Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all time relevant to this proceeding, the Respondent was licensed to practice medicine in the state of Florida, having been issued license number ME 0020485. The Respondent has been licensed to practice medicine in the state of Florida since 1973. Respondent is Board Certified in Obstetrics and Gynecology having fulfilled the requirements of the American Board of Obstetrics and Gynecology. The requirements include a multi-year residency program in obstetrics and gynecology and successfully passing written and oral examinations. After graduating from medical school the Respondent completed a two- year residency in obstetrics and gynecology at St. Joseph's Hospital in Baltimore, Maryland. Respondent then spent one year as Chief Resident in Obstetrics and Gynecology at Lutheran Hospital in Baltimore, Maryland where approximately 2000 babies were born during the time Respondent was in residency. The Respondent then completed a two-year clinical fellowship in obstetrics and gynecology at Peninsula General Hospital in Salisbury, Maryland where approximately 3,000 babies were born each year during the time Respondent was in residency. Respondent received additional training in the subspecialty of fetal maternal medicine through a one-year fellowship at New Jersey Medical School. After the fellowship at New Jersey Medical School, Respondent served one year as a clinical instructor at University Hospital, affiliated with Mercy Hospital in Baltimore, Maryland. Since the time of his first residency, the Respondent has been involved in the delivery of several thousand babies. The Respondent moved to Florida in 1975 and has been engaged in the private practice of medicine since that time. The Respondent opened the Venice Obstetrics Clinic (Clinic) in 1983, and has served as its Medical Director since that time. The Clinic was at all times relevant to these proceedings licensed by the State of Florida in accordance with Sections 387.30 through 383.335, Florida Statutes, (referred to as the Birth Center Licensure Act). At all times relevant to these proceedings, the Respondent was permitted to perform surgical services (including episiotomies) and forceps delivery in the Clinic in accordance with the partial exemptions provided in Section 383.335(1), Florida Statutes. The Clinic's license has never been disciplined for noncompliance with Sections 383.30 through 383.335, Florida Statutes, or Chapter 59A-11, Florida Statutes, by the Department of Health and Rehabilitative Services (HRS), the agency charged with the responsibility of licensing and regulating birth centers. At all times relevant to these proceedings, Marcos Lara, M.D. acted as the Clinic's consultant, and was board certified with hospital privileges at St. Joseph's Hospital and at Faucett Memorial Hospital in Port Charlotte. In July 1988, the Clinic employed several nurses licensed by the state of Florida. At the time the patient K.Z. came into the Clinic, the nurse-to- patient ratio was two-to-one. Normally, the ratio was one-to-one. The patient's first visit to the clinic, and with Respondent, was on March 18, 1988. The patient continued with regular visits to the Clinic seeing the Respondent through July 8, 1988. On the patient's April 27, 1988 visit the Respondent gave the patient a score of "one" on the HRS, Pre-Term Delivery Risk Scoring Form (Form), indicating that the patient was a low-risk patient. On the patient's June 28, 1988 visit the Respondent gave the patient a score of "zero" on the Form, again indicating that she was a low-risk patient. The Respondent in scoring the patient's risk did not circle or use several of the risk factors listed on the Form that would have applied to the patient, including a patient under 20 years, single parent and low socioeconomic status. Based solely on the risk factors of (a) works outside of home, (b) younger than 20 years, (c) single parent, and (d) low socioeconomic status (based only on patient's level of education), and the points assigned those risk factors, the Respondent should have given the patient a score of "six". This would have placed her in the medium-risk classification which requires a score between six and nine points. However, since the patient no longer worked outside of the home on June 28, 1988, the date of the reevaluation, her score would have been "five", placing her in the low-risk classification. Many of the factors listed in the Form are risk factors used by obstetricians in assessing a patient's risk classification. However, many of the risk factors listed in the Form, including those risk factors used to assess this patient's risk classification, are not relied on solely by obstetricians, either singularly or in combinations, to assess a patient's risk classification. The purpose of the Form is to assist birth centers in assessing a patient's risk classification to determine whether the patient should be permitted to give birth in a birth center, and not to supplant the obstetricians' knowledge and skill in assessing a patient's risk classification. There is insufficient evidence to establish facts to show that Respondent's failure to correctly fill out the Form was the result of Respondent's failure to use his knowledge and skill as an obstetrician to properly assess the patient's risk classification and thereby fail to practice medicine within the prescribed standard of care. On June 28, 1988 the patient signed a form wherein she consented to the delivery of her child at the Clinic. At this time, the patient was advised of the risks of not delivering in a hospital and the advantages of delivering at a birth center. The normal period of gestation is 40 weeks. The methods used to calculate the estimated date of confinement (due date) are: (a) if a patient's menstrual periods are on a 28-day cycle, the due date can be determined by taking the last menstrual period (LMP) and adding 280 days; (b) substract three months from the LMP and add seven days; (c) an ultrasound can be used; (d) from the size of the fetus as determined by physical and pelvic examinations; and (e) fundal height measurement. None of these methods are absolutely accurate and therefore, the due date is considered an estimate. The fundus is the upper portion of the uterus which grows during pregnancy, with the cervix at the bottom portion of the uterus. The fundal height measurement is made from the top of the bone, which is the front of the pelvic, called the symphsis, to the top of the uterus. Both ends of this measurement are subjective in placement and vary between those making the measurement. Fundal height measurement is a way of determining the increase in size of the uterine content which is significantly, in normal cases, influenced by the growth of the fetus. The fundal height measurement is relevant to fetal age if it is consistent with other clinical assessments such as, how low is the baby to help determine the length, palpating to determine the width of the uterus, and a pelvic examination. Some obstetricians correlate the fundal height measurement with the gestation period where roughly one centimeter of fundal height equals one week of gestation, plus or minus two to four centimeters. While the Respondent measures the patient's fundal height at each visit, and did so with this patient, he does not use fundal height alone to determine the age of the fetus but uses fundal height in conjunction with other assessments found as a result of physical and pelvic examinations. On her first visit, the patient told the Respondent that her LMP had begun around the first part of December, 1987. Assuming the patient's LMP had begun on December 1, 1987, her due date should have been during the first week of September, 1988, using either method (a) or (b) above. Also on the patient's first visit the Respondent conducted physical and pelvic examinations. The physical examination consisted of palpation of the abdomen to note the size. The pelvic examination enabled the Respondent to assess the size of the uterus, which indicates the age of the pregnancy. Based on his physical and pelvic examinations of the patient on March 18, 1988 and the fundal height of 20 centimeters, the Respondent determined the age of the pregnancy to be 22 weeks with a due date of July 22, 1988. There was a difference in the due date calculated using the date expressed by the patient as her LMP as opposed to the due date determined by the Respondent from his clinical assessment as to the size of the fetus in conjunction with the fundal height. However, since the Respondent's clinical assessment did not reveal any problems, and the fact that approximately 25 percent of the pregnant women experience two or more false menstrual periods, the Respondent concluded that any size/date discrepancy was explainable. Therefore, the Respondent considered his determination of July 22, 1988 as the due date reasonable, and did not order an ultrasound since it was neither beneficial to the patient nor medically necessary at this point of the pregnancy. On April 27, 1988, June 8, 1988 and June 22, 1988 the Respondent measured the patient's fundal height as 23, 28 and 31 centimeters respectively. However, on these same dates the Respondent determined the age of the fetus to be 28, 34 and of the size of the fetus 36 weeks, respectively, based on his examination of the patient. On April 27, 1988, June 8, 1988 and June 22, 1988 the Respondent concluded that an ultrasound was not needed based on the same reasoning he had employed on March 18, 1988. On her June 28, 1988 visit, the Respondent performed physical and pelvic examinations, including palpating the abdomen, estimated the age of the fetus to be 39 weeks based on its size and advised the patient that her due date may be earlier than July 22, 1988, the initial due date. The fundal height measurement was 31 centimeters. Respondent's examination of the patient on her July 6, 1988 visit made him suspect twins and a possible abnormal delivery. Therefore, Respondent ordered an ultrasound. The ultrasound revealed a single baby in cephalic presentation (baby's head first), at term (fetus at least 37 weeks). The ultrasound did not indicate any problems in delivering the patient's baby. In fact, no risk factor was identified by the ultrasound. While the Respondent's records are sketchy in regard to his reasoning of the date/size discrepancy, the testimony of both the Respondent and Herbert F. Sandmire, M. D. supports the Respondent's reasoning in not ordering the ultrasound until the July 6, 1988 even though normally the date/size discrepancy may have justified the use of an ultrasound. Therefore, the Respondent was practicing medicine within the prescribed standard of care by not ordering an ultrasound until July 6, 1988 because there was sufficient reasons justifying the size/date discrepancy on the earlier dates, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. The patient went into labor on July 8, 1988. The patient arrived at the Clinic around 11:50 a.m. on July 8, 1988, and at that time her cervix was dilated two centimeters and was 100 per cent effaced. Nurses Sally Azima and Virginia Lane were assisting with the patient and made the notations on the Nurses' Notes, with Nurse Lane making the notes from 1:30 p.m. through 7:00 p.m. and Nurse Azima making the notes from 7:30 until the end of the Nurses Notes. The patient's fetal heart rate was monitored with a Doptone. A Doptone is a devise that is placed on the abdomen which allows the fetal heart beat to be heard in the room. At 5:27 p.m., the cervix was 9 centimeters, 100 per cent effaced with membranes bulging. At 7:00 p.m., the patient suffered dysfunctional labor. The patient's uterine contractions were irregular and weak. The Respondent decided to administer Pitocin to the patient in order to regulate her uterine contractions. Pitocin is a brand name for a drug that stimulates uterine contractions. Pitocin is used for dysfunctional labor. Pitocin does not increase any risk that is not already present, and no change in management decisions is needed merely because Pitocin is being administered to the patient. The Respondent administered Pitocin to the patient by making a single injection of one ampule (10 units) of Pitocin into an existing intravenous bag. Another method of administering Pitocin is referred to as the piggy- back system wherein the Pitocin is maintained in a separate bag and infused through the existing intravenous line. While the piggy-back system may be the preferred method of administering Pitocin to a patient, neither the Birth Center Licensure Act nor the prescirbed medical standard of care in July, 1988 required the use of the piggy-back system to administer Pitocin to a patient. At the time the Pitocin was injected, the existing intravenous bag contained approximately 900 milliliters of fluid, plus or minus 20 milliliters. The Respondent set the IV flow rate at 20 drops per minute which resulted in a dosage level of approximately 10 milliunits per minute. While a dosage level of 10 milliunits per minute of Pitocin is higher than what was previously thought to be the correct dosage level of Pitocin, a patient could benefit from the higher dosage level of Pitocin, particularly under the circumstances and conditions that existed with this patient on July 8, 1988. The Respondent was practicing medicine within the prescribed standard of care when he administered the higher dosage level of Pitocin to the patient on July 8, 1988, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. After setting the IV flow rate at 20 drops per minute, the Respondent instructed Nurse Azima to monitor the flow to be sure the flow remained at 20 drops per minute. Nurse Azima checked the flow by counting the drops with a second hand on her watch every 15 to 20 minutes. Nurse Azima, under the supervision of Respondent, has administered Pitocin using the drop count method ever since Respondent's residency in obstetrics. While the use of an infusion pump may be the preferred method of administering Pitocin by some obstetricians, the Respondent was practicing medicine within the prescribed standard of care when he used the drop count method of administering Pitocin to the patient on July 8, 1988 rather than using an infusion pump. His use of the drop count method, including allowing Nurse Azima to monitor the flow, met the prescibed standard of care, notwithstanding the testimony of Robert Brauner, M. D. to the contrary. An electronic fetal monitor records both the baby's heart rate and the mother's uterine contractions, and presents this information on a graph. The Respondent did not use an electronic fetal monitor while administering Pitocin to the patient on July 8, 1988. Instead, Respondent used intermittent auscultation. Intermittent auscultation involves using a stethoscope or Doptone to listen to the fetal heart beat at prescribed intervals. A nurse is assigned to check the baby's heart beat periodically and to notify the physician of any abnormality. When an electronic fetal monitor is used, a nurse is assigned to watch the chart and notify the physician of any changes indicated by the chart. Intermittent auscultation is equivalent to electronic fetal monitoring when it is done on a frequent basis, such as listening every 30 minutes when the patient is in the active part of the first stage of labor and every 15 minutes during the second stage of labor. Pitocin was administered by the Respondent at 7:00 p.m. and thereafter, Nurse Azima checked the fetal heart rate every 15 to 20 minutes. However, she did not record the fetal heart rate each time because the fetal heart rate was within an acceptable range, nothing was abnormal. The Nurses Notes indicate that Nurse Azima recorded the fetal heart rate at 7:30 p.m., 8:30 p.m., 9:00 p.m. and 9:35 p.m. There was no indication of any abnormality in the patient's heart rate or of any fetal distress at any time during the course of the patient's labor. Again, while the use of an electronic fetal monitor may be preferred by some obstetricians, the Respondent was practicing medicine within the prescribed standard of care when he used intermittent auscultation instead of an electronic fetal monitor and in his use of intermittent auscultation on July 8, 1988, notwithstanding the testimony of Robert Brauner, M. D. or the information contained in the Physician's Desk Reference to the contrary. At 7:30 p.m. the patient was fully dilated and the fetal head was at "zero" station. Station refers to the progress of the fetal head down the pelvis toward the outside. When the very edge of the fetal head is even with an imaginary line drawn between the patient's two spines (prominence in the middle of patient's pelvis) the fetal head is considered at zero station. Progressing past zero station would be indicated as zero-plus-one station, plus-two, etc. Progressing past plus-three station would be delivery of the fetal head. At 8:00 p.m., the fetal head was in right occiput posterior (ROP) position. This means the baby's face, as the mother is lying on her back, is looking up and, is a less favorable position for delivery, in that it usually leads to a longer labor. At 8:30 p.m., an hour after the patient had been fully dilated, the fetal head was at zero-plus-one station. The fetal head was now in the occiput anterior (AO) position, meaning the baby is now looking straight down while the mother is lying on her back. This position is the favorable position for delivery. The patient was transferred to the procedure room, prepped and given a local anesthetic when the fetal head was at plus-one to plus-two station. Thereafter, the Respondent noted that patient was fully dilated, fetal head was at plus-two station, but there was no further descent of the head. At this point, the Respondent decided that the patient should be assisted in the delivery by using the forceps to bring the fetal head down and deliver the baby. Before applying the forceps, the Respondent performed an episiotomy on the patient. An episiotomy is a obstetrical cut made between the vagina and the rectum (the perineum), through the tissue, separating the muscle to help open the vagina for delivery. The decision on whether to perform the episiotomy before or after applying forceps is a matter of clinical judgment based upon the physical characteristics of the patient, in particular the size of the introitus and the perineum. The Respondent decided to perform the episiotomy on the patient before applying the forceps based on his clinical judgment of what was best for the patient. Forceps are obstetrical instruments used to assist in the delivery of the fetal head. The Respondent used Simpson forceps, a commonly used forceps, which are designed to come apart. The Respondent attempted forceps delivery several times without success, even with the patient pushing and fundal pressure being applied simultaneously by Nurse Azima and Nurse Lane. Fundal pressure is applied by pressing down on the top of the patient's abdomen to help in the delivery of the baby and is a fairly common obstetrical procedure. During the attempt to deliver the baby with the forceps the IV came out but was restored by the Respondent. The Pitocin was discontinued at this time. The Respondent was practicing medicine within the prescribed standard of care when he performed the episiotomy before the use of the forceps and in his attempt to delivery the baby with the forceps, notwithstanding Dr. Brauner's testimony to the contrary. After the unsuccessful attempt to deliver the baby with forceps, the Respondent decided to transfer the patient to a hospital for a cesarean section. Nurse lane was instructed by the Respondent to call for an ambulance. Nurse Lane called the Sarasota Fire Department which responded in approximately three minutes. After calling the Sarasota Fire Department, Nurse Lane called St. Joseph's Hospital and advised the hospital that the patient would be on the way. The episiotomy was not bleeding excessively and the bleeding could be controlled by packing the incision with gauze sponges and keeping the patient lying down with her legs together. Since the repair of the episiotomy would have required 10 to 15 minutes, the Respondent, using his best clinical judgment, decided to control the bleeding as set out above rather than to repair the episiotomy and delay the patient's transport to the hospital. The patient's life or well-being was not threatened by not repairing the episiotomy. While blood loss is a concern, specially for someone facing an operation, apparently the blood loss for this particular patient was not an overriding concern since the decision was made at the hospital not to repair the episiotomy until after the cesarean section, some two hours later. Under the circumstances and conditions existing at the time, the Respondent was practicing medicine within the prescribed standard of care when he, in his best clinical judgment, decided not repair the episiotomy which would have delayed transporting the patient to the hospital. Upon arrival the paramedics were advised of the patient's condition, that the patient was to be transported to St. Joseph's Hospital and that the Respondent was attempting to reach Respondent's back-up physician. However, the Respondent did not want to delay transport of the patient to the hospital so he advised the paramedics to proceed to St. Joseph's Hospital in Port Charlotte before he had made contact with the back-up physician, other than with the doctor's answering service. On July 8, 1988 the Respondent's consultant (back-up obstetrician) was Dr. Lara, who was a Board certified obstetrician with hospital privileges at St. Joseph's Hospital in Port Charlotte. After the ambulance had departed for St. Joseph's Hospital, the Respondent, being unable to make contact with the Dr. Lara other than with answering service, called St. Joseph's Hospital and advised them of the patient's condition, Nurse Lane having already called the hospital to advised them that the patient was being transported there. In route to St. Joseph's Hospital, the paramedics made their own assessment of the patient's conditions and, under the conditions and circumstances existing at that time, decided to reroute the patient to the Venice Hospital which was closer. Venice Hospital did not have an obstetrical unit. Therefore, contact was established with a Dr. Chen, the supervising emergency room physician, who advised the paramedics to transport the patient to Venice Hospital for evaluation. After examining the patient, Dr. Chen called the Respondent and told him that he thought the patient was ready to deliver. However, after the Respondent told Dr. Chen of the patient's condition and not to delay getting the patient to a hospital with obstetrical service, Dr. Chen directed transport of the patient to Memorial Hospital in Sarasota. After talking with Dr. Chen, the Respondent called the Memorial Hospital, discussed the patient's condition with the nurse on the obstetrics floor, advised the nurse of what had been attempted with the patient, and that in his opinion a cesarean section was necessary. The Respondent left his phone number with the nurse so that the obstetrician handling the case could call the Respondent, if necessary. The obstetrician handling the patient's care at Memorial Hospital did not call Respondent and Respondent made no attempt to call the obstetrician. The patient was admitted to Memorial Hospital at 11:40 p.m., and was monitored with an external monitor for nearly 55 minutes before being taking to the operating room at 11:34 p.m. where she underwent an emergency cesarean section delivery at 11:49 p.m. After the delivery, the patient's episiotomy was repaired. Although the baby had forceps marks graded from "no marks" to "bad forceps marks" by personnel at Memorial Hospital, there was no evidence that the baby was in any way affected by the Respondent's attempted forceps delivery. The mother and the baby fared well while in the hospital and were discharged on July 12, 1988. There is competent substantial evidence to establish facts to show that the Respondent was practicing medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances throughout the treatment and management of the patient, K. Z. from March 18, 1988 through July 8, 1988. During the course of the hearing the Department stipulated on the record that it did not intend to pursue Count III of the Administrative Complaint (failure to keep written medical records justifying the course of treatment for the patient) and presented no evidence on this charge.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Medicine enter a final order dismissing Counts I, II, III, IV, and V of the Administrative Complaint filed in this case. RECOMMENDED this 15th day of February, 1993, at Tallahassee, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of February, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 91-3149 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the parties in this case. Petitioner's Proposed Findings of Fact. The following proposed findings of fact are adopted in substance as modified in the Recommended Order. The number in parenthesis is the Finding(s) of Fact which so adopts the proposed finding(s) of fact: 1(1); 2(9,14); 3 -11 (15,24,30,32,32,26,27,29,and 28,respectively); 12(28,29); 13(32); 14(25,27); 15(25); 16(38); 17(32-34,36 and 38); 24(37); 26(28,29); 27 - 30(16-18 and 22, respectively); 32 - 35(19); 36(43,46); 38(51,53); 43(52); 47(55); 50(46); 52 - 59(60 - 63,65,67,68); 61(66); 64(74); 67(74); 68(75); 70(74- 76); 72-74(67,68); 76(69); 79-89(72-75,77,80-84); 90-94(77- 79,82,83); 96-97(83,84); 100(84); and 105-106(85). The following proposed findings of fact are not supported by competent substantial evidence in the record: 19, 21, 23, 25, 39-42, 44, 45, 48, 49, 51, 62, 63, 69, 71, 78, 95, 98, and 99. The first sentence of proposed findings of fact 18, 20, 22 and 37 are adopted in Findings of Fact 32, 34 and 44. The balance of proposed findings of fact 18, 20, 22 and 37 are not supported by competent substantial evidence in the record. The following proposed findings of fact are neither material nor relevant to the conclusion reached in the Recommended Order: 31, 46, 60, 65, 66, 75, 77, 101 - 104 and 107. 6. The Findings of Fact 1 - 30 concerning Expert Witnesses go to the credibility of those expert witnesses and are not addressed in the Findings of Fact. Respondent's Proposed Findings of Fact. Proposed findings of fact 1 - 11 are adopted in substance as modified in Findings of Fact 2 - 12, respectively. Proposed finding of fact 12 is unnecessary. Proposed findings of fact 13 and 14 are adopted in substance as modified in Finding of Fact 13. Proposed findings of fact 15 and 16 are adopted in substance as modified in Findings of Fact 14, 15 and 19. Proposed findings of fact 17 - 24 are adopted in substance as modified in Findings of Fact 25, 27, 30 - 33 and 84. Proposed findings of fact 25 - 29 are adopted in substance as modified in Findings of Fact 27, 28, 31, and 34. Proposed findings of fact 30 - 36 are adopted in substance as modified in Findings of Fact 25,33 and 37. Proposed findings of fact 37 - 45 are adopted in substance as modified in Findings of Fact 16 - 24. Proposed findings of fact 46 - 52 are adopted in substance as modified in Findings of Fact 39 - 42. Proposed findings of fact 53 - 56 are adopted in substance as modified in Findings of Fact 43 - 45. Proposed findings of fact 57 - 61 are adopted in substance as modified in Findings of Fact 46 - 49. Proposed findings of fact 62 - 68 are adopted in substance as modified in Findings of Fact 50, 51 and 69. Proposed findings of fact 69 - 88 are adopted in substance as modified in Findings of Fact 52 - 58. Proposed findings of fact 89 - 94 are adopted in substance as modified in Findings of Fact 59 - 64. 15 Proposed findings of fact 95 - 100 are adopted in substance as modified in Findings of Fact 65 - 71. Proposed findings of fact 101 - 110 are adopted in substance as modified in Findings of Fact 71 - 76. Proposed findings of fact 111 - 129 are adopted in substance as modified in Findings of Fact 77 - 83. Proposed findings of fact 129 - 137 are adopted in substance as modified in Findings of Fact 84 - 86. Proposed findings of fact 138 - 162 are matters relating to the witnesses and go to the credibility of those witnesses and are not addressed as Findings of Fact. COPIES FURNISHED: Michael K. Blazicek, Esquire Senior Attorney Department of Professional Regulation 730 South Sterling Avenue, Suite 201 Tampa, Florida 33609-4582 Darol Carr, Esquire Farr, Farr, Emerich & Hackett, P. A. 2315 Aaron Street Post Office Box 2159 Port Charlotte, Florida 33949 James W. Linn, Esquire Carson, Linn & Adkins 1711-D Mahan Station Tallahassee, Florida 32308 Dorothy Faircloth Executive Director Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Jack McRay General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
The Issue Whether the Agency for Health Care Administration has a policy regarding the determination of the need for long term care beds which constitutes a rule and, if so, whether rulemaking is feasible and practicable.
Findings Of Fact Vencor Hospitals South, Inc. (Vencor), applied for a certificate of need (CON No. 8614) to establish a 60-bed long term care hospital in Agency for Health Care Administration (AHCA) District 8, for Fort Myers, Lee County, Florida. AHCA is the state agency authorized to administer the CON program for health care services and facilities in Florida. AHCA reviewed and preliminarily denied Vencor's application for CON No. 8614. The reasons for AHCA's actions on this or any other CON application are memorialized in documents called State Agency Action Reports (SAARs). Vencor alleges that the following statement generally describes AHCA's policy in regard to the review of CON applications for long term care hospitals: Long term care is not a separate category of health service, but is instead merely an allowable form of reimbursement pursuant to Medicare regulations. The care provided in acute care hospitals, hospital based skilled nursing beds, "subacute" care in nursing homes, and care at rehabilitation facilities, are all equivalent to the care provided at long term care hospitals. Therefore, in evaluating the need for long term care hospital beds, AHCA will assess the availability of other categories of beds and services to meet the need for the services proposed by the applicant for long term care hospital beds. Need for long term care beds is determined on a regional basis. Prior to 1994, long term care hospitals were not regulated separately and were considered comparable to general acute care hospitals. In 1994, AHCA amended the CON rules to establish long term care beds and hospitals as separate categories of health care providers. In 1994, AHCA defined and continues to the present to define long term care hospital as follows: "Long term care hospital" means a hospital licensed under Chapter 395, Part I, F.S., which meets the requirements of Part 412, subpart B, paragraph 412.23(e), [C]ode of Federal Regulations (1994), and seeks exclusion from the Medicare prospective payment system for inpatient hospital services. Rule 59C-1.002(29), Florida Administrative Code. In the federal regulations referenced by the AHCA rule, long term care hospital is more specifically defined as a hospital with an independent governing structure, an average length of stay greater than 25 days, referral of at least 75 percent of total patients from separate hospitals, and which meets the requirements for Medicare participation. 42 CFR Ch. IV, Subch. B, Pt. 412, Subpt. B, s. 412.23. AHCA also distinguishes long term care in its rules governing the conversions from one type of health care provider to another. The applicable conversion rules provide: "Conversion from one type of health care facility to another" means the reclassification of one licensed facility type to another licensed facility type, including reclassification from a general acute care hospital to a long term care hospital or specialty hospital or from a long term care hospital or specialty hospital to a general acute care hospital. Rule 59C-1.002(14), Florida Administrative Code (emphasis added); and "Conversion of beds" means the reclassification of licensed beds from one category to another including, for facilities licensed under Chapter 395, F.S., conversion to or from acute care beds, neonatal intensive care beds, hospital inpatient psychiatric beds, comprehensive medical rehabilitation beds, hospital inpatient substance abuse beds, distinct part skilled nursing facility beds, or beds in a long term care hospital; and, for facilities licensed under Chapter 400, Part I, F.S., conversion to or from skilled beds and intermediate care beds in a facility that is not certified for both skilled and intermediate nursing care if such conversion effects a change in the level of care of 10 beds or 10 percent of the total bed capacity of the facility within a 2-year period, or conversion to or from sheltered beds and community beds. Rule 59C-1.002 (15), Florida Administrative Code (emphasis added). AHCA also defined "substantial change in health services" to include: The conversion of a general acute care or specialty hospital licensed under Chapter 395, Part I, F.S., to a long term care hospital. Rule 59C-1.002(41)(c), Florida Administrative Code. Taken together AHCA's rules recognize long term care hospitals or beds as a separate and distinct category. Elfie Stamm was responsible for the development of the rules and is currently the chief of the CON and Budget Review Office at AHCA. Ms. Stamm testified in a 1994 rule challenge case, when AHCA was drafting a rule with a numeric need methodology for long term care beds, that: long term care hospitals serve patients who cannot be cost effectively treated in an acute care hospital, who do not have the same needs for the same types of service; it would not be fair for an applicant for the new construction of a long term care hospital to be compared to an acute care hospital; comprehensive medical rehabilitation (CMR) services are different than services in a long term care hospital; a long term care hospital with an average length of stay of 25 days or more is different from an acute care hospital that generally has a length of stay of 5 to 6 days but provides a full range of services; the patient populations in long term care hospitals are different from those in an acute care hospital in terms of overall patient characteristics, including older than average age, higher percentage of patients with particular diagnoses, such as ventilator dependency, higher overall mortality rates than acute care hospitals, and a much higher percentage of admissions by referrals from acute care hospitals. [T. 262-283]. See also Tarpon Springs Hospital Foundation, etc. v. AHCA, et al., DOAH Case No. 94-0958RU (R.O. 8/2/94). On behalf of AHCA, Ms. Stamm testified in this proceeding that: AHCA has changed its mind on whether or not it is appropriate to leave a patient in an acute care setting rather than transfer to long term care, specifically with regard to cost-effectiveness. [T. 373]. AHCA has not changed its mind and still says acute care hospitals and long term care hospitals should be reviewed separately, because if they would be reviewed comparatively, . . . there would be no chance for any [long term] beds ever because we don't show any need for acute care beds anywhere in the state. [T. 376]. But in evaluating Vencor's application for long term care hospitals in District 8 that would be located in Lee County, the Agency viewed hospital-based skilled nursing units, community nursing home subacute beds and comprehensive medical rehab beds throughout the entire district as existing and like potential alternatives to the proposed project. [T. 389]. AHCA does not necessarily agree that CMR services are different from long term care hospital services. [T. 265]. AHCA does not have a clearly identified population group for whom long term care would be more cost-effective, or to determine a numeric need methodology. [TR. 324]. Although there is a population that does need services that exceed 25 days or prolonged ventilator service, AHCA is not sure what is the most appropriate setting for their care because of inadequate data on comparative costs and outcomes. [TR. 327-8]. AHCA attributes its change in position to the publication titled Subacute Care: Policy Synthesis And Market Area Analysis, submitted to the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, on November 1, 1995, by Lewin-VHI, Inc. The document is commonly referred to as the Lewin Report. The Lewin Report concludes that long term care hospitals serve patients who are also served in other subacute settings, including CMR beds and hospitals, acute care hospital skilled nursing units, and skilled nursing units in freestanding nursing homes. As a result of the conclusions in the Lewin Report, AHCA maintains that it is unable to develop a numeric need methodology without an identifiable patient population. AHCA has not, however, repealed the rules establishing long term care as a separate type of health care service. Rather, the agency intends to wait for additional studies, including one being conducted for Vencor. The Medicare prospective payment system (PPS) for acute care hospitals created the market for subacute and long term care. Under the PPS, acute care hospitals receive a fixed payment based on the patient's diagnosis or diagnostic related group (DRG). Upon discharge to a subacute or long term setting, the patient's care is no longer reimbursed on a fixed basis, but at actual, reasonable costs. AHCA maintains that financial pressures created the current system, but without cost/benefit or outcomes analyses to demonstrate the appropriateness of using long term care hospitals. Therefore, AHCA considered the occupancy levels of acute care hospitals and available nursing home beds in determining the need for Vencor's project. AHCA has no rule defining subacute care, no inventory of subacute care units in nursing homes, and no reporting requirements from which it can determine the level of care or services provided in hospital based skilled nursing units. AHCA has no reports on specific levels or types of services provided in CMR beds. AHCA, nevertheless, presumed that the services are like those provided in long term care beds based on the Lewin Report. In rejecting Vencor's attempts to distinguish itself from other types of health care providers, AHCA relied, in part, on its finding that 1995 District 8 acute care hospital occupancy averaged 47.69 percent and peaked at 60.26 percent. By not adopting rules for determining the numeric need for long term care, AHCA also failed to establish the appropriate service area for determining need. AHCA considers the need for long term care services on a regional basis. In support of AHCA's decision to deny a long term care hospital application in District 9, Ms. Stamm's predecessor, Elizabeth Dudek, testified that long term care is a regional service. As further evidence of AHCA's position, the SAARs issued by AHCA on long term care hospital applications, have examined available services beyond the limits of the district. AHCA contends that long term care is regional, but determines its need by comparison to available hospital based skilled nursing units and subacute beds in community nursing homes, which are evaluated on a subdistrict basis, and CMR services which are tertiary but evaluated on a district-wide basis. See Finding of Fact 22. Since November 1995, AHCA has preliminarily denied all CON applications for long term care hospitals. Its policy of comparing the need for long term care to available beds in nursing homes and other types of hospitals is consistently repeated in the portions of the SAARs which address need. In analyzing the need for long term care hospitals in AHCA District 1, the SAAR dated January 10, 1997, includes the following statements: Vencor Hospitals South, Inc. defines its patient population as those currently being treated in ICUs and belonging to roughly 10 DRGs (which account for approximately 83% of Vencor patients. . . .) However these DRGs could also [be] appropriate for acute care, hospital based freestanding skilled nursing care, skilled nursing facility care and comprehensive medical rehabilitation care and the applicant does not demonstrate that these services are not available to residents of District 1. and The applicant [Baptist Health Affiliates Inc.] also discusses the differences between its proposed patient population and that of an acute care hospital, nursing home and those treated at home. However, there is no documentation provided which demonstrates the applicant's potential patients could not receive appropriate care in the District's existing rehabilitation facility, hospital based or nursing home skilled subacute nursing units. . . . Vencor Exhibit 12, pages 3-4 and 8. AHCA reviewed a CON application filed by Columbia of Pinellas County, Inc., to convert acute care beds to a long term care hospital in District 5, and concluded: The patient population represented by the DRGs listed above (by the applicant) are typical of freestanding nursing home with subacute units and hospital based SNUs in the state. There appear to be strong similarities between the subacute patient population of nursing homes/units and those of a long term care hospital. Vencor Exhibit 13, page 8. The SAAR issued on the Columbia of Pinellas County CON application continued with an extensive discussion of the Lewin Report. The SAAR reported AHCA's finding that CMR hospitals are alternatives since they admit patients who do not fit federal guidelines for CMR admissions (being able to tolerate three hours of therapy a day), and who might otherwise be in long term care hospitals. In the SAAR issued after the review of long term care applications for District 7, the same statement appears: The patient population represented by the DRGs listed above [by Orlando Regional Hospital] are typical of freestanding nursing home with subacute units and hospital based SNUs in the state. There appear to be strong similarities between the subacute patient population of nursing homes/units and those of a long term care hospital. Vencor Exhibit 14, page 11. Finally, in reviewing applications from Palm Beach County in District 9, AHCA concluded again: The applicant states that generally speaking the long term care hospital patients have respiratory complications, . . . tracheostomies, . . . chronic diseases, an infectious process requiring antibiotic therapy, . . . skin complications . . . need a combination of rehabilitation and complex medical treatment or are technology dependent individuals requiring high levels of nursing care. However, these patients could also [be] appropriate for acute care, hospital based skilled nursing care, skilled nursing facility care and comprehensive medical rehabilitation care and the applicant does not demonstrate that these services are not available to the residents of District IX. Vencor Exhibit 15, page 4. AHCA relies on the statutory review criteria in Subsection 408.035(1)(b), Florida Statutes, as authority for its consideration of all beds and facilities which may serve the same patients. That provision requires consideration of: (b) The availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing health care facilities and health services in the service district of the applicant. The expert witness for AHCA, however, distinguished between "like and existing" services for purposes of determining numeric need and the statutory criteria. She noted that once numeric need is established and published for nursing beds or CMR beds, for example, that same category of beds outside the appropriate health service planning subdistrict or district is not considered "like and existing." Similarly, within the district or subdistrict, there is a factual issue in each case but no presumption that beds of a different category are "like and existing." AHCA contends that it has no policy related to long term care and any comparable services. Since 1995, long term care CON applicants, according to AHCA, have failed to meet the requirements of Rule 59C-1.008(e), which provides in pertinent part: If no agency policy exists, the applicant will be responsible for demonstrating need through a needs assessment methodology which must include, at a minimum, consideration of the following topics, except where they are inconsistent with the applicable statutory or rule criteria: Population demographics and dynamics; Availability, utilization and quality of like services in the district, subdistrict or both; Medical treatment trends; and Market conditions. (Emphasis added). AHCA's argument ignores the fact that its expert witness provided competent, substantial evidence that it has redefined and expanded the meaning of "like services" for purposes of demonstrating need through a needs assessment methodology. It also ignores the fact that AHCA has expanded the comparison of need beyond the geographical limits of the district. AHCA's argument that it is waiting for additional data before adopting a need methodology, including data from a Vencor study, is to no avail since AHCA has already changed its policy. After reviewing a total of eighteen CON applications for long term care hospitals, AHCA has issued two CONs, one as part of a settlement agreement and the other approving an application filed by St. Petersburg Health Care Management, Inc. (St. Petersburg), for CON 8213. The St. Petersburg application demonstrated need using an identical methodology prepared by the same health planner as Vencor in this case. Referring to CON 8213, AHCA's expert witness candidly admitted . . . "I want to make clear that particular application was actually submitted and approved prior to the Lewin study." (T. 393). Subsequent to the Lewin study, AHCA has consistently denied applications for long term care beds or hospitals.
The Issue The issue to be resolved in this proceeding is whether Petitioner, as a child day-care facility operator, committed the violations of Florida Statutes and Florida Administrative Code, as alleged in the Administrative Complaint, of failing to obtain or maintain proof that at least one staff member physically has a valid certificate of training in first-aid and infant and child cardiopulmonary resuscitation procedures and that such staff member is physically present at the facility.
Findings Of Fact Petitioner is a licensed day-care facility licensed by the Department of Children and Family Services (Department). On May 11, 2001, Susan Kipen, Family Services Counselor, Day-Care Licensure, of the Department, conducted an inspection of the Petitioner's facility. During the May 2001 inspection, Kipen discovered that no member of the facility's staff had the required training in first-aid and infant and child cardiopulmonary resuscitation (CPR) and that no evidence of such training was contained in the facility's records. The Department cited the facility for noncompliance. On May 29, 2001, a warning letter was issued regarding the lack of training. The letter established a correction date of June 8, 2001. On August 28, 2001, the Department again inspected Petitioner's facility. The inspection revealed that no staff present at the facility had the required first-aid or CPR training and no certificate of such training was maintained in the facilities records. At least one staff person had completed the training, however, that person was not physically present at the facility. The Department again cited Petitioner for noncompliance.
Recommendation Having considered the foregoing Findings of Facts, Conclusions of Law, the evidence of record, and the candor and demeanor of the witness, it is RECOMMENDED that a final order be entered confirming the imposition of an administrative fine against Petitioner in the amount of $50.00. DONE AND ENTERED this 2nd day of May, 2002, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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 2nd day of May, 2002. COPIES FURNISHED: Temple DePlato Head Start at Green Cove Springs 100 Bel Tel Way, Suite 100 Jacksonville, Florida 32216 Robin Whipple-Hunter, Esquire Department of Children and Family Services Post Office Box 2417 Jacksonville, Florida 32231-0083 Peggy Sanford, Agency Clerk Department of Children and Family Services 1317 Winewood Boulevard Building 2, Room 204B Tallahassee, Florida 32399-0700 Josie Tomayo, General Counsel Department of Children and Family Services 1317 Winewood Boulevard Building 2, Room 204 Tallahassee, Florida 32399-0700
The Issue DOAH Case No. 01-3148: Whether the Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 01-4649: Whether the Respondent committed the violations alleged in the Administrative Complaint dated October 15, 2001, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: AHCA is the state agency responsible for licensing and regulating the operation of nursing home facilities, including ensuring that nursing homes are in compliance with criteria established by Florida statute. Chapter 400, Part II, Florida Statutes (2001). AHCA is authorized in Section 400.23(8), Florida Statutes, to impose administrative fines on nursing home facilities that fail to meet the applicable criteria. Florence Treakle conducted surveys of Life Care on May 9, 2001, and June 12, 2001, as a result of complaints received by AHCA. Because the surveys were conducted as a result of complaints received by AHCA, Ms. Treakle was the only AHCA surveyor conducting the surveys. The results of the surveys were reported on a form identified as "HCFA-2567," which is generated by the federal Department of Health and Human Services, Health Care Financing Administration, and is commonly referred to as a "Form 2567." Several deficiencies were identified in the Form 2567s completed for the May 9, 2001, and June 12, 2001, surveys, which were each cited to a federal "tag number" designated as "F" tags,1 to the applicable provision of the Code of Federal Regulations, and to the applicable Florida administrative rule. Each deficiency was also classified under Florida law as either a Class II or a Class III deficiency, and a factual narrative was included to support each deficiency cited. May 9, 2001, survey.2 The Form 2567 for the May 9, 2001, survey included a citation for a Class III deficiency under F-279, "Resident Assessment," and Section 483.13(c), Code of Federal Regulations. This citation involved the care provided to residents L.D. and A.M. and was supported by the assertion that, "[b]ased on observation and record review[,] . . . the facility did not have comprehensive care plans in place for healing of the residents [sic] pressure sores." A care plan is a tool used by the nursing staff to ensure that the resident is getting consistent care and is compiled from data included in a resident's Comprehensive Assessment. An entry in a care plan includes the identification of a problem, a goal for resolving or improving the problem, and the approaches, or means, to be used to reach the goal. Resident L.D. L.D. came into Life Care with pressure ulcers, including a Stage IV pressure ulcer3 on his coccyx, which is located at the bottom of the backbone. L.D. was receiving wound care both at Life Care and at a wound care center pursuant to a physician's order dated April 4, 2001, which contained the following requirement: "[O]ffload[] all boni [sic] prominences as much as possible." In accordance with this order, L.D. was turned and repositioned in bed every two hours, and he was provided with a special, pressure-relieving mattress. L.D. was a very quiet person, but he had no cognitive impairment and was able to communicate his needs to staff. L.D.'s wife visited him every day; she usually arrived in mid-morning and left in mid-afternoon, and she returned for a few hours in the evening. Both L.D. and his wife made it clear to the Life Care staff that L.D. wanted to sit in a wheelchair as much as possible so that he could move around the facility, take walks outdoors with his wife, and have his meals sitting up. L.D. used a special, high-backed wheelchair that he provided for his use while he was a resident of Life Care. The chair reclined so that pressure on his coccyx could be relieved somewhat, and Life Care furnished him a gel cushion for his wheelchair, also to help relieve pressure on his coccyx. On May 9, 2001, Ms. Treakle observed L.D. sitting in his wheelchair for over two hours, from 10:20 a.m. until 1:00 p.m. She found nothing in L.D.'s Care Plan regarding the amount of time L.D. would be permitted to sit in a wheelchair. Resident A.M. A.M. entered Life Care with a Stage III pressure ulcer on his left buttock. A.M. was receiving wound care at Life Care in accordance with the approaches included in his Care Plan. A.M. was not cognitively impaired, and he could communicate his needs to staff. His granddaughter and one year-old great-grandson visited him every day, and he enjoyed sitting outside in a wheelchair with his great-grandson on his lap. A.M. also liked to spend most of his time outside his room, moving himself around the facility in a wheelchair. Life Care provided a gel cushion for his wheelchair to help relieve pressure on A.M.'s buttock. On May 9, 2001, Ms. Treakle observed A.M. sitting in a wheelchair from 2:00 p.m. until 3:30 p.m. A.M.'s Care Plan did not contain an entry establishing the amount of time A.M. would be permitted to sit in a wheelchair. Summary. AHCA has failed to establish by even the greater weight of the evidence that the Care Plans developed for L.D. and A.M. were deficient. AHCA failed to present credible evidence of the contents of L.D.'s Care Plan,4 but the evidence is uncontroverted that L.D.'s wound care orders contained approaches for healing his pressure sores. A.M.'s Care Plan included several approaches for healing his pressure sores, and AHCA has not alleged that the required wound care was not provided to either L.D. or A.M. Rather, AHCA's specific complaint regarding the Care Plans of L.D. and A.M. is that there was no approach specifying the amount of time L.D. and A.M. would be permitted to sit in their wheelchairs. This complaint is based exclusively on the expectations of Ms. Treakle. Ms. Treakle expected to find this approach in the Care Plans because, in her opinion, pressure on the coccyx and buttocks can never be completely relieved when a resident is sitting,5 and any pressure on a pressure ulcer impedes healing because it decreases blood flow to an area. Accordingly, Ms. Treakle "would expect good practice would [sic] be for the Care Plan to indicate how long the resident was going to sit on this pressure sore."6 AHCA did not, however, submit any evidence of a standard of care requiring that the duration of time a resident can sit in a wheelchair be included as an approach in the care plan of a resident with a pressure ulcer, especially when the resident is alert, mobile, and able to communicate with staff. June 12, 2001, survey. The Form 2567 for the June 12, 2001, survey cited Life Care for three deficiencies: A Class II deficiency was cited under F-224, "Staff Treatment of Residents," and Section 483.13(c)(1)(i), Code of Federal Regulations, involving the care provided to residents E.G. and N.D. and supported by the assertion that "[b]ased on observation, record review and interview[,] the facility did not monitor and supervise the delivery of care and services." A Class III deficiency was cited under F-279, "Resident Assessment," and Section 483.20(k), Code of Federal Regulations, supported by the assertion that, "[b]ased on review of the care plan for resident #1 [N.D.], . . . the facility did not complete a comprehensive care plan that was revised to reflect all fall risks." A Class II deficiency was cited under F-281, "Resident Assessment," and Section 483.20(k)(3)(i), Code of Federal Regulations, supported by the assertion that, "[b]ased on citations at F 224[,] F 279 and F 324[,] the facility nursing staff did not provide care that met professional standards for residents #1 [N.D.] and #2 [E.G.]." Resident E.G. Diabetes management. Pertinent to these proceedings, E.G. was diagnosed with insulin-dependent diabetes; his blood sugar generally ranged from 150 to 270, which is in the mid-range, although it once reached 348. E.G. was alert, oriented, self-ambulatory, and somewhat grouchy. E.G.'s brother visited him about three times each week, and E.G. often left the facility with his brother for a meal. He did not adhere strictly to his diet, but often ate fried foods when he went out with his brother, and he kept a supply of orange juice in the small refrigerator in his room. Both fried foods and orange juice are contraindicated for diabetics. Pursuant to physician's orders, E.G.'s blood sugar was to be monitored four times a day, before each meal and at bedtime,7 and insulin was to be administered on a sliding scale, in an amount to be determined based on his blood sugar level. This order was transcribed on E.G.'s Medication Record, which, for each day of the month, included spaces for the time, the blood sugar level, the insulin coverage (the dosage expressed in number of units administered), and the site of injection, together with the initials of the staff member providing the care. Life Care staff also maintained glucose monitoring sheets, which included spaces for the date, the time, the blood sugar level, the dosage of insulin administered, and the initials of the staff member providing the care. There is no documentation in E.G.'s Medication Records, his glucose monitoring sheets, or the Nurses Notes that his blood sugar was checked at 11:30 a.m. on June 7, 2001. When his blood sugar was checked at 4:30 p.m. on June 7, it was 317, which is substantially higher than usual. For the 6:30 a.m. checks on June 2, 3, and 8, 2001, E.G.'s blood sugar level was documented and there are notations that insulin was given, but the dosages and sites of injection were not noted; E.G.'s blood sugar at the 11:30 a.m. checks on these days was either virtually the same as, or less than, the levels noted at the 6:30 a.m. checks. For the 6:30 a.m. check on June 4, 2001, E.G.'s blood sugar level was documented, but there is no notation that insulin was given; E.G.'s blood sugar at the 11:30 a.m. check on June 4 was less than the level noted at the 6:30 a.m. check. Wound Care. On June 5, 2001, a dermatologist removed a lesion from the top of E.G.'s left hand. The dermatologist prescribed Bactroban ointment, which was to be applied to the wound twice a day. Wound care instructions were included with the prescription, which provided as follows: Leave bandage on for 24 hours only without getting wet. Remove bandage after 24 hours and then do not apply another bandage. Leave the area open and clean the wound twice daily with warm water. Pat the wound dry and then apply Bactroban Ointment. Bactroban Ointment is a topical antibiotic that can be purchased without a prescription. Continue to do this until the wound has healed. Normal bathing can be resumed after the bandage is removed. Some redness and swelling are normal in the immediate area of the wound. If the wound develops significant redness, tenderness or a yellow drainage, please contact this office immediately . . . . A physician's order dated June 5, 2001, was written for E.G. for "Bactroban oint to wound on L hand, 45gm." The order did not state how often the ointment was to be applied or include the other instructions accompanying the prescription. The order was transcribed on E.G.'s Treatment Record on June 5, 2001, but the entry provided only that Bactroban ointment was to be applied to the wound once a day. There is nothing in E.G.'s Care Plan, Treatment Record, or Medication Record to document that his wound was treated between June 5 and June 12, 2001, nor was there any indication in E.G.'s chart that anyone signed for the Bactroban ointment. Marion Neuhaus, the Director of Nursing at Life Care at the times pertinent to these proceedings, observed E.G.'s wound every day because E.G. came to her office to show her the wound and other bumps and scrapes he accumulated as he walked around the facility. Ms. Neuhaus noted that the wound was scabbed, that there was a pink area around the wound, and that there was no swelling or drainage. Treatment was begun on the wound on June 12, 2001, and it healed without any complications. Summary. AHCA has established clearly and convincingly that Life Care did not provide E.G. with the wound care that was ordered by his physician. AHCA has, however, failed to establish by even the greater weight of the evidence that the healing process of E.G.'s wound was compromised by this lack of treatment. Ms. Treakle observed E.G.'s wound on June 12, 2001, and noted that it was scabbed and red around the edges. Ms. Treakle concluded that this redness alone indicated that the wound was infected. This conclusion is undermined by the notation in the wound care instructions included with E.G.'s prescription from the Dermatology Center that "[s]ome redness and swelling are normal in the immediate area of the wound." Furthermore, Ms. Treakle did not follow E.G.'s wound after June 12, 2001, and the evidence presented by Life Care that E.G.'s wound healed in a timely manner is uncontroverted. AHCA has established clearly and convincingly that there are several omissions in the documentation of Life Care's monitoring of E.G.'s blood, but these omissions do not reasonably support the inference that Life Care failed to monitor E.G.'s blood sugar and administer insulin on these dates as required by the physician's orders; rather, Life Care's failure on these occasions was inadequate documentation, not inadequate care. AHCA has, however, established clearly and convincingly that Life Care did not monitor E.G.'s blood sugar as required by his physician's order at 11:30 a.m. on June 7, 2001; this inference may reasonably be drawn based on the lack of documentation and E.G.'s elevated blood sugar at the next check at 4:30 p.m. Ms. Treakle assumed that E.G. suffered actual harm as a result of this omission because, in her view, hyperglycemia, or elevated blood sugar, always causes damage to the body; Ms. Treakle could not, however, identify any specific harm to E.G. caused by this one omission. AHCA has failed to establish by even the greater weight of the evidence that E.G.'s physical well-being was compromised by Life Care's failure to monitor his blood sugar on this one occasion. Resident N.D. Fall from Shower Chair.8 At the times pertinent to these proceedings, N.D. was a 79 year-old woman who had been a resident of Life Care since October 26, 1999. According to the assessment of N.D. included in the Minimum Data Set completed on May 3, 2001, N.D. suffered from Alzheimer's disease, had long- and short-term memory problems, and was severely impaired and unable to make decisions; as of June 12, 2001, N.D. was almost entirely dependent on staff for all of the activities of daily living. N.D.'s Care Plan for November 6, 2000, which was updated with handwritten notes, reflects that she had poor safety awareness. The Interdisciplinary Notes maintained by Life Care reflect that, on June 5, 2001, a nurse observed N.D. leaning forward in her wheelchair at breakfast; this was the first mention of this behavior in N.D.'s chart. Dr. Gil, N.D.'s physician, included a notation in the Physician's Progress Notes for June 8, 2001, that he observed N.D. leaning forward but was unable to assess her abdomen because of her anxiety. The Interdisciplinary Notes reflect that Dr. Gil visited N.D. on Saturday, June 9, 2001, and that she was again leaning forward in her wheelchair, "almost falling out of [her] chair." Dr. Gil ordered an ultra-sound of N.D.'s abdomen and a "lap buddy while in w/c [wheelchair] to prevent falls." Dr. Gil's order was noted in the Interdisciplinary Notes for June 9, 2001, as well as on a physician's order form signed by Dr. Gil on June 10, 2001. According to Life Care's written policy, physician orders are to be transcribed into a patient's care plan, treatment plan, or medication administration record, depending on the nature of the order. Dr. Gil's order for a lap buddy had not been transcribed into N.D.'s November 6, 2000, Care Plan at the time Ms. Treakle conducted her survey on June 12, 2001.9 A lap buddy was used on N.D.'s wheelchair beginning on the morning of June 11, 2001. On the evening of June 11, 2001, CNA Nova Coleman was caring for N.D. Ms. Coleman had been working for Life Care for only a short time, and N.D. was one of the first patients Ms. Coleman cared for after finishing her initial training. Ms. Coleman was, however, not an inexperienced CNA, having previously worked at another nursing home. At approximately 8:30 p.m., Ms. Coleman and another CNA had just finished showering N.D., and N.D. was sitting in a shower chair; her hair had been toweled dry, and she was dressed in her night clothes. The second CNA left the room, and Ms. Coleman, who had been standing in front of N.D., moved to the back of the shower chair so she could push N.D. out of the shower area. As she moved around the chair, N.D. pitched forward and fell face-first onto the floor. Ms. Coleman tried to grab N.D. to stop her from falling, but N.D. toppled over so quickly that Ms. Coleman could not reach her. N.D. suffered severe bruises to her face and a laceration on her lip as a result of the fall, but she did not break any bones. Ms. Coleman had not been advised prior to the fall of N.D.'s tendency to lean forward in her chair. N.D.'s tendency to lean forward in her wheelchair should have been entered in her Care Plan, together with the requirement that a lap buddy was to be used whenever she was in a wheelchair. In addition, Ms. Coleman should have been briefed on N.D.'s condition, including her tendency to lean forward, before Ms. Coleman was allowed to care for N.D. Although a lap buddy was not ordered for the shower chair and, in fact, could not appropriately have been used on a shower chair, the former Nursing Director of Life Care conceded that there were other means by which N.D.'s fall could have been prevented.10 The former Nursing Director also conceded that the failure to brief Ms. Coleman on N.D.'s condition probably contributed to the fall from the shower chair. Summary. AHCA has established clearly and convincingly that Life Care failed to provide N.D. with the services necessary to prevent her from falling from the shower chair and injuring herself, that Life Care failed to provide services that met professional standards, and that Life Care failed to revise N.D.'s Care Plan to include the risk of her falling forward while seated and the approaches Life Care would take to prevent her from injuring herself. Life Care conceded that the Care Plan should have included N.D.'s tendency to lean forward while seated and Dr. Gil's order of June 9, 2001, that N.D. be provided with a lap buddy when she was in the wheelchair. Life Care also conceded that the CNA should have been briefed on N.D.'s condition before she was assigned to care for N.D. Life Care further conceded that, even though Dr. Gil did not specifically prescribe a restraint to be used in the shower chair, measures could have been taken to ensure that N.D. did not fall out of the shower chair. AHCA has also established clearly and convincingly that Life Care's failure to provide proper care to N.D. resulted in her suffering significant injuries to her face. Although the injuries were to soft tissue and ultimately healed, N.D.'s physical well-being was adversely affected. In addition, AHCA has established clearly and convincingly that, even had N.D. not fallen and suffered injuries, the failure to include in N.D.'s Care Plan her tendency to lean forward and its failure to transcribe the physician's orders regarding the lap buddy into the Care Plan could have caused a lapse in the care provided to N.D. that could have possibly resulted in injury.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order Sustaining the reduction in the licensure status of Life Care Center of Port Saint Lucie to conditional for the period extending from June 12, 2001, to August 17, 2001; and Imposing an administrative fine in the amount of $5,000.00. DONE AND ENTERED this 15th day of May, 2002, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO 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 15th day of May, 2002.
The Issue Whether St. Joseph's Hospital, Inc.'s application for certification as a State Approved Pediatric Trauma Referral Center should be approved.
Findings Of Fact The Hillsborough County Hospital Authority d/b/a Tampa General Hospital ("TGH" or "Petitioner") is a licensed general acute care hospital in Tampa, Florida and is a verified level I trauma center. By definition, a level I trauma center is required to include an adult trauma center and a state-approved pediatric trauma referral center ("SAPTRC"). The Department of Health and Rehabilitative Services ("DHRS" or "Respondent") is the state agency with statutory responsibility for certification and regulation of trauma centers in Florida. St. Joseph's Hospital ("SJH" or "Intervenor") is a licensed general acute care hospital in Tampa, Florida and is a verified level II trauma center. SJH was provisionally approved as a level II trauma center on May 1, 1991 and was verified on July 1, 1992. A level II trauma center is not required to operate a SAPTRC. By letter of August 17, 1993, the DHRS notified the chief executive officers for all Florida hospitals of next trauma center application review cycle. Pursuant to statute, letters of intent were due by October 1, 1993 for the referenced review cycle. A letter of intent to apply for certification as a trauma center is an nonbinding expression of intent. Frequently a hospital files a letter of intent to become a trauma center but and then fails to file the application. A hospital seeking trauma unit certification must submit a letter of intent by the October 1 preceding the April 1 application deadline. A letter of intent is only valid for the application review cycle for which it is submitted. A hospital which submits a letter of intent but does not file the subsequent application must submit another letter of intent in order to file an application in a later review cycle. Pursuant to Section 395.4025(2)(a), Florida Statutes, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a state-approved trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. The cited statute specifically provides that this requirement does not apply to any hospital that is certified as a provisional or verified trauma center on January 1, 1992. A trauma agency ("agency") is a planning unit of one or more county governments which plans for the development of the trauma system in that county or multi-county region. The DHRS is charged with review and approval of all local trauma agencies, the trauma systems plans adopted by such agencies and annual updates and amendments to local trauma plans. The Hillsborough County Trauma Agency ("HCTA"), is the DHRS-approved local trauma agency for Hillsborough County, Florida and is responsible for trauma service area #10. The Petitioner asserts that the SJH application will increase the number of service area #10 trauma centers beyond the limit of two imposed by statute and rule. There are currently two trauma centers in Hillsborough County (service area #10) including the Petitioner and the Intervenor. The expansion of services proposed by SJH will not increase the number of trauma centers in service area #10. If SJH is awarded the certification, there will still be two trauma centers. The trauma services plan submitted by the HCTA and approved by the DHRS does not expressly address whether or not any need exists for a second SAPTRC in service area #10. The 1990 amendment to the local plan references SJH's interest in operating a SAPTRC, but does not state whether need exists for a second SAPTRC. By letter of intent dated September 23, 1993 and received by the DHRS on September 30, 1993, SJH filed notice of intent to apply for certification as a state approved pediatric trauma referral center. By letter of October 14, 1993, the DHRS acknowledged receipt of SJH's letter of intent. The SJH letter of intent does not certify that the SJH's planned pediatric trauma referral center was consistent with the local trauma agency's plan. The failure of SJH to certify that the proposed SAPTRC is consistent with the local trauma agency plan is of no consequence. Section 395.4025(2)(a), Florida Statutes, specifically exempts any hospital that is certified as a provisional or verified trauma center on January 1, 1992. SJH was provisionally approved as a level II trauma center on May 1, 1991. Consideration of whether the local plan indicates need for an additional SAPTRC or whether the SJH proposal is consistent with the local trauma plan is not required. Until immediately prior to this case being heard, and despite the aforementioned exemption for some facilities, the DHRS required all hospitals located in areas where local or regional trauma agencies exist to submit some type of certification that the proposed trauma unit was consistent with the local plan. Since adoption of the 1992 statutory amendments, the DHRS has failed to appropriately apply the referenced exemption. Immediately preceding commencement of the hearing in this matter, the DHRS position was revised to reflect the exemption. The SJH application for certification as a SAPTRC was filed with the DHRS on or before April 1, 1993. On May 13, 1993, the DHRS notified SJH of certain omissions and requested additional information. On May 19, 1993, SJH filed its response to the request for information. Thereafter, the DHRS performed a preliminary review of the application to determine whether SJH met the requirements for approval as a "provisional" SAPTRC. Included in the information considered by the DHRS in evaluating the SJH application were documents submitted by representatives of the HCTA related to whether the SJH application was supported by the local agency and was consistent with the local trauma plan. The HCTA documents submitted are immaterial because, as previously addressed, SJH is exempted from the requirement related to local trauma plan consistency. The DHRS determined that the SJH application met the required critical standards for provisional approval. The DHRS notified SJH of the provisional approval on May 31, 1994. TGH challenged the DHRS determination that the SJH application met the critical standards. A hospital which meets the "critical elements" set forth in statute may receive provisional approval as a SAPTRC. Section 395.4025(2)(c), Florida Statutes, provides as follows: ....The department shall conduct a provisional review of each application for the purpose of determining that the hospital's application is complete and that the hospital has the critical elements required for a state approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has: Equipment and physical facilities necessary to provide trauma services. Personnel in sufficient numbers and with proper qualifications to provide trauma services. An effective quality assurance program. Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This subparagraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992. As previously stated, because SJH was a provisionally approved trauma center on January 1, 1992, it is not required to submit written confirmation by the local or regional trauma agency that verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency. The parties stipulated that the SJH application meets the standards regarding staffing, facilities, equipment, and quality assurance required for provisional approval, except as to the following: Whether St. Joseph's will have adequate surgeon coverage and support to meet the require- ments to be a provisional SAPTRC. Whether St. Joseph's will have adequate physician coverage in its pediatric ICU to meet the requirements to be a provisional SAPTRC. Whether St. Joseph's meets the statute and rule requirements for provisional review as they relate to quality of care to pediatric trauma alert patients. There was attention directed at the hearing to the fact that the DHRS application form fails to accurately track the applicable rules setting forth the requirements for certification as a SAPTRC. Notwithstanding the agency's failure to create an accurate application form, the minimum standards for review for Provisional SAPTRCs as identified in Rule 10D-66.109(d)2, Florida Administrative Code, are the following portions of HRSP 150-9, October 91: STANDARD Type of Hospital Surgery Department; Division; Services; Sections: A Surgical Specialties Availabilities: A 1, 2, 3 & 4 Non-Surgical Specialties Availabilities: 1, 8 & 13 Emergency Department (ED): A, B, D & H Operating Suite Special Requirements: A IX. Pediatric Intensive Care (P-ICU): A, C, 1 XVI. Quality Management: A, B, C, D, & E The booklet identified as "State-Approved Trauma Center and State- Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91" provides specific information related to each standard. The following constitutes review of the minimum standards for Provisional SAPTRCs as related to the application submitted by SJH. Standard I. Type of Hospital SJH is a level II trauma facility and is a general acute care hospital with independent pediatric trauma patient care services within the facility, from emergency department admission through rehabilitation, separate and distinct from adult patient care services. SJH meets the Standard I requirement. Standard II. Surgery Department; Division; Services; Sections: A SJH offers the required types of surgery, including general surgery, orthopedic surgery and neurosurgery. Orthopedic surgery and neurosurgery are divisions within the Department of Surgery. SJH meets the Standard II A requirement. Standard III. Surgical Specialties Availabilities: A 1, 2, 3 & 4 SJH meets the Standard III A requirement. SJH offers general surgery, neurosurgery, orthopedic surgery and otorhinolaryngologic surgery on call and promptly available 24 hours a day. Standard V. Non-Surgical Specialties Availabilities: 1, 8 & 13 SJH meets the specified Standard V requirement. SJH offers the required types of non-surgical specialties, including anesthesia, pediatric intensive and critical care medicine, and radiology including diagnostic x-ray and computerized tomography. The specialists in each area have special competence in the care of the pediatric trauma patient in their specialties. Standard VI. Emergency Department (ED): A, B, D & H SJH meets the specified Standard VI A requirement. SJH has an identifiable intake and resuscitation area specifically equipped for pediatric trauma patients . The SJH pediatric trauma area is located in the Emergency Department and is easily accessible to land and air transportation. SJH meets the specified Standard VI B requirement. SJH's Emergency Department has a designated medical director/physician for pediatrics, a trauma/general surgeon, emergency department physicians, a nursing staff and respiratory therapy staff. The personnel have special competence in the care of the pediatric trauma patients. SJH Emergency Department staff are available as follows: At least one E.D. physician is present in the E.D. 24 hours a day; Nursing staff is present in the E.D. 24 hours a day; and Respiratory therapy staff are on call and immediately available in-hospital 24 hours a day. SJH meets the specified Standard VI D requirement. SJH has a radio communication system that conforms to the State EMS Communications Plan and telephone and paging equipment to contact trauma team members. The equipment is functional and is located in the trauma center intake area. SJH meets the specified Standard VI H requirement. SJH has written protocols for the immediate response to the emergency department from the blood bank, laboratory, respiratory therapy and operating room. Standard VII. Operating Suite Special Requirements: A SJH meets the specified Standard VII A requirement. SJH has a fully staffed and equipped operating room, available 24 hours a day for immediate use. Written operating procedures for 24 hour a day operating room availability for pediatric trauma patients and staffing are available for review by the DHRS. Standard IX. Pediatric Intensive Care (P-ICU): A, C, 1 SJH fails to comply with Standard IX as set forth in Rule 10D- 66.109(d)2, Florida Administrative Code, referencing "State-Approved Trauma Center and State-Approved Pediatric Trauma Referral Center Approval Standards, HRSP 150-9, October 91." Standard A, C, 1 specifically requires that the P-ICU medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. SJH does not propose to place the P-ICU medical director or a physician designated by the P-ICU medical director in the unit 24 hours a day. SJH proposes to make the P-ICU medical director or a physician designated by the P-ICU medical director available to the unit 24 hours a day. "Available to" the unit does not require that the identified employee be present in the hospital. As much as 30 minutes could pass before the P-ICU medical director or his designee arrives at the P-ICU. Although the evidence establishes that the DHRS has accepted such arrangements in previous applications, the rule specifically requires that the referenced personnel be located in the P-ICU. There is no legal authority for the DHRS to disregard the requirement set forth in its own rules. Standard XVI. Quality Management: A, B, C, D, & E SJH meets the specified Standard XVI A requirement in that it has a comprehensive quality management plan in operation. SJH meets the specified Standard XVI B requirement. SJH's quality management plan include protocols for 1) pediatric trauma patient triage and the issuance of an in-hospital trauma alert; 2) response of trauma team and documentation of response time in each patient record for members of the trauma team, neurosurgical, laboratory, x-ray, social work, pastoral, consultants and elapsed time for laboratory results. Protocols are also included related to trauma, medical and nursing staff patient care responsibilities, trauma operating room team response, assuring operating room and operating room staff availability to the pediatric trauma patient, pediatric trauma patient care in ICU, post-anesthetic recovery room and wards, transport of the pediatric trauma patient to the operating room, x-ray suites, CT scanner, ICU, and other hospital areas and hospital transfers. SJH meets the specified Standard XVI C requirement. SJH plan includes, and SJH will implement and perform monthly trauma quality management, consisting of a trauma quality management committee that will meet at least monthly to review pediatric trauma cases, including cases involving morbidity and mortality. The pediatric trauma service medical director or trauma nurse coordinator will review specified cases including all pediatric trauma alert cases, all critical admissions for traumatic injuries, all pediatric trauma Operating Room admissions from the emergency department and/or state-approved trauma center, any critical pediatric trauma transfers into or out of the emergency department and/or trauma center, and all traumatic deaths. Review of such cases will include application of "audit filters" as identified in the rule. Appropriate records will be maintained in-hospital, of all cases to which audit filters were applied. Pediatric trauma cases will be evaluated by the medical director of the trauma service and/or trauma nurse coordinator. The trauma nurse coordinator and the medical director will present a summary of the reviewed cases not referred to the committee, along with cases requiring further evaluation where there is no clear and appropriate reason for a situation to have occurred. Cases referred to the trauma quality management committee for which the committee can find no clear and appropriate reason for the situation to have occurred will be sent to appropriate persons or committees responsible for corrective action. The medical director of the trauma service will report back to the trauma quality assessment committee the resolution of each case. The SJH trauma quality management committee is composed of the trauma nurse coordinator, a trauma surgeon (other than the pediatric trauma service medical director), an emergency physician, a surgical specialist (other than trauma surgeon), a representative from SJH administration, the operating room nursing director, the Emergency Department nursing director and the intensive care unit nursing director. At least 75 percent attendance of the committee members is required at the monthly trauma quality management committee meetings. SJH will maintain minutes of all trauma quality management committee meetings for at least three years and are readily available for review by the DHRS. The minutes shall include at a minimum, the names of the attendees and the subject matter discussed, and actions toward resolution(s) of identified problems. The trauma quality management committee will prepare and submit a quarterly report to the DHRS at the end of each calendar year quarter by the 15th of the month following the end of the previous quarter. The report will list every case selected for corrective action by the trauma quality management committee and will provide identify the hospital case number, the trauma registry number (from HRS Form 1728, "Trauma/Head Injury/Spinal Cord Injury Registry"), a description of questionable care, and the corrective action taken. If corrective action is not necessary, an explanation is required. The medical director/chair of the trauma management committee will compile monthly statistics on each trauma surgeon on the trauma call roster. The statistics will be available for the DHRS review or will be submitted upon request. The statistics for each surgeon shall reflect the total number of cases per calendar month for which each trauma surgeon was notified to respond to a pediatric trauma alert and the total number of cases for which the trauma surgeon did not meet the pediatric trauma alert patient at the time of the trauma alert patient's arrival at the SAPTRC. SJH will conduct a monthly multi-disciplinary trauma conference for case management and education. When appropriate, the conference will include review of the local/regional emergency medical service system, individual case management, the SAPTRC, solution of specific problems including organ procurement and donations, and trauma care education. The attendees will include representatives from trauma services, the emergency department, neurosurgery, orthopedics, nursing, social work, rehabilitation medicine, laboratory, x-ray, prehospital providers and hospital administration. At least 50 percent attendance will be required at the monthly multi-disciplinary trauma conference. Minutes from these conferences, including the names of the attendees and subject matter discussed, will be maintained at the SAPTRC for a minimum of three years and will be readily available for review by the DHRS upon request. SJH meets the specified Standard XVI D requirement relating to file maintenance. The trauma unit will have on file credentials of all surgeons in the trauma service as well as consultants, morbidity and mortality figures for the pediatric trauma service, CME data on all physicians participating in the pediatric trauma service, research and CME activities on all surgeons participating in the trauma services, nursing credentials, nursing CEU, any nursing research, a written plan of how the trauma nurse coordinator and the trauma service medical director's duties and responsibilities are integrated, a written disaster plan, the county or regional disaster plan and evidence of disaster drill activities. SJH meets the specified Standard XVI E requirement relating to file maintenance. The SAPTRC will fully participate in the trauma registry
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is hereby RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order denying the application of St. Joseph's Hospital for certification as a State-Approved Pediatric Trauma Referral Unit. DONE and RECOMMENDED this 3rd day of March, 1995, in Tallahassee, Florida. WILLIAM F. QUATTLEBAUM Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of March, 1995. APPENDIX TO RECOMMENDED ORDER, CASE NO. 94-3669 The following constitute rulings on proposed findings of facts submitted by the parties. Petitioner Tampa General Hospital The Petitioner's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 1-14. Rejected, irrelevant. 15-20. Rejected, unnecessary. It is not unreasonable to address free standing units or new trauma centers differently that service expansions to existing facilities. 21-22. Rejected, irrelevant. 24-79. Rejected, irrelevant. 81. Rejected, unnecessary. 83-120. Rejected, irrelevant. 121. Rejected, unnecessary. 123-128. Rejected, irrelevant. 130-134. Rejected, irrelevant. Rejected, irrelevant. The rules which set forth the specific requirements for certification supersede application form. Rejected, irrelevant. Respondent Department of Health and Rehabilitative Services The Respondent's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 11-13. Rejected, unnecessary. Rejected, subordinate. Rejected, unnecessary. 17. Rejected, unnecessary. 19. Rejected, unnecessary. 21-23. Rejected, subordinate. 24. Rejected, irrelevant. 25-27. Rejected, subordinate. 28-29. Rejected, unnecessary. 30. Rejected, not supported by credible evidence. 32. Rejected, unnecessary. 34. Rejected, irrelevant. 36. Rejected, irrelevant. 38-40. Rejected, irrelevant. 41. Rejected, unnecessary. 42-58. Rejected, irrelevant. 59. Rejected, unnecessary. 60-81. Rejected, irrelevant. 82. Rejected, not supported by the greater weight of the evidence. 83-86. Rejected, unnecessary. Rejected, not supported by the greater weight of the evidence. Rejected, irrelevant. 89-91. Rejected, unnecessary. 92. Rejected, contrary to law. The rules set forth the specific requirements which must be met for certification as a provisional SAPTRC. The rule unambiguously requires that the Pediatric Intensive Care Unit medical director or a physician designated by the P-ICU medical director must be available in the unit 24 hours a day. There is no legal authority for the DHRS to disregard the requirement, notwithstanding the agency's apparent failure to enforce the rule in previous instances. Intervenor St. Joseph's Hospital The Intervenor's proposed findings of fact are accepted as modified and incorporated in the Recommended Order except as follows: 7-9. Rejected, unnecessary. 13-14. Rejected, unnecessary. 16-17. Rejected, unnecessary. 19-31. Rejected, unnecessary. 64-65. Rejected, not supported by the greater weight of the evidence. Despite the DHRS practice, the rule specifically requires that the referenced personnel be located in the P-ICU. The rule is not satisfied by the SJH proposal. 82. Rejected, not supported by the greater weight of the evidence. COPIES FURNISHED: Robert L. Powell, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Kim Tucker, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Elizabeth McArthur, Esquire Radey Hinkle Thomas & McArthur 101 N. Monroe Street, Suite 1000 Post Office Drawer 11307 Tallahassee, Florida 32302 Robert P. Daniti, Esquire Senior Attorney Emergency Medical Services Department of Health and Rehabilitative Services 1317 Winewood Blvd. Tallahassee, Florida 32399-0700 Bruce D. Lamb, Esquire Christopher J. Schulte, Esquire 201 East Kennedy Blvd., Suite 1000 Tampa, Florida 33602
