safety work product to the rest of the organiza-
tion in breach of confidentiality. 
‘‘(C) The mission of the entity does not cre-
ate a conflict of interest with the rest of the orga-
nization. 
‘‘(c) REVIEW OF CERTIFICATION.— 
‘‘(1) IN GENERAL.— 
‘‘(A) INITIAL
CERTIFICATION.—Upon the 
submission by an entity of an initial certifi-
cation under subsection (a)(1), the Secretary 
shall determine if the certification meets the re-
quirements of subparagraphs (A) and (B) of such 
subsection. 
‘‘(B) SUBSEQUENT CERTIFICATION.—Upon 
the submission by an entity of a subsequent cer-
tification under subsection (a)(2), the Secretary 
shall review the certification with respect to re-
quirements of subparagraphs (A) and (B) of such 
subsection. 
‘‘(2) NOTICE OF ACCEPTANCE OR NON-ACCEPT-
ANCE.—If the Secretary determines that— 
‘‘(A) an entity’s initial certification meets 
requirements referred to in paragraph (1)(A), the 
Secretary shall notify the entity of the accept-
ance of such certification; or
‘‘(B) an entity’s initial certification does 
not meet such requirements, the Secretary shall 
notify the entity that such certification is not ac-
cepted and the reasons therefor. 
‘‘(3) DISCLOSURES
REGARDING
RELATIONSHIP 
TO
PROVIDERS.—The Secretary shall consider any 
disclosures under subsection (b)(1)(E) by an entity 
and shall make public findings on whether the entity 
can fairly and accurately perform the patient safety 
activities of a patient safety organization. The Sec-
retary shall take those findings into consideration in 
determining whether to accept the entity’s initial cer-
tification and any subsequent certification submitted 
under subsection (a) and, based on those findings, 
may deny, condition, or revoke acceptance of the enti-
ty’s certification. 
‘‘(d) LISTING.—The Secretary shall compile and 
maintain a listing of entities with respect to which there 
is an acceptance of a certification pursuant to subsection 
(c)(2)(A) that has not been revoked under subsection (e) or 
voluntarily relinquished. 
‘‘(e) REVOCATION
OF
ACCEPTANCE
OF
CERTIFI-
CATION.— 
‘‘(1) IN GENERAL.—If, after notice of deficiency, 
an opportunity for a hearing, and a reasonable op-
portunity for correction, the Secretary determines 
that a patient safety organization does not meet the 
certification requirements under subsection (a)(2), in-
cluding subparagraphs (A) and (B) of such sub-
section, the Secretary shall revoke the Secretary’s ac-
ceptance of the certification of such organization. 
‘‘(2) SUPPLYING
CONFIRMATION
OF
NOTIFICA-
TION TO PROVIDERS.—Within 15 days of a revocation 
under paragraph (1), a patient safety organization 
shall submit to the Secretary a confirmation that the 
organization has taken all reasonable actions to no-
tify each provider whose patient safety work product 
is collected or analyzed by the organization of such 
revocation. 
‘‘(3) PUBLICATION
OF
DECISION.—If the Sec-
retary revokes the certification of an organization 
under paragraph (1), the Secretary shall— 
‘‘(A) remove the organization from the list-
ing maintained under subsection (d); and 
‘‘(B) publish notice of the revocation in the 
Federal Register. 
‘‘(f) STATUS OF DATA AFTER REMOVAL FROM LIST-
ING.— 
‘‘(1) NEW DATA.—With respect to the privilege 
and confidentiality protections described in section
922, data submitted to an entity within 30 days after 
the entity is removed from the listing under sub-
section (e)(3)(A) shall have the same status as data 
submitted while the entity was still listed. 
‘‘(2) PROTECTION TO CONTINUE TO APPLY.—If 
the privilege and confidentiality protections described 
in section 922 applied to patient safety work product 
while an entity was listed, or to data described in 
paragraph (1), such protections shall continue to 
apply to such work product or data after the entity 
is removed from the listing under subsection (e)(3)(A). 
‘‘(g) DISPOSITION OF WORK PRODUCT AND DATA.— 
If the Secretary removes a patient safety organization from 
the listing as provided for in subsection (e)(3)(A), with re-
spect to the patient safety work product or data described 
in subsection (f)(1) that the patient safety organization re-
ceived from another entity, such former patient safety orga-
nization shall— 
‘‘(1) with the approval of the other entity and a 
patient safety organization, transfer such work prod-
uct or data to such patient safety organization; 
‘‘(2) return such work product or data to the en-
tity that submitted the work product or data; or
‘‘(3) if returning such work product or data to 
such entity is not practicable, destroy such work 
product or data. 
‘‘SEC. 925. TECHNICAL ASSISTANCE. 
‘‘The Secretary, acting through the Director, may pro-
vide technical assistance to patient safety organizations, in-
cluding convening annual meetings for patient safety orga-
nizations to discuss methodology, communication, data col-
lection, or privacy concerns. 
‘‘SEC. 926. SEVERABILITY. 
‘‘If any provision of this part is held to be unconstitu-
tional, the remainder of this part shall not be affected.’’. 
(b) AUTHORIZATION
OF APPROPRIATIONS.—Section 
937 of the Public Health Service Act (as redesignated by 
subsection (a)) is amended by adding at the end the fol-
lowing: 
‘‘(e) PATIENT SAFETY AND QUALITY IMPROVEMENT.— 
For the purpose of carrying out part C, there are authorized 
to be appropriated such sums as may be necessary for each 
of the fiscal years 2006 through 2010.’’. 
(c) GAO STUDY ON IMPLEMENTATION.— 
(1) STUDY.—The Comptroller General of the 
United States shall conduct a study on the effective-
ness of part C of title IX of the Public Health Service
Act (as added by subsection (a)) in accomplishing the 
purposes of such part. 
(2) REPORT.—Not later than February 1, 2010, 
the Comptroller General shall submit a report on the 
study conducted under paragraph (1). Such report 
shall include such recommendations for changes in 
such part as the Comptroller General deems appro-
priate.
Union Calendar No. 117 
109TH CONGRESS 
1ST SESSION 
H. R. 3205 
[Report No. 109–197] 
A BILL 
To amend title IX of the Public Health Service Act 
to provide for the improvement of patient safety 
and to reduce the incidence of events that ad-
versely affect patient safety, and for other pur-
poses. 
JULY 27, 2005 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed