[Federal Register Volume 78, Number 144 (Friday, July 26, 2013)]
[Notices]
[Pages 45231-45233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3280-FN]


Medicare and Medicaid Programs; Initial Approval of Center for 
Improvement in Healthcare Quality's (CIHQ'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 Center 
for Improvement in Healthcare Quality (CIHQ) as a national accrediting 
organization for hospitals that wish to participate in the Medicare or 
Medicaid programs.

DATES: This final notice is effective July 26, 2013 through July 26, 
2017.

FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310. Monda 
Shaver, (410) 786-3410. Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a hospital provided certain requirements are met. 
Section 1861(e) of the Social Security Act (the Act) establishes 
distinct criteria for facilities seeking designation as a hospital. 
Regulations concerning provider agreements are at 42 CFR part 489 and 
those pertaining to activities relating to the survey and certification 
of facilities are at 42 CFR part 488. The regulations at 42 CFR part 
482 specify the conditions that a hospital must meet to participate in 
the Medicare program, the scope of covered services, and the conditions 
for Medicare payment for hospitals.
    Generally, to enter into an agreement, a hospital must first be 
certified by a State survey agency as complying with the conditions or 
requirements set forth in part 482. Thereafter, the hospital is subject 
to regular surveys by a State survey agency to determine whether it 
continues to meet these requirements. However, there is an alternative 
to surveys by State agencies. Certification by a nationally recognized 
accreditation program can substitute for ongoing State review.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization (AO) that all applicable Medicare conditions are met or 
exceeded, we will deem that provider entity as having met the 
requirements. Accreditation by an AO is voluntary and is not required 
for Medicare participation.
    If an AO is recognized by the Secretary as having standards for 
accreditation that meet or exceed Medicare requirements, any provider 
entity accredited by the national accrediting body's approved program 
would be deemed to have met the Medicare conditions. A national AO 
applying for approval of its accreditation program under part 488, 
subpart A, must provide CMS with reasonable assurance that the AO 
requires the accredited provider entities to meet requirements that are 
at least as stringent as the Medicare conditions. Our regulations 
concerning the approval of AOs are set forth at Sec.  488.4 and Sec.  
488.8(d)(3). The regulations at Sec.  488.8(d)(3) require AOs to 
reapply for continued approval of their accreditation program every 6 
years, or sooner, as determined by CMS.

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

    On February 22, 2013, we published a proposed notice in the Federal 
Register (78 FR 12325) announcing CIHQ's request for approval of its 
hospital accreditation program. In the 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 
CIHQ's application in accordance with the criteria specified by our 
regulations, which include, but are not limited to, the following:
     An onsite administrative review of CIHQ's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited facilities; and, (5) 
survey review and decision-making process for accreditation.
     The comparison of CIHQ's accreditation to our current 
Medicare hospital conditions of participation.
     A documentation review of CIHQ's survey process to 
determine the following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and CIHQ's ability to provide continuing surveyor 
training.
    ++ Compare CIHQ's processes to those of State survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ Evaluate CIHQ's procedures for monitoring hospitals out of 
compliance with CIHQ's program requirements. The monitoring procedures 
are used only when CIHQ identifies noncompliance. If noncompliance is 
identified through validation reviews, the State survey agency monitors 
corrections as specified at Sec.  488.7(d).
    ++ Assess CIHQ's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ Establish CIHQ's ability to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ Determine the adequacy of staff and other resources.
    ++ Confirm CIHQ's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm CIHQ's policies with respect to whether surveys are 
announced or unannounced.
    ++ Obtain CIHQ's agreement to provide CMS 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 February 
22, 2013 proposed notice also solicited public comments regarding 
whether CIHQ's requirements met or exceeded the Medicare conditions of 
participation for hospitals. We received 56 comments in response to our 
proposed notice. The commenters expressed unanimous support for CIHQ's 
hospital

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accreditation program. In addition, the commenters stated CIHQ's 
standards are closely aligned with the hospital conditions of 
participation, thus allowing hospitals to be in compliance with the 
Medicare requirements.

IV. Provisions of the Final Notice

A. Differences Between CIHQ's Standards and Requirements for 
Accreditation and Medicare's Conditions and Survey Requirements

    We compared CIHQ's hospital requirements and survey process with 
the Medicare conditions of participation and survey process as outlined 
in the State Operations Manual (SOM). Our review and evaluation of 
CIHQ's hospital application, which were conducted as described in 
section III of this final notice, yielded the following:
     To meet the requirements at Sec.  482.13(a)(2), CIHQ 
revised its standards to address the hospital's responsibility to 
provide a process for prompt resolution of patient grievances.
     To meet the requirements at Sec.  482.13(b)(2), CIHQ 
revised its standards to address the role of the patient's 
representative (as allowed under State law) .
     To meet the requirements at Sec.  482.13(b)(3), CIHQ 
revised its standards to include the requirements at Sec.  489.100, 
Sec.  489.102, and Sec.  489.104 regarding advance directives.
     To meet the requirements at Sec.  482.13(d)(2), CIHQ 
revised its standards to ensure that hospitals have a responsibility to 
meet patient requests for access to information as quickly as its 
record keeping system permits.
     To meet the requirements at Sec.  482.13(e)(4)(i), CIHQ 
modified its standards to require the hospital update the patient's 
plan of care when restraints or seclusion are utilized.
     To meet the requirements at Sec.  482.13(e)(5), CIHQ 
modified its standards to include the provision allowing other licensed 
independent practitioners, who are responsible for the care of the 
patient, to write orders for restraint or seclusion.
     To meet the requirements at Sec.  482.13(e)(8)(ii), CIHQ 
modified its standards to include the reference to a physician or other 
licensed independent practitioner, as delineated at Sec.  482.12(c).
     To meet the requirements at Sec.  482.13(e)(11), CIHQ 
modified its standards to address that the physician and other licensed 
independent practitioners training requirements must be specified in 
hospital policy.
     To meet the requirements at Sec.  482.13(g)(1), CIHQ 
modified its standards to permit the hospital to communicate deaths to 
CMS by facsimile or electronically as determined by CMS.
     To meet the requirements at Sec.  482.13(h)(1), CIHQ 
modified its standards to require the hospital to inform each patient 
of his or her visitation rights.
     To meet the requirements at Sec.  482.22(a)(2), CIHQ 
modified its standards to require that a candidate who has been 
recommended by the medical staff and appointed by the governing body be 
subject to all medical staff bylaws, rules, and regulations, in 
addition to the requirements contained at Sec.  482.22.
     To meet the requirements at Sec.  482.23(b)(3), CIHQ 
modified its standards to include language that a registered nurse must 
supervise the care of each patient.
     To meet the requirements at Sec.  482.23(c)(1), CIHQ 
modified its standards to address biologicals.
     To meet the requirements at Sec.  482.23(c)(1)(ii), CIHQ 
modified its standards to address pre-printed and electronic standing 
orders, order sets, and protocols for orders related to the preparation 
and administration of drugs and biologicals.
     To meet the requirements at Sec.  482.23(c)(4), CIHQ 
modified its standards to address the requirement that blood and 
intravenous medication administration occurs only in accordance with 
state law and approved medical staff policies and procedures.
     To meet the requirements at Sec.  482.24(c)(1) through 
(c)(3)(iv), CIHQ modified its standards to address the requirements 
related to the appropriate authentication of all orders, including 
verbal orders; the appropriate use of standing orders, order sets and 
protocols within nationally recognized guidelines; the periodic review 
of such orders and protocols; and the authentication of such orders and 
protocols within the medical record.
     To meet the requirements at Sec.  482.25, CIHQ modified 
its standards to address the medical staff's responsibility to oversee 
the development of policies and procedures to minimize drug errors.
     To meet the requirements at Sec.  482.25(a), CIHQ modified 
its standards to require that the pharmacy or drug storage area be 
administered in accordance with accepted professional principles.
     To meet the requirements atSec.  482.25(b)(4), CIHQ 
modified its standards to limit the removal of drugs and biologicals 
from the pharmacy or storage area only by personnel designated in the 
policies of the medical staff and pharmaceutical service, in accordance 
with federal and sState law.
     To meet the requirements at Sec.  482.25(b)(5), CIHQ 
modified its standards to address the medical staff's responsibility to 
predetermine a reasonable time to automatically stop drugs and 
biologicals.
     To meet the requirements at Sec.  482.25(b)(6), CIHQ 
modified its standards to address the immediate reporting of drug 
errors, adverse reactions, and incompatibilities to the attending 
physician.
     To meet the requirements at Sec.  482.26, CIHQ modified 
its standards to clearly identify radiologic services as a service that 
the hospital is required to provide its patients.
     To meet the requirements at Sec.  482.41(a), CIHQ modified 
its standards to delineate that building inspections and maintenance 
are to be conducted on an on-going basis. CIHQ also modified its 
standards to specify that if a hospital intends to provide medical 
treatment to the victims of a disaster, it must be in compliance with 
NFPA99, Section 11-3.
     To meet the requirements at Sec.  482.41(b)(7) and NFPA 
101 (LSC) 18/19.7.1, CIHQ modified its standards to require: a written 
evacuation and relocation plan be available to all supervisory 
personnel and employees; that employees are informed of their duties 
under the plan; and that a copy of the plan is to be readily available 
at all times in the telephone operator's position or at the security 
center. In addition, CIHQ modified its standards to require that the 
hospital instruct employees on life safety procedures and devices.
     To meet the requirements at Sec.  482.41(b)(7), the NFPA 
101 (LSC) 18/19.7.2.1, and the Life Safety Code Annex A 19.7.1.2, CIHQ 
modified its standards to require signal transmission of alarms for all 
fire drills and that all fire drills be scheduled unannounced on a 
random basis.
     To meet the requirements at Sec.  482.43, CIHQ modified 
its standards to address the hospital's responsibility to have a 
discharge planning process in writing that applies to all patients.
     To meet the requirements at Sec.  482.43(b)(6), CIHQ 
modified its standards to require that the results of the discharge 
planning evaluation be discussed with the patient or an individual 
acting on behalf of the patient.
     To meet the requirements at Sec.  482.51, CIHQ modified 
its standards to specify that if outpatient surgical services are 
offered, the services must be

[[Page 45233]]

consistent in quality with inpatient surgical services.
     To meet the requirements at Sec.  482.51(b)(5), CIHQ 
modified its standards to require that the operating room register be 
complete and up-to-date.
     To meet the requirements at Sec.  482.51(b)(6), CIHQ 
modified its standards to address the requirement that an operative 
report must be written or dictated immediately following surgery and 
signed by the surgeon.
     To meet the requirements at Sec.  482.56(a)(2), CIHQ 
modified its standards to include the reference to part 484 of the Code 
of Federal Regulations.
     To meet the survey process requirements in Appendix A of 
the SOM, CIHQ revised its policies outlining the survey size and 
composition to require that every survey will include at least one 
registered nurse with hospital survey experience.
     To meet the survey process requirements in Appendix Q of 
the SOM, CIHQ revised its policies to require notification to CMS of an 
immediate jeopardy situation, the content of the CMS notification, and 
the appropriate level of citation related to immediate jeopardy 
findings.
     To meet the requirements found at Section 2728B of the 
SOM, CIHQ revised its policies to require a more detailed monitoring 
plan that includes frequency of monitoring, duration of monitoring, 
sample size and target threshold, as part of a hospital's plan of 
correction for deficiencies found on survey.
     To meet the requirements found at Section 2005A2 of the 
SOM, CIHQ revised its policies to require the issuance of an 
accreditation denial for hospitals initially seeking participation in 
the Medicare program when the hospital has been found to be non-
compliant with a condition of participation.
     To meet the requirements at Sec.  498.13 and Section 2008D 
of the SOM, CIHQ revised its policies to clearly state that the final 
accreditation decision is based on the final survey report in which the 
provider meets all requirements or the date, which the provider is 
found to meet all conditions but has lower level deficiencies and CIHQ 
has received an acceptable plan of correction.
     To meet the requirements at Section 3012 of the SOM, CIHQ 
revised its policies to accurately reflect the requirement that follow-
up surveys must be conducted within 45 calendar days from the survey 
end-date of the survey, which the condition level finding was cited.
     To clarify the survey process and to ensure the consistent 
application of survey activities, CIHQ updated its policies, survey 
tools and guidance to surveyors related to tracer activities, patient 
interviews, and staff interviews.
     To eliminate any real or perceived conflict of interest 
between CIHQ's consulting services through ``Accreditation Resource 
Services'' and its accreditation activities, CIHQ updated its plan to 
ensure that both entities are separated by a firewall and that 
information is not shared.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that CIHQ's requirements for 
hospitals meet or exceed our requirements. Therefore, we approve CIHQ 
as a national accreditation organization for hospitals that request 
participation in the Medicare program, effective July 26, 2013. through 
July 26, 2017.

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).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program)

    Dated: July 2, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-18014 Filed 7-25-13; 8:45 am]
BILLING CODE 4120-01-P