Category Archives: Administrative Law

Price Transparency and Posting for Urgent Care Centers, Health Care Clinics, and Physician Practices

Chapter 2011-122, Laws of Florida (the “Act”) pertains to “health care price transparency” and took effect on July 1, 2011. The Act, which is ambiguous in various ways, was originally drafted to basically apply only to “urgent care centers” owned by hospitals. However, the Act was amended suddenly and substantially on the last day of the 2011 Session resulting in a much broader potential reach, additional ambiguity, and some surprise and lack of notice to the agencies, as well as the industry.

To better address the inherent ambiguities in the Act and answer key questions about the Act, the below will first quote the key provisions, than give a general overview of the Act, and finally specifically address key issues in a question and answer format.

  • THE ACT’ S KEY LANGUAGE

    The key new provisions of the Act are quoted below (all emphasis is added). The Act’ s provisions basically address three types of entities: (1) primary care providers (“PCPs”); (2) urgent care centers (“UCCs”); and (3) health care clinics (“HCCs”).

    PCPs –added to 381.026(2), (4), Fla. Stat. (Patient’ s Rights & Responsibilities):

    (2)(c) “Health care provider” means a physician licensed under chapter 458, an osteopathic physician licensed under chapter 459, or a podiatric physician licensed under chapter 461.

    (2)(d) “Primary care provider” means a health care provider [as defined above – a physician] licensed under chapter 458 [physician], chapter 459 [osteopathic], or chapter 464 [nurses, nursing assistants] who provides medical services to patients which are commonly provided without referral from another health care provider, including family and general practice, general pediatrics, and general internal medicine.

    (4)(c)3 A primary care provider may publish a schedule of charges for the medical services that the provider offers to patients. The schedule must include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area of the provider’ s office and must include, but is not limited to, the 50 services most frequently provided by the primary care provider. The schedule may group services by three price levels, listing services in each price level. The posting must be at least 15 square feet in size. A primary care provider who publishes and maintains a schedule of charges for medical services is exempt from the license fee requirements for a single period of renewal of a professional license under chapter 456 for that licensure term and is exempt from the continuing education requirements of chapter 456 and the rules implementing those requirements for a single 2-year period.

    UCCs — Parts added to Chapter 395, Fla. Stat. (Hospitals):

    395.002 Definitions. – As used in this chapter:

    (30) “Urgent care center” means a facility or clinic that provides immediate but not emergent ambulatory medical care to patients with or without an appointment. It does not include the emergency department of a hospital.

    Section 3. Section 395.107, Florida Statutes, is created to read:

    395.107 Urgent care centers; publishing and posting schedule of charges. An urgent care center must publish a schedule of charges for the medical services offered to patients. The schedule must include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area of the urgent care center and must include, but is not limited to, the 50 services most frequently provided by the urgent care center. The schedule may group services by three price levels, listing services in each price level. The posting must be at least 15 square feet in size. The failure of an urgent care center to publish and post a schedule of charges as required by this section shall result in a fine of not more than $1,000, per day, until the schedule is published and posted.

    HCCs — Parts added to Chapter 400.9935 Fla. Stat. (HCC Responsibilities):

    (1) [Each medical director or the clinical director shall:] …

    (h) Ensure that the clinic publishes a schedule of charges for the medical services offered to patients. The schedule must include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area of the urgent care center and must include, but is not limited to, the 50 services most frequently provided by the clinic. The schedule may group services by three price levels, listing services in each price level. The posting must be at least 15 square feet in size. The failure of a clinic to publish and post a schedule of charges as required by this section shall result in a fine of not more than $1,000, per day, until the schedule is published and posted. …

    (6) … An entity seeking a certificate of exemption must publish and maintain a schedule of charges for the medical services offered to patients. The schedule must include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area of the entity and must include, but is not limited to, the 50 services most frequently provided by the entity. The schedule may group services by three price levels, listing services in each price level. The posting must be at least 15 square feet in size. As a condition precedent to receiving a certificate of exemption, an applicant must provide to the agency documentation of compliance with these requirements.

  • OVERVIEW OF THE NEW LAW

    In short, the Act requires the posting of a “price board” for the top 50 most common procedures:

  • PCPs – Posting is optional. Has incentive benefit of waiving license fees, and CME requirements for those physicians and practitioners who voluntarily participate.
  • UCCs – Posting is mandatory.
  • HCCs – Posting is mandatory.
  • “Exempt” HCCs – Posting is mandatory for those who seek an exemption for first time–but not for HCCs which already have obtained exemption (per AHCA verbal interpretation).

The Florida Agency for Health Care Administration (AHCA) has partial regulatory oversight of the portions relating to just HCCs and hospital-based UCCs, whereas the Department of Health (DOH) has oversight as to PCPs. To the extent a PCP, UCC, or HCC is required to publish prices, each part of the Act requires exactly the same type of schedule to be posted. That is, the Act’ s language in each part provides that:

The schedule must [“may” as to PCPs] include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area of the provider’ s office and must include, but is not limited to, the 50 services most frequently provided by the [provider, UCC, or entity]. The schedule may group services by three price levels, listing services in each price level. The posting must be at least 15 square feet in size.

Thus to the extent the Act applies to any facility, the price publishing requirements are the same: (1) publishing of a schedule of charges, (2) to uninsured persons who pay by cash, check, credit card, or debit card, (3) for the 50 most frequently performed medical services that are offered to the facility’ s patients, must be (4) posted in a conspicuous place in the reception area of the office, and (5) be at least 15 square feet in size. Accordingly, the Act apparently only requires prices to be posted as to uninsured patients who are paying cash or equivalent. It does not require posting of prices charged to those using insurance. As noted elsewhere herein, various ambiguities exist in the Act, including that it is unclear what is meant by “three price levels.” Some examples of price posting are mentioned in the final Staff Analysis to HB 935. See the following links: (1) http://www.solantic.com; (2) http://lwruc.com/selfpaycosts.shtml; and (3) http://walkincliniccoralsprings.com/feeschedule.html. Neither AHCA nor DOH have published any guidelines or begun a rule adoption process.

PCPs.The foregoing price publishing requirements are optional for PCPs. PCPs are defined to include physicians practicing in the fields of family and general medical practice, general pediatrics, and general internal medicine, advanced registered nurse practitioners and physician assistants.

UCCs.The price publishing requirements are mandatory for UCCs. The Act defines the term “urgent care center” so as to exclude emergent care and emergency departments of hospitals. Thus, a UCC is defined as follows: “a facility or clinic that provides immediate [but not emergent ambulatory] medical services to patients with or without an appointment. The definition is inherently ambiguous, in part due to the inherent ambiguity of the word “immediate” in this context, especially when juxtaposed with the phrase “with … an appointment.” The potential reach of this definition could include simple walk-in patients, convenience care patients seeking quick “immediate” treatment, and all even though they arrive for a pre-scheduled appointment. Given the ambiguity and the possibility of substantial fines, a conservative interpretation is in order, and so it should be assumed that the statute has a broad reach. Note that the failure of a UCC to post a schedule as required by the Act “shall result in a fine of not more than $1,000, per day,” until the schedule is posted. Moreover, hospitals and other health care facilities have a general duty under Medicare and other laws to fully comply with all state laws. However, it should be noted that AHCA, through its Hospital Unit, only has regulatory oversight jurisdiction over hospital-owned UCCs that bill on an outpatient provider based manner using the Hospital’ s provider number; (2) AHCA’ s HCC Unit will only enforce as to licensed HCCs; (3) even in those limited cases, AHCA intends to have a 6-month “grace period” until December 31, 2011 whereby fines will not be imposed for any violations.

Licensed HCCs.The price publishing is mandatory for licensed HCCs, and appears to apply whether or not the HCC meets the definition of a UCC, in that the Act simply states that the medical director or clinic director of a HCC licensed under the Florida Health Care Clinic Act, “shall” ensure compliance with specified publishing and posting requirement. Like UCCs, the failure of a licensed HCC to comply with the publishing and posting requirements results in a fine of not more than $1,000, per day, until the schedule of charges is published and posted as required.

HCCs that Prospectively Apply for Exemption. The price publishing is also mandatory for any facility that applies for an exemption from the Health Care Clinic Act. However, on its website, AHCA has recently taken the position that because the Act did not take effect until July 1, 2011, current exemption certificate holders who are not currently required to renew their certificate of exemption (because exemptions are indefinite in duration) are not required to comply. However, if the facility comes within the definition of urgent care center, it is independently required to comply as a statutory matter, although AHCA currently has no enforcement oversight to survey such an exempt facility. Thus, AHCA’ s position is that the Act requires that any facility which applies for an HCC exemption certificate must provide proof of compliance with the publishing and posting requirements of the Act prior to receiving the certificate of exemption. It is likely that AHCA’ s HCC Unit will only request documentation of proof compliance from applicants seeking exemption, and even after the exemption is obtained, there is no intent or plan to survey or monitor such exempt facilities.

HCCs that Are Already Exempt (Self-Determined Exemption, or Via Certificate). The price publishing requirement is optional for facilities that already have an HCC exemption. That is, there is no specific requirement in the Act that an HCC that is already exempt (whether an HCC possessing an exemption certificate, or one that has self-determined its exemption as permitted by the Health Care Clinic Act) comply with the price posting requirements set forth in the Act, and as noted above, AHCA has offered the interpretation that existing “exempt” facilities are not affected.

    KEY QUESTIONS AND ANSWERS

    • What is the definition of "Urgent Care Center" and does it include "walk-in clinics" and "convenient care clinics"?

    Answer: See above definition and the Part II “UCC” discussion. As noted there, the definition of a UCC is: “a facility or clinic that provides immediate [but not emergent ambulatory] medical services to patients with or without an appointment. This would appear to include “walk in clinics” and “convenient care clinics” that are operated by a hospital. If the “clinic” is actually a physician practice owned by a hospital, and the billing is under the physician billing numbers (as opposed to outpatient hospital) then it would be subject to the optional PCP requirement. A conservative interpretation is in order and absent a different policy, rule or ruling from AHCA, it should be assumed that the statute does reach walk-in-clinics and convenient care clinics that are owned and operated by the hospital. It should be noted that there are indications from AHCA that: (1) a hospital Unit only has regulatory oversight jurisdiction over hospital owned UCCs that bill on an outpatient provider based manner using the Hospital’ s provider number; (2) the HCC Unit will only enforce the Act as to licensed HCCs or those who apply for an HCC exemption certificate; (3) even in those limited cases, AHCA intends to have a 6-month “grace period” until December 31, 2011 whereby fines will not be imposed for any violations.

    • Generally, what is the impact of the new law on Health Care Clinics, and are all HCCs required to meet the fee schedule publication requirements of the statute or simply urgent care centers as defined above?

    Answer: See the above Part II “HCC” discussion. All licensed HCCs must meet the requirements. Also, any facility applying after July 1 for a HCC exemption certificate will have to document compliance with the Act as part of the application process. However, previously exempt HCCs (self-determined, or holding a certificate of exemption) are required to comply with the Act only if they meet the (broad) statutory definition of a UCC, but it should be noted that AHCA has indicated it has no regulatory oversight over such HCCs and will not attempt to survey or enforce that obligation. AHCA will exercise its regulatory authority over any HCC (exempt or licensed) that is provider based and bills through a hospital provider number.

    • Are primary care practices, with normal routine weekday schedules but open hours on Saturday morning, covered under UCC requirements?

    Answer: The Act is intended to make physician practice locations (PCPs) only subject to the optional requirement for PCPs. The Act does not make the applicability of the “optional” requirements for PCPs dependent upon the office hours of the practice, and whether they are open on Saturdays. Thus, if it is a PCP (physician practice), compliance with price posting would be optional. If the facility is a UCC — i.e. a facility that is owned and operated by a hospital and billing as outpatient hospital department services, then the mandatory UCC price posting requirements would apply.

    • Are primary care practices, with normal routine weekday schedules but which have open hours in the evening ("after-hours”), covered under UCC requirements?

    Answer: Probably not. The Act does not make the definition of a PCP dependent upon the hours of operation of the PCP (physician practice). It seems that the distinction between UCC and PCP will be whether it is operated as a physician practice or group practice, as opposed to an outpatient department of a hospital.

    • Under Section 3 of the Act, which requires schedules to include "the prices charged to an uninsured person … ” what is the definition of the "prices charged”? Is this the consistent price for each service or the amount expected to be paid after any uninsured discount by patient?

    Answer: While the Act does not speak directly to the difference between “charges” and “reimbursement” that is received from an uninsured patient, it appears that the intent is to post the amount that the uninsured patient will actually be required to pay for services. Therefore, if a consistent discount is offered, the price should include the amount after the discount.

    • Under Section 3 referenced above, if a practice has one established price for a service and offers various payer and uninsured discounts, is it appropriate to publish the established non-discounted price?

    Answer: It appears that the intent is to advise uninsured patients the amounts they will be expected to pay. However, there is nothing specifically stated in the Act that would prevent also publishing non-discounted prices. Whether to publish such non-discounted prices would be a business/operational decision.

    • Is an Urgent Care Center required to disclose such an uninsured discount policy?

    Answer: The Act requires posting of the price to be actually paid by the uninsured patient. There is nothing that requires (or precludes) a facility from publishing their policy on discounts for uninsured patients. Whether to disclose the discount policy would be a business judgment decision.

    • How often is a UCC required to update its pricing?

    Answer: There is no clear delineation in the Act on this issue. A reasonable approach would be to update the posting whenever prices substantially change so that the posted prices are no longer accurate.

    • If a UCC adopts a 3-tiered pricing model as the Act allows, is the 50 diagnosis requirement waived?

    Answer: No, there is no indication in the Act or the legislative staff analyses that the requirement of “50 services most frequently provided” can be waived in this or any other manner. Although the Act is not at all clear what is meant by the “price levels,” a reasonable interpretation would be that the 50 most common services could be grouped into “buckets” and that all services in the defined level would be at or below the stated price for that “bucket.” For example and by way of illustration only — Bucket A specifies the services (from the 50 most common) that are $50 or less; Bucket B specifies services (from the 50 most common) that are $100 or less; and Bucket C includes services (from the 50 most common) that are $150 or less. To meet the intent of fair notice to the patient in advance of delivering services, the patient should be informed of the price (of maximum) that could be expected for the specific service. Please note that the Act is unclear, and there may be other interpretation as to how to accomplish “price level” posting.

    • Under Section 1(4)(c)6 of the Act which references "Each licensed facility," what is definition of each licensed facility?

    Answer: It refers to a hospital as regulated by Chapter 395, Florida Statutes. That is, Section 381.026(2)(b) defines “health care facility” as “a facility licensed under chapter 395.” Also, note that the “Each licensed facility” language in the Act was not amended by the Act, but instead was pre-existing language included in the Act for context.

If you have any questions regarding this new Price Transparency law or issues relating to Urgent Care Centers, Health Care Clinics, or Primary Care Practice operations or regulations one of the attorneys at Smith & Associates will be happy to help you.

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.