Proposed Medicare Conditions of Participation at Hospitals

February 17, 1998

Nancy-Ann Min DeParle
Administrator
Health Care Financing Administration
Department of Health and Human Services
Attention: HCFA-3745-P
PO Box 7517
Baltimore, MD 21207-0517

Re: Proposed Medicare Conditions of Participation for Hospitals

Dear Ms. DeParle:

The American Nurses Association (ANA) offers the following comments for your consideration regarding HCFA's proposed rule revising Medicare conditions of participation (COPs) for hospitals. The proposed rule was published in the Federal Register on December 19, 1997.

ANA represents the nation’s 2.5 million registered nurses, including hospital staff nurses, nurse practitioners, clinical nurse specialists, certified nurse mid-wives, nurse educators, nurse managers and certified registered nurse anesthetists through its 53 state and territorial nurses associations. On behalf of America's nurses, ANA is gratified that HCFA has undertaken a revision of the hospital COPs. Much has changed in hospital practice, in quality measurement, and in health care generally since the conditions were last revised in 1986. We applaud your effort to make the conditions more responsive to patient needs and more focused on ensuring that patients receive safe, quality health care services.

We are especially pleased that you have recognized the necessity of requiring hospital nurse staffing to reflect “the volume of patients, patient acuity, and intensity of the services provided.” You have appropriately noted the dangerous trend toward significant reductions in nurse staffing in many hospitals. We also believe you have taken an important step to hold hospitals more accountable for their staffing decisions by requiring an “explicit process to determine on an ongoing basis the needed level of nurse staffing” that will be available for public inspection. At a minimum, we believe hospitals should be prepared to disclose their staffing methodology and demonstrate compliance with their own staffing policy.

We generally concur with HCFA's assessment that Medicare hospital conditions of participation need to be more clearly outcomes-oriented, and that, accordingly, those process- and structure-oriented conditions that are not related to safety and quality of care should be revised or eliminated. However, we are also acutely aware that as a result of cost pressures--both real and perceived--many hospitals have sought continuously to cut corners on patient care, often without sufficient regard as to the consequences for patient safety and quality of services. Absent clear and enforceable requirements for the provision of patient care services, we fear that too many hospitals will regard the elimination of some current standards as an invitation to make further cuts that may endanger their patients.

We are also aware that outcomes measurement and evaluation remain at an early stage of development, and that in some areas no outcomes-focused measures yet exist to substitute for structure- and process-oriented ones. Thus, while we generally support the move to focus the conditions more on actual patient outcomes, in specific, identified areas, we urge HCFA to retain the current requirements it has proposed to eliminate.

Our specific comments on the proposed rule are presented in the balance of this letter.

1. Development of Performance-Based Measures

Before addressing the specific revisions contained in the proposed rule, we wish to respond to HCFA's request for comments regarding development of national outcomes-based performance measures for hospitals.

First, we are disappointed that HCFA has decided not to put forward any standard performance measures at this time. We recognize that efforts to develop reliable and valid quality measures for hospital performance are still in progress, and -- as HCFA is aware -- ANA's current work on nursing-sensitive outcomes measures is an important contribution to these efforts. While it may not be possible at this time to launch a complete set of uniform performance measures, we believe that a preliminary set of measures, based on experience in collecting data related to adverse patient events, could yield important information on hospital performance and also provide a rich source of data from which to produce a more refined and complete set of measures.

A significant problem that complicates quality research is hospital assertions of the private, proprietary nature of patient outcome data, and particularly data concerning adverse patient incidents. Some of the data items mentioned as examples by HCFA -- nosocomial infection rates, medication errors, reports of falls and other injuries, for example -- provide a good start in formulating a useful preliminary set of performance measures for hospitals, as do some other possible items, such as incidence of nosocomial urinary tract infections and decubitus ulcers.

ANA strongly believes that summary data regarding adverse patient outcomes, along with data on staffing levels and mix, should be routinely available to the public as well as to federal and state regulators. These measures are not only related to quality and patient safety to which the public is entitled; they provide an important early warning of systemic problems and help to link outcomes of care to the structure and processes of care -- precisely the links which are needed in order to select regulatory requirements that can effectively ensure safe, quality patient care.

Short of a decision to require reporting of identified performance measures at this time, ANA believes that HCFA should, as the preamble to the proposed rule asks, "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." Such an effort should include the participation of researchers and of organizations, such as ANA, that have been involved in producing relevant data on quality outcomes.

We believe it would be ill-advised in the extreme for such an effort to be undertaken on a piecemeal basis by individual hospitals or hospital groups. Under the Balanced Budget Act, HCFA is already developing uniform outcome measures for Medicare+Choice plans -- some of which are likely to be related to the provision of hospital services. Thus, we believe that there are inherent problems in allowing hospitals to develop the criteria by which their performance will be judged, particularly considering that the selection of performance criteria may not capture those areas where performance needs to be improved. We also believe that only a uniform, consistent system can produce the standardized data that will allow comparisons between hospitals and offer real potential for continuous improvement.

We do not believe that it is premature to develop "placeholder" language in the COPs concerning the need for hospitals to report relevant data. If HCFA decides not to proceed at this time with actual data-reporting requirements, at the very least hospitals should be put on notice that such requirements will be imposed in the near future. Nor should the imposition of such requirements need to await a future revision of the COPs. By referencing a requirement for reporting of data through a process and mechanism that allows public input, the COPs can allow for speedy development and implementation of data reporting requirements without the delay of a lengthy administrative process that would be associated with a future revision of the COPs.

2. Patients Rights (Section 482.10)

The ANA strongly endorses the inclusion of a condition on patient rights. The proposed standards recognize the patient's right to dignified care, to privacy, safety and autonomy. We propose one revision to the proposed condition. Under proposed standard (b), "Exercise of rights," we propose adding a new subsection (b)(4), to read:

The patient has the right to know the credentials, licensure and professional qualifications of all personnel involved in his or her care.

Nurses across the country have reported that many hospitals have attempted to make it more difficult for patients to know the qualifications and licensure (if any) of personnel who provide their care. This has taken various forms, including actively discouraging registered nurses from wearing name tags that include the initials "RN" after their names, or reclassifying all nursing personnel to delete references to professional licensure. The effect has been that patients are uninformed as to whether the individuals providing their care are registered nurses, licensed practical/vocational nurses, or unlicensed personnel. Some states have enacted legislation requiring that the licensure status of individuals providing patient care be known to patients. We believe that the COPs should reflect and ensure patients' right to this basic information.

3. Patient Admission, Assessment, and Plan of Care (Section 482.15)

A. Proposed Section 482.15(a)(1) would require that a patient be "admitted to the hospital only on the recommendation of a licensed practitioner permitted by the State to admit patients to a hospital." We applaud the use of this language, which recognizes that in many states non-physician practitioners such as nurse practitioners (NPs), clinical nurse specialists (CNSs) and certified nurse-midwives (CNMs) are authorized by State law and/or regulation to admit patients to the hospital. The language proposed for this subsection means that HCFA would not interfere with this practice in those states which authorize it.

B. We propose revising subsection 482.15(b)(1) by inserting the following language at the end:

The plan of care must include the elements of a nursing plan of care to be provided by or under the oversight of a registered nurse.

While we agree that hospital patient care is interdisciplinary in nature and that the COPs should recognize this, we also believe it is critical to recognize that professional nursing care is a critical component of such care--it is, in fact, the primary reason why patients are admitted to the hospital in the first place. A recognition of the interdisciplinary nature of patient care should not be the basis for diluting that care or obscuring the importance of nursing in care planning and providing for a patient's overall care needs.

4. Patient Care (Section 482.20)

A. We support the intent of the language of proposed subsection 482.20(b)(3), which would require that "Patient care services are provided in accordance with the order of practitioners who are qualified and have delineated clinical privileges as specified under Section 482.125(a)." We suggest, however, one modification to change this language to read as follows:

Patient care services are provided in accordance with the order of practitioners who are qualified, and have delineated clinical privileges, and are practicing within the scope of State law and/or regulation.

Proposed Section 482.125(a) specifically addresses practitioners who are "permitted by the State to admit patients to a hospital." Some States may not yet permit certain non-physician practitioners to admit patients to the hospital, but may allow them to order and provide a broad range of patient care services to hospitalized patients. Many hospitals may utilize acute care nurse practitioners, for example, to order and provide services for hospitalized patients, and have extended to them delineated clinical privileges related to the management of a patient's care following admission, even if the practitioner is not authorized to admit the patient. We are confident that it is not the intent of this proposed subsection to restrict or override existing State scope of practice acts for any licensed practitioners, or to restrict hospitals' ability to utilize the full range of licensed practitioners in the provision of patient care consistent with State licensure laws and regulation.

B. We also suggest a modification in Section 482.20(a). We propose moving the word "or" at the end of subpart (v) to the end of subpart (vi), and then adding the following new subpart (vii):

(vii) another licensed practitioner who provides physicians' services as defined by Section 1861(s)(2)(K) of the Social Security Act.

As a result of Section 4511 of the Balanced Budget Act of 1997, covered physician services may be provided by nurse practitioners and clinical nurse specialists and paid for under the Medicare Fee Schedule. The services of certified nurse- midwives (CNMs) are similarly covered and reimbursed. These practitioners often have primary responsibility for the care of hospitalized patients. The fact that they are practicing in collaboration with a physician or physician group in the provision of such care does not obviate their primary responsibility for a patient's care.

HCFA's proposed language in subpart (a)(1)(I) which would permit a doctor of medicine or osteopathy "to delegate tasks to other qualified health care personnel to the extent recognized under State law or a State's regulatory mechanism" only partially addresses this issue. NPs, CNSs and CNMs are independent practitioners. Their scope of practice extends beyond the performance of delegated tasks.

C. ANA strongly supports proposed Section 482.20(b)(4), which would require that care provided to hospital outpatients meet the same requirements that apply to inpatient care. As outpatient services are used to treat increasingly acute patients with complex care needs, patients treated in outpatient settings require the protection of clear and enforceable standards for patient care. Moreover, care should not be shifted to outpatient departments for the purpose of circumventing regulatory requirements that apply to inpatient care. HCFA's proposed language would go far in providing needed protections for patients cared for in outpatient settings.

5. Quality Assessment and Performance Improvement (Section 482.25)

Under section 482.25(a), we propose adding a new subpart (7), to read as follows:

(7) The hospital must ensure that information collected under this standard is made readily available to the public.

6. Pharmaceutical Services (Section 482.35)

We propose changing Section 482.35(b)(5) by adding, at the end of the proposed language, the following:

Medications may only be administered by personnel who are appropriately licensed by the state and authorized to administer medications.

The level of acuity and the complexity of problems experienced by today's hospitalized patient population demands that medications be administered only by licensed personnel. We have heard from many nurses who have reported attempts by hospitals to have them delegate or assign the administration of medications to unlicensed personnel. We believe that federal standards for this important area be as clear and explicit as possible.

7. Surgical and Anesthesia Services (Section 482.45)

A. We strongly support HCFA's proposed, straightforward approach to the administration of anesthesia services, as set forth in Section 482.45(a)(2): "Anesthesia is administered only by a licensed practitioner permitted by the state to administer anesthetics.". This revision would remove cumbersome, restrictive, burdensome, and anti-competitive requirements for physician supervision of certified registered nurse anesthetists (CRNAs). These requirements have operated to supplant existing state laws that govern CRNA practice. They have served no demonstrated or practical purpose in protecting patient safety. CRNAs are independently licensed and certified practitioners who have specialized in the administration of anesthetic agents. In practice, the relationship between CRNAs and physicians has been that of professional colleagues working in collaboration with one another. The relationship is generally not a supervisorial one. This is particularly true in the case of operating surgeons, who lack CRNAs' expertise in administering anesthesia, and yet have been called upon to "supervise" them because of existing regulatory requirements.

B. On the other hand, we oppose HCFA's proposal to eliminate current requirements in the COP that a registered nurse serve as circulating nurse. This is a role that requires a professionally educated and licensed registered nurse in order to assess patients fully and competently and to supervise other personnel who serve as scrub persons. Unlike the proposal for anesthesia services, which would require that such services be provided by a licensed practitioner who is authorized to administer anesthesia, the elimination of current requirements for circulating nurses in operating rooms provides no standard for the appropriate licensure of personnel who perform this function. We believe that the elimination of this requirement is one that poses a significant threat to the safety of patients in hospital operating rooms.

8. Discharge Planning (Section 482.55)

We strongly concur with the inclusion of standard 482.55(a), "Identification of patients in need of discharge planning." The special discharge planning needs of hospitalized patients need to be identified at or near admission in order to assure adequate discharge planning. However, we suggest rephrasing the title and content of this standard. All patients require discharge planning. An initial assessment of discharge planning needs should identify the intensity and complexity of those needs. We suggest the following language for standard (a):

(a) Standard: Assessment and identification of patients' discharge planning needs. The hospital must identify, upon admission or at an early stage of hospitalization (but no more than 24 hours after admission), a patient's discharge planning needs and identify the level and intensity of those needs, particularly those that would avoid adverse health consequences following discharge.

9. Human Resources (Section 482.125)

A. The proposed standard at 482.125(a)(2) on Credentials/qualifications would require that "If State law requires that an employee, contractor or a practitioner with practice privileges be licensed . . ." that "compliance with applicable licensure requirements" be verified and periodically reverified. ANA supports this requirement. However, we believe it should be made more explicit by changing it to read as follows:

The licensure status of all employees, contractors and practitioners with practice privileges who are required by State law to be licensed shall be verified (and periodically reverified) by the hospital for compliance with all applicable licensure requirements, and shall be documented by the hospital. The hospital shall ensure that any employee, contractor or practitioner is appropriately licensed to perform any patient care service, function or task for which licensure is required by State law.

The above language is predicated on a hospital’s responsibility for ensuring that any employee who performs an act for which State law requires licensure is duly and appropriately licensed. Regrettably, some hospitals utilize unlicensed personnel to perform functions that, under State law, must be performed only by registered nurses. Hospitals should not only be responsible for ensuring that individuals in identified categories or positions that require licensure hold current, valid licenses; they should also ensure that patient care activities that require licensure are only performed by appropriately licensed individuals.

B. Proposed section 482.125(b), "Staffing," includes several standards which ANA strongly supports. Specifically, we believe that the proposal contained in subpart (1) -- that staffing reflect patient volume, acuity, and complexity of services provided -- and subpart (2) -- that the hospital develop and use an explicit process to determine the needed level of nursing staff -- are of critical importance in protecting patient safety and helping to ensure quality. We laud HCFA for proposing that the methodology described in subpart (2), along with "evidence of its use in meeting the nursing staffing needs of the patients," be made available for public inspection. We fully concur with HCFA, as set forth in the preamble to the regulations, that these two new conditions are necessary because of "concern about an apparent trend in the country toward reductions in hospital nurse staffing. These proposed requirements represent an important step toward establishing and enforcing a much-needed level of accountability for hospitals in the provision of high quality and safe patient care.

We would like to propose two modifications in Section 482.125(b)(2). First, we suggest adding and words "and mix" between "needed level" and of "nursing staff." Hospitals should use a consistent methodology not only for determining the aggregate number of nursing staff to be utilized (the "needed level,") but also to determine the appropriate number of different categories of nursing and other personnel. Second, we propose adding, at the end of this subpart, the following language:

Such evidence shall include, but not be limited to, the actual numbers and mix of nursing staff deployed and the average number of patients per registered nurse providing direct patient care, broken down in terms of the total nursing staff, each unit, and each shift.

C. In subpart (3), we suggest deleting the words "licensed practical nurse or," so that the affected phrase would read "and have a registered nurse on duty at all times." We strongly believe that the current acuity and complexity of the hospitalized patient population demands that, at an absolute minimum, every hospital have an RN on duty at all times. For a hospital in today's environment to operate without even one RN present is unacceptable.

D. We suggest a revision to subpart (5) that would replace "must assign" with "may assign tasks related to" and insert the word "only" between "personnel" and "in accordance," so that the revised language would read as follows:

A registered nurse must be responsible for the provision and evaluation of nursing care for each patient and may assign tasks related to the nursing care of each patient to other nursing personnel only in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available.

This recommendation is offered to ensure that the intent of the standard is clear: assignment is permissive, not mandatory. We propose the insertion of the word "only" to make it clear that the criteria for assignments -- that is, to be in accordance with a patient's needs and the qualifications and competence of available staff -- must be satisfied for an assignment to be made.

Finally, we suggest adding "tasks related to" to modify "the nursing care of each patient." The nursing care of each patient is the responsibility of the registered nurse. While specific patient care tasks may be assigned and delegated, the registered nurse cannot delegate the overall nursing care of any patient to non-RN nursing staff.

Thank you for the opportunity to provide these comments and recommendations on the proposed hospital conditions of participation. We hope our recommendations will be considered favorably. We look forward to working with you and would be pleased to provide such additional information as you may require. Please contact Reeder Franklin at the ANA for any necessary follow up.

Sincerely,

Argene Carswell, JD, RN
American Nurses Association