Glossary

Agency: Massachusetts Department of Public Health

An entity subject to licensure by the Department of Public Health under 105 CMR §158, whether it participates in MassHealth. An adult day health program:

• is community-based and non-residential;
• provides nursing care, supervision, and health-related support services in a structured group setting to persons 18 years of age or older who have physical, cognitive, or behavioral health impairments; and
• supports families and other caregivers thereby enabling the participant to live in the community.

Agency: Massachusetts Department of Public Health

A clinic licensed by the Department of Public Health to provide ambulatory surgery services. Ambulatory surgery services are surgical services typically provided to ambulatory patients on an elective, urgent, or emergency basis, not requiring overnight stay. Includes any Massachusetts entity that is certified by, or is seeking certification by, the Centers for Medicare and Medicaid Services as an ambulatory surgery center.

ASCs include practices wholly owned by practitioners. Note that although ASCs are a type of “clinic,” this tool treats them separately.

For more information, see M.G.L. c. 111 §25B and 105 CMR §140.020.

Agency: Massachusetts Department of Public Health

Any entity providing, or that is advertised or established to provide, ambulatory medical, surgical, dental, physical rehabilitation, or mental health services, and that is licensed as a “clinic” by the Department of Public Health (DPH). Although the DPH definition of “clinic” includes ambulatory surgery centers (ASCs), for purposes of this tool, ASCs should enter the “ASC” door and should not enter the “clinics” door. Clinics also include any entity that uses the word “clinic,” “dispensary,” or “institute” in its name (including advertisements of its name) in a way to suggest that it provides clinic services. Clinics (non-ASCs) do not include:

• Clinics conducted by a hospital, by the federal government, or by the state of Massachusetts
• Medical office buildings or practitioner practices where the practice is wholly owned and controlled by (or its only members are) one or more of the practitioners, unless it is uses the term “clinic, "dispensary", or "institute" in its name (including advertisements of its name)
• Clinics established solely to provide service to employees or students of [certain institutions], unless it is uses the term “clinic, "dispensary", or "institute" in its name (or advertises as such)
• Dental clinics operated by local school and health departments solely to provide education and dental hygiene services
• Ad hoc health promotion and screening programs

Examples of entities that may qualify as “clinics” include, but are not limited to:

• Community health centers
• Counseling and mental health centers
• Outpatient clinics and urgent care centers
• University health services centers
• Medical centers
• Rehabilitation centers
• Some physician practices
• Imaging centers

For further detail, see the definitions of “clinic” under 105 CMR §140.020 and M.G.L. c. 111 §51.

Agency: Massachusetts Department of Public Health

An EMS First Response Service (EFR Service) or ambulance service licensed by the Department of Public Health (DPH). An EFR Service is the “business or regular activity by a licensed EMS provider designated as a service zone provider under a DPH-approved service zone plan, for the purpose of providing rapid response and emergency medical services,” and an ambulance service is the “business or regular activity of providing emergency medical services, emergency response, primary ambulance response, pre-hospital emergency care, with or without transportation, to sick or injured individuals by ambulance.”

For the full definitions, including the definition of EMS Provider, see 105 CMR § 170.020.

Agency: Massachusetts Department of Public Health

An entity that provides health and/or homemaker services to individuals in their residences.

For more information, see M.G.L. c. 111, §72F; 105 CMR § 155.003.

Agency: Massachusetts Department of Public Health

See “hospice inpatient facility” and “hospice program.” For purposes of the tool, both hospice inpatient facilities and hospice programs should visit the “hospice” door.

Agency: Massachusetts Department of Public Health

A palliative care facility that cares solely for hospice patients requiring short-term, general inpatient or respite care and is owned and operated directly by a hospice program licensed by the Department of Public Health.

For more information, see 105 CMR 141.020.

Agency: Massachusetts Department of Public Health

A program that is licensed by the Department of Public Health under M.G.L. c. 111, § 57D, or operates within a Massachusetts hospital, that provides palliative and supportive care and other services, under the direction of an identifiable hospice administration, to terminally ill patients with a limited life expectancy and their families.

Agency: Massachusetts Department of Public Health

An institution that provides admitted patients with diagnostic, medical, surgical or restorative treatment within the institution. Hospitals are subject to licensure by the Department of Public Health under M.G.L. c. 111, §51. (Hospitals owned or operated by the government are not included within the scope of this tool, even though they are subject to many of the same reporting obligations.)

Agency: Massachusetts Department of Public Health

Any facility licensed by the Department of Public Health (DPH) under M.G.L. c. 111 §71 that provides (to three or more individuals) long-term resident/rehabilitative care, supervision, care incident to old age for ambulatory persons, or retirement home care for the elderly. This includes nursing homes, convalescent homes, rest homes, town infirmaries, and charitable homes for the aged. (Intermediate care facilities for individuals with intellectual disabilities, though licensed under M.G.L. c. 111, §71, are not considered a “long term care facility” by DPH and are not addressed in this tool.)

For DPH’s full definition of “long-term care facility,” see 105 CMR § 150.001. (Note a few reporting requirements in the tool may only apply to facilities that are licensed under M.G.L. c. 111, §71, i.e. nursing homes, convalescent homes, rest homes, town infirmaries, charitable homes for the aged.)

Agency: Massachusetts Department of Mental Health

For purposes of this tool, a mental health facility or program is any facility/program licensed by, contracting with, or operated by the Department of Mental Health (DMH), including a:

• DMH-operated hospital or DMH-licensed psychiatric hospital
• Community mental health center with an inpatient unit
• Psychiatric unit within a public health hospital, or a DMH-licensed psychiatric unit within a general hospital;
• Community-based mental health programs or services; or
• Intensive residential treatment program licensed by, or under control by, DMH

Some facilities providing mental health services are not “mental health facilities” for purposes of the tool. For instance, mental health clinics that are not licensed or operated by DMH should refer to “clinics.” Also, some facilities may qualify as both a “mental health facility” and another facility type (e.g., psychiatric units in general hospitals or hospitals licensed under both DMH and DPH). Please note that “mental health facility” is not the official term used in DMH regulations.

TBD

Agency: Massachusetts Department of Public Health

For purposes of this tool, this includes any substance abuse program licensed by the Department of Public Health (DPH) or otherwise subject to DPH’s reporting requirements for substance abuse programs or facilities. This includes — but is not limited to — clinics that provide separately identifiable substance abuse service and free-standing substance abuse treatment facilities. This section does not apply to private hospitals, unless it operates an outpatient SAMHSA-accredited opioid treatment program, or to mental health facilities.

• If you are a mental health facility that is licensed by the Department of Mental Health, return to the main menu and enter through the “mental health facility” door.
• If you are a hospital, and the event did not take place at an outpatient opioid treatment program, return to the main menu and enter through “hospital" door.
• If you are a clinic (or other facility operating a DPH-licensed substance abuse program), visit both this section and the “Clinics” section.

Agency: Massachusetts Department of Public Health
Context: Patient Abuse Law

The state’s Patient Abuse Law defines what is considered abuse in a health care setting in Massachusetts. The same law also describes neglect, mistreatment, and misappropriation of property. This law requires specific licensed facilities and programs — mostly those providing long-term care services — as well as some individual providers working in those settings to report instances of suspected abuse of patients or residents to the Department of Public Health.

The Patient Abuse Law defines abuse as follows:

The willful infliction of injury, unreasonable confinement, intimidation, including verbal or mental abuse, or punishment with resulting physical harm, pain, or mental anguish, or assault and battery; provided, however, that verbal or mental abuse shall require a knowing and willful act directed at a specific patient or resident. In determining whether or not abuse has occurred, the following standards shall apply:

A patient or resident has been abused if:

• An individual has made or caused physical contact with the patient or resident in question, either through direct bodily contact or through the use of some object or substance; and
• The physical contact in question resulted in death, physical injury, pain or psychological harm to the patient or resident in question; and
• The physical contact in question cannot be justified under any of the exceptions set forth in 105 CMR 155.003: Abuse(3).

A patient or resident has been abused if an individual has knowingly and willfully used oral, written, or gestured language with the intent to injure, confine, intimidate, or punish the patient or resident in question.

Notwithstanding the provisions of 105 CMR 155.003: Abuse(1)(a) through (c) and (2), if an individual has used physical contact with a patient or resident which harms that patient or resident, such contact shall not constitute abuse if:

• The physical contact with the patient or resident occurs in the course of carrying out a prescribed form of care, treatment or therapy, and both the type of physical contact involved and the amount of force used are necessary in order to carry out that prescribed form of care, treatment or therapy, provided that the patient or resident has not refused such care, treatment or therapy; or
• The physical contact with the patient or resident occurs in the course of providing comfort or assistance to the patient or resident, and both the type of physical contact involved and the amount of force used are necessary in order to provide comfort or assistance to the patient or resident; or
• The physical contact with the patient or resident occurs in the course of attempting to restrain the behavior of the patient or resident in question, and both the type of physical contact involved and the amount of force used are necessary in order to prevent that patient or resident from injuring himself, herself, or any other person; or
• The patient or resident, in accordance with his or her expressed or implied consent, is being furnished or relies upon treatment by spiritual means through prayer alone in accordance with a religious method of healing in lieu of medical treatment.

Physical contact with a patient or resident which harms that patient or resident, and which occurs for the purpose of retaliating against that patient or resident, shall constitute abuse.

Agency: U.S. Food and Drug Administration

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with microchip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to pre-marketing and post-marketing regulatory controls.

More specifically, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

This definition provides a clear distinction between a medical device and other FDA-regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDA's Center for Drug Evaluation and Research (CDER). Biological products which include blood and blood products, and blood banking equipment are regulated by FDA's Center for Biologics Evaluation and Research (CBER). FDA's Center for Veterinary Medicine (CVM) regulates products used with animals. If your product is not a medical device but regulated by another Center in the FDA, each component of the FDA has an office to assist with questions about the products they regulate. In cases where it is not clear whether a product is a medical device, please reach out to DICE to assist in making a determination.

Agency: U.S. Food and Drug Administration

A device user facility is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, outpatient treatment facility, each as defined by the Food and Drug Administration (FDA) in 21 CFR § 830.30; not included are physician’s office, school nurse offices and employee health units.

Note that each of these facility types is defined more broadly by the federal government than by the Massachusetts Department of Public Health. For instance, “nursing home” includes entities providing hospice or rehabilitation services, and “outpatient treatment facilities” include ambulance providers and home health care programs. Do not rely on the Department of Public Health’s definitions of health care facilities to determine whether you are a “device user facility.”

Pages 11-14 of this FDA document can help you determine if you are a device user facility.

Agency: Massachusetts Department of Public Health

The health care facility reporting system (HCFRS) is the Department of Public Health’s online system for facilities to report serious reportable events, serious incidents, and allegations of abuse, neglect and misappropriation.

HCFRS is accessible through the virtual gateway, the Executive Office of Health and Human Services’ internet portal.

Agency: Massachusetts Department of Public Health
Context: Serious Reportable Events

The following are examples of invasive procedures, as the term is used in descriptions of Serious Reportable Events (SREs). Some procedures not included below may be considered “invasive procedures;” ask the Department of Public Health if you are unsure.

• Any procedures involving skin incision
• Any procedures involving general or regional anesthesia, monitored anesthesia care, or conscious sedation
• Injections of any substance into a joint space or body cavity
• Percutaneous aspiration of bodily fluids or air through the skin (e.g., arthrocentesis, bone marrow aspiration, lumbar puncture, paracentesis, thoracentesis, suprapubic catheterization, chest tube)
• Biopsy (e.g., bone marrow, breast, liver, muscle, kidney, genitourinary, prostate, bladder, skin)
• Cardiac procedures (e.g., cardiac catheterization, cardiac pacemaker implantation, angioplasty, stent-implantation, intra-aortic balloon catheter insertion, elective cardioversion)
• Endoscopy (e.g., colonoscopy, bronchoscopy, esophagogastric endoscopy, cystoscopy, percutaneous endoscopic gastronomy, J-tube placements, nephrostomy tube placements)
• Invasive radiologic procedures (e.g., angiography, angioplasty, percutaneous biopsy)
• Dermatology procedures (biopsy, excision and deep cryotherapy for malignant lesions- excluding cryotherapy for benign lesions)
• Invasive ophthalmic procedures including miscellaneous procedures involving implants
• Oral procedures including tooth extraction or gingival biopsy
• Podiatric invasive procedures (e.g., removal of ingrown toenail)
• Skin or wound debridement
• Electroconvulsive therapy
• Radiation oncology procedures
• Central line placements or PICC
• Kidney stone lithotripsy
• Colposcopy and/or endometrial biopsy

Agency: The Massachusetts Board of Registration in Medicine (BORIM)

An incident that a health care facility must report to BORIM on a Safety and Quality Review (SQR) form, falling on one or more of the following categories:

1. Maternal deaths that are related to delivery
2. Death in the course of, or resulting from, elective ambulatory procedures
3. Any invasive diagnostic procedure or surgical intervention performed on the wrong organ, extremity or body part
4. Death or major or permanent impairment of bodily functions that is not ordinarily expected as a result of the patient’s condition on presentation

Type 4 covers all “severe adverse outcomes that fall outside the realm of ordinarily expectable results, taking into account the nature of the underlying disease process and the recognized risks and benefits of appropriate medical responses to it.” Types 1 to 3 are reportable regardless of the underlying circumstances. For each type, the event need not be preventable, rare, or the result of substandard medical practice.

Agency: Massachusetts Department of Public Health
Context: Patient Abuse Law

Under the Patient Abuse Law, misappropriation of patient or resident property is defined as the deliberate misplacement, exploitation or wrongful temporary or permanent use of a patient’s or resident’s belongings or money without the patient’s or resident’s consent.

Agency: Massachusetts Department of Public Health
Context: Patient Abuse Law

Mistreatment encompasses the use of medications, or treatments, or isolation, or physical or chemical restraints that harm or are likely to harm a patient or resident.

A patient or resident has been mistreated if:

1. An individual used some type of medication, treatment, isolation technique or restraint on the patient or resident; and
2. The particular use of the medication, treatment, isolation technique or restraint was either intentional or careless in nature, contrary to the patient or resident’s expressed decision to refuse such treatment, or contrary to the patient’s or resident’s written care plan; and
3. The particular use of the medication, treatment, isolation technique or restraint resulted, or was likely to result, in harm to the patient or resident involved, including but not limited to, physical injury, pain, or death, unreasonable restriction of the ability to move around, unreasonable restriction of the ability to communicate with others, or psychological harm; and
4. The particular use of the medication, treatment, isolation technique or restraint cannot be justified under any of the exceptions set forth [below].

There are exceptions. The following are not instances of mistreatment:

1. Use of an isolation technique for the purpose of preventing a documented contagious disease from spreading to other persons, as long as this technique is the least restrictive available method of preventing the spread of that disease, and reasonable care is exercised with the use of that technique; or
2. Use of a particular medication, isolation technique or restraint in the course of carrying out a prescribed form of treatment or therapy, if such use has been authorized by a physician’s order or, when applicable, by a court of competent jurisdiction in accordance with applicable law; or
3. Use of a particular medication, isolation technique, or restraint for the purpose of preventing a patient or resident from engaging in behavior which may injure him or her or injure another person, as long as the particular use in question is the least restrictive available alternative which will be effective in preventing such harm and reasonable care is exercised in connection with that use.

Agency: Massachusetts Department of Public Health
Context: Patient Abuse Law

Neglect is a failure to provide goods and services necessary to avoid physical harm, mental anguish or mental illness. In determining whether or not neglect has occurred, the following standards shall apply.

A patient or resident has been neglected if:

1. An individual has failed to provide appropriate care, treatment or service to the patient or resident; and
2. The individual’s failure to provide the treatment, care or service to the patient or resident is either intentional or the result of carelessness; and
3. As a result of the failure to provide the treatment, care or service, the individual has failed to maintain the health or safety of the patient or resident, as evidenced by harm to the patient or resident, or a deterioration in the patient or resident’s physical, mental or emotional condition.

There are exceptions. The following are not instances of neglect:

1. A patient or resident shall not be considered to be neglected for the reason that such patient or resident, in accordance with his or her expressed or implied consent, is being furnished or relies upon treatment by spiritual means through prayer alone in accordance with a religious method of healing in lieu of medical treatment.
2. Neglect of a patient or resident shall not be considered to have been caused by an accused if such accused can demonstrate that such neglect was caused by factors beyond his or her control.

Agency: Massachusetts Department of Public Health
Context: Serious Reportable Events

Facilities need to apply the following definition of a preventable event to their analysis of an Serious Reportable Event: “Events that could have been avoided by proper adherence to applicable patient safety guidelines, best practices, and hospital policies and procedures.”

Agency: Massachusetts Department of Public Health
Context: Serious Reportable Events

Hospitals and Ambulatory Surgery Centers (ASC) must establish policies and procedures for determining the preventability of a Serious Reportable Event (SRE). As part of its second 30-day follow-up report to the Department of Public Health, the facility must provide a narrative of its preventability determination, including an analysis of a document review to determine whether the SRE was:

• preventable,
• within the hospital or ASC’s control, and
• unambiguously the result of a system failure.

Remember that the preventability determination narrative should also include an analysis and identification of the root cause of the SRE, and a description of any corrective measures taken.

Agency: U.S. Department of Health & Human Services
Context: Clinical privileges actions - National Practitioner Data Bank

This is an action or recommendation of a health care entity:

• Taken in the course of professional review activity;
• Based on the professional competence or professional conduct of an individual health care practitioner which affects or could affect adversely the health or welfare of a patient or patients; and
• Which adversely affects or may adversely affect the clinical privileges or membership in a professional society of the health care practitioner.

It does not include actions which are primarily based on:

• The health care practitioner's association, or lack of association, with a professional society or association;
• The health care practitioner's fees or the health care practitioner's advertising or engaging in other competitive acts intended to solicit or retain business;
• The health care practitioner's participation in prepaid group health plans, salaried employment, or any other manner of delivering health services whether on a fee-for-service or other basis;
• A health care practitioner's association with, supervision of, delegation of authority to, support for, training of, or participation in a private group practice with, a member or members of a particular class of health care practitioner or professional; or
• Any other matter that does not relate to the competence or professional conduct of a health care practitioner.

Agency: U.S. Department of Health & Human Services
Context: Clinical privileges actions - National Practitioner Data Bank

This is an activity of a health care entity, regarding an individual health care practitioner, to:

• Determine whether the health care practitioner may have clinical privileges with respect to, or membership in, the entity;
• Determine the scope or conditions of the privileges or membership; or
• Change or modify the privileges or membership.

Agency: Massachusetts Department of Public Health

This is any untoward, preventable medical occurrence associated with the use of a drug in humans that results in:

• Death
• A life-threatening outcome
• Inpatient hospitalization or prolongation of existing hospitalization
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
• A congenital anomaly or birth defect, or
• Any other kind of harm that the Department of Public Health may determine by regulation.

The outcome need not be immediate. An adverse occurrence directly associated with the use of a drug may become a serious adverse drug event if one or more of the outcomes above later develop.

Agency: Massachusetts Board of Registration in Medicine

A safety and quality review (SQR) is a report by a facility of a “major incident,” filed up to 30 days following the end of the calendar quarter in which the incident occurred.

The term “serious incident” is used in several places in the Navigator to describe patient safety events of a serious nature that need to be reported to authorities. However, the term does not have a common meaning across Massachusetts state agencies, nor between state and federal agencies. As a result, please use the event descriptions and “more information” link provided in step 3 of the report module for fuller explanation or examples of the types of incidents considered serious by each agency.

Agency: Massachusetts Department of Public Health
Context: Applicable to Serious Reportable Event (SRE) descriptions; it does not apply to every instance of the term “serious injury” used in the Navigator.

For purposes of determining whether or not an event is an SRE, a serious injury is defined by the Department of Public Health (DPH) as: “Physical or mental damage that substantially limits or results in loss of one or more of the major life activities (e.g., breathing; dressing/undressing; drinking; eating; eliminating waste products; getting into or out of bed, chair, etc.; hearing; seeing; sitting; sleeping; walking; and working) of an individual in the short term, which may become a disability if extended long term. A serious injury can result in death, loss of a body part, long- or short-term disability, loss of bodily function, or require a major intervention for correction (e.g., higher level of care, surgery, and dialysis). Serious injury includes a substantial change in the patient’s risk status such that care or monitoring, based on national accepted standards, whether provided or not, is required that was not required before the event.”

Agency: U.S. Food and Drug Administration
Context: Reporting device-related events to FDA.

Events involving a device are reportable to the U.S. Food and Drug Administration (FDA) when they result in an injury or illness that:

• Is life-threatening,
• Results in permanent impairment of a body function or permanent damage to a body structure, or
• Requires medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Agency: Massachusetts Department of Public Health

These are adverse events that take place at a Massachusetts hospital or ambulatory surgical center and fall under one or more of the 29 events listed in National Quality Forum’s Serious Reportable Events In Healthcare — 2011 Update. The Department of Public Health (DPH) added some clarification to the list and modified some definitions by guidance but adopted the list as a whole to satisfy the definition of SRE under the regulations and statute. SREs are subject to special reporting obligations, but are not the only type of events reportable to DPH. For the legal definitions of SRE, see 105 CMR §§ 130.332, 140.308 and M.G.L. c. 111, §51H. For DPH’s guidance on SREs (which includes the list of SRE’s and clarification by DPH), see SRE Reporting Guidance.