Pennsylvania Department of Health
Chapter 51 Questions & Answers
ANSWERS TO HAP QUESTIONS REGARDING CHAPTER 51
The answers to the questions are intended as guidelines for reporting, not a substitute for the regulation text.
QUESTION: Will a standardized form be developed for the reporting of serious events to the Department of Health?
ANSWER: Yes. Currently, all licensed healthcare facilities, including hospitals and ambulatory surgical facilities (ASFs) report incidents to the Department by writing either a letter or memorandum containing the information. However, two of the field offices (Norristown & Pittsburgh) currently use an incident reporting form. This form is being developed for use by all hospitals and ASFs to report incidents throughout the Commonwealth. The form will be disseminated to acute-care facilities along with a letter of instruction on its use in the near future.
QUESTION: In an acute care setting, many deaths occur as the result of sepsis originating from a non-hospital acquired infection. Are these deaths required to be reported?
ANSWER: No. Deaths only need to be reported if a sepsis infection was acquired in the health care facility.
QUESTION: Under Section 51.3(g)(2), does this apply to only a principal diagnosis of any of the three items listed or do hospitals report any diagnosis of the three? Many elderly patients die of some illness which results in one, two, or three of these diagnoses close to the time of death. Do these situations need to be reported to the Department of Health?
ANSWER: Report any of the three (malnutrition, sepsis, dehydration), when they are the primary cause of death.
QUESTION: Are all "deaths due to malnutrition, dehydration or sepsis" reportable? What about patients with advance directives who request withholding and withdrawal of nutrition and hydration? If deaths due to malnutrition, dehydration or sepsis are not determined to be an event that seriously compromises quality assurance or patient safety by the facility, is reporting required? Further clarification is needed.
ANSWER: The facility should report all deaths whose primary cause was malnutrition, dehydration or sepsis. An explanation should be provided for the patients who had advance directives.
QUESTION: Does the requirement stated in Section 51.3(g)(5) apply to acute care facilities? For example, if a hospital stabilizes and transfers a patient due to the facility’s inability to appropriately treat the patient (i.e., the patient requires the treatment of a trauma facility) must the facility report this to the Department of Health? Can the already established reporting process with the State Trauma Program be considered compliance with this requirement?
ANSWER: The licensed health care facility in which the injury occurred is responsible to report the incident to the Department. The report filed with the State Trauma Program is not to be considered compliance with this reporting regulation; this information must also be reported to the Department.
QUESTION:Under Section 51.3(g)(6), what are the descriptors for "complaints of patient abuse, whether or not confirmed by the facility?" Must there be witnesses, physical evidence, or reasonable suspicion? Does the condition of the complaining patient (delusional, confused, perseverating, and/or many other psychiatric conditions) qualify the complaint?
ANSWER: All complaints of alleged abuse which occur in the health care facility are to be reported immediately regardless of the circumstances. There will be an investigation that may require the surveyor to interview witnesses, and review physical evidence, in order to determine if abuse actually occurred. All relevant information will be considered in the Department’s investigation.
QUESTION:Under Section 51.3(g)(6), do complaints have to be reported when they originate from geriatric and adolescent psychiatry patients and other patients who are abusive to the staff, drug seeking patients, intoxicated patients in the Emergency Department that have to be restrained?
ANSWER: Yes. All allegations of patient abuse are to be reported to the Department.
QUESTION: Does every hemolytic transfusion reaction require reporting, regardless of patient outcome or precipitating factors?
ANSWER: Yes, all hemolytic transfusions must be reported. Other transfusions should be reported only if there are serious adverse reactions. This allows the quality of care aspect to be reviewed.
REPORTING TIME FRAMES
QUESTION: What are the time frames for reporting? What does the Department of Health mean by "immediately?" Will adequate time be allotted for investigating the alleged event?
ANSWER: All events must be reported within 24 hours of the facility’s awareness of the occurrence. The Department is aware that the facility may still be investigating the occurrence, and determining the steps necessary to rectify the situation. This information must be provided to the Department within 60 days of the knowledge of the occurrence of the event.
QUESTION:Under Section 51.3(f), what will the Department of Health’s response time be to the hospital’s submissions? What will the Department of Health do if it finds the hospital’s response unsatisfactory? What are the circumstances under which the Department of Health will conduct a survey of the facility based on one of the reported serious events?
ANSWER: The Department reviews every incident which is reported to determine whether or not the incident is serious enough to warrant an investigation. For instance, a strike notice or power outage would normally not require an investigation. However, a medication error with fatal results would result in an investigation. The Department’s response time may also depend on the type of incident reported and the extent to which it impacts quality assurance and patient safety concerns.
QUESTION: Are there times or instances when renovations can be performed without the approval of the Department of Health under Section 51.3(d), for example, interior office renovations, modifications to existing labs, etc.?
ANSWER: Yes, if the renovation does not directly or indirectly affect patient care or services. However, this does not negate any other existing regulatory requirements.
QUESTION:Under Section 51.3(g)(1), does the suicide reporting requirements include patients who commit suicide off the premises or does it only pertain to suicides on the facility site by inpatients?
ANSWER: No. If a suicide occurs in or on the premises of the facility, it should be reported to the Department.
QUESTION:Will the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) have access to the information on serious events reported to the Department of Health? If so, will that make the information discoverable?
ANSWER: No. This information is held in strict confidence unless a court order to release the information is issued. This requirement applies to any third party requesting the information.
QUESTION:Who is going to educate the court system as to the intent to protect the discoverability of the information reported to the Department of Health on serious events?
ANSWER: If the issue of the confidentiality of incident reports is raised in a court proceeding, attorneys involved in the case will bring this regulation to the courts attention. If the Department receives a subpoena for this information, it will attempt to have the subpoena quashed.
QUESTION: How do these new serious events reporting requirements/regulations relate to the Peer Review Protection Act?
ANSWER: The Department does not expect facilities to release peer review information. Facilities should discuss the impact of the Peer Review Protection Act with their legal counsel.
QUESTION:Detail regarding the reason for the occurrence of a serious event would most often be determined through a health facility’s peer review program which is considered confidential. Therefore, in accordance with 51.3(k), "the notification requirements of this section do not require a facility, in providing a notification under subsection (e) or (f), to include information which is deemed confidential and not reportable to the Department of Health under other provisions of Federal or State law or regulations." Does this mean that peer review protected information should not be included in the "detail" reported to the Department of Health?
ANSWER: The Department does not expect to receive "peer review" information from facilities.
QUESTION: Will all information be protected from discovery in the event of litigation? Section 51.3(I) states that information may not, unless ordered by a court for good cause, be produced for inspection or copying. Does that mean in the event of civil litigation, the information can be discovered at the order of the court?
ANSWER: The Department will be not voluntarily release information reported under § 51.3(e)-(g).under a court order unless other State or federal law requires confidentiality or privileges attach. See answers to questions #13 and #14.
QUESTION: Under Section 51.6, can the Department of Health provide a list of health care practitioners licensed or certified by Commonwealth agencies and their corresponding abbreviated professional designations that are acceptable to use on identification tags?
ANSWER: As stated in §51.6, abbreviated professional designations may be used only when the designation indicates licensure or certification by a Commonwealth agency. Most professional licensures and certifications are under the jurisdiction of the Bureau of Professional & Occupational Affairs in the Department of State.
QUESTION:Do all physicians have to wear identification tags – even if they are not employees of the hospital?
ANSWER: When working in a healthcare facility (i.e., consulting, etc.) and when clinically feasible, all health care practitioners must wear an identification tag which displays that person’s name and professional designation.
QUESTION:What is the Department of Health’s definition of someone providing direct patient care for purposes of Section 51.6?
ANSWER: The term "direct patient care" is not contained in §51.6. Any health care facility employees or consultants who may come into contact with a patient must wear an identification tag.
QUESTION:Do all employees whether or not they provide direct patient care services have to wear identification tags?
ANSWER: Yes, the regulation is clear in terms of who must wear an identification tag. We believe this should extend to all employees coming into contact with patients. However, if a patient is abusive and/or threatening, a facility may choose to cover the last name of the employee in order to protect them. Refer to answer to question #18 above.
QUESTION: Do titles of employees have to be written out in their entirety on the identification badges or may the titles be abbreviated, for example, transport aides or dietary aides – "transport" or "dietary?"
ANSWER: The full title and name must be printed on the identification tag.
QUESTION: What if the employee’s title is too long to reasonably fit on the identification badge – can it be abbreviated?
ANSWER: The full title and name must be contained on the identification tag. Abbreviated professional designation may be used only when the designation indicates licensure or certification by a Commonwealth agency.
QUESTION: Can nicknames be used in place of the employee’s full name, for example, Pat instead of Patricia?
ANSWER: The full first and last name the employee chooses to use must be on the identification tag.
QUESTION: What should be placed on the identification badge if the employee has more than one job function and therefore more than one job title? Should the employee have both titles on the badge? Should the employee have two badges?
ANSWER: The purpose of this regulation is that patients and their families can identify the person and what their responsibilities are in the hospital. When the person has more than one job function and job title, facilities must develop a written policy which addresses this issue. The facility must determine whether employees shall wear one badge with multiple job functions or multiple badges with each job function.
QUESTION: Do volunteers have to wear identification badges?
ANSWER: Yes, if they come into contact with patients.
QUESTION: Do visitors have to wear identification badges? If a sales person or consultant is working at a health care facility for one day or a short time period, do these individuals need to wear identification badges? If yes, do the badges need to say "consultant" or "sales person" or can it simply say "visitor?" Also, does the badge need to state the person’s name or can it be a generic "visitor" badge without a name?
ANSWER: Section 51.6 does not address visitors wearing identification badges. All persons who are working at the facility and who come into direct contact with patients, must wear identification badges. A determination as to whether visitors must wear identification tags is based upon the facility’s own policies and procedures.
QUESTION: If a physician or other health care practitioner has his/her name embroidered on a lab coat, will this meet the intent of the wearing of an identification badge?
ANSWER: No. The requirement is that the health care practitioner must wear an identification tag.
QUESTION: Under what circumstances may the name of an individual be omitted or concealed when treating patients who exhibit symptoms of irrationality or violence? Can all emergency room personnel omit their last names routinely since there is no way to tell what patients may become violent? Can all staff working on a psychiatric unit routinely omit their last names?
ANSWER: Section 51.6 (c) provides that the individual’s last name may be concealed or omitted when treating patients who exhibit symptoms of irrationality or violence. It cannot be assumed that all patients in an ER will meet this criteria. Since these symptoms are more likely to be prevalent in a psychiatric unit, staff in these units may wear tags containing only their first name. However, for individuals working psychiatric units may use only their first name at all times.
QUESTION: Do staff have to wear identification badges while in the sterile environment of the operating room?
ANSWER: No, if the facility determines that it is not clinically feasible.
QUESTION: Are private employees of physicians required to wear identification badges when they are treating patients in the hospital?
ANSWER: Yes, if they come into contact with patients.
QUESTION: Will the Department of Health provide a definition or examples of what is meant by "health care services?" Does it include such things as a cardiac home care program provided by a home health agency?
ANSWER: Anytime a health care facility commences the provision of a new health care service, notification must be provided to the Department. The addition of a cardiac home care program by a home health agency requires notification. All health care services for hospitals are listed in the Department’s regulations at 28 Pa. Code ' ser.101.1 et seq.
QUESTION: Do the notification requirements under Section 51.3(d) apply to home health agency offices?
QUESTION: Under Section 51.3(g)(11), does a significant disruption in services due to disaster include cancellation of home health visits for a snow emergency (state police mandated or not?)
ANSWER: Yes. If the event is significant enough to cause detriment to the patient report it – always err on the side of over-reporting rather then underreporting. This will allow the Department to determine where assistance can be provided in the case of a disaster.
QUESTION: Under Section 51.3(g)(7), is this rape by a staff member or another patient or is it a patient reporting a rape prior to admission or visit to the emergency room?
ANSWER: Section 51.3(g)(7) requires reporting of any occurrence of rape occurring on the premises of the facility.
QUALITY OF CARE
QUESTION: Can the Department of Health clarify the phrase "…which could seriously compromise quality assurance or patient safety?"
ANSWER: The regulations give 14 examples for interpretation purposes which facilities should utilize to develop specific policies & procedures. These are only for explanation purposes and are not meant to be inclusive. Any event that jeopardizes patient quality of care must be reported.
QUESTION: Can the Department of Health provide facility specific examples of the serious events that require reporting?
ANSWER: These examples are already provided at §51.3(g)(1)-(14). Facilities must report all events which seriously jeopardize patient quality of care.
QUESTION:Does Section 51.3(g)(4) mean that all "elopements" are considered to seriously compromise quality assurance or patient safety and are therefore reportable to the Department of Health? Will a definition of "elopement" be developed in order to clarify what cases are to be reported to the Department of Health? For example, many hospitalized patients with previous history of substance abuse precipitously leave a hospital in search of drugs. Would this scenario require reporting? Or, does it mean only elopements that seriously compromise quality assurance or patient safety be reported?
ANSWER: An unauthorized absence occurs when an individual leaves the facility while being admitted or undergoing treatment. For example, if an individual was waiting to be seen in the ER, but got tired of waiting and left after being triaged, this is not reportable. However, if a substance abuse patient was already hospitalized and left the facility in search of drugs, then this would be considered a reportable elopement. All hospitals must have a definition of what they consider an elopement in their policy and procedures for reporting Chapter 51 related incidents.
QUESTION: Under Section 51.3(g)(4), does the definition of elopement include only inpatients or does it include patients who leave the emergency room before treatment is given? Patients frequently leave the emergency room without being seen when the ER is very busy or when they decide they feel better and do not need to be seen by a physician. Are these cases supposed to be reported to the Department of Health?
ANSWER: This is reportable only if it has occurred after registration within the hospital.