[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36524-36527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3290-FN]
Medicare and Medicaid Programs; Continued Approval of The Joint
Commission's (TJC's) Hospital Accreditation Program
AGENCY: Centers for Medicare and Medicaid Services, HHS.
ACTION: Final notice.
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SUMMARY: This final notice announces our decision to approve The Joint
Commission (TJC) for continued recognition as a national accrediting
organization for hospitals that wish to participate in the Medicare or
Medicaid programs. A hospital that participates in Medicaid must also
meet the Medicare conditions of participation (CoPs) as required under
section 1905(a) of the Social Security Act (``Act'') and 42 CFR
482.1(a)(5). This approval is effective July 15, 2014 through July 15,
2020.
DATES: This final notice is effective July 15, 2014 through July 15,
2020.
FOR FURTHER INFORMATION CONTACT: Monda Shaver (410) 786-3410, Cindy
Melanson, (410) 786-0310, or Patricia Chmielewski, (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
A healthcare provider may enter into an agreement with Medicare to
participate in the program as a hospital provided certain requirements
are met. Section 1861(e) of the Social Security Act (the Act)
establishes criteria for providers seeking participation as a hospital.
Regulations concerning Medicare provider agreements in general are at
42 CFR part 489 and those pertaining to the survey and certification
for Medicare participation of providers and certain types of suppliers
are at part 488. The regulations at part 482 specify the specific
conditions that a provider must meet to participate in the Medicare
program as a hospital.
Generally, to enter into a Medicare hospital provider agreement, a
facility must first be certified as complying with the conditions set
forth in part 482 and recommended to us for participation by a state
survey agency. Thereafter, the hospital is subject to periodic surveys
by a state survey agency to determine whether it continues to meet
these conditions. However, there is an alternative to certification
surveys by state agencies. Accreditation by a nationally recognized
Medicare accreditation program approved by us may substitute for both
initial and ongoing state review.
Section 1865(a)(1) of the Act provides that, if the Secretary finds
that accreditation of a provider entity by an approved national
accrediting organization meets or exceeds all applicable Medicare
conditions, we may treat the provider entity as having met those
conditions, that is, we may ``deem'' the provider entity to be in
compliance. Accreditation by an accrediting organization is voluntary
and is not required for Medicare participation.
Part 488, subpart A, implements the provisions of section 1865 and
requires that a national accrediting organization applying for approval
of its Medicare accreditation program must provide us with reasonable
assurance that the accrediting organization requires its accredited
provider entities to meet requirements that are at least as stringent
as the Medicare conditions. Our regulations concerning the approval of
accrediting organizations are set forth at Sec. 488.4 and Sec.
488.8(d)(3). The regulations at Sec. 488.8(d)(3) require an
accrediting organization to reapply for continued approval of its
Medicare accreditation program every 6 years or sooner as determined by
us. TJC's current term of approval as a recognized
[[Page 36525]]
Medicare accreditation program for hospitals expires July 15, 2014.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of applications for CMS-approval of an
accreditation program is conducted in a timely manner. The Act provides
us 210 days after the date of receipt of a complete application, with
any documentation necessary to make the determination, to complete our
survey activities and application process. Within 60 days after
receiving a complete application, we must publish a notice in the
Federal Register that identifies the national accrediting body making
the request, describes the request, and provides no less than a 30-day
public comment period. At the end of the 210-day period, we must
publish a notice in the Federal Register approving or denying the
application.
III. Provisions of the Proposed Notice
In the January 29, 2014 Federal Register (79 FR 4727), we published
a proposed notice announcing TJC's request for continued approval of
its Medicare hospital accreditation program. In the January 29, 2014
proposed notice, we detailed our evaluation criteria. Under section
1865(a)(2) of the Act and in our regulations at Sec. 488.4 and Sec.
488.8, we conducted a review of TJC's Medicare hospital accreditation
application in accordance with the criteria specified by our
regulations, which include, but are not limited to the following:
An onsite administrative review of TJC's: (1) Corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its hospital surveyors; (4) ability to investigate and
respond appropriately to complaints against accredited hospitals; and,
(5) survey review and decision-making process for accreditation.
The comparison of TJC's Medicare accreditation program
standards to our current Medicare hospital CoPs.
A documentation review of TJC's survey process to
determine the following:
++ Determine the composition of the survey team, surveyor
qualifications, and TJC's ability to provide continuing surveyor
training.
++ Compare TJC's processes to those we require of state survey
agencies, including periodic resurvey and the ability to investigate
and respond appropriately to complaints against accredited hospitals.
++ Evaluate TJC's procedures for monitoring hospitals it has found
to be out of compliance with TJC's program requirements. (This pertains
only to monitoring procedures when TJC identifies non-compliance. If
noncompliance is identified by a state survey agency through a
validation survey, the state survey agency monitors corrections as
specified at Sec. 488.7(d).)
++ Assess TJC's ability to report deficiencies to the surveyed
hospitals and respond to the hospital's plan of correction in a timely
manner.
++ Establish TJC's ability to provide us with electronic data and
reports necessary for effective validation and assessment of the
organization's survey process.
++ Determine the adequacy of TJC's staff and other resources.
++ Confirm TJC's ability to provide adequate funding for performing
required surveys.
++ Confirm TJC's policies with respect to surveys being
unannounced.
++ Obtain TJC's agreement to provide us with a copy of the most
current accreditation survey together with any other information
related to the survey as we may require, including corrective action
plans.
In accordance with section 1865(a)(3)(A) of the Act, the January
29, 2014 proposed notice also solicited public comments regarding
whether TJC's requirements met or exceeded the Medicare CoPs for
hospitals. We received two unrelated comments in response to our
proposed notice.
IV. Provisions of the Final Notice
A. Differences Between TJC's Standards and Requirements for
Accreditation and Medicare Conditions and Survey Requirements
We compared TJC's hospital accreditation requirements and survey
process with the Medicare CoPs of 42 CFR Part 482, and the survey and
certification process requirements of Parts 488 and 489. Our review and
evaluation of TJC's hospital application, which were conducted as
described in section III of this final notice, yielded the following
areas where, as of the date of this notice, TJC is in the process of or
has completed revising its standards and certification processes in
order to meet the requirements at:
Sec. 482.12(a)(1), to address the hospital's
responsibility to determine which categories of practitioners are
eligible candidates for appointment to the medical staff.
Sec. 482.12(a)(2), to ensure recommendations of the
existing members of the medical staff are considered by the governing
body during the medical staff appointment process.
Sec. 482.12(c)(2), to include the requirement that
patients are admitted to the hospital only on the recommendation of a
licensed practitioner.
Sec. 482.13(a)(1), to ensure hospitals inform each
patient or patient's representative of the patient's rights, in advance
of furnishing or discontinuing patient care whenever possible.
Sec. 482.13(b)(4), to address the patient's right to have
a family member or representative of his or her choice notified
promptly of the patient's admission to the hospital.
Sec. 482.13(h) and Sec. 482.13(h)(1), to include the
provisions that require hospitals inform each patient of his or her
visitation rights and address the requirement for hospitals to have
written policies and procedures regarding the visitation rights of
patients, including those setting forth any clinical restriction or
limitation that the hospital may need to place on such rights and the
reasons for the clinical restriction or limitation.
To meet the requirements at Sec. 482.13(h)(2), TJC
revised its standards to include the requirement that the hospital must
inform each patient of their right to receive designated visitors.
Sec. 482.13(h)(4), to ensure all visitors enjoy full and
equal visitation privileges consistent with patient preferences.
Sec. 482.21, to address the hospital governing body's
responsibility for maintaining an ongoing quality assessment and
performance improvement (QAPI) program that includes services provided
under arrangement; maintenance and demonstration of evidence of its
QAPI program for review by us; and that the QAPI program is developed
and executed in a manner that reflects the complexity of the hospital
scope and focus.
Sec. 482.22(a), to indicate that the medical staff may
also include other categories of non-physician practitioners as
eligible for appointment by the governing body.
Sec. 482.23(b)(3), to require that a registered nurse
must supervise the nursing care of each patient.
Sec. 482.23(b)(5), to ensure a registered nurse assigns
the nursing care of each patient to other nursing personnel.
Sec. 482.23(c)(6)(i)(A) and Sec. 482.23(c)(6)(ii)(A), to
require a written order permitting patient self-administration of
hospital issued medications and the patient's own medications brought
to the hospital.
[[Page 36526]]
Sec. 482.23(c)(6)(ii)(B), to include a provision for
assessing the patient's capacity to self-administer medications and
determining if the patient needs instruction in the safe and accurate
administration of medications.
Sec. 482.24(a), to ensure the organization of the medical
record service is appropriate to the scope and complexity of the
services performed.
Sec. 482.24(b), related to the form and retention of the
medical record.
Sec. 482.24(b)(2), to include a provision that hospitals
have a system that allows for timely retrieval by diagnosis and
procedure, in order to support medical care evaluation and studies.
Sec. 482.24(c)(2), to require all orders, including
verbal orders, be dated, timed, and authenticated promptly by the
ordering practitioner or another practitioner who is responsible for
the care of the patient.
Sec. 482.24(c)(4)(iv), to require documentation of
complications, hospital-acquired infections, and unfavorable reactions
to drugs and anesthesia.
Sec. 482.25(a), to include the requirement that the
pharmacy or drug storage area must be administered in accordance with
accepted professional principles.
Sec. 482.26, to include therapeutic radiologic services
and the requirement that radiologic services must meet professionally
approved standards for safety and personnel qualifications.
Sec. 482.26(b)(3), to require radiation workers be
checked periodically for amounts of radiation exposure.
Sec. 482.27, to require that the hospital maintain, or
have available, adequate laboratory services to meet the needs of its
patients and that such services are performed in a facility certified
in accordance with part 493 of this chapter.
Sec. 482.28, to address the hospital's responsibility to
have a dietitian who serves the hospital on a full-time, part-time, or
consultant basis either directly or through a contractual arrangement.
Sec. 482.28(a)(1), to require that hospitals have a full-
time employee responsible for the food and dietetic service.
Sec. 482.41, to address the hospital's responsibility to
provide facilities for special services appropriate to the needs of the
community.
Sec. 482.41(a)(1), to address the requirement for
emergency power and lighting in intensive care and emergency rooms.
Sec. 482.41(b)(1)(i) and chapters 18/19.7.1.2 and 18/
19.7.1.3 of the Life Safety Code (LSC), to address various fire drill
requirements that include transmission of a fire alarm signal,
simulation of emergency fire conditions, varying conditions, and
employees being instructed in life safety procedures and devices.
Sec. 482.41(b)(2), to require submission of an
equivalency or waiver request, including the supporting documentation
along with TJC's recommendation for approval, to the applicable CMS
Regional Office for processing.
Sec. 482.41(b)(6), to address the proper routine storage
and prompt disposal of trash.
Sec. 482.41(b)(7), to include the requirement that the
fire control plan must contain provisions for the prompt reporting of
fires.
Sec. 482.43(c)(4), to address the hospital's
responsibility to reassess the patient's discharge plan if there are
factors that may affect continuing care needs or the appropriateness of
the discharge plan.
Sec. 482.43(c)(6), to include the requirement that a home
health agency (HHA) must request to be included on the list of HHAs a
hospital provides to patients as part of their discharge plan.
Sec. 482.51(a)(4), to include a requirement for surgical
services to maintain a roster of practitioners, specifying the surgical
privileges of each practitioner.
Sec. 482.51(b)(2), to include a requirement that a
properly executed informed consent for an operation must be in the
patient's chart before surgery, except in emergencies.
Sec. 482.52(a)(5), to include a requirement that the
supervising anesthesiologist for an anesthesiologist's assistant be
immediately available if needed.
Sec. 482.53(b)(3), to ensure laboratory tests performed
in the nuclear medicine service meet the applicable requirement for
laboratory services specified in Sec. 482.27.
Sec. 482.53(d)(3), to require the hospital maintain
records of the disposition of radiopharmaceuticals.
Sec. 482.55, to require the hospital to meet the
emergency needs of patients in accordance with acceptable standards of
practice.
Sec. 482.56(a)(2), to ensure physical therapy,
occupational therapy, speech-language pathology, and audiology services
are provided by qualified therapists, as defined in 42 CFR part 484.
Sec. 482.56(b)(2), to require the personnel
qualifications of those providing care must be in accordance with
nationally accepted standards of practice and meet the requirements at
Sec. 409.17.
Sec. 482.57(b)(2), to require blood gases or other
laboratory tests performed in the respiratory care unit to meet the
applicable requirements for laboratory services specified in Sec.
482.27.
Sec. 488.3(a), to ensure that all services, including
physician and ambulatory care services, which are furnished under the
hospital's Medicare provider agreement are surveyed for compliance with
TJC's CMS-approved Medicare hospital accreditation program.
Sec. 488.4(a)(4), to clarify the minimum composition of
its survey team for its Medicare hospital accreditation program.
Sec. 488.4(a)(4)(ii) through (v), to ensure compliance
with its own policies that require evidence that its surveyors are
appropriately qualified, trained, and evaluated.
Sec. 488.4(a)(6), to ensure compliance with its own
policies that require plan of correction requests to be timely, follow-
up surveys for ITL situations to be conducted timely, and that findings
are accurately reported to us via the ASSURE database system.
Sec. 488.4(b)(3)(iii) and Sec. 488.8(d), to ensure we
are notified of any proposed changes in its CMS-approved Medicare
hospital accreditation program prior to implementation of such changes
within 30 days, and to confirm that it will not implement changes we
have disapproved or required to be modified.
Sec. 488.8, to provide us with data that ensures the
following information is accurately reported: The date of a complaint
receipt; determination of complaints as substantiated or
unsubstantiated; determinations of ITL situations; final accreditation
decisions for surveys where no deficiencies are found; and surveyor
documentation that includes a detailed deficiency statement that
clearly supports the determination of manner and degree of non-
compliance and the appropriate level of citation.
To ensure comparability with the survey process
requirements at Sec. 488.26(d), TJC:
++ Updated its accreditation process policies to clarify that all
surveys for TJC's Medicare hospital accreditation program are conducted
unannounced.
++ Updated its accreditation process policies to ensure all
required follow-up surveys for its Medicare hospital accreditation
program meet the Medicare requirements.
++ Revised its accreditation process policies to clarify that the
appropriate level of citation be made when an
[[Page 36527]]
Immediate Threat to Health or Safety (ITL) is identified.
++ Clarified its survey policies in the surveyor activity guide
(SAG) to address how ``Special Issue Resolution'' is handled during
surveys lasting only one day.
++ Updated its accreditation process policies to ensure its
definition of a small hospital is consistent across its policies.
Sec. 488.28(a), to include all documented observations of
non-compliance and all internal, uncompleted Plans for Improvement
(PFI) listed in the accredited hospital's ``Statement of Condition
(SOC) to correct Life Safety Code Deficiencies'' into the survey
report.
Sec. 489.13, related to the effective date of
accreditation for facilities undergoing a survey for purposes of its
initial participation in Medicare to ensure the survey process and
effective date of accreditation when deficiencies have been identified
are consistent with the regulatory requirements.
Complied with section 1861(e)(9)(C) of the Act, to require
that waiver and equivalency requests submitted by accredited
organizations for Life Safety Code deficiencies that would result in
unreasonable hardship for such a facility to resolve and would not
jeopardize patient health or safety, be reviewed by TJC, and forwarded
to us for approval, as appropriate.
B. Term of Approval
Based on our review and observations described in section III of
this final notice, we approve TJC as a national accreditation
organization for hospitals that request participation in the Medicare
program, effective July 15, 2014 through July 15, 2020.
To verify TJC's continued compliance with the provisions of this
final notice, we will conduct a follow-up corporate on-site visit and
survey observation within 18 months of the date of publication of this
notice.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
Dated: June 16, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-15103 Filed 6-26-14; 8:45 am]
BILLING CODE 4120-01-P