12-001140
Agency For Health Care Administration vs.
A Medical Office For Women, Inc., D/B/A Medical Office For Women
Status: Closed
Recommended Order on Tuesday, July 10, 2012.
Recommended Order on Tuesday, July 10, 2012.
1STATE OF FLORIDA
4DIVISION OF ADMINISTRATIVE HEARINGS
8AGENCY FOR HEALTH CARE )
13ADMINISTRATION , )
15)
16Petitioner , )
18)
19vs. ) Case No. 12 - 1140
26)
27A MEDICAL OFFICE FOR WOMEN, )
33INC., d/b/a MEDICAL OFFICE FOR )
39WOMEN , )
41)
42Respondent . )
45_ )
47RECOMMENDED ORDER
49On June 8, 2012, Robert E. Meale, Administrative Law Judge,
59conducted the final hearing by video teleconference in
67Tallahassee and Miami, Florid a.
72APPEARANCES
73For Petitioner: Nelson E. Rodney, Esquire
79Senior Attorney
81Agen cy for Health Care Administration
87Suite 300
898333 Northwest 53rd Street
93Doral, Florida 33166
96For Respondent: Vl ad Van Rosenthal, M.D.
103Qualified Representative
105Medical Office for Women
109Suite 402
111909 Northeast 163rd Street
115Miami, Florida 33160
118STATEMENT OF THE ISSUE S
123The issues are whether Respondent failed to maintain
131emergency medications, in violation of Florida Administrative
138Code Rule 59A - 9.0225(1), and failed to ensure that a
149defibrillator was available for immediate use, in violation of
158Florida Administrative Code Rule 59A - 9.0225(2). If so, another
168issue is the penalty that should be imposed.
176PRELIMINARY STAT EMENT
179By Administrative Complaint dated February 7, 2012,
186Petitioner alleged that Respondent operates a licensed abortion
194clinic in North Miami Beach. The Administrative Complaint
202contains two counts.
205Count I alleges that, during a relicensure survey conducted
214on June 8, 2010, Petitioner ' s surveyor determined that
224Respondent " failed to maintain sterile suturing equipment and
232supplies, and their crash cart, which includes emergency
240medications. " During a followup survey conducted on April 21,
2492011, Pet itioner ' s surveyor determined that medications on the
260crash cart wer e out - of - date: one 500 - ml bag o f Lactated
277Ringer ' s Intravenous Solution bore an expiration date of April
2882009, a one - mg vial of Atropine bore an expiration date of
301November 2010, and one 2% Lid ocaine Hydrochloride injection bore
311an expiration date of November 2010. For this uncorrected
320deficiency, which allegedly violates Florida Administrative Code
327Rule 59A - 9.0225(1), the Administrative Complaint seeks an
336administrative fine of $500.
340Count II alleges that, during a relicensure survey on
349June 8, 2010, Petitioner ' s surveyor determined that Respondent
359failed to ensure that emergency equipment was provided for
368immediate use. In particular, the surveyor found that
376Respondent ' s facility la cked a defibrillator. During a followup
387survey conducted by the surveyor on April 21, 2011, the surveyor
398determined that Respondent ' s facility still did not have a
409defibrillator. For this uncorrected deficiency, which allegedly
416violates Florida Administr ative Code Rule 59A - 9.0225(2), the
426Administrative Complaint seeks an administrative fine of $500.
434At the hearing, the Administrative Law Judge determined
442that Dr. Rosenthal was a Qualified Representative of Respondent.
451Petitioner called four witne sses and offered into evidence the
461following pages from its exhibit binder: 1 - 12, 18, 21, 32, 39 -
47542, and 47 . Respondent calle d one witness and offered into
487evidence no exhibits. All exhibits we re admitted into evidence .
498The court reporter filed the transcript o n June 2 7, 2012.
510Petitioner filed a proposed recommended order on July 9, 2012 .
521FINDING S OF FACT
5251. At all material times, Respondent has operated , under
534the jurisdiction of Petitioner, a licensed abortion clinic
542facil ity, bearing license number 899 . The facility in question
553is located in North Miami Beach. At the time of the surveys
565described below , Respondent also operated another facility in
573south Miami , but that facility is not involved in this case.
584All references to " facility " will therefore re fer to the North
595Miami Beach location.
5982. On June 8, 2010, one of Petitioner ' s surveyor s
610conducted a relicensure survey of Respondent ' s facility. As is
621typical of such surveys, this survey was unannounced.
6293. During the survey, the surveyor discovered three
637expired medications in the facility: 0.2 mg Isuprel ® -- expired
648August 2009, 0.4 mg atropine -- expired February 2010, and an
659unspecified dosage of nalbuphone -- expired February 2010. These
668expired medications were on a shelf in the operating room.
678During the survey, the surveyor also discovered that the
687facility did not have a defibrillator.
6934. At the conclusion of the survey, the surveyor conducted
703an exit conference with the sole employee present at the
713facility. During this conference, the surv eyor explained these
722deficiencies and gave Respondent until July 8, 2010, to correct
732them. Subsequently, the surveyor prepared a re port showing
741these violations and confirming that the deadline for correcting
750both deficiencies was July 8, 2010.
7565. On Apr il 21, 2011, the surveyor returned , again
766unannounced, to the facility to conduct a followup survey and
776again found only one employee present at the facility . During
787this survey, the surveyor discovered three expired medications
795in the facility: one 500 - ml IV bag of Lactated Ringer ' s --
810expired April 2009, 1 mg atropine -- expired November 2010, and 2%
822lidocaine hydrochloride injection -- expired November 2010. The
830surveyor found these expired medications in a locked storage box
840on the crash cart, which is the cart used for medical
851emergencies. During the followup survey, the surveyor also
859discovered that the facility did not have a defibrillator.
8686. On the dates of both surveys, the facility did not have
880any surgical procedures scheduled. Also, no patient s were
889present at anytime during either survey.
8957. During each survey, the surveyor selected five dates at
905random to determine if the facility had performed any second -
916trimester abortions, and she found that no such procedures had
926been performed on any of the se dates. For this reason, the
938surveyor did not cite the facility for any violations that are
949contingent on the actual performance of second - trimester
958abortions -- such as, the failure to have a registered nurse in
970the recovery room. Similarly, becau se no patient was present
980during the survey s , the surveyor testified that she did not cite
992the facility for a failure to maintain anaesthesia equipment in
1002the operating room; the surveyor explained that the
1010anaesthesiologist brings his or her own equipment when attending
1019a surgical procedure .
10238. The surveyor explained that she cited Respondent for
1032the deficiencies alleged in this case because they are
1041contingent upon licensure only, not licensure and the actual
1050performance of second - trimester abortions. A t the time of each
1062survey , regardless of the level of patient activity, the
1071facility was open and capable of supporting the procedures for
1081which it is licensed.
10859 . Dr. Rosenthal offered an explanation for each of the
1096deficiencies cited in this case. As h e testified , t he expired
1108medications found during the followup survey were in a locked
1118storage box maintained by a certified registered nurse
1126anesthetist, who had not worked at the facility for several
1136years , but had never returned to retrieve her storage box .
1147However, Dr. Rosenthal ' s explanation does not account f or why
1159the surveyor missed the Lactated Ringer ' s IV fluid during the
1171original relicensure survey, if, in fact, she did miss this
1181item . (The other two items were not expired at the time of the
1195ea rlier survey.)
119810. Notwithstanding any shortcoming in Dr. Rosenthal ' s
1207explanation, more importantly, the record fails to establish the
1216absence of current emergency medications and IV fluids at the
1226facility . As noted below, the cited rule requires that the
1237facility contains these items; as long as it does, the cited
1248rule is not violated by the presence of expired medications and
1259fluids at the facility . The p resence of such expired items is
1272insufficient, especially when the standard of proof, as noted
1281below, is clear and convincing evidence, to support an inference
1291that adequate, current medications and IV fluids were not also
1301available at the facility.
130511 . A s Dr. Rosenthal testified, a t the time of both
1318surveys, Respondent maintained a single defibrillator, which he
1326transferred from one facility to another, depending on which
1335facility was to be the site of surgical procedures on a given
1347day. This explanation is not responsive to the requirement of a
1358defibrillator at each facility.
1362CONCLUSIONS OF LAW
136512 . The Division of Administrative Hearings has
1373jurisdiction. § § 120.569 and 120.57, Fla. Stat.
138113 . Florida Administrative Code Rule 59A - 9.0225(1) and (2)
1392provides:
1393(1) Each abortion clinic providing second
1399trimester abortions shall provide esse ntial
1405clinic supplies and equipment as required in
1412subsections (1) through (7) when performing
1418second trimester abortions. Any such
1423abortion clinic which is in operation at the
1431time of adoption of this rule and providing
1439second trimester abortions shall b e given
1446one year within which to meet these
1453standards as follows:
1456(a) A surgical or gynecological
1461examination table(s);
1463(b) A bed or recliner(s) suitable for
1470recovery;
1471(c) Oxygen with flow meters and masks or
1479equivalent;
1480(d) Mechanical suction;
1483(e) Resuscitation equipment to include,
1488at a minimum, resuscitation bags and oral
1495airways;
1496(f) Emergency medications, intravenous
1500fluids, and related supplies and equipment;
1506(g) Sterile suturing equipment and
1511supplies;
1512(h) Adjustab le examination light;
1517(i) Containers for soiled linen and
1523waste materials with covers; and
1528(j) Appropriate equipment for the
1533administering of general anesthesia, if
1538applicable.
1539(2) Emergency equipment shall be provided
1545for immediate use, maintain ed in functional
1552condition, and capable of providing at least
1559the following services:
1562(a) Inhalation therapy;
1565(b) Defibrillation;
1567(c) Cardiac monitoring;
1570(d) Suctioning; and
1573(e) Maintenance of patient airway.
157814 . The burden of proof is on Petitioner to prove the
1590material allegations by clear and convincing evidence. Dep ' t of
1601Banking & Fin . v. Osborne Stern & Co. , Inc. , 670 So. 2d 932
1615(Fla. 1996) .
161815 . As explained above, Petitioner has failed to prove
1628that the facility lacked adequate emergency medications and IV
1637fluids at the time of either survey. However, Petitioner has
1647provided that the facility lacked the required defibrillator at
1656the time of bo th surveys.
166216. Section 390.018, Florida Statutes, authorizes an
1669administrative fine of up to $1000 for any violation of, among
1680other things, the rules governing an abortion clinic.
1688Petitioner has proved one of the two counts that it asserted in
1700the Admi nistrative Complaint, which seeks a fine of $500 for
1711each count. Thus, a fine of $500 is reasonable for the offense
1723of failing to maintain a defibrillator at the facility.
1732RECOMMENDATION
1733I t is RECOMMENDED that the Agency for Health Care
1743Administration ent er a final order finding Respondent guilty of
1753failing to maintain a defibrillator and imposing an
1761administrative fine of $500 for this violation and dismissing
1770the charge pertaining to expired medications and IV fluids.
1779DONE AND ENTERED this 10 th day of July, 2012 , in
1790Tallahassee, Leon County, Florida.
1794S
1795ROBERT E. MEALE
1798Administrative Law Judge
1801Division of Administrative Hearings
1805The DeSoto Building
18081230 Apalachee Parkway
1811Tallahassee, Florida 32399 - 3060
1816(850) 488 - 9675
1820Fax Filing (850) 921 - 6847
1826www.doah.state.fl.us
1827Filed with the Clerk of the
1833Division of Administrative Hearings
1837this 10 th day of July, 2012 .
1845COPIES FURNISHED :
1848Vlad Van Rosenthal
1851A Medical Office for Women
1856Suite 402
1858909 Northeast 163rd Street
1862Miami, Florida 33160
1865Nelson E. Rodney, Esquire
1869Agency for Health Care Administration
1874Suite 300
18768333 Northwest 53rd Street
1880Miami, Florida 33166
1883nelson.rodney@ahca.myflorida.com
1884Richard J. Shoop, Agency Clerk
1889Agency for Health Care Administration
18942727 Mahan Drive, Mail Stop 3
1900Tallahassee, Florida 32308
1903Stuart Williams, General Counsel
1907Agency for Health Care Administration
19122727 Mahan Drive, Mail Stop 3
1918Tallahassee, Florida 32308
1921Elizabeth Dudek, Secretary
1924Agency for Health Care Administration
19292727 Mahan Drive, Mail Stop 1
1935Ta llahassee, Florida 32308
1939NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
1945All parties have the right to submit written exceptions within
195515 days from the date of this Recommended Order. Any exceptions
1966to this Recommended Order should be filed with the agency that
1977will issue the Final Order in this case.
- Date
- Proceedings
- PDF:
- Date: 07/17/2012
- Proceedings: Transmittal letter from Claudia Llado forwarding Petitioner's Exhibits numbered 13-17, 19-20, 22-31, 33-38, 43-46, and 48, and Respondent's Exhibits numbered 1-10, which were not admitted into evidence to the agency.
- PDF:
- Date: 07/10/2012
- Proceedings: Recommended Order cover letter identifying the hearing record referred to the Agency.
- Date: 06/27/2012
- Proceedings: Transcript of Proceedings (not available for viewing) filed.
- Date: 06/08/2012
- Proceedings: CASE STATUS: Hearing Held.
- Date: 06/05/2012
- Proceedings: Respondent's List of Exhibits (exhibits not available for viewing)
- Date: 06/01/2012
- Proceedings: Respondent's List of Exhibits (exhibits not available for viewing)
- Date: 05/31/2012
- Proceedings: Petitioner's Proposed Exhibits (exhibits not available for viewing)
- PDF:
- Date: 04/18/2012
- Proceedings: Notice of Filing Admissions, Interrogatories, and Request to Produce filed.
- PDF:
- Date: 04/09/2012
- Proceedings: Notice of Hearing by Video Teleconference (hearing set for June 8, 2012; 9:00 a.m.; Miami and Tallahassee, FL).
Case Information
- Judge:
- ROBERT E. MEALE
- Date Filed:
- 03/28/2012
- Date Assignment:
- 03/29/2012
- Last Docket Entry:
- 08/13/2012
- Location:
- Miami Beach, Florida
- District:
- Southern
- Agency:
- ADOPTED IN TOTO
Counsels
-
Nelson E. Rodney, Esquire
Address of Record -
Vlad Van Rosenthal
Address of Record -
Nelson E Rodney, Esquire
Address of Record -
Vlad Van Rosenthal, M.D.
Address of Record