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Advocacy

Comment Letter to DOH on Draft Guidance for Mcare Reporting Requirements

February 3, 2014

The Honorable Michael Wolf
Secretary of Health
Pennsylvania Department of Health  
Health and Welfare Building  
8th Floor West  
625 Forster Street  
Harrisburg, PA 17120   

RE: Draft Guidance for Acute Healthcare Facility Determinations of Reporting Requirements under the Medical Care Availability and Reduction of Error (Mcare) Act

Dear Secretary Wolf: 

The Hospital & Healthsystem Association of Pennsylvania (HAP) on the behalf of its approximately 240 member hospitals and health systems appreciates the opportunity to provide comments and recommendations on the draft guidance for Mcare reporting requirements.  

Pennsylvania health care facilities are dedicated to providing safe, high quality care. There are 137 hospitals and ambulatory surgery centers that just embarked on their third year of working with HAP through the Centers for Medicaid & Medicare Services’ Hospital Engagement Network program. The first two years of this work resulted in an estimated 50,066 Pennsylvanian’s lives saved from harm and an estimated cost avoidance of $483 million. HAP, its members, and HEN partners will continue to identify quality and safety projects aimed at reducing harm and readmissions.  We hold safety and quality for the patients and communities that we serve as a core value of our services.  

HAP appreciate the efforts of the Pennsylvania Department of Health and the Pennsylvania Patient Safety Authority to provide guidance as health care facilities work to comply with the legal reporting requirements for Serious Events, Infrastructure Failures, and Incidents. HAP offers the following recommendations for your consideration as you move through the public comment process.   

Statutory Definitions of Reportable Events   

The definitions of Serious Event, Incident, and Infrastructure Failure are directly cited from current state law. HAP has no comments at this time with regard to the definitions.    

Draft Interpretations of Serious Event Definition and Component Terms   

The draft reporting guidance states:   

1.  The concepts of human error and preventability do not appear in the Serious Event definition.  It is not necessary for an error to be involved, nor for the harm to be preventable, for a death or unanticipated injury to constitute a Serious Event.       

2.  The unanticipated nature of the injury is from the perspective of a reasonably prudent patient. While every provider anticipates some rate of complications from the procedures they perform, infrequent complications are rarely anticipated by the patient unless the patient is somehow at increased risk. While the Authority does not specify an exact threshold for the frequency of complications that makes a particular complication transition from unanticipated to anticipated, complications that occur rarely would be unanticipated by most patients.   

HAP Comments:  HAP recognizes the difficulty in identifying a definition of the word “unanticipated” that allows for standardized oversight.  In the same respect, HAP urges the Department to consider these same challenges as health care facilities attempt to operationalize such standards as well.  Identifying the very fine line that sometimes crosses from anticipated to unanticipated requires more review and analysis than what a guideline could provide. Therefore, HAP recommends the Department work with the Authority to update the most recent algorithm, which is several years old now. Providing an updated algorithm would give health care providers a methodical approach to thoughtfully identify the proper reporting category.   

The draft reporting guidance states:

3.  The disclosure of a potential complication on a patient consent form does not, in itself, constitute anticipation of the complication by the patient. Informing the patient of a risk does not mean the patient or the provider anticipates that the untoward outcome will actually occur.    

4.  Complications may be considered anticipated (and therefore not meeting the Serious Event definition) when they occur frequently or the risk of the complication is considered high for a particular patient and the high probability of this complication was disclosed to the patient in the informed consent discussion and documented on the consent form.    

5.  A Serious Event that is within statistical norms or within benchmarks available in the clinical literature must still be reported. There is nothing in the law that allows for reporting Serious Events only when they exceed a statistical norm or benchmark.    

HAP Comments:  HAP supports the need for a thoughtful informed consent process that allows a patient to ask questions, express concerns, and make educated decisions about their care with their health care provider. Health care providers take their relationship with their patients and the informed consent process very seriously. Health care providers engage in regular training and education on engaging patients in their care and many have created patient advisory councils to achieve even better communication and experiences. HAP fully supports the concept of informed and engaged patients in their physical and mental health and wellness.   

HAP strongly recommends the department remove #5 of the draft interpretations. While the interpretation notes there is nothing in the law that allows for reporting Serious Events only when they exceed a statistical norm or benchmark, there is also nothing restricting this approach. The law is silent in this regard. In 2002, the Pennsylvania General Assembly used their leadership and foresight to create the Mcare Act and as such, the Pennsylvania Patient Safety Authority. It is unreasonable to think these same elected leaders would stifle the bold, successful path that Pennsylvania forged in patient safety and limit the use of statistical norms and benchmarks. Statistical norms and benchmarks are often the basis of the informed consent discussions between a patient and a health care provider. The current health care environment provides publicly available data and information to patients. The environment provides for technology, including electronic health records, patient portals, and smart phones. Federal regulators hold health care providers to such statistical norms and benchmarks. It is very unreasonable to state that such a plethora of information would not be used for a patient to make an informed decision in their health care. In their most vulnerable times, patients are faced with making very difficult decisions. To limit the information available to patients and health care providers in such crucial decision making would fail the patients we serve.   

The draft reporting guidance states:   

6.  An event, occurrence or situation that: a) hastens death (as in a terminally ill patient); or b) exacerbates a preexisting condition requiring additional healthcare services, is a Serious Event.    

7.  The event, occurrence, or situation that caused the death or unanticipated injury may be unknown but may still constitute a Serious Event.  For example a health (ASA I) patient undergoing elective surgery dies unexpectedly during the procedure and the cause of death is unknown.    

HAP Comments:  HAP recommends the Department delete interpretation #7. Health care providers have appropriate policies and procedures in place to examine unexpected deaths in facilities. This may be done through processes identified in patient safety plans and through peer review, such as a morbidity and mortality conferences and root cause analyses. These processes assist health care providers not only for the occurrence in question, but also in their overall quality improvement projects. Interpretation #7 is unnecessary in light of current processes and procedures already used by health care providers.    

The draft reporting guidance states:   

8.  Any unnecessary procedure or procedure performed in error that carries risk for the patient constitutes an injury and performance of the correct or intended procedure then constitutes additional healthcare services.  These occurrences are Serious Events.   

9.  Additional healthcare services: 

a.  If a patient sustains an unanticipated injury for which no additional healthcare services are possible, but treatment would be provided if options were available, this is considered a Serious Event.  

b.  If a patient sustains an unanticipated injury and additional healthcare services are possible, but the risk of those services outweigh the negative consequences of the injury, this is considered a Serious Event. 

c.  If additional healthcare services are required to treat an unanticipated injury and these additional healthcare services are not provided either because of unintentional omission or because the patient declines treatment, the occurrence is still a Serious Event.    

HAP Comments:  HAP recommends editing the Interpretation #8 to read: Any unnecessary, invasive procedure performed in error that carries risk for the patient constitutes an injury and performance of the correct or intended, invasive procedure then constitutes additional healthcare services. These occurrences are Serious Events

This edit of Interpretation #8 clarifies the type of procedure involved.    

Exclusions   

The draft reporting guidance states:   

10.  Deaths or injuries resulting from the patient’s disease, in the absence of a contributing event, occurrence or situation, are not Serious Events.   

HAP Comment:  HAP suggests the Department delete #10 as it is unnecessary.    

The draft reporting guidance states:   

11.  It is not necessary to report a Serious Event that occurred in another healthcare setting. If the facility discovers a Serious Event that occurred in another facility, the facility is strongly encouraged to notify the other facility.   

HAP Comment:  HAP appreciates the Department incorporating Exclusion #11 in the guidance as it provides clarity for the field.   

The draft reporting guidance states:   

12.  A mid-procedure change in the plan of care in response to new information discovered during the procedure does not constitute an injury, so long as this potential change was discussed with the patient or the patient’s representative at the time of consent.    

HAP Comments:  HAP fully supports the concept of informed consent as described previously. Health care providers make every effort to fully consider and discuss possible occurrences in advance of a procedure. If a health care provider determines mid-procedure, the patient’s best interest would mean a change in the care plan discussed; the health care provider would make every effort to consult the patient’s family or other representative for consent prior to moving forward.  The revised plan should not be considered to be a Serious Event.    

In addition, HAP recommends editing Exclusion #12 to read: A mid-procedure change in the plan of care in response to new information discovered during the procedure does not constitute an injury.   

The draft reporting guidance states:   

13.  Additional healthcare services:   

a.  Healthcare services provided to prevent an injury from occurring are excluded from this term for the purpose of Serious Event determinations. 

b.  Services that could be provided by someone other than a licensed healthcare practitioner outside the clinical setting-essentially, first aid care—do not constitute additional healthcare services. 

c.  Noninvasive diagnostic services provided to rule out an injury (for example, x-ray following a fall) do not constitute additional healthcare services for purposes of the Serious Event determination.    

HAP Comment:  HAP appreciates the clarification provided in Exclusion #13.   

Reporting of Specific Event Types

The draft reporting guidance states:   

14.  Restraints and seclusion: 

a.  Restraint- or seclusion-related death or injury (that is, in which the restraints or seclusion played a role in the death or injury) are reportable as Serious Events. 

b.  Restraints or seclusion may be involved in Incidents in which there is no death or injury requiring additional healthcare services (for example, failure to timely remove restraints or end seclusion following MD order, finding patients in unsafe position while in restraints). 

c.  Any death in restraints or in which restraints were used within 24 hours of death (other than soft wrist restraints) in which the restraints are not suspected of playing a role are reportable as Infrastructure Failures.   

HAP Comments:  HAP recommends the Department delete #14(c). Infrastructure failures are defined as “an undesirable or unintended event, occurrence or situation involving the infrastructure of a medical facility or the discontinuation or significant disruption of a service which could seriously compromise patient safety.” Additionally, CMS requires a log of any patient who dies while in restraints, within 24 hours of being in restraints or within a week of being in restraints if related to the restraints. The first two guidelines in 14(a) and 14(b) provide sufficient reporting.      

The draft reporting guidance states:    

15.  Suicide and Other Forms of Patient Self-Harm: 

a.  Suicide attempts that result in death or injury requiring additional healthcare services are reportable as Serious Events. Suicide attempts not resulting in injury requiring additional healthcare services are reportable as Infrastructure Failures. 

b.  Other forms of intentional self-harm that result in injury requiring additional healthcare services are reportable as Serious Events. Other forms of intentional self-harm not resulting in injury requiring additional healthcare services may be reportable as Incidents.   

HAP Comments:  HAP recommends the Department edit #15(a) to read: Suicide attempts that result in death or injury requiring additional healthcare services are reportable as Serious Events. Suicide attempts not resulting in injury requiring additional healthcare services are reportable as Incidents. This description does not fall within the definition under the law of what an Infrastructure Failure is.    

HAP further recommends the Department remove #15(b).  The guidance provided for in 15(a) is sufficient to address the concerns of 15(b) particularly in the absence of a compromise of patient safety. A health care provider should not be held responsible for the intentional self-harm of a patient as such intentional behavior is outside the control of the health care provider.    

The draft reporting guidance states:   

16.  Inter- and Intra-Hospital Patient Transfers: 

a.  Patient transfers are reportable only when they involve an event that meets one of the three definitions in the Mcare Act: Serious Event, Incident or Infrastructure Failure. Routine intra-hospital transfers to higher levels of care due to changes in the patient’s condition—in the absence of a precipitating event that would meet the definition of a Serious Event, Incident, or Infrastructure Failure—are not reportable.  

b.  Routine intra-hospital transfers between nearby buildings for specialized testing or other services in the normal course of treatment are not reportable. 

c.  Unexpected intra-hospital transfers to higher levels of care due to an error or complication of care are reportable as a Serious Event.

d.  Inpatient transfers from a specialty hospital to an acute care hospital or from one acute hospital to another acute hospital, due to the patient requiring a clinical service not offered in the transferring hospital are not reportable.    

HAP Comments:  HAP recommends the Department edit #16(c) to read: Unanticipated intra-hospital transfers to higher levels of care due to an error are reportable as a Serious Event. The term “unanticipated” should be used as opposed to “unexpected” for consistency throughout this guidance. HAP recommends that the terminology, “complication of care” should be deleted as it is not defined in the Mcare Act. Adding such terminology is unnecessary to achieve the goal of this guideline.  

The draft reporting guidance states:   

17.  Transfers and Cancellations from Ambulatory Surgery Facilities:  

a.  Consistent with National Quality Forum-endorsed measure “percentage of Ambulatory Surgery Center (ASC) admissions requiring a hospital transfer or hospital admission upon discharge from the ASC,” when a patient admitted to an Ambulatory Surgical Facility (ASF) requires transfer to a hospital, these events are reportable at least as Incidents.
     i.    ASF admissions includes patients who have completed registration upon entry into the facility.
     ii.    Cancellations prior to completing registration are not reportable.                                        
     iii.    Hospital Transfer/Admission: Any transfer/admission from an ASF directly to an acute care hospital, including hospital emergency room.                                       
     iv.    ASF discharge occurs when the patient leaves the confines of the ASF. 

b.  Intra-operative transfer from an ASF to a hospital due to an error or complication of care is reportable as a Serious Event. 

c.  Complications or other events associated with a surgical procedure that require hospital admission, even if after discharge, are reportable as Serious Events by the ASF, assuming they become aware of it.   

HAP Comments:  HAP recommends the Department edit #17(a) to read: Consistent with the NQF-endorsed measure “percentage of Ambulatory Surgery Center (ASC) admissions requiring a hospital transfer or hospital admission upon discharge from the ASC,” when a patient admitted to an Ambulatory Surgery Facility (ASF) requires transfer to a hospital, these events may be reportable as Incidents.   

HAP recommends the Department edit #17(b) to read: Intra-operative transfer from an ASF to a hospital due to an error is reportable as a Serious Event. As earlier noted, “complication of care” is not defined in the Mcare Act.   

HAP recommends the Department delete #17(c). The act of transferring and/or admitting an ASF patient to a hospital or emergency room likely does not meet the definition of incident (an event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient.) Rather, it is the event that prompted the transfer or admission is the event that should be evaluated on whether it is reportable by definition or not. Further, the length of time that passes once a patient leaves the care and control of a facility should be considered.    

The draft reporting guidance states:   

18.  Patients leaving the Emergency Department without being seen/treated: 

a.  Patients leaving the ED waiting room or treatment area without being seen are not reportable unless they are in the 302 process. 

b.  Elopement of a patient who has been involuntarily committed or is in the process of being involuntarily committed is reportable as an Infrastructure Failure. If the patient is injured during the elopement, this is reportable as a Serious Event.

19.   Inpatient elopements are reportable as Infrastructure Failures. If an eloped patient is injured during an elopement, this is reportable as a Serious Event.   

20.  Events in which a patient leaves against medical advice, whether or not they sign a waiver, are not reportable.    

HAP Comments:  HAP recommends the Department edit #18(b) to read: Elopement of a patient who has been involuntarily committed is reportable as an Infrastructure Failure. A health care provider may not have knowledge of the injury once the patient elopes. Possible injury to an eloped patient is outside of the control of the health care provider.  Further, this proposed guidance is unclear on the time period involved, i.e., how long after a patient has eloped.   

HAP recommends the Department edit #19 to read: Inpatient elopements are reportable as Infrastructure Failures.  The second sentence of 19 should be removed for the same reasons outlined in 18 above.

The draft reporting guidance states:   

21.  Use of unlicensed beds for patient care or patients receiving treatment in an area not designated for patient care (for example, hallways, atrium, quiet room, tent on grounds) is reportable as an Infrastructure Failure.    

22.  Boarding patients in the Emergency Department or Post-Anesthesia Care Unit    more than 2 hours after the ED or PACU physician has determined they meet discharge criteria is reportable as an Infrastructure Failure.    

HAP Comments:  HAP recommends the Department edit #21 to read: Use of unlicensed beds for inpatient care or inpatients receiving treatment in an area not designated for patient care (for example, atrium, quiet room, tent on grounds) is reportable as an Infrastructure Failure. HAP further recommends reporting for this guideline may be done in a bundled report, including multiple occurrences.    

HAP recommends the Department edit #22 to read: Boarding patients in the Emergency Department or Post-Anesthesia Care Unit more than 6 hours after the ED or PACU physician has written the discharge order is reportable as an Infrastructure Failure. HAP further recommends reporting for this guideline may be done in a bundled report, including multiple occurrences. It is important to note that this involves no interruption of care or service to patients.  Further, HAP recommends special flexibility be given in cases of large scale events, including but not limited to flu season, natural disasters, and trauma or other health care required during large public events, such as that which occurred with the Boston Marathon incident. 

There are well thought out and strategic disaster preparedness plans made for such occurrences, and HAP recommends the Department be particularly flexible in these circumstances.

HAP further urges the Department to note that national accreditation standards provide more than two hours after a decision to admit or transfer is made. Health care providers would identify patient acuity and best practice to move the patient as soon as possible, but two hours may be insufficient time to do so. HAP recommends a six-hour time frame.    

The draft reporting guidance states:   

23.  Patient Falls: 

a.  Patient falls are to be reported as either Serious Events or Incidents. 

b.  A fall is defined as any unplanned descent to the floor (or other horizontal surface such as a chair or table), with or without injury to the patient. The definition of falls includes: 1) assisted falls in which a caregiver sees a patient about to fall and intervenes, lowering them to a bed or floor; 2) therapeutic falls, in which a patient falls during a physical therapy session with a caregiver present specifically to catch the patient in case of fall; or 3) physiologic falls in which a patient falls as a result of seizure or syncope.  

c.  The definition excludes failures to rise, in which a patient attempts but fails to rise from a sitting or reclining position. 

d.  Falls with harm: Any fall that requires more than first aid care. Treatment beyond first aid care includes a laceration that requires physician intervention (for example, sutures), more serious injury (for example, fracture) or death. 

e.  Note: The Authority believe the criteria for falls as outlined here are consistent with the definitions and criteria used by the National Database of Nursing Quality Indicators (NDNQI). One notable exception is that NDNQI only counts fall occurring on nursing units and excludes other care settings (for example, physical therapy). Mcare Act reporting requirements apply to the entire facility.   

HAP Comments:  HAP recommends the Department edit #23(a) to read: Patient falls may be reported as Serious Events or Incidents. The Mcare Act does not explicitly identify patient falls, therefore, the guidance cannot mandate how falls are treated.   

HAP recommends the Department edit #23(b) to read: A fall is defined as any unplanned descent to the floor with or without injury to the patient. The definition of falls includes: 1) assisted fall in which a caregiver sees a patient about to fall and intervenes, lowering them to the floor or 2) falls during a physical therapy session. Physiologic falls in which a patient falls as the result of seizure or syncope should be reported as an incident.              

The draft reporting guidance states:   

24.  Fires/Patient burns: 

a.  Any fire of any kind is reportable as an Infrastructure Failure. 

b.  Fire alarms that warrant activation of a facility’s internal fire response plan are reportable as Infrastructure Failures. A fire alarm resulting from an occurrence or cause that is clearly and immediately identified and does not require activation of the facility’s internal fire response plan is not reportable.

c.  Any fire alarm or sprinkler system that is out of service for 4 hours or more in a 24-hour period is reportable as an Infrastructure Failure. 

d.  Patient burns requiring additional healthcare services are reportable as Serious Events, even if the associated fire is reported as an Infrastructure Failure. 

e.  Patient burns from sources other than fires (for example, chemical burns, cautery burns) may be reportable as Serious Events depending on the severity of the injury.   

HAP Comments:  HAP recommends the Department delete #24(b). Patient safety is not compromised when there is no interruption of service. Health care providers develop thoughtful and rehearsed response plans so there is not an interruption of service. When these plans deploy and there is no interruption in service there is not a reason to report such scenarios.    

HAP recommends the Department edit #24(c) to read: Any fire alarm or sprinkler system that is unplanned out of service for 10 hours or more in a 24-hour period is reportable as an Infrastructure Failure. For the same reasons applied in #24(b), HAP recommends the word “unplanned” be added to 24 c. Further HAP recommends consistency with NFPA 101 (ed. 2000) Life Safety Code 9.7.6.2, which provides, “Sprinkler impairment procedures shall comply with NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems.” NFPA 25 (e. 2014) Life Safety code 15.5.2 (4) speaks to actions and notifications to be made “Where a fire protection system is out of service for more than 10 hours in a 24-hour period.”   

The draft reporting guidance states:   

25.  Health Information Technology (IT): 

a.  Many patient safety concerns involving Health IT are already reported under Event Types associated with Serious Events and Incidents, such as medication errors, laboratory test-related errors and radiology errors. 

b.  Safety concerns with Health IT cut across multiple event types and should continue being reported as Serious Events or Incidents.

HAP Comment:  HAP recommends reporting for this guideline may be done in a bundled report, including multiple occurrences.            

The draft reporting guidance states:     

26.  Healthcare-Associated Infections (HAIs): 

a.  Any HAI that meets Centers for Disease Control and Prevention (CDC) definitions/criteria and which a hospital reports into NHSN should not also be reported into PA-PSRS. 

b.  Any HAI that is clearly healthcare-acquired but which falls outside the CDC definitions/criteria should be reported as an Infrastructure Failure. 

c.  This is a temporary measure that may be revisited in the future as CDC’s surveillance criteria evolve and deal with changing healthcare delivery patterns (for example, shortening length of stay).    

HAP Comments:  HAP very strongly recommends the Department delete #26(b) and #26(c). Act 52 of 2007 provides for the reporting requirements related to HAIs. Further the CDC provides more than sufficient guidelines to health care providers in reporting HAIs. HAP reiterates that the purpose of the Authority and Department in providing these guidelines is to provide clearer reporting guidelines for health care providers. Adding to the already existing framework of Act 52 and the CDC reporting requirements simply adds confusion and burden to already heavy reporting obligations of health care providers in this area. Such additional reporting guidelines do not improve the quality of patient care provided.    

The draft reporting guidance states:   

27.  Unplanned power failures involving backup generator deployment or in which the backup generator fails to deploy, are reportable as Infrastructure Failures.   

HAP Comments:  HAP recommends the Department edit #27 to read: Unplanned power failures involving backup generator deployment in which the backup generator fails to deploy, are reportable as Infrastructure Failures. Planned power failures where there is no interruption of service should not be reported. HAP reiterates the logic provided in #24(b) and #24(c) above.  

Reporting of Incidents   

The draft reporting guidance states:   

28.  Incidents must be reported within the healthcare organization by healthcare workers within 24 hours. Healthcare organizations should report them to the Authority in a timely manner. It is not the Authority’s expectation that healthcare facilities report Incidents within 24 hours. Most if not all Incidents should be reported within 90 days of occurrence.    

HAP Comments:  HAP recommends the Department edit #28 to read: Healthcare organizations should report Incidents to the Authority in a timely manner. It is not the Authority’s expectation that healthcare facilities report Incidents within 24 hours. Guidance for reporting cannot go beyond the statutory provisions of the Mcare Act. Requiring more than the statutory provisions is stepping beyond the authority the legislature gave to the Department and the Authority in implementing the Mcare Act.

Additional HAP Recommendations:  Health care facilities and their provider teams seek to comply with all necessary federal and state laws. They seek to provide the right care, at the right time, and in the right setting. Health care facilities and their provider teams establish goals of delivering high quality, respectful health care to patients and their families. While guidelines are helpful in most circumstances, the Department must recognize the need for flexibility in that these guidelines do not carry the weight of law or regulation. HAP strongly recommends the Department work with the Authority to develop an updated algorithm that allows health care facilities and their provider teams to analyze occurrences in a logical format. Such a methodical approach allows a fair and just review of each occurrence in a facility and a thoughtful discussion and analysis under the auspices of a hospital’s patient safety committee.  This results in a thoughtful description of occurrences and the appropriate reporting and notification as required by the Mcare Act.    

HAP appreciates the opportunity to the work with the Department and the Authority to reasonably standardize the reporting and oversight of Infrastructure Failures, Serious Events, and Incidents.    

If you need additional information regarding HAP’s comments, please feel free to contact Kelly Thompson, Esq., HAP’s senior director, regulatory advocacy, at (717) 561-5325 or me at (717) 561-5344.

Sincerely,    
Paula A. Bussard
Senior Vice President, Policy and Regulatory Services   

c:  Mr. Michael Doering, Executive Director, Pennsylvania Patient Safety Authority       

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