Home health companies must comply with FDA device-reporting regulations
April 1, 1996 7 minutes read
Home health companies must comply with FDA device-reporting regulations
Fines could put a home health company out of business
Effective April 11, home health care companies will be required to comply with the Safe Medical Devices Act of 1990 (SMDA). This is an exhaustive legal requirement that if left unmet could cost you significant fines -- up to $1 million-- or loss of licensure.
Risk management experts urge risk managers with home health care operations to familiarize themselves with the requirements of the SMDA and to revise their reporting practices to make sure they are in compliance with federal law. If not, risk managers could find their home health care divisions under federal scrutiny or the subject of a costly fine -- ranging from $15,000 per violation, up to $1 million.
"Risk managers who have accountability for home health care entities must make sure they have their ducks in a row," warns Fay Rozovsky, JD, MPH, DASHRM, director of risk management and legal affairs for AIG Consultants in Wynnewood, PA. "If you are contracting with a subcontractor for home health services, you need to make sure they have reporting procedures in place. If you are in an integrated delivery network, you need to know who is running the show. Who is accountable? Does the left hand know what the right one is doing?"
Under a recent Food and Drug Administration final rule pertaining to the SMDA, a home health care company's adverse incident reporting, record keeping, forms, and written policies and procedures must now parallel those followed by hospitals, nursing homes, and other health care facilities since the SMDA went into effect in 1991.
When the first proposal for SMDA regulations targeting manufacturers, hospitals, and nursing homes was released, it did not seem to be the FDA's intention to impose the law's reporting requirements on home health care entities, says Ronni P. Solomon, JD, vice president of legal affairs at ECRI, an independent, nonprofit health service research agency in Plymouth Meeting, PA.
That changed in December 1995, however, when FDA officials released the SMDA final rule in the Federal Register. It included language that extended the law's reach to cover "outpatient treatment and diagnosis facilities."1
"What the amendments did is extend the reporting requirements throughout the chain of use, rather than just have the manufacturers [report]," says Robert B. Nicholas, JD, a partner in the law firm of McDermott, Will, & Emery in Washington, DC. "The rule that came out on Dec. 11 is the final rule with respect to reporting for the user community."
"The admonition to the field is that any kind of event, incident, or accident in which a medical device is part of the scenario must be reported," says Susan Pascoe, RN, MSN, director of home care services for the Daughters of Charity National Health System, based in St. Louis.
Failure to comply with the reporting requirements can result in serious consequences for health care providers, legal experts warn. Under the SMDA, any company that violates the new device-reporting rules can be issued a civil penalty of up to $15,000 for each violation, and up to $1 million for a series of violations. "That could put a home health company out of business," Solomon warns.
Legal and risk management experts urge home health care companies to be prepared for the SMDA and the additional reporting and record-keeping burdens now required of them.
Here are highlights of these new reporting and record requirements from the regulation:
* Regulation: More is better.
In addition to extending SMDA to cover more facilities, the FDA's final rule increases reporting responsibilities among providers. These include requirements to keep ongoing records of any adverse events within your facility and to submit semiannual reports to the FDA that are a compilation of any reports submitted during each six-month period. Even if no events occur, providers still must submit the semiannual report indicating that fact.
* Expansion of definition.
The definition of a reportable event has been expanded to include, among other provisions, the requirement to report on incidents in which devices have caused or may have caused or contributed to a death or serious injury, even if the events occur as a result of user error.
* Addition of reporting procedures for medical devices.
Home health entities and device manufacturers also must establish and maintain medical device reporting procedures as part of their written policies and procedures within their company. Likewise, providers must maintain "event files" containing information related to the adverse event, documentation of deliberations and decision-making processes on what course of action was taken, and copies of forms and other information submitted to the FDA and other entities. The law requires two-year record retention for reports submitted by clinicians related to medical device events. "Also, if you decide not to report an event, you should detail your reasoning in this file," Nicholas says.
New reporting forms and coding manuals are being made available through the FDA's MedWatch office, also in Washington, DC, and providers have the option of submitting their semiannual reports electronically. (See sample MedWatch form, inserted in this issue.) Directions on how to fill out the report properly can be found in the FDA's Mandatory Reporting Coding Manual. (See resources, p. 43.) Keeping records of incidents does not require that providers maintain the entire patient file, FDA officials note. Rather, providers reporting an adverse incident should cross-reference the report to the patient's medical file.
Take five steps toward compliance
Now is the time to implement these new regulations, legal experts say. Here is what you should be doing:
Step No. 1: Designate an individual who will "manage" your reporting program.
"Providers need to assign responsibility to an individual or committee to get up to speed with this [law]," Solomon says. Risk managers for the home care entity or the hospital are the most likely people to learn about the nuances of the reporting requirements and to manage the program.
"The whole reporting program should be centralized and the [responsible party] should have full responsibility to implement the program," Solomon says.
If risk management does not handle the reporting, Rozovsky cautions risk managers not to be left out of the loop. "The key is if something has caused serious injury that would rise to the level of a claim, it is very, very important, that the risk manager be [informed]." If the hospital risk manager does not have this responsibility, he or she should at least review the reports and remain informed.
Step No. 2: Assess your company's or facility's current policies for recording adverse events or incidents.
"See what your home health agency has in place. Does it need to be tweaked to bring it up to par?" Rozovsky advises. "If it's hospital-based, streamline the reporting so it is all being done the same way."
Step No. 3: Plan for modifying or developing standardized policies and procedures for reporting incidents.
After reviewing current policies, risk managers can compare their practices to the new regulations and determine a plan to make any necessary modifications, Solomon says. This may involve developing an incident reporting form for clinicians' use.
"This is different from the MedWatch form, which should only be filled out and submitted by the risk manager or other centralized person who manages [the reporting program], she notes. The clinician's form should be "simple and easy to fill out" and should include the following information:
* the date of the event;
* what happened;
* which devices, if any, were involved;
* what action was taken in response.
Step No. 4: Plan and implement an educational program for clinicians.
An inservice on the new reporting requirements should be held as soon as possible. The goal of the program should be to make clinical staff aware of the final SMDA rules, answer questions about the law, and inform them of any new procedures related to the company's reporting program.
Teach providers about event reports
"Providers have to know that if a [device] malfunctions, even if there is a defect, or if there is a user error attributable to human factors or even poor labeling, they should fill out an event report and submit it to the [reporting program] manager," Solomon says. The manager should have the responsibility and authority for determining whether the report should be submitted to the manufacturer and/or the FDA, she says.
Step No. 5: Develop a procedure on what to do in the event of an FDA inspection.
Be warned: SMDA gives regulatory authority to the FDA, which allows for on-site inspections of user facilities to review reporting documentation and procedures. This inspection may be done for a variety of reasons, including to determine whether a user facility is complying with the reporting requirements or just to check whether a manufacturer has properly notified users about problems with a device or recalls.
"I've had providers call me in a panic and say, 'The FDA is here and wants to look through our files. What should I do?'" Solomon says. For this reason, she urges home health care providers to have procedures in place in the event of an inspection, including a determination of which individual(s) will meet with the FDA inspector, which records will be made available, and where those records will be kept. It is preferable to store them in one centralized file or branch location. Under the SMDA, inspectors are allowed to photocopy all documents within a provider's medical device reporting file.
While many hospitals already have SMDA reporting systems in place, by carefully extending these systems to your home health operations, you may be able to keep the FDA out of your facility.
Reference
1. 60 Fed Reg (Dec. 11, 1995) 63,578-63,607. *
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