs of the
residents; and
(e) a substance abuse specialist with experience in the
direct treatment of drug abuse, who is responsible for
substance abuse counseling and referral of the resident to
other programs as needed.
422.5 Social services. The operator shall ensure that:
(a) social services are provided for each resident as
needed;
(b) the facility either provides these services directly or
arranges for them with qualified outside resources; and
(c) the facility designates one staff member, qualified by
training or experience, to be responsible for arranging for
social services and integrating plans for social services
into the resident's plan of care.
422.6 Pharmaceutical services. The operator shall
ensure that:
(a) a formal agreement exists with a registered pharmacist
to assist with the development and implementation of written
policies and procedures for the ordering, storage,
dispensing, administration, disposal, and recordkeeping of
drugs and biologicals, in accordance with current standards
of professional practice;
(b) verbal orders made by a physician are given to only a
licensed nurse, pharmacist or another physician. Such orders
must be reduced to writing, signed by the nurse and
countersigned by the physician within 48 hours;
(c) only physicians and licensed nurses administer
medications, except that residents be allowed to administer
their own medications if the attending physician gives
permission in writing: and
(d) a pharmacist reviews each resident's medications as
needed, but at least every month, and notifies the physician
if changes are needed.
422.7 Dietary services. The operator shall ensure that:
(a) dietary services are under the supervision of a staff
person trained or experienced in food management and
nutrition;
(b) the dietary supervisor is responsible for planning
menus that meet the nutritional needs of each resident in
accordance with medical orders and current professional
nutritional standards.
(c) medically prescribed, therapeutic diets are planned by
a dietitian;
(d) at least three meals or their equivalent are served
each day at regular times, with more than 14 hours between
the evening meal and breakfast;
(e) menus are kept for at least 30 days;
(f) appropriate eating equipment and utensils are provided
as needed for residents; and
(g) the facility complies with the sanitary requirements of
Part 14 of this Title.
422.8 Activities and recreational programs. The
operator shall:
(a) designate a staff member, qualified by training or
experience in activity and recreational programming, to be
responsible for planning individual and group activities and
recreation; and
(b) ensure that there are ongoing programs of activities
appropriate to the residents needs and interests.
422.9 Comprehensive care plans. The operator shall ensure
that:
(a) a written, comprehensive care plan is developed and
implemented for each resident in coordination with the case
manager and in consultation with the resident or the
resident's authorized representative. The care plan is
developed by an interdisciplinary team of health-care
professionals as appropriate to the needs of the resident,
to include, as a minimum, the attending physician, a
registered professional nurse and a social worker; and
(b) the care plan is reviewed and modified as necessary,
but at least monthly, by the interdisciplinary team.
422.10 Medical record system. The operator shall ensure
that:
(a) the facility maintains a medical record system that
contains a record of each resident in accordance with
accepted professional standards of practice. Each resident's
medical record shall contain, as a minimum:
(1) identification and admission information;
(2) a current comprehensive care plan;
(3) documentation of medical examinations, progress notes
and discharge summaries; and
(4) all other pertinent information related to the
resident's care;
(b) the facility shall develop and implement policies and
procedures to ensure the confidentiality of all medical
records.
422.11 Utilization control. The operator shall ensure
that:
(a) the utilization control program of the facility
conforms to the regulations set forth in sections 86-
2.30(i), 400.12 and 421.13 of this Title; and
(b) each resident is reviewed every 30 days in accordance
with a utilization review plan approved by the department.
REPORTS
455.44 Acquired Immune Deficiency Syndrome. This
functional reporting center must contain all the expenses
associated with the care of individuals with AIDS, AIDS-
related complex, and those diagnosed with other human
immunodeficiency virus-related illnesses in a discrete AIDS
unit within a residential health care facility or in a free-
standing designated AIDS center. Costs associated with AIDS
patients in designated or undesignated AIDS beds in an
existing non-AIDS unit will remain a part of that unit's
costs.
(a) Standard unit of measure: number of patient days of
care for all patients admitted to this unit. Include the day
of admission, but not the day of discharge or death. If both
admission and discharge or death occur on the same day, the
day is considered a day of admission and counts as one
patient day.
(b) Data source. The number of patient days shall be taken
from dally census counts.
714.20 Health-related facilities-AIDS patients; general.
New free-standing health-related facilities to be
constructed and designed specifically for persons suffering
with acquired immune deficiency syndrome (AIDS) need not
comply with any other provision of this Part but shall be
subject to sections 711.1-711.3 and 711.9 of this Title and
to the following:
(a) The residential board and care occupancies provisions
of the National Fire Protection Association's Life Safety
Code 101. Further details concerning this referenced
material are contained in section 711.2(a) of this Title.
(b) To the extent permitted by section 2812 of the Public
Health Law, local laws, rules and regulations relating to
fire and safety, sanitation and other health requirements,
where such local laws impose standards in addition to those
required by this section.
(c) Applicable requirements of American National Standards
Institute (ANSI) Standard No. A117.1, for building and
facilities providing accessibility and usability for
physically handicapped people. Further details concerning
this referenced material are contained in section 711.2(b)
of this Title.
(d) Resident rooms. Each resident room shall meet the
following requirements:
(1) The maximum room capacity shall be two residents. At
least two single-occupancy rooms shall be provided.
(2) Minimum room area, exclusive of toilet rooms, closets,
lockers, wardrobes, alcoves or vestibules, shall be 100
square feet in single rooms and 80 square feet per bed in
double rooms.
(3) Each room shall be at or above grade level.
(4) Each room shall be equipped with a device for calling
the staff member on duty.
(5) Each room shall be equipped with closet or wardrobe
space, at least 18 inches by 60 inches high, that provides
security and privacy for the clothing and personal
belongings of each resident.
(6) Each room shall be equipped with or conveniently
located near toilet and bathing facilities.
(7) Each room shall contain a suitable bed and appropriate
furniture for each resident.
(8) Each resident sleeping room shall be protected by an
automatic smoke and heat detector interconnected with the
fire alarm system.
(e) Bathroom facilities. Toilet and bathing facilities
shall be appropriate in number, size and design to meet the
needs of the residents. In no case shall the facility
provide less than one toilet, lavatory and bathing fixture
for every six or fewer number of residents. Toilet and
bathing facilities shall be provided on the same floor as
the resident bedrooms served.
(f) Lounge facilities. Each facility shall provide adequate
lounge area(s) to meet the residents' recreational and
social needs. In addition to the dining area(s) required in
this section, each facility shall provide at least one
lounge area of 200 square feet or e square feet per
resident, whichever is greater.
(g) Dining area. Each facility shall provide adequate
dining facilities to meet the needs of the residents at the
rate of 15 square feet per resident.
(h) Service areas. (1) An office for staff use must be
provided onsite to provide for administrative and records
storage area.
(2) Drug distribution station. Provision shall be made for
convenient and prompt 24-hour distribution of drugs. This
may be a medicine preparation room or unit, or a self-
contained medicine dispensing unit. If used, a medicine
preparation room or unit shall be under the staff's visual
control and contain a work counter, refrigerator, and locked
storage for drugs.
(3) At least one toilet and lavatory shall be provided for
staff and visitor use.
(4) Janitor's closet. At least one janitor's closet shall
be provided.
(5) Soiled linen. An enclosed space shall be provided for
the storage and/or treatment of soiled linens.
(6) Clean linen. Separate closet(s) or designated area(s)
for the storage of clean linens shall be provided. Adequate
linen shall he available at all times for the proper care
and comfort of the residents.
(7) Waste disposal. An enclosed space shall be provided for
the proper storage and removal of waste materials.
(8) Therapy space. Therapy areas must be properly designed
in terms of size and equipment to support all program
functions.
(9) Dietary. Adequate space and equipment for the storage,
preparation and service of meals shall be provided.
PART 759
ADULT DAY HEALTH CARE SERVICES FOR PATIENTS WITH AIDS
Section 759.1 Definitions. As used in this Part, unless the
context otherwise requires:
(a) For purposes of this Part, AIDS shall mean acquired
immune deficiency syndrome and other human immunodeficiency
(HIV) related illnesses.
(b) Registrant means a person who has AIDS or HIV illness:
(1) who is not a resident of a residential health care
facility, is functionally impaired and not homebound, and
requires certain preventive, diagnostic, therapeutic,
rehabilitative or palliative items or services but does not
require the continuous 24-hour-a-day inpatient care and
services provided by a general hospital, or residential
health care facility; and
(2) whose assessed social and health care needs, in the
professional judgment of the physician of record, nursing
staff, social services and other professional personnel of
the adult day health care program can be met satisfactorily
in whole or in part by delivery of appropriate services in
such program.
(c) Adult day health care means care and services provided
to a registrant in a diagnostic and treatment center or
approved extension site under the medical direction of a
physician by personnel of the adult day health care program
in accord with a comprehensive assessment of care needs and
individualized health care plan, ongoing implementation and
coordination of the health care plan, and transportation.
759.2 Applicability.
(a) (1) The operator of a diagnostic and treatment center
may provide adult day health care services to registrants
when approved pursuant to Part 710 of this Title -
(2) A diagnostic and treatment center which has been
approved by the department to operate an adult day health
care program at its primary site may provide adult day
health care services at an extension site approved by the
department under the provisions of section 710.1 of this
Title.
(3) A diagnostic and treatment center which does not
operate an adult day health care program at its primary site
may provide such a program at an extension site approved by
the department in accordance with section 710.1 of this
Title if there is not sufficient suitable space within the
center to accommodate a full range of adult day health care
program activities and services. The department may conduct
an onsite survey of the center to determine whether the
facility space and/or location is suitable for an adult day
health care program.
(b) Prior to operation of the facility's adult day health
care services program, the operator shall apply to the
department for approval in accordance with Part 710 of this
Title and shall submit a description of the proposed
program, including but not limited to:
(1) need for the program, including statements on
philosophy and objectives of the program;
(2) range of services provided;
(3) methods of delivery of services;
(4) transportation arrangements for registrants;
(5) physical space and use thereof;
(6) number and expected characteristics of registrants to
be served;
(7) personnel participating in the program, including
qualifications;
(8) case management services and use of and coordination
with existing community resources, including AIDS centers,
alcohol and substance abuse programs and rehabilitation
facilities as appropriate;
(9) financial policies and procedures;
(10) program budget;
(11) methods for program evaluation; and
(12) proximity to an identified number of potential
registrants.
759.3 General requirements. The operator shall have and
implement written policies and procedures which shall
provide for:
(a) a written transfer agreement with a designated AIDS
center or other hospital for the transfer of registrants
requiring emergency care and acute inpatient care services;
(b) the appropriate transfer of registrants when
applicable, to the care or supervision of other health
facilities in accordance with the provisions for transfer
and affiliation under section 400.9 of this Title;
(c) staff experienced in the care and management of persons
with AIDS or HIV related illness, equipment and space
sufficient to meet the assessed needs of registrants,
including sufficient bath and toilet facilities pursuant to
section 713-2.12 of this Title; and
(d) the development and implementation of in-service and
continuing educational programs, staff counseling and
supportive services, and infection control specific AIDS and
HIV illness.
759.4 Admission and patient assessment. (a) The
operator shall:
(1) select and admit to the adult day health care program
only those persons for whom adequate care and needed
services can be provided and who, according to the needs
assessment, can benefit from the services and require a
minimum of three hours of health care services provided on
the basis of at least one visit per week to the program;
(2) assess each applicant, utilizing an assessment
instrument provided by the department as part of the
admission review process, which assessment shall include at
a minimum the following:
(i) medical needs, including the determination that the
applicant is expected to need continued service for a period
of 60 or more days;
(ii) use of medication and required treatment;
(iii) nursing care needs;
(iv) functional status;
(v) mental status;
(vi) sensory impairments;
(vii) rehabilitation therapy needs, including a
determination regarding the specific need for physical
therapy, occupational therapy, and speech language pathology
services;
(viii) family and other informal supports;
(ix) home environment;
(x) psycho-social needs;
(xi) financial status;
(xii) nutritional status;
(xiii) ability to tolerate the duration and method of
transportation to the program;
(xiv) evidence of any substance abuse problem; and
(xv) need for HIV risk reduction counseling.
(3) register each applicant only upon recommendation from
the applicant's physician and after completion of a personal
interview by qualified personnel with the applicant, next of
kin and/or sponsor;
(4) register each applicant only after determining that the
applicant is not receiving the same services from any other
facility or agency;
(5) admit an applicant to the service only after execution
of a written agreement which shall include but not be
limited to a requirement that:
(i) the applicant agrees to a medical examination at a
physician's office, the facility or other appropriate site,
within six weeks prior to or seven days after admission and
as indicated in the physician's plan of care, HIV
comprehensive care protocols or by medical necessity; and
(ii) the operator provides to the applicant, next of kin
and/or sponsor a written list of basic services furnished by
the facility to registrants and paid for as part of the
registrant visit at daily, weekly or monthly rates;
(6) record all financial arrangements with the applicant or
designated representative, with copies executed by and
furnished to each party;
(7) make no arrangement for prepayment for basic services
exceeding one month;
(8) comply with the provision of financial policies as set
forth in the applicable section of this Title; and
(9) register applicants in an adult day health care program
only if the pre-registration evaluation determines that the
program can adequately and appropriately care for the
applicants.
(b) No applicant suffering from the infectious stages of
tuberculosis may be registered or retained for services on
the premises unless a physician certifies that the reg
istrant presents no significant risk to any person.
759.5 Comprehensive care planning. (a) The operator shall:
(1) develop a comprehensive care plan and, when applicable,
a transfer or discharge plan, for each registrant within
five visits, not to exceed 30 days, from registration;
(2) designate staff members to ensure the completion of the
comprehensive care plan with the participation of
consultants in the medical, social, paramedical and related
fields as appropriate;
(3) ensure that the comprehensive registrant care plan
includes for each registrant:
(i) the medical and nursing goals and limitations
anticipated for each registrant and, as appropriate, the
nutritional, social, rehabilitative and leisure time goals
and limitations;
(ii) the registrant's potential for remaining in the
community; and
(iii) transportation arrangements;
(4) ensure that development and modification of the
comprehensive care plan is coordinated with other health
care providers outside the program who are involved in the
registrant's care.
(b) Designated staff members, with the participation of
consultants in the medical, social, paramedical and related
fields, as appropriate, shall:
(1) record changes in the registrant's status which require
alterations in the registrant comprehensive care plan;
(2) modify the plan accordingly; and
(3) review the plan at least quarterly.
759.6 Registrant services. Registrant services shall be
provided and/or arranged for in accord with the
multidisciplinary assessment of needs and comprehensive care
plan which include but are not limited to:
(a) medical services and HIV primary care services
including gynecologic services as appropriate;
(b) case management services;
(c) food and nutrition services;
(d) social services as the registrant's medically related
social and emotional needs indicate;
(e) assistance and/or supervision, when required, with
activities of daily living, such as toileting, feeding,
ambulation, bathing including routine skin care, care of
hair and nails, and oral hygiene;
(f) rehabilitation therapy services as the registrant's
needs indicate;
(g) an activities program involving community,
interpersonal and self-care functions appropriate and
sufficient in scope to the needs and interests of each
registrant to sustain physical and psychosocial functioning;
(h) nursing services;
(i) religious services and pastoral counseling and
counseling for HIV risk reduction for any registrants
requesting such services;
(j) pharmaceutical services;
(k) substance abuse treatment, if appropriate; and
(1) dental services as the registrant's needs indicate.
759.7 Medical record system. The operator shall ensure
that:
(a) the facility maintains a medical record system that
contains a record, including current comprehensive care plan
for each registrant, in accordance with accepted
professional standards of practice and the medical records
system section of this Title. Each registrant's medical
record shall contain, as a minimum:
(1) identification and admission information;
(2) documentation of medical examinations, progress notes
and discharge summaries; and
(3) all other pertinent information related to the
resident's care including record of attendance;
(b) the facility shall develop and implement policies and
procedures to ensure the confidentiality of all medical
records.
759.8 Utilization control and quality assurance. The
operator shall ensure that the utilization control and
quality assurance program of the facility conforms to the
regulations set forth in section 751.8 of this Title.
759.9 Evaluation. The operator shall develop and
implement procedures which provide for at least an annual
written evaluation of the adult day health care program to
include, at a minimum, a profile of the characteristics of
the registrants admitted to the program, the services and
degree of services most utilized, the length of stay and use
rate, registrant need for care and services and disposition
upon discharge. The evaluation shall also include such data
items as are available to the operator and are identified
and set forth on forms provided by the department.
PART 772
AIDS HOME CARE PROGRAMS PROVIDED BY AIDS CENTERS
Section 772.1 Definition. An AIDS home care program
provided by an AIDS center shall mean, for purposes of this
Part, a long term home health care program as defined in
Part 700 of this Title which is authorized only to provide
an AIDS home care program as defined in Part 700 of this
Title.
772.2 General. (a) No AIDS center shall provide an
AIDS home care program without the written authorization of
the commissioner pursuant to Part 770 of this Title to
provide such a program.
(b) An AIDS home care program provided by an AIDS center
shall comply with the standards of organization and
administration for a long term home health care program as
set forth in Part 771 of this Title.
NEW YORK ADMINISTRATIVE CODE, PART 7
SUBPART 43.2
AIDS DRUG ASSISTANCE PROGRAM
Section 43.2.1 Scope. These regulations govern the
application and eligibility determination process for the
AIDS Drug Assistance Program and establish the rights and
responsibilities of applicants, participants, medical
providers, and the contractor in that process.
43.2.2 Definitions. (a) An applicant is a person who
has directly or by a representative applied in writing to
the New York State Department of Health.
(b) An application is the process by which a person
indicates, in writing on a Department of Health approved
form, his/her desire to receive assistance.
(c) Resident means a person domiciled within the State.
(d) Authorized representative means any person authorized
by an applicant or participant to act on his/her behalf.
(e) Period of coverage. Coverage for assistance is
effective on the first date a drug is dispensed to an
individual who is determined to be eligible for
participation in the program. Coverage will terminate under
the following circumstances:
(1) the applicant indicates in writing that he/she no
longer needs or desires assistance;
(2) the department determines that a change in the
participant's circumstances or residence has affected
his/her eligibility;
(3) the participant has died or cannot be located; and
(4) funding for the AIDS Drug Assistance Program is
exhausted.
(f) Program means the AIDS Drug Assistance Program.
(g) Household. The applicant, and persons legally
responsible for the applicant, and persons for whom the
applicant is legally responsible, shall be considered part
of the household.
(h) Income means total gross income of the household.
Income shall include: monetary compensation for services,
including wages, salary, commissions, or fees; net income
from self-employment; unemployment insurance compensation;
government civilian employee or military retirement or
pension, including veteran's payments; pensions or
annuities; alimony or child support payments; regular
contributions from persons not living in the household; net
royalties; social security benefits; dividends or interest
on savings or bonds; income from estates or trusts; net
rental income; public assistance or welfare payments; cash
or any other income resource.
(I) Contractor means any corporation which has entered into
a contract with the department to assist in carrying out the
provisions of the program.
43-2.3 Confidentiality. All information which may
identify an applicant which is received by the program will
be confidential and can only be used when necessary for
supervision, monitoring or administration of the program.
Information received by any contractor, his agents,
employees, or by any other person or agency concerning appli
cants or participants in the program is confidential and may
not be disclosed without the written approval of the AIDS
Drug Assistance Program director, who shall approve
disclosure only in conformance with article 27-F of the
Public Health Law.
43-2.4 Use of the application form. (a) The State-
approved application form must be completed:
(1) for each applicant upon initial application and
recertification, if required; and
(2) when there is a change in status affecting eligibility.
(b) The signature of the individual applying for assistance
is required on the State-approved application form. In any
case where the applicant is incapable of signing the
application because of physical incapability, or mental
incompetency, application shall be signed on behalf of such
a person by his/her authorized representative.
(c) The State-approved form shall contain the following
information, in addition to any other information which the
Department of Health may require for the proper
administration of the program:
(1) name, sex, date of birth, social security number,
marital status, address and telephone number of the
applicant;
(2) name and relationship to applicant for applicant's
household members;
(3) income information for the applicant and members of the
applicant's household; and
(4) information regarding any other health benefits or
insurance coverage that is available to the applicant.
43-2.5 Eligibility for coverage. (a) An applicant must
be confirmed as medically eligible to participate in the
program. The Department of Health will confirm medical
eligibility based upon information received from the
applicant or the applicant's physician or the physician's
designee. The applicant's physician or the physician's de
signee will be required to submit information regarding an
applicant's medical condition on a State-approved form.
(b) Financial eligibility will be based upon the total
gross income available to the applicant's household.
(1) In order to be eligible, an applicant's household
income must be equal to or less than the income guideline
for the applicant's family size as specified below:
Schedule-Statewide Standard of Need (Annual)
Number of Persons in Household
One Two Three +
44,000 59,200 74,400
(2) Applicants must provide income information for a
reasonable period prior to application. Applicants who are
self-employed must provide business records for the three
months prior to application indicating type of business,
gross income and net income.
(c) Liquid resources shall be reviewed to determine their
availability in determining eligibility for the program. In
order to be eligible, an applicant's liquid resources must
be less than $25,000.
(1) Liquid resources are cash or those assets which can be
readily converted to cash such as bank accounts, lump sum
payments, i.e., stocks, bonds and mutual fund shares.
Resources in an individual retirement account (IRA) or other
tax deferred compensation plan will be calculated at the
rate of 50 percent for purposes of determining liquid
assets.
(d) Full and proper use shall be made of existing public
and private medical and health services and facilities for
obtaining therapeutic drugs for the treatment of AIDS.
(e) An applicant or recipient of assistance may be required
as a condition of eligibility or continued eligibility to
assign any rights he/she may have for drug coverage benefits
under any health insurance policy or group health plan to
the department.
(f) The department may employ a contractor to determine
eligibility consistent with the requirements and
responsibilities of Subpart 43-2 of this Part. Eligibility
determinations are subject to department review and
adjustment.
43-2.6 Decision on eligibility. (a) The department
shall make one of the following decisions, based upon the
application information:
(1) Accepted for coverage. This means that eligibility has
been established through review and verification to the
satisfaction of the department; or
(2) Not accepted for coverage. Applications are denied when
the information given by the applicant establishes that the
applicant is ineligible, or when the applicant refuses to
comply with any requirement essential to the determination
of eligibility.
(b) No decision is required when:
(1) an application is withdrawn by the applicant; or
(2) the department documents that the applicant has died,
cannot be located, or has left the State prior to the
completion of the review and verification.
43-2.7 Responsibility for prompt determination of
eligibility. The decision to accept or deny the application
shall be made as soon as sufficient information to make a
determination about eligibility is obtained.
43-2.8 Notification. Written notification shall be given
of the decision to accept or deny an application.
Notification of denial shall clearly set forth the specific
reason why the application was denied.
43-2.9 Issuance of program eligibility cards. (a) The
department or authorized parties shall issue a program
eligibility card to each person determined eligible for
benefits.
(b) The card shall include the following information:
(1) participant's full name;
(2) participant's identification number;
(3) participant's effective date of coverage;
(4) category of drugs for which the participant is
eligible; and
(5) the effective date of coverage for each category.
43-2.10 Investigation. The department official shall
review and verify information received on applications, as
required. Documents, personal observation, personal and
collateral interviews and contacts, reports, correspondence
and conferences are means of verification of information
supplied. When information is sought from collateral sources
other than public records because the applicant or
participant cannot provide verification, the department will
inform the applicant/ participant or his/her representative
of what information is desired, why it is needed and how it
will be used.
43-2.11 Fraud and abuse. (a) The commissioner, his
agents or designees, shall investigate and refer for
prosecution any violations of State laws pertaining to fraud
or abuse in the program.
(b) Where review indicates substantial evidence of abuse of
the program, the participant may be removed from the program
or restricted to a single provider.
(c) If the recipient did not provide accurate information
regarding his income and expenses, the commissioner may
summarily suspend an enrollee's participation in the
program, and the department can recover the amount of
assistance granted, to which the recipient is not entitled.
43-2.12 Appeals. (a) An applicant may request a
reconsideration of an adverse decision within 60 days of a
decision.
(b) The department shall review any additional submissions
and issue a written decision within 30 days of an
applicant's request and submission of additional documents.
43-2.13 Continuing eligibility. (a) Participants may be
required to establish periodically that they remain eligible
for the program.
(b) The applicant/participant must notify the department
immediately of any changes in circumstances that may affect
eligibility.
43.2.14 Enrollment of providers. The department will
contract with pharmacies and health care providers which
demonstrate that they are qualified to provide prescription
drugs.
43.2.15 Audit and claim review. (a) Providers shall be
subject to audit by the commissioner, his agents or
designees. With respect to such audits, the provider may be
required:
(1) to reimburse the department for overpayments discovered
by audits; and
(2) to pay restitution for any direct or indirect monetary
damage to the program resulting from their improperly or
inappropriately furnishing covered drugs.
(b) The commissioner, his agents or designees, may conduct
audits and claim reviews, and investigate potential fraud or
abuse in a provider's conduct.
(c) The commissioner, his agents or designees, may pay or
deny claims, or delay claims for audit review.
(d) When audit findings indicate that a provider has
provided covered drugs in a manner which may be inconsistent
with regulations governing the program, or with established
standards for quality, or in an otherwise unauthorized
manner, the commissioner may summarily suspend a provider's
participation in the program and/or payment of all claims
submitted and of all future claims may be delayed or
suspended. When claims are delayed or suspended, a notice of
withholding payment or recoupment shall be sent to the
provider by the department. This notice shall inform the
provider that within 30 days he/she may request in writing
an administrative review of the audit determination before a
designee of the commissioner. The review must occur and a
decision rendered within a reasonable time after a request
for recoupment is warranted, or if no request for review is
made by the provider within the 30 days provided, the
department shall continue to recoup or withhold funds
pursuant to the audit determination.
(e) Where investigation indicates evidence of abuse by a
provider, the provider may be fined, suspended, restricted
or terminated from the program.
43-2.16 Audits and recovery of overpayments. (a)
Recovery of overpayments shall be made only upon a
determination by the commissioner, his agents or designees,
at such overpayments have been made, and recovery shall be
made of all money paid to the provider to which it has no
lawful right or entitlement.
(b) Recovery of overpayments pursuant to this subject shall
not preclude the commissioner or any other authorized
governmental body or agency from taking any other action
with respect to the provider, including auditing or
reviewing other payments or claims for payment for the same
or similar periods, imposing program sanctions, or taking
any other action authorized by law.
(c) The commissioner may utilize any lawful means to
recover overpayments, including civil lawsuit, participation
in a proceeding in bankruptcy, common law set-off, or such
other actions or proceedings authorized or recognized by
law.
(d) All fiscal and statistical records and reports of
providers and prescriptions filled or refilled which are
used for the purpose of establishing the provider's right to
payment under the program and any underlying books, records,
documentation which formed the basis for such fiscal and
statistical records and reports shall be subject to audit.
All underlying books, records and documentation including
all prescriptions filled or refilled shall be kept and
maintained by the provider for a period of not less than
three years from the date of completion of such reports, or
the date upon which the fiscal and statistical records were
required to be filed, whichever is later, or the date the
prescription was filled or refilled.
(e) All claims made under the program shall be subject to
audit by the Commissioner, his agents or designees, for a
period of three years from the date of their filing this
limitation shall not apply to situations in which fraud may
be involved or where the provider or an agent thereof
prevents or obstructs the performance of an audit pursuant
to this Part.
43.2.17 Recoupment of overpayments. Overpayments
determined to have been made pursuant to this section and
section 43-2.16 of this Subpart shall be recovered by
withholding the provider's current or future payments on
claims submitted or a percentage of payments otherwise
payable on such claims, or such other remedies as may be
available through a court of law.
CHAPTER II ADMINISTRATIVE RULES AND REGULATIONS
SUBCHAPTER G
AIDS Testing, Communicable Diseases and Poisoning
PART 63
AIDS TESTING AND CONFIDENTIALITY OF HIV-RELATED INFORMATION
Section 63.1 Definitions. (a) HIV-infection means
infection with the human immunodeficiency virus or any other
agent identified as a probable cause of AIDS.
(b) AIDS means acquired immune deficiency syndrome, as may
be defined from time to time by the centers for disease
control of the United States Public Health Services.
(c) HIV-related illness means any clinical illness that may
result from or be associated with HIV infection.
(d) HIV- related test means any laboratory test or series
of tests for any virus, antibody, antigen or etiologic agent
whatsoever, thought to cause or to indicate the presence of
HIV infection.
(e) Capacity to consent means an individual's ability,
determined without regard to the individual's age, to
understand and appreciate the nature and consequences of
proposed health care service, treatment, or procedure, or of
a proposed disclosure of confidential HIV-related
information, and to make an informed decision concerning the
service, treatment, procedure or disclosure.
(f) Protected individual means a person who is the subject
of an HIV-related test or who has been diagnosed as having
HIV infection, AIDS or HIV-related illness.
(g) Confidential HIV-related information means any
information, in the possession of a person who provides
health or social services or who obtains the information
pursuant to a release of confidential HIV-related
information, concerning whether an individual has been the
subject of an HIV-related test, or has HIV infection, HIV-
related illnesses or AIDS, or information which identifies
or reasonably could identify an individual as having one or
more of such conditions, including information pertaining to
such individual's contacts.
(h) Health or social service means any care, treatment,
clinical laboratory test, counseling or educational service
for adults or children, and acute, chronic, custodial,
residential, outpatient, home or other health care; public
assistance, including disability payments available pursuant
to the Social Security Act; employment-related services,
housing services, foster care, shelter, protective services,
day care or preventive services; services for the mentally
disabled; probation services; parole services; correctional
services; detention and rehabilitative services; and the
activities of the Health Care Worker HIV/HBV Advisory Panel
(see Public Health Law article 27-DD), all as defined in
section 2780(8) of the Public Health Law.
(i) Health facility means a hospital as defined in section
2801 of the Public Health Law, blood bank, blood center,
sperm bank, organ or tissue bank, clinical laboratory, or
facility providing care or treatment to persons with a
mental disability.
(j) Health care provider means any physician, nurse,
provider of services for the mentally disabled or other
person involved in providing medical, nursing, counseling,
or other health care or mental health service, including
those associated with, or under contract to, a health
maintenance organization or medical services plan.
(k) Contact means an identified spouse or sex partner of
the protected individual or a person identified as having
shared hypodermic needles or syringes with protected
individual.
(1) Person includes any natural person, partnership,
association, joint venture, trust, public or private
corporation or State or local government agency.
(m) Release of confidential HIV- related information means
a written authorization for disclosure of confidential HIV-
related information which is signed by the protected
individual, or if the protected individual lacks capacity to
consent, a person authorized pursuant to law to consent to
health care for the individual. Such release shall be dated
and shall specify to whom disclosure is authorized, the
purpose for such disclosure and the time period during which
the release is to be effective. A general authorization for
the release of medical or other information shall not be
construed as a release of confidential HIV-related
information, unless such authorization specifically
indicates its dual purpose as a general authorization and an
authorization for the release of confidential HIV-related
information and complies with this definition.
(n) Insurance institution means any corporation,
association, partnership, reciprocal exchange, interinsurer,
fraternal benefits society, agent, broker or other entity in
the business of providing health, life and disability
coverage including, but not limited to, any health
maintenance organization, medical service plan, or hospital
plan which:
(1) is engaged in the business of insurance;
(2) provides health services coverage plans; or
(3) provides benefits under, administers, or provides
services for, an employee welfare benefit as defined in 29
USC 1002(1).
63.2 Application. These regulations apply to persons who
order an HIV-related test, to persons who receive
confidential HIV-related information in the course of pro
viding any health or social service or who receive
confidential HIV-related information pursuant to a release.
All disclosures of confidential HIV-related information made
on or after February 1, 1989 are subject to such
regulations. These regulations do not apply to information
which is received by the commissioner under Subpart 24-1 of
this Title and protected from disclosure pursuant to Public
Health Law, section 206(1)(j). These regulations do not
apply to insurance institutions and insurance support
organizations, except as noted in section 63.5(a)(9), (10)
and (12) of this Part. Health care providers associated with
or under contract to a health maintenance organization or
other medical services plan are subject to these
regulations.