January 16, 2007

Dr. Robert Wise
Vice President
Division of Standards and Survey Methods
Joint Commission on Accreditation of Healthcare Organizations
1 Renaissance Boulevard
Oakbrook Terrace, IL 60181

Dear Dr. Wise:

The Hospital & Healthsystem Association of Pennsylvania (HAP), on behalf of its members, more than 225 acute and specialty hospitals and health systems, appreciates the opportunity to comment on several items that have been presented to the hospital field for review, including:

• proposed 2008 National Patient Safety Goals
• proposed changes to the medication management standards and elements of performance (MM.4.10 and MM.8.10)
• a proposed new standard and elements of performance around conflict management (LD.2.40)
• a new proposed standard and elements of performance related to disruptive behavior
• the environment assessment related to the completion and updating of the history and physical examination (PC.2.120)

Proposed 2008 National Patient Safety Goals

HAP would like to offer the following comments on each of the proposed National Patient Safety Goals and implementation expectations.

Goal 1: Improve Accuracy of Patient Identification.
The Joint Commission has proposed to include a new implementation expectation that would essentially require organizations to evaluate and implement technology that would assist in patient identification. HAP does not recommend adoption of this new requirement given that the present technology that is currently available is not foolproof and represents substantial expense to the organization. As proposed, the organization is not only required to evaluate technology, but presumes that the organization would select, purchase, and implement technology designed to assist in the identification of patients. HAP believes that while health care organizations should be constantly evaluating technology available on the market to assist in patient identification, that it should fall within the purview of the organization to determine the priority for health information technology acquisition and the sequencing of various health information projects. The proposed Joint Commission requirement essentially requires organizations to place greater priority on this type of technology compared to other technologies that could offer substantial enhancements to patient safety, such as automating medication dispensing. HAP believes that Joint Commission standards already exist wherein organizations are required to establish an information management plan and hospitals are required to assess their information management needs based on a whole series of issues, including patient safety considerations (see IM.1.10 and related elements of performance). HAP believes that the existing standards represent a more balanced approach because of the need to consider a whole host of issues, including patient safety issues.

Goal 3: Improve the Safety of Using Medications.
The Joint Commission has proposed adding a new requirement and implementation expectations that would focus exclusively on reducing the likelihood of patient harm associated with the use of anticoagulation therapy. This proposed goal is consistent with an endorsed National Quality Forum (NQF) safe practice and one of the interventions of the Institute for Healthcare Improvement’s most recently launched 5 Million Lives Campaign. Additionally, HAP believes that this has been an area of ongoing focus for Pennsylvania hospitals for quite a period of time, and supported adoption of this proposed goal when it was put forward last year. HAP again would support this as a candidate for a proposed 2008 National Patient Safety Goal on the basis of its alignment with the NQF safe practices and the IHI Campaign with two modifications to the implementation expectations.

Specifically, HAP objects to a requirement that would require an organization to consider a defined anticoagulation management service for both outpatients and inpatients. HAP believes that this is too prescriptive and may be too expensive for hospitals to implement depending on their configuration, particularly for those organizations with a substantial complement of physician office practices or other ambulatory service settings. HAP also objects to the implementation expectation that would require annual education about safe use of anticoagulants. It seems like the answer to any area of significant importance ends up as a new annual education requirement in Joint Commission standards. HAP believes that there are other ways to ensure that there is organizational learning on an ongoing basis for affected staff around this issue without having to require formal annual education. HAP supports the goal and implementation expectations with the removal of these two provisions.

Goal 16: Recognition and Response to Changes in Patient’s Condition.
The Joint Commission has proposed a new goal and implementation expectations that would require organizations to select a method that enables health care staff members to directly request assistance from a specially trained individual when the patient’s condition appears to be worsening. This goal is consistent with an intervention that was included in the original IHI 100K Lives Campaign; however, this particular intervention is not included as part of the NQF endorsed safe practices.

In an article recently published in The Journal of the American Medical Association (JAMA), the authors cautioned making implementation of rapid response teams a standard of care because of lack of evidence on the effectiveness of the intervention from valid clinical studies. The authors state, “While the concept of and rationale for rapid response team programs are strong, more research is needed before implementation of rapid response team programs should be required or strongly recommended.” The authors also pointed out that rapid response teams may be one of many viable approaches for intervening on behalf of patients demonstrating clinical deterioration. Other approaches may be equally effective, including the use of hospitalists, nurse practitioners, or physician assistants on hospital units or the use of automated monitoring systems. The authors note, “It is unclear whether the potential benefit of the rapid response team programs actually derives from summoning a special team to intervene on behalf of a deteriorating patient or from educating the general staff on how to better recognize deteriorating patients earlier.” (“Rapid Response Teams—Walk, Don’t Run,” JAMA, October 4, 2006, 296:13, pp. 1645-1647)

In spite of not having enough evidence to unequivocally support implementation of rapid response team, HAP believes that there has been substantial implementation of this intervention by Pennsylvania hospitals and that the results have resulted in significant improvements in patient safety and lives saved. On the basis of individual hospital experiences, HAP would support adoption of this proposed goal and implementation expectations as well as because of its alignment with an intervention in the IHI campaign.

Goal 17. Obstructive Sleep Apnea.
The Joint Commission is considering requiring organizations to screen for obstructive sleep apnea prior to the performance of surgical procedures involving the use of centrally-acting anesthesia and/or analgesic agents. HAP believes that it is critical that there be alignment among the Joint Commission National Patient Safety Goals and other nationally recognized practices or interventions. In this case, there is no alignment between this proposed goal with the endorsed NQF safe practices or with the IHI Campaign interventions. On that basis alone, HAP does not support adoption of this proposed goal and implementation standards.

A number of Pennsylvania hospitals indicated to HAP that they have implemented a process wherein various questions are posed to surgical patients to determine the possible existence of obstructive sleep apnea, particularly among patients scheduled for bariatric surgery. However, there were a number of concerns raised upon review of the implementation expectations including, what constitutes an adequate screening to determine who may be at risk for obstructive sleep apnea; whether a series of questions would serve as an adequate screening device without additional definitive testing; the potential that this requirement would result in more definitive testing for obstructive sleep apnea because of the potential for litigation; the need to clarify whether this evaluation would be the sole responsibility of anesthesia personnel; and concerns about the logistics associated with that assessment if it is the intent of Joint Commission to make this the responsibility of anesthesia personnel.

HAP recommends that the Joint Commission develop more information on this goal and implementation expectations to share with the hospital community, which may take the form of education programs or serve as the basis of different articles in various Joint Commission publications in order to raise field’s awareness about this intervention, reasons for the intervention, and ways that different organizations have implemented this intervention. HAP believes that more general awareness about this intervention needs to be created in the field, that the implementation expectations need more refinement, and that following these efforts, the Joint Commission should consider bringing this goal and implementation expectations forward as a proposed National Patient Safety Goal at a future point in time.

Goal 18. Health Care Worker Fatigue.
The Joint Commission has again recommended that health care organizations acknowledge that fatigue poses a risk to patient safety, identify conditions or practices that contribute to health care worker fatigue, and take action to minimize the risk. This is now the second year that the Joint Commission has advanced this as a proposed National Patient Safety Goal.

HAP and Pennsylvania hospitals remain particularly concerned about the implications associated with this proposed goal. Of all the goals proposed by the Joint Commission, this is the goal that raises the most concern in terms of the issues that it could raise for organizational operations because of the implications of possibly having to reduce access to services by placing limitations on work hours; problems that the goal may present for hospitals with limited operating margins where to comply with the implementation expectations as states, hospitals would have to hire more staff; the lack of a sufficient supply of various types of health care professionals in certain markets which would make it impossible to be in complete compliance with the implementation expectations as outlined; and the complexities associated with the relationships between employers and employees, including dealing with specific requests by employees to work particular schedules because of other personal interests or commitments.

The implementation expectations, as written, presume that an organization could easily identify those tasks affected by levels of fatigue, identify tasks that should no longer be performed by individuals after extended duty hours, and have the ability to intervene when those thresholds are reached. HAP questions whether organizations would have the expertise to truly identify those tasks, establish respective thresholds, and police employees in the organization for adherence to those standards. It appears that all of the risk in the proposed goal and implementation standards rests with the employer and not the employee.

HAP strongly recommends against adoption of this proposed standard because of the complexities associated with it and the lack of a balanced approach between employer and employee accountabilities and expectations. HAP also does not support adoption of this as a national patient safety goal because it does not appear as a separately endorsed NQF safe practice. Rather, it is part of a larger safe practice related to the creation of a culture of safety. And, finally, HAP believes that Joint Commission already has standards where issues related to staff fatigue should be addressed, including the Joint Commission’s existing standards related to staffing effectiveness, patient safety, and performance improvement.

Goal 19. Prevent Catheter and Tubing Misconnections.
The Joint Commission has proposed that organizations take steps to prevent catheter and tubing misconnections through risk assessment, line reconciliation processes, and education. HAP received mixed feedback about this proposed National Patient Safety Goal and implementation expectations from Pennsylvania hospitals. The concerns and issues raised by Pennsylvania hospitals include:

• There is no specific NQF endorsed safe practice or IHI Campaign intervention that corresponds directly with this goal and implementation expectations. Therefore, concerns about overall alignment were expressed as with some of the other National Patient Safety Goals already mentioned above.
• There was general sentiment that these expectations should represent standard nursing care and that such a goal and implementation requirements were not necessary.
• There was overall concern expressed that organizations would pay too much attention to demonstrating adherence to the requirements through some sort of documentation process because of the way the implementation expectations were written and because of uncertainty as to how compliance with the goal and implementation expectations would be surveyed.
• There was some support for the goal and implementation expectations provided there were modifications made where a focus would be placed on the complex patient with multiple lines and catheters and provided there was more certainty as to how the Joint Commission intended to survey for compliance with the goal during hospital survey.
• Finally, questions were raised about why the Joint Commission believes it is necessary to educate non-clinical hospital staff about the hazards of misconnecting tubing and other devices when they by definition have no contact with patients, particularly around this goal.

HAP would only support this goal and implementation expectations with a much more defined focus and a clear understanding of exactly how the Joint Commission intends to survey for compliance.

Medication Management Standards Proposed Revisions

The Joint Commission proposes to incorporate exceptions that it has made around the prospective review of medication orders and prescriptions be incorporated into Joint Commission standards, including that medications that need to be administered urgently; in instances where a licensed independent practitioner controls the ordering, preparation, and administration of a medication; when dispensing and administration is performed under an approved medication protocol; or when the pharmacy is closed can be administered without a pharmacist’s prospective review. The proposed standard revisions also recognize that all medications administered in select areas of the hospital, such as the emergency department or intensive care units do not need to be administered urgently. Therefore, organizations cannot assume that every medication administered in the emergency department or intensive care unit is urgent and a prospective pharmacist’s review is no longer necessary; however, the Joint Commission has indicated that it will accept a list of non-urgent medications that can be administered in the emergency department without a pharmacist’s prospective review.

Because of the removal of some of the restrictions around conducting a prospective review, the Joint Commission has proposed implementation of a retrospective review for those situations in which a prospective review was not performed. Additionally, the Joint Commission is proposing that when non-ionic intravenous contrast is used in radiology that the organization establish and implement a medication protocol in the absence of a pharmacist’s review of the medication order.

HAP would like to offer the following comments about the proposed standards revisions:

• HAP appreciates the effort that Joint Commission has made to try to balance the interests of patient safety with the constraints that hospitals and practitioners face real-time in attempting to provide timely care to patients. However, even with the ability to create a list of non-urgent medications that could be administered without a pharmacist’s prospective review and the ability to create more medication protocols, there is strong sentiment that there are still so many medications that will require prospective review that the process will create only further delays in treatment and facilitating movement of patients through the hospital emergency department.
• There is considerable concern that the retrospective review requirements will be difficult if not impossible for hospitals to conduct. Quite simply, HAP does not believe that the majority of hospitals have systems that are sophisticated enough to identify those cases where a retrospective review needs to be performed, including being able to identify the right patients where the retrospective review needs to be conducted, in identifying the medications that were administered to that patient, or in having a complete enough patient profile to conduct the review. There is also considerable concern that the time spent on retrospective reviews could compromise resources that should be appropriately expended on a prospective review or in other more meaningful and valuable patient safety pharmacy interventions.
• While the retrospective review could potentially identify some risk areas for the organization, HAP believes that organizations could discern these kinds of concerns through some sort of audit procedure as opposed to performing a 100 percent review on all cases that meet the criteria recommended by the Joint Commission.
• Further, hospital pharmacists question the value of the retrospective review in averting an adverse drug event, particularly since the patient is likely to have already experienced an adverse drug event by the time the pharmacist conducts the retrospective review.
• Other questions about the hospital’s responsibility around contacting the patient who was seen in the emergency department, treated and released were also raised and need further clarification to truly understand the burden that these retrospective review requirements could have on hospitals.
• There is unequivocal agreement that there needs to be a better way to ensure patient safety related to medication-related issues against other competing patient safety interests in the emergency department, including timely treatment of patients, particularly in the hospital emergency department. HAP and Pennsylvania hospitals don’t believe that the standards revisions proposed create that needed balance among competing patient safety interests.
• There is support for ensuring prospective review of medications for those patients that are being held in the emergency room awaiting bed placement in the organization, but the hospital community did not believe that this aspect was explicitly addressed in the revisions to the standards.
• There was a sense that there would be value in establishing a medication protocol related to the administration of non-ionic intravenous contrast in radiology, especially because of the varied levels of nursing support among hospitals in radiology departments.
• Hospital pharmacists and other hospital personnel pointed out that the Joint Commission focused on only one aspect of medication use in radiology in this standard. In general, there was discomfort around medication use/processes in hospital radiology departments and some support for recommendations that would require hospitals to better evaluate medication use and processes in this area and other similar areas of the hospital to better understand organizational risk and patient safety concerns that need to be addressed.

Additional points that Pennsylvania hospitals raised and that HAP believes should be shared with the Joint Commission include:

• The American Academy of Emergency Medicine has stated that it believes that there is no valid, scientific evidence that justifies prospective review by a pharmacist of medications ordered by an emergency physician. Adding such unnecessary complexity may actually increase the rate of errors in predictable and unpredictable ways. Further, the delay that such prospective review creates will worsen emergency department crowding, which has already reached crisis levels according to a comprehensive Institute of Medicine study released in June 2006.
• All medications in the emergency room should be designated as emergency medications due to the complexity of the Emergency Department.
• Pharmacist review of medications before being administered in the Emergency Department will increase patient waiting times and could cause delays in implementing patient treatment.
• In most instances, there is always at least one emergency physician in the Emergency Department.

At this point, given the concerns expressed by Pennsylvania hospitals related to this standard, HAP cannot support the retrospective review provisions in the revised standard. HAP recommends that the Joint Commission work more closely with emergency room physicians and representatives from the Association of Health Systems Pharmacists to craft a more realistic and workable solution that balances multiple patient safety priorities that are present when patients seek treatment in hospital emergency departments.

Conflict Management Proposed Standard

The Joint Commission is proposing adoption of a new standard and elements of performance that would require an organization to manage conflict between leadership groups to protect the quality and safety of care. Currently, there is an element of performance in LD.1.20 related to governance responsibilities that states, “Governance provides a system for resolving conflicts among leaders and the individuals under their leadership.” The Joint Commission has indicated that this standard requires resolution of conflicts, but fails to recognize that not all conflicts can be resolved. Additionally, the current element of performance does not appear to address issues that could arise between the governing board, hospital leadership, and the medical staff.

HAP would like to offer the following comments on the proposed standard and elements of performance.

• Elimination of the “leadership components” framework used in the previous draft of the Leadership Chapter is a welcome change that seems to ensure that the standard remains consistent with the ultimate authority of the hospital’s governing board.
• HAP agrees with element of performance #2, which indicates that it is the governing board that approves a process for conflict management within the organization.
• Element of performance #3 states that the conflict management process is implemented when needed, but it does not explicitly link the process to improvements in quality of care and patient safety. A more appropriate approach would be to have a conflict management process in place and implemented when it is clear that conflict among leadership groups is the cause of a quality of care or patient safety problem or concern. The exercise of a board’s ultimate governing authority may cause disagreement or conflicts with medical staff, but these conflicts do not necessarily hurt the quality of care for patients. Obligating the hospital’s governing board to submit all potentially controversial decisions to a process of conflict management would diminish the board’s ability to govern and could in fact create obstacles to quality improvement efforts.
• Joint Commission indicates in the rationale that a person in the organization and in a leadership position needs to be skilled in conflict management. HAP believes that there may be several individuals with these skills within an organization, including counselors, patient advocates, lawyers, psychologists, human resource professionals, and persons in organizational development. In fact, in cases of conflict, it may be advisable to utilize persons outside of a “leadership group” to assist in the management and resolution of conflict rather than relying on a person who may be seen as having a vested interest in the result. HAP suggests that organizations should have the ability to utilize other persons internally outside the formal leadership group or from outside the organization as needed to help in the management and resolution of conflict.
• Elements of performance #5, 6, 7, and 8 are overly prescriptive in defining what the process needs to address.

HAP does not support the adoption of a separate standard and element of performance around conflict management, particularly since the elements of performance are so prescriptive. Additionally, HAP believes that the element of performance that currently exists under LD.1.20 could be modified to achieve the aims of the Joint Commission. HAP recommends the following modification to the existing element of performance, “Governance provides a system for managing and resolving conflicts within the organization, especially when conflict among leadership groups is or may result in a quality of care or patient safety problem.”

Disruptive Behavior Proposed Standard

The Joint Commission is proposing adoption of a new leadership standard that requires organizations to establish expectations around behavior for those that work in the organization, including hospital employees, members of the medical staff, volunteers, and board members. Last year, the Joint Commission proposed a similar requirement as a 2007 National Patient Safety Goal.

HAP believes that dealing with disruptive behavior is an important issue that organizations need to address because of its direct relationship to an organization’s culture of safety and impact on staff morale and turnover. However, HAP does not believe that this issue warrants a separate standard with an identified and prescriptive list of elements of performance. In fact, most Pennsylvania hospitals believe that existing Joint Commission standards in large part already require organizations to address unacceptable behavior and that adoption of another standard with elements of performance would be redundant. However, there was some sense that perhaps the Joint Commission wants to make expectations around dealing with disruptive behavior much more explicit in the standards.

There were also questions or concerns with the elements of performance included in the field review. These included the following:

• HAP and the hospital community question why it would be necessary for a code of conduct to define desirable and undesirable behavior. Might it not be possible to codify unacceptable behavior rather than both?
• HAP believes that proposed element of performance #4 and #7 could be combined into one that states, “Leaders establish mechanisms for managing disruptive behavior, including use of a progressive disciplinary action process.”
• Element of performance #7 focuses on only one aspect of what might be part of a progressive disciplinary action process and appears to more oriented to members of the medical staff. HAP also questions what processes would be utilized by hospitals in dealing with hospital volunteers and board members since these represent a different relationship than the hospital has with its employees or members of its medical staff.
• HAP is unclear of what the Joint Commission means by “individual leadership groups” in element of performance #5.
• HAP recommends that element of performance #6 read, “The organized medical staff manages disruptive behavior exhibited by members of the medical staff.” The medical staff only has jurisdiction over those who are identified members of the medical staff and not all individuals who are granted clinical privileges, since some of these individuals would not necessarily be members of the medical staff.

In sum, HAP does not support the creation of a separate standard with such prescriptive elements of performance. HAP recommends that the Joint Commission consider tucking in a broad performance expectation as an element of performance under one of the existing leadership standards that deals with the patient safety program (LD.4.40 or LD.4.50) that would require the organization at a minimum define disruptive behavior and establish mechanisms for managing disruptive behavior, including the use of a consistent and equitable progressive disciplinary action process. HAP believes that this accomplishes the aims of the Joint Commission by making the expectation more explicit without making the requirements so prescriptive.

Environmental Assessment Related to History and Physical Requirements

The Centers for Medicare & Medicaid Services has recently issued final regulations in regard to history and physical examination. Specifically, the final Medicare Condition of Participation reads, “The medical staff bylaws must include a requirement that a medical history and physical examination be completed no more than 30 days before or 24 hours after admission for each patient by a physician, or oromaxillofacial surgeon, or other qualified individual in accordance with state law and hospital policy. The medical history and physical examination must be placed in the patient’s medical record within 24 hours after admission. When the medical history and physical are completed within 30 days before admission, the hospital must ensure that an updated medical record entry documenting an examination for any changes in the patient’s condition is completed. This updated examination must be completed and documented in the patient’s medical record within 24 hours after admission.”

Currently, it is HAP’s understanding that the Joint Commission requires updates be recorded since the original examination at the time of admission. In the proposed environmental assessment, the Joint Commission has outlined several options which allow organizations to waive the update at the time of admission depending on when the history and physical was performed (24 hours prior to surgery, 72 hours prior to surgery, 7 days prior to surgery, or 30 days prior to surgery) and document the update within 24 hours of admission.

Regardless of the results of the environmental assessment, hospitals will be required to meet Medicare standards. Therefore, the only options that could be selected by the Joint Commission would be to retain its current requirements, which are stricter than the Medicare requirements or to loosen its requirements to match Medicare requirements noted above. HAP recommends that JCAHO modify its requirements to match the final Medicare Conditions of Participation related to history and physical examinations. This would allow hospitals the discretion to determine which patients require an update at the time of admission and which could be done within 24 hours of admission, but in all cases, the updates would need to be accomplished within that 24-hour period of time.

Field Review Concerns

HAP understands and appreciates that the Joint Commission has its own infrastructure in place, which requires certain timing for the review and approval to changes in Joint Commission policy and standards. However, this is now the second consecutive year where there has been multiple field reviews released at the same time, toward the end of the calendar year right before the holidays. HAP has commented before to the Joint Commission about the need to better time and space its field reviews. Simultaneous release of numerous proposed standards with similar comment deadlines does not allow hospitals sufficient time for thorough evaluation of the impact of the proposals and development of comments. It is also difficult for hospital associations to schedule meetings to obtain the needed hospital input to respond to the proposed standards or standards revisions. HAP again is asking the Joint Commission to evaluate its process, particularly the end of the calendar year timing for field reviews, and to minimize the number of field reviews it conducts at any one time.

Should you have any questions about the comments or suggestions contained in this comment letter, please feel free to contact me at lgleighton@haponline.org or at (717) 561-5308. If I am not available, you can speak to Sharon Muscatell, director, quality & accreditation services, HAP at (717) 561- 5347.

Sincerely,

LYNN G. LEIGHTON
Vice President, Professional & Clinical Services
The Hospital & Healthsystem Association of Pennsylvania