[Federal Register: January 14, 2005 (Volume 70, Number 10)]
[Notices]
[Page 2637-2641]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja05-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Privacy Act of 1974; Report of New System
AGENCY: Department of Health and Human Services (HHS), Centers for
Medicare & Medicaid Services (CMS).
ACTION: Notice of New System of Records (SOR).
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SUMMARY: In accordance with the requirements of the Privacy Act of
1974, we are proposing to establish a new system of records, called the
``Cytology Personnel Record System (CYPERS), HHS/CMS/CMSO, 09-70-
0543.'' The primary purpose of CYPERS is to assure CMS of the accuracy
and reliability of gynecologic cytology testing by compliance with the
CLIA statutory requirements. This will be accomplished by tracking and
monitoring the enrollment, participation, and performance of individual
cytotechnologists and physicians participating in CMS approved
gynecologic cytology proficiency testing programs.
Information retrieved from this system of records will be used to
support regulatory, reimbursement, and policy functions performed
within the agency or by a contractor or consultant; support constituent
requests made to a Congressional representative; and support litigation
involving the agency.
We have provided background information about the proposed system
in the SUPPLEMENTARY INFORMATION section, below. Although the Privacy
Act requires only that the ``routine use'' portion of the system be
published for comment, CMS invites comments on all portions of this
notice. See EFFECTIVE DATES section for comment period.
EFFECTIVE DATES: CMS filed a new system report with the Chair of the
House Committee on Government Reform and Oversight, the Chair of the
Senate Committee on Governmental Affairs, and the Administrator, Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB) on December 23, 2004. In any event, we will not disclose any
information under a routine use until forty (40) calendar days after
publication. We may defer implementation of this system of records or
one or more of the routine use statements listed below if we receive
comments that persuade us to defer implementation.
ADDRESSES: The public should address comments to: Director, Division of
Privacy Compliance Data Development (DPCDD), CMS, Room N2-04-27, 7500
Security Boulevard, Baltimore, Maryland 21244-1850. Comments received
will be available for review at this location, by appointment, during
regular business hours, Monday through Friday from 9 a.m.-3 p.m.,
eastern time zone.
FOR FURTHER INFORMATION CONTACT:
David Escobedo, Finance, Systems and Budget Group, Center for Medicaid
and State Operations, Centers for Medicare and Medicaid Services, 7500
Security Boulevard, Room S3-18-11, Baltimore, Maryland 21244-1850,
Telephone Number: (410) 786-5401.
Thomas Hamilton, Survey and Certification Group, Center for Medicaid
and State Operations, Centers for Medicare and Medicaid Services, 7500
Security Boulevard, Room S2-12-25, Baltimore, Maryland 21244-1850,
Telephone Number: (410) 786-9493.
SUPPLEMENTARY INFORMATION:
I. Description of the New System of Records
A. Statutory and Regulatory Basis for System of Records
Section 353(f)(4)(A) of the Public Health Service Act (42 U.S.C.
263a) mandates that the Secretary establish national standards for
quality assurance in cytology services designed to assure consistent,
valid, and reliable test performance by cytology laboratories. Section
353(f)(4)(B)(iv) requires, ``* * * the periodic confirmation and
evaluation of the proficiency of individuals involved in screening or
interpreting cytological preparations, including announced and
unannounced
[[Page 2638]]
on-site proficiency testing of such individuals, with such testing to
take place, to the extent practicable, under normal working conditions,
* * *'' due to the unique nature of this statutory requirement,
authority to initiate this system of records is granted. In addition,
the general and specific CLIA regulations for laboratories mandating
proficiency testing of cytotechnologists and physicians are found in 42
CFR 493.801-493.807 and 493.855. General and specific CLIA requirements
for CMS approval of proficiency testing programs in gynecologic
cytology are found at 42 CFR 493.901-493.905 and 493.945.
B. Background
Because of highly publicized articles originating in the Wall
Street Journal, and in Washington, DC television exposes, national
attention focused on clinical laboratory testing, with specific
interest on the testing that occurred in cytology laboratories.
Congressional hearings followed.
Many laboratories performing testing on cytology specimens were not
regulated and had no limit on the number of gynecologic specimens (Pap
smears) that could be examined by an individual in a 24-hour period.
Consequently, a number of ``Pap Mills'' appeared that produced Pap
smear results that were erroneous and life threatening.
The failure of laboratories performing cytology testing to provide
accurate and reliable patient test results particularly in the area of
gynecologic cytology prompted the Congress to enact the Clinical
Laboratory Improvement Amendments of 1988 (CLIA).
Certain cytology provisions of the CLIA statute require the
Secretary of Health and Human Services to periodically confirm and
evaluate the proficiency of individuals involved in screening or
interpreting cytological preparations (42 U.S.C. 263a, Section
353(f)(4)(b)(iv)). The Secretary has delegated to the CMS the
responsibility to regulate and monitor the accuracy and reliability of
results of cytology preparations. The implementing regulations are
found at 42 CFR part 493 and apply to all clinical laboratories,
performing non-waived testing, including those individuals who examine
gynecologic cytology (Pap smears).
To comply with these statutory provisions, a mechanism to monitor
the proficiency of individuals who examine gynecologic cytology
preparations, a record system must be established. This system, CYPERS,
is a national tracking system designed to monitor the enrollment and
performance of all cytotechnologists and physicians who must
participate in a CMS approved cytology proficiency testing program.
In general, CMS approves proficiency testing (PT) programs offered
by private, nonprofit organizations and states that meet the PT program
requirements of the CLIA regulations. Laboratories performing certain
non-waived testing must enroll and participate in a CMS approved PT
program. PT samples are sent to laboratories by the PT programs; the
results are unknown to the laboratory staff. After testing,
laboratories return their PT sample results to the PT program where
they are evaluated and graded for accuracy. The PT program sends the
final scores and evaluations to CMS and CMS approved accreditation
organizations where monitoring of laboratory performance occurs on a
continual basis. In the case of gynecologic cytology PT, the
performance of individuals, not laboratories, is monitored using the
CYPERS record system.
II. Collection and Maintenance of Data in the System
A. Scope of the Data Collected
The CYPERS contains each individual's name, Proficiency Testing
Registration Number (a unique identifier), Medical Licensure Number, if
employed at more than one laboratory: the names, location, and CLIA
number of each laboratory; test scores; and in which testing event the
individual has participated. CYPERS will also be able to produce user-
defined reports on request by Central Office staff only.
B. Agency Policies, Procedures, and Restrictions on the Routine Use
The Privacy Act permits us to disclose information without an
individual's consent if the information is to be used for a purpose
that is compatible with the purpose(s) for which the information was
collected. Any such disclosure of data is known as a ``routine use.''
The government will only release CYPERS information that can be
associated with an individual as provided for under ``Section III.
Entities Who May Receive Disclosures Under Routine Use.'' Both
identifiable and non-identifiable data may be disclosed under a routine
use. Identifiable data includes individual records with CYPERS
information and identifiers. Non-identifiable data includes individual
records with CYPERS information and masked identifiers or CYPERS
information with identifiers stripped out of the file.
CMS will only disclose the minimum personal data necessary to
achieve the purpose of the CYPERS. CMS has the following policies and
procedures concerning disclosures of information that will be
maintained in the system. In general, disclosure of information from
the SOR will be approved only for the minimum information necessary to
accomplish the purpose of the disclosure after CMS:
1. Determines that the use or disclosure is consistent with the
reason that the data are being collected; e.g., monitoring the
registration, participation, and outcome of annual cytology proficiency
testing events for cytotechnologist and physicians who evaluate
gynecologic cytology specimens, assure remedial actions are taken when
necessary, and develop the data necessary for CMS to determine the
continued or reduced frequency of testing.
2. Determines that:
a. The purpose for which the disclosure is to be made can only be
accomplished if the record is provided in individually identifiable
form;
b. the purpose for which the disclosure is to be made is of
sufficient importance to warrant the effect and/or risk on the privacy
of the individual that additional exposure of the record might bring;
and
c. there is a strong probability that the proposed use of the data
would, in fact, accomplish the stated purpose(s).
3. Requires the information recipient to:
a. Establish administrative, technical, and physical safeguards to
prevent unauthorized use of disclosure of the record;
b. remove or destroy at the earliest time all individually,
identifiable information; and
c. agree to not use or disclose the information for any purpose
other than the stated purpose under which the information was
disclosed.
4. Determines that the data are valid and reliable.
III. Proposed Routine Use Disclosures of Data in the System
A. Entities That May Receive Disclosures Under Routine Use
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which CMS may
release information from the CYPERS without the consent of the
individual to whom such information pertains. Each proposed disclosure
of information under these routine uses will be evaluated to ensure
that the disclosure is legally permissible, including but not limited
to ensuring that the purpose of
[[Page 2639]]
the disclosure is compatible with the purpose for which the information
was collected. CMS proposes to establish the following routine use
disclosures of information maintained in the system:
1. To agency contractors, or consultants that have been contracted
by the agency to assist in the performance of a service related to this
system of records and that need to have access to the records in order
to perform the activity.
CMS contemplates disclosing information under this routine use only
in situations in which CMS may enter into a contractual or similar
agreement with a third party to assist in accomplishing agency business
functions relating to purposes for this system of records.
CMS occasionally contracts out certain of its functions when doing
so would contribute to effective and efficient operations. CMS must be
able to give a contractor whatever information is necessary for the
contractor to fulfill its duties. In these situations, safeguards are
provided in the contract prohibiting the contractor from using or
disclosing the information for any purpose other than that described in
the contract and requires the contractor to return or destroy all
information at the completion of the contract.
2. To a Member of Congress or to a Congressional staff member in
response to an inquiry of the Congressional Office made at the written
request of the constituent about whom the record is maintained.
Individuals sometimes request the help of a Member of Congress in
resolving some issue relating to a matter before CMS. The Member of
Congress then writes CMS, and CMS must be able to give sufficient
information to be responsive to the inquiry.
3. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity; or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government; is a party to litigation or has an
interest in such litigation, and by careful review, CMS determines that
the records are both relevant and necessary to the litigation.
Whenever CMS is involved in litigation, or occasionally when
another party is involved in litigation and CMS's policies or
operations could be affected by the outcome of the litigation, CMS
would be able to disclose information to the DOJ, court or adjudicatory
body involved. A determination would be made in each instance that,
under the circumstances involved, the purposes served by the use of the
information in the particular litigation is compatible with a purpose
for which CMS collects the information.
B. Additional Provisions Affecting Routine Use Disclosures
In addition, CMS policy will be to prohibit release even of non-
identifiable data, except pursuant to one of the routine uses, if there
is a possibility that an individual can be identified through implicit
deduction based on small cell sizes (instances where the patient
population is so small that individuals who are familiar with the
enrollees could, because of the small size, use this information to
deduce the identity of the beneficiary).
This System of Records contains Protected Health Information as
defined by the Department of Health and Human Services' regulation
``Standards for Privacy of Individually Identifiable Health
Information'' (45 CFR Parts 160 and 164, 65 FR 82462 as amended by 66
FR 12434). Disclosures of Protected Health Information authorized by
these routine uses may only be made if, and as, permitted or required
by the ``Standards for Privacy of Individually Identifiable Health
Information.''
IV. Safeguards
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, DHHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations include but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
Of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies. Federal, DHHS, and CMS policies and
standards include but are not limited to: all pertinent NIST
publications; the DHHS Automated Information Systems Security Handbook
and the CMS Information Security Handbook.
V. Effects of the New System on Individual Rights
CMS proposes to establish this system in accordance with the
principles and requirements of the Privacy Act and will collect, use,
and disseminate information only as prescribed therein. Data in this
system will be subject to the authorized releases in accordance with
the routine uses identified in this system of records.
CMS will monitor the collection and reporting of CYPERS data.
CYPERS information is submitted to CMS through standard systems. CMS
will use a variety of onsite and offsite edits and audits to increase
the accuracy of CYPERS data.
CMS will take precautionary measures (see item IV, above) to
minimize the risks of unauthorized access to the records and the
potential harm to individual privacy or other personal or property
rights of individuals whose data are maintained in the system. CMS will
collect only that information necessary to perform the system's
functions. In addition, CMS will make disclosure from the proposed
system only with consent of the subject individual, or his/her legal
representative, or in accordance with an applicable exception provision
of the Privacy Act.
CMS, therefore, does not anticipate an unfavorable effect on
individual privacy because of maintaining this system of records.
Dated: December 23, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
SYSTEM NO. 09-70-0543
SYSTEM NAME:
``Cytology Personnel Record System (CYPERS), HHS/CMS/CMSO, 09-70-
0543.''
SECURITY CLASSIFICATION:
Level 3, Privacy Act Sensitive.
SYSTEM LOCATION:
HCFA Data Center, 7500 Security Boulevard, North Building, First
Floor,
[[Page 2640]]
Baltimore, Maryland 21244-1850. CMS contractors and agents at various
locations.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Individual cytotechnologists and physicians participating in CMS
approved gynecologic cytology proficiency testing programs.
CATEGORIES OF RECORDS IN THE SYSTEM:
This system will contain each individual's name, Proficiency
Testing Registration Number (a unique identifier), Medical Licensure
Number, if employed at more than one laboratory: the names, location,
and CLIA number of each laboratory; test scores, and in which testing
event the individual has participated. CYPERS will also be able to
produce user-defined reports on request by Central Office staff only.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Section 353(f)(4)(A) of the Public Health Service Act (42 U.S.C.
263a), Section 353(f)(4)(B)(iv), 42 CFR 493.801, 493.803, 493.807,
493.855, 42 CFR 493.901, 493.903, 493.905, and 493.945.
PURPOSE(S) OF THE SYSTEM:
The primary purpose of CYPERS is to assure CMS of the accuracy and
reliability of gynecologic cytology testing by compliance with the CLIA
statutory requirements. This will be accomplished by tracking and
monitoring the enrollment, participation, and performance of individual
cytotechnologists and physicians participating in CMS approved
gynecologic cytology proficiency testing programs.
Information retrieved from this system of records will be used to
support regulatory, reimbursement, and policy functions performed
within the agency or by a contractor or consultant; support constituent
requests made to a Congressional representative; and support litigation
involving the agency.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OR USERS AND THE PURPOSES OF SUCH USES:
These routine uses specify circumstances, in addition to those
provided by statute in the Privacy Act of 1974, under which CMS may
release information from the CYPERS Registration and Product Ordering
System without the consent of the individual to whom such information
pertains. Each proposed disclosure of information under these routine
uses will be evaluated to ensure that the disclosure is legally
permissible, including but not limited to ensuring that the purpose of
the disclosure is compatible with the purpose for which the information
was collected. In addition, CMS policy will be to prohibit release even
of non-identifiable data, except pursuant to one of the routine uses,
if there is a possibility that an individual can be identified through
implicit deduction based on small cell sizes (instances where the
patient population is so small that individuals who are familiar with
the enrollees could, because of the small size, use this information to
deduce the identity of the beneficiary). Be advised, this System of
Records contains Protected Health Information as defined by the
Department of Health and Human Services' (HHS) regulation ``Standards
for Privacy of Individually Identifiable Health Information'' (45 CFR
Parts 160 and 164, 65 FR 8462 as amended by 66 FR 12434). Disclosures
of Protected Health Information authorized by these routine uses may
only be made if, and as, permitted or required by the ``Standards for
Privacy of Individually Identifiable Health Information.''
1. To agency contractors, or consultants that have been contracted
by the agency to assist in the performance of a service related to this
system of records and that need to have access to the records in order
to perform the activity.
2. To a Member of Congress or to a Congressional staff member in
response to an inquiry of the Congressional Office made at the written
request of the constituent about whom the record is maintained.
3. To the Department of Justice (DOJ), court or adjudicatory body
when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity; or
c. Any employee of the agency in his or her individual capacity
where the DOJ has agreed to represent the employee, or
d. The United States Government; is a party to litigation or has an
interest in such litigation, and by careful review, CMS determines that
the records are both relevant and necessary to the litigation.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
All records are stored on the magnetic disk sub-system of the
Windows 2000 server.
RETRIEVABILITY:
The CYPERS records are retrieved by individual's name, Proficiency
Testing Registration Number unique identifier, Medical Licensure
Number, test scores, or which testing event the individual has
participated. CYPERS will also be able to produce user-defined reports
on request by Central Office staff only.
SAFEGUARDS:
CMS has safeguards in place for authorized users and monitors such
users to ensure against excessive or unauthorized use. Personnel having
access to the system have been trained in the Privacy Act and
information security requirements. Employees who maintain records in
this system are instructed not to release data until the intended
recipient agrees to implement appropriate management, operational and
technical safeguards sufficient to protect the confidentiality,
integrity and availability of the information and information systems
and to prevent unauthorized access.
This system will conform to all applicable Federal laws and
regulations and Federal, DHHS, and CMS policies and standards as they
relate to information security and data privacy. These laws and
regulations include but are not limited to: the Privacy Act of 1974;
the Federal Information Security Management Act of 2002; the Computer
Fraud and Abuse Act of 1986; the Health Insurance Portability and
Accountability Act of 1996; the E-Government Act of 2002, the Clinger-
Cohen Act of 1996; the Medicare Modernization Act of 2003, and the
corresponding implementing regulations. OMB Circular A-130, Management
Of Federal Resources, Appendix III, Security of Federal Automated
Information Resources also applies.
Federal, DHHS, and CMS policies and standards include but are not
limited to: all pertinent NIST publications; the DHHS Automated
Information Systems Security Handbook and the CMS Information Security
Handbook.
RETENTION AND DISPOSAL:
CMS will retain identifiable CYPERS data for a total period of 10
years.
SYSTEM MANAGER AND ADDRESS:
Director, Finance, Systems and Budget Group, Center for Medicaid
and State Operations, Centers for Medicare and Medicaid Services, 7500
Security Boulevard, Room S3-18-11, Baltimore, Maryland 21244-1850,
Telephone Number: (410) 786-5401.
Director, Survey and Certification Group, Center for Medicaid and
State Operations, Centers for Medicare and Medicaid Services, 7500
Security Boulevard, Room S2-12-25, Baltimore,
[[Page 2641]]
Maryland 21244-1850, Telephone Number: (410) 786-9493.
NOTIFICATION PROCEDURE:
For purpose of access, the subject individual should write to the
system manager, who will require the system name, the subject
individual's name (woman's maiden name, if applicable), address, date
of correspondence and control number.
RECORD ACCESS PROCEDURE:
For purpose of access, use the same procedures outlined in
Notification Procedures above. Requestors should also reasonably
specify the record contents being sought. (These procedures are in
accordance with Department regulation 45 CFR 5b.5 (a) (2).)
CONTESTING RECORD PROCEDURES:
The subject individual should contact the system manager named
above, and reasonably identify the record and specify the information
to be contested. State the corrective action sought and the reasons for
the correction with supporting justification. (These procedures are in
accordance with Department regulation 45 CFR 5b.7.)
RECORD SOURCE CATEGORIES:
CMS will receive CYPERS data periodically from CMS-approved
cytology proficiency testing programs only. This System of Records
protects the data transmitted by CMS-approved cytology proficiency
testing programs at all stages of collection, manipulation,
transmissions, storage, and maintenance, at the PT program and at CMS.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.
[FR Doc. 05-836 Filed 1-13-05; 8:45 am]
BILLING CODE 4120-03-P