Testing and Certification Records

ONC Temporary Certification Program's Application, Reporting and Records Requirements

0990-ONC-ATCB_Application_PART ONE_FINAL_(Both Conformant and Partially Conformant Applicants)

Testing and Certification Records

OMB: 0955-0010

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A PPLICATION FOR ONC-AUTHORIZED TESTING & CERTIFICATION BODY (ONC-ATCB) STATUS: PART I

Application Instructions

Please complete all sections of the application form and submit the completed application and requested supporting documentation to the National Coordinator for Health Information Technology.

A complete Part I of the application will include the following components:

Application Components for Part I

Action Required


General Identifying Information

Provide Information


Designated Point of Contact for ONC-ATCB Applicant

Provide Information


ISO/IEC 17025:2005 Self-Audit Conformance Checklist

Complete Self-Audit


Proof of Conformance to ISO/IEC 17025:2005

Document Conformance


ISO/IEC Guide 65:1996 Self-Audit Conformance Checklist

Complete Self-Audit


Proof of Conformance to ISO/IEC Guide 65:1996

Document Conformance


Agreement to Adhere to the Principles of Proper Conduct for ONC-ATCBs

Sign Original Agreement

Submission Instructions

Preferred Method – Electronic Submissions:

For electronic submissions, applicants must return a completed application, including all documents, in PDF to [email protected].

If submitting the completed application form by e-mail, please include the applicant’s name and the date in the subject line. In addition, in the body of the mail, please include a list of the names of all the attachments submitted with the e-mail, indicating to which application requirement each attachment applies. All supporting documents must be clearly labeled with a document title and the organization name.

Alternate Method – Postal Mail Submissions:

Paper applications must be submitted to the following address. Two (2) copies of submitted documentation are required for postal mail submission.

Office of the National Coordinator for Health Information Technology

Attention: Certification Programs

Hubert H. Humphrey Building, Suite 729D

200 Independence Ave, S.W., Washington, D.C. 20201

Questions?

Please review all information contained within the application form carefully before submission.

For inquiries and questions about the application process or how to complete the application form, please contact the Office of the National Coordinator for Health Information Technology:

Office of the National Coordinator for Health Information Technology

Attention: Certification Programs

Hubert H. Humphrey Building, Suite 729D

200 Independence Ave, S.W., Washington, D.C. 20201


Phone: (202) 690-7151

E-mail: [email protected] (Application Questions)

Email: [email protected] (General Questions)





Application Form

Part I

General Information

Applicant Name(s):      

Address:      

City, State:       Zip Code:      

Homepage URL:      


Designated Point of Contact for ONC-ATCB Applicant

Name (Last, First):       Title:      

Phone:       Cell:      

E-mail:      


ISO/IEC 17025:2005 Self-Audit Conformance Checklist

Please check each box as appropriate. If you believe that a particular requirement of ISO 17025 does not apply to your application for authorization as an ONC-ATCB, please clearly identify the requirement and attach a detailed explanation for why the requirement should not apply.

Management Requirements

Section 4

Organization

Section 4.1

Management System

Section 4.2

Document Control

Section 4.3

General

Section 4.3.1

Document approval and issue

Section 4.3.2

Document changes

Section 4.3.3

Review of requests, tenders and contracts

Section 4.4

Subcontracting of tests and calibrations

Section 4.5

Purchasing services and supplies

Section 4.6

Service to the customer

Section 4.7

Complaints

Section 4.8

Control of nonconforming testing and/or calibration work

Section 4.9

Improvement

Section 4.10

Corrective action

Section 4.11

General

Section 4.11.1

Cause analysis

Section 4.11.2

Selection and implementation of corrective actions

Section 4.11.3

Monitoring of corrective actions

Section 4.11.4

Additional audits

Section 4.11.5

Preventive action

Section 4.12

Control of records

Section 4.13

General

Section 4.13.1

Technical records

Section 4.13.2

Internal audits

Section 4.14

Management reviews

Section 4.15

Technical Requirements

Section 5

General

Section 5.1

Personnel

Section 5.2

Accommodation and environmental conditions

Section 5.3

Test and calibration methods and method validation

Section 5.4

General

Section 5.4.1

Selection of methods

Section 5.4.2

Laboratory-developed methods

Section 5.4.3

Non-standard methods

Section 5.4.4

Validation of methods

Section 5.4.5

Estimation of uncertainty of measurement

Section 5.4.6

Control of data

Section 5.4.7

Equipment

Section 5.5

Measurement traceability

Section 5.6

General

Section 5.6.1

Specific Requirements

Section 5.6.2

Reference standards and reference materials

Section 5.6.3

Sampling

Section 5.7

Handling of test and calibration items

Section 5.8

Assuring the quality of test and calibration results

Section 5.9

General

Section 5.10.1

Test reports and calibration certificates

Section 5.10.2

Test report

Section 5.10.3

Calibration certificates

Section 5.10.4

Opinions and interpretations

Section 5.10.5

Testing and calibration results obtained from subcontractors

Section 5.10.6

Electronic transmission of results

Section 5.10.7

Format of reports and certificates

Section 5.10.8

Amendments to test reports and calibration certificates

Section 5.10.9



Proof of Conformance to ISO/IEC 17025 2005 (ISO 17025) 1


Please provide copies of the following documents as evidence of conformance.

  1. Documentation of the Completion and Results of the Self-Audit Against All Sections of ISO 17025 (Above)

  1. Copy of the Applicant’s Quality System Document According To Section 4.2.2 of ISO 17025

  1. Copy of Applicant’s Policies and Procedures for Handling Testing Nonconformities According to Section 4.9.1 of ISO 17025

  1. Copy of Qualifications of Each of the Applicant’s Personnel Who Oversee Or Conduct Testing According to Section 5.2 of ISO 17025


By completing the check-boxes and signing below, I hereby attest that I have read and understood the requirements as outlined in ISO/IEC 17025:2005 and my organization is conformant with the requirements listed except as noted above and in the explained attachments.

Signature: ______________________________________________________

Name: _________________________________________________________

Date: __________________________________________________________

Organization: ___________________________________________________

ISO/IEC Guide 65:1996 (Guide 65) Self-Audit Conformance Checklist

Please check each box as appropriate. If you believe that a particular requirement of Guide 65 does not apply to your application for authorization as an ONC-ATCB, please clearly identify the requirement and attach a detailed explanation for why the requirement should not apply.


Certification Body

Section 4

General Provisions

Section 4.1

Organization

Section 4.2

Subcontracting

Section 4.4

Quality Systems

Section 4.5

Conditions and procedures for granting, maintaining, extending, suspending and withdrawing certification

Section 4.6

Internal audits and management reviews

Section 4.7

Documentation

Section 4.8

Records

Section 4.9

Confidentiality

Section 4.10

Certification Body Personnel

Section 5

General

Section 5.1

Qualification Criteria

Section 5.2

Changes in certification requirements

Section 6

Changes in the certification requirements

Section 6

Appeals, complaints, and disputes

Section 7

Appeals, complaints and disputes procedures

Section 7.1

Application for certification

Section 7.2

Application for Certification

Section 8

Information on the procedure

Section 8.1

The application

Section 8.2

Preparation for Evaluation

Section 9

Maintain records

Section 9.1

Prepare plan for evaluation activities

Section 9.2

Assign evaluation personnel

Section 9.3

Provision of working documents to personnel

Section 9.4

Evaluation

Section 10

Evaluation

Section 10

Evaluation Report

Section 11

Evaluation Report

Section 11

Decision on Certification

Section 12

Decision on certification

Section 12.1

Delegation of authority

Section 12.2

Certification documents

Section 12.3

Surveillance

Section 13

Documented surveillance procedures

Section 13.1

Product changes and modification updates

Section 13.2

Documentation of surveillance activities

Section 13.3

Periodic evaluation to confirm conformance of marked products

Section 13.4

Use of licenses, certificates and marks of conformity

Section 14

Control over ownership, use and display of licenses, certificates and marks of conformity

Section 14.1

Guidance on use of certificates and marks

Section 14.2

Action in response to misrepresentation of certification systems, licenses, certificates and marks

Section 14.3

Complaints to suppliers

Section 15

Complaints to suppliers

Section 15


Proof of Conformance to ISO/IEC Guide 65:1996 (Guide 65)2


Please provide copies of the following documents as evidence of conformance.

  1. Documentation of the completion and results of the self-audit against all sections of Guide 65 (Above)

  1. Copy or Description of Applicant’s Management Structure According to Section 4.2 of Guide 65

  1. Copy of Applicant’s Quality Manual developed According to Section 4.5.3 of Guide 65

  1. Copy of Applicant’s Policies and Approach to Confidentiality According to Section 4.10 of Guide 65

  1. Copy of Qualifications of each of the Applicant’s Personnel who Oversees or Conducts Certification According to Section 5.2 of Guide 65

  1. Copy of the Applicant’s Evaluation Reporting Procedures According to Section 11 of Guide 65

  1. Copy of Applicant’s Policies for Use and Display of Certificates According to Section 14 of Guide 65


By completing the check-boxes above and signing below, I hereby attest that I have read and understood the requirements as outlined in ISO/IEC Guide 65:1996 and my organization is conformant with the requirements listed except as noted above and in the explained attachments.


Signature: ______________________________________________________

Name: _________________________________________________________

Date: __________________________________________________________

Organization: ___________________________________________________

Agreement to Adhere to the Principles of Proper Conduct for ONC-ATCBs

Please confirm that you have read, understand, and agree that your organization(s) will adhere to the following Principles of Proper Conduct by checking the box next to each Principle of Proper Conduct and signing and dating the attestation below.


Principles of Proper Conduct for ONC-ATCBs

Operate a certification program in accordance with ISO/IEC Guide 65:1996 and testing program in accordance with ISO/IEC 17025:2005.

Maintain an effective quality management system which addresses all requirements of ISO/IEC 17025:2005.

Attend all mandatory ONC training and program update sessions.

Maintain a training program, consistent with the ISO/IEC standards that include documented procedures and training requirements to ensure its personnel are competent to test and certify Complete EHRs and/or EHR Modules.

Use test tools and test procedures approved by the National Coordinator for the purposes of assessing Complete EHRs and/or EHR Modules compliance with the certification criteria adopted by the Secretary of the U.S. Department of Health and Human Services.

As set forth in 45 CFR, Part §170.423; Final Rule (the Rule) Report to ONC within 15 days any changes that materially affect its:

    1. Legal, commercial, organizational, or ownership status;

    2. Organization and management, including key testing and certification personnel;

    3. Policies or procedures;

    4. Location;

    5. Facilities, working environment or other resources;

    6. ONC authorized representative (point of contact); or

(7) Other such matters that may otherwise materially affect its ability to test and certify Complete EHRs and/or EHR Modules.

Allow ONC, or its authorized agents(s), to periodically observe on site (unannounced or scheduled) during normal business hours, any testing and/or certification performed to demonstrate compliance with the requirements of the temporary certification program.

Provide ONC, no less frequently than weekly, a current list of Complete EHRs and/or EHR Modules that have been tested and certified which includes, at a minimum:

    1. The vendor name (if applicable),

    2. The date certified,

    3. The product version,

    4. The unique certification number or other specific product identification;

    5. The clinical quality measures to which a Complete EHR or EHR Module has been tested and certified;

    6. Where applicable, any additional software a Complete EHR or EHR Module relied upon to demonstrate its compliance with a certification criterion or several certification criteria adopted by the Secretary of the U.S. Department of Health and Human Services; and

    7. Where applicable, the certification criterion or certification criteria to which each EHR Module has been tested and certified.

Retain all records related to tests and certifications according to ISO/IEC Guide 65:1996 and ISO/IEC 17025:2005 for the duration of the temporary certification program and provide copies of the final results of performed tests and certifications to ONC at the sunset of the temporary certification program.

Promptly refund any and all fees received for:

    1. Requests for testing and certification that are withdrawn while its operations are suspended by the National Coordinator;

    2. Testing and certification that will not be completed as a result of its conduct; and

    3. Previous testing and certification if its conduct necessitates the recertification of Complete EHRs and EHR Modules it previously certified.

Ensure adherence to the following requirements when issuing a certification to Complete EHRs and/or EHR Modules:

    1. All certifications must require that a Complete EHR or EHR Module developer conspicuously include the following text on its website and in all marketing materials, communications statements, and other assertions related to the Complete EHR or EHR Module’s certification:

      1. i. “This [Complete EHR or EHR Module] is 201[X]/201[X] compliant and has been certified by an ONC-ATCB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments.”; and

      2. ii. The information an ONC-ATCB is required to report to the National Coordinator under paragraph (h) of this section.

    2. A certification issued to an integrated, bundle of EHR Modules shall be treated the same as a certification issued to a Complete EHR for the purposes of paragraph (k)(1) of this section except that it must also indicate each EHR Module that comprises the bundle.

    3. All certifications must require that a Complete EHR or EHR Module developer conspicuously include the following text on its website and in all marketing materials, communications statements, and other assertions related to the Complete EHR or EHR Module’s certification: “This [Complete EHR or EHR Module] is 201[X]/201[X] compliant and has been certified by an ONC-ATCB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments.”;

    4. A certification issued to an EHR Module must also include an indication as to the specific certification criterion or certification criteria to which it has been tested and certified; and

    5. A certification issued to an integrated, bundle of EHR Modules shall be treated the same as a certification issued to Complete EHR for the purposes of the above requirement, except that its label must also indicate each EHR Module that comprises the bundle.



Further, I acknowledge and agree to abide by the regulatory requirements listed in 45 CFR, Part 170; § 170.465, Revocation of Authorized Testing and Certification Body Status.


As the applicant ATCB’s Authorized Representative, I agree and am bound to the above conditions for authorization. Further, I attest that all statements made in this application are correct to the best of my knowledge and are made in good faith.



Signature: ______________________________________________________

Name: _________________________________________________________

Date: __________________________________________________________

Organization: ___________________________________________________








10 Part I

File Typeapplication/msword
File TitleAPPLICATION TO ACHIEVE STATUS OF ONC-AUTHORIZED TESTING & CERTIFICATION BODY
AuthorCoon, Constanze
Last Modified ByMichael L. Lipinski
File Modified2010-11-17
File Created2010-11-17

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