Ohio Administrative Code
Title 3701 - Department of Health - Administration and Director
Chapter 3701-22 - Hospital Licensure
Section 3701-22-07 - Basic hospital functions
Universal Citation: OH Admin Code 3701-22-07
Current through all regulations passed and filed through September 16, 2024
Each hospital, other than a critical access hospital or a rural emergency hospital, is to provide for the following:
(A) A quality assessment and performance improvement program, in accordance with 42 CFR 482.21. In addition, the hospital will participate in quality assessment and performance improvement projects identified by the director in consultation with the representatives of the regulated industry. Such projects may include those:
(1)
Required by the
United States centers for medicare and medicaid services or the hospital's
accrediting organization; or
(2)
For a hospital
with a maternity unit and newborn care nursery, implementation of one or more
maternal safety bundle(s) developed by the alliance for innovation in maternal
health.
(B) Medical staff, in accordance with 42 CFR 482.22;
(C) Nursing services, in accordance with 42 CFR 482.23;
(D) Medical records services, in accordance with 42 CFR 482.24;
(E) Pharmaceutical services, in accordance with 42 CFR 482.25;
(F) Radiologic services, in accordance with 42 CFR 482.26;
(G) Laboratory services, in accordance with 42 CFR 482.27;
(H) Food and dietetic services, in accordance with 42 CFR 482.28;
(I) Utilization review, in accordance with 42 CFR 482.30;
(J) Physical environment, in accordance with 42 CFR 482.41;
(K) Infection prevention and control and antibiotic stewardship programs, in accordance with 42 CFR 482.42. In addition, the hospital will:
(1)
Maintain a
tuberculosis control plan that meets the standards set forth in rule
3701-15-03 of the Administrative
Code;
(2)
Implement a written surveillance plan outlining the
activities for monitoring/tracking infections based on nationally-recognized
surveillance criteria such as the CDC's national healthcare safety network
(NHSN) criteria to define infections or other nationally recognized system for
hospitals and:
(a)
Includes a surveillance system that includes a data
collection tool; and
(b)
Uses surveillance data to implement timely corrective
actions when:
(i)
A greater than expected number healthcare-associated
infections are detected;
(ii)
Transmission of targeted multi-drug resistant organisms
(e.g., cre, candida auris) are detected;
(3)
Establish and
implement an effective water management program to identify hazardous
conditions, and take steps to manage the risk of occurrence and transmission of
waterborne pathogens, including but not limited to legionella, in building
water systems in accordance with guidance from the United States centers for
disease control and prevention (available at
https://www.cdc.gov/control-legionella/php/toolkit/wmp-toolkit.html) and recommendations of the United States centers for
disease control and prevention healthcare infection control practices advisory
committee, "Environmental Infection Control Guidelines" (2019) or its
successors.
(a)
Within the first twelve months, two sets of validation
testing in the building water system of each building that provides inpatient
medical or surgical services, taken no fewer than four months apart and more
than eight months apart, is to occur. Each set of water samples will be
representative of all hot potable water loops and water sources based upon the
risk assessment and conditions identified in the water management program,
including but not limited to cooling towers, therapy spas, decorative fountains
or water features where exposure to aerosols may occur in order to evaluate the
performance of the water management program in controlling legionella risk or
other waterborne pathogens. A hospital that has demonstrated detections of less
than one cfu/ml of legionella through at least two prior validation test sets
collected over a one year period may conduct annual validation testing in lieu
of twice-yearly testing. Validation testing includes all of the
following:
(i)
At least one cold water sample obtained from the incoming
water mains from the public water system or the water source;
(ii)
At minimum,
representative samples obtained from distal and proximal locations on each hot
water loop on the hot water distribution system; and
(iii)
Measurement of
total or free chlorine residual, as appropriate, at the time of sample
collection, and the observed sustained maximum temperatures for cold and hot
water samples.
(b)
Collection of water samples under this paragraph will
conform to the United States centers for disease control and prevention's
guidelines for water testing for legionella available at
https://www.cdc.gov/control-legionella/php/toolkit/routine-testing-module.html
and
https://www.cdc.gov/investigate-legionella/media/pdfs/cdc-sampling-procedure.pdf. Samples collected may be less than one liter in volume.
Collected samples are to be analyzed at a laboratory that has been accredited
by a national or international accrediting body according to national or
international recognized standards, that has legionella culture testing
included in the laboratory's scope of accreditation.
(4)
As it relates to
waterborne pathogens, coordinate with the Ohio department of health and the
local health district having jurisdiction when there is a legionellosis
presumptive healthcare-associated case, there are two or more legionellosis
possible healthcare-associated cases in a twelve-month period, or when a
legionellosis outbreak occurs. When an investigation is required, investigation
activities are coordinated with the disease surveillance and recommendations in
the Ohio department of health's "Infectious Disease Control Manual," available
online at
https://odh.ohio.gov/know-our-programs/infectious-disease-control-manual , the CDC guidance on defining healthcare-associated cases
available at
https://www.cdc.gov/investigate-legionella/php/healthcare-resources/healthcare-facilities.html, and CDC guidance on conducting investigations available
at
https://www.cdc.gov/investigate-legionella/php/healthcare-resources/testing-collecting-specimens.html, and includes any or all of the following:
(a)
Implementing
water use restrictions and/or installation of absolute 0.2 micron biological
United States food and drug administration-approved point of use filters on
potable hot water fixtures throughout the facility as appropriate or where
separate water loops are present and can be isolated within the facility, in
locations where the legionellosis case or cases resided, or received treatment
or services while in the facility, or otherwise may have been exposed to
aerosols from the hot water system or other water features. A hospital with a
continuous secondary disinfection system that has demonstrated detections of
less than one cfu/ml of legionella through validation testing and control
measures specified in the water management plan, may, after consultation of the
Ohio department of health and the local health district having jurisdiction,
avoid installation of point of use water filters;
(b)
Conducting or
updating an environmental facility assessment using the United States centers
for disease control and prevention's "Legionella Environmental Assessment
Form," available online at
https://www.cdc.gov/legionella/downloads/legionella-environmental-assessment-p.pdf , or equivalent assessment, for the facility to identify
risk conditions that may promote the growth of Legionella or other waterborne
pathogens;
(c)
Providing a copy of the water management program and at
least one year of prior validation testing results to the Ohio department of
health and the health district having jurisdiction;
(d)
Identification
and collection of a set of water samples that is representative of all potable
water loops and water sources associated with the investigation, including but
not limited to cooling towers, therapy spas, decorative fountains or water
features where exposure to aerosols may occur. Water sample testing
includes:
(i)
At least one cold water sample will be obtained from the incoming water mains
from the public water system or the water source;
(ii)
Representative
samples obtained from a minimum of distal and proximal locations on each floor
of each hot water loop on the hot water distribution system, including hot
water storage tanks or storage units when present, both a swab or first draw
sample, and a bulk water sample from the fixture or location;
(iii)
A sample or
samples from locations in the hot water system or water features where the
legionellosis case or cases resided, or received treatment or services while in
the facility, or otherwise may have been exposed to aerosols from the hot water
system or other water features;
(iv)
Measurement of
total and free chlorine residual, as appropriate, at the time of sample
collection, and the observed sustained maximum temperatures for cold and hot
water samples.
(v)
Preservation and provision of all cultured water and
swab samples with observed Legionella cultures that were collected during an
investigation of a case or outbreak to the Ohio department of health's public
health laboratory for potential comparison against clinically cultured
samples.
(e)
Collection of water samples under this paragraph will
conform to the United States centers for disease control and prevention's
"Sampling Procedure and Potential Sampling Sites for Investigation" available
at
https://www.cdc.gov/legionella/downloads/cdc-sampling-procedure.pdf , to include collection of one liter samples, and "CDC
Laboratory Guidance for Processing Environmental Samples" (2005), respectively,
with collected samples to be analyzed at a laboratory that has been accredited
by a national or international accrediting body according to national or
international recognized standards, that has legionella culture testing
included in the laboratory's scope of accreditation, and that has demonstrated
proficiency in the detection of legionella culture in accordance with the
United States centers for disease control and prevention environmental
legionella isolation techniques evaluation program.
(f)
Implementation of
identified actions to correct the risk conditions identified as part of the
environmental facility assessment, and environmental water testing results,
which may include but not be limited to:
(i)
Adjustments to
hot water temperatures in storage tanks or circulation systems;
(ii)
Correction of
areas of poor water flow or stagnation;
(iii)
Conducting
short-term remediation; or
(iv)
Installing
permanent disinfection systems;
(g)
Provision of
appropriate communications to patients, employees, and visitors regarding the
investigative and corrective actions to help reduce risk of further
exposures;
(h)
After remediation actions are completed, or permanent
disinfection is installed, collection of the same sample locations and types as
set forth in paragraph (K)(4)(d) of this rule as follows:
(i)
The first sample
set, no earlier than forty-eight hours after remediation actions have ceased;
and
(ii)
For the second and subsequent sample sets, no earlier
than ten days having elapsed since the last sample collection date;
All sample results collected under this paragraph are to be reported to both the Ohio department of health and the local health district having jurisdiction.
(i)
Obtaining the
concurrence of the Ohio department of health and the local health district
having jurisdiction, before lifting of water restrictions or removal of point
of use water filters from fixtures when all water or swab samples have
legionella detections of less than one colony forming unit per milliliter for
potable water
(j)
Flushing of all hot water distribution systems and
fixtures after water restrictions are lifted and/or point of use water filters
are removed; and
(k)
An investigation conducted under this paragraph
includes revising the hospital's water management program based on the full
investigations results and the recommendations of the Ohio department of health
and the local health district.
(L) Discharge planning, in accordance with 42 CFR 482.43; and
(M) Organ, tissue, and eye procurement, in accordance with 42 CFR 482.45.
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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