Federal Register / Vol. 78, No. 144 / Friday, July 26, 2013 / Notices 45231 

[FR Doc. 2013–17965 Filed 7–25–13; 8:45 am] 

BILLING CODE 4120–01–P 

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. 

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 § 488.4 and 

§ 488.8(d)(3). The regulations at 

§ 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 CMSapproval 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 § 488.4 and § 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 decisionmaking 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 § 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 


tkelley on DSK3SPTVN1PROD with NOTICES
45232 Federal Register / Vol. 78, No. 144 / Friday, July 26, 2013 / Notices 

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 

§ 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 

§ 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 

§ 482.13(b)(3), CIHQ revised its 

standards to include the requirements at 

§ 489.100, § 489.102, and § 489.104 

regarding advance directives. 

• To meet the requirements at 

§ 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 

§ 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 

§ 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 

§ 482.13(e)(8)(ii), CIHQ modified its 

standards to include the reference to a 

physician or other licensed independent 

practitioner, as delineated at § 482.12(c). 

• To meet the requirements at 

§ 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 

§ 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 

§ 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 

§ 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 § 482.22. 

• To meet the requirements at 

§ 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 

§ 482.23(c)(1), CIHQ modified its 

standards to address biologicals. 

• To meet the requirements at 

§ 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 

§ 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 

§ 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 

§ 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 

§ 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 

at§ 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 

§ 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 

§ 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 

§ 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 

§ 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 

§ 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 

§ 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 

§ 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 

§ 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 

§ 482.51, CIHQ modified its standards to 

specify that if outpatient surgical 

services are offered, the services must be 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 144 / Friday, July 26, 2013 / Notices 45233 

consistent in quality with inpatient 

surgical services. 

• To meet the requirements at 

§ 482.51(b)(5), CIHQ modified its 

standards to require that the operating 

room register be complete and up-todate. 

• To meet the requirements at 

§ 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 

§ 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 noncompliant with a condition of 

participation. 

• To meet the requirements at 

§ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9080–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—April Through June 2013 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This quarterly notice lists 

CMS manual instructions, substantive 

and interpretive regulations, and other 

Federal Register notices that were 

published from April through June 

2013, relating to the Medicare and 

Medicaid programs and other programs 

administered by CMS. 

FOR FURTHER INFORMATION CONTACT: It is 

possible that an interested party may 

need specific information and not be 

able to determine from the listed 

information whether the issuance or 

regulation would fulfill that need. 

Consequently, we are providing contact 

persons to answer general questions 

concerning each of the addenda 

published in this notice. 


tkelley on DSK3SPTVN1PROD with NOTICES