42 C.F.R. Subpart B—Special Requirements
Title 42 - Public Health
Title 42: Public Health
PART 488—SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
Subpart B—Special Requirements
§ 488.52 [Reserved]
§ 488.54 Temporary waivers applicable to hospitals.
(a) General provisions. If a hospital is found to be out of compliance with one or more conditions of participation for hospitals, as specified in part 482 of this chapter, a temporary waiver may be granted by CMS. CMS may extend a temporary waiver only if such a waiver would not jeopardize or adversely affect the health and safety of patients. The waiver may be issued for any one year period or less under certain circumstances. The waiver may be withdrawn earlier if CMS determines this action is necessary to protect the health and safety of patients. A waiver may be granted only if:
(1) The hospital is located in a rural area. This includes all areas not delineated as “urban” by the Bureau of the Census, based on the most recent census;
(2) The hospital has 50 or fewer inpatient hospital beds;
(3) The character and seriousness of the deficiencies do not adversely affect the health and safety of patients; and
(4) The hospital has made and continues to make a good faith effort to comply with personnel requirements consistent with any waiver.
(b) Minimum compliance requirements. Each case will have to be decided on its individual merits, and while the degree and extent of compliance will vary, the institution must, as a minimum, meet all of the statutory conditions in section 1861(e)(1)–(8), in addition to meeting such other requirements as the Secretary finds necessary under section 1861(e)(9). (For further information relating to the exception in section 1861(e)(5) of the Act, see paragraph (c) of this section.)
(c) Temporary waiver of 24-hour nursing requirement of 24-hour registered nurse requirement. CMS may waive the requirement contained in section 1861(e)(5) that a hospital must provide 24-hour nursing service furnished or supervised by a registered nurse. Such a waiver may be granted when the following criteria are met:
(1) The hospital's failure to comply fully with the 24-hour nursing requirement is attributable to a temporary shortage of qualified nursing personnel in the area in which the hospital is located.
(2) A registered nurse is present on the premises to furnish or supervise the nursing services during at least the daytime shift, 7 days a week.
(3) The hospital has in charge, on all tours of duty not covered by a registered nurse, a licensed practical (vocational) nurse.
(4) The hospital complies with all requirements specified in paragraph (a) of this section.
(d) Temporary waiver for technical personnel. CMS may waive technical personnel requirements, issued under section 1861(e)(9) of the Act, contained in the Conditions of Participation; Hospitals (part 482 of this chapter). Such a waiver must take into account the availability of technical personnel and the educational opportunities for technical personnel in the area in which the hospital is located. CMS may also limit the scope of services furnished by a hospital in conjunction with the waiver in order not to adversely affect the health and safety of the patients. In addition, the hospital must also comply with all requirements specified in paragraph (a) of this section.
[39 FR 2251, Jan. 17, 1974. Redesignated at 39 FR 11419, Mar. 28, 1974, and amended at 41 FR 27962, July 8, 1976. Further redesignated at 42 FR 52826, Sept. 30, 1977, and amended at 47 FR 31531, July 20, 1982; 51 FR 22041, June 17, 1986. Redesignated at 53 FR 23100, June 17, 1988]
§ 488.56 Temporary waivers applicable to skilled nursing facilities.
(a) Waiver of 7-day registered nurse requirement. To the extent that §483.30 of this chapter requires any skilled nursing facility to engage the services of a registered nurse more than 40 hours a week, the Secretary may waive such requirement for such periods as he deems appropriate if, based upon documented findings of the State agency, he determines that:
(1) Such facility is located in a rural area and the supply of skilled nursing facility services in such area is not sufficient to meet the needs of individual patients therein,
(2) Such facility has at least one fulltime registered nurse who is regularly on duty at such facility 40 hours a week, and
(3) Such facility (i) has only patients whose attending physicians have indicated (through physicians' orders or admission notes) that each such patient does not require the services of a registered nurse for a 48-hour period, or (ii) has made arrangements for a registered nurse or a physician to spend such time at the facility as is determined necessary by the patient's attending physician to provide necessary services on days when the regular fulltime registered nurse is not on duty.
(4) Such facility has made and continues to make a good faith effort to comply with the more than 40-hour registered nurse requirement, but such compliance is impeded by the unavailability of registered nurses in the area.
(b) Waiver of medical director requirement. To the extent that §488.75(i) of this chapter requires any skilled nursing facility to engage the services of a medical director either part-time or full-time, the Secretary may waive such requirement for such periods as he deems appropriate if, based upon documented findings of the State agency, he determines that:
(1) Such facility is located in an area where the supply of physicians is not sufficient to permit compliance with this requirement without seriously reducing the availability of physician services within the area, and
(2) Such facility has made and continues to make a good faith effort to comply with §488.75(i) of this chapter, but such compliance is impeded by the unavailability of physicians in the area.
[39 FR 35777, Oct. 3, 1974. Redesignated and amended at 42 FR 52826, Sept. 30, 1977. Further redesignated and amended at 53 FR 23100, June 17, 1988, and further amended at 56 FR 48879, Sept. 26, 1991; 57 FR 43925, Sept. 23, 1992]
§ 488.60 Special procedures for approving end stage renal disease facilities.
(a) Considerations for approval. An ESRD facility which wishes to be approved for coverage, or which wishes any expansion of dialysis services to be approved for coverage in accordance with subpart U of part 405, must secure the Secretary's determination thereunder. In addition to the certification by the State agency referred to in §488.12 of this part, data furnished by network organizations and recommendations of the Public Health Service, concerning the contribution of a facility to the furnishing of end-stage renal disease services in its network and concerning the facility's compliance with professional norms and standards (see subpart U of part 405), shall be considered by the Secretary in determining whether to approve a facility for coverage or for any expansion of services under the End-Stage Renal Disease Program. The facility will also be required to submit data pertaining to its qualifications for approval or for any expansion of services, for consideration in the Secretary's determination.
(b) Determining compliance with minimal utilization rates: Time limitations—(1) Unconditional status. A facility which meets minimal utilization requirements will be assigned this status as long as it continues to meet these requirements.
(2) Conditional status. A conditional status may be granted to a facility for not more than four consecutive calendar years and will not be renewable (see §405.2122(b) of this chapter). Its status may be examined each calendar year to ascertain its compliance with Subpart U.
(3) Exception status. Under unusual circumstances (see §405.2122 (b) of this chapter) the Secretary may grant a time-limited exception to a facility which is not in compliance with the minimal utilization rate(s) for either unconditional status or conditional status. This exception status may be granted, and may be renewed on an annual basis, under circumstances where rigid application of minimal utilization rate requirements would adversely affect the achievement of ESRD program objectives.
(c) New applicant. A facility which has not previously participated in the ESRD program must submit a plan detailing how it expects to meet the conditional minimal utilization rate status by the end of the second calendar year of its operation under the program and meet the unconditional minimal utilization rate status by the end of the fourth calendar year of its operation under the program.
(d) Notification. The Secretary will notify each facility and its network coordinating council of its initial and its subsequent minimal utilization rate classification.
(e) Failure to meet minimal utilization rate. A facility failing to meet standards for unconditional status or conditional status, or if applicable, for exception status, will be so notified at the time of such classification.
(f) Interim regulations participant. A facility previously participating under the interim regulations will not be approved under the program established by subpart U until it has demonstrated that it meets all the applicable requirements of this subpart, including the appropriate minimal utilization rate. It may continue under the interim program only for a period not to exceed 1 year from the effective date of these amendments (see §405.2100(c) of this chapter). During this period it may demonstrate its ability to meet the appropriate minimal utilization rate. Failure to qualify under this subpart will automatically terminate coverage of such facility's services under the ESRD program at the end of such year.
[41 FR 22510, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, and further amended at 45 FR 58124, Sept. 2, 1980. Redesignated and amended at 53 FR 23100, June 17, 1988]
§ 488.64 Remote facility variances for utilization review requirements.
(a) As used in this section:
(1) An “available” individual is one who:
(i) Possesses the necessary professional qualifications;
(ii) Is not precluded from participating by reason of financial interest in any such facility or direct responsibility for the care of the patients being reviewed or, in the case of a skilled nursing facility, employment by the facility; and
(iii) Is not precluded from effective participation by the distance between the facility and his residence, office, or other place of work. An individual whose residence, office, or other place of work is more than approximately one hour's travel time from the facility shall be considered precluded from effective participation.
(2) “Adjacent facility” means a health care facility located within a 50-mile radius of the facility which requests a variance.
(b) The Secretary may grant a requesting facility a variance from the time frames set forth in §§405.1137(d) of this chapter and 482.30 as applicable, within which reviews all of cases must be commenced and completed, upon a showing satisfactory to the Secretary that the requesting facility has been unable to meet one or more of the requirements of §405.1137 of this chapter or §482.30 of this chapter, as applicable, by reason of insufficient medical and other professional personnel available to conduct the utilization review required by §405.1137 of this chapter or §482.30 of this chapter, as applicable.
(c) The request for variance shall document the requesting facility's inability to meet the requirements for which a variance is requested and the facility's good faith efforts to comply with the requirements contained in §405.1137 of this chapter or §482.30 of this chapter, as applicable.
(d) The request shall include an assurance by the requesting facility that it will continue its good faith efforts to meet the requirements contained in §405.1137 of this chapter or §482.30 of this chapter, as applicable.
(e) A revised utilization review plan for the requesting facility shall be submitted concurrently with the request for a variance. The revised plan shall specify the methods and procedures which the requesting facility will use, if a variance is granted, to assure:
(1) That effective and timely control will be maintained over the utilization of services; and
(2) That reviews will be conducted so as to improve the quality of care provided to patients.
(f) The request for a variance shall include:
(1) The name, location, and type (e.g., hospital, skilled nursing facility) of the facility for which the variance is requested;
(2) The total number of patient admissions and average daily patient census at the facility within the previous six months;
(3) The total number of title XVIII and title XIX patient admissions and the average daily patient census of title XVIII and title XIX patients in the facility within the previous six months;
(4) As relevant to the request, the names of all physicians on the active staff of the facility and the names of all other professional personnel on the staff of the facility, or both;
(5) The name, location, and type of each adjacent facility (e.g., hospital, skilled nursing facility);
(6) The distance and average travel time between the facility and each adjacent facility;
(7) As relevant to the request, the location of practice of available physicians and the estimated number of other available professional personnel, or both (see paragraph (a)(1)(iii) of this section);
(8) Documentation by the facility of its attempt to obtain the services of available physicians or other professional personnel, or both; and
(9) A statement of whether a QIO exists in the area where the facility is located.
(g) The Secretary shall promptly notify the facility of the action taken on the request. Where a variance is in effect, the validation of utilization review pursuant to §405.1137 of this chapter or §482.30 shall be made with reference to the revised utilization review plan submitted with the request for variance.
(h) The Secretary, in granting a variance, will specify the period for which the variance has been granted; such period will not exceed one year. A request for a renewal shall be submitted not later than 30 days prior to the expiration of the variance and shall contain all information required by paragraphs (c), (d), and (f) of this section. Renewal of the variance will be contingent upon the facility's continuing to meet the provisions of this section.
[40 FR 30818, July 23, 1975. Redesignated at 42 FR 52826, Sept. 30, 1977; 51 FR 22041, June 17, 1986; 51 FR 27847, Aug. 4, 1986; 51 FR 43197, Dec. 1, 1986. Redesignated and amended at 53 FR 23100, June 17, 1988]
§ 488.68 State Agency responsibilities for OASIS collection and data base requirements.
As part of State agency survey responsibilities, the State agency or other entity designated by CMS has overall responsibility for fulfilling the following requirements for operating the OASIS system:
(a) Establish and maintain an OASIS database. The State agency or other entity designated by CMS must—
(1) Use a standard system developed or approved by CMS to collect, store, and analyze data;
(2) Conduct basic system management activities including hardware and software maintenance, system back-up, and monitoring the status of the database; and
(3) Obtain CMS approval before modifying any parts of the CMS standard system including, but not limited to, standard CMS-approved—
(i) OASIS data items;
(ii) Record formats and validation edits; and
(iii) Agency encoding and transmission methods.
(b) Analyze and edit OASIS data. The State agency or other entity designated by CMS must—
(1) Upon receipt of data from an HHA, edit the data as specified by CMS and ensure that the HHA resolves errors within the limits specified by CMS;
(2) At least monthly, make available for retrieval by CMS all edited OASIS records received during that period, according to formats specified by CMS, and correct and retransmit previously rejected data as needed; and
(3) Analyze data and generate reports as specified by CMS.
(c) Ensure accuracy of OASIS data. The State agency must audit the accuracy of the OASIS data through the survey process.
(d) Restrict access to OASIS data. The State agency or other entity designated by CMS must do the following:
(1) Ensure that access to data is restricted except for the transmission of data and reports to—
(i) CMS;
(ii) The State agency component that conducts surveys for purposes related to this function; and
(iii) Other entities if authorized by CMS.
(2) Ensure that patient identifiable OASIS data is released only to the extent that it is permitted under the Privacy Act of 1974.
(e) Provide training and technical support for HHAs. The State agency or other entity designated by CMS must—
(1) Instruct each HHA on the administration of the data set, privacy/confidentiality of the data set, and integration of the OASIS data set into the facility's own record keeping system;
(2) Instruct each HHA on the use of software to encode and transmit OASIS data to the State;
(3) Specify to a facility the method of transmission of data to the State, and instruct the facility on this method.
(4) Monitor each HHA's ability to transmit OASIS data.
(5) Provide ongoing technical assistance and general support to HHAs in implementing the OASIS reporting requirements specified in the conditions of participation for home health agencies; and
(6) Carry out any other functions as designated by CMS necessary to maintain OASIS data on the standard State system.
[64 FR 3763, Jan. 25, 1999]
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