The RO evaluates the information required to be reported by the hospital or CAH DPU
under 42 CFR 482.13(g)(1) to determine whether the situation might involve a violation
of 42 CFR 482.13(e) through 42 CFR 482.13(g) and authorizes an on-site investigation if
there appears to be a possible violation.
Using the information provided by the hospital or CAH DPU in the worksheet, the RO
evaluates whether the case warrants an on-site investigation. If the RO determines that
the restraint/seclusion death report requires on-site investigation, within two business
days of receiving the report, the RO enters the reported information into the ACTS
restraint/seclusion module and immediately notifies the SA to authorize a complaint
survey to investigate the hospital’s or CAH DPU’s compliance with the Patient’s Rights
requirement at 42 CFR 482.13(e), (f), and (g), including the reported case. The SA
accesses the ACTS restraint/seclusion module to see the information reported by the
hospital or CAH DPU prior to conducting the on-site investigation. The SA is expected
to be onsite to initiate the investigation within two business days of receipt of survey
authorization from the RO.
Notice to Protection and Advocacy Organizations
At the same time that the RO notifies the SA that it authorizes the on-site survey,
consistent with the ACTS Notice of a Modified or Altered System of Records (SOR) (71
FR 29643, May 23, 2006, SOR 09-70-0565), the RO also provides written notification,
by mail or email, to the appropriate Protection and Advocacy Organization (P&A) within
the State where the hospital is located, only if the P&A has a current Data Use
Agreement (DUA) with CMS. The RO may contact CMS Central Office for a list of
P&A’s with current DUAs. The names and addresses for each State’s P&A can be
located at the following website, at the drop down menu entitled “Get Help in Your
State:” www.ndrn.org . Notification is provided only in those cases for which an on-
site survey is authorized.
The RO provides the following information to the P&A: hospital or CAH DPU name,
hospital or CAH DPU address, name of the deceased, and a copy of the
restraint/seclusion death report submitted by the hospital or CAH DPU. An entry must
be made on the intake in ACTS indicating the name of the P&A to which the
restraint/seclusion death report data was sent and the date it was sent.
The P&A must have an approved CMS Data Use Agreement (DUA), Form CMS-R-
0235, (Exhibit 292) in place before restraint/seclusion death report data may be disclosed
to it. In order to get an approved DUA, the P&A must complete and submit a signed
CMS DUA, Form CMS-R-0235, including an initialed DUA ACTS SOR- P&A
Attachment (Exhibit 293) to the Director, Division of Information Security and Privacy
Management (DISPM), Centers for Medicare and Medicaid Services, Mailstop N2-04-27,
7500 Security Boulevard, Baltimore, MD 21244-1850. DISPM will review the DUA,
assign a unique DUA identifier and expiration date to it, and return a signed copy to the
P&A, including an expiration date. CMS Central Office Survey and Certification will
maintain and make available to ROs a list of P&As with DUAs.
When completing the Form, P&As must note the following in particular: