Proposed Changes to Medicare COPs

Department of Health and Human Services

Medicare and Medicaid Programs; Hospital Conditions of Participation;
Provider Agreements and Supplier Approval; Proposed Rule

[[Page 66726]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 416, 482, 485, and 489

[HCFA-3745-P]
RIN 0938-AG79

Medicare and Medicaid Programs; Hospital Conditions of Participation; Provider Agreements and Supplier Approval

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Proposed rule.

DATES: Comments will be considered if received at the appropriate address, as provided below, no later than 5 p.m. on February 17, 1998.

ADDRESSES: Mail written comments (one original and three copies) to the following address:
Health Care Financing Administration
Department of Health and Human Services
Attention: HCFA-3745-P
P.O. Box 7517
Baltimore, MD 21207-0517.

If you prefer, you may deliver your written comments (one original and three copies) to one of the following addresses:

Room 309-G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201,

or

Room C5-09-26, Central Building
7500 Security Boulevard
Baltimore, MD 21244-1850.

Because of staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commenting, please refer to file code HCFA-3745-P. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 309-G of the Department's offices at 200 Independence Avenue, SW, Washington, DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: (202) 690-7890).
      For comments that relate to information collection requirements, mail a copy of comments to: Office of Information and Regulatory Affairs
Office of Management and Budget
Room 10235, New Executive Office Building
Washington, DC 20503, Attn: Allison Herron Eydt, HCFA Desk Officer.
      Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1530 or by faxing to (202) 512-2250. The cost for each copy is $8.00. As an alternative, you can view and photocopy the Federal Register document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the Federal Register.

FOR FURTHER INFORMATION CONTACT: Frank Emerson, (410) 786-4656, Doris Jackson, RN, (410) 786-0095, Rachael Weinstein, RN, (410) 786-6775.

SUPPLEMENTARY INFORMATION:

I. Introduction

      As part of the President's and Vice President's regulatory reform initiative, the Health Care Financing Administration (HCFA) is committed to changing current regulations that focus largely on requirements for measuring procedural standards. One of HCFA's key initiatives in Reinventing Government (REGO) is to revise many of its conditions of participation (COPs) to focus on outcomes of care and to eliminate unnecessary procedural requirements. HCFA is working in partnership with the rest of the health care community to institute better, more commonsense ways of operating. On March 10, 1997 we published a proposed rule (62 FR 11004) that includes revisions for COPs for HHAs. Within the coming year, HCFA plans to propose revisions to the COPs for hospitals and end stage renal disease (ESRD) facilities and also to mount additional research in the area of ESRD to provide the basis for future changes. What these efforts have in common is

1. Reinventing Government (REGO) Initiative
      To meet our REGO commitment, we are focusing on an approach for all sets of COPs that are:
      Transitional toward a patient outcome based system.
      Intended to stimulate improvements in processes, outcomes of care, and patient satisfaction.
      Patient centered.
      Supported by patient outcomes data.
      Interdisciplinary in the approach to care delivery, reflecting the team approach to health care delivery.

      The COPs generally adhere to these basic requirements, varying in some degree due to the unique environment and patient case mix of the provider type.

2. Transitional Framework
      The transitional framework for each set of COPs--
      Begins shifting the oversight focus toward patient health outcomes and away from burdensome and costly procedural requirements, restructures the traditional COPs along essential conditions centered on patient care, and reflects an interdisciplinary team approach to patient care.
      Prepares the foundation for provider adoption and use of more detailed patient outcome measures developed through private sector experience and research.
      Provides a flexible framework for incorporating better measures as they are developed and tested.

3. Structure
      The basic structure of all of the COP follows the Joint Commission on Accreditation of Healthcare Organizations' (JCAHOs) ``Agenda for Change.'' This structure involves reducing the number of conditions; focusing on comprehensive assessment and patient outcomes; and deleting, [[Page 66727]] where possible, process requirements that are not specifically mandated by the statute or believed likely to produce outcomes vital to the protection of patient safety. Each set of COPs has the same essential four conditions that reflect the cycle of patient-centered care. The essential four conditions are:
      Patient rights.
      Patient assessment.
      Care planning and coordination of services.
      Quality assessment and performance improvement.

      Each of the sets of COP requirements are tailored to specific statutory requirements, the historical context of the provider type, and the unique form of care delivery and patient case mix.4. Professional Input For each set of COP, national meetings of provider and practitioner groups and beneficiary representatives were held. Our partners in State survey agencies were also consulted about our approach and provided comments. Each proposed set of COP reflects extensive consultation with these groups. We recognize the importance of collaboration and communication with the industry and invite further comment on the proposed COP and related rules.

II. Background
A. Statutory Basis

      Sections 1861(e) (1) through (8) of the Social Security Act (the Act) provide that a hospital participating in the Medicare program must meet certain specified requirements. Section 1861(e)(9) of the Act specifies that a hospital also must meet such other requirements as the Secretary finds necessary in the interest of the health and safety of the hospital's patients. Under this authority, the Secretary has established the requirements that a hospital must meet to participate in Medicare in regulations at 42 CFR Part 482, Conditions of Participation for Hospitals.
      Section 1905(a) of the Act provides that Medicaid payments may be applied to hospital services. Under regulations at 42 CFR 440.10(a)(3)(iii), hospitals generally are required to meet the Medicare conditions of participation in order to participate in Medicaid.
      The purposes of these conditions are to protect patient health and safety and to ensure that quality care is furnished to all patients in Medicare-participating hospitals. Surveyors use the conditions to determine whether a hospital qualifies for a provider agreement under Medicare and Medicaid. Under section 1865 of the Act and 42 CFR 488.5 of the regulations, hospitals that are accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or the American Osteopathic Association (AOA) are not routinely surveyed for compliance with the conditions but are deemed to meet most of the requirements in the hospital conditions of participation based on their accreditation. (See 42 CFR part 488, Survey and Certification Procedures.)

B. Why Revise the Conditions of Participation

      The current conditions of participation (COPs) were adopted in 1986 and for the most part have not been revised since that time. They are organized according to the types of services a hospital may offer, and include specific, process-oriented requirements for each hospital service or department. Since the current conditions were developed, however, significant innovations in hospital patient care delivery systems and quality assessment practices have emerged, as evidenced by the JCAHO's recent revision of its accreditation standards and redesign of its survey process.
      Moreover, as discussed above, the revision of the hospital requirements is part of a larger effort by HCFA to bring about improvements in the quality of care furnished to Federal beneficiaries through a new approach to our quality of care responsibilities. The existing hospital COPs do not provide patient-centered, outcome-oriented standards, nor do they provide for the operation of a quality assessment and performance improvement program. Historically, we set requirements for participation in the Medicare program by establishing requirements that address the structures and processes of health care. These requirements are largely the result of professional consensus, since there are no data supporting the link between structure and process requirements and positive patient outcomes. The combination of process-oriented requirements with an enforcement approach that focuses on identifying providers that do not have the required structures and procedures in place no longer represents the best available method for assessing and improving hospital quality of care. Thus, we have concluded that significant revisions to the hospital conditions of participation are essential.

C. Transforming the Hospital Conditions of Participation

      We are committed to working with affected parties to implement revised COPs that impose the minimum burden on hospitals and allow hospitals maximum flexibility in meeting the Federal requirements necessary to fulfill our quality of care responsibilities. Thus, in developing revised conditions, we have solicited suggestions from organizations representing hospitals, practitioners, patients, and States, including distributing an informal, preliminary draft of the proposed hospital COPs to approximately 70 groups for comment. We have used those comments in the development of the revised COPs contained in this proposed rule.
      The fundamental principles that guided the development of the proposed COPs were the need to:
      Focus on the continuous, integrated care process that a patient experiences across all aspects of hospital services, centered around patient assessment, care planning, service delivery, and quality assessment and performance improvement.

      Adopt a patient-centered approach that recognizes the contributions of various skilled professionals and how they interact with each other to meet the patient's needs. Thus, we would eliminate requirements that encourage ``stovepipe'' administrative and enforcement structures.
      Stress quality improvements, incorporating to the greatest possible extent an outcome-oriented, data-driven quality assessment and performance improvement program. Thus, the new COPs would invest our principal expectations for performance in an overarching requirement that each hospital participate in its own quality assessment and performance improvement program.
      Facilitate flexibility in how a hospital meets our performance expectations, and eliminate process requirements unless there is consensus or evidence that they are predictive of desired outcomes for patients.
      Require that patient rights are assured.

      Based on these principles, we are proposing new hospital conditions of participation that revise or eliminate many existing requirements and incorporate critical requirements into four ``core conditions.'' These four COPs--Patient Rights; Patient Admission, Assessment, and Plan of Care; Patient Care; and Quality Assessment and Performance Improvement--would focus both [[Page 66728]] provider and surveyor efforts on the actual care delivered to the patient, the performance of the hospital as an organization, and the impact of the treatment furnished by the hospital on the health status of its patients. The first, Patient Rights, emphasizes a hospital's responsibility to respect and promote the rights of each hospital patient. The second proposed core COP, Patient Admission, Assessment, and Plan of Care, reflects the critical nature of a comprehensive assessment and a resulting plan of care in determining appropriate treatments and accomplishing desired health outcomes. It also would incorporate the need for a coordinated, team approach to planning care. The third proposed core COP, Patient Care, focuses on the actual delivery of care. Finally, the proposed Quality Assessment and Performance Improvement COP would charge each hospital with responsibility for carrying out a performance improvement program of its own design to effect continuing improvement in the quality of care furnished to its patients.
      In the revised COPs, we are proposing to include process-oriented requirements only where we believe they remain highly predictive of ensuring desired outcomes or are necessary to deter or prevent fraud and abuse (for example, the requirement for error-free medication administration under the pharmaceutical services COP). Far more frequently, however, we have eliminated process details from the existing requirements and instead included the related area of concern as a component that must be evaluated as part of the hospital's overall quality assessment and performance improvement responsibilities. For example, we would no longer specify that a hospital must make available to medical staff a written description of its laboratory services. However, we would continue to require that a hospital provide laboratory services needed to meet its patients' needs and would specify under the proposed quality assessment and performance improvement condition that a hospital's assessment and performance improvement program must include evaluation of its diagnostic services. The practical effect of this approach would be to stimulate the hospital to find its own performance problems, fix them, and continuously strive to improve patient outcomes and satisfaction, as well as efficiency and economy.
      We believe that the proposed COPs based on these principles reflect a fundamental change in HCFA's regulatory approach, a change that to a large extent establishes a shared commitment between HCFA and Medicare providers to achieve improvements in the quality of care furnished to their patients. The proposed COPs invest hospitals with internal responsibility for improving their performance, rather than relying on an externally-based approach in which prescriptive Federal requirements are enforced through the punitive aspects of the survey process. This change would enable HCFA and the States to focus more resources on joining with hospitals (in this case, principally non-accredited hospitals) in partnerships for improvement. It should result in fewer compliance surveys and the reduced need to threaten or take adverse actions that could jeopardize a hospital's reputation, financial viability, and participation in the Medicare and Medicaid programs.
      Yet these requirements provide the Secretary and State Medicaid agencies with more than adequate regulatory basis for compelling improved performance or termination of participation based on failure to correct seriously deficient performance that can or does threaten the health and safety of patients, or seriously impairs the hospital's capacity to provide needed care and services to patients. Under the current regulations, termination actions are initiated based on the evidence found during the survey. We foresee no changes in that regard in applying the new COPs.
      Thus, as with the current COPs, the enforceability of the proposed COPs will be rooted in the evidence found during the onsite survey when poor performance is identified and corrective action is not taken. We believe that if there is a need to seek a provider agreement termination based on the proposed COP, although a hospital may argue that its performance met the regulatory standards, HCFA will be successful at arguing that based on the evidence found during a survey the requirements of the regulation were not met. In fact, we believe the enforceability is strengthened by standards that establish outcome-oriented performance expectations. When poor performance is documented from the evidence found during a survey and compared to the performance expectations embodied in these patient-centered, outcome-oriented COPs, we believe the contrast between the poor performance identified and the performance expectation of the COP will be clear.
      We recognize that an important part of the successful implementation of these proposed regulations will depend on how effectively State and Federal surveyors are able to learn and internalize this patient-centered, outcome-oriented approach and incorporate it into the survey process. The proposed approach embodied in these regulations, in fact, parallels the approach that we have taken in survey and certification, beginning as early as 1985 (for intermediate care facilities for the mentally retarded) and 1986 (for nursing homes). In concert with the States, we have trained surveyors to develop information from the survey process that leads to conclusions about how the provider's performance has impacted--positively and negatively--on patients, especially in terms of what the patients actually experience. For example, for nearly a decade, nursing home surveyors have been trained to interview residents and family members, seeking information that contributes to their assessment of how the nursing home's performance is experienced by the residents and their families. Before the use of outcome-oriented surveys, surveyors focused almost exclusively on record reviews and observing care processes and organizational structures.
      These proposed regulations contain two critical improvements that support and extend the change to patient-centered, outcome-oriented surveys. First, the proposed regulations are designed to enable surveyors to focus explicitly on assessing outcomes of care, because the regulations would specify that each individual receive the care her or his assessed needs show is necessary, rather than requiring that certain services and processes be in place. Also, the addition of a strong, quality assessment and performance improvement requirement not only stimulates the provider to continuously monitor its performance and to find opportunities for improvement, it affords the surveyor the opportunity to assess how effectively the provider has pursued a continuous quality improvement agenda. All of these changes are directed toward improving outcomes of care and satisfaction for patients.
      We have already begun the process of identifying the tasks necessary to train surveyors and their supervisors and managers effectively in this refined, expanded approach. In addition, HCFA is implementing a new State survey agency quality improvement program that is designed to help State survey agencies increase their focus on improvement strategies in the survey and certification process. As more sources of performance data become available, we will be helping State survey agencies to learn how to use [[Page 66729]] these data effectively to target scarce survey resources and to identify and implement opportunities for improvement (e.g., reduction in falls or in nosocomial infection rates).
      The proposed COPs are designed to decrease the regulatory burden on hospitals and provide them with greatly enhanced flexibility. At the same time, the proposed requirement for a program of continuous quality assessment and performance improvement would increase performance expectations for hospitals in terms of achieving needed and desired outcomes for patients and increasing patient satisfaction with services provided. We invite public comment on this fundamental shift in our regulatory approach. We are especially interested in comments that address how HCFA could improve this approach, what additional flexibility could be provided, what process requirements are critical to patient care and safety and how well HCFA's investment in the hospital's participation in a strong continuous quality assessment and performance improvement program of their own design will achieve our intended goal of improving the efficiency, effectiveness and quality of patient outcomes and satisfaction.

D. Development of National Outcome-Based Performance Measures for Hospitals

      Before proceeding to a detailed discussion of the proposed requirements, we want to touch briefly on the prospects for standard outcome-based performance measures for hospital services. As mentioned above, HCFA is committed, through its Strategic Plan, to increasing the amount and quality of information about health care to beneficiaries, providers, plans, and the public at large. The purpose of this effort is to improve the ability of:
      Beneficiaries to make informed choices about their health care;
      Providers to improve the effectiveness and efficiency of their services, improve the outcomes of care they provide, and increase beneficiary satisfaction with their services;
      Organizations such as health maintenance organizations and insurance companies to choose providers, and evaluate and improve the performance of providers with which they contract; and
      The public to know more about the availability and quality of health care services in their communities.

      Through various initiatives, such as the Consumer Information Program's mammography screening initiative, HCFA is implementing its broad-based information strategy. A strong quality assessment and performance improvement (QAPI) requirement in the proposed hospital conditions of participation, as well as similar requirements in proposed HHA, hospice, and ESRD conditions, is intended to stimulate providers to develop and use a wide variety of information and data, from internal and external sources, to inform their improvement efforts. We go into more detail on this and industry efforts to implement QAPI later in the discussion on the QAPI conditions in section II.B.5 of the preamble.
      We have proposed requiring that HHAS and we are contemplating requiring that ESRD facilities report certain standard core data to HCFA to serve as the basis of a national performance measures data base, which could then be used for provider improvement, consumer information and other purposes. We are able to suggest this for HHAs and ESRD facilities because extensive work has been done on performance measures in both areas. However, with hospitals the challenge is greater and sufficient similar work has not been done on hospital measures, as described later in section II.B.5 of this preamble (Sec. 482.25), that could produce common agreement on measures that would be acceptable for use on a national basis.
      Therefore, we have decided not to include in the hospital COPs any requirement for hospitals to collect and report certain standard data items (for example, nosocomial infection rates, medication errors, reports of falls and other injuries, restraint use, various patient characteristic data elements, etc.) that could produce quality of care predictors in the future. Although we eventually intend to move in that direction in hospitals, we do not believe it is reasonable to establish any related requirements at this time, in view of the lack of any current consensus or science that could establish a reliable and valid set of measures.
      However, we invite comments from the public in response to the following questions:
      1. Should HCFA (either separately or in a public/private partnership of some sort) assume a leadership role in developing and implementing hospital-based performance measures that would serve as the basis of a national quality assessment and performance improvement data base?
      2. If so, how should HCFA proceed to develop and implement this system?
      3. If HCFA does not assume a leadership role in this area, individual hospitals invest in the development of multiple systems, and those systems are later superseded by a single required system, would the overall burden be greater than if a single system had been imposed at the outset? 4. If HCFA does not assume a leadership role in this area and individual hospitals adopt multiple systems that produce nonstandardized data, to what extent would it be difficult or impossible to use these data to make comparisons between hospitals?
      5. Should HCFA require or encourage hospitals to use the standardized measures that some accredited hospitals are using? The advantage would be that hospitals using such standardized choices would not have to develop their own measures and their results could be compared to other hospitals with similar characteristics. Examples include:
           (1) Number of days from initial surgery to discharge for patients undergoing isolated coronary artery bypass graft procedures; and
           (2) time from the emergency department arrival to procedure for trauma patients undergoing specified abdominal surgical procedures.
      6. Would it be appropriate for HCFA to include any ``placeholder'' language in the revised COPs concerning the eventual need for hospitals to report relevant data, or is this premature?
      7. If HCFA should include placeholder language, what changes should we make to these proposed requirements to set the stage for the development and implementation of such a system?

      Even without a performance measure-based national system, we expect hospitals to develop and use their own measures and other available external information to inform their own quality assessment and improvement programs, and to participate in any external quality improvement programs (such as a national program to reduce the use of inappropriate psychoactive medications in hospitals) as the Secretary may direct.

II. Provisions of the Proposed Rule

A. Overview

      Under our proposal, the hospital conditions of participation would continue to be set forth in regulations under 42 CFR part 482. However, since the majority of the existing requirements in part 482 would be revised, consolidated with other requirements, or eliminated, we are proposing a complete overhaul of the organizational scheme. The most significant change would be our proposal to group together all COPs directly related to patient care in Subpart B, Patient Care Activities. Then, in Subpart C, Organizational [[Page 66730]] Environment, we would group together those organizational activities the hospital must perform to support the delivery of patient care. We believe that this proposed format would embody the patient-centered focus of our proposed changes, emphasizing the continuous, integrated care processes that a patient experiences across all aspects of the hospital environment. Also, because functions and processes for delivering patient care often require interdisciplinary teamwork involving many hospital departments and services, the proposed regulations would incorporate a functional framework for the COPs rather than maintaining a stovepipe approach that gives the appearance that patient care activities can occur in isolation.
      The complete proposed new organizational format for part 482 is as follows:

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

Subpart A--General Provisions

      482.5 Basis and scope.
      482.10 Condition of participation: Patient rights.

Subpart B--Patient Care Activities

      482.15 Condition of participation: Patient admission, assessment, and plan of care.
      482.20 Condition of participation: Patient care.
      482.25 Condition of participation: Quality assessment and performance improvement.
      482.30 Condition of participation: Diagnostic and therapeutic services or rehabilitative services.
      482.35 Condition of participation: Pharmaceutical services.
      482.40 Condition of participation: Nutritional services.
      482.45 Condition of participation: Surgical and anesthesia services.
      482.50 Condition of participation: Emergency services.
      482.55 Condition of participation: Discharge planning.

Subpart C--Organizational Environment

      482.110 Condition of participation: Administration of organizational environment.
      482.115 Condition of participation: Infection control.
      482.120 Condition of participation: Information management.
      482.125 Condition of participation: Human resources.
      482.130 Condition of participation: Physical environment.
      482.135 Condition of participation: Life safety from fire.
      482.140 Condition of participation: Blood and blood product transfusions.
      482.145 Condition of participation: Potentially infectious blood and blood products.
      482.150 Condition of participation: Utilization review.

Subpart D--Requirements for Specialty Hospitals

      482.155 Special provisions applying to psychiatric hospitals.
      482.160 Condition of participation: Special medical record requirement for psychiatric hospitals.
      482.165 Condition of participation: Special staff requirements for psychiatric hospitals.
      482.170 Special requirements for hospital providers of long-term care services (``swing-beds'').

      We note that although we are proposing no changes to the requirements for specialty hospitals, the existing requirements would be redesignated numerically to accommodate the proposed changes to the preceding COPs.

B. Discussion of Proposed Conditions

Subpart A--General Provisions

1. Basis and Scope (Sec. 482.1)
      We are proposing to add a new paragraph (a)(6) to the statutory basis section for part 482 that sets forth, under section 1138 of the Act, requirements for hospital protocols for organ procurement and standards for organ procurement agencies' agreements with hospitals for organ procurements. This provision will further the authority governing organ procurements.

2. Patient Rights (Sec. 482.10)
      Under section 1861(e)(9) of the Act, an institution may be recognized by Medicare as a hospital only if, in addition to meeting the specific requirements in the preceding sections of that provision, it meets such other requirements as the Secretary finds necessary in the interest of patient health and safety. In our view, patient health and safety cannot be protected simply by avoiding obvious risk factors such as poor infection control practices or inadequate nurse staffing (as documented in recent literature on the effects of Nursing on patient outcomes such as morbidity, mortality, length of stay, and cost--see Keeler, E., et al., ``Hospital Characteristics and Quality of Care,'' JAMA 268 (1992): 1709-1714.; and Krakauer, H., et al., ``Evaluation of the HCFA for the Analysis of Mortality Following Hospitalization,'' Health Services Research 27 (1992): 317-335). Patient rights dealing with freedom from physical or verbal abuse, harassment, or inappropriate restraints are examples of direct protections of patients' physical and emotional health and safety. In addition, patients' successful recoveries from illness or injury depend on many factors related to their psychological and emotional health, including their general feeling of well-being. Because of the importance of these psychological and emotional factors, we believe patient health and safety can be protected adequately only if patient care is delivered in an atmosphere of respect for the individual patient's comfort, dignity, and privacy.
      This view is shared by other parties involved in the development of these conditions of participation, many of whom expressed strong support for the inclusion of specific provisions addressing patient rights. Therefore, we propose to set forth a new condition of participation that would recognize explicitly that a hospital must protect and promote certain patient rights.
      The proposed condition is composed of five standards. The first proposed standard would require that a hospital inform each patient of his or her rights in advance of furnishing care. It also would require that a hospital have a grievance process and must indicate who a patient should contact if he or she desires to express a grievance. We are not proposing a specific method as to how a hospital should notify each patient of his or her rights, or establishing structural or procedural expectations about how a hospital's patient grievance process should be set up. Instead, we believe each hospital should implement a patient rights policy that reflects its specific manner of operations and minimizes administrative burden, as long as the hospital meets the underlying expectation that it informs patients about their rights and about whom to contact when patients believe these rights have been violated.      The remaining four proposed standards under the patient rights condition would establish a minimum set of required patient rights. In developing these provisions, we closely examined the regulations concerning patient rights for other provider types, such as nursing homes and HHAs. Because the nature of patient care varies among provider types, we are proposing only those patient rights that we believe are appropriate and necessary in the hospital setting. Based on the strong support from all parties involved in the development of these proposed hospital conditions, we are proposing that a patient should have the following rights:
      The right to be informed of his or her rights, to participate in the development and implementation of the individual's plan of care, and to make decisions regarding that care. [[Page 66731]]
      The right to formulate advance directives and to have those directives followed.
      The right to privacy and to receive care in a safe setting.
      The right to be free from verbal or physical abuse or harassment.
      The right to confidentiality of his or her clinical records.
      The right to access information contained in his or her clinical records within a reasonable time.
      The right to be free from the use of seclusion and restraints as a means of coercion, convenience, or retaliation by staff. If seclusion or restraints are used (including psychopharmacological drugs used as restraints) they must be used in accordance with a patient's plan of care and may be used only as a last resort and in the least restrictive manner possible, to protect the patient or others from harm. Restraints must be removed or seclusion ended at the earliest possible time.

      We believe these proposed patient rights are clearly necessary in the interest of patient health and safety and are for the most part self-explanatory. We note that the rights concerning advance directives are tied directly to the statute (section 1866(f) of the Act), and the hospital's responsibilities in these areas are more fully described in other sections of the regulations (see existing Sec. 489.102). However, we believe it is appropriate to reference advance directives in the proposed patient rights section, consistent with the reference to advance directives in the patient rights sections of the existing regulations for both nursing homes and HHAs.
      We considered proposing a specific time period within which a hospital would be required to provide access to requested medical records under proposed Sec. 482.10(d)(2), but concluded that the proposed requirement that a hospital provide access to such information within a ``reasonable'' time is more feasible. If a former patient requests access to 3-year-old closed medical records, which could be in storage, a ``reasonable'' time to retrieve them likely would be longer than if the spouse (with appropriate power of attorney) of an inpatient requests to see the medical records of her or his spouse who is still in the hospital. In the former case, a ``reasonable'' time might be measured in days, whereas it could be hours in the latter example. Thus, we believe that ``reasonable'' must be defined in terms of the individual circumstances. Most important, we believe that ``reasonable'' means that the hospital will not frustrate the legitimate efforts of individuals to gain access to their own medical records and will actively seek to meet those requests as quickly as its recordkeeping system permits. If a hospital receives complaints from patients or their legal representatives about delays in gaining access to properly requested records, we would expect that the hospital would both respond quickly to resolve the complaints and consider the complaints as an opportunity for improvement as part of its quality assessment and performance improvement program. In summary, we believe that the use of the word ``reasonable'' sets the proper performance standard for the hospital without imposing an arbitrary burden, while at the same time enabling surveyors to take action if a hospital is systematically frustrating legitimate efforts to gain access to medical records. We welcome comments on the appropriateness of our decision not to propose any specific timeframe for providing access to a patient's records.
      We also strongly considered expanding the proposed patient rights provisions (or establishing separate requirements) to provide further detail related to a patient's right to be free from seclusion or restraints. We recognize that the use of restraints or seclusion has the potential to produce serious consequences for a patient's health and safety, such as physical and psychological harm, loss of dignity, violation of civil rights, and even death. Thus, our expectation is that a hospital would impose restraints or seclusion only when absolutely necessary to prevent immediate injury to the patient or others and when no alternative means are sufficient to accomplish this purpose. We also expect that when restraints or seclusion are used, the plan of care should address how and when such practices are to be employed, and patients placed under restraints or in seclusion would be released as soon as they no longer pose an immediate threat of injury to themselves or others. Although we have built these expectations into the proposed patient rights provisions, the question remains whether it would be advisable to add further, more prescriptive requirements concerning the use of seclusion or restraints. One possibility would be to incorporate into the regulations a series of specific requirements governing the use of restraints and seclusion, as detailed below:       Seclusion or restraints may only be used to the extent authorized by the signed order of a physician. Written authorization must include the date and time of the order, and the reason for seclusion or restraint. For restraint, the order must include the type of restraint(s) and the number of restraint points.
      Each order for seclusion or restraints must be in writing, must be time-limited and specify start and end times. Implementing a time-limited order does not require applying the intervention for the entire period if the patient demonstrates a reduction or change in the behavior that led to being placed in restraint or seclusion.
      A renewal order may be issued if the physician clinically assesses the patient face to face and determines that seclusion or restraint continues to be necessary to prevent injury to self or others, and there is no less restrictive method of preventing the injurious behavior.
      Orders for seclusion or restraint must never be written on a standing or as needed basis.
      Written orders for restraint and seclusion for adults must be valid for no more than 6 hours; written orders for restraint and seclusion for children and adolescents must be valid for no more than 2 hours.
      A patient in seclusion or restraint must be checked by a person trained in the use of restraints and seclusion at least every 15 minutes for comfort, body alignment, circulation, hydration, feeding, and toilet needs. A patient in seclusion or restraint must have vital signs checked a minimum of every 2 hours. Written documentation of checks must include, at a minimum, the name of the person doing the check, the date and time of the check, and the patient's condition.

      For purposes of this proposed rule, we have opted not to set forth these kinds of detailed requirements in the regulations but instead to require that a hospital achieve the intended outcome that restraints or seclusion are never imposed inappropriately, without limiting a hospital's flexibility in how it meets this requirement. However, we welcome comments on the prevalence of the use of restraints and seclusion in the hospital setting and whether the above standards, or alternative requirements, are needed to ensure patient health and safety.

Subpart B--Patient Care Activities

3. Patient Admission, Assessment, and Plan of Care (Sec. 482.15)
      The first proposed condition under proposed Subpart B, Patient Care Activities, would combine the requirements for patient admission, assessment, and care plan development in a single condition, which would be followed by a separate condition on patient care. We believe this [[Page 66732]] organization is in keeping with the patient centered orientation of these regulations and would help illustrate our view that patient assessment and planning is a prerequisite for the delivery of high quality care.
      The underlying requirements of this COP would be first that a hospital ensure that each patient receives a comprehensive assessment of his or her care needs, including an initial estimate of posthospital needs, if any, and then that the hospital establish a coordinated plan for how all relevant hospital disciplines will meet those needs. A comprehensive assessment of patient care needs is critical for planning patient care and achieving desired health care outcomes. Because patient assessment activities are performed by various disciplines within the hospital setting, coordination of the information obtained during patient assessment activities is vital to assuring a well-developed plan for meeting the patient's identified care needs. Moreover, a coordinated plan for care delivery is increasingly important in a health care environment where payment incentives encourage shorter hospital stays. We note for an assessment to be truly ``comprehensive,'' it must address all of a patient's anticipated care needs; thus, we believe it is appropriate to include a reference to posthospital needs under the proposed assessment COP. The inclusion of posthospital needs in a comprehensive assessment does not constitute an added burden on hospitals but simply reflects current, accepted practice in patient assessment activities. For example, in conducting a comprehensive assessment on a 17-year-old male with no history of medical problems who will undergo surgery to repair a fractured femur resulting from a football injury, it would be appropriate to gather information on who will be available to assist the patient at home, who is available to take the patient to follow-up medical appointments, and necessary instructions for posthospital needs (e.g., crutch walking, body positioning, medication administration, etc). (We note that, in accordance with section 1861(ee) of the Act, the proposed COPs would continue to address separately the formal discharge planning procedures required to ensure that patients receive appropriate posthospital care and services. As explained in further detail later in this preamble, we are proposing to retain the existing discharge planning COP (now codified at Sec. 482.43) and redesignate it as proposed Sec. 482.55.)
      Under the first proposed standard, ``Admission and comprehensive assessment'' (proposed Sec. 482.15(a)), we propose to retain the current flexible requirement (at existing Sec. 482.12(c)(2)) under which patients can be admitted to the hospital by any licensed practitioner allowed by the State to do so. Then, with respect to assessment, we would revise the requirement under existing Sec. 482.22(c)(5) that a physical examination and medical history be done no more than 7 days before or 48 hours after an admission. Instead, we propose to require that each patient receive a comprehensive assessment that identifies the patient's condition and care needs as well as an initial estimate of posthospital needs, if any, at the time of admission and is placed in the patient's medical record within 24 hours of admission.

      We propose to provide the hospital and medical staff the flexibility to define the content and activities of the comprehensive patient assessment. We recognize that to require, for example, that every patient have an evaluation of rehabilitation potential or nutritional status, is not necessarily appropriate. The information to be included in the comprehensive assessment would be determined by the hospital based on the characteristics and needs of the specific patient. For example, when the patient's condition or symptoms indicate possible alcohol or drug abuse, an alcohol or drug abuse assessment should be performed as part of a mental status assessment. Again, the performance expectation is that a hospital would ensure that each patient's assessment is comprehensive relative to the reason the patient is in the hospital. We do not believe it is appropriate to prescribe how a hospital meets this responsibility.
      We are proposing that the comprehensive assessment must be completed in a timely manner consistent with the patient's immediate needs and placed into a patient's medical record within 24 hours of admission. We believe that this proposed requirement sets a clear expectation for a close, effective relationship between assessment and care planning, a relationship that is essential to achieving desired health care outcomes. We view the maximum 24-hour timeframe for completion of the assessment as essential for adequate patient care and safety, since by definition a patient being admitted to a hospital is at a point of immediate need. The 24-hour timeframe should pose no burden for the well-managed hospital, since in all likelihood it would already be performing assessments within this timeframe for initial care planning and decision making purposes.
      We are also proposing a 12-hour timeframe for placement into the patient's medical record of any assessment information collected before admission to the hospital. For example, a patient may have had a health history and physical examination completed in the physician's office before admission. Allowing a copy of a previously completed health history and physical examination to be placed in the hospital records would eliminate duplication in the creation of these records, especially if the findings during the physician office visit were the basis of the admission to the hospital. Unlike under existing regulations, which permit use of a physical examination or medical history done within 7 days of a patient's admission, the proposed requirements would not establish an arbitrary limit on the use of such information. Instead, we would require that any comprehensive assessment information recorded before admission be updated to reflect the patient's condition on admission. That is, a hospital would be expected to reassess the necessity of the patient's admission to the hospital and document, as appropriate, any changes in the patient's condition at the time of admission. We believe this requirement would reduce the hospital's information collection burden without compromising patient health and safety. Because, in such a case, the history taking and physical examination activities essentially are completed before admission, we believe that 12 hours is a reasonable timeframe for placement of that assessment information into the medical record. That is, it should take the hospital less time to update the assessment information than the proposed 24-hour timeframe for a comprehensive assessment performed after admission.
      The second standard under this COP, proposed Sec. 482.15(b)(1), would require that each patient have an initial written plan of care that meets the needs identified in the comprehensive assessment and that the plan of care must be placed in the medical record within 24 hours of admission. Thus, each patient would be assured of having a comprehensive assessment and an initial care plan within 24 hours of admission to the hospital. We believe that this 24-hour timeframe for care planning is both reasonable and necessary, given the continuing decreases in average lengths of stay in hospitals.
      Presently, responsibility for a patient's plan of care is addressed under various separate COPs, including governing body, medical staff, and nursing services. In place of this [[Page 66733]] fragmented approach, we would focus on the need for coordination in care planning for hospital patients by requiring that the plan include care to be delivered by all disciplines. We would not specify which disciplines must be involved in care planning; instead, the hospital would have the flexibility to determine which disciplines should be involved based on the nature of a patient's illness or injury. Similarly, we are not proposing to require that a hospital have a single care plan that documents interdisciplinary care planning needs, but only that care planning by all relevant disciplines be included in the medical record using whatever organizational structure or format the hospital believes is appropriate.
      Under proposed Sec. 482.15(b)(2), we would require that the patient's plan of care be modified to meet any changes in the patient's condition that affects the patient's needs. We believe this requirement is preferable to a mandate that reassessments be conducted at specified time intervals on all patients. Instead, each practitioner involved in a patient's care may perform reassessments and modify the plan of care, as needed.
      We welcome comments on whether the specific proposed timeframes in the regulation text are reasonable and consistent with current medical practice and whether the timeframes should be used as benchmarks to reflect patient health and safety concerns involving the timeliness of the assessment components.

4. Patient Care (Sec. 482.20)
      Patient care activities occur in all areas and departments of a hospital. These activities are carried out by a variety of staff and licensed practitioners from the medical, nursing, pharmacy, dietetics, rehabilitation, and other departments and services. Rather than describing distinct patient care responsibilities for each service or department, we have organized these regulations to reflect the integrated way in which a patient experiences care, by establishing a single, unified patient care condition. Thus, by consolidating patient care activities into one COP, the proposed regulations would no longer support a ``stovepipe'' approach to patient care and instead foster a hospital's efforts to integrate, coordinate, and evaluate patient care in the same way as the patient experiences care in a contemporary hospital setting.
      Overall, the proposed patient care COP would require that each Medicare patient be under the care of an appropriately qualified practitioner, and that the care provided to each patient be coordinated and based on the plan of care required under proposed Sec. 482.15. The first standard under the proposed patient care COP (Sec. 482.20(a)) concerns the assignment of a practitioner responsible for each Medicare patient's care. Under this standard, we would retain, with only minor editorial changes and one substantive change (discussed below) the current requirements in Sec. 482.12(c)(1), (3), and (4). These requirements, while specific and detailed, are needed to implement section 1861(e)(1) of the Act, which defines a hospital as an institution that provides services by or under the supervision of physicians, and section 1861(e)(4) of the Act, which requires that every Medicare patient be under the care of a physician. It is necessary to implement the latter requirement in a way that recognizes the many types of practitioners who are authorized by State scope of practice laws and hospital staff bylaws to treat patients in hospitals.
      Within this standard, the only substantive change from current requirements appears at proposed Sec. 482.20(a)(1)(vi), which would permit a clinical psychologist to admit and treat patients receiving qualified psychologist services (as defined in section 1861(ii) of the Act), to the extent this is permitted under State law. This change is needed to implement a change in section 1861(e)(4) of the Act that was made by section 104 of Public Law 103-432, the Social Security Act Amendments of 1994.
      Proposed paragraphs (a)(2) and (3) of this standard restate current requirements under Sec. 482.12(c)(3) and (4) concerning the presence of doctors and their responsibilities toward patients.
      The second proposed standard, delivery of patient care (Sec. 482.20(b)), would require that each patient be provided care and treatment interventions that are coordinated by all relevant disciplines and conform to the plan of care. We then would require a hospital to evaluate the patient's progress and adjust care when appropriate progress is not being achieved. That is, in keeping with the requirement under proposed Sec. 482.15(b)(2) that the plan of care be modified as needed, we believe it is essential to include under this COP the companion requirement that actual care provided also be changed as needed, thus establishing the essential linkage between evaluation of treatment results and care plan modification.
      We also propose that patient care services are provided only on the order of qualified practitioners with delineated clinical privileges. This proposed provision is in keeping with the overall approach of the patient care COP, that is, the focus on the integration and coordination of hospital services rather than the former ``stovepipe'' approach. Thus, rather than specifying under the nutrition services COP that therapeutic diets must be prescribed by the responsible practitioner (now required under Sec. 482.28(b)(1)), we intend that such department-specific requirements would be encompassed within the hospital's overall responsibility to ensure that all patient care services be provided in accordance with the orders of qualified practitioners. So, if a surveyor finds evidence that therapeutic diets were prescribed inappropriately, the hospital could then be cited for a deficiency under this standard and, if applicable, under proposed Sec. 482.40 (Nutrition services) if the outcome of this problem was that patients' nutritional needs were not met.
      Finally, if a hospital provides care to outpatients, it would be responsible for ensuring that outpatient care meets the same quality of care requirements as inpatient care and that inpatient and outpatient services are coordinated to promote continuity of care for patients who move between levels of care. Inpatient and outpatient care should be coordinated, so that a patient does not experience any disruption of care or duplication of services simply because of a change from inpatient to outpatient status, or vice versa. We recognize that some procedures can appropriately be done only on an inpatient basis, and we do not intend to require that every service be available on either an inpatient or outpatient basis. The intent of this proposed provision is to ensure that if a service is provided in both the inpatient and outpatient settings, the level of quality in each setting is the same, so that there is a uniform level of care throughout the hospital. For example, infection control procedures and practices should be followed uniformly throughout the hospital, not merely in inpatient areas, and we would expect a hospital to investigate adverse outcomes among outpatients as thoroughly as those among inpatients. Thus, as noted below, we would expect a hospital's quality assessment and performance improvement program to encompass outpatient services, if the hospital provides those services.

5. Quality Assessment and Performance Improvement (Sec. 482.25)
      The current quality assurance condition of participation (Sec. 482.21) [[Page 66734]] relies on a problem-focused approach to identify and correct problems in patient care delivery. During the last decade, the health care industry has moved beyond the problem-focused approach of quality assurance in favor of focusing on systemic quality improvements, as evidenced by the JCAHO's overhaul of its accreditation standards over the last few years. We propose to follow suit by requiring a Medicare-participating hospital to participate in a continuous effort to improve its performance, incorporating to the greatest extent possible an approach that focuses on the hospital's performance in improving patient outcomes and satisfaction. Specifically, we are proposing a new COP that would require that each hospital develop, implement, maintain, and evaluate an effective data-driven quality assessment and performance improvement program.
      We do not propose to prescribe specific methodologies to achieve this objective, with the exception of retaining the current rule on autopsies (see below). Instead, we would specify that a hospital's quality assessment and performance improvement program should reflect the complexity of the hospital's organization and services. Thus, each hospital would be free to pursue quality improvement in a manner best suited to its individual characteristics and resources. However, every hospital would be responsible for implementing actions that result in performance improvements across the full range of the hospital's services to patients. Also, we would require that a hospital's quality assessment and performance improvement program must use objective measures that make it possible to track performance to ensure that improvements are sustained over time.
      The proposed quality assessment and performance improvement condition (Sec. 482.25) contains three standards, the first addressing the scope and direction of the performance improvement program, the second on responsibility for the program, and the third on autopsies. The first proposed standard would require that a hospital's quality assessment and performance improvement program include the use of objective measures to evaluate performance changes and would delineate the minimum items that must be included in the hospital's program. Specifically, we would require that a hospital objectively evaluate the following areas that we believe are critical to hospital performance: Access to care; patient satisfaction; staff, administrative, and practitioner performance; complaints and grievances; diagnostic and therapeutic services provided; medication error incidents, achievement of drug therapy goals, and incidents of adverse drug effects; nutritional services, including, if applicable, patient's responses to therapeutic diets and parenteral nutrition; surgery and anesthesia services; safety issues, including infection control and physical environment; emergency services (if provided); discharge planning activities; and the results of autopsies. We included the first 11 items as the minimum elements of the performance improvement program because we believe they comprise the fundamental building blocks of a well-managed hospital, whose primary business is achieving desired outcomes for patients and ensuring their satisfaction. We are proposing the twelfth item, ``results of autopsies,'' because we believe that autopsies can be an important source of information to both individual practitioners and hospitals that can point to opportunities for improvement in both practitioner and hospital performance. We are asking for comments on the minimum content of the Quality Assessment and Improvement Program as well as the twelve elements that are part of the Whole Quality Assessment standard.
      The next standard (proposed Sec. 482.25(a)(2)) would then state that for each of the areas listed above, and any others the hospital includes, the hospital must measure, analyze, and track quality indicators or other aspects of performance that the hospital adopts or develops that reflect processes of care and hospital operations. These measures must be shown to be predictive of desired outcomes or be the outcomes themselves. As explained below, we also would require a hospital to use hospital-specific data, as well as Peer Review Organization (PRO) and other relevant data, in its quality assessment and performance improvement strategy.
      Again, when we use the word ``measure,'' we mean that the hospital must use objective means of tracking performance that enable a hospital (and a surveyor) to identify the differences in performance between two points in time. For example, we would not consider a hospital's subjective statement that it is ``doing better'' in a given performance area as a result of an improvement process to be an acceptable measure. There must be identifiable units of measure that any reasonably knowledgeable person would be able to distinguish as evidence of change. Not all objective measures must have been shown to be valid and reliable (that is, subjected to scientific development) to be useable in improvement projects, but they must at least identify a start point and end point stated in objective terms, most often, numbers, that actually relate directly to the objectives and expected/desired outcomes of the improvement project.
      We do not believe it is feasible at this time to propose that a specific set of quality indicators or objective performance measures be used. However, systematic collection and analysis of quality indicators or performance measures that each hospital identifies should foster the eventual development of a data-driven system of hospital indicators. Many hospitals are already very active in this area. We recognize that collection and analysis of clinical outcome data may represent an increased burden on some hospitals, particularly on the subset of hospitals that are routinely subject to HCFA's survey process. These non-accredited hospitals typically are smaller than JCAHO-accredited hospitals, are located in more sparsely populated areas, and may not have the resources for extensive data gathering and reporting. However, rather than mandating specific performance measures, we would allow each hospital the flexibility to identify its own measures of performance for the activities it identifies as priorities in its quality assessment and performance improvement strategy. With this in mind, we believe the proposed quality assessment and performance improvement condition would lay the foundation for specific hospital quality indicators that might be developed by consensus in the future.
      We anticipate that hospitals, both large and small, rural and urban, will or already use a variety of performance measures to inform their internal quality assessment and performance improvement programs. Some of these measures may be designed by the hospital itself, while others will be developed through research or by consensus groups or other sources outside the hospital. Regardless, HCFA intends, through its survey process, to assess the hospital's success in using performance measures principally in terms of whether the hospital can demonstrate with objective data that sustained improvements have taken place in: (1) Actual care outcomes, patient satisfaction levels, or other performance data, and/or (2) processes of care and hospital operations that are predictive of improved outcomes of care and satisfaction for patients. HCFA does not intend and would not be in a position to judge the measures themselves; instead, we would assess [[Page 66735]] their utility for the hospital in its own efforts to improve its performance.
      While we recognize that there is no single system available for the measurement of a hospital performance, we are also aware of efforts in the hospital industry to find ways to increase the use of intra- and inter-hospital performance measurement systems. For example, under programs called ORYX and ORYX PLUS JCAHO plans to require hospitals to use a defined number of performance measures that evaluate care to a percentage of patients in an initiative to integrate performance measures with the accreditation process. Initially, we understand these programs set forth an initial framework for evaluating a wide range of performance measurement systems. The specific attributes of the measurement systems that will be evaluated include: the performance measures and data elements (how they focus on processes and/or outcomes related to patient care and organizational performance); the construction of the database; the quality of the database; the extent of risk adjustment/stratification for patient factors; performance-related feedback; and the relevance of the performance measurement system for accreditation.
      Under this proposed rule, we would require a hospital to engage in a quality assessment and performance improvement program that uses objective measures, but we are not proposing that a hospital be required to participate in a system of performance measurement with other hospitals. However, we intend to develop such a requirement for inclusion in our final rule, and welcome public comments addressing the appropriateness of such a requirement or how it could best be structured. For example, one possibility is that the final rule would set forth the requirement as suggested above, and would include the evaluation criteria for the system or systems the hospitals might use. We do not envision that we would require the use of a specific system. Again, we are not proposing any specific provisions at this time, but we invite comment on whether HCFA should require non-accredited hospitals to participate in one or more performance measurement systems as part of their overall quality assessment and performance improvement program (both internally and externally).
      Example of a quality improvement project. HCFA wants to assure hospitals, particularly smaller, more rural hospitals, that our expectations for the use of performance measures are commensurate with the size and resources available to the hospital. Powerful improvement programs can be and are often premised on simple, straightforward designs, using measures that are direct and uncomplicated. For example, a hospital might collect information on a routine, sampled basis about the rate of utilization of psychoactive medications that are initiated during a hospital stay, when none were used by the patient prior to hospitalization. This data collection could be a part of the hospital's quality assessment and performance improvement program associated with the proposed drug management requirements (proposed Sec. 482.35(b)). The data could be collected manually or electronically and could be analyzed by case mix, age, physician specific prescribing patterns, the shift most likely to request medication orders, etc. This data would fulfill our requirement that it be an ``objective measure'' because the unit of measure in this example is the number of patients for whom psychoactive medications are prescribed after admission. If this data is taken for 1 month as a start period, and taken again 6 months later as an end period, the differences in the number of patients for whom psychoactive medications were prescribed after admission (both increase and decrease) would inform the hospital staff responsible for this project how well (or poorly) their intervention plan worked.
      The hospital's quality assessment and performance improvement team could then use that data to design a specific improvement project, implement it, and continue to collect data to demonstrate, in a nonstatistical way change over time (for example, a steady reduction in orders for psychoactive medications during a hospital stay). The performance measures for a project like this are immediate and simple to collect, and well within the reach of any hospital. Hospitals that have more resources could be expected to produce more sophisticated measures that involve more complicated issues, but the key expectation of these requirements is that the hospital make an aggressive and continuous effort to improve its performance across the board. HCFA is more interested in the outcomes of such an effort than in the specific processes the hospital uses to achieve the performance improvements. We recognize that: (1) There is not yet a wide menu of available performance measures that have been shown to be reliable and valid that could be offered to a hospital to use to meet these requirements; (2) a hospital cannot control many related nonpatient care outcomes (such as substance abuse practices of the patient, or lack of adequate support systems to ensure lasting positive outcomes from the hospital stay, etc.); and (3) many hospitals will need more experience with data collection methods and in the design implementation and monitoring of improvement projects. However, experience in many hospitals, other health care providers, and business and industry in general has shown convincingly that creating an expectation for continuous improvement is a far more powerful performance incentive than maintaining a set of process and structural requirements.
      Therefore, we want to stress that our emphasis at this time is on the improvement of processes. The process of improvement entails: (1) Identification of an organization's critical patient care and services components; (2) application of performance measures that are predictive of quality outcomes that would result from delivery of the patient care and services; and (3) continuous use of a method of data collection and evaluation that identifies or triggers further opportunities for improvement. We do not intend for hospitals to collect data from performance measures for the sake of meeting a regulatory requirement. The hospital must have the flexibility to identify the processes targeted for improvement based on the unique needs and priorities of the facility and its patients. Moreover, we would expect the processes targeted for improvement to change over time as the hospital makes the necessary improvement efforts.
      As stated by W. Edwards Deming, the late quality management expert, ``* * * quality comes from * * * improvement of process(es)'' and the degree to which improvement occurs is measured through analysis of collected data. (Katz, Jacqueline, Managing Quality, St. Louis: Mosby Year Book, 1992, p. 122). Likewise, the intent of this requirement is that each hospital will engage in improvement activities, based on its own analysis of data, that improve care outcomes and patient satisfaction and lead to greater efficiency and economy of operation.
      How to Measure Hospital Quality Improvement Efforts--Options for Establishing a Required Minimum Level of Improvement Projects Per Year. As the preceding discussion illustrates, even small, rural hospitals and those without sophisticated ``research'' capabilities can develop and manage effective quality assessment and [[Page 66736]] improvement programs that demonstrate sustained improvement over time. However, we are concerned that some hospitals may make token efforts to meet this requirement, efforts that are aimed primarily at avoiding adverse enforcement action resulting from a survey, rather than at improving processes and outcomes of care and satisfaction for patients. Thus, depending on the comments we receive, we intend to develop for the final regulation a requirement that a hospital engage in a minimum number of improvement projects that are based upon the hospital's own quality assessments of its performance and that show measured, sustained results that actually benefit patients.
      We are not proposing specific language in the regulation text at this time because we recognize there are many ways in which a minimum level of effort can be set.
      We are inviting comment not only on the advisability and necessity of such a requirement, but also on the best approaches to achieve this minimum level of effort. At a minimum, we would require under the quality assessment and performance improvement condition of participation that the number of distinct successful improvement activities to be conducted annually must be proportional to the scope and complexity of the hospital's program. The success of the activity would be measured in terms of demonstrated sustained improvement over time. We intend to then supplement this underlying requirement with a more precise explanation of what would be expected of each hospital. Among the possible alternatives that we are considering are the following:
      (1) Require the hospital to engage in a specific number of improvement projects equal to not less than 1 project per 1,000 patient discharges.
      (2) Require a minimum set number of projects (e.g., five) that are hospital-wide and most broadly affect patient outcomes and satisfaction.
      (3) Require a minimum set number of projects (e.g., five) that are not hospital-wide, but that are developed and implemented in various areas of the hospital's range of care and services (e.g., one project might reduce waiting time in the emergency room, another might focus on improving the accuracy of medication administration, etc.).
      (4) Require a minimum number of projects based on bed-size, rather than discharges (e.g., 8 projects in a 600-bed hospital, 2 in a 50-bed hospital).
      (5) Rather than requiring a minimum number of projects, require the hospital to demonstrate (e.g., to the PRO and/or survey agency) what projects they are doing and what progress is being achieved.
      (6) Again, rather than specifying minimum number of projects, establish a minimum set of types of projects that must be done (e.g., hospital operational processes that are predictive of positive outcomes, such as infection control measures, or condition-specific projects that improve certain clinical outcomes, such as emergency room responses to heart attack patients).
      We are certain there are many other ways to approach the ``minimum effort'' discussion. The examples noted above illustrate some of the possible approaches to ensuring that hospitals invest substantial efforts in quality assessment and improvement. The purpose of these examples is to elicit comment and suggestions in this regard, and we welcome alternative approaches. We note that although our intention is to specify in the final rule a minimum level of effort, it is also possible that after reviewing all the comments we may conclude that it is neither feasible nor desirable to do so.
      Other Elements of the Proposed Quality Assessment and Performance Improvement Condition. We propose a new requirement at Sec. 482.25(a)(3) that a hospital must use hospital-specific as well as PRO data and any other available relevant data, as an integral part of its quality assessment and performance improvement strategy, to develop its improvement plans and projects. However, if a hospital elects not to participate in an improvement project with its PRO, we propose at Sec. 482.25(a)(4) that it must be able to demonstrate a level of achievement through its own quality assessment and performance improvement strategy comparable to or better than that to be expected from such participation. Thus, we intend that each hospital have the responsibility to engage in improvement projects that are vigorous and needed to improve performance across the range of hospital activities that affect patient outcomes. For example, if a PRO proposes a cooperative project to improve the outcomes for Medicare patients with pneumonia, and the hospital chooses not to participate, HCFA surveyors would expect to find that projects that the hospital designed and implemented on its own (e.g., an improvement project to reduce the use of psychoactive medications and physical restraints as patient management tools) achieved improvements that were demonstrably as important as the expected outcomes that would have been expected from the pneumonia study had the hospital chosen to participate in that cooperative study. (In assessing the comparability of a hospital project with a PRO project, we would consider the number of patients affected, the projected magnitude of the benefit to individual patients, and the actual changes achieved by the project to the changes achieved by participants in the PRO project.)
      We also would require that a hospital set priorities for performance improvement, based on the prevalence and severity of identified problems. Of course, we expect that a hospital will immediately correct problems that are identified through its quality assessment and performance improvement program that actually or potentially affect the health and safety of patients. For example, if a hospital's quality assessment and performance improvement process identifies problems with accuracy of medication administration, it is not enough for the hospital to consider this area a candidate for an improvement program that may or may not be chosen from a priority list of potential projects. Rather, since accuracy of medication administration is critical to the health and safety of patients, the hospital must intervene with a correction and improvement program immediately. Overall, a hospital would be expected to give priority to improvement activities that most affect clinical outcomes.
      As noted above, perhaps the most fundamental change proposed in the new quality assessment and performance COP in comparison to the present condition on quality assurance is the focus on taking action to correct problems identified through the hospital's quality assessment and performance improvement program. This change is reemphasized in the proposed requirement at Sec. 482.25(a)(6) that a hospital must take actions based on measurement and tracking that result in demonstrable, sustained improvements. We envision a hospital meeting this requirement by conducting a systems/process analysis when adverse outcomes are identified and then taking action to afford long-term correction and improvement of the identified problems, as illustrated in the above example concerning medication administration.
      The second proposed standard under this COP, proposed Sec. 482.25(b), basically builds on the current requirement under Sec. 482.21 that the hospital's governing body ensures that there is an effective, hospital-wide quality assessment and performance improvement program, as well as on the current requirements concerning [[Page 66737]] medical staff responsibilities under Sec. 482.22(b) and (c). Under the new proposed standard, we would state that the hospital governing body, medical staff, and administration officials are responsible for ensuring that the hospital-wide quality assessment and performance improvement efforts address identified priorities in the hospital and for implementing and evaluating improvement actions. We would, however, eliminate several procedural requirements under the current medical staffing provisions, such as those concerning the organization of the medical staff. Finally, in keeping with the cross-cutting, hospital-wide approach to quality improvement that we believe represents current best practices, the standard includes a requirement that all programs, departments, and functions be involved in the hospital's quality assessment and performance improvement program. This would include services that are carried out under contract or by arrangement. Under the third standard in this COP, we would retain the current requirement on autopsies (existing Sec. 482.22(d)). Under this requirement a hospital's medical staff must attempt to secure autopsies in cases of unusual deaths or of medical, legal, or educational interest. Although this requirement is somewhat prescriptive, we believe it is necessary because autopsies are a valuable educational tool that contribute to the quality of care in a hospital and, as we stated above, can be used by the hospital to improve its performance.

6. Diagnostic and Therapeutic Services or Rehabilitative Services (Sec. 482.30)
      We are proposing to restate and consolidate current standards from several COPs that relate to required and optional diagnostic and therapeutic services into one COP. The condition would have four standards. The first standard would require that a hospital be primarily engaged in providing, by or under the supervision of one of the practitioners described in 42 CFR 410.20(b) (which specifies by whom physician services must be furnished to be eligible for Medicare Part B payment), either diagnostic and therapeutic services to inpatients, or rehabilitative services to inpatients. This standard would implement the statutory requirement at section 1861(e)(1) of the Act. If a hospital does not meet this standard, it would be found out of compliance and would risk termination of its participation in the Medicare program.
      The second standard of this condition at proposed Sec. 482.30(b) would require that a hospital furnish diagnostic radiology services, as required under existing Sec. 482.26. We would expect a patient's initial needs for radiology services would be identified in the comprehensive assessment performed at admission. In addition we are proposing that a hospital that furnishes emergency services on a full-time basis must provide diagnostic radiology services on a full-time basis.
      Separate mention is not made in this condition of the personnel, safety, and record standards that are now found under Sec. 482.26(b), (c), and (d). As discussed earlier in this preamble, under our proposed reorganization of these COPS, we try to deal with such common elements in one place instead of repeating them for each condition. Therefore, the personnel and safety standards accompanying these conditions are now encompassed in the proposed Human Resources and Physical Environment conditions, respectively.
      In the next standard, proposed Sec. 482.30(c), we would require hospitals to furnish laboratory services, including 24 hour-a-day emergency laboratory services, as presently required under existing regulations (see Sec. 482.27). We are also proposing to retain the current requirement at Sec. 482.27(a) that laboratory services provided to patients in the hospital must meet the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as codified in 42 CFR part 493. We propose to delete the requirements of existing Sec. 482.27(b)(2), (3) and (4). Section 482.27(b)(3) requires the hospital laboratory to make provisions for the proper receipt and reporting of specimens the laboratory handles. Since this requirement is covered under CLIA provisions, it would be redundant to place it in the proposed hospital COP. We are requesting comment on our proposal to eliminate the current requirements at Sec. 482.27(b)(2) which requires that a written description of laboratory services be available to the medical staff and at Sec. 482.27(b)(4) which requires the medical staff and a pathologist to determine which tissue specimens require a microscopic and/or macroscopic examination. We recognize that it is essential for practitioners to know what laboratory services are available for diagnosing and delivering care. However, we believe that hospitals make their services known to their practitioners, and we are not convinced that a regulation is necessary to assure that this process occurs. In addition, although microscopic and macroscopic examination of tissue specimens may provide valuable information, we are requesting comment on whether it is necessary to have a regulation which states who can determine what tissue specimens require these examinations.
      The fourth proposed standard at Sec. 482.30(d) would state that a hospital may elect to offer services in addition to these required diagnostic and therapeutic services, such as nuclear medicine, ultra sound, rehabilitation medicine services, psychology services, respiratory care services, speech and language pathology services, audiology services, social work and vocational rehabilitation services, to name a few. This listing illustrates but does not limit the range of diagnostic and therapeutic services a hospital may provide. If the hospital elects to offer such additional optional services, those services must be delivered in accordance with the requirements of part 482.

7. Pharmaceutical Services (Sec. 482.35)
      Overview. Under the proposed condition on pharmaceutical services, which would replace current Sec. 482.25, we would require the hospital to provide needed medication therapy through a safe, accurate, and effective system that minimizes adverse drug events and evaluates the patient's response to the therapy.
      In general, we propose to adopt requirements that integrate drug therapy services and support a coordination of services by the various disciplines that provide them (medicine, nursing, and pharmacy). This integration of services is intended to protect patients by establishing a four-layer ``safety net'' to prevent adverse drug events (including medication errors). It is intended also to detect system errors that result from the multiple nodes in the drug distribution process: Ordering, transcription, dispensing, and administration.
      The first layer of this safety net is a peer review activity for the identification of events that are predictive of adverse drug events (see Sec. 482.35(a)(1)). The second layer is the detection of medication errors (see Sec. 482.35(a) (2) and (3)). This layer focuses on the more objective errors of transcription, dispensing, and administration, and leaves the more subjective drug error issues to peer review and nurse review mechanisms. The third layer of the net is the comprehensive drug information resource, which endeavors to provide vital drug and patient information at keys points in the drug distribution process (see Sec. 482.35(b)(4)). The fourth layer of the net relies on nursing personnel to review drug orders for [[Page 66738]] accuracy of the entire system before drugs are administered (see Sec. 482.35(b)(5)).
      As a consequence, we are proposing to delete a number of narrowly focused, structure and process-oriented requirements, as follows:
      In existing Sec. 482.25(a)--
      (1) Requiring a full-time, part-time or consultant pharmacist.
      (2) Requiring the pharmaceutical service to have adequate personnel.

      In existing Sec. 482.25(b)--
      (1) All compounding, packaging, and supervision of drugs must be under the supervision of a pharmacist.
      (2) All drugs must be kept in a locked storage area. (Note: Locked storage of only controlled drugs is proposed at Sec. 482.35(b)(1).)
      (3) Outdated, mislabeled or otherwise unusable drugs are not available for patient use.
      (4) When the pharmacist is not available, drugs and biologicals may only be removed from the pharmacy or drug storage area by a designated person.
      (6) Drug administration errors, adverse drug reactions and incompatibilities are immediately reported to the attending physician and the quality assurance program.
      (9) A drug formulary system must be established by the medical staff to assure quality pharmaceuticals at a reasonable cost.
      A drug formulary is a system for determining the best quality and least expensive drugs, listing them in a formulary, and restricting the medical staff to the drugs listed in the formulary. This is a vastly different document than the ``comprehensive drug information resource'' referred to under Sec. 482.25(b)(4) of this proposed rule. A drug 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.
      Finally, we plan to eliminate the explicit, process-oriented requirements for administration of drugs, and acceptance of telephone and other oral orders for drugs, that are now set forth in our nursing services requirements at Sec. 482.23(c)(2).
      Description of Standards. The first proposed standard has to do with monitoring of adverse drug events (ADEs) and with eliminating or minimizing medication errors. We believe a separate standard covering ADE monitoring is needed because of its importance to patient care quality and patient health and safety. This standard is based on Journal of the American Medical Association (JAMA) papers on adverse drug events (see Bates, D. W., et al., ``Incidence of Adverse Drug Events and Potential Adverse Drug Events,'' JAMA, 274 (1995): 29-34, and Leape, L. L., et al., ``Systems Analysis of Adverse Drug Events,'' JAMA, 274 (1995): 35-43).
      These papers make the following salient points:     
      Forty-two percent of serious and life-threatening ADEs were preventable (Bates, page 33).
      Adverse drug events have multiple etiologies, but the lack of readily accessible and current drug information along with patient care information is a significant part of the problem with adverse drug events (Leape, page 40).
      Computerized detection programs that search for events likely to be associated with an ADE (e.g., naloxone, an opiate antagonist), supplemented by spontaneous reporting using the computerized information system and a dedicated person or group with responsibility for evaluating these events have been found to represent an effective, relatively inexpensive method for identifying ADEs and will probably be the strategy of the future (Bates, page 33).
      The most common defects were in systems to disseminate knowledge about drugs and to make drug and patient information readily accessible at the time it is needed. System changes to improve dissemination and display of drugs and patient data should make errors in the use of drugs less likely (Leape, page 35).

      We have endeavored to implement the principles established in these papers in the first standard, ``Adverse Drug Monitoring.'' First we propose that the facility must establish a system of evaluation of ADEs by searching current clinical records for events that are predictive of an ADE and reporting them to the quality assessment and performance program for action. We have not proposed to require that a computerized system be used by all hospitals since these regulations primarily will affect small, rural, nonaccredited hospitals who may not have the resources to develop such a computer system. The second and third parts of the ADE standard deal with medication errors. A longstanding body of research exists concerning medication errors in hospitals. In a paper by Allan and Barker (Allan, Elizabeth L. and Barker, Kenneth N., ``Fundamentals of Medication Error Research,'' American Journal of Hospital Pharmacy, 47 (1990): 555-71), the authors documented medication error studies in approximately 40 hospitals and nursing homes in the United States and Canada. These studies covered a period of time from 1962 to 1987. The hospitals' medication error rates ranged from a high of 20.6 percent to a low of 1.6 percent when wrong timing errors were excluded. When wrong timing errors were included, the range was 42.9 percent to 4.4 percent.
      This proposal would permit an overall medication error rate in a hospital of no greater than 2 percent and require zero tolerance for significant medication errors. Significant medication errors are defined as errors that jeopardize or cause serious potential for jeopardizing the health and safety of the patient. HCFA has used this concept for many years in long-term care facilities, and has considerable experience at defining what would constitute a significant medication error. The overall error rate would include significant as well as nonsignificant (e.g., wrong timing) errors and would result in a deficiency citation. Setting an overall limit on medication errors, including significant errors, does not mean significant errors are tolerated if they remain below 2 percent. Rather, even though the regulation provides zero tolerance for significant errors, if significant errors do occur, and they are added to the nonsignificant errors, a deficiency occurs where the result is greater than 2 percent. This deficiency is in addition to the separate deficiency for the significant errors. We are proposing the 2-percent standard because research and expert opinion has determined that this is a reasonable medication error rate to achieve, given modern drug packaging and drug information systems. (See Barker, Kenneth N., et al., ``Consultant Evaluation of a Hospital Medication System: Analysis of the Existing System,'' American Journal of Hospital Pharmacy, 41 (1984): 2013). In the Bates, et al, paper, adverse drug events are categorized as follows: Ordering, Transcription, Dispensing and Administration. It is important to point out that the medication error regulation proposal would examine all these categories except ADEs occurring from physician ordering questions. For this issue we would rely on the licensed nurse (that is, a registered nurse (RN), licensed practical nurse (LPN), or licensed vocational nurse (LVN)) review, as proposed under Sec. 482.35(b)(5). This is necessary because physician ordering questions dealing with the drug, the dose, the route of [[Page 66739]] administration, etc., frequently require consultation before a positive determination about the occurrence of an ADE.
      The second standard, ``Drug Management Procedures,'' has seven parts. The first one requires that drugs and biologicals be kept in secure areas; however, those drugs that are ``controlled'' must be stored in locked areas as required by the Comprehensive Drug Abuse Prevention and Control Act. (We are not requiring that biologicals be stored in locked areas because this Act does not include ``biologicals'' in its provisions.) We are not requiring that the areas where the controlled drugs are stored be double locked, since what is usually found in most facilities is an individual with a ring of keys containing both keys to the double locked compartment. In this case ``double locked'' is hardly an added security feature. The key to the locked compartment should be restricted strictly to individuals who have an identified need to access these drugs.
      The requirement for the facility to maintain a record of receipt and disposition of controlled drugs may be met in ways other than the use of proof of use sheets for each controlled drug. For example, the facility may use existing patient records such as the medication administration record as a record of disposition of controlled drugs. If the facility wishes to maintain records of receipt and disposition of controlled drugs by using existing patient care records, it will reduce its paperwork burden considerably.
      Proposed Sec. 482.35(b)(3) requires that discrepancies in the record of controlled drugs be reported to the individual responsible for pharmaceutical services and to the hospital administrator. Discrepancies in these records indicate that controlled drugs are being used for unauthorized purposes. Proposed Sec. 482.35(b)(3) would require that these discrepancies be reported to responsible individuals in the hospital, who will then decide whether the local police or the Drug Enforcement Agency should be involved.
      The fourth part of the Drug Management Procedures standard would require the hospital to establish a computerized or hard copy ability to merge patient information with current comprehensive drug information at the points of drug ordering, dispensing, and administration. This system would promote the development of information systems that bring patient information and drug information together at critical junctures in the drug ordering and distribution process. Comprehensive drug information resources would include the United States Pharmacopoeia-Drug Information, American Medical Association Drug Evaluations, and the American Hospital Formulary Service--Drug Information. (These drug information resources are those used to establish Medicaid drug use review under the provisions of section 1927(g)(1)(B) of the Social Security Act. Drug information resources would not include the Physician Desk Reference since this reference is not considered comprehensive and was not listed in the statute.)
      The fifth part of this standard would require that before medications are administered, a licensed nurse, or a physician if he or she is personally administering the drug, review the patient's information and the drug order. (The comprehensive drug information would also be available for review if there was a need for this information.) The purpose of this proposal is to support the established practice of nursing personnel questioning the drug order from the standpoint of the correctness of the order itself in relation to specific patient and drug information that must be readily available before or at the point of drug administration. In reviewing this information to prevent drug errors, a nurse would be acting only within the scope of her or his State licensure. The expectation is that the nurse would report any potential errors in drug prescribing to the physician, so the physician could determine whether the order needed to be changed. This proposed requirement is consistent with current research. Leape identified a total of 334 adverse drug events that were identified by review of all admissions in 11 medical and surgical units in 2 tertiary hospitals for a period of 6 months. Of the 334 adverse drug events, 91 or 27 percent were intercepted (prevented). Of these 91 prevented adverse drug events, 86 percent were prevented by nurses and 12 percent by pharmacists. This proposed regulation is intended to strengthen the potential for nurses and pharmacists to intercept adverse drug events of all kinds by providing them with readily available information necessary to prevent these events.
      The sixth part of the Drug Management Procedures standard deals with positive identification of medication. The current regulations do not contain a requirement for positively identifying drugs brought to the facility by the patient and then obtaining physician orders before they can be administered. We are proposing such a requirement here because when an individual is hospitalized it indicates a considerable change in their status. ``Positively identified'' in the context of this proposed rule means that a pharmacist or someone with similar drug identification skills must make sure that the drugs brought to the facility are in fact the same drugs that the label represents. This is necessary because patients often mix drugs within one container, or they separate drugs from their proper labeling. The drugs that the individual was taking prior to this hospitalization should be reviewed by competent medical personnel to determine if these drugs are still necessary, or if they may interfere with other therapies that are underway in the hospital.
      Unlike current regulations, this proposed rule would make it clear that self-administration of drugs is permitted, but only under orders and hospital policy. This proposed rule is important for patients being prepared for discharge. These patients should become familiar with self-administration of drugs (especially eye drops, inhalers, intramuscular injections), so they become well-practiced with this task while still under competent supervision.
      Regarding our seventh proposal, existing Sec. 482.25(b)(5) requires that orders for drugs and biologicals be automatically stopped after a reasonable period of time as predetermined by the medical staff. This proposed rule endeavors to achieve the same objective as the current rule, that is, the cessation of drug therapy when it is no longer necessary. However, our proposal would not limit the hospital to the option of automatic stop orders, which discontinue drug therapy (especially on holidays and weekends) by administrative fiat without any medical assessment as to whether the drug therapy has achieved its therapeutic objectives. The proposed rule allows the hospital to develop its own approaches for achieving this objective.
      The last standard of the Pharmaceutical Services COP (proposed Sec. 482.35(c)) deals with discharge orders for psychopharmacological drugs. Under this standard, we would require that orders for psychopharmacological drugs be discontinued upon the patient's discharge unless the patient has been diagnosed (using standard criteria for such diagnoses) with a mental illness. This will prevent the use of these drugs (which may be temporarily necessary during a hospitalization) from becoming routine after discharge unless a valid reason for their use is established. This is particularly necessary in patients
[[Page 66740]]
transferred to long-term care facilities, who can suffer considerable adverse effects from long-term use of antipsychotic and antianxiety drugs that may have been started in the hospital for very valid reasons but that may no longer be valid after discharge. A study by Garrard (Garrard, Judith, et al., ``Evaluation of neuroleptic drug use by nursing home elderly under proposed Medicare and Medicaid regulations,'' JAMA, 265 (1991): 463-467) showed that the rate of use of neuroleptic (antipsychotic) drugs among nursing home admissions was: 16 percent when admitted from hospitals, 18 percent from the community, and 21 percent from other nursing homes. Regulation of the use of these drugs (in the absence of proper differential diagnoses) in nursing homes have been in effect since 1990 (see 42 CFR 483.25), and we have been criticized because similar rules were not imposed on hospital and community practice (Thurston, Ronald G., Letters, JAMA, 265 (1991): 2962). We believe this proposed requirement represents a fair way to address this issue, but invite public comment on alternatives for achieving the same objective.

8. Nutritional Services (Sec. 482.40)
      Currently, the food and dietetic services requirements that a hospital must meet are found at Sec. 482.28. These requirements emphasize the organizational aspects of a hospital's food and dietetic services program, including provisions that specify allowable contractual arrangements, employee qualifications, and other process-oriented details.
      We are proposing extensive revisions to these provisions under a new nutritional services condition of participation. In keeping with the principles discussed above, the new condition of participation would promote a patient-centered approach to nutrition. Thus, the introductory language for these proposed requirements states explicitly that each patient must receive adequate nutrition, including therapeutic diets or parenteral nutrition if needed.
      The proposed condition includes only two standards. The first standard, ``Sanitary conditions,'' requires that food provided to patients be obtained, stored, prepared, distributed and served under sanitary conditions. (Note that the term ``food'' is intended to include all forms of nutrition, liquid or solid, provided to patients.) Although this requirement is not contained in the current hospital conditions of participation, we believe that it clearly is an underlying necessity for any acceptable nutritional services program. Thus, we are proposing to include it explicitly under the nutritional services condition. The only other standard would require that menus be prepared in advance and meet the nutritional needs of patients based on the recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences. We believe the Board's guidelines can appropriately be used here because they represent accepted best practices and are already in widespread use among hospitals.
      In developing the proposed requirements, we have attempted to incorporate straightforward statements of a hospital's responsibilities, while eliminating procedural requirements and avoiding unnecessary details of how the hospital should carry out its nutritional services function. We believe that the requirements largely incorporate current best practices in hospital nutrition services, while eliminating several burdensome process requirements that are not central to meeting the patient's dietary needs (such as the requirement under current Sec. 482.28(b)(3) that a current therapeutic diet manual approved by the dietitian and medical staff be readily available to all medical, nursing, and food service personnel.) We considered supplementing the requirements with additional provisions concerning staffing requirements or qualifications. Instead, however, we decided that the staffing requirements set forth under the proposed human resources condition of participation are sufficiently broad to ensure that a hospital has adequate qualified staff to carry out its nutritional services function. Rather than prescribing how a hospital should organize itself to meet its nutritional services responsibilities, we prefer to allow each hospital as much flexibility as possible in this regard, so that it can focus on incorporating its nutritional services program into a cross-cutting approach toward achieving optimal patient outcomes. Finally, as discussed above in section II.B.4 of this preamble, we note that the existing requirement under Sec. 482.28(b)(1) that a therapeutic diet be prescribed by the responsible practitioner would now be encompassed within the hospital's responsibility under proposed Sec. 482.20(b) to ensure that all patient care services be provided in accordance with the orders of qualified practitioners.

9. Surgical and Anesthesia Services (Sec. 482.45)
      The proposed condition on surgical and anesthesia services would replace the existing regulations at Sec. 482.51 (Condition of participation: Surgical services) and Sec. 482.52 (Condition of participation: Anesthesia services). We have decided to address both areas under a single condition in order to simplify the organization of part 482, and to emphasize the close relationship between surgery and anesthesia.
      In the new condition, we would delete current process-oriented standards having to do with the organization and staffing of the hospital's surgical and anesthesia departments or services (existing Sec. 482.51(a) and Sec. 482.52(a)), and with hospital policies governing surgical and anesthesia care (existing Sec. 482.51(b) and Sec. 482.52(b)). In particular, we propose to delete the current specific requirements regarding the types of personnel who can serve as scrub nurses or perform circulating duties in the operating room. We also would eliminate current rules on which practitioners can administer anesthesia, and what level of supervision must be provided to them. We also propose to delete current prescriptive requirements specifying the types of equipment that must be maintained in operating suites (existing Sec. 482.51(b)(3)). We believe those requirements should be eliminated in favor of those that focus more directly on outcomes.
      In place of the current requirements, we propose two basic rules on staffing. We would require that surgical procedures be performed only by practitioners with appropriate clinical privileges, and that anesthesia be administered only by a licensed practitioner permitted by the State to administer anesthetics.
      One effect of our proposed staffing and equipment requirement would be to allow more flexibility to certified registered nurse anesthetists (CRNAs) to practice without oversight by another practitioner. Currently, the anesthesia condition (Sec. 482.52(a)(4)) requires that a CRNA administer anesthesia only under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed. To allow greater flexibility to hospitals and practitioners and to give deference to State scope of practice law, we propose to delete this supervision requirement and allow the CRNA to function without supervision by another practitioner, where this is in accordance with State law. We emphasize that CRNAs are allowed to practice in this way only where doing so is consistent with State law. If State law establishes a more stringent rule, the hospitals (42 CFR 482.110) would be required to furnish care in a way that is consistent with that rule. [[Page 66741]]

      To ensure that our requirements are consistent across the settings in which surgery may be performed, we propose also to eliminate the supervision requirement for CRNAs in ambulatory surgical centers (ASCs) (42 CFR 416.42) and in critical access hospitals (CAHs) (formerly rural primary care hospitals) (RPCHs) (42 CFR 485.639) and allow the CRNA to function without supervision by another practitioner, where this is in accordance with State law. In addition, if State law establishes a more stringent rule, the ambulatory surgical centers (42 CFR 416.40) and critical access hospitals (42 CFR 485.608) would be required to furnish care in a way that is consistent with that rule.
      We believe it is critical to the health and safety of surgical patients to have accurate information on each patient's condition before anesthesia is administered and a surgical procedure is undertaken. Therefore, we would require under proposed Sec. 482.45(b) that a comprehensive assessment be performed before surgery (with a modified assessment being permitted in emergency cases) and that a preanesthesia evaluation be done by an individual qualified to administer anesthesia. We also would require that a postanesthesia evaluation for proper recovery be done by an individual qualified to administer anesthesia. We propose to delete the current prescriptive rule under which the postanesthesia evaluation must be done by the same individual who administered the anesthesia.
      In the standard on documentation of care, we have included requirements for entry of specified information in the medical record. The information that would be required includes a report of the comprehensive or modified pre-surgical assessment, a properly executed informed consent form, an operative report describing complications, reactions, length of time, techniques, findings, tissues removed or altered, a record of intraoperative anesthesia, and a report of the postanesthesia evaluation. By ``properly executed informed consent,'' we mean only that the patient understands the information the hospital wishes to convey. The pre-surgical assessment and informed consent form would have to be entered in the record before surgery except in emergency cases, while the operative report, intraoperative anesthesia record, and a report of the postanesthesia evaluation would have to be entered in the record promptly following surgery. (The postanesthesia evaluation report combines the current requirements for an inpatient postanesthesia followup report (Sec. 482.52(b)(3)), and for an outpatient postanesthesia evaluation (Sec. 482.52(b)(4)) into a single new requirement.) The hospital also would be required to maintain a complete, up-to-date operating room register. We recognize that our proposal for the documentation requirements for the surgical and anesthesia services COP is more extensive and specific than many other requirements in these proposals. However, such documentation is common to current practice and imposes no additional burden to hospitals as these documentation requirements are part of the existing COPs.

10. Emergency Services (Sec. 482.50)
      We propose to delete the existing regulations at Sec. 482.2 (Condition of participation: Provision of emergency services by nonparticipating hospitals), and to add a single new emergency services condition that would replace both current Sec. 482.12(f) (Condition of participation: Governing body; Standard: Emergency services) and current Sec. 482.55 (Condition of participation: Emergency services). We believe Sec. 482.2 need not be retained since the regulations at 42 CFR 424.101 set forth a definition of ``hospital'' that is used for purposes of payment for services to Medicare patients that are furnished on an emergency basis by a hospital that does not participate in the program. By addressing the two latter areas under a single regulation, we hope to simplify the organization of the regulations and eliminate the need for the user of the regulations to refer to separate sections to review the rules on closely related services. For the reasons explained below, we also are proposing to add a separate standard for hospitals that offer emergency services on less than a full-time basis.
      In the standard on hospitals providing full-time emergency services, we have emphasized requirements that most directly affect the safety of patients. These are the requirements regarding the personnel who furnish the services, the appropriateness of the services to patient needs, and the integration of emergency services with those of other hospital departments. Regarding the proposed requirement for sufficient numbers of personnel, we note that some hospitals may choose to meet patient needs by using a comparatively smaller, but more highly trained and skilled staff. In assessing compliance with this requirement, our primary concern will be to determine whether emergency service staffing is adequate to produce good treatment outcomes.
      We are proposing the second standard, which is applicable only to hospitals providing part-time emergency services, in order to allow more flexibility to hospitals that find it necessary, because of staffing limitations, low emergency room volumes, or other factors, to limit the times during which emergency services can be offered. Because of the nature of emergency services, it clearly would be desirable to have them available on a 24-hour per day, 7-day per week basis. However, many hospitals, particularly those that are small and are located in remote rural areas, find it difficult to recruit and pay staff to furnish emergency services on this schedule. To avoid a situation in which these hospitals find it necessary to terminate emergency services altogether, we propose that hospitals that are located in rural areas and have fewer than 100 beds may offer emergency services on a part-time basis. We propose to use the definition of ``rural area'' now set forth in our regulations at 42 CFR 412.62(f)(1)(ii). Under that definition, an area is considered ``rural'' if it is located outside any Metropolitan Statistical Area (MSA) or New England County Metropolitan Area (NECMA), and outside specified New England counties.
      We emphasize that this flexibility is not intended to foster development of dual standards of care--during its stated hours of operation, a hospital emergency department or service must meet exactly the same standards as full-time departments or services. However, at the times when it chooses not to offer emergency services, the hospital would be required to meet only the standard for hospitals that do not offer emergency care.