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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsSeptember 2019


Regulatory Flexibility Act Form

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Title 16 of the Delaware Code, Chapter 55, Subchapter 1, Section 5506
29 Del.C. §7909A(e)
The original version of this proposed regulation was published in the June 1, 2019 Register of Regulations on page 989 (22 DE Reg. 989) for public comment through July 1, 2019. In response to public comment, substantial changes have been made to the proposed regulation. In light of this, DDDS is reposting the revised document for public comment. Due to the amount of revision and in the interest of readability, DDDS is reposting as a new proposed regulation.
The Division is authorized by 29 Del.C. §7909A(e) to promulgate rules and regulations to ensure the health and safety of HCBS service recipients. This regulation shall apply to all DDDS providers of direct HCBS, as defined in this regulation.
Abuse” means any of the following:
Emotional Abuse” means the use of oral, written, or gestured language that includes disparaging and derogatory terms to or within the hearing distance of service recipients, residents or their families, regardless of their age, ability to comprehend, or disability. "Emotional abuse" includes the violation of resident rights and privacy through the posting of inappropriate materials on social media. "Emotional abuse" includes all of the following: ridiculing, demeaning, humiliating, bullying, or cursing at a patient or resident; punishment or deprivation; or threatening a patient or resident with physical harm.
Physical Abuse” means the infliction of pain or injury to a service recipient. This includes, but is not limited to, hitting, kicking, punching, slapping or pulling hair. When any act constituting physical abuse has been proven, the infliction of pain is presumed. These actions may be taken by staff to service recipient; service recipient to service recipient (sometimes referred to as resident to resident); or other to service recipient.
Sexual Abuse” means but is not limited to: a) any sexual contact, sexual penetration, or sexual intercourse by an employee or contractor with a service recipient, as defined in §761 of Title 11. It shall be no defense that the sexual contact, sexual penetration, or sexual intercourse was consensual; b) non-consensual service recipient to service recipient; or c) non-consensual other to service recipient.
Adverse Outcome” means a substantial and undesirable effect resulting from 1) administration of the wrong medication; administration of the wrong dose of a medication; failure to administer medication as prescribed; or 2) failure to deliver non-medical services as indicated in the person-centered-plan. Adverse outcomes may be physical, mental, emotional or behavioral. A licensed and qualified medical provider shall determine if an adverse outcome has occurred related to medication and can reasonably be attributed to a medication treatment error. Non-medication related adverse outcomes may be determined by DDDS subject matter experts.
Bullying” means any written, digital, electronic, verbal, or physical action that is intended to elicit fear or cause harm, directly or indirectly through inciting others to act, to a service recipient’s emotional, psychological, or physical wellbeing. The actions may be taken by staff to service recipient; service recipient to service recipient; or others to service recipient.
Chief Executive Officer” or “CEO” means a provider’s highest-ranking administrator.
Corrective Measures” means actions that include a series of required activities or limitations of activities developed in collaboration with a provider for systemic failures to comply with federal/ state/ DMMA/ DDDS regulations, standards, policies, rules and mandates. Such measures include Enhanced Monitoring, Mandatory Technical Assistance, Enrollment Moratorium, Management Transfer, and Termination of Provider Agreement. Some examples of situations requiring imposition of corrective measures include but are not limited to: obstruction of a DDDS investigation; revocation or suspension of a site license, or issue of a provisional license by The Division of Health Care Quality (DHCQ); or failure to maintain minimum training requirements, as defined in the DDDS training policy, for direct service staff.
Corrective Measures Committee” means an internal DDDS body chaired by the DDDS Director of Service Integrity and Enhancement and composed of, but not limited to: DDDS Service Integrity and Enhancement staff; DDDS Program Evaluators; Chief of Office of Business Support Services (or designee); the DDDS Director of Community Services (or designee); a DDDS Regional Program Director designated by the DDDS Director of Community Services; and the DDDS Deputy Director. The committee may call on subject matter experts as need to assess the specifics of each corrective measures review. The committee is tasked with reviewing relevant data and making recommendations to the chair regarding applying or not applying corrective measures to a provider. The Corrective Measures Committee meetings are closed, as they deal with HIPAA protected information and confidential information about investigations.
Corrective Measures Plan” or “CMP” means a plan created to address one or more systemic issues as part of the corrective measures process as presented in Sections 15.0 and 16.0. The CMP must address the common root causes found among the incident-level quality improvement plans (QIPs) generated to address individual substantiated incidents within a site, program or provider.
Critical Incidents” means a subset of reportable incidents that has resulted in actual physical, financial, mental or emotional harm to (adverse outcome); or presents a significant and immediate threat to the health and safety of a service recipient. This includes, but is not limited to: physical/emotional/sexual abuse; neglect; mistreatment; financial exploitation; errors in medication administration of a prescription medication resulting in an adverse outcome, medication diversion; missed medical appointments required for maintenance of serious health conditions; and significant injury to a service recipient.
DDDS means the Division of Developmental Disabilities Services a division within the Department of Health and Social Services established under 29 Del.C. §7909A.
DDDS Director” means the Director of the Division of Developmental Disabilities Services.
DDDS Investigator” means an employee of the Division of Developmental Disabilities Services who has completed a DDDS-approved training on the investigation of reportable incidents.
Delay of Treatment” means when a service recipient, due to provider’s failure to seek treatment, does not receive a planned or emergency medical service (lab test, physical therapy treatment or any kind of significant treatment) that had been ordered for them in the timeframe in which it was supposed to be delivered; or a delay in seeking assessment and treatment for injuries or conditions that are a threat to the service recipient’s physical or mental health.
Deputy Director” means the Deputy Director of the Division of Developmental Disabilities Services.
DHCQ” means the Delaware Division of Health Care Quality.
DHSS Policy Memorandum 46” or “PM 46” means the approved, published document describing the Department of Health and Social Services’ response to reportable incidents/allegations of abuse, neglect, mistreatment, significant injury and financial exploitation of HCBS service recipients.
Direct Support Professional” or “DSP” means a person who is employed or contracted by a provider to assist a HCBS service recipient to lead a self-determined life and contribute to the community; assist with activities of daily living, if needed; and encourage attitudes and behaviors that enhance community inclusion.
DMMA” means the Delaware Division of Medicaid and Medical Assistance.
Elopement” means when the whereabouts of the service recipient was unknown and was in contradiction with the level of support specified in the service recipient’s person-centered plan, with any of the following circumstances:
Enhanced Collaboration” means the process by which Service Integrity and Enhancement (SIE) works with providers that are at risk for corrective measures due to the number and types of incidents that they are reporting, which may indicate a need for technical assistance. Enhanced Collaboration is voluntary, is initiated by request of DDDS or providers, and is implemented by mutual agreement. The objective of enhanced collaboration is to provide sufficient technical assistance to improve quality of services provided and avoid the need to officially impose corrective measures.
Enhanced Monitoring” means a corrective measure of service quality checks that augments standard DDDS monitoring of service provisions and may include, but is not limited to: increased routine site visits, unannounced site visits, record review, billing review and observation of service delivery.
Enrollment Moratorium” means a corrective measure that prohibits a provider from accepting new referrals of service recipients into DDDS services at individual provider service sites, other provider service locations, or provider type of service or across the entire provider’s line of businesses covered under the DDDS HCBS contract.
Financial Exploitation” means the illegal or improper use, control over, or withholding of a service recipient’s property, income, resources, or financial rights by another person, whether through intent to exploit or through benign neglect of financial management laws, regulations, policies or procedures. Financial Exploitation includes, but is not limited to, use of deception, intimidation or undue influence by a person or entity in a position of trust and confidence with a service recipient to obtain or use the service recipient’s resources in a manner not in the best interest of the service recipient.
Home and Community Based Services” or “HCBS” means services offered to prevent institutionalization and in lieu of institutional care that focus on integration of those with developmental disabilities into the wider community, to facilitate their ‘best lives’ through inclusive person-centered-planning. HCBS services include, but are not limited to Medicaid authorized services under sections 1915(c),(i),(j) or (k) of the Social Security Act and State Plan Day Services under the Rehabilitative Services Option approved by the Centers for Medicare and Medicaid Services (CMS) and administered by DDDS.
Incident-Level Quality Improvement Plan” or “QIP” means a description of quality improvement action steps recommended by the provider, and approved by DDDS designed to remediate a substantiated critical incident or a pattern of non-critical incidents. The Quality Improvement Plan documents the steps that shall be taken to address the root causes of the incident and clearly indicates the criteria for the successful completion of the QIP.
Incident Management System” means the software system designated by DDDS to record and manage incident reporting, investigation processes, and incident remediation efforts related to reportable incidents.
Incident Record” means a set of data with all details of an incident, documenting the history of the incident from occurrence to resolution, including original report, investigation, conclusions, remediation, verification of completion of remediation, and assessment of the resilience of improvements achieved. Contents of the incident record shall contain only information permitted by state law or DHSS/DDDS policies.
Inconclusive” shall mean that there is no conclusion that can reasonably be made based on the available evidence and for which lack of documentation is typically the primary factor.
Infestation” means the presence of lice, bed bugs or other pests sufficient to cause harm or medical symptoms in service recipients. Infestation is a reportable incident.
Investigation Summary Report” means a standardized report used by DDDS to document and summarize the comprehensive investigation: process, evidence, and conclusions. This report is also sometimes known as the “Report of Findings” and is sent to providers by Office of Incident Resolution at the conclusion of an investigation.
"Knowingly" means having actual knowledge of, or acting with deliberate ignorance, or reckless disregard for the laws, regulations, standards, or contract provisions governing service provision and environmental safety.
Limited Lay Administration of Medications” or “LLAM” means a set of rules and regulation devised by the Delaware Board of Nursing defining criteria and requirements for administration of medications by unlicensed care givers in specified service settings, authorized by 24 DE Admin. Code 1900 – Section 5.0.
Management Transfer of a Service Site” means a corrective measure that requires the mandatory transfer of provider services and service sites to another provider at the direction of DDDS. Every attempt shall be made to honor the wishes of the service recipient, in balance with documented health and safety issues. A Management Transfer of the site shall not occur if the site is owned by the provider unless the provider supports the Management Transfer. The provider shall retain all other rights regarding the disposition of its physical property, if a management transfer is ordered. Management transfer is a last resort corrective measure, under the conditions described in subsection 15.1.4.
Mandatory Technical Assistance” means a corrective measure in which technical assistance (TA) is required by DDDS to assist the provider to address and correct persistent, specific, localized or systemic compliance challenges. TA may include, but is not limited to: facilitation of root cause analysis and other discovery processes; quality improvement planning sessions and plan development; review of agency policies and policy implementation practices and assistance with necessary revisions to ensure compliance; training; on-site observation of services; development of formal quality Improvement plans. Technical assistance may be provided by DDDS (or one of its delegates), or by consultant chosen, contracted and paid by the provider.
Medical Intervention” means any action that requires involvement of a health care professional in response to an event requiring medical treatment beyond first aid.
Medication Administration Error” means a deviation from the prescriber's medication order in administration of a prescription medication. See definition of “prescription medication” for purposes of this regulation.
Medication Diversion” means the knowing or intentional interruption, obstruction, or alteration of the delivery, or administration of a prescription drug to a service recipient, if both of the following apply:
Mistreatment” means the inappropriate application on a service recipient of medications, isolation, or physical or chemical restraints as negative reinforcements, punishment, or retaliation for behaviors.
Neglect” means any of the following:
Non-Critical Incident” means a reportable incident that has not resulted in observable physical, mental, or emotional harm to a service recipient (adverse outcome); and does not present a significant or immediate threat to the health and safety of DDDS service recipients or are correctable issues not likely to cause immediate or significant harm or injury. This includes all incidents not classified as a critical incident such as: minor physical injuries, errors administering medications not identified as critical by the prescriber, service recipients not receiving preferred choice of foods, and other correctable issues not likely to cause immediate or significant harm or injury.
Nuisance Complaint” means a service-related complaint that is likely to be part of a documented pattern of reporting not related to potential abuse, neglect or exploitation of a service recipient.
Obstruction of Investigation” means hindering incident investigations. This includes withholding of documentation; preventing or discouraging staff from being available to investigators; failure to respond to requests for information in a timely manner; intimidation of witnesses; and any other actions intentionally taken to interfere with an investigation.
Office of Incident Resolution” or “OIR” means a unit within the DDDS Service Integrity and Enhancement Unit that is responsible for the investigation of all reportable incidents, directly or through delegates.
Office of Incident Resolution Administrator” means the DDDS administrator responsible for overseeing OIR.
Office of Service Enhancement” or “OSE” means a unit within the DDDS Service Integrity and Enhancement Unit responsible for monitoring provider performance and providing technical assistance to address quality improvement issues both within DDDS and with DDDS providers.
Person-Centered Plan” means a document that identifies how services and supports will enhance the participant’s life. This assessment data, including information about services the participant receives through other state and federal programs is coordinated by the case manager.
Preliminary Investigation” means the initial assessment by the Office of Incident Resolution Administrator of an allegation to determine if: 1) sufficient detail about the reported incident exists or can be quickly gathered to guide further investigation; 2) the alleged incident is critical or non-critical; and 3) the investigation will be assigned to a DDDS or provider investigator.
"Prescription Medication" means a medication required by federal or state law or regulation to be dispensed only by a prescription, which means a lawful written or verbal order of a practitioner for a drug, including finished dosage forms and active ingredients, subject to §503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §353(b)). For the purpose of this regulation, this does not include medications that may have been prescribed, but can be typically bought over-the-counter.
Primary Provider Contact” means the person designated by the CEO of a provider that shall receive DDDS notifications, shall work directly with DDDS on incident investigations and the Quality Improvement Plans that may be required for incidents, and shall be responsible for ensuring that all provider incident remediation processes included in this regulation are executed.
Provider” means an entity that has been authorized to provide one or more DDDS HCBS services to meet the specialized needs of DDDS service recipients.
Provider Investigator” means an employee of the provider who has completed DDDS-approved training on the investigation of reportable incidents.
Reportable Incident” means an event that is witnessed by a mandated reporter, that has been reported to a mandated reporter, or that the mandated reporter has reason to suspect has occurred, including the following]: abuse (physical/ sexual/ emotional); bullying; criminal offense; delay of treatment; service recipient to service recipient incidents; elopement; financial exploitation; infestation; medication diversion; medication error; missed medical appointments; mistreatment; neglect; significant injury; unanticipated death; property damage caused by the service recipient; abuse of substances; aggression of service recipient toward the general public; or use of restraints not permitted in the person-centered plan or as specified in DDDS policy. An incident may be comprised of multiple component incidents or attributed to a combination of multiple causes and, therefore, may be substantiated with a combination of the sub-classifications listed below. For instance, a medication scheduling error that affects four service recipients shall be recorded as four individual reportable incidents; multiple errors affecting a single service recipient shall be recorded as multiple reportable incidents; a medication error may be attributed to a combination of lack of training, lack of supervision, and lack of properly documented procedures.
Root Cause Analysis” means a class of problem solving methods aimed at identifying the root causes of problems or events. The practice of root cause analysis is predicated on the belief that problems are best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms.
Service Integrity and Enhancement Unit” or “SIE” is the unit within DDDS that is responsible for evaluating DDDS and provider performance; measuring compliance with all applicable regulations, standards, policies, rules, and mandates; providing technical assistance to providers to help correct persistent performance or compliance challenges; recognizing providers who exhibit superior performance; and sharing best practices by providers, as they are observed. SIE is the umbrella unit for the Office of Service Integrity, Office of Incident Resolution, Office of Service Enhancement, and Office of Constituent Relations.
Service Recipient” is any person eligible for and receiving DDDS services.
Service Recipient to Service Recipient Incident” means any reportable incident that is between or among service recipients who receive DDDS services that results in injury or significant potential for harm.
Significant Injury” means:
Substantiated” means when a reasonable person weighing the facts and circumstances has concluded that the incident did occur and enough information is available to reasonably assign fault or determine no-fault for the incident. The following are the sub-classifications of substantiated incidents:
1. Dereliction of Duty
a. “Administrative” means a type of incident in which a likely contributing factor is a failure of provider administration, including but not limited to: failure to communicate new standards, regulations, or policies affecting the health or safety of service recipients to employees or failure to assure staff training; failure to staff facilities at levels that are needed to meet the needs of service recipients; failure to repair or ensure repair of facility infrastructure, that results in significant injury or risk of such injury to service recipients (such as a broken window).
b. “DSP / Employee” means a type of incident in which a DSP or another staff member employed or contracted by a provider, having been documented to have completed all necessary training, failed to follow established policy, protocol or training that put a service recipient at risk, including but not limited to: sleeping on the job; failure to document or report incidents properly; and failure to provide medications as scheduled.
c. “Supervisory” means a type of incident in which a likely contributing factor is lack of proper supervision including but not limited to: supervisory staff employed by a provider directly observed DSPs failing to follow policy, protocols, or procedures without providing correction to the DSPs; failure to properly schedule coverage, putting service recipients at risk; and failure to communicate vulnerability risks to their direct reports.
2. “Criminal Offense” means a type of incident that included alleged criminal activities, whether or not the police were called or the service recipient (victim) pressed charges, including but not limited to: drug use on premises; assault/abuse; sexual abuse/assault; or theft of the property/assets of a service recipient.
3. “Inadequate Training” means a type of incident in which a likely contributing factor is a lack of proper training including, but not limited to: DSPs administering medications without proper LLAM training; DSPs not following safety / vulnerability protocols, such as monitoring of food intake for service recipients with swallowing difficulties; or the inability of staff to recognize a reportable incident.
4. “No Fault / Accidental” means a type of incident that was verified to have occurred, but is deemed to have been the result of an accident without a breach in policy, protocol, or standard of care.
Termination of Provider Contract” means the termination or non-renewal of a contract between DDDS and a provider for the provision of a DDDS HCBS service. This level of corrective measure requires the approval of the Division Director prior to imposition.
Unanticipated Death” means death of a service recipient that could not have been anticipated based on the circumstances of the service recipient. These cases are referred to the Division of Forensic Science, Department of Safety and Homeland Security.
Unsubstantiated” means when a reasonable person weighing the facts and circumstances has concluded that the incident did not occur. In some cases, DDDS may require a quality improvement plan to address conditions discovered as part of an investigation, in accord with subsection 11.1.2 of this regulation.
Witness/Victim Intimidation” means any situation in which a victim or witness of a reportable incident is coached, threatened, or otherwise pressured in a way intended to prevent or retaliate for reporting of a reportable incident or testifying in an investigation.
6.3 If the reportable incident occurs in a setting that is licensed by the Division of Health Care Quality (DHCQ), the DDDS Office of Incident Resolution shall inform DHCQ via the web reporting form within 48 hours of the incident report.
15.1.5 Termination of the DDDS Provider Contract for the complete failure of the provider to provide a safe and healthy environment for service recipients at any of its program sites.
15.2.7 If two (2) sequential revised CMP submissions are not accepted by DDDS, the provider shall be required to accept Mandatory Technical Assistance from DDDS Service Enhancement Unit (or its delegates) to produce the needed CMP.
17.2.4.2 Within ten (10) business days of the receipt of the notification of outcome of the second level of appeal, the provider must submit to the Health Care Quality Hearing Officer and DDDS Division Director a written request for third level appeal, documenting the basis for the appeal and including all supporting data or evidence to be considered in the appeal. The request submission must identify supporting data or evidence that is new or different than what was presented in the second level of appeal. The request must identify the provider’s primary contact and CEO to be notified of the appeal decision.
17.2.5 The fourth and final level of appeal shall be with Division of Medicaid and Medical Assistance (DMMA) in accordance with The Delaware Medical Assistance Program (DMAP), General policy Manual, Section 6.0, Appendix A – Appeals Procedures. This level of appeal is available only for corrective measures that constitute an adverse action, as defined in the DMAP policy.
Last Updated: December 31 1969 19:00:00.
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