Spring 2006
Voluntary Compliance with Federal Law May Insulate Reportable Events From Disclosure
The federal Patient Safety and Quality Improvement Act ("PSQIA") signed into law in July 2005 may benefit Pennsylvania health care facilities in light of the mandatory reporting under MCARE. Voluntary reporting under the federal act is induced by the promise of protection from disclosure in discovery and from public view except under limited circumstances. The open disclosure policy under MCARE and the Peer Review Protection Act at 63 P.S. §§425.1 et seq., necessarily come into conflict as it is unclear whether reports made to either the Patient Safety Authority or the Department of Health (DOH) would be shielded from discovery in litigation, even when resulting from an investigation relating to patient safety. In fact, a trial court recently held that MCARE protection applied only to investigations of a patient safety committee, and thus required disclosure of the report.
The PSQIA provides that a facility that performs patient safety or quality improvement activities and voluntarily reports errors to a patient safety organization may do so with the understanding that any materials that have been reported for the purpose of medical error reduction and/or other patient safety/quality improvement activity data shall be protected from disclosure. This protection would encompass not only traditional "peer review materials" of and by professionals, but also self-critical analysis and internal patient safety review.
In light of the expanded protections from disclosure available under the federal law, it would behoove Pennsylvania health care facilities to consider restructuring their internal patient safety reporting mechanisms under MCARE to mirror the patient safety evaluation system outlined in the federal law.
Outside counsel familiar with the MCARE reporting mechanisms and those of the federal law may review internal policies and procedures with respect to reporting to ensure that a compliance plan would comport with federal law as well as state law to gain the protections afforded by voluntary reporting.
PaDOH Proposes General Hospital Regulations Focused on Patient Safety
The long-awaited General Hospital regulations have been posted in draft form on DOH's web site for public comment. As Chapter 51 indicates in its Statement of Purpose, the proposed regulations will focus upon patient safety through reporting of errors and quality assurance measures. The draft regulations incorporate the mandatory reporting obligations under MCARE through Chapter 52 entitled "Patient Safety & Quality Improvement." These regulations would pertain to every health care facility as defined under the health care facility act regardless of whether the facility is subject to MCARE reporting requirements.
The draft regulations indicate how DOH and the Patient Safety Authority intend to implement and enforce MCARE reporting and reduce serious events for all facilities. Data learned from mandatory reporting will be used to develop performance and quality standards. DOH regulations would impose broad obligations upon not only the facility, but also each individual within that facility.
The reporting obligations would provide that "For those health care providers that are not required to report under MCARE, the health care provider must notify the Department in writing whenever a health care provider becomes aware of any situation or event at any health facility that seriously compromises quality of care or patient safety; or becomes aware of information that any health facility it operates is out of compliance with Department regulations and that the non-compliance could seriously compromise quality of care or patient safety."
Events that "seriously compromise quality of care or patient safety" remain mandatorily reportable under the draft regulations for all health care facilities. However, the limbo status of reporting obligations under Chapter 51 created by the enactment of MCARE would be resolved by separating reporting obligations of MCARE covered facilities from those of non-MCARE covered facilities.
Facilities required to report serious events and infrastructure failures under MCARE must continue their reporting through the Patient Safety Reporting System. Health care providers' operating facilities not required to report under MCARE continue to be responsible for reporting serious events and infrastructure failures previously outlined in 28 Pa. Code §51.3 (f) and (g). The reporting obligations have been relocated to the Patient Safety chapter and are identical to the prior regulations with the exception that "events which seriously compromise quality of care or patient safety" would be expanded to include "deaths or serious injuries as a result of medication errors or medical procedure errors." It is unclear whether a complication would be a "medical procedure error."
Prior to the issuance of these draft regulations, the Department had not disclosed how it would be reviewing incidents which are reported to the Patient Safety Authority, but not to the Department itself. These regulations require incidents to be reported in aggregate form to DOH on a "patient safety and quality improvement report." As this report would be made to a Commonwealth agency, and the regulation does not provide that such aggregate reports are shielded from discovery or disclosure, the question is raised as to whether these reports would be open to public view pursuant to the Right to Know Law.
In addition to a chapter devoted to Patient Safety and Quality Improvement, DOH plans to add Chapter 53 focusing upon Public Health Preparedness.
HIPAA Enforcement Rule Effective March 16th
Final regulations implementing the enforcement provisions of the administrative simplification standards established by the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") were issued on February 16, 2006. The final rule adopts most of the proposed provisions. One relevant difference between the final rule and the proposed is the manner in which the "number of violations" are calculated. The proposed rule utilized three "variables" in determining the number of violations without fully defining what a "violation" was. The final rule specifies that the number of violations will be based upon the nature of each covered entity's substantive obligation to act or not act, and that a separate violation occurs each day the covered entity is in violation.
With respect to affirmative defenses, the final rule clarifies the following terms: "reasonable cause," "reasonable diligence," and "willful neglect." A defense may be shown when failure to comply is due to a reasonable cause as opposed to willful neglect, which is indicated when a correction is made within 30 days from discovering the violation. When such affirmative defenses can be shown upon an initial complaint, the Secretary of Health and Human Services will not pursue a civil penalty action.
For more information about state reporting obligations and compliance assistance with any of the above statutes and regulations, contact the author Lucinda C. Glinn at lcglinn@nssh.com.
Disclaimer and IRS Circular 230 Notice:
The material on our website and in this newsletter has been prepared for informational purposes only. It does not constitute legal advice, and transmission of information from this site is not intended to create, nor does its receipt constitute, an attorney-client relationship between Nauman Smith Shissler and Hall, LLP and the visitor to this site. The information contained in this newsletter is not intended as tax advice. As required by IRS Circular 230, we inform you that any information contained in this newsletter is not intended or written to be used, and cannot be used, for the purpose of avoiding penalties under the Internal Revenue Code or for the purpose of promoting, marketing or recommending to another party, any tax-related matter addressed herein.
Nauman Smith Shissler & Hall, LLP
200 North 3rd Street, 18th Floor
Harrisburg, PA 17101
717.236.3010
fax: 717.234.1925
info@nssh.com