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ASHP Submits Comments on HCFA's Hospital Conditions of Participation



April 20, 1998 

Nancy-Ann Min DeParle, Administrator
Health Care Financing Administration
Department of Health and Human Services
Attention: HCFA-3745-P
Room 309-G, Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, DC 20201

RE: File Code HCFA-3745-P: Medicare and Medicaid Programs; Hospital Conditions of Participation 

Dear Ms. DeParle: 

The American Society of Health-System Pharmacists (ASHP) is pleased to provide comments on the Health Care Financing Administration's proposal to revise the existing conditions of participation (COPs) that hospitals must meet in order to participate in the Medicare program that was published in the December 19, 1997, Federal Register. ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care agencies, and other components of health care systems. 

The proposed rule is a serious threat to the care and safety of hospitalized patients, and ASHP urges HCFA to withdraw the proposal and meet with us and other health professional organizations to develop a more workable approach to achieve the common objective of better patient care. 

As noted in the preamble to the proposed regulation, the COPs for hospitals were last revised in 1986, after a six-year public comment process. Since then, health care and medication use have changed dramatically, so the need to revise the COPs is obvious. HCFA's stated intention is to focus its COPs on patient-centered, outcome-oriented standards. While ASHP recognizes the value of outcomes standards, we believe strongly that it is premature to focus only on outcomes. 

In its support of outcomes standards, HCFA is riding a contemporary wave of thinking in health care quality assessment. However, the theory of outcomes standards is significantly ahead of its practical application, which is acknowledged by the leaders of quality assessment. There is no health care accreditation body today, including the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), that has converted entirely from structure and process standards to outcomes standards, and such a total conversion may never be feasible. It would be dangerous to make a precipitous and wholesale shift from HCFA's well-established approach to ensuring hospital quality to an untested model. There is simply insufficient evidence and experience to support a comprehensive shift solely to outcomes standards. 

ASHP has three major concerns with the proposed revisions to the "Pharmaceutical Services" COP. Those concerns relate to: 1) the role of the pharmacist in the medication-use process, 2) elimination of the requirement for a formulary system, and 3) HCFA's proposed 2% medication error rate target. We believe that the risk to patients posed by HCFA's proposed revision of the hospital COPs in these areas is so great that the agency must withdraw the proposed rule. 

Pharmacists are essential for patient care 

The proposed COPs will delete many of the components of the current "pharmacy management and administration" standard, including the following requirements in 42 CFR 482.25(a): 

  1. A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.      
  2. The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.
HCFA proposes to delete the following requirements from the "delivery of services" standard in current 42 CFR 482.25(b):
  1. All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal law.      
  2. Drugs and biologicals must be kept in a locked storage area.      
  3. Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.      
  4. When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law.      
  5. Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital-wide quality assurance program.
In the interests of patient care and patient safety, these requirements must not be deleted; indeed, they should be strengthened. Medication use is one of the primary tools available for intervention in hospital care. High-risk, costly medications are a staple of acute care. The risk associated with medication use in hospitals is exacerbated because many drugs used in this setting are injectable products for which onset of action is immediate and for which sterility is a vital requirement. Over the past several decades, hospital pharmacists have developed numerous interconnected processes for ensuring patient safety related to all the steps in the medication use process, including product selection and acquisition, formulary system management, i.v. admixture services, quality assurance for hospital-prepared sterile products, infection control, unit dose drug distribution, adverse drug reaction monitoring and reporting, handling cytotoxic and hazardous drugs, individual patient drug regimen review, review of overall drug use patterns, handling investigational drugs, and pharmacokinetic dosing services (this is a partial list). Hospital pharmacists have developed well-defined and time-tested structure and process guidelines (based on both evidence and expert opinion) for the optimal ways of conducting these activities, from the standpoint of patient safety. (Much of the literature supporting these structure and process guidelines is included in the attached compilation of articles and abstracts.)

The complete removal of the requirement for a qualified pharmacist who is responsible for developing, supervising, and coordinating all activities involved in pharmaceutical care dismisses a vital component of the organizational fabric of the safety net that supports patient care. The best way for HCFA to ensure that patients benefit from the body of evidence that has accumulated about safe medication use is to require that the medication use process be under the guidance of pharmacists. Any approach less than this would be blatant disregard for the body of accumulated experience and evidence on best practices in medication use. Not requiring pharmacists to be involved in the medication-use process would be equivalent to not requiring that the diagnosis of disease be under the control of physicians or to not requiring that implementation of treatment plans be under the supervision of nurses. 

The preamble to the proposed revisions to the "Pharmaceutical Services" standard of the COPs states that HCFA supports an interdisciplinary approach to the coordination of drug therapy services. This is a commendable statement, and in keeping with current JCAHO standards, which identify interviews with an interdisciplinary team of medical, nursing, and pharmacy staff as a means of evaluating a hospital's performance of medication-use processes. ASHP, therefore, finds it inconceivable and contrary to best practices for HCFA to believe that patient care will be improved if a third of the interdisciplinary team involved in the medication-use process is deleted from the COP standards. That this deletion is HCFA's goal is evident from the requirement in proposed ?482.35(b)(5), which states that "before medications are administered, a licensed nurse (that is, a registered nurse, licensed practical nurse, or licensed vocational nurse) or a doctor of medicine or osteopathy must review the individual patient's information, and the orders of the practitioner who prescribed the medication." This requirement would empower nurses for a role that i s beyond their education and experience in the medication-use process. 

Such medication reviews are properly a function of the hospital pharmacist. No other health care professional has the extensive education, training, or experience in medication use as the pharmacist. Attached as Appendix A is a copy of the curriculum for the entry-level degree for pharmacists at one of the nation's 82 schools of pharmacy. It will give you an overview of the extensive education, training, and practical experience pharmacists undergo to prepare them for their unique responsibilities in providing quality patient care. In addition, hospital pharmacists have developed postgraduate residency training programs that concentrate on the specific knowledge, skills, and abilities required to ensure safe medication use systems in hospitals. The accreditation standards for these residencies programs are attached as Appendix B. Currently, JCAHO standards state (TX.3.5.2) that "to ensure safe and accurate dispensing of medications," pharmacists must "review each prescription or order for medication and contact the prescriber or orderer when questions arise". Furthermore, ASHP members tell us that the nurses and physicians they work with say that if this function were to be delegated to them, they would still rely on their hospital's pharmacist for the expertise necessary to detect and prevent the most significant medication errors. 

Although the proposed revision to the COPs, in the "Staffing" standard in ?482.125(b) requires that hospitals should be staffed so as "to ensure that desired outcomes of care are achieved and negative outcomes are avoided," only nurses are specifically mentioned in that standard. ASHP members believe that if staffing requirements are considered necessary and appropriate for nurses, they are equally appropriate for pharmacists who prevent harm to patients and otherwise improve patient outcomes related to medication use on a daily basis. 

Some comments you receive may suggest that, instead of requiring nurses to perform the medication review, this task be delegated to "an appropriate health care professional." Upon reflection, ASHP finds this alternative equally unacceptable. If the "appropriate health care professional" is the pharmacist -- and it is -- then the pharmacist should be specified in the standard. 

HCFA previously retracted a proposal that would have compromised the patient safety of medication regimen reviews. In a proposed rule issued by the agency on May 16, 1986, HCFA contemplated changing its skilled nursing facility and intermediate care facility regulations to allow either a licensed pharmacist or a registered nurse to conduct these reviews. In the preamble to the final rule, published in the Federal Register on June 15, 1987, HCFA noted that it had received 100 comments on this aspect of its 1986 proposal, all of them opposed to allowing nurses to conduct drug reviews. The argument used in most of the comments was "that nurses are not equipped by their training and experience to perform drug regimen reviews and that they do not have sufficient time to perform them in the course of their duties." In its final rule, HCFA agreed that only pharmacists should conduct drug regimen reviews in skilled nursing facilities and intermediate care facilities because "the commenters have persuaded us that the proper conduct of these reviews can best be assured by requiring that a pharmacist perform them." The same argument holds true in hospitals. 

HCFA must recognize that there are many other patient outcomes that are improved through the interventions of hospital pharmacists that should be considered, in addition to safety outcomes. These include therapeutic outcomes, patient satisfaction outcomes, economic outcomes, and quality of life outcomes. For your information, we have attached a compilation of the most pertinent literature on studies delineating pharmacist involvement in improving patient outcomes. You will have also received comments from many ASHP members who are concerned about the proposed revisions in the "Pharmaceutical Services" section of the hospital COPs. Their comments are replete with personal and institutional examples of how pharmacists' involvement in the medication-use process improves patient outcomes. We urge you to carefully and thought-fully consider these comments and the successes these pharmacists have had in improving patient outcomes when you develop a final rule on the COPs. 

To summarize, ASHP believes that HCFA should retain in the hospital COPs the requirements currently in 42 CFR 482.25(a) that a pharmacist must be responsible for developing, supervising, and coordinating the activities of the hospital's pharmacy services and that the pharmaceutical service must have an adequate number of personnel. In addition, we believe that HCFA should add to this section the requirement that a pharmacist should be available in a hospital 24 hours a day. And we urge HCFA to require that the director of the pharmacy service in hospitals be a graduate of an accredited residency pharmacy training program or have comparable experience. 

HCFA should also retain the requirements in the current "delivery of services" standard in 42 CFR 482.25(b) that the agency proposes to delete in the revision of the hospital COPs. 

The System is Essential for Quality Medication Use 

Formulary HCFA proposes to delete the requirement in the "delivery of services" standard in current 42 CFR 482.25(b) that "formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs." The agency argues that a formulary "is a cost control and quality mechanism. We do not think it would be a wise investment of survey agency time to pursue this cost control mechanism through enforcement of the COPs, since current efforts at cost controls and an emphasis on managed care will probably be far more effective at constraining drug costs in hospitals." 

Prior to 1986, the hospital COPs required that hospitals maintain a "formulary or list of drugs." When HCFA revised the hospital COPs in 1986, the agency accepted a suggestion that "formformularyulary or drug list" be changed to "formulary system" because the agency was convinced that such a system was an effective method to "assure quality pharmaceuticals at reasonable cost." 

That suggestion came from ASHP. We argued then, and we are still convinced, that a formulary system should be required in all hospitals. We are not referring to a formulary or drug list, which is merely a compilation of drugs used in the hospital, and whose development involves no objective assessment of how any of the included drugs contribute to rational drug therapy. A formulary system, as defined in ASHP's "Statement on the Formulary System" (a copy was attached to this letter) is a "method whereby the medical staff of an institution, working through the pharmacy and therapeutics committee, evaluates, appraises, and selects from among the numerous available drug entities and drug products those that are considered most useful in patient care." 

Formulary systems have been used for over five decades and are universally accepted in hospitals of all sizes as a means for overseeing all facets of the medication-use process -- not simply cost containment. Health systems need a process in place that continuously monitors the growing body of information about both the desired and undesired effects of medications and translates that information into operational policies for the physicians, pharmacists, nurses, and other health professionals participating in the hospital's medication-use process. 

A formulary system is a major tool for improving the quality of patient care and, as such, the requirement for a formulary system should be retained in the hospital COPs. 

HCFA Must Seek To Eliminate Medication Errors 

While we applaud HCFA's goal in the proposed hospital COPs to reduce medication errors, we believe that the COPs, as currently proposed, unfortunately would (1) stimulate a heightened fear of revealing medication errors and (2) create the impression that HCFA implicitly sanctions a certain level of errors. Ironically, both of these outcomes would ultimately interfere with the ongoing monitoring and improvement of medication safety in hospitals. We strongly believe that an alternative approach should be taken. 

We are especially concerned about the fixed 2% threshold for medication errors in the current proposal. Experience has made it very clear that minor errors should never be considered negligible. Most serious errors, upon analysis, have been shown to be the result of a confluence of underlying circumstances and smaller errors. We know of no other area of public safety in which a specific rate of errors is officially allowed. The public expects error-free or fail-safe health care. Therefore, the establishment of any fixed, allowable rate of medication errors by HCFA suggests an official tolerance for errors that is unwise. 

We believe that the elimination of medication errors must be the common aim of practitioners, hospitals, and HCFA. We also believe the COPs should focus especially on the prevention of errors. Last month (March 1998) the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry submitted its final report to President Clinton. Chapter 10 of that report, entitled "Reducing Errors and Increasing Safety in Health Care," noted that "Current systems to reduce or prevent errors in the provision of health care services tend to focus too much on individual practitioners and not enough on system problems. The Commission is recommending steps to improve error reporting and focus on determining the causes of errors." ASHP believes that HCFA's hospital COPs should be similarly focused. 

We urge HCFA to take advantage of the well-documented research findings, experience, and insights that have been developed on this subject and to adopt an alternative, five-point approach that would address both prevention and active follow up of serious errors in hospitals. We believe this approach could be reflected in the COPs and easily reviewed to assess a given hospital's compliance: 

1. Adoption of a standardized definition of medication errors. The COPs should specify that all sites use a common definition of medication errors.

    • Common definitions for medication errors are not used across all hospitals. Even in published research studies, consistent definitions are not used. We would be pleased to collaborate with HCFA in crafting a definition that has the support of experts in medication error prevention. 
    • Inspectors could readily determine whether hospitals are using the standard definition. 

2. Measuring and following up on medication errors. Every hospital should have an effective, ongoing process for monitoring, documenting, analyzing, and following up on medication errors. Documentation of root-cause analyses of serious errors should be readily accessible and available. The exact methodologies used for these tasks by a hospital should remain flexible. The important things for inspectors to judge are whether the processes exist and how effective they are, especially with respect to follow-ups. Clear documentation of actions to improve performance, secondary to serious errors, should exist and be readily demonstrable to inspectors in every hospital. 

3. Periodic, interdisciplinary analysis of medication-use safety. All hospitals should conduct and document periodic interdisciplinary analyses of the safety aspects (and the error potentials) of their medication-use processes. 

  • HCFA should foster the realization that safety must be consciously designed into medication-use processes and that every medication-use system is inherently designed to produce exactly the performance that it actually delivers. In other words, the prevalence of errors is largely a product of systems design. 
  • "Periodic" could be specified as annual or biennial, for example. 
  • "Interdisciplinary," at a minimum, should mean the involvement of prescribers, pharmacists, and nurses. Others should be involved as needed -- for example, risk managers and other medication handlers (such as respiratory therapists). 
  • All phases of medication use should be addressed, including prescribing, preparation, dispensing, distribution, and administration to patients. 
  • Documented records of such analyses should be available to inspectors, who could judge whether the hospitals are truly engaged in this activity on an ongoing basis. 

4. Identification of the inherently most hazardous aspects of medication use. Every hospital should develop and maintain a list of the medications and the medication-use processes that they judge as inherently most risky. An interdisciplinary team of physicians, pharmacists, and nurses should develop this list. For these medications, hospitals should have current policies and procedures that are developed in an interdisciplinary manner and are periodically actively reviewed with all appropriate staff. The lists and documentation of these activities should be available for inspectors, who could judge whether the hospital is engaged in this safety-focused activity on an ongoing basis. 

5. Reporting serious medication errors. The COPs should encourage every hospital to report serious errors to existing voluntary national medication error reporting programs. 

  • Much can be learned from others' experiences with medication errors, and such national reporting will enable the compilation of such needed information.      
  • The final report of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry noted that efforts toward "developing a non-punitive error-reporting system to better identify needed improvement" in reducing errors were needed, and the commission called for "interested parties to work together to develop a health care error reporting system to identify errors and prevent their recurrence. Efforts ... to focus on identifying and reducing errors show great promise and need to be expanded."
As a closing thought, we urge HCFA to be extremely cautious about judging the current overall rate of medication errors in hospitals. In its proposed rule, HCFA cited several scientific and professional articles to support its conclusions about overall rates. We must observe, however, that while each of these studies and reports was sound in its own context and using its own operational definitions of medication errors, and while each of these has added importantly to the evolving knowledge on this subject, we simply do not know yet what the real prevalence of medication errors is across all hospitals or other health-care settings.

Health care professionals must focus on what is important in preventing medication errors. Simply tracking the medication rate precisely -- through a 2% error rate target -- is less important than putting into place a mechanism, such as JCAHO's Sentinel Event policy, to respond appropriately to problems in the medication-use process. That response would include a thorough root-cause analysis, implementing improvements to eliminate medication errors, and monitoring the effectiveness of those improvements. 

Further, judging the seriousness of outcomes from errors is not always possible based on observation reports. An inspector's observation of errors might seem to get around the problem of inadequate reporting. However, if safety is the goal, then to be comprehensively effective, that approach would have to be applied to all phases of the medication-use process -- prescribing, drug preparation, dispensing, and administration -- to encompass drug related problems such as improper drug selection, subtherapeutic dosage or overdosage, drug interactions, etc., rather than limiting the observation to errors of transcribing, dispensing and administration as proposed in the COP revision. Further, all of these phases include cognitive steps at which errors might occur but which do not lend themselves to observation. Also, to be statistically defensible, such an approach would have to consist of observation of more events than time will allow during a typical inspection visit. 

Pragmatically, before the prevalence of medication errors can be determined -- and before HCFA should form public policy on a medication error threshold -- we will need a greater consensus on the definition of medication errors and their standards of measurement. Expanded research efforts on both of these matters is underway through various groups. ASHP is prepared to advise HCFA on the public policy implications of the findings of research in the field of medication error prevention. 

Additional Comment 

Section 482.35(b)(1) of the proposed revision reads, in part: "...all drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1976 must be stored in locked compartments within secure storage areas." This proposal is in direct conflict with current Drug Enforcement Administration regulations in 21 CFR 1301.75(b), which state: 

Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances [emphasis added].
To avoid confusion among hospital personnel, as well as among various inspection groups who might visit a hospital and find conflicting procedures for storing controlled substances, HCFA must reconcile its proposed COP standard with current DEA regulations.


ASHP believes that the proposed revisions to the "Pharmaceutical Services" standard of the hospital COPs pose a serious threat to patient care and patient safety and, therefore, are unacceptable. We know that other health professional organizations and their individual members have also raised major concerns with other standards in the COPs. We encourage HCFA to withdraw the proposed rule and meet with the appropriate health professional organizations to develop COPs that are more in keeping with modern health care practices, processes, and goals. 


Henri R. Manasse, Jr., Ph.D., Sc.D.
Executive Vice President and Chief Executive Officer