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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsAugust 2014

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Statutory Authority: 16 Delaware Code, Section 122(3)(m) (16 Del.C. §122(3)(m))
16 DE Admin. Code 4468
On April 1, 2014 (Volume 17, Issue 10), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Del.C. §10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by April 30, 2014, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
First, the proposed standards are comprehensive but only establish guidelines for hospice providers. Hospice agencies must adopt policies which conform to an outline rather than adhering to specific standards. For example, each hospice agency could adopt a different timetable for medication disposal (§A.2) and a different approach if there is evidence of missing unused prescription medication (§A.7). Reasonable persons could differ on whether this approach conforms to the statutory requirement of a “standardized protocol”.
Agency Response: The Agency appreciates and acknowledges these comments. The intent of Senate Bill 119 was to address the prescription drug abuse epidemic by promoting the safe disposal of prescription medications by hospice programs and their patients. Because of the uniqueness of each hospice, and the multitude of circumstances that surround each in-home hospice patient death, this protocol, as written, provides the appropriate latitude to promote the safe disposal of all prescription medications. Each hospice agency was required to develop and submit policies that were inclusive of each requirement defined in the Agency’s protocol. In addition, each hospice agency was required to submit the policies addressing the protocol requirements to the Agency for approval prior to implementation.
Second, there are some anomalies in punctuation. For example, there is no period at the end of §A.3.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency acknowledges the lack of a period at the end of §A.3. and will make the correction. Additionally, the Agency has reviewed the entire regulation for correct punctuation.
Third, in §C.2.a, the word “was” should be substituted for “were” since the subject (documentation) is singular.
Agency Response: The Agency appreciates and acknowledges these comments. The regulation will remain as written. The verb “were” refers to the hospice’s policies and procedures which is plural.
Fourth, §§B.1.b, B.2, C.2.b, and D1 have “odd” introductory symbols prior to subsections amounting to a bullet with a dash underneath. It’s unclear what this symbol represents. If it is intended to be construed as “and/or”, that term “should never be used”. See Delaware Administrative Code Drafting & Style Manual, §6.6. Moreover, the Delaware Administrative Code Drafting & Style Manual (§2.3.1; §2.4.2) only permits numeric subparts and disallows bullets. If numeric subparts were used, appropriate punctuation (currently absent from the subparts) could also be added. See Manual, Figure 2.2.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has revised Appendix A to remove the bullets and add the appropriate punctuation.
First, the proposed standards are comprehensive but only establish guidelines for hospice providers. Hospice agencies must adopt policies which conform to an outline rather than adhering to specific standards. For example, each hospice agency could adopt a different timetable for medication disposal (§A.2) and a different approach if there is evidence of missing unused prescription medication (§A.7). Reasonable persons could differ on whether this approach conforms to the statutory requirement of a “standardized protocol”.
Agency Response: The Agency appreciates and acknowledges these comments. The intent of Senate Bill 119 was to address the prescription drug abuse epidemic by promoting the safe disposal of prescription medications by hospice programs and their patients. Because of the uniqueness of each hospice, and the multitude of circumstances that surround each in-home hospice patient death, this protocol, as written, provides the appropriate latitude to promote the safe disposal of all prescription medications. Each hospice agency was required to develop and submit policies that were inclusive of each requirement defined in the Agency’s protocol. In addition, each hospice agency was required to submit the policies addressing the protocol requirements to the Agency for approval prior to implementation.
Second, there appears to be conflicting information in appendix A in terms of the responsibilities of designated hospice staff and family members in the disposal of medications. This section would benefit from additional clarifications.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency will clarify this section by adding the word “or” between §A.2.b and §A.2.c.
Third, there are some abnormalities in punctuation. For example, there is no period at the end of §A.3.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency acknowledges the lack of a period at the end of §A.3. and will make the correction. Additionally, the Agency has reviewed the entire regulation for correct punctuation.
Fourth, in §C.2.a, the word “was” should be substituted for “were” since the subject (documentation) is singular.
Agency Response: The Agency appreciates and acknowledges these comments. The regulation will remain as written. The subject for the verb “were” is the hospice’s policies and procedures.
Fifth, §§B.1.b, B.2, C.2.b, and D1 have unusual introductory symbols prior to subsections amounting to a bullet with a dash underneath. It’s unclear what this symbol represents. If it is intended to be construed as “and/or”, that term “should never be used”. See Delaware Administrative Code Drafting & Style Manual, §6.6. Also, the Delaware Administrative Code Drafting & Style Manual (§2.3.1; §2.4.2) only permits numeric subparts and disallows bullets. If numeric subparts were used, appropriate punctuation (currently absent from the subparts) could also be added. See Manual, Figure 2.2.
Agency Response: The Agency appreciates and acknowledges these comments. The Agency has revised Appendix A to remove the bullets and add the appropriate punctuation.
THEREFORE, IT IS ORDERED, that the proposed State of Delaware Regulations Governing Delivery of Hospice Services are adopted and shall become effective August 11, 2014, after publication of the final regulation in the Delaware Register of Regulations.
“A Coordinated Program” (including both services and personnel) implies the capacity to respond to patient/family needs whenever they arise. It also implies enough administrative and staff integration to ensure continuation of the same high quality care when the patient moves from home to inpatient care or vice versa.
“Bereavement” means that period of time, usually at least one year, during which survivors mourn the death and resolve their grief.
“Bereavement Service” means counseling and support services to be offered during the bereavement period.
“Family” means the hospice patient's kin. Other relations and individuals with significant personal ties to the hospice patient may be designated as members of the hospice patient's family.
“Governing Authority” means the policy-making body of a government agency, the Board of Directors or trustees of a not-for-profit corporation, or the proprietor or proprietors of an organization.
“Home Care Services” means services which are provided primarily in the patient's home. These services may include, but are not necessarily limited to, one or more of the following services: nursing services, physician services, home health aide services, homemaker services, physical therapy, social services, pastoral counseling and trained volunteer services.
“Hospice” means a coordinated program of home, outpatient and inpatient care under the direction of an identifiable hospice administration providing palliative and supportive medical and other health services to terminally ill patients and their families. Hospice is an option for care which utilizes a medically directed interdisciplinary team, which may also include services provided by trained volunteers. A hospice program provides care to meet the physical, psychological, social, spiritual and other special needs which are experienced during the final stages of illness, and during dying and bereavement. Hospice care shall be available twenty-four hours a day, seven days a week.
“Identifiable Hospice Administration” means an administrative group, individual or legal entity. This administration shall be responsible for the management of all aspects of the program.
“Inpatient Services” means those services to patients/families who require either 24 hour supervision in a health care facility; i.e., acute care hospital, skilled or intermediate care facility or services which necessitate the admission of the patient for treatment in the health care facility.
“Institution” as it appears in these regulations is used to refer to acute care hospitals, skilled nursing care facilities and intermediate care facilities (Title 16, Delaware Code).
“Interdisciplinary Care Team” means a care group of qualified individuals consisting of at least a physician, registered nurse, and social worker who collectively have expertise in assessing the special needs of hospice patients/families and in providing palliative and supportive care to meet the special needs arising out of the physical, psychological, spiritual, social and economic stress which are experienced during the final stages of illness, dying, and bereavement.
“Optional Mode of Care” means the patient volunteers to become a hospice patient after meeting certain eligibility criteria and signs a consent agreement to participate in the program.
“Outpatient Services” means those services which are delivered in other than the home setting or as an inpatient in a hospital facility. They are delivered on an ambulatory basis either in a physician's office, clinic setting, emergency room or other area such as an x-ray department.
“Palliative Services” means those services, and/or treatments which produce the greatest degree of relief from the symptoms caused by disease for the longest period of time, minimizing side effects. The goal of hospice care is to provide symptom control through appropriate palliative therapies.
“Patient/family Unit” means the patient and family are considered as one, and are the primary unit of care.
“Symptom Control” means the relief of distressing physical, emotional, social and spiritual symptoms of both patient and family. It does not mean "cure of disease".
“Terminally Ill Patient” means an individual in the terminal stage of illness, with an anticipated life expectancy of six months or less, who, alone or in conjunction with a family member, or members, has voluntarily requested admission and been accepted into a hospice.
“Trained Volunteers” means individuals who are required to participate in a structured orientation and training program before they become participants in the hospice program.
2.6 In addition to the annual license noted in 2.5 above provisional licensure may be granted by the Department of Health and Social Services for a period not exceeding three (3) months, when the hospice is in compliance with most but not all of these regulations and has demonstrated the ability and willingness to comply within the three (3) month period.
The Department of Health and Social Services expects that each in-home hospice agency’s policies and procedures will address each of the following:
[i.] the hospice’s policies and procedures for the safe disposal of all prescription medications following the death of an in-home hospice patient[; and]
[ii.] the diversion/retention of the deceased patient’s unused prescription medications could result in criminal offenses[.]
[a.] prior to implementation of the policies and procedures[;]
[b.] prior to any policy and procedure revision[; and]
[c.] upon hire (if applicable)[.]
[i.] an inventory of all disposed prescription medications and the signature of the family member/designated primary care giver that witnessed the disposal[; or]
[ii.] family member/designated primary care giver refusal to dispose of prescription medications[.]
[a.] prior to implementation of the policies and procedures[;]
[b.] prior to any policy and procedure revision[; and]
[c.] upon hire (if applicable)[.]
Last Updated: December 31 1969 19:00:00.
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