[Federal Register Volume 70, Number 10 (Friday, January 14, 2005)]
[Notices]
[Pages 2637-2641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-836]


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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