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).

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 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 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.

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, 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, 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.