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Comment Letter to JCAHO on Proposed 2009 Joint Commission National Patient Safety Goals
Regulatory Advocacy
Last Updated: 2/26/2008
February 26, 2008
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 the proposed 2009 Joint Commission National Patient Safety Goals. In addition to providing the Joint Commission with specific feedback about the proposed National Patient Safety Goals for 2009, HAP would like to share other feedback from the field with respect to the introduction of new National Patient Safety Goals and the updating of existing goals, requirements, and implementation expectations.
Overriding Concerns and Recommendations
National Patient Safety Goal Criteria: It remains unclear to the hospital field how the Joint Commission makes a decision as to what should be addressed in the standards versus as a National Patient Safety Goal. In recent years, the field has seen the Joint Commission propose that certain issues be addressed as a National Patient Safety Goal, such as addressing organizational disruptive behavior, only to then make a decision that this could be incorporated into standards. There should be more clearly articulated and transparent criteria around how decisions are made about what should be addressed as a National Patient Safety Goal versus a standard and element of performance. One is left to wonder why the Joint Commission is electing to put forth three infection-related topics as standalone National Patient Safety Goals that could be easily addressed through existing Joint Commission standards and elements of performance.
Prescriptive Nature of Implementation Requirements: HAP questions the need for the Joint Commission to be as prescriptive as they appear to be in many of the proposed goal requirements and implementation expectations. There appears to be inordinate emphasis placed on process rather than outcomes in many cases. For instance, if an organization can demonstrate that it has reduced the incidence of central line associated bloodstream infections in its organization, HAP questions whether it is really necessary to score the hospital on all of the processes spelled out in the implementation expectations for those proposed goals.
Overlap Between Standards and National Patient Safety Goals: There is considerable concern about the ever expanding number of goal requirements and implementation expectations, including comments that the goals have essentially become a separate chapter in the hospital accreditation manual. As currently proposed, the infection-related goals contain requirements that overlap into the existing infection prevention and control standards and elements of
performance, as well as, other National Patient Safety Goal requirements, including hand hygiene. As a result, a compliance failure in one or more of the implementation expectations for the proposed infection-related goal requirements may also result in non- compliant scores in other elements of performance or other goal requirement implementation expectations, placing an organization at greater risk for requirements for improvement, which presently affects the organization’s accreditation decision.
Field Testing: During a Pennsylvania Continuous Service Readiness program that was attended by former Joint Commission president, Dennis O’Leary, and other Joint Commission staff, attendees urged the Joint Commission to consider fully field testing goal requirements and implementation expectations in order to better understand which requirements actually help make hospitals safer and how best to clearly state the implementation expectations.
Based on feedback from Pennsylvania hospitals, HAP feels compelled to again make this recommendation for the following reasons.
- Field testing would promote a better understanding as to what the issues are in implementing the requirements and implementation expectations in different settings.
- The Joint Commission has indicated an interest in selecting goals, requirements, and implementation expectations that are setting specific, but often the goal’s requirements and implementation expectations don’t really work or apply in specific settings. Hospitals are often at a loss as to how the Joint Commission expects certain goal requirements to be implemented in outpatient settings. Too often, the Joint Commission selects a requirement and spells out implementation expectations that work in the inpatient setting, but it appears that little thought is given to how to operationalize the requirement or goals in the outpatient setting or whether even the same problem exists in that setting that needs to be addressed in the first place. This continues to be a weakness that the Joint Commission needs to examine and address in making decisions as to where to apply a goal’s requirements and in developing implementation expectations. As an example, the medication reconciliation requirements and implementation expectations need to better reflect care practice in outpatient settings.
- Field testing would allow the Joint Commission to better present the rationale behind the reasons for some of the implementation expectations and at the same time develop sound advice on how to meet the goal’s requirements and implementation expectations.
Availability of Implementation Materials: HAP believes that the Joint Commission needs to consider providing free materials to hospitals to assist them to meet the goal requirements and implementation expectations. Through such organizations as the Institute for Healthcare Improvement, organizations are offered many free materials, including How-To Guides, best practices and documentation tools from other facilities, free audioconferences, PowerPoint presentations, free expert staff advice, and other resources. Right now, virtually all guidance offered through the Joint Commission must be secured at a price. HAP believes that the Joint Commission could more fully demonstrate its commitment to patient safety by making resources available for free to the field and that many of them could be developed as a result of field testing the requirements and implementation expectations in various types of accredited facilities and various types of settings as already mentioned above.
Organizational Rework: HAP is concerned about the constant revising and reworking of many of the goal’s requirements and implementation expectations. The Joint Commission needs to fully appreciate what even minor edits to the goal requirements or implementation expectations means to an organization with respect to work, including re-educating staff, revising existing forms, and auditing of documentation to demonstrate evidence of compliance, to name just a few of the operational issues associated with one change to a goal’s requirements or implementation expectations.
Proposed 2009 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 the accuracy of patient identification.
Proposed Requirement 1C – Eliminate transfusion errors related to patient misidentification.
The Joint Commission is proposing a requirement and implementation expectations that will work to eliminate blood product transfusion errors. HAP questions the need for this proposed requirement and implementation expectations given the rare occurrence of blood transfusion errors and the fact that the implementation expectations are already widely accepted practice. HAP would appreciate understanding the reasons that the Joint Commission has elected to put forth this new requirement and implementation expectations.
While it is clear in the second implementation expectation that at least one of the persons involved in the verification process needs to be a practitioner who is qualified to administer the blood product and will administer the blood product to the patient, it is not clear what qualifications the second person involved in the verification process needs to have. Depending on how you read the third implementation expectation, it might be interpreted that this person just needs to be qualified to conduct the verification process or it could be interpreted that this person also needs to be able to administer the blood product.
HAP recommends that the Joint Commission clarify that the second person involved in the verification only needs to be qualified to perform the verification procedure with the practitioner that will administer the blood product. Hospitals utilize ancillary staff to witness the identification of patients in other aspects of care such as obtaining a witness of a signature for an informed consent and do not see this process as different. There may also be situations where there is one licensed practitioner available that can administer the blood, such as in some hospital clinical departments or on during certain shifts, and it may be necessary for this licensed practitioner to carry out the verification process with support staff or other staff who are not qualified to administer blood.
Finally, HAP would recommend a reordering of language in the first implementation expectation to read, “Before initiating a blood product transfusion, the blood product is matched to the computer order and the patient is matched to the blood product using either a two person verification process or an automated identification technology, such as bar coding.”
Goal 7: Reduce the risk of health care-associated infections.
Proposed Requirement 7C. Implement best practices to facilitate the prevention of multiple drug resistant organisms infections in acute care settings, focusing on methicillan-resistant Staphylococcus aureus (MRSA) and Clostridium difficile-associated disease (CDAD).
Proposed Requirement 7D. Implement best practices for prevention of catheter-associated bloodstream infections.
Proposed Requirement 7E. Implement best practices for prevention of surgical site infections.
While HAP acknowledges the Joint Commission’s efforts to recognize the importance of eliminating healthcare-associated infections, HAP believes the implementation expectations set forth for these proposed new requirements are far too prescriptive. Additionally, HAP believes that the Joint Commision’s existing and recently updated infection prevention and control standards already provide the framework for organizations to address these specific issues. Specifically, the standards and elements of performance already require the organization to identify and prioritize infection risks; describe the activities, including surveillance, to minimize, reduce, or eliminate the risk of infection; and implement processes to evaluate infection prevention and control processes. If the Joint Commission is concerned that accredited organizations are not being aggressive enough in addressing multi-drug resistant organisms infections, device-associated infections, or surgical site infections, then the Joint Commission should strengthen its infection prevention and control standards and elements of performance to ensure that these types of infections are being aggressively addressed, rather than carving them out as specific additional requirements with very prescriptive implementation expectations under a National Patient Safety Goal.
As HAP has already mentioned, there appears to be an inordinate emphasis placed on process rather than outcomes in many cases. For instance, if an organization can demonstrate that it has reduced the incidence of central line associated bloodstream infections in its organization, HAP questions whether it is really necessary to score the hospital on all of the processes spelled out in the implementation expectations for those proposed goals. HAP also questions how the Joint Commission intends to use surgical infection prevention measure data in connection with the proposed requirements related to surgical site infection reduction.
While HAP acknowledges the rise in specific multi-drug resistant organizations, including MRSA and CDAD within specific settings and geographic areas, hospitals need to be given the flexibility to assess infection risks within their own facilities and apply nationally recognized and published standards such as those set forth by Centers for Disease Control and Prevention (CDC), the Association for Professional in Infection Control and Epidemiology (APIC), and the Society for Healthcare Epidemiology of America (SHEA) as evidence-based practices to prevent and reduce various types of healthcare-associated infections. HAP supports keeping the standards and elements of performance broader than what is proposed by the Joint Commission as new requirements under an existing National Patient Safety Goal because of evolving changes in diagnostic testing; evidence-based practice; risk presented to an organization because of changing services or patient populations served; and the organization’s own outcome information with respect to various types of infections.
In short, HAP does not support the adoption of any of these topics as new requirements under the existing National Patient Safety Goal 7. Rather, HAP believes that these requirements are already addressed through existing standards and elements of performance. HAP supports furthering strengthening of infection prevention and control standards and elements of performance, rather than identifying these as separate requirements if the Joint Commission does not feel that organizations are adequately addressing these infection-related topics.
Goal 8: Accurately and completely reconcile patient medications across the continuum of care.
Several requirements currently exist within this National Patient Safety Goal, including that organizations implement a process to compare a patient’s current medication with those ordered for the patient while under the care of the organization; to communicate the reconciled medication list to the next provider of service; and to provide a reconciled medication list to patient at the time of discharge. The Joint Commission is proposing several revisions to these existing requirements, most of which increase documentation requirements. Given the challenges that organizations already have in meeting the requirements and implementation expectations associated with this National Patient Safety Goal, Pennsylvania hospitals question why the Joint Commission has elected to add additional documentation requirements. Specifically, Pennsylvania hospitals have voiced concerns that the revisions that the Joint Commission has proposed focus much more on documentation than on making sure the process is working in hospitals.
Additionally, while the Joint Commission appears to have attempted to clarify some of the confusion with respect to this goal’s requirements and implementation expectations, it now appears that some additional confusion has been added. For instance, does the first implementation expectation under requirement 8B now require the hospital to provide the two lists of medications to the patient’s next provider of care – a reconciled medication list and a separate list of the patient’s home medications? In the second implementation expectation, the discharging or transferring organization is expected to provide information to the next provider of care about how to obtain clarification about medications. This implementation expectation raises more questions for accredited hospitals than it answers. Finally, in several places throughout these requirements, the Joint Commission makes reference to a complete and reconciled list of the patient’s medications. Again, questions have been raised about what the Joint Commission means by complete and whether the term “complete” should simply be replaced with the term “reconciled” medication list.
The Joint Commission has seemingly heard the from the hospital field that there needs to be modifications to this goal’s requirements for outpatient settings because the Joint Commission has added a new requirement 8D that states, “In settings where medications are not used, are used minimally, or prescribed for short duration, modified medication reconciliation processes are performed.” However, Pennsylvania hospitals question whether the Joint Commission has sufficiently addressed the field’s concerns in what the Joint Commission is proposing and may have added more confusion by trying to make a distinction between what is required when a long-term versus a short-term medication is prescribed since the organization might not know whether the intention is to keep a patient on certain medication for an appreciable duration of time given the abbreviated interaction that an organization has with some patients in certain outpatient encounters.
In the November 2007 This Month newsletter, the Joint Commission reports on its Medication Reconciliation Summit. In that newsletter article, the Joint Commission reports that it instituted medication reconciliation requirements as part of its 2005 National Patient Safety Goals. “Compliance rates for 2006 reveal the requirements 8A and 8B have proven to be difficult for many health care organizations to meet. Non-compliance rates for these requirements, 18.9 percent for 8A and 14.2 percent for 8B, remain much higher than desired. The consensus of the Summit was that the process of medication reconciliation, obtaining an accurate medication list from the patient, and assuring its accuracy throughout the care continuum, improves patient safety. However, more guidance on implementation is required. Additionally, NPSG 8A needs clarification, particularly in regards to the information that should be included on a medication list, the appropriate times and settings for taking medication information (as well as information about allergies, etc.), and how to handle temporary changes to a medication list. Discussion included the process of medication reconciliation, the role of the patient in improving the process, and the barriers to implementation. A document outlining the suggestions of the Summit attendees and next steps is being developed. The Joint Commission will communicate new developments from the Summit in future issues of This Month, Joint Commission Online, and Perspectives.”
Pennsylvania hospitals don’t believe that the Joint Commission’s revisions to existing requirements have appreciably clarified the concerns and challenges in meeting this goal in the field. In fact, many of the revisions proposed by the Joint Commission seemingly add more requirements, introduce new documentation requirements, or further add to the confusion that already exists in the field. Given these concerns and the recommendations made at the Summit, HAP cannot support the revisions that the Joint Commission has proposed to the medication reconciliation goal requirement and implementation expectations.
Goal 13: Encourage patient’s active involvement in their own care as a patient safety strategy.
HAP certainly appreciates the Joint Commission’s interest in ensuring patient’s involvement in their own care and agrees that such involvement is important as a patient safety strategy. However, HAP does not subscribe to adding a laundry list of condition-specific patient education requirements as implementation expectations under Goal 13. Again, HAP believes that these requirements are already addressed in PC.6.10 which requires the patient to receive education and training specific to the patient’s needs and as appropriate to the care, treatment, and services provided. Further in PC.6.10, EP 3, the Joint Commission requires the patient to be educated about the following:
- The plan for care, treatment, and services
- Basic health practices and safety
- The safe and effective use of medications
- Nutrition interventions, modified diets, or oral health
- Safe and effective use of medical equipment or supplies when provided by the hospital
- Understanding pain, the risk for pain, the importance of effective pain management, the pain assessment process, and methods for pain management
- Habilitation or rehabilitation techniques to help them reach the maximum independence possible.
HAP believes that the specific issues associated with infection prevention and processes of care associated with surgery are already addressed in this standard and its related elements of performance. HAP does not support adding additional implementation expectations under Goal 13. Instead, the Joint Commission should clarify that the prevention of adverse surgical events and infection prevention practices are understood to be part of basic health practices and safety as part of EP 3 under PC.6.10.
With the proposed third implementation expectation, the Joint Commission would require accredited hospitals to educate patients and their families on infection control measures appropriate for the patient’s condition on the day of admission. There may be instances where the patient may be unable to participate in the education process such as in the case of trauma admissions or because other medical conditions render the patient too ill to participate. There may also be uncertainty of the infectious diagnosis at the time of admission and educating patients with information other than that appropriate to their diagnosis may be confusing. Again, HAP suggests this information could be incorporated within PC.6.10, which already specifically addresses health care education requirements related to care, treatment, and services.
Universal Protocol
The Joint Commission has expressed concern that despite adoption of the Universal Protocol, there continue to be situations where wrong person, site, or procedure surgery is performed. The Joint Commission is proposing changes to the universal protocol with the addition and/or revision of several implementation expectations focused specifically on the pre-operative verification process, operative site identification, and the “time out” verification process.
Requirement 1A: Conduct a preoperative verification process
The Joint Commission has added several new implementation expectations to ensure that there is verification of the correct person, procedure, and site, including during the preadmission assessment and testing process and anytime that care is transferred to another provider of care, including anesthesia providers who may relief each other during the operative procedure.
Several issues and questions emerged in regard to these changes, including that many times the preadmission testing and screening is performed in locations not affiliated with the accredited organization. Several questioned what the Joint Commission meant by using the term emergent, since by its very nature, emergency surgery may not lend itself to the standard verification process. And, perhaps most importantly, there were questions regarding the survey process that would be used to assess compliance with the implementation expectations. Specifically, would the Joint Commission be assessing organizational compliance through use of tracer methodology, documentation, or a combination of both? For example, would surveyors observe cases in which there was a transfer among caregivers or would there be an expectation that this is documented in some way?
Requirement 1B: Mark the operative site
There were multiple concerns raised by Pennsylvania hospitals in response to the revisions made to the implementation expectations related to the marking of the surgical site, including:
- The Joint Commission needs to recognize that for procedures performed at the bedside, the site cannot be marked before moving the patient to location whether the procedure will be performed.
- Residents or physician assistants are not considered licensed independent practitioners and would not be permitted to mark the procedure site even though they will be directly involved with and present at the time that the procedure occurs. In many organizations, physician assistants, surgical residents and nurses perform a preliminary identification
check including the verification of the correct surgical site prior to the surgeon’s marking and identification during the “time out” procedure.
- The Joint Commission appears to be requiring surgical site marking for virtually all cases; however, there may be some procedures where the Joint Commission is requiring marking that cannot remain visible after sterile draping.
- Requiring the surgeon to initial the site. A Pennsylvania hospital cited a case where the surgeon’s initial were N.O. and this was interpreted as meaning that this was not the site on which to perform the surgery.
- That in addition to the list of types of patients or procedures for which alternative approaches to site marking is indicated would be burn patients.
Requirement 1C: Conduct a final “Time out” verification immediately before starting the procedure
While HAP agrees with the proposed implementation expectations 1-6 for requirement 1C, Pennsylvania hospitals question how the time-out process is different from the pre-operative verification checklist process as it appears that the Joint Commission would require the same process to be completed during the time-out. It this indeed what the Joint Commission is intending through these revisions? Additionally, there are questions about what the Joint Commission expects by requiring that the time-out address special safety precautions based on patient history or medication use and what evidence was used by the Joint Commission to suggest adding the final two bullet points under implementation expectation 7. Further, there is concern about adding other items in this time-out as organizations have already incorporated other process verification items in this time-out, such as the administration of prophylactic antibiotics.
Finally, Pennsylvania hospitals believe that the Joint Commission is being far too prescriptive in regards to how the organization documents its time-out procedure and recommends that the Joint Commission recognize that the time-out can be documented on other operative record forms or through electronic means.
HAP and its member organizations question if these changes were vetted through professional and specialty organizations, particularly those whose initial endorsement of the Universal Protocol was received. When considering changes such as those proposed to the Universal Protocol, HAP and its member organizations suggest that the Joint Commission seek guidance from evidence based protocols that have been adopted by either professional and/or specialty organizations. HAP has also discovered the New York State Surgical and Invasive Procedure Protocol and is enclosing this protocol as additional reference material for the Joint Commission to consider in making changes to the Universal Protocol with the field.
HAP appreciates the opportunity to comment on the proposed 2009 National Patient Safety Goals. 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 or Sharon Muscatell, director, quality & accreditation services, HAP at smuscatell@haponline.org or (717) 561- 5347.
Sincerely, LYNN G. LEIGHTON
Vice President, Professional & Clinical Services
The Hospital & Healthsystem Association of Pennsylvania
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