Erie County Medical Center Corporation Resolution Agreement and Corrective Action Plan

I. Recitals

Parties. The Parties to this Resolution Agreement ("Agreement") are:
1. The United States Department of Health and Human Services, Office for Civil Rights ("HHS"), which enforces the Federal standards that govern the privacy of individually identifiable health information (45 C.F.R. Part 160 and Subparts A and E of Part 164, the "Privacy Rule"), the Federal standards that govern the security of electronic individually identifiable health information (45 C.F.R. Part 160 and Subparts A and C of Part 164, the "Security Rule"), and the Federal standards for notification in the case of breach of unsecured protected health information (45 C.F.R. Part 160 and Subparts A and D of 45 C.F.R. Part 164, the "Breach Notification Rule"). HHS has the authority to conduct compliance reviews and investigations of complaints alleging violations of the Privacy, Security, and Breach Notification Rules (the "HIPAA Rules") by covered entities and business associates, and covered entities and business associates must cooperate with HHS compliance reviews and investigations. See 45 C.F.R. §§ 160.306(c), 160.308, and 160.310(b).
2. Erie County Medical Center Corporation, (ECMCC) meets the definition of a "covered entity" under 45 C.F.R §160.103 and therefore is required to comply with the HIPAA Rules. ECMCC is a public benefit corporation that operates a hospital, Erie County Medical Center (ECMC), located in Buffalo, New York. HHS and ECMCC shall together be referred to herein as the "Parties."
Factual Background and Covered Conduct. On December 26, 2019, the complainant, filed a complaint with OCR alleging that ECMCC failed to provide her husband with a complete copy of his medical records. During the course of the investigation, ECMCC provided the complainant's husband with a complete copy of his medical records. The investigation established that ECMCC failed to timely provide the complainant's husband with a complete copy of his medical records. HHS's investigation indicated that the following conduct occurred ("Covered Conduct"):
1. ECMCC failed to provide timely access to protected health information. See 45 C.F.R. § 164.524.

No Admission. This Agreement is not an admission of liability by ECMCC.
No Concession. This Agreement is not a concession by HHS that ECMCC is not in violation of the HIPAA Rules and not liable for civil money penalties.
Intention of Parties to Effect Resolution. This Agreement is intended to resolve HHS TN 20-368722 and any violations of the HIPAA Rules related to the Covered Conduct specified in paragraph I.2 of this Agreement. In consideration of the Parties' interest in avoiding the uncertainty, burden, and expense of formal proceedings, the Parties agree to resolve this matter according to the Terms and Conditions below.

II. Terms and Conditions

Payment. HHS has agreed to accept, and ECMCC has agreed to pay HHS, the amount of $50,000.00 ("Resolution Amount"). ECMCC agrees to pay the Resolution Amount on the Effective Date of this Agreement as defined in paragraph II.14 pursuant to written instructions provided by HHS.
Corrective Action Plan. ECMCC has entered into and agrees to comply with the Corrective Action Plan ("CAP"), attached as Appendix A, which is incorporated into this Agreement by reference. If ECMCC breaches the CAP, and fails to cure the breach as set forth in the CAP, then ECMCC will be in breach of this Agreement and HHS will not be subject to the Release set forth in paragraph II.8 of this Agreement.
Release by HHS. In consideration of and conditioned upon ECMCC performance of its obligations under this Agreement, HHS releases ECMCC from any actions it may have against ECMCC under the HIPAA Rules arising out of or related to the Covered Conduct identified in paragraph I.2 of this Agreement. HHS does not release ECMCC from, nor waive any rights, obligations, or causes of action other than those arising out of or related to the Covered Conduct and referred to in this paragraph. This release does not extend to actions that may be brought under section 1177 of the Social Security Act, 42 U.S.C. § 1320d-6.
Agreement by Released Parties. ECMCC shall not contest the validity of its obligation to pay, nor the amount of, the Resolution Amount or any other obligations agreed to under this Agreement. ECMCC waives all procedural rights granted under Section 1128A of the Social Security Act (42 U.S.C. § 1320a- 7a) and 45 C.F.R. Part 160 Subpart E, and HHS claims collection regulations at 45 C.F.R. Part 30, including, but not limited to, notice, hearing, and appeal with respect to the Resolution Amount.
Binding on Successors. This Agreement is binding on ECMCC and their successors, heirs, transferees, and assigns.
Costs. Each Party to this Agreement shall bear its own legal and other costs incurred in connection with this matter, including the preparation and performance of this Agreement.
No Additional Releases. This Agreement is intended to be for the benefit of the Parties only and by this instrument the Parties do not release any claims against or by any other person or entity.
Effect of Agreement. This Agreement constitutes the complete agreement between the Parties. All material representations, understandings, and promises of the Parties are contained in this Agreement. Any modifications to this Agreement shall be set forth in writing and signed by all Parties.
Execution of Agreement and Effective Date. The Agreement shall become effective (i.e., final and binding) upon the date of signing of this Agreement and the CAP by the last signatory (Effective Date).
Tolling of Statute of Limitations. Pursuant to 42 U.S.C. § 1320a-7a(c)(1), a civil money penalty ("CMP") must be imposed within six years from the date of the occurrence of the violation. To ensure that this six-year period does not expire during the term of this Agreement, ECMCC agrees that the time between the Effective Date of this Agreement and the date the Agreement may be terminated by reason of ECMCC, plus one-year thereafter, will not be included in calculating the six (6) year statute of limitations applicable to the violations which are the subject of this Agreement. ECMCC waives and will not plead any statute of limitations, laches, or similar defenses to any administrative action relating to the Covered Conduct identified in paragraph I.2 that is filed by HHS within the time period set forth above, except to the extent that such defenses would have been available had an administrative action been filed on the Effective Date of this Agreement.
Disclosure. HHS places no restriction on the publication of the Agreement.
Execution in Counterparts. This Agreement may be executed in counterparts, each of which constitutes an original, and all of which shall constitute one and the same agreement.
Authorizations. The individual(s) signing this Agreement on behalf of ECMCC represents and warrants that they are authorized to execute this Agreement and bind ECMCC, as set forth in paragraph I.1.b. The individual(s) signing this Agreement on behalf of HHS represent and warrant that they are signing this Agreement in their official capacities and that they are authorized to execute this Agreement.

For Covered Entity

/s/

Jonathan T. Swiatkowski, CPA
Chief Financial Officer
Erie County Medical Center Corporation
462 Grider Street
716-898-6291
jswiatkows@ecmc.edu

Date: 6/2/2022

For the United States Department of Health and Human Services

/s/

Linda C. Colón
Regional Manager
Eastern and Caribbean Region
Office for Civil Rights

Date: 6/3/2022

Appendix A

CORRECTIVE ACTION PLAN BETWEEN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES AND ERIE COUNTY MEDICAL CENTER CORPORATION

I. Preamble

ECMCC hereby enters into this Corrective Action Plan ("CAP") with the United States Department of Health and Human Services, Office for Civil Rights ("HHS"). Contemporaneously with this CAP, ECMCC is entering into the Agreement with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. ECMCC enters into this CAP as part of consideration for the release set forth in paragraph II.8 of the Agreement. Capitalized terms without definition in this CAP shall have the same meaning assigned to them under the Agreement.

II. Contact Persons and Submissions

Contact Persons

ECMCC has identified the following individual as its authorized representative and contact person regarding the implementation of this CAP and for receipt and submission of notifications and reports:

Jonathan T. Swiatkowski, CPA
Chief Financial Officer
Erie County Medical Center Corporation
462 Grider Street
716-898-6291
jswiatkows@ecmc.edu

HHS has identified the following individual as its authorized representative and contact person with whom ECMCC is to report information regarding the implementation of this CAP:

Linda C. Colón, Regional Manager
Eastern and Caribbean Region
Office for Civil Rights
U.S. Department of Health and Human Services
26 Federal Plaza, Suite 3312
New York, New York 10278
Voice Phone 212-264-4136

ECMCC and HHS agree to promptly notify each other of any changes in the contact person or the other information provided above.

Proof of Submissions. Unless otherwise specified, all notifications and reports required by this CAP may be made by any means, including certified mail, overnight mail, electronic mail, or hand delivery, provided that there is proof that such notification was received. For purposes of this requirement, internal facsimile confirmation sheets do not constitute proof of receipt.

III. Effective Date and Term of CAP

The Effective Date for this CAP shall be calculated in accordance with paragraph II.14 of the Agreement ("Effective Date"). The period for compliance ("Compliance Term") with the obligations assumed by ECMCC under this CAP shall begin on the Effective Date of this CAP and end two (2) years from the Effective Date, unless HHS has notified ECMCC under section VIII hereof of its determination that ECMCC has breached this CAP. In the event of such a notification by HHS under section VIII hereof, the Compliance Term shall not end until HHS notifies ECMCC that it has determined that the breach has been cured. After the Compliance Term ends, ECMCC shall still be obligated to: (a) submit the final Annual Report as required by section VI; and (b) comply with the document retention requirement in section VII.

IV. Time

In computing any period of time prescribed or allowed by this CAP, all days referred to shall be calendar days. The day of the act, event, or default from which the designated period of time begins to run shall not be included. The last day of the period so computed shall be included, unless it is a Saturday, a Sunday, or a legal holiday, in which event the period runs until the end of the next day which is not one of the aforementioned days.

V. Corrective Action Obligations

ECMCC agrees to the following:

Review and Revise Policy and Procedures for Individual Access to PHI
1. Within thirty (30) calendar days of the Effective Date, ECMCC shall review, and to the extent necessary, revise its written policy and procedures related to access to PHI consistent with 45 C.F.R. § 164.524, and provide such policies to OCR for review consistent with paragraph A.2 of this section. ECMCC shall ensure that its policies include the following:
  1. A requirement that individuals who request access to their medical records are provided timely access to a complete copy of their records consistent with 45 C.F.R. § 164.524.
  2. Modification of its present policy of providing a limited record abstract when an individual requests a copy of their medical records. ECMCC's policy shall require that individuals are to be provided a complete copy of their records upon request.
  3. A requirement that individuals who request their PHI are to be provided with access to the PHI in the form and format requested, if it is readily producible in such form and format; or, if not, in a readable hard copy form or such other form and format as agreed to by the covered entity and the individual.
2. HHS shall review and, if necessary, recommend changes to the aforementioned policy and procedures for individual access to PHI. Upon receiving recommended changes from HHS, ECMCC shall have thirty (30) calendar days to provide revised policy and procedures for individual access to PHI for HHS's approval.
Privacy Training on Individual Access to Protected Health Information
1. Within sixty (60) calendar days of the Effective Date, ECMCC shall provide training materials regarding the individual's right of access to PHI consistent with 45 C.F.R. § 164.524 to HHS for review and approval.
2. Within sixty (60) calendar days of HHS's approval (and notice to ECMCC of such approval) and annually while under the Compliance Term of this CAP, ECMCC shall provide training to its workforce members whose job functions involve receiving, processing, handling or responding to requests for individual access to PHI on the Privacy Rule requirements concerning the individual's right of access to PHI.
Access Request Status Requirements
1. Within ninety (90) calendar days of the Effective Date of this Agreement and every ninety (90) days thereafter while under the Compliance Term of this CAP, ECMCC shall submit to HHS a list of requests for access to PHI received by ECMCC from patients or patient personal representatives, including the date request received, date request completed, format requested, format provided, number of pages (if provided in paper format), and cost, excluding postage.
2. If ECMCC denied any request for access, in whole or in part, ECMCC shall submit to HHS all documentation consistent with 45 C.F.R. § 164.524(d).
Reportable Events
1. During the Compliance Term, ECMCC shall, upon receiving information that a workforce member may have failed to comply with its access policies and procedures, promptly investigate this matter. If ECMCC determines, after review and investigation, that a member of its workforce has failed to comply with these policies and procedures, ECMCC shall notify HHS in writing within thirty (30) days. Such violations shall be known as Reportable Events. The report to HHS shall include the following information:
  1. A complete description of the event, including the relevant facts, the persons involved, and the provision(s) of the policies and procedures implicated; and

(1) A description of the actions taken and any further steps ECMCC plans to take to address the matter to mitigate any harm, and to prevent it from recurring, including application of appropriate sanctions against workforce members who failed to comply with its Privacy Rule policies and procedures.

VI. Implementation Report and Annual Reports

Implementation Report.
1. Within one hundred twenty (120) calendar days after the Effective Date of this Agreement, ECMCC shall submit a written report to HHS summarizing the status of its implementation of the requirements of this CAP. This report, known as the "Implementation Report," shall include:
  1. An attestation signed by an owner or officer of ECMCC attesting that the required members of the workforce have completed the initial training as required by the terms of section V.B.2;
  2. An attestation signed by an owner or officer of ECMCC stating that he or she has reviewed the Implementation Report, has made a reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful.
Annual Reports.
1. The one (1) year period after the Effective Date and each subsequent one (1) year period during the course of the Compliance Term shall be known as a "Reporting Period." Within sixty (60) calendar days after the close of each corresponding Reporting Period, ECMCC shall submit a report to HHS regarding ECMCC's compliance with this CAP for each corresponding Reporting Period ("Annual Report").
2. An attestation signed by an owner or officer of ECMCC attesting that the required members of the workforce have completed the training as required by the terms of section V.B.2 during the Reporting Period;
3. A summary of Reportable Events (defined in V.D.), if any, the status of any corrective and preventative action(s) relating to all such Reportable Events, or an attestation signed by an officer or director of ECMCC stating that no Reportable Events occurred during the Compliance Term.
4. An attestation signed by an owner or office of ECMCC attesting that he or she has reviewed the Annual Report, has made a reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful.

VII. Document Retention

ECMCC shall maintain for inspection and copying, and shall provide to HHS, upon request, all documents and records relating to compliance with this CAP for six (6) years from the Effective Date.

VIII. Breach Provisions

ECMCC is expected to fully and timely comply with all provisions contained in this CAP.

Timely Written Requests for Extensions. ECMCC may, in advance of any due date set forth in this CAP, submit a timely written request for an extension of time to perform any act required by this CAP. A "timely written request" is defined as a request in writing received by HHS at least five (5) calendar days prior to the date such an act is required or due to be performed.
Notice of Breach of this CAP and Intent to Impose Civil Monetary Penalty. The parties agree that a breach of this CAP by ECMCC constitutes a breach of the Agreement. Upon a determination by HHS that ECMCC has breached this CAP, HHS may notify ECMCC of: (1) ECMCC's breach; and (2) HHS's intent to impose a civil money penalty (CMP), pursuant to 45 C.F.R. Part 160, or other remedies, for the Covered Conduct set forth in paragraph I.2 of the Agreement and for any other conduct that constitutes a violation of the HIPAA Privacy, Security, and Breach Notification Rules ("Notice of Breach and Intent to Impose CMP").
ECMCC Response. ECMCC shall have thirty (30) calendar days from the date of receipt of the Notice of Breach and Intent to Impose CMP to demonstrate to HHS's satisfaction that:
1. ECMCC is in compliance with the obligations of the CAP that HHS cited as the basis for the breach;
2. the alleged breach has been cured; or
3. the alleged breach cannot be cured within the 30-day period, but that: (a) ECMCC has begun to take action to cure the breach; (b) ECMCC is pursuing such action with due diligence; and (c) ECMCC has provided to HHS a reasonable timetable for curing the breach.
Imposition of CMP. If at the conclusion of the 30-day period, ECMCC fails to meet the requirements of section VIII.C of this CAP to HHS's satisfaction, HHS may proceed with the imposition of the CMP against ECMCC pursuant to 45 C.F.R. Part 160 for any violations of the Covered Conduct set forth in paragraph 2 of the Agreement and for any other act or failure to act that constitutes a violation of the HIPAA Rules. HHS shall notify ECMCC in writing of its determination to proceed with the imposition of the CMP.

For Erie County Medical Center Corporation

/s/

Authorized Representative
Erie County Medical Center Corporation

Date: 6/2/2022

For the United States Department of Health and Human Services

/s/

Linda C. Colón
Regional Manager
Office for Civil Rights
Eastern and Caribbean Region

Date: 6/3/2022

Erie County Medical Center Corporation Resolution Agreement and Corrective Action Plan

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