Category Archives: AHCA

Assisted Living Facilities: Asserting a Legal Defense in Response to AHCA Enforcement Action

Recent news reports show increased legal sanctions are being imposed by the Agency for Health Care Administration (AHCA) against operators of Assisted Living Facilities (ALFs) for alleged violations of licensure standards. The sanctions available in the AHCA enforcement arsenal are many and include imposition of a moratorium on admissions, imposition of fines and penalties, or the suspension or revocation of the ALF’s license to operate. Recent developments suggest AHCA is presently engaged in an orchestrated “crackdown” on ALF operators, leading some to ask: What are my legal rights and responsibilities? What should I do if my facility becomes the subject of an AHCA investigation or enforcement action?

Chapter 429, Florida Statutes, includes the basic laws governing operations of an ALF. The rules governing licensure and operations are contained in Chapter 59A-5, Florida Administrative Code. These Rules address such areas as licensure requirements, resident care standards, staffing standards, physical plant standards, fiscal standards, and detailed Agency administrative enforcement mechanisms including inspections, survey deficiencies, and sanctions. Sections 408.811, and 429.34, Florida Statutes, provide the authority for AHCA and other state agencies to make unannounced inspections of an ALF. If faced with an inspection, an ALF operator has no legal right to refuse to allow the inspectors access to the facility. However, there is a right to require that proper identification be presented by AHCA or other agency employees. An ALF operator may also request that an Administrator or other designated representative accompany the inspectors while at the facility. It is advisable that the ALF operator immediately consult with legal counsel if an unannounced AHCA inspection is made. During an exit interview, the AHCA representatives should explain their findings, including any alleged deficiencies that were found.

Subsequent to an inspection, AHCA will provide the ALF Administrator with a survey report that provides a detailed written explanation of the findings made during an inspection. The ALF will be given 10 days in which to present a Plan of Correction. Although seldom asserted, an ALF operator may assert a legal right to challenge a survey report and petition for a formal administrative hearing pursuant to Section 120.569 and 120.57(1), Florida Statutes, if the provider believes that there were in fact no deficiencies that should result in a Plan of Correction being submitted. However, in most instances, the results of a licensure or complaint survey can be resolved through submission and implementation of a Plan of Correction.

In the event of alleged severe deficiencies which AHCA claims threaten the health, safety or welfare of an ALF resident, AHCA can impose an immediate moratorium on admissions, or an emergency order of license suspension pursuant to Section 408.814, Florida Statutes. In order to support such emergency action, AHCA is required by Section 120.60(6), Florida Statutes, to make specific findings that document the existence of the emergency situation, and may take only such action as is required to address the emergency. Further, an ALF operator faced with an emergency moratorium, or suspension order, or any other effort to suspend or revoke a license is entitled to file a Petition for Formal Administrative Hearing to challenge the validity of AHCA’s action or proposed action on the license. Hearings on license proceedings are held before an independent administrative law judge at the Division of Administrative Hearings. Such hearings are an opportunity to prove that the true facts do not support a moratorium, suspension or revocation of the ALF license.

In addition to taking direct action against an ALF operator’s license, AHCA is also empowered to seek imposition of civil penalties for alleged violation of licensure rules and standards. Pursuant to Section 429.19, Florida Statutes, according to the “classification” assigned to the alleged violation, as follows:

Class I violations: present an imminent danger to clients (residents) or a substantial probability that death or serious physical or emotional harm would result. These must be corrected within 24 hours. Imposition of a fine is mandatory in an amount of $5,000-$10,000 per violation, even if the violation is corrected.

Class II violations: directly threaten the physical or emotional health, safety or security of clients (other than Class I). Fine in the amount of $1,000-$5,000 per violation, even if the violation is corrected.

Class III violations: indirectly or potentially threaten the physical or emotional health, safety or security of clients (other than Class I or Class II). Fine in the amount of $500-$1,000 per violation.

Class IV violations: pertain to reports, forms or documents that do not have the potential of negatively affecting clients (purely paperwork type violations). Fine in the amount of $100-$200 per violation.

In order to assess a penalty against an ALF operator, AHCA is required to file an Administrative Complaint. An ALF operator has the right to demand a formal hearing to challenge the facts, and to challenge the amount or appropriateness of the fines being imposed. While it is clear that fines for Class I and Class II violations are mandatory, even when the violation is corrected, it is less clear whether a fine should be imposed when a Class III or Class IV violation is timely corrected by the ALF operator. Language in Section 408.813 (AHCA’s “Core Licensure Act”) suggests that no fine shall be imposed when such minor violations are corrected. However, there is some language in the statute that creates ambiguity, and the specific fine amounts for violation of ALF licensure standards are also stated in mandatory language in Chapter 429, Florida Statutes. Section 408.832, Florida Statutes, provides that when the AHCA Core Licensing Act conflicts with the specific facility governing statutes (such as the ALF statute) that the Core Licensure Act should prevail. Applying that principle, then no fines should be imposed for minor Class III and IV violations when they are timely corrected. AHCA takes a contrary view, and this legal issue will likely need to be resolved through legal challenges if an operator feels that a fine is not appropriate.

Undoubtedly the best course of action for any ALF operator is to develop and implement a strong staff education and compliance program. This can be done with assistance of a qualified health care consulting firm, or health care attorneys. An ounce of prevention in this respect will be well worth avoiding the costs of a bad survey or inspection by AHCA.

However, even with a good education and compliance program in place, AHCA may still seek to suspend or revoke a license, or impose a moratorium on admissions or levy substantial fines. The ALF Operator in such situations may assert the legal right to contest and defend against such actions by retaining qualified legal counsel and filing a Petition for Formal Administrative Hearing. Further, for small operators, Florida’s Equal Access to Justice Act, Section 57.111, Florida Statutes, allows for recovery of attorneys’ fees and costs in an amount of up to $50,000 for a “prevailing small business party.” Thus, an ALF operator is not without legal rights when AHCA takes action. To the contrary, ALF operators are entitled to basic due process, and can assert the right to require that the State prove its case in an administrative hearing process.

As always, please refer specific questions regarding ALFs, and their role under the new federal health care reform, to any of our attorneys at Smith & Associates.

Alternate-Site Testing in Hospitals

The Agency on Health Care Administration (AHCA) will be holding a public meeting on Tuesday, May 25, 2010, at its Tallahassee headquarters to discuss current practices and requirements under the “ Alternate-Site Testing” rule (Rule 59A-7.034, Florida Administrative Code).  Simply stated, the alternate-site testing rule allows for certain laboratory tests to be performed by designated hospital personnel at sites other than the hospital’ s licensed clinical laboratory.  Examples of alternate sites are the patient’ s bedside, emergency room, or nurses’ station.  Hospitals must have approval from AHCA to conduct alternate-site tests.

Navigating through Rule 59A-7.034 can be a daunting task for a hospital seeking approval for alternate-site testing.  At this time, there is no standard application form to submit for approval to test at alternate sites. Therefore, careful attention to each requirement in the rule is necessary to ensure that the hospital’ s alternate-site testing is approved. This article will provide a brief overview of the rule’ s requirements.

History of Alternate-Site Testing
The alternate-site statute was signed into law in 1993.  Section 483.051(9), Florida Statutes, required AHCA, DOH and the Board of Clinical Laboratory Personnel to adopt criteria for alternate-site testing performed under the supervision of a clinical laboratory director.   In 1995, Rule 59A-7.034, Florida Administrative Code, was adopted.  The rule was amended in 2009 to further specify the parameters for tests performed at alternate test sites within hospitals.

Overview of Laboratory Testing at Alternate Sites
Generally, clinical laboratory testing may be done at a hospital’ s main or central laboratory or satellite laboratories, which are licensed clinical laboratories established on the same or adjoining grounds of a hospital licensed under Chapter 395. Testing at satellite labs must be done by licensed clinical laboratory personnel.  However, the legislature created a limited exception to this requirement under Section 483.051(9), Florida Statutes, which allows for alternate-site testing. The term "alternate-site testing" means any laboratory testing done under the administrative control of a hospital, but performed out of the physical or administrative confines of the central laboratory. Section 483.051(9), Florida Statutes.

Alternate-site testing provides two distinct advantages for hospitals with a licensed clinical laboratory on site.  First, certain lab tests can be performed bedside, at a nurse station, operating room, ER or anywhere else under the administrative control of a hospital.  Second, alternate-site testing can be performed by non-clinical laboratory personnel if agency approval is granted under Rule 59A-7.034.

If hospital staff (other than licensed clinical laboratory personnel) will be performing the tests at alternate sites, then an
internal needs assessment must be submitted for agency approval of alternate-site testing. The assessment must be completed by the laboratory director and contain specific information relating to the patient benefits and criteria for testing, proposed methodologies for tests, and other information and protocols to insure the accuracy and integrity of the tests being performed at the alternate site.   The internal needs assessment – along with a list of the clinical tests and testing locations where they are to be performed – must be submitted with each biennial laboratory licensure renewal application.

Who can perform tests at alternate sites?
Licensed clinical laboratory personnel can always perform certain tests at alternate sites as long as the laboratory director is responsible for the testing.  If a laboratory clinician is not performing the test, there are specific personnel requirements for the tester. Testers must have a high school diploma, have met the HIV/AIDS educational requirements, and be one of the following (with designated certifications or exemptions): RN, LPN, radiologic technologist, respiratory care practitioner certified in critical care services, respiratory therapist, nationally-certified phlebotomist, physician’ s assistant, perfusionist, cardiovascular technician, or any licensed director, supervisor technologist or technician under Chapter 483.  The laboratory director is responsible for training, evaluating for competency and documenting necessary qualifications of all personnel to perform alternate-site testing.

What tests can be performed under alternate-site rule?
Any test the supervising director and laboratory personnel are qualified to conduct can be documented in the internal needs assessment for approval from AHCA.  However, certain restrictions apply.  In general, the tests performed at alternate sites must not exceed “ moderately complex” test procedures.  Further, they must employ whole blood specimens that require no processing of any kind and use automated test systems in which a specimen is directly introduced into the system.

Where can alternate-site tests be conducted?
Alternate-site testing can only be conducted at those sites where the laboratory director has established and documented as necessary for the proper care and treatment of patients in the internal needs assessment.  Each test site must have a procedure manual that specifically addresses the testing done at that location and shall be noted on all laboratory licensure applications submitted to the agency.

Violations
AHCA may revoke the approval for any alternate-testing site where the agency determines that said sites have operated in violation of Chapter 483, Part 1, of the Florida Statutes or the provisions of Rule 59A-7.  Further, it may even revoke the license of the laboratory maintaining the alternate-site testing in the event of a violation.

Conclusion
Hospital laboratories must assess what tests will be performed at alternate sites and who will be performing them before applying to AHCA for alternate-site testing approval.  Because AHCA has not yet developed a standardized application for alternate-site approval, hospitals must create a letter-form application that carefully addresses each requirement under Rule 59A-7.034.  If you need assistance with obtaining approval for alternate-site testing, please feel free to contact us.