The Issue At issue in this proceeding is whether Respondent, Department of Health ("Department"), acted contrary to the agency's governing statutes, rules or policies, or the bid specifications in its proposed decision to award the contract for Invitation to Bid No. DOH 12-007 (the "ITB") to Intervenor Quest Diagnostics Clinical Laboratories, Inc. ("Quest").
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of the proceeding, the following findings of fact are made: On July 10, 2012, the Department issued the ITB. The ITB solicited bids for a three-year contract for the provision of clinical laboratory services to the Department and county health departments. The ITB estimated that the winning bidder will perform approximately 861,000 tests annually, which will produce sales of $9.3 million per year. Bids were received from four vendors: LabCorp, Quest, Florida Reference Laboratory, and Ecolab Group Co. The bids were opened on August 17, 2012. The Department found all four bids responsive. The ITB specified that the Department would make a single award based on the grand total of pricing for specified "core tests" for the initial three-year term and for a contingent three-year renewal term. Quest was the lowest bidder, and LabCorp was the second lowest bidder. The sum of Quest's core test pricing for the original three-year term and the contingent three-year renewal term for the relevant laboratory services was $29,555,864.96. The sum of LabCorp's core test pricing for the original three-year term and the contingent three-year renewal term was $36,059,437.52. Section 3.2 of the ITB provided definitions pertinent to the bid, including the following: Mandatory Requirements or Minimum Requirements -- means that the Department has established certain requirements with respect to proposals to be submitted by Respondent.1/ The use of shall, must, or will (except to indicate simple futurity) in this solicitation indicates compliance is mandatory. Failure to meet mandatory requirements will cause rejection of the bid or termination of the Contract/Purchase Order. Minor Irregularity -- used in the context of this solicitation and prospective Contract/Purchase Order, indicates a variation from the proposal terms and conditions which does not affect the price of the response, or give the respondent an advantage or benefit not enjoyed by other Bidders, or does not adversely impact the interests of the Department.2/ Section 4.15 of the ITB, titled "Responsive and Responsible," provided as follows: The Bidder shall complete and submit the following mandatory information or documentation as a part of the Bid Package. Any response which does not contain the information below shall be deemed non- responsive. Licensures-- Centers for Medicare & Medicaid Services, Clinical Laboratory Improvement Amendments, Certificate of Compliance and State of Florida Agency for Health Care Administration Clinical Laboratory License Staffing Plan Attachment I Bid Price Pages-- Attachment III Initial Term & Renewal term (including balance of line minimum volume discount and phlebotomy services Required Certifications, Attachment VI The ITB provided no further clarification regarding the contents of the "Staffing Plan" beyond directing the bidders to "Attachment I" to the ITB. Attachment I was titled "Specifications of Clinical Laboratory Services" and contained six pages of additional specifications regarding services included in the bidders' prices, contractor liability, minimum tasks to be completed by the winning bidder, deliverables, and other requirements. Attachment I included the following specifications regarding staffing: Staffing Levels Each prospective offeror shall include its proposed staffing for technical, administrative, and clerical support including but not limited to a Contract Representative, Quality Control Manager, Staff Pathologist, Project Manager, Technical Support Manager, Technical Support Staff and statewide field representatives. The bidder shall provide hourly rate pricing, as an option to the contract, for an on-site Phlebotomist. The successful offeror shall maintain an adequate administrative organizational structure and support staff sufficient to discharge its contractual responsibilities. In the event the Department determines that the successful bidder's staffing levels do not conform to those promised in the proposal, it shall advise the successful offeror in writing and the successful offeror shall have 30 days to remedy the identified staffing deficiencies. Professional Qualification The successful bidder will be responsible for the staff affiliated with this proposal, insuring that they have the education, any professional licensure or certification which may be required by law, and experience necessary to carry out their duties. Staffing Changes The successful bidder shall staff the project with key personnel identified in the bidder's proposal, which are considered by the Department to be essential to this project. The bidder shall keep the Department notified of key staffing changes that directly impact services related to this solicitation. (Textual emphasis added.) The underscored language required the prospective offerer to include "proposed staffing" and required that the winning bidder staff the project with "key personnel identified in the bidder's proposal." The issue is whether the "Staffing Levels" and "Staffing Changes" provisions quoted above required the bidder to name the specific persons who would fill the "proposed staffing" and "key personnel" positions, or whether it would suffice for a bidder to indicate that it would fill those positions with qualified persons to be named after the bid is awarded. The term "key personnel" is undefined by the ITB. It is unclear from the specifications whether the "key personnel" referenced in "Staffing Changes" is synonymous with the "proposed staffing" referenced in "Staffing Levels." LabCorp interpreted "key personnel" to mean those persons named in the "Staffing Levels" provision: Contract Representative, Quality Control Manager, Staff Pathologist, Project Manager, Technical Support Manager, Technical Support Staff, and statewide field representatives. In its staffing plan, LabCorp provided the names of persons corresponding to each of the "Staffing Levels" positions named in the ITB, including a list of 69 field representatives and 19 sales support persons. The staffing plan submitted by Quest stated as follows: Quest Diagnostics has more than adequate staffing and capacity to meet the needs of the Florida Department of Health. Quest Diagnostics employs a Customer Solutions Manager (contract representative), Quality Assurance Manager (quality control manager), Medical Director and Senior Staff Pathologists, Project Manager, Specimen Processing Manager (technical support manager), Lab Manager (technical support staff), and Account Managers (statewide field representatives). Job descriptions for these positions are attached. Following this statement was a series of detailed job descriptions setting forth the qualifications, experience requirements and responsibilities for each of the named positions. Thus, Quest provided the Department with a set of job qualifications corresponding to the "Staffing Levels" provision of Attachment I to the ITB, but did not provide the name of a specific person to fill any of the positions. The Department concluded that Quest had sufficiently "identified" its key personnel. LabCorp did not provide the detailed job descriptions that Quest provided. For example, Sharon Kaplan is listed as "Project Manager" without further description of her qualifications, experience or duties. LabCorp contends that the ITB required the vendors to name specific persons who would fill those positions. The Department counters that the requirement to "identify" key personnel does not necessarily mean that the bidder must name the persons involved, and that Quest satisfied the ITB's requirement by "identifying" the positions it intended to fill and the qualifications for the positions named in the "Staffing Levels" section of Attachment I. Regina Taylor, the administrative service director of the Department's Bureau of Public Health Laboratories, performed the "responsive and responsible" review of the bids.3/ Ms. Taylor testified that the ITB "left the staffing plan a bit open-ended and left it up to the vendor as to how they would present it to us." The Department found both bids responsive though Quest and LabCorp each took a different approach to describing its staffing plan. Ms. Taylor stated that Quest would be able to name its personnel during the implementation process. She noted that LabCorp's bid provided the names of personnel but offered no detailed information regarding the qualifications or responsibilities of those persons beyond their job titles, whereas Quest provided detailed job descriptions without naming the persons who would fill the jobs. Ms. Taylor was not overly concerned about either company's ability to satisfy the requirements of the ITB. She stated, "Both Quest and LabCorp are national companies, so I'm sure that they have the adequate staff." The "Professional Qualification" section of Attachment I provides that the successful bidder is responsible for insuring that staff is properly qualified and certified. The "Staffing Levels" section allows the Department to review the successful bidder's staffing levels and require the bidder to remedy any deficiencies within 30 days of the Department's written notice. Ms. Taylor testified that the staffing provision section of the ITB was intended to ensure that the winning bidder had within its organization certain critical positions. The Department relied on its own experience in operating the state public health laboratory to identify the staffing requirements of the ITB. LabCorp points out that Quest was the only bidder that failed to submit a list of names of key personnel. Like LabCorp, Florida Reference Laboratory, and Ecolab Group Co. submitted the names of their key personnel. LabCorp also points out that Ms. Taylor's initial reaction to Quest's staffing plan submission was to call it "lame." Ms. Taylor's pronouncement on the quality of the Quest staffing plan was not a part of her review or of the Department's decision. Whether or not it she found it "lame," Ms. Taylor concluded that Quest's staffing plan was responsive to the bid criteria. The ITB requires the bidder to "identify" the "key personnel" with whom it proposes to staff the project. The ITB also states that the Department considers these key personnel to be "essential to this project." However, the ITB does not expressly define the term "key personnel." LabCorp named persons to fill the positions named in the Staffing Levels provision of Attachment I, which it reasonably took to be synonymous with "key personnel" referenced in the Staffing Changes provision of Attachment I. Via its staffing plan, Quest "identified" the key personnel without naming them. Given the lack of precision in these "open-ended" ITB specifications, both LabCorp and Quest made reasonable responses to the staffing requirements. Each chose a different way of "identifying" key personnel. Neither could be found to have clearly failed to comply with the bid specifications. The Department acted reasonably in finding both bids responsive. If LabCorp were correct that Quest's bid response did not comply with the staffing specifications, the question would arise as to whether Quest's deviation from the ITB specifications was a "minor irregularity" that could be waived by the Department. As noted above, the ITB defines "minor irregularity" as a variation from the bid specifications that does not affect the bidder's price or give the bidder an advantage or benefit not enjoyed by other bidders, or does not adversely impact the interests of the Department. LabCorp has not identified any adverse impact on the Department that Quest's failure to name its proposed staff or key personnel would have. Indeed, LabCorp is hard pressed to state what advantage the Department gains by having the vendor name 69 field representatives and 19 sales support persons in its bid. The names are likely meaningless to the Department. "Sharon Kaplan, Project Manager" provides no more useful information than does Quest's description of the education, knowledge, and experience it requires of a project manager. The Department's concern was vendor capability to adequately staff the project, and the Department reasonably concluded that both vendors' bids demonstrated that capability. The basis for award of this bid was the lowest price. There was no scored evaluation of the ITB responses, no ranking of the staffing plans, and no effort contemplated by the Department to investigate the qualifications of the named personnel. The staffing plans submitted by LabCorp and Quest were of equal value to the Department as an indication of the vendors' understanding of the bid criteria and ability to fill the necessary positions. The ITB anticipates that the Department will deal with any staffing problems after the contract is awarded and the successful bidder begins to implement its program. LabCorp fails to identify any price advantage that Quest would gain by not naming the persons who would fill the key personnel positions, and none is apparent. Whether or not the personnel are named in the bid, the key positions would have to be filled at a cost that would presumably be roughly the same for each vendor. Again, the ITB gives the Department the power to raise staffing questions with the successful bidder and to require that problems be remedied within 30 days of written notice. LabCorp contends that Quest's failure to name key personnel gave it an advantage not enjoyed by other bidders. LabCorp argues that it went to the time and expense of preparing a detailed staffing plan, whereas Quest cut corners by submitting a set of generic job descriptions. Quest's method of setting forth its staffing plan may or may not have made its bid preparation easier, but did nothing to improve its competitive position in the bidding process. Quest's commitment to fill the required staffing positions was equal to LabCorp's. LabCorp points out that its own staffing plan included persons who are already on its payroll. LabCorp did not offer an estimate as to the likelihood that all of the approximately 102 persons named in its staffing plan would still be on its payroll by the time the company commenced performing the contract. LabCorp has no way of guaranteeing that all of those persons will be present to perform on the contract. Under the "Staffing Changes" provision, LabCorp would be allowed to substitute other qualified LabCorp employees for the named persons should the need arise. The virtual certainty of employee turnover supports the Department's position that the ITB did not require that bidders undertake the task of naming the employees who would fill the positions set forth in the "Staffing Levels" section of Attachment I. LabCorp argues that Quest's staffing plan gives it the opportunity to delay or avoid altogether hiring the staff necessary to perform the contract to the Department's satisfaction. As noted above, the inclusion of employee names in the bid could not guarantee that the named employees would still be working for LabCorp after the bid award. Quest's commitment to staff the project was no less than LabCorp's. LabCorp's argument suggests that Quest's bid should be rejected because Quest may later choose to breach the contract, which specifically requires the vendor to provide adequate qualified staff. In any procurement, there is always a remote potential that the winning vendor will breach or default. The Department's contract provides remedies for such defaults. In summary, it is found that the bids of both LabCorp and Quest met the requirements of the ITB as to staffing plans. Even if LabCorp's narrow interpretation of the ITB's requirements were correct, Quest's non-conforming response would constitute a minor irregularity.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED that the Department of Health enter a final order dismissing Laboratory Corporation of America, Inc.'s formal written protest and awarding the contract for Invitation to Bid No. DOH 12-007 to Quest Diagnostics Clinical Laboratories, Inc. DONE AND ENTERED this 10th day of December, 2012, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of December, 2012.
Conclusions Having reviewed the four Notices of Intent to Deny Application issued May 13-18, 2010, attached hereto and incorporated herein (Ex. 1, 2, 3, and 4), and all other matters of record, the Agency for Health Care Administration (“Agency”) has entered into a Settlement Agreement (Ex. 5) with the other party to these proceedings, and being otherwise well-advised in the premises, finds and concludes as follows: ORDERED: 1. The attached Settlement Agreement is approved and adopted as part of this Final Order, and the parties are directed to comply with the terms of the Settlement Agreement. 2. The Petitioner shall remit to the Agency, within thirty (30) days of the entry of a Final Order adopting this agreement, an administrative fee in the sum of thirty thousand dollars ($30,000.00) to resolve the Agency's allegations of unlicensed activity, in the interest of expediently resolving these matters and in recognition of the expense and uncertainty of litigation. 3. Checks should be made payable to the “Agency for Health Care Administration.” The check, along with a reference to this case number, should be sent directly to: Filed January 10, 2012 1:47 PM Division of Administrative Hearings Agency for Health Care Administration Office of Finance and Accounting Revenue Management Unit 2727 Mahan Drive, MS# 14 Tallahassee, Florida 32308 4. Unpaid amounts pursuant to this Order will be subject to statutory interest and may be collected by all methods legally available. 5. Any requests for an administrative hearing are withdrawn. The parties shall bear their own costs and attorney’s fees. This matter is closed. DONE and ORDERED this [0 day of ~ Bettie: ; 20/2, in Tallahassee, Leon County, Florida. — Ds we { izabeth Dudek, retary fey ir wacked 0. th€are Administration A PARTY WHO JS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW OF PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: Lance P. Cohen, Esquire Warren J. Bird, Asst. General Counsel Cohen & Thurston, P.A. Office of the General Counsel 1723 Blanding Boulevard, Suite # 102 Agency for Health Care Administration Jacksonville, Florida 32310 2727 Mahan Drive, Bldg #3, MS #3 (U. S. Mail) Tallahassee, Florida 32308 (Interoffice Mail) Jan Mills Agency for Health Care Administration 2727 Mahan Drive, Bldg #3, MS #3 Tallahassee, Florida 32308 (Interoffice Mail) Roger Bell Health Care Clinic Unit Manager Agency for Health Care Administration 2727 Mahan Drive, MS #53 Tallahassee, Florida 32308 (Interoffice Mail) Agency for Health Care Administration Office of Finance and Accounting Revenue Management Unit 2727 Mahan Drive, MS# 14 Tallahassee, Florida 32308 (Interoffice Mail) Suzanne F. Hood Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399 (U.S. Mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of this Final Order was served on the oa above-named person(s) and entities by U.S. Mail, or the method designated, on this the 10 day of aaa » 2012" Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 412-3630 Certified Article Number , ?bbO 390) Y5778 8971 SEMDERS RECORD i", Certified Article Number (?160 3901 9846 7935 1337 SENDERS RECORD One Nofice $1149/1° CHARLIE CRIST FIORDAAGENCY FOR HEATH CARE ADMINS TRATION Better Health Care for ail Floridians THOMAS W. ARNOLD GOVERNOR SECRETARY May 12, 2010 Physicians Medical Centers - Jax Inc File Number: 8428 1680 Dunn Ave Case #: 2010004935 Ste 39 Jacksonville, FL 32218 F INTENT TO DENY APP TION It Is the decision of this Agency that the application for certificate of exemption from health care clinic licensure for Physicians Medical Centers - Jax Inc, located at 1680 DUNN AVE, STE 39, JACKSONVILLE, FL, 32218, be DENIED. The specific basis for this determination is based on the fact that: Requested information was not complete or timely received by the Agency pursuant to Section 408.806(3)(b), Florida Statutes. You were notified by correspondence dated April 9, 2010 to provide further Information addressing identified apparent errors or omissions within twenty-one days (21) from the receipt of the Agency's correspondence. Our records indicate you received this correspondence by certified mail on April 15, 2010. The outstanding issues remaining are: A copy of the closing documents, stock or similar certificates signed and dated by both the buyer and seller is required, In addition, the Agency received information that the facility does not meet exemption requirements as it is not wholly owned by a Florida licensed health care practitioner, pursuant to Section 400.9905(4)(g). EXPLANATION OF RIGH Pursuant to Section 120.569, F.S., you have the right to request an administrative hearing. In order to obtain a formal proceeding before the Division of Administrative Hearings under Section 120.57(1), F.S., your request for an administrative hearing must conform to the requirements in Section 28-106.201, Florida Administrative Code (F.A.C), and must state the material facts you dispute. SEE ATTACHED ELECTION AND EXPLANATION OF RIGHTS FORMS. ce: Agency Clerk, Mail Stop 3 ; Legal Intake Unit, Mall Stop 3. EXHIBIT 14 Visit AHCA online at http://ahca.myflorida.com 2727 Mahan Drive,MS-53 Tallahassee, Florida 32308 " Certified Article Number , 7260 3901 9648 57748 8995 SENDERS RECORD FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION CHARLIE CRIST THOMAS W. ARNOLD GOVERNOR Better Health Care for all Floridians SECRETARY May 12, 2010 Physicians Medical Centers - Jax Inc File Number: 8430 9826 San Jose Blvd Case #: 2010004881 Jacksonville, FL 32257 .. : NOTICE OF INTENT TO DENY APPLICATION It is the decision of this Agency that the application for certificate of exemption from health care clinic licensure for Physicians Medical Centers - Jax Inc, located at 9826 San Jose Bivd, Jacksonville, FL, 32257, be DENIED. The specific basis for this determination is based on the fact that: Requested information was not complete or timely received by the Agency pursuant to Section 408.806(3)(b), Florida Statutes. You were notified by correspondence dated March 27, 2010 to provide further information addressing identified apparent errors or omissions within twenty- one days (21) from the receipt of the Agency's correspondence. Our records indicate you received this correspondence by certified mail on April 8, 2010, The outstanding issues remaining are: Subpart 1.B, Name-of.Applicant: The name of the applicant must be the corporation or legal entity as it is registered with. the Division of Corporations, it must also match-the FEIN indicated in section 1.C. This subpart was submitted as a response to the omissions, but the. applicant's name indicated does not match the FEIN# listed in section 1.C. of the application. : As this facility did a change of ownership, provide a copy of the closing documents signed and dated by both the buyer (new owner) and seller (previous owner). Acceptable documentation may include any one of the following: Copy of final sale/transfer documents showing date of final transfer and signatures of buyer(s) and seller(s), or a signed, written statement from an attorney, on letterhead, that confirms sale/transfer completion and provides the date of final action. : In addition, the Agency received information that the facility does not meet exemption requirements as it is not wholly owned by a Florida licensed health care practitioner, pursuant to Section 400.9905(4)(g). TION OF HT! Pursuant to Section 120.569, F.S., you have the right to request an administrative hearing, In order to obtain a formal proceeding before -the Division of Administrative Hearings under Section 120,57(1), F.S., your request for an administrative hearing-must conform to the - requirements in Section 28-106.201, Florida Administrative Code (F.A.C), and must state the material facts you dispute. ; : : Visit AHCA online at http://ahca.myflorida,com 2727 Mahan Drive,MS-53 Tallahassee, Florida 32308 EXHIBIT 2 Physicians Medical Centers -. . Inc Page 2 : May 12, 2010 SEE ATTACHED ELECTION AND EXPLANATION OF RIGHTS FORMS. ce: Agency Clerk, Mail Stop 3 Legal Intake Unit, Mail Stop 3 Te thictee-Va thet [9 Number fd60 3901 9848 7495 a2, SENDERS RECORD FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION CHARLIE CRIST THOMAS W. ARNOLD GOVERNOR Better Health Care for all Floridians SECRETARY May 13, 2010 Physicians Medical Centers - Jax Inc File #8427 5960 Beach Blvd : Case #2010004956 Ste3 ; Jacksonville, FL 32207 NOTICE OF INTENT TQ DENY APPLICATION It is the decision of this Agency that the application for certificate of exemption from health care clinic licensure for Physicians Medical Centers - Jax Inc, located at 5960 Beach Bivd., Ste 3, Jacksonville, FL, 32207, be DENIED. The specific basis for this determination is based on the fact that: Requested information was not complete or timely received by the Agency pursuant to Section 408.806(3)(b), Florida Statutes. You were notified by correspondence dated April 7, 2010 to provide further information addressing identified apparent errors or omissions within twenty- one days (21) from the receipt of the Agency's correspondence. Our records indicate you received this correspondence by certified mail on Apri! 9, 2010. The outstanding issues remaining are: As this facility did a change of ownership, provide a copy of the closing documents signed and dated by both the buyer (new owner) and seller (previous owner). Acceptable documentation may include any one of the following: Copy of final sale/transfer documents showing date of final transfer and signatures of buyer(s) and seller(s), or a signed, written statement from an attorney, on letterhéad, that confirms sale/transfer completion and provides the date of final action. ; In addition, the Agency received information that the facility does not meet exemption requirements as it is not wholly owned by a Florida licensed health care practitioner, pursuant to Section 400.9905(4)(g). EXPLANATION OF RIGHTS Pursuant to Section 120.569, F.S., you have the right to request an administrative hearing. In order to obtain a formal proceeding before the Division of Administrative Hearings under Section 120.57(1), F.S., your request for an administrative hearing must conform to the requirements in Section 28-106.201, Florida Administrative Code (F.A.C), and must state the material facts you dispute. EXHIBIT 3 Visit AHCA online at http://ahca.myflorida.com 2727 Mahan Drive,MS-53 Tallahassee, Florida 32308 Physicians Medical Centers - Jax Page 2 May 13, 2010 SEE ATTACHED ELECTION AND EXPLANATION OF RIGHTS FORMS. Health Cae Clinic Unit ce: Agency Clerk, Mail Stop 3 Legal Intake Unit, Mail Stop 3 RTE ecm 3901 94a 7935 yy74 SENDERS RECORD FLORIDA AGENCY TOR HEALTH CARE ADMINISTRATION oe ERNGS Better Health Care for all Floridians THOMAS W. ARNOLD May 18, 2010 CERTIFIED MAIL / RETURN RECEIPT REQUESTED File Number: 8429 Physicians Medical Centers - Jax, Inc 2020 Kingsley Ave Case #: 2010005135 Suite A Orange Park, FL 32073 NOTICE OF INTENT TO DENY APPLICATION It is the decision of this Agency that the application for certificate of exemption from health care clinic licensure for Physicians Medical Centers - Jax Inc, located at 2020 Kingsley Avenue, Suite A, Orange Park, Florida, 32073 be DENIED. The specific basis for this determination is based on the fact that: Requested information was not complete or timely received by the Agency pursuant to Section 408.806(3)(b), Florida Statutes, You were notified by correspondence dated April 9, 2010 to provide further information addressing identified apparent errors or omissions within twenty-one days (21) from the receipt of the Agency’s correspondence, Our records indicate you received this correspondence by certified mail on April 12, 2010, The outstanding issues remaining are: Evidence of Ownership — Information received by the Agency states that Victoria Critzer is the owner of Physicians Medical Centers-Jax Inc. Provide the following documentation as evidence of ownership: * A copy of the final closing documents such as a bill of sale or stock purchase agreement. signed and dated by both the buyer and seller including the effective date sale or transfer. The closing documents should contain the signature of Gordon Garver DC, previous owner of Physicians Medical Center-Jax Inc and Joseph Thomas MD, new owner of Physicians Medical Center-Jax Inc. ¢ A copy of the cancelled and reissued stock certificates transferring shared to Joseph Thomas MD. ¢ Acopy of the lease agreement that includes the name(s) of the owner(s). e Acopy of the business tax receipt that includes the name of the corporation and owner. In addition, the Agency received information indicating that the facility does not meet exemption requirements as it is not wholly owned by a Florida licensed health care practitioner, pursuant to Section 400.9905(4)(g). EXHIBIT 2727 Mahan Drive,MS-53 Tallahassee, Florida 32308 Visit AHCA online at http://ahca.myflorida.com . Physicians Medical Centers - Ja... .nc Page 2 May 18, 2010 EXPLANATION OF RIGHTS Pursuant to Section 120,569, F.S., you have the right to request an administrative hearing. In order to obtain a formal proceeding before the Division of Administrative Hearings under Section 120.57(1), F.S. your request for an administrative hearing must conform to the requirements in Section 28-106.201, Florida Administrative Code (F.A.C), and must state the material facts you dispute. ey SEE ATTACHED ELECTION AND EXPLANATION OF RIGHTS FORMS, For questions regarding this notice, please contact Ruby Schmigel, Health Services & Facilities Consultant with the Health Care Clinic Unit at (850) 412-4413. oger Bgl, Mandger Health Care Clinic Unit ce: Agency Clerk, Mail Stop 3 Legal Intake Unit, Mail Stop 3 STATE OF FLORIDA DIVISION OF ADMINISTRATIVE HEARINGS PHYSICIANS MEDICAL CENTERS-JAX, INC., Petitioner, DOAH Case Nos. 10-3202, 10-3203, 10-3204 and 10-3205 vs. AHCA CASE Nos.: 2010004881, 2010004956 AGENCY FOR HEALTH CARE 2010004935 and 2010005135, ADMINISTRATION, Respondent. / SETTLEMENT AGREEMENT Respondent, State of Florida, Agency for Health Care Administration (hereinafter the “Agency”), through its undersigned representatives, and Petitioner, Physicians Medical Centers- Jax, Inc. (hereinafter “Petitioner”), pursuant to Section 120.57(4), Florida Statutes, each individually, a “party,” collectively as “parties,” hereby enter into this Settlement Agreement (“Agreement”) and agree as follows: WHEREAS, the Petitioner applied for four certificates of exemption from licensure pursuant to Section 400.9935(6), Florida Statutes and Chapter 59A-33, Florida Administrative Code; and WHEREAS, Victoria Critzer has applied for four initial health care clinic licenses, expressly intending to purchase the interest of Dr. Joseph Thomas in Petitioner upon issuance by the Agency of those licenses; and WHEREAS, the Agency has jurisdiction of the license and exemption applications described in the foregoing paragraphs, by virtue of being the regulatory and licensing authority over the said licenses and exemptions; and EXHIBIT 5 WHEREAS, the Agency served the Petitioner with four Notices of Intent to Deny Application on or about May 13, 2010, notifying the Petitioner of the Agency’s intent to deny the certificates of exemption for the reasons stated thereon, in Agency cases numbered 2010004881, 2010004956, 2010004935 and 2010005135; and WHEREAS, Petitioner timely requested a formal hearing pursuant to Section 120.57(2), Florida Statutes, and in response to said request the matters were forwarded to the Division of Administrative Hearings (DOAH), and were designated as cases numbered 10-3202, 10-3203, 10-3204 and 10-3205 in that tribunal; and subsequently the parties agreed to, and did abate those cases in DOAH, for the purpose of discussing settlement; and WHEREAS, the Agency alleges, and Petitioner denies, that during the period of processing of the aforementioned applications, Petitioner operated one or more unlicensed health care clinics in violation of Florida law as to which no formal administrative, civil or criminal action has thus far been brought; and WHEREAS, the parties have agreed that a fair, efficient, and cost effective resolution of this dispute would avoid the expenditure of substantial sums to litigate the dispute; and WHEREAS, the parties stipulate to the adequacy of consideration exchanged; and WHEREAS, the parties have negotiated in good faith and agreed that the best interest of all the parties will be served by a settlement of these proceedings; and NOW THEREFORE, in consideration of the mutual promises and recitals herein, the parties intending to be legally bound, agree as follows: 1. All recitals are true and correct and are expressly incorporated herein. 2. Both parties agree that the “whereas” clauses incorporated herein are binding findings of the parties. 3. Joseph Thomas, M.D. hereby acknowledges, affirms and certifies that, at the time this agreement is executed by him, he is the sole owner of the Florida corporation Physicians Medical Center-Jax, Inc. 4, Victoria Critzer hereby acknowledges, affirms and certifies that, at the time this agreement is executed by her, she is the sole owner of the Florida corporation Physicians Medical Center, Inc. 5. Upon full execution of this Agreement, Petitioner agrees to waive any and all proceedings and appeals to which it may be entitled including, but not limited to, an informal proceeding under Subsection 120.57(2), a formal proceeding under Subsection 120.57(1), appeals under Section 120.68, Florida Statutes; and declaratory and all writs of relief in any court or quasi-court (DOAH) of competent jurisdiction; and further agrees to waive compliance with the form of the Final Order (findings of fact and conclusions of law) to which it may be entitled. Provided, however, that no Agreement herein, shall be deemed a waiver by either party of its right to judicial enforcement of this Agreement. 6. Upon full execution of this Agreement, the parties agree to the following: a. Petitioner's four (4) applications for exemption from licensure are hereby withdrawn, and Petitioner expressly waives its right to challenge or appeal, or both, in DOAH or elsewhere, the denial by the Agency of the exemptions. b. The Agency will resume processing the four initial licensure applications submitted by Victoria Critzer as intended future 100% owner of Physicians Medical Centers-Jax, Inc., now pending, and if the applications are complete and the applicant qualified under applicable law, the Agency will issue the licenses upon full payment by Petitioner of an agreed upon sum, as set forth below, to resolve the Agency's claim of unlicensed activity against Physicians Medical Center, Inc. Ms. Critzer agrees to use reasonable diligence to timely remedy any omissions from the applications cited by the Agency, to make the facilities available as required by law for all inspections required in connection with the licensure of the facilities, and to otherwise comply with all requirements of the application process, and all statutes and administrative rules thereunto appertaining, including background screening as may be applicable. c. The Agency agrees to use all reasonable diligence to process the initial license applications, and to issue the initial licenses as expeditiously as reasonably possible, provided that Ms. Critzer timely complies with all reasonable requests for additional information to which the Agency is entitled as a component of the application and licensure process, and provided that Victoria Critzer, and the applications she presented, are qualified for the licenses under all applicable statutes and administrative rules. d. Victoria Critzer will maintain the health care clinic license #HCC6732 currently held by Physicians Medical Center Inc. (PMC), for purposes of billing health care services provided solely at the licensed location, 9826 San Jose Boulevard, Suite B, Jacksonville, Florida. Whereas, Ms. Critzer, through counsel, has advised the Agency of a change of address for the license from 9826 San Jose Boulevard, to 9826 San Jose Boulevard, Suite B, PMC will submit a change of address application to the Agency together with the appropriate fee, within 10 days of execution of this agreement, and prior to resumption by the Agency of processing of the subject licensure applications. The license will be maintained 7. under a different federal employer identification number from any other licenses issued to Victoria Critzer or any entity in which she has a controlling interest. A separate health care clinic license must be obtained for any other location at which any health care services will be provided and third-party reimbursement sought for on behalf of Physicians Medical Centers Inc. e. Physicians Medical Centers, Inc. agrees to pay the sum of thirty thousand and no/100s dollars ($30,000.00) to the Agency, to resolve the Agency's allegations of unlicensed activity, in the interest of expediently resolving these matters and in recognition of the expense and uncertainty of litigation. The sum will be paid in lump sum at the time that the initial licenses referenced in paragraph b., above, are issued, or within 30 days following rendition of a Final Order by the Agency that incorporates this Agreement, whichever occurs first. f. Nothing in this Agreement shall prohibit the Agency from denying Petitioner’s application for licensure based upon any statutory and/or regulatory provision, including, but not limited to, the failure of Petitioner to satisfactorily complete a survey reflecting compliance with all statutory and rule provisions as required by law. By executing this Agreement, the Petitioner neither admits nor denies the allegations raised in the Notices of Intent to Deny referenced herein. 8. Upon full execution of this Agreement, the Agency shall enter a Final Order adopting and incorporating this Agreement in its entirety, and closing the above-styled case(s). The cases resident in DOAH, referenced above as DOAH cases numbered 10-3202, 10-3203, 10- 3204 and 10-3205, are currently closed by Order entered in that tribunal on October 7, 2010. The parties hereby further agree that those cases shall remain closed permanently, and each party hereby waives its right to seek to have any of those cases re-opened. 9. Each party shall bear its own costs and attorney’s fees. 10. This Agreement shall become effective on the date upon which it is fully executed by all the parties. 11. The Petitioner for itself and for its related or resulting organizations, its successors or transferees, attorneys, heirs, and executors or administrators, does hereby discharge the Agency and its agents, representatives, and attorneys of all claims, demands, actions, causes of action, suits, damages, losses, and expenses, of any and every nature whatsoever, arising out of or in any way related to this matter and the Agency’s actions, including, but not limited to, any claims that were or may be asserted in any federal or state court or administrative forum, including any claims arising out of this Agreement, by or on behalf of the Petitioner or related or resulting organizations. 12. This Agreement is binding upon all parties herein and those identified as a party, or a beneficiary, of the provisions of this Agreement, and each signatory acknowledges same and the adequacy of consideration therefor. 13. In the event that Petitioner is or was a Medicaid provider, this settlement does not prevent the Agency from seeking Medicaid overpayments or from imposing any sanctions pursuant to Rule 59G-9.070, Florida Administrative Code. This Agreement does not prohibit the Agency from taking action regarding Petitioner’s Medicaid provider status, conditions, requirements or contract. 14. The undersigned have read and understand this Agreement and have authority to bind their respective principals to it. Both parties have been represented by counsel in the negotiation and execution of this Agreement. The Petitioner fully understands that counsel for the Agency represents solely the Agency and Agency counsel has not provided legal advice to or influenced the Petitioner in its decision to enter into this Agreement. 15. This Agreement contains the entire understandings and Agreements of the parties. 16. | This Agreement supersedes any prior oral or written Agreements between the parties. This Agreement may not be amended except in writing. Any attempted assignment of this Agreement shall be void. 17. Venue for any action brought to interpret, challenge or enforce the terms of this Agreement or the Final Order entered pursuant hereto shall lie solely in the Circuit Court in Leon County, Florida. 18. ‘Ifa court of competent jurisdiction finds any part of this Agreement to be void, voidable, or unenforceable, then the remainder of the contract shall remain in full force and effect. 19. All parties agree that a facsimile signature suffices fe 20. The following representatives and beneficiaries hereby ae duly S. to enter into this Agreement. Molly McKéns eputy Secretary {_ panes P. Céhen, Esquire Health Quality ance Cohen & Thurston, P.A. Agency for Health Care Administration 1723 Blanding Boulevard, Suite 102 2727 Mahan Drive, Bldg #3 Jacksonville, Florida 32310 Tallahassee, Florida 32308 Counsel to Petitioner DATED: (frolir DATED: 1-1 U~ aye William R. Roberts Acting General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 DATED: /7 [(3l 4 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 DATED: Uf (5) WH Physicians Medical Centers-Jax, Inc. 9826 San Jose Boulevard Jacksonville, Florida 32257 patep: _})-14~!/ ~~ x. 1 _f- Victoria Critzer as president, sole director and 100% Owner Physicians Medical Center, Inc. 9826-B San Jose Boulevard Jacksonville, Florida 32257 DATED: _|1- (4-//
Findings Of Fact Petitioner is licensed by the State of Florida as a Clinical Laboratory Technician. He applied to the Respondent for licensure as a Clinical Laboratory Technologist with specialties in microbiology, serology, clinical chemistry, hematology, immunohematology, histology, and chemistry (special). On March 25, 1980, Respondent denied Petitioner's application for technologist's license for the reason that Petitioner has not completed the sixty semester hours required by Section 10D-41.25(9), Florida Administrative Code. Petitioner holds a high school equivalency diploma. He has taken courses at Chicago City College, Southeast Junior College, Roosevelt University, Olive-Harvey, and the U.S. Army medical school. He is a graduate of the American Academy of Medical Technology; however, the Academy is not an accredited school. He holds a Medical Technologist`s Certificate from the Registry of the American Medical Technologists. He has been employed as a technologist for over twelve years, principally at Michael Reese Hospital and Medical Center, and is licensed as a medical technologist in the State of Illinois. Based upon his college transcripts, the Respondent has given Petitioner credit for forty-eight hours of academic work and as advised the Petitioner that he need obtain only twelve additional credits for satisfying educational requirements. An approved course of study is available to him at Miami-Dade Community College. Petitioner has not taken the U. S. Public Health Service proficiency examination in clinical laboratory technology.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED THAT: A Final Order be entered denying Petitioner's application for a technologist's license pursuant to the provisions of The Florida Clinical Laboratory Law. RECOMMENDED this 16th day of October, 1980, in Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The Collins Building Room 101 Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of October, 1980. COPIES FURNISHED: Morton Laitner, Esquire Dade County Department of Public Health 1350 N.W. 14th Street Miami, Florida 33125 Mr. Yehuda Weinbaum 536 Euclid Avenue Miami Beach, Florida 33139 Mr. Alvin J. Taylor, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32301
Recommendation Based upon the findings of fact and conclusions of law recited above, it is recommended that petitioner's application for a clinical laboratory technologist's license be DENIED. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 6th day of September, 1978. DIANE D. TREMOR Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-99775 COPIES FURNISHED: Terry L. Bennett Route 6, Box 249 Lake City, FL 32055 Also mailed to Ms. Bennett at the following address: 1461 Cedar Bay Road Jacksonville, FL 32218 Robert M. Eisenberg District IV Counsel Post Office Box 2417F Jacksonville, FL 32231 William J. Page, Jr. Secretary Department of HRS 1323 Winewood Boulevard Tallahassee, FL 32301
The Issue Whether the Florida Medical Association and Florida Association of Physicians Assistants have standing to initiate this challenge to the proposed rules. (See Section 120.56(3) Florida Statutes.) Whether proposed Rules 64B1-4.010 and 64B1-4.011, Florida Administrative Code, constitute invalid exercises of delegated legislative authority because they exceed the Board of Acupuncture's rulemaking authority contained in Section 457.104, Florida Statutes. (See Section 120.52(8)(b), Florida Statutes.) Whether proposed Rules 64B1-4.010 and 64B1-4.011, Florida Administrative Code, constitute invalid exercises of delegated legislative authority because they enlarge, modify, or contravene the provisions of Section 457.102, Florida Statutes. (See Section 120.52(8)(c), Florida Statutes.)
Findings Of Fact It was stipulated that Petitioner FMA is organized and maintained for the benefit of approximately 16,000 licensed allopathic and osteopathic Florida physicians. FMA's standing in this proceeding has always been at issue. The foregoing stipulation encompasses all of the factual allegations about Petitioner contained in the Petition. Dr. Steven West, an allopathic physician licensed in the State of Florida pursuant to Chapter 458, Florida Statutes, and a member of FMA, testified as follows: Well, we have two interests. Certainly one interest is that we want to make certain that only qualified individuals and practitioners treat patients and diagnose patients because we have an interest in the health and welfare of the people of the State of Florida. Secondly, we have an interest in making certain that all of the hard work and time that we have spent in our training remains valuable and is considered unique and important. And so we have a concern about the devaluation of the practice of medicine. (TR-17) It was stipulated that there is only one Respondent, the Board of Acupuncture, created by the Florida Legislature and placed within the Florida Department of Health. It is axiomatic that Respondent has standing herein. There were no stipulations as to the standing of either intervenor, and both the Board and FSOMA have asserted in their respective Proposed Final Orders that FAPA, as well as FMA, is without standing to bring this rule challenge. However, no party has contested the veracity of the factual statements concerning standing in either Petition to Intervene, and no party opposed intervention. The Petitions to Intervene of FAPA and FSOMA were granted, subject to proving-up standing at hearing. Even stipulations as to standing do not preclude consideration of standing as a matter of law. Florida Medical Ass'n., Inc., et al. v. Dept. of Health, Florida Bd. of Nursing, et al., DOAH Case No. 99-5337RP (Final Order March 13, 2000), per curiam affirmed Bd. of Nursing, et al. v. Florida Medical Ass'n., Inc., et al, So. 2d (Fla. 1st DCA 2001). Therefore, under these circumstances, and applying that case, the intervenors' factual allegations for purposes of standing may be taken as true for findings of fact, but each intervenor's status still depends upon that of the respective party upon whose behalf each intervenor entered this case. Therefore, with regard to the status of FAPA, it is found that: FAPA is organized and maintained for the benefit of the licensed Florida physicians assistants who compromise [sic] its membership and has as one of its primary functions to represent the interests of its members before various governmental entities of the State of Florida, including the Department of Health and its boards. (FAPA Petition to Intervene) Therefore, with regard to the status of FSOMA, it is found that: FSOMA is a Florida nonprofit corporation comprised of over one-third of the doctors of oriental medicine and licensed acupuncturists under the regulatory aegis of the Board of Acupuncture, State of Florida Department of Health, Chapter 457, F.S., with a mission to represent the acupuncture and oriental medicine practitioner interests of its members in judicial, administrative, legislative and other proceedings. (FSOMA Petition to Intervene) The text of proposed Rule 64B1-4.010, set forth in the petition is no longer correct, because it has been altered by Notices of Change, pursuant to Chapter 120, Florida Statutes. Rule 64B1-4.010, as currently proposed, would provide: Traditional Chinese Medical Concepts, Modern Oriental Medical Techniques. Traditional Chinese medical concepts and modern oriental medical techniques shall include acupuncture diagnosis and treatment to prevent or correct malady, illness, injury, pain, addictions, other conditions, disorders, and dysfunction of the human body; to harmonize the flow of Qi or vital force; to balance the energy and functions of a patient; and to promote, maintain, and restore health; for pain management and palliative care; for acupuncture anesthesia; and to prevent disease by the use or administration of: stimulation to acupuncture points, ah-shi points, auricular points, channels, collaterals, meridians, and microsystems which shall include the use of: akabane; allergy elimination techniques; breathing; cold; color; correspondence; cupping; dietary guidelines; electricity; electroacupuncture; electrodermal screening (EDS); exercise; eight principles; five elements; four levels; hara; heat; herbal therapy consisting of plant, animal, and/or mineral substances; infrared and other forms of light; inquiring of history; jing-luo; listening; moxibustion; needles; NAET; observation; oriental massage -- manual and mechanical methods; palpation; physiognomy; point micro-bleeding therapy; pulses; qi; xue and jin-ye; ryodoraku; san-jiao; six stages; smelling; tongue; tai qi; qi gong; wulun- baguo; yin-yang; zang-fu; Ayurvedic, Chinese, Japanese, Korean, Manchurian, Mongolian, Tibetan, Uighurian, Vietnamese, and other east Asian acupuncture and oriental medical concepts and treatment techniques; French acupuncture; German acupuncture including electroacupuncture and diagnosis; and, the use of laboratory test and imaging findings. (Emphasis supplied). The "authority" cited by the Board for proposed Rule 64B1-4.010 is Sections 457.102 and 457.104, Florida Statutes. The Board cites the "law implemented" for Rule 64B1- 4.010 as Section 457.102, Florida Statutes. The text of Rule 64B1-4.011, as set forth in the petition also is no longer correct, because it has been changed by Notices of Change, pursuant to Chapter 120, Florida Statutes. Rule 64B1-4.011, as currently proposed, would provide: Diagnostic techniques which assist in acupuncture diagnosis, corroboration and monitoring of an acupuncture treatment plan or in making a determination to refer a patient to other health care providers shall include: traditional Chinese medical concepts and modern oriental medical techniques, recommendation of home diagnostic screening; physical examination; use of laboratory test findings; use of imaging films, reports, or test findings; office screening of hair, saliva and urine; muscle response testing; palpation; reflex; range of motion, sensory testing; thermography; trigger points; vital signs; first-aid; hygiene; and sanitation. (Emphasis supplied). The "authority" cited by the Board for proposed Rule 64B1-4.011 is Sections 457.102(1) and 457.104, Florida Statutes. The Board cites the "law implemented" for proposed Rule 64B1-4.011 as Section 457.102 (1), Florida Statutes. Section 457.104, Florida Statutes, currently provides: The board has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement provisions of this chapter conferring duties upon it. Section 457.102, Florida Statutes, currently provides: "Acupuncture" means a form of primary health care, based on traditional Chinese medical concepts and modern oriental medical techniques, that employs acupuncture diagnosis and treatment, as well as adjunctive therapies and diagnostic techniques, for the promotion, maintenance, and restoration of health and the prevention of disease. Acupuncture shall include, but not be limited to, the insertion of acupuncture needles and the application of moxibustion to specific areas of the human body and the use of electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies, as defined by board rule. "Acupuncturist" means any person licensed as provided in this chapter to practice acupuncture as a primary health care provider. "Board" means the Board of Acupuncture. "License" means the document of authorization issued by the department for a person to engage in the practice of acupuncture. "Department" means the Department of Health. "Oriental medicine" means the use of acupuncture, electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies. "Prescriptive rights" means the prescription, administration, and use of needles and devices, restricted devices, and prescription devices that are used in the practice of acupuncture and oriental medicine. (Emphasis supplied) The Board asserts that the use of a comma between "other adjunctive therapies" and "as defined by board rule" in the second sentence of Section 457.102(1), Florida Statutes, establishes that the clause "as defined by board rule" applies to "the insertion of acupuncture needles and the application of moxibustion to specific areas of the human body and the use of electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies," and those practices "included but not listed." Rule 64B1-3.001, Florida Administrative Code, most recently amended February 27, 1992, addresses "adjunctive therapies" of acupuncturists as follows: Acupuncture diagnostic techniques shall include but not be limited to the use of observation, listening, smelling, inquiring, palpation, pulses, tongues, physiognomy, five element correspondence, ryordoraku, akabani, German electro acupuncture, Kirlian photography, and thermography. (Emphasis supplied). * * * Adjunctive therapies shall include but not be limited to: Nutritional counseling and the recommendation of nonprescription substances which meet the Food and Drug Administration labeling requirements, as dietary supplements to promote health; Recommendation of breathing techniques and therapeutic exercises; and Lifestyle and stress counseling; The recommendation of all homeopathic preparations approved by the Food and Drug Administration and the United States Homeopathic Pharmacopeia Committee; and Herbology. This rule has not been challenged.1 Likewise, Rule 64B1-4.008, Florida Administrative Code, promulgated December 24, 2000, has not been challenged,2 and defines "adjunctive therapies," of acupuncturists as follows: Adjunctive therapies shall include the stimulation of acupuncture points, ah-shi points, auricular points, channels, collaterals, meridians, and microsystems with the use of: air; aromatherapy; color; cryotherapy; electric moxibustion; homeopathy; hyperthermia; ion pumping cords; iridology; kirlian photography; laser acupuncture; lifestyle counseling; magnet therapy; paraffin; photonic stimulation; recommendation of breathing techniques; therapeutic exercises and daily activities; sound including sonopuncture; traction; water; thermal therapy; and other adjunctive therapies and diagnostic techniques of traditional Chinese medical concepts and modern oriental medical techniques as set forth in Rule 64B1-4.010. (Emphasis supplied). Acupuncturists are, by law, "primary health providers." Subsections 457.102(1) and (2), Florida Statutes. (See Finding of Fact 14). A primary health care provider is a professional to whom patients can go without a referring physician and who, by diagnosis and treatment, assumes responsibility for patients' appropriate care. Allopaths and osteopaths are also primary health care providers. FSOMA asserted that the challenged rules are supported by Section 457.1085, Florida Statutes, which provides, 457.1085 Infection control--Prior to November 1, 1986, the board shall adopt rules relating to the prevention of infection, the safe disposal of any potentially infectious materials, and other requirements to protect the health, safety, and welfare of the public. Beginning October 1, 1997, all acupuncture needles that are to be used on a patient must be sterile and disposable, and each needle may be used only once. The traditional course of education, training, and experience for allopathic physicians and osteopathic physicians involves four years of undergraduate college education, four years of medical school, one-year internship, and one to two years of residency, but is more specifically set out for licensing purposes in Sections 458.311-458.318, Florida Statutes, for allopaths, and Sections 459.0055-459.008, Florida Statutes, for osteopaths. All of these courses/periods of learning involve, to a greater or lesser degree, learning to use and interpret modern laboratory and imaging tests. The traditional course of education for acupuncturists involves only two years of college and four years of acupuncture schooling, but is more specifically set out for licensing purposes by Section 457.105, Florida Statutes. Four hours per week for one year is about the extent of training in the use and interpretation of modern laboratory tests and imaging films afforded acupuncture students. There clearly are more stringent requirements for licensure of allopaths and osteopaths than for acupuncturists. Allopaths and osteopaths clearly spend more time training in the ordering, use, and interpretation of modern laboratory tests and film imaging. As previously stated (see Finding of Fact 14), an acupuncturist, as defined by law, . . . employs acupuncture diagnosis and treatment, as well as adjunctive therapies and diagnostic techniques for the promotion, maintenance, and restoration of health and the prevention of disease . . .(Emphasis supplied). Section 458.305(3), Florida Statutes, defines the "practice of medicine" as "Practice of medicine" means the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or physical or mental condition. (Emphasis supplied). Section 459.003(3), Florida Statutes, defines the "practice of osteopathic medicine" as "Practice of osteopathic medicine means the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition, which practice is based in part upon educational standards and requirements which emphasize the importance of the musculoskeletal structure and manipulative therapy in the maintenance and restoration of health. (Emphasis supplied). The following statutes express the Legislature's intent with regard to regulation of acupuncturists, allopaths, and osteopaths: 457.101 Legislative Intent - The Legislature finds that the interests of the public health require the regulation of the practice of acupuncture in this state for the purpose of protecting the health, safety, and welfare of our citizens while making this healing art available to those who seek it. 458.301 Purpose - The Legislature recognizes that the practice of medicine is potentially dangerous to the public if conducted by unsafe and incompetent practitioners. The Legislature finds further that it is difficult for the public to make an informed choice when selecting a physician and that the consequences of a wrong decision could seriously harm the public health and safety. The primary legislative purpose in enacting this chapter is to ensure that every physician practicing in this state meets minimum requirements for safe practice. It is the legislative intent that physicians who fall below minimum competency or who otherwise present a danger to the public shall be prohibited from practicing in this state. 459.001 Purpose - The Legislature recognizes that the practice of osteopathic medicine is potentially dangerous to the public if conducted by unsafe and incompetent practitioners. The Legislature finds further that it is difficult for the public to make an informed choice when selecting an osteopathic physician and that the consequences of a wrong decision could seriously harm the public health and safety. The primary legislative purpose in enacting this chapter is to ensure that every osteopathic physician practicing in this state meets minimum requirements for safe and effective practice. It is the legislative intent that osteopathic physicians who fall below minimum competency or who otherwise present a danger to the public shall be prohibited from practicing in this state. There was competent testimony that allopathic and osteopathic physicians may utilize acupuncture in the practice of their professions, as defined respectively at Sections 458.305(3) and 459.003(3), Florida Statutes. They are permitted to perform acupuncture, although their traditional course of professional education and training involves fewer (or no) hours of acupuncture education and training than are required under Chapter 457, Florida Statutes, the acupuncture practice Act. Presumably, that is because their respective professions and the Legislature have recognized that the training of allopaths and osteopaths encompasses the appropriate skills for acupuncture. However, if they perform acupuncture, they can only be disciplined under their respective practice Acts, Chapters 458 and 459, Florida Statutes. The Board of Acupuncture has no authority to discipline them. The record is silent as to whether or not Physicians Assistants, whether FAPA members or not, may legitimately perform acupuncture. To "practice medicine" or to "practice osteopathic medicine," as those terms have been respectively defined by Sections 458.305(3) and 459.003(3), Florida Statutes, do not render modern laboratory tests and imaging films unique to medical or osteopathic diagnosis. However, Harvey Kaltsas, a Florida-licensed acupuncturist and a member of the Board of Acupuncture, testified that "traditional Chinese medical concepts," and "modern oriental medical techniques" include gynecological and obstetric services, abortions, and cut-and-stitch surgery and that these services are performed by acupuncturists in China today. He further testified that the Board of Acupuncture believed that these tasks are "better handled" by allopathic physicians, and therefore the Board of Acupuncture has promulgated rules (most particularly the unchallenged rules addressing adjunctive therapies) which do not list these services. The Board believed that by not listing these services, it was prohibiting its licensees from performing them. The Board further asserts that its challenged rules only define "traditional Chinese medical concepts" and "modern oriental medical techniques" as used in Chapter 457, Florida Statutes, to include the use of laboratory tests and imaging findings and to clearly specify that "diagnostic techniques" for acupuncturists also include the use of modern laboratory test findings, and use of imaging films, reports, and test findings. There was competent testimony that modern laboratory Chinese medical tests on urine and feces evolved from ancient and traditional concepts and are regularly used in China and the orient by acupuncturists today. There was competent testimony that comparison of x-rays, at least for gross chest problems or for placement of acupuncture needles, is taught in an acupuncture college in Florida as part of its usual and required curriculum today. Allopaths and osteopaths use laboratory tests, imaging films, and reports thereon to reach an initial diagnosis and to test and revise that diagnosis through a course of treatment. Dr. West testified that he relies on his own "reading" of x-rays for his specialty of cardiology, while other allopaths may rely on a radiologist to read x-rays for them or may rely on a radiology report. Diagnosis is also a part of acupuncture. Acupuncturists want to use modern laboratory tests and imaging films to reach an initial diagnosis and to test that diagnosis through a course of treatment. They want to use laboratory tests and film imaging to properly direct their own initial treatment efforts, such as using urinalysis to eliminate a urinary tract infection before treating muscles and bones for a backache. They want to determine blood clotting speeds via an INR test on persons presenting with a prescriptive history of blood-thinner use, such as Coumadin, before using acupuncture needles. They want to be able to eliminate conditions they do not feel competent to treat, i.e. cancer, and to properly refer those patients for treatment by allopaths and osteopaths. Modern laboratory test results are variously formatted, sometimes as a report or value and result. X-rays are frequently the subject of a narrative report from a radiologist. Some modern imaging results are available directly to the public, like mobile TB screenings.
