November 25, 2009

A Lawyer's Perspective: Quality Care Programs Based on Objective Quality Indicators for the Strategic Purpose of Reducing Bedsores in Nursing Home Residents and Hospital Patients

We have written numerous blogs concerning the development of decubitis ulcers, commonly known as bedsores, due to the negligent treatment of the nursing home resident or hospital patient by staff members. One blog suggested using a quality-control approach to reducing the possibility of pressure ulcers. In this blog, we will revisit the concept of objective quality care approaches as a valid means of reducing: 1) the incidence of bedsores in the first place and/or 2) reducing the possibility of developing particularly serious Stage III (associated with open sores) and Stage IV (associated with craters or holes) bedsores.

This blog is intended to emphasize that: 1) the causes of bedsore development are known; 2) the risk factors for developing bedsores are known; and 3) steps/procedures which will help reduce the development of bedsores or at the very lease allow for early “treatment” intervention are well known. The above prevention tactics are nothing more than common-sense procedures that every nursing home and hospital can implement via specific quality care programs which are actually followed. That this blog contains references to Dr. Deming is due to the fact that one of the authors, prior to attending law school, was involved in product development in the medical device industry for an international medical device manufacturing company where product development was carried out through product development teams consisting of members ranging from R&D to regulatory affairs. The teams’ responsibilities included the establishment of objective quality assurance indicators. As discussed below, the authors believe that Dr. Deming’s principles are applicable to hospital and nursing home settings for reducing the development of bedsores.

As the name suggests, pressure sores result when the weight of the person’s body presses against a firm surface such as a bed mattress or a chair. Or put another way, the bed sores develop due to the pressure exerted by the bed or chair on the person’s body. In understanding just how such pressure cause bedsores, remember that the skin contains hundreds of blood vessels. Bedsore occur when the pressure cuts off the skin’s blood supply to the "pressure-contact" area. This area of damaged skin will become more susceptible to pressure-induced damage if steps are not taken to relieve/reduce pressure on the now-compromised skin. (Reference #2)

It should not be surprising that the elderly, who are often frail due to poor bone and skin integrity, are particularly susceptible to pressure sores because of their lower tissue tolerance for pressure. Old age is thus a “no brainer” risk factor for developing bedsores. Yet, many other well-known risk factors are associated with the development of pressure sores. Obviously the greater the number of risk factors specific to the person, the greater the likelihood that the person will develop bedsores. Besides old age, the following factors are known to increase the risk for developing pressure sores:

• Being bedridden
• Spending considerable time in a wheelchair
• Diabetes or vascular disease that prevents areas of the body from receiving proper blood flow
• Spinal cord injury (paralysis), brain injury, or other physical condition which prevents the person from moving parts of his/her body without assistance.
• Malnourishment
• Mental disability such as Alzheimer’s disease or dementia which may prevent the patient from moving parts of his/her body without assistance not necessarily because they are unable to do so, but because they are not aware that then need to do so
• Urinary incontinence or bowel incontinence (Reference #1).

Many of the listed risk factors are typically associated with old age; therefore most elderly persons have multiple risk factors ranging from confinement to bed and wheelchairs to incontinence, mental disability, and/or malnutrition. Upon their admission to a nursing home or hospital, elderly persons should thus undergo a formal risk factor assessment to determine their risk of developing bedsores. They should then be monitored carefully for the onset of bedsores so that treatment can be timely rendered while the bedsore is still at a readily treatable stage.

Unfortunately, failure of nursing home staff members and administrators to actively take measures to minimize the onset of bedsores and/or initiate prompt medical intervention can result in dire consequences for the “bedsore” patient, especially where Stage III and Stage IV bedsores are at issue. Obviously, nursing home patients confined to their beds should be turned frequently to “spread out” the pressure from the hard surface across a large area of the person’s body. The medical literature suggests that turning should occur every two hours. Nor should residents be allowed to sit for hours on end in a wheel chair without pillows or other means to reduce pressure points between their skin and the chair itself.

Pressure sores may also result if the bed-ridden elderly person is dragged or slid across bed sheets, thereby creating potentially harmful frictional forces between the person’s skin and the bed sheet. (Reference 2). It is also conceivable that “dragging” an elderly frail person may result in injuries to muscles or bones quite apart from bedsores. Such treatment may also constitute abuse. Nursing home patients are entitled to respectful, gentle treatment to prevent injuries, and it is up to the administrators to ensure that the residents are treated appropriately.

Another known risk factor involves incontinence. Failure to frequently change the underwear of individuals who are incontinent may increase the risk of developing bedsores; the resultant wetness from bodily waste can make the skin too soft and more likely to be injured by pressure.

Diabetes and hyperglycemia are two other well known risk factors for bedsores. One would hope that any nursing home resident or hospital patient who is known to be diabetic or hyperglycemic would receive a “heightened scrutiny” type of monitoring for bedsores from the onset of his or her hospitalization or residence at a nursing home.

Bedsores are generally associated with nursing homes. It must be emphasized, however, that bedsores do not only originate in nursing homes. Elderly people who are hospitalized also have a high risk of developing bedsores due to the various risk factors which make them susceptible to bedsores. Patients transferred from hospitals to nursing home rehabilitation centers or being returned to their previous nursing home residences, are particularly vulnerable to bedsores according to the statistics. It has been estimated that at least 10% and upwards of 35% of individuals transferred from hospitals to nursing home rehabilitation centers or the nursing home where they had previously resided prior to hospitalization already have bedsores at the time of admission. (Reference #4). Nursing homes should thus make every effort to carefully check any patient being transferred to the nursing home for bedsores at the time of admission. Without proper medical care, even minor bedsores originating at the hospital may “turn into” serious Stage III and Stage IV bedsores.

We further emphasize that pressure sores are not merely a condition of the elderly. Individuals suffering from conditions which prevent movement such as paralysis, severe arthritis and/or multiple sclerosis, are susceptible to bedsores because of their inability to move without assistance. Recently, Eric Trainor, a 30-year-old New York State resident, was awarded $2.2 million by a jury for the pain and suffering caused by horrific bedsores. As a consequence of a motor vehicle accident in which he had been a passenger, the Mr. Trainor had been hospitalized at Westchester Medical Center. His injuries had caused him to become a quadriplegic. Because of the hospital’s failure to turn the injured patient every two hours during his 6 week stay, the patient developed Stage IV bedsores which had to be surgically closed. Furthermore, as a consequence of the bedsores, the injured man had to refrain from participating in physical rehabilitation so much so that he lost the chance to build up his upper body strength.

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November 8, 2009

The Reasonableness Standard for Triggering the Statute of Limitations for Medical Malpractice Suits in the State of Florida

At first blush, Florida’s statute of limitations for bringing a medical malpractice suit appears to be quite straight forward. The Florida Statute which governs medical malpractice claims states the following:

An action for medical malpractice shall be commenced within 2 years from the time the incident giving rise to the action occurred or within 2 years from the time the incident is discovered, or should have been discovered with the exercise of due diligence.” Section 95.11(4)(b), Florida Statutes.

This particular time frame imposed by the Florida Legislature is considerably shorter than the statute of limitations for bringing actions for personal injuries caused, for example, by motor vehicle accidents, dog bites, and slip and fall accidents. For these "non-med mal" negligence cases, the statute of limitations under Florida law is four (4) years.

The medical malpractice statute of limitations is not as cut and dry as it may seem. For example, in the case of motor vehicle accident, the date and time of the event which caused the the plaintiff’s injuries is documented, generally through an accident report form prepared by police officer called to the scene of the accident. Also, in many cases, the injured plaintiff will have been transported by an ambulance to a hospital.

In medical malpractice cases, the start date from which the statute of limitations is calculated may well be open to interpretation. In the case of a malpractice matter, the negligence may not be discovered for a considerable time after the negligence which gave rise to the malpractice occurred. For example, the ramifications of a missed cancer diagnosis may not be known for years. Also, pain is often the result of surgery. When should a patient be required to know that certain pain manifestations following surgery were a possible cause of medical malpractice? The bottom line is that for medical malpractice cases, the start date for assessing the statute of limitations is not always as easy to pin down as it may seem.

The most recent Florida case to deal with the issue of the medical malpractice statute of limitations is Cohen v. Cooper, a case decided by the Fourth District Court of Appeal on October 28, 2009. No. 4D07-4056. In Cohen, the Plaintiff appealed the lower court judge’s ruling that her medical malpractice claim for “eye” complications resulting from cosmetic surgery was barred by the statute of limitations for medical malpractice lawsuits and that the defendant was therefore entitled to final summary judgment as a matter or law. The plaintiff appealed..

In arriving at a decision favorable to the plaintiff, the Cohen court discussed the numerous Florida cases which have held inter alia that the “determination of timeliness under the statute of limitations is fact specific and within the province of the jury, not the trial judge.” For example, in Tanner v. Hartog, 618 S0. 2d 177, 181 (Fla. 1993), the Florida Supreme Court held that “the knowledge of the injury as referred to in the rule as triggering the statute of limitations means not only knowledge of the injury but also knowledge that there is a reasonable possibility that the injury was caused by medical practice.” The Tanner court was concerned over situations where the injured party became aware of a detrimental medical result after treatment by a medical practitioner, but did not have enough information available to ascertain that there was a reasonable possibility that the injury was caused by medical malpractice.

In Cunningham v. Lowery, 724 So. 2d 176, 178 (Fla. 5th DCA 1999), the court held that the plaintiff’s awareness of a medical condition “is not the same thing as knowledge that there was a reasonable possibility” that the plaintiff was injured through the malpractice of a doctor. The Cunningham court further opined that the statute’s requirement of “due diligence” does not require that courts hold a plaintiff struggling with the fact of a crippling or horrifying illness to undertake sophisticated medical analysis. Furthermore, the defendant-doctor in Cunningham continued to treat the plaintiff for a bacterial infection which was diagnosed following spinal surgery performed by that same doctor. The Cunningham court found this fact troublesome, and held that the continued treatment of the injured plaintiff by the defendant “embodies an estoppel concept; Medical providers or their agents who convince patients than untoward medical event was ‘natural’ and non-negligent will rarely be permitted to deny that same representation is correct for purposes of the statute of limitations.” Cohen citing Cunningham, 724 So. 2d at 180.

In 2008, the Florida Third District Court of Appeal held that “pain after a medical procedure, standing alone, does not trigger the statute of limitations and creates a question of fact on the issue of notice [of intent to initiate medical malpractice litigation]." Cohen citing Gonzalez v. Tracy, 994 So. 2d 402, 405 (Fla. 3d 2008).

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August 30, 2009

Your Right to Know: Medical Malpractice Litigation, Discovery, and Florida’s Amendment 7

On November 2, 2004, eighty percent of Florida’s voters voted to pass Amendment 7, known as the “Patients’ Right to Know” Amendment. Amendment 7, now a part of Florida’s Constitution under Article X, Section 25, provides that “any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident are subject to discovery.” “Adverse Medical Incident” is defined as:

“[M]edical negligence, intentional misconduct, and any other act, neglect, or default of a health care facility or health care provider that caused or could have caused injury to or death of a patient, incuding, but not limited to, those incidents that are required by state or federal law to be reported to any government agency or body, and incidents that are reported to or reviewed by any health care facility peer review, risk management, quality assurance, credentials, or similar committee of representative of any such committees. See Article X, Section 25(c), Fla. Const.

Perhaps not surprisingly, requests for the release of medical incident reports pursuant to the requirements of Amendment have been met with resistance. Medical providers have engaged in lengthy and costly litigation over the scope and applicability of the amendment to no avail. See e.g., Florida Eye Clinic, P.A. v. Gmach, (5th DCA, May 29, 2009); and Florida Hospital Waterman, Inc. v. Buster, 984 So. 2d 478 (Fla. 2008). Arguments used by the defendants in such cases have ranged from “protected attorney work product” arguments to “federal law preemption” arguments.

Recently even the constitutionality of Amendment 7 was challenged in Columbia Hospital Corporation of S. Broward v. Fain, (Fla. 4th DCA, August 19, 2009). In Fain, William Fain, while a patient at a hospital operated by Columbia, died as the result of a fall from his hospital bed. His estate sued Columbia for medical negligence. As part of its discovery request, the estate had requested incident reports for Fain’s fall and all adverse medical incident reports involving falls of patients under “fall precautions” within the past five years. Columbia objected to the request on a number of grounds based on Florida’s Amendment 7, including an argument that incident reports such as the ones requested were protected work product. Columbia appealed the trial court’s order overruling many of Columbia’s objections, and Columbia appealed.

Columbia’s first argument against providing the requested incident report was based on its assertion the information was protected work product under the Florida Rules of Civil Procedure and therefore not discoverable under Amendment 7. As stated above, such arguments have been used in other Florida cases. The Fain Court noted that, “[p]rior to the passage of Amendment 7, a hospital’s incident reports have generally been considered protected as a fact work product and discoverable only upon a showing of need and undue hardship.”

The Fain Court declined to decide on the work product issue on “lack of ripeness grounds”, but did state that “[a] distinction may need to be made between fact work product and opinion work product” to provide clarity on the records discoverable under Amendment 7. The Fain Court did opine that “[i]t is not clear that a provider or healthcare facility may, after the amendment, continue to refuse to provide an adverse medical incident report based on a fact work product.”

Columbia further argued that the “estate’s discovery requests are irrelevant, overbroad, and unduly burdensome.” The Fain Court noted that other decisions of Florida’s courts have held that the Amendment’s scope is very broad. For example, in Morton Plant Hospital Ass’n v. Shahbas ex rel. , 960 So. 2d 820, 825 (Fla. 2d DCA 2007) the Court held that “burdensome is not a relevant consideration under Amendment 7.” The Shabas Court further stated held that “Amendment 7 contains no requirement that information sought by a patient be relevant to any pending medical malpractice action or medical care decision.” Fain Court citing Shahbas at 825.

Also in 2008, the Florida Supreme Court found that Amendment 7 applied retroactively to materials prepared before its passage and that attempts by the Florida legislature to limit requests under Amendment 7 to facilities or providers where the party seeking the information was physically a “patient” receiving treatment were unconstitutional. Fain, citing Florida Hospital Waterman, Inc. v. Buster, 984 So. 2d 478, 493 (Fla. 2008).

As the Fain Court noted, “[t]he purpose of Amendment 7 was to lift the shroud of secrecy from records of adverse medical incidents and to make them widely available." In finding that the estate’s discovery request was not irrelevant, overbroad, and burdensome, the court went on to state:

A request for Amendment 7 materials is not an ordinary discovery request which can be subjected to overbreadth, irrelevance, or burdensome objections. Pursuant to the amendment, a “patient” has the absolute right to discover records relating to an adverse medical incident and that right is not conditioned on the discovery being relevant to a pending claim. A litigant in a medical malpractice case clearly qualifies as a “patient” under the amendment and is entitled to discover the information. It is illogical to conclude that the estate could discover information regarding adverse medical incidents out the context of this litigation but cannot discover the same information as part of its discovery in this case.

Columbia also argued that the estate’s request should be limited to those incidents which must be reported by law under Florida Statute 395.0197. The Fain Court again recognized the broadness of Amendment 7 by stating that “[t]he amendment provides that it is “not limited to” incidents that already must reported under law.” Fain Court citing Article X, section 25(c)(3).

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