Pennsylvania physicians who received a rebate for 2006’s Mcare assessment are required to continue practicing in the Commonwealth through the end of 2007. Physicians who receive a rebate on 2007 Mcare assessment must continue to practice in Pennsylvania through the end of 2008. Physicians who do not fulfill their practice pledge, which was required on the application, will have to repay the abatement.
On October 27, 2006, Governor Edward G. Rendell signed Senate Bill 972 to extend the Mcare abatement through December 31, 2007. The new law, Act 128 of 2006, requires physicians who receive an abatement to practice in the state of Pennsylvania through December 31, 2008.
Under Act 128, high-risk specialists will have 100 percent of their Mcare payment abated. The bill also adds any physicians providing emergency services in hospital emergency departments to those eligible for the 100 percent abatement. All other physicians will receive a 50 percent abatement. This year, the Mcare annual assessment was levied at 23 percent.
For more information, please visit the Mcare website at www.mcare.state.pa.us or call (717) 783-3770, ext. 243.
POMA would like to thank Governor Rendell and all of the legislators who voted yes on Mcare abatement. Your support is greatly appreciated.
Under Act 13 of 2002 (Mcare Act), non-active and retired physicians are no longer required to maintain professional liability insurance if they only write prescriptions for themselves and their immediate family. Physicians affected by this change should contact their professional liability insurance carrier to discuss their options.
Under the Medical Care Availability and Reduction of Error (Mcare) Act, physicians are required to self-report all medical professional liability incidents to their licensure board. The Bureau of Professional and Occupational Affairs requires that the physician provide the following in their report:
- the docket number of the case
- a description of the allegations in the complaint
- a copy of the civil complaint
- a cover letter that includes the physician's signature
The Mcare Act requires physicians to report complaints to the State Board of Osteopathic Medicine (SBOM) within 60 days after the malpractice complaint is filed. These requirements, which became effective on May 20, 2002, only apply to new incidents. Physicians who received complaint papers on or after May 20, even if the complaint was filed prior to this date, must send notice to the SBOM.
Physicians can send their reports to the SBOM at P.O. Box 2649, Harrisburg, PA 17105 or e-mail the SBOM at osteopat@pados.dos.state.pa.us. When e-mailing reports to the state Board, a signed cover letter and a copy of the civil complaint must be mailed to the proper board to complete the filing.
By Lawrence J. Beaser, Esq., and Howard A. Burde, Esq.
On March 20, Governor Schweiker signed into law the “Medical Care Availability and Reduction of Error (Mcare) Act” as Act 13 of 2002. In 83 pages of detailed legislation, the General Assembly addressed three main areas:
- Insurance reform — among other provisions, enactment of changes to mandatory medical professional liability insurance amounts; abolition of the CAT fund and its replacement by a new, similar fund supervised by the Pennsylvania Insurance Department, to be known as the Mcare Fund; provisions for a small discount on surcharges and assessments and eventual phase out of all required excess coverage through increases in basic insurance limits.
- Medical professional liability reform — enactment of certain “tort reform” covering actions against physicians, hospitals and certain other health care providers, including caps on punitive damages, prohibiting duplicate recovery for past medical expenses and lost earnings, a statute of repose, structured settlements, etc. These reforms are discussed below.
- Patient safety — new requirements in the area of patient safety, including establishment of a Patient Safety Authority and a Patient Safety Trust Fund to be funded by medical facilities, requirements for the development of Patient Safety Plans and appointment of Patient Safety Officers, mandatory reporting and patient safety discounts.
In addition, the Mcare Act adds administrative provisions that impose reporting requirements and expand the duties and powers of the State Board of Osteopathic Medicine and the State Board of Medicine.
The Mcare Act is complex legislation. This summary is intended to provide you with a brief overview of the insurance, medical professional liability and administrative reform provisions of the Mcare Act. The next issue of the POMA Newsletter will contain a summary of the patient safety provisions.
Insurance Reform
Initially, the Mcare Act will provide modest savings to primary care physicians and slightly more relief for specialists through discounts on surcharges and assessments. Additional savings will occur in future years, so that the full impact of the savings will not be realized for three to five years. The Mcare Act contains no mandatory reductions in basic insurance premiums.
Under the Mcare Act, physicians must still maintain medical professional liability insurance; however, in 2003, the maximum required coverage amount will be reduced to $1,000,000 per occurrence, from the current $1,200,000 ($500,000 in basic coverage and $700,000 from the CAT Fund to $500,000 basic coverage and $500,000 from the new Mcare Fund in 2003). Aggregate annual limits will also be lowered. The Mcare Act contains similar reductions in mandatory coverage amounts for hospitals.
The CAT Fund will be abolished in September 2002, to be replaced by the Mcare Fund, a fund with similar functions to that of the CAT fund. It will be administered by the Insurance Department.
Excess coverage by the new Mcare Fund will be phased out by increasing basic insurance limits, which are expected to occur in 2006 and 2009. Thus, it is expected (although not guaranteed) that by 2009, physicians will no longer be paying surcharges to the CAT or Mcare Fund. Governor Schweiker predicted, at the time he signed the legislation, that phase-out of the CAT fund will mean a 5 percent annual savings to physicians. Only time will tell whether this prediction is correct.
Medical Professional Liability (Tort) Reform
The Mcare Act contains significant “tort reforms” that will have a long-lasting, positive effect on the medical professional liability system. Over the next few years, as the reforms in the Mcare Act make themselves felt, the system will become more balanced and fair.
In the short term, however, the reforms will have little, if any, effect on the size of awards or the cost of insurance, because the reforms apply only to “causes of action which arise” on or after March 20, 2002, the effective date of these sections.
With that caveat, the following are important reforms contained in the Mcare Act. Each applies only to medical professional liability actions.
- Caps on Punitive Damages. The Mcare Act limits when awards of punitive damages may be made and specifically provides that, if punitive damages are awarded, the damages may not exceed 200 percent of the compensatory damages awarded (with an exception that would allow higher damages if the misconduct was intentional). The minimum punitive damage award that may be made is $100,000 (unless a lower verdict amount is returned). The plaintiff would receive 75 percent of the punitive damage award and 25 percent would be paid to the Mcare Fund discussed above. This would be used to offset medical professional liability surcharges.
- Collateral Source Rule. The Mcare Act limits duplicative recovery for past medical expenses or lost earnings. A plaintiff may not recover for damages for past medical expenses or lost earnings when the plaintiff has already been compensated for those damages. There are limited exceptions to this rule that permit a plaintiff to recover for past medical expenses to the extent that the plaintiff remains legally responsible for them.
- Statute of Repose. The General Assembly has enacted a definite time within which a medical professional liability action must be brought. In the long run, this will reduce insurance risk and should have a downward effect on premiums. The Mcare Act provides that an action for medical professional liability may not be brought more than seven years from the date of the alleged tort or breach of contract (i.e., the plaintiff has seven years from the date of the occurrence giving rise to the action to file his or her suit). An exception is made for foreign objects unintentionally left in an individual’s body. Special provision is also made for minors.
- Affidavit of Noninvolvement. Any health care provider named as a defendant in an action may cause the action to be dismissed by filing an affidavit of noninvolvement with the court. This affidavit must set forth the facts that demonstrate that the health care provider has been misidentified or was not involved in the treatment of the plaintiff. The affidavit of noninvolvement may be challenged by a codefendant or plaintiff and tolls the statute of limitations.
- Structured Settlements for Payment of Future Medical Damages. Payment of damages for future medical expenses will now be paid in a structured settlement (i.e., paid in periodic payments rather than in one lump sum). All other types of damages (including all past damages and future damages for lost earnings and non-economic loss) are to be awarded in a lump sum. A plaintiff may receive a lump sum payment for future medical expense damages if the plaintiff objects to the structured settlement and stipulates that the amount of his or her future damages for medical expenses does not exceed $100,000.
- Reduction to Present Value. Future damages for loss of earnings will be reduced to present value, based on the return that the plaintiff can earn on a reasonably secure fixed income investment. At present, losses for future earnings are paid in a lump sum. This reduction of the award to present value will result in lower payments for future lost earnings in medical professional liability cases.
- Additional Qualifications for Expert Opinions. An expert must satisfy specific requirements, which are above and beyond what is required in other actions under Pennsylvania law, before being permitted to render an expert medical opinion. An expert may not offer an opinion unless he or she possesses sufficient education, training, knowledge and experience to provide credible, competent testimony. In addition, the expert must meet the following qualifications: (1) to testify on a medical matter, the expert must possess an unrestricted physician’s license to practice medicine in any state or the District of Columbia, and must be engaged in (or have retired from in the last five years) active clinical practice or teaching; (2) to testify on the applicable physician’s standard of care, in addition to the above requirements, the expert must also be substantially familiar with the applicable standard of care for the specific care at issue, must practice in the same or a substantially similar subspecialty as the defendant physician, and, generally, possess the same board certifications as the defendant physician. The provisions are detailed and should be reviewed carefully on a case by case basis.
- Advance Payments Inadmissible. Any advance payment made by a health care provider (or its insurer) to a plaintiff cannot be construed as an admission of liability and evidence of such an advance payment is inadmissible.
- Reduction of Excessive Awards (Remittitur). In deciding a motion to reduce a jury verdict on the ground that the award is excessive (a motion for remittitur), the court is required to consider the availability or access to health care if the defendant health care provider is required to satisfy the verdict. According to Governor Schweiker in a release issue at the time he signed the bill, the intent of this provision is to permit “doctors and hospitals to have verdicts lowered by a judge if it would force a doctor out of business or force a hospital to cut services, thereby damaging the community.”
- Limitations on Agency Law (Vicarious Liability). A hospital may be held vicariously liable for the actions of another health care provider only if the evidence shows that: (1) a reasonable person in the patient’s position would be justified in believing that the care was being rendered by the hospital or its agents; or (2) the care was advertised or represented to the patient as being rendered by the hospital or its agents.
Patient Safety
As noted above, the General Assembly enacted detailed patient safety provisions in the Mcare Act. Due to space constraints, these will be discussed in detail in the next POMA Newsletter.
Administrative Provisions
The Mcare Act contains administrative provisions that affect physicians and their licensing boards. The administrative provisions are intended to be read together with the Osteopathic Medical Practice Act and the Medical Practice Act; however, if there is a conflict, the Mcare Act provisions prevail.
- Mandatory Reporting By Physicians. A physician is required to report to the State Board of Osteopathic Medicine or the State Board of Medicine, as applicable, within 60 days of the occurrence of any of the following: (1) Notice of a complaint in a medical professional liability action that is filed against the physician. The physician shall provide the docket number of the case, where the case is filed and a description of the allegations in the complaint; (2) Information regarding disciplinary action taken against the physician by a health care licensing authority of another state; (3) Information regarding sentencing of the physician for an offense as provided in Section 15 of the Osteopathic Medical Practice Act and Section 41 of the Medical Practice Act; (4) Information regarding an arrest of the physician for any of the following offenses in Pennsylvania or in another state: i) criminal homicide; ii) aggravated assault; iii) sexual offenses; iv) a violation of The Controlled Substance Drug, Device and Cosmetic Act.
- Mandatory Continuing Medical Education. Beginning with the licensure period commencing January 1, 2003, and following written notice to licensees by the appropriate licensure board, physicians will be required to enroll in and complete 100 hours of mandatory continuing education during each two-year licensure period. As part of the 100-hour requirement, the licensure board shall establish a minimum number of hours that must be completed in improving patient safety and risk management subject areas. There are certain limited exceptions, such as for a retired physician who provides care only to immediate family members. This will be a new requirement for allopathic physicians, but not for osteopathic physicians.
- Investigations of physicians due to frequency and severity of medical professional liability actions. The Mcare Act requires the licensing boards to develop criteria and standards for review based on the frequency and severity of medical professional liability actions filed against a physician. A licensure board investigation of a physician is required to be commenced within four years after the notices described above or notice that payment against the physician has been reported to the National Practitioner Data Bank or payment in a medical professional liability action against the physician has been reported to the licensure board by an insurer. If the licensure board determines that a physician has practiced negligently, the licensure board may impose disciplinary sanctions or corrective measures.
- Imposition of civil monetary penalties. The Mcare Act gives the licensure boards new authority to levy a civil penalty of up to $10,000 on any current licensee who violates any provision of the Mcare Act, the Osteopathic Medical Practice Act or the Medical Practice Act, or practices medicine or osteopathic medicine without being properly licensed to do so.
- Confidentiality of information. A confidentiality agreement or court order sealing the settlement and related records for purposes of confidentiality will not stop the licensure board from obtaining copies of the medical records of the patient on whose behalf the action was commenced. However, prior to obtaining such medical records, the licensure board would be required to obtain the consent of the patient or the patient’s legal representative. In addition, all documents, materials or information utilized solely for an investigation undertaken by the licensure boards are to be confidential and privileged. No person who has investigated or has access to or custody of documents, materials or information that are confidential and privileged may be required to testify in any judicial or administrative proceeding without the written consent of the licensure board.
¹Mr. Beaser and Mr. Burde are partners of Blank Rome Comisky & McCauley LLP and co-chairs of its Health Law Group. Mr. Beaser is general counsel to the Pennsylvania Osteopathic Medical Association. Mr. Burde serves as Deputy General Counsel to Pennsylvania Governor Mark Schweiker and was active in the development of the Mcare Act. The information contained in this article is for general information purposes only, should not be construed as legal advice or opinion, and is not a substitute for the advice of counsel. The Mcare Act contains detailed provisions, all of which are not summarized in this article.
By Lawrence J. Beaser, Esq., and Howard A. Burde, Esq (1)
Background Note: This is the second of two articles on Pennsylvania's new "Medical Care Availability and Reduction of Error (Mcare) Act," which was signed into law on March 20 by Governor Schweiker as Act 13 of 2002. The first article, which appeared in the March 27, 2002, edition of the POMA Newsletter, reviewed the insurance, medical professional liability and administrative reform provisions of the Mcare Act. This article focuses on the Mcare Act's patient safety provisions.
One of the primary goals of the Medical Care Availability and Reduction of Error (Mcare) Act is to "reduce and eliminate medical errors by identifying problems and implementing solutions that promote patient safety."(2)
To do this, the Mcare Act's patient safety provisions focus on three types of "medical facilities," hospitals, ambulatory surgical facilities and birth centers. These are the only health care entities that are covered by the patient safety provisions of the Mcare Act. Thus, for example, long-term care facilities are not covered by the Mcare Act's patient safety provisions.
In addition, the Mcare Act directly affects physicians and other "health care workers"(3) in a number of ways.
Specifically, in the area of patient safety, the Mcare Act:
- Establishes a new agency, the "Patient Safety Authority," to be funded by surcharges paid by medical facilities into a "Patient Safety Trust Fund;"
- Provides the Patient Safety Authority (in conjunction with the Pennsylvania Department of Health) with specific duties in the area of patient safety;
- Imposes new duties on medical facilities, including the development of patient safety plans, mandatory reporting of medical errors to the Patient Safety Authority and the Department of Health, in an effort to identify preventable patient safety trends and problems;
- Requires "health care workers" in a Medical facility to report a "serious event or incident" in accordance with a Medical facility's patient safety plan;
- Provides for confidentiality of patient safety committee records;
- Sets out rules on informed consent.(4)
The Patient Safety Authority and Duties of the Department of Health
The new Patient Safety Authority (the "Authority") is to be composed of 11 members, with varying backgrounds, appointed by the Governor and legislative leaders, and chaired by the Physician General. A majority of the members will be health care workers, including at least one physician. Funding will be provided through a Patient Safety Trust Fund to be administered by the Authority. Medical facilities will be required to pay a licensing surcharge, with total surcharges from all Medical facilities not exceeding $5,000,000 in fiscal year 2002-2003 (and increasing in later years according to the Consumer Price Index).(5)
The Authority is required to contract "with a for-profit or registered nonprofit entity or entities, other than a health care provider..." for the contractor to: i) collect, analyze and evaluate data regarding reports of serious events and incidents, including the identification of performance indicators and patterns in frequency or severity at certain Medical facilities or in certain regions of the Commonwealth; ii) transmit to the Authority recommendations for changes in health care practices and procedures, which may be instituted for the purpose of reducing the number and severity of serious events an incidents; iii) directly advise reporting Medical facilities of immediate changes that can be instituted for the purpose of reducing the number and severity of serious events and incidents; and iv) conduct reviews.
The Authority may receive and evaluate recommendations made by the contractor and, after consultation and approval by the Department of Health (and after giving consideration to a number of factors set forth in the Mcare Act), the Authority may issue recommendations to medical facilities "on a facility-specific or statewide basis regarding changes, trends and improvements in health care practices and procedures for the purpose of reducing the number and severity of serious events and incidents." The Authority may receive and investigate anonymous reports from health care workers regarding serious events (discussed below).
An annual report must be issued by the Authority.
The Department of Health is required to 1) review and approve patient safety plans; 2) receive reports of serious events and infrastructure failures; 3) investigate serious events and infrastructure failures; 4) in conjunction with the Authority, analyze and evaluate existing health care procedures and approve recommendations issued by the Authority; and 5) meet with the Authority for purposes of implementing the provisions of the Mcare Act.
Duties of Medical Facilities
Patient Safety Plans
Each Medical facility is required to develop, implement and comply with an internal patient safety plan "for the purpose of improving the health and safety of patients." Patient safety plans are subject to approval by the Department of Health. The patient safety plan is required to: 1) designate a patient safety officer; 2) establish a patient safety committee; 3) establish a system for the health care workers of a Medical facility to report serious events and incidents, which is required to be accessible 24 hours a day, seven days a week; 4) prohibit any retaliatory action against a health care worker for reporting a serious event or incident; and 5) provide for written notification to a patient (or representative) affected by a serious event within 7 days after the occurrence or discovery of the event. Initial patient safety plans will be required to be filed on or before July 18, 2002.
The Mcare Act requires that all health care workers of the Medical facility be notified upon approval of the patient safety plan. Compliance with the patient safety plan is required as a condition of employment or credentialing at the Medical facility.
The patient safety officer shall: 1) serve on the patient safety committee; 2) ensure the investigation of all reports of serious events and incidents; 3) take such action as is immediately necessary to ensure patient safety as a result of any investigation; and 4) report to the patient safety committee regarding any investigations commenced pursuant to this section.
The patient safety committee is required to: 1) receive reports from the patient safety officer; 2) evaluate investigations and actions of the patient safety officer on all reports; 3) review and evaluate the quality of patient safety measures utilized by the Medical facility; 4) make recommendations to eliminate future serious events and incidents; and 5) report to the administrative officer and governing body of the Medical facility on a quarterly basis regarding the number of serious events and incidents and its recommendations to eliminate future serious events and incidents.
Medical Facility Reporting
- Serious event reporting - Serious events(6) must be reported to the Department of Health and the Authority within 24 hours after the Medical facility's confirmation of the occurrence of the serious event. Medical facilities must notify patients (or, with the consent of the patient, an available family member or designee) within 7 days after the occurrence or discovery of a serious event. Provisions are made for notification if the patient is unable to give consent or is a minor.
- Incident reports - Incidents(7) must be reported to the Authority in a form and manner prescribed by the Authority. Neither the patient's name nor any other identifiable individual information is to be included in the incident report. The Mcare Act does not state a time within which the incident report must be made. We assume the Authority will prescribe a time within which Medical facilities must act.
- Infrastructure failure reports - Reports of "infrastructure failures"(8) must be made to the Department of Health within 24 hours after the Medical facility's confirmation of the occurrence or discovery of the failure.
Failure to report a serious event or an infrastructure failure, to develop and comply with the patient safety plan or to notify the patient shall be a violation of the Health Care Facilities Act. In addition to any penalty, that may be imposed under the Health Care Facilities Act, a Medical facility, that fails to report a serious event or an infrastructure failure, or to notify a licensure board, may be subject to an administrative penalty of $1,000 per day imposed by the Department of Health.
Patient Safety Discount
A Medical facility may make application to the Department of Health for certification of any program that is recommended by the Authority that results in the reduction of serious events. Insurers are required to file with the Insurance Department a discount in the rate or rates applicable for mandated basic insurance coverage to reflect the initiation of a certified program.
Reporting by Health Care Workers (including physicians)
If a health care worker "reasonably believes" that a serious event or incident has occurred, the health care worker must report the serious event or incident in accordance with the patient safety plan of the Medical facility unless the health care worker "knows" that a report has already been made. The report must be made immediately or as soon as reasonably practicable, but in no event later than 24 hours after the occurrence or discovery of a serious event or incident.
Anonymous reports to the Authority of serious events are permitted by health care workers who file the mandatory report discussed above. The Authority is required to conduct its own review of the report, unless the Medical facility has already begun an investigation, in which case the Medical facility must provide the Authority with the results of its investigation within 30 days. The Authority can take action outlined in the Mcare Act if it is dissatisfied with the adequacy of the Medical facility's investigation.
Notification to licensure boards - If a Medical facility discovers that a licensee failed to report a serious event, the Medical facility is required to notify the licensee's licensing board of the failure to report. The licensure boards are required to "develop criteria and standards for review based on the frequency and severity of complaints filed against a physician."
Confidentiality
Any document prepared pursuant to the responsibilities of the patient safety committee or the governing board of a Medical facility, which is otherwise unavailable from original sources, is confidential and shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding. In the event an original source document is determined by a court of competent jurisdiction to be unavailable from the health care worker or Medical facility in a civil action or proceeding, then in that circumstance alone, the Department of Health may be required pursuant to a court order to release that original source document to the party identified in the court order.
No person performing responsibilities for a patient safety committee is permitted to testify regarding matters within the knowledge gained during the person's participation on the patient safety committee or governing board of a Medical facility.
Any documents, materials or information received by the Authority or the Department of Health from the Medical facility, health care worker, patient safety committee or governing board of a Medical facility solely prepared or created for the purpose of compliance or reporting under the Mcare Act is not discoverable or admissible as evidence in any civil or administrative action or proceeding, except that these materials may be accessed by: 1) the Department of Health for purposes of licensure or corrective action; and 2) the Department of State for purposes of licensure or disciplinary action against a health care worker. Documents prepared in compliance with the Mcare Act are not subject to the Right-to-Know Law.
Informed Consent
Except in emergencies, the Mcare Act provides that physicians "have a duty to a patient" to obtain the informed consent of the patient or the patients' authorized representative prior to conducting any of the following five specific types of procedures: 1) performing surgery, including the related administration of anesthesia; 2) administering radiation or chemotherapy; 3) administering a blood transfusion; 4) inserting a surgical device or appliance; and 5) administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.
The Mcare Act considers consent to be informed if the patient has been given a description of the procedure and the risks and alternatives that a reasonably prudent patient would require to make an informed decision. Expert testimony is required to determine whether the procedure is one of the five categories and to identify the risks of the procedure and the risks of the alternatives.
If a physician fails to seek informed consent, the physician is liable only if the patient proves that receiving such information would have been a substantial factor in the patient's decision whether to undergo the procedure. Moreover, a physician may be held liable for failure to seek a patient's informed consent if the physician knowingly misrepresents to the patient his or her professional credentials, training or experience.
- Mr. Beaser and Mr. Burde are partners of Blank, Rome, Comisky & McCauley LLP, and co-chairs of its Health Law Group. Mr. Beaser is general counsel to POMA. Mr. Burde served as Deputy General Counsel to Pennsylvania Governor Mark Schweiker and was active in the development of the Mcare Act. The information contained in this article is for general information purposes only, should not be construed as legal advice or opinion, and is not a substitute for the advice of counsel. The Mcare Act contains detailed provisions, all of which are not summarized in this article.
- Act of March 20, 2002, P.L.___, No.13 (the "Mcare Act"), § 102(5).
- This is the first time that the term "health care worker" has been defined in Pennsylvania statutes. The Mcare Act defines this term as "an employee, independent contractor, licensee or other individual authorized to provide services in a medical facility." The definition is very broad, may include more than those who provide traditional health care services, and, we suggest, will likely be interpreted broadly by the Department of Health or the courts. In developing a Medical facility's patient safety plan (discussed below), Medical facilities should carefully review who in the Medical facility "provides services" and thus is subject to the Mcare Act's patient safety provisions.
- Reasonable minds can differ about whether "informed consent" is a patient safety provision; however, as we did not cover this issue in our last article, we will discuss it here.
- If after 30 days notice a Medical facility fails to pay a surcharge, the Department of Health may assess an administrative penalty of $1,000 per day until the surcharge is paid. Mcare Act, § 305(g).
- A "serious event" is defined in the Mcare Act as "[a]n event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident." Mcare Act, § 301.
- An "incident" is defined in the Mcare Act as "An event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The terms does not include a serious event." Id.
- "Infrastructure failure" is defined in the Mcare Act as "[A]n undesirable or unintended event, occurrence or situation involving the [physical plant and service delivery systems necessary for providing health care services in a Medical facility, i.e., the medical facility's infrastructure] or the discontinuation or significant disruption of a service which could seriously compromise patient safety." Id.