rare Ne STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINTSTRATIO STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case No. 2011011239. FLORIDA HEALTH SCIENCE CENTER, INC., d/b/a TAMPA GENERAL HOSPITAL, Respondent. / ADMINISTRATIVE COMPLAINT “COMES NOW. the Petitioner, the State of Florida’s Agency For. Health Care Administration (“the Agency”), and files this administrative complaint against the Respondent, Florida Health Science Center, Inc., d/b/a Tampa General Hospital (the “Respondent” or “Respondent Facility”), pursuant to Sections 120.569 and 120.57, Florida’ Statutes, and alleges as follows: NATURE OF THE ACTION This is an action to impose an administrative fine against a hospital in the amount of five thousand dollars ($5,000.00) pursuant to Section 395.1065, Florida Statutes. JURISDICTION AND VENUE 1. The Agency has jurisdiction over the Respondent pursuant to Sections 20.42 and 120.60, Florida Statutes, Chapters 408, Parts I and Il, and 395, Part I, Florida Statutes, and Chapter 59A-3, Florida Administrative Code. Page 1 of 26 Filed April 11, 2012 4:52 PM Division of Administrative Hearings a ee ee 2. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code. PARTIES 3. The Agency licenses and regulates hospitals in Florida and enforces the applicable federal and. state regulations and statutes governing hospitals pursuant to Chapter 408, Parts I and II, Florida Statutes, Chapter 395, Part I, Florida Statutes, and Chapter 59A~-3, Florida Administrative Code. The Agency may deny, revoke, suspend a license, or impose an administrative .fine against a hospital, for the violation of any provision of ' Chapter 395, Part I, Florida Statutes, or any rule adopted under that chapter. 4. . The Respondent was issued a license by the Agency to operate a 1018-bed Class I hospital, license number 4044, located at One Tampa General Circle, Tampa, Florida 33606. 5. At all times material to the allegations of this complaint, Respondent was required to comply with all applicable federal and state regulations and statutes. mo | COUNT I_HO120 6. the Agency re-alleges and incorporates by reference paragraphs 1 through 5. T. Rule 59A-3.2085(5), Florida Administrative Code, requires: (5) Nursing Service. Each hospital shall be organized and staffed to provide quality nursing care to each Page 2 of 26 we patient. (a) Each hospital shall document the relationship of the nursing department to other units of the hospital by an organizational chart, and each nursing departmént shall have a written organizational plan that delineates lines of authority, accountability and communication. The nursing department shall assure that the following nursing management functions are fulfilled: 1. Review and approval. of policies and procedures that relate to qualifications and employment of nurses. 2. Retablishment of standards for nursing care and mechanisms for evaluating such care. 3, Implementing approved policies of the nursing department. 4. Assuring that a written evaluation is made of the performance of registered nurses and ancillary nursing personnel at the end of any probationary period and at a defined interval thereafter. 5. Bach hospital shall employ a registered nurse on a full’ time basis who shall have the authority and responsibility for managing nursing services and taking all reasonable steps to assure that a uniformly optimal level of nursing care is provided throughout the hospital. (a) Rach hospital shall develop written standards of nursing practice and related policies and procedures to define and describe the scope and conduct of patient care provided by the nursing staff. These policies and procedures shall be reviewed at least annually, revised as necessary, dated to indicate the time of the last review, signed by the responsible reviewing authority, and enforced. (e) The nursing process: of assessment, planning, intervention and evaluation shall be documented for each hospitalized patient from admission through discharge. 1. Each patient’s nursing needs shall be assessed by a registered nurse at the time of admission or within the period established by each facility's policy. 2. Nursing goals shall be consistent with the therapy prescribed by the responsible medical practitioner. 3. Nursing intervention and patient response, and patient status on discharge from the hospital, must be noted on the medical record. (f) A sufficient number of qualified registered nurses shall be on duty at all times to give patients the Page 3 of 26 nursing care that requires the judgment and specialized skills of a régistered nurse, and shall be sufficient to ensure immediate availability of a registered nurse for bedside care of any patient when needed, to assure prompt recognition of an untoward change in a patient’s condition, and to facilitate appropriate intervention by nursing, medical or other hospital staff members. (g) Hach Class I and Class II hospital shall have at least one licensed registered nurse on duty at all times on each floor or similarly titled part of the hospital for rendering patient care services. 8. On September 16, 2011, the Agency conducted a complaint investigation survey of the Respondent Facility. 9. Based.on the Agency’s surveyor’s review of Respondent’ s clinical records and interviews with members of Respondént’s staff, the Agency determined that the nursing staff failed to adequately implement the nursing process of assessment, planning, intervention and evaluation for one (#1) of sixteen (16) patients whose care was reviewed by the Agency. Specifically, a medically complex pediatric patient was not “assessed for hydration and medication needs prior to transfer. This practice did not ensure hydration and medication needs of the patient were met during an approximately five hour transport. 10. Patient #1's History and Physical dated 3/29/11 revealed that a fourteen year old child was admitted to the facility due to concern for medical neglect. The history included cerebral palsy, significant global developmental delay, and seizure disorder, The child also suffered’ from constipation Page 4 of 26 ~~ and chronic sinus infections. Review of the nursing admission data base, dated 3/29/11, noted the child had been hospitalized two weeks prior for pneumonia. 11. Review of -physician admission orders, dated 3/29/11, at 9:00 p.m. instructed that Patient #1 required a pureed diet with assistance and that vital signs were to be taken every four hours. Patient #1’ s medications included Neurontin 300 milligrams (mg) three times a day at 9A~3P-9P and Tegretol ‘220 mg three times a day at the same time. Both of the above medications are anti-seizure medications. Patient #1/s other medications included Diastat per rectum as needed for séizure activity and Albuterol as needed for cough or wheeze. Physician’s orders for Patient #1 included Cod Liver Oil 5 , milliliters (ml) every day. 12. Patient #1’s physician’s orders, dated 4/4/11 at 3:00 p.m., instructed to “push” oral fluids. ) 13. A physician's order, dated 4/21/11 at 1:45 Pom, instructed for the patient to be placed on continuous pulse oximetry, oxygen monitoring, at night. 14, Patient #1’s physician's orders, dated 4/23/11, at 7:30 a.m. instructed for the patient to receive a minimum of 2000 ml “every day-example 400 ml per meal/snack 5 times per day. A physician’s order, dated 4/24/11, no time, instructed fora Page 5 of 26 4° weight to be obtained on 4/25/11 as the last weight before _ discharge. 15.. Patient #1’s physician's orders, dated 4/26/11 at 8:00 a.m., instructed for the patient to be transferred to a Skilled Nursing Facility (SNE”) which was on the East Coast of Florida. Review of the Physician Medication Discharge Order form, signed and dated 4/26/11 at 9:00 a.m., ordered that Patient #1 should continue thé. same medication, which included the Neurontin and Tegretol. Review of the Patient Discharge Teaching form ’ revealed the child was on a pureed diet and fall precautions. The teaching form lacked specification that the child was also on seizure precaution. 16. Respondent’s Nursing Medication Discharge Teaching: form revealed the Tegretol administration time was 9A-3P-9P. The Neurontin was listed as every eight hours; however, the time due was listed as 9A-3P~9P. This was in conflict with the physician's order specifying administration every eight hours. The Agency’s surveyor observed that there was a line drawn through the entire list and "error" was written and initialed. 17. The Agency’s surveyor’s review of Respondent’s nursing documentation, dated 4/23/11, revealed vital signs. were done every four hours, and that Patient #1’s fluid intake was 2160 ml. Review of nursing documentation, dated 4/24/11, noted the vital signs were done every four hours and the intake was 1410 Page 6 of 26 ml, a deficit of 590 ml. Review of nursing documentation from 4/25/11 revealed the child was not weighed as ordered as the last weight prior to discharge;.a vital signs check wag performed every four hours as ordered; and intake was 1880 ml, a deficit of 120 ml, for the twenty four hour period. The last oral fluid intake was 200 ml documented at midnight on 4/26/11. The child already had a deficit of 710 ml, There was no further documentation of the child receiving fluid hydration prior to _ transport, 18. Review of Respondent’s nursing documentation for Patient #1, dated 4/26/11 for the 7:00 a.m.'to 3:00 p.m. shift, ' revealed the child was fed 75% of her breakfast, but no fluid intake was.documented. The documentation noted ‘the child had one diaper change. Review of vital signs documentation, dated 4/26/11, showed the vital signs were obtained at 8:45 a.m. with a heart rate of 135, and the child was crying. The child's usual heart rate was 70 to 110. The vital signs were to.be reassessed at approximately noon, but were not done. 19. Respondent’s documentation for Patient #1 at 12:00 p.m. noted the patient was transferred with no distress with the .ambulance transport. The patient had no documented fluid intake» from midnight until the time of transport at approximately noon. There was also no plan from the physician or nursing to provide Page 7 of 26 Patient #1’s seizure medication during the transport, placing the child at a potential risk for seizures. 20. Patient #1 expired within eighteen hours of being transferred. . 21. On 9/16/11 at approximately 9:55 a.m., the Agency’s surveyor interviewed the Registered Nurse (RN) who cared for Patient #1 on the day the child was discharged by Respondent. Respondent’ s RN had no recollection of telling the ambulance personnel about the two seizure medications that were due at -3:00 and 4:00 p.m. during transport. The RN did not remember if the child had lunch, a snack, or fluids before she was transported. ‘Respondent’ s RN stated to the Agency’s surveyor that vital.signs and a reassessment, to determine if. the. child was stable and hydrated for the five hour trip, were not done _prior to discharge. | 22. The above interview and review of documentation revealed the Registered Nurse did not supervise and evaluate care for fluid therapy and discharge needs of a medically complex child with specific needs. 23. The above recited facts show that Respondent violated Rule 59A-3.2085, Florida Administrative Code, by failing to assess, plan, intervene and evaluate Patient #1 to ensure that Patient #1’s hydration and medication needs were met prior to transfer. Page 8 of 26 -| ~~ 24. The above cited deficiency subjects the Respondent Facility to the imposition of an administrative penalty in a sum not to exceed one thousand dollars ($1,000.00) per violation per day. § 395.1065 (2) (a) Florida Statutes. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, requests that this tribunal impose - an administrative fine against the Respondent in the total amount of $2,000.00, or such other relief as this tribunal deems just. ) . COUNT IT 0022. 25. The Agency re-alleges and incorporates by reference above paragraphs 1 through 5 and paragraphs 10 through 21. 26. Rule 59A-3.254 (2) (a)-(d), Florida Administrative ‘Code, requires: 59A-3.254 Patient Rights and Care. (2) Coordination of Care. Each hospital shall develop and implement policies and Procedures on discharge planning which address: (a) Identification of patients requiring discharge planning; .(b) Initiation of discharge planning on a timely basis; (c) The role of the physician, other health care givers, the patient, and the patient’s family in the discharge planning process; and (ad) Documentation of the discharge plan in the patient’s medical record including an assessment of the availability of appropriate: services to meet identified needs following hospitalization. 27. On September 16, 2011, the Agency conducted a complaint investigation survey of the Respondent Facility. Page 9 of 26 aed 28. The Agency’s surveyor reviewed Respondent’s policy and procedure, "Patient Transfers In & Out of TGH" #CC-19 last revised 8/10. On page 11, #9 indicates that the physician and Qualified Medical. Personnel (QMP)/Transport nurse will determine the appropriate level of transport, personnel and equipment. They will review and sign the Certification and Consent to transfer form. 29. Based on the Agency’s surveyor’s review of clinical records, policy, and procedure and staff interviews it was determined that the Respondent failed to follow Respondent’s policy and procedure on discharge planning for four of sixteen patients whose care was reviewed by the Agency - Patients #1, "#3, $13 and #5. 30. Patient #1's Physician orders, dated 4/26/11 at 8:00 a.m., called for the patient to be transferred to a Skilled Nursing Facility (SNF) after the child was seen by the attending physician, soft pureed diet with assistance, home nursing care _Gaily from midnight to 7:00 a.m., and medications per the medication reconciliation form. 31. The Agency’s surveyor’s review of the Physician Medication Discharge Order form for Patient #1, signed and dated 4/26/11 at 9:00 a.m., ordered to continue the same medication, which included the Neurontin and Tegretol. Review of the Patient Discharge Teaching form revealed the form was signed by Page 10 of 26 Emergency Medical Technician B on 4/26/11, no time, showed the child was on a pureed diet, fall precautions, and was to receive home nursing care from midnight to 1:00 a.m. The teaching form did not include that the child was on seizure precautions and would require medications. The Nursing Discharge Medication Teaching Sheet, “signed by the saine Emergency Medical Technician B, had the medication listed. The Tegretol was due at 9A-3P-9P, The Neurontin was listed as every eight hours; however, the time _due was listed as 9A-3P-9P, which was in conflict with the “original physician’s order. There was a line drawn through the ‘entire list and "error" was written and initialed. This did ‘not provide clear information regarding medications for the transport personnel. 32, Review of Respondent’s nursing documentation for Patient #1, dated 4/23/11, revealed vital signs were done every four hours and the fluid intake was 2160 ml. Review of nursing documentation, dated 4/24/11, noted the vital signs were done every four hours and the intake was 1410 ml, a deficit of 590 ml. Review of nursing documentation from 4/25/11 revealed the child was not weighed as ordered as the last weight prior to discharge, vitals sign were performed every four hours as ordered, and intake was 1880 ml, a deficit of 120 ml, for the twenty four hour period. The last oral fluid intake was 200 ml documented at midnight on 4/26/11. The child already had a Page 11 of 26 | ~~ deficit of 710 ml. There was no further documentation of the child receiving fluid hydration prior to transport. 33. The Agency’ s surveyor’s review of Respondent’s nursing documentation for Patient #1, dated 4/26/11 for the 7:00 a.m. to 3:00 p.m, shift revealed the child was fed 75% of her breakfast but no fluid intake was documented. The documentation noted the child had one diaper change prior to transport. Review of vital signs documentation, dated 4/26/11, showed the vital signs were obtained at 8:45 a.m. with a heart rate of 135 and the child was crying. The child's normal heart was 70-110. . There was no evidence of Patient #1’s vital signs being reassessed by the nursing staff as ordered and indicated by clinical symptoms. Nursing documentation at 12:00 p.m. noted that Patient #1 was” transferred with no distress with the ambulance transport. 34. . Review of Respondent’s physician's progress note for patient #1, dated 4/24/11, showed the incréased fluid intake was. started secondary to low urine output that was improving with the increased fluids. Review of physician orders and physician progress notes from 4/14/11, the day medically: cleared to 4/26/11, the date of transfer, revealed no evidence of documentation of the type of transportation the child would require for the approximately five hour drive to the Bast Coast of Florida. Review of the physician’s progress notes revealed a Page 12 of 26 note dated 4/26/11 at 7:30 a.m., and the attending physician's. note was signed: at 8:45 a.m. 35. The Agency’ 8 surveyor interviewed Patient #l’s attending pediatrician on 9/16/11 at approximately 6:35 p.m. The attending pediatrician was aware of the BLS transport and had no concerns with the BLS transport. However, there was no documentation as such. The interview revealed the child would "quickly dehydrate"; but when questioned on that statement, she stated that can happen when the child has a temperature. When questioned about the length of time it would take the child to dehydrate, she was unable to answer the question with a timeframe. . 36. Review of the Medication Administration Record (“MAR”), for Patient #1 revealed that Neurontin was given at 10:00 a.M., and Tegretol was given at 9:00 a.m. on 4/26/11, the day of discharge. The MAR indicated the Cod Liver Oil was not given at 8:00 a.m. The next dose of Neurontin was due at 4:00 p.m., and the Tegretol was due at 3:00 p.m, there was no plan from the physician or nursing to provide the medication during the transport, placing the child at a potential risk for seizures. _37. The Agency’s surveyor’s review of Case Management (*cM”) notes for Patient #1, dated 4/22/11, found that transport of Patient #1 at discharge from Respondent. was by a private vehicle, by the Skilled Nursing Facility (“SNF”) that had Page 13 of 26 accepted the patient, and the SNF was in agreement with the child arriving at approximately 3:00 p.m. The documentation noted the consent for transfer was in the chart. A CM note, dated 4/26/11, .revealed the child’s transportation was “private vehicle.” There was no documentation of the rationale for using the private vehicle. The ambulance company was called on “4/26/11 and told transportation was needed ASAP and would be scheduled for.11:00 a.m. that day. The documentation did not show the rationale for the type of transportation selected to ensure: the medically complex child's needs could be met. 38. Review of the ambulance Physician Certification Statement, dated 4/22/11, revealed that Patient #1 was a fall risk, No other information regarding feedings, medication, or _ seizure precautions was noted, The form was signed by Respondent’s case manager. 39." Review of the Certification and Consent to Transfer form indicated Patient #1 would be transferred via Basic Life Support (BLS) and the diagnosis was cerebral palsy and medical neglect. The form was signed by Respondent’s resident physician at 4:00 p.m. on 4/26/11, approximately four hours after the child had been transferred. . There was no evidence that Respondent’s physician had reviewed the form, including the mode of transportation, prior to the child's transport. t Page 14 of 26 tet a 40. The Agency’s surveyor’s review of the receiving facility’s documentation showed that Patient #1 arrived at the SNF at 5:30 p.m. The documentation noted the child was screaming and-thrashing about. The child's temperature on 4/26/11, no time listed on the admission nursing history and skin, condition form, was 99.7 degrees Fahrenheit axillary. Review of SNF documentation revealed only a bottle of Cod Liver Oil arrived with the child. 41. The Agency’s surveyor’ s review of the receiving SNF’s nursing documentation dated 4/27/11 at 5:40 a.m. revealed Patient #1 began to experience respiratory distress. At 5:45 a.m., the child was unresponsive. and Cardiopulmonary Resuscitation (CPR) was started. 911 was called. The child was transported to an acute care facility and pronounced expired in the Emergency. Room. 42. Review of the transferring facility documentation and interview with the Pediatric Nurse who cared for Patient #1 on the day of discharge on 9/16/11 at approximately 9:55 a.m. revealed no evidence of the medication being sent with the child or a physician's order to send the medication with the child. The Cod Liver Oil was sent with the child without a physician's order; however, the Nevrontin, Tegretol, that were due at 3:00 p.m. and 4:00 p.m. were not sent or addressed by the Registered Nurse or physician. The “as needed” medications, Diastat for Page 15 of 26 seizures and Albuterol for coughing and wheezing, were not sent or addressed by either | Respondent’ s Registered Nurse or physician, 43. The Agency's’ surveyor reviewed the ambulance run report for Patient #1, dated 4/26/11. The report revealed no evidence of planning for seizure precautions and listed Patient #1's medications as Miralax, Cod Liver Oil, and Neurontin. There was no documentation of planning for the contingencies if the child was. thirsty or hungry or the type of diet the child was allowed. There was no documentation. of planning for _ emergency medications of Diastat or Albuterol. 44, Although Respondent! s policy and procedure, "Patient Transfers In & Out of TGH" #CC-19 last revised 8/10, on page 11, 49, indicated the physician and Qualified Medical “Personnel (QMP) /Transport nurse. will determine the appropriate level of transport, personnel and equipment, and they will review and sign the Certification and Consent to transfer form, the Agency's surveyor’ s review of the clinical record showed there was no physician or QMP order for the mode of transportation, and the Certification and Consent form was signed approximately four hours after the child left the facility. 45. On 9/15/11 at approximately 5:35 p.m., the Agency’s surveyor interviewed the transporting ambulance company's Transportation Coordinator. The Coordinator told the Agency's Page 16 of 26 — surveyor that BLS personnel cannot give any oral medications. The Coordinator told the Agency’ s surveyor that the ambulance ordered for Patient #1 arrived at the transferring facility at 12:08 p.m. on 4/26/11 and at the receiving facility at 5:08 p.m. The Coordinator told the Agency’s surveyor that an envelope was given to the receiving facility from the transferring facility. The crew consisted of the driver and one EMT. The interview revealed the type of transport final decision is with the physician, if Advanced Life Support is needed. 46. ‘On 9/15/11 at 4:35 p.m., the Agency’s surveyor interviewed Respondent's social worker manager regarding Patient ‘#1. The Agency’s surveyor was told that the Certification and Consent to Transfer form-shows the physician's authorization, Respondent’s social worker manager confirmed that there was no order for the type of transportation or the decision regarding the oral seizure medications that were due during transportation in the child's. clinical records. Respondent's social worker manager confirmed there was no documentation of the CM discussing the type of .transportation with the physician or the interdisciplinary team. He stated there was no policy and procedure on how to determine the type of transportation to be used. He indicated the ambulance company’s graph is used. ' 47, The Agency’s surveyor’s interviews with the Pediatric Nurse Manager on 9/15/11 at approximately 6:00 p.m. and the Risk Page 17 of 26 ee Manager on 4/26/11 at approximately 3:45 p.m. confirmed there was no physician’s order for the type of transportation for Patient #1, or what was to be done.about Patient #1's seizure medications. Respondent’s Pediatric Nurse Manager told the Agency’s surveyor that there is no policy or procedure for nursing related to transportation or discharge assessment. 48. During the Agency’ s surveyor’s interview with the Risk Manager, Vice President of Pediatrics, Director of Risk Management, and the Pediatric Nurse Manager on 9/16/11. at approximately 10:20 a.m., the Agency’s surveyor was told that the clinical record for Patient #1 was reviewed by the attending physician and pediatric nurse manager who indicted no concerns with the care provided for discharge planning by the physician or nursing. . 7 . . 49, The Agency's surveyor’s review of the Physician Discharge orders, dated 4/26/11, and the Nurses Discharge Teaching form, dated 4/26/11, Showed Patient #1 was being transferred to a SNF and was to receive home nursing care from “midnight until 7 a.m. This order should have been clarified, as home nursing care is not provided in a SNF setting. 50. The above interviews and review of documentation revealed a safe discharge to meet the needs of a medically complex child.was not implemented in compliance with Respondent’s policy and procedure for Patient #1. The type of Page 18 of 26 transportation was not ordered or acknowledged by the physician or the interdisciplinary team. There was no evidence of the physician being involved in the transportation plan for a child with seizure precautions and medications needs, the child being unable to communicate, and the child not receiving’ fluid since midnight prior to discharge who was on a fluid minimum. There was no documentation if the child was to have nothing by mouth during transportation or according to the discharge instruction of a pureed diet. There was no planning for the Diastat or Albuterol that was ordered for seizures or wheezing/coughing on a as needed basis or if the medications would be available during transport. There was no clarification with the physician or planning with the receiving facility about two seizure medications that were due during transportation. The Certification and Consent for Transfer was not signed by the physician prior to transfer as per facility policy and procedure. This practice and lack of acknowledgement of concerns for this practice by facility staff placed Patient #1, and possibly future patients, in danger while being transported. . 51. Patient #13, an infant, was admitted to the pediatric unit on 08/16/11 with a diagnosis of a metabolic disorder, abnormal blood clotting with deep vein thrombosis and stroke. The infant had a gastronomy tube feeding tube and seizures. Case Management note, dated 9/14/11, noted the child was Page 19 of 26 transferred to another hospital closer to home on 9/15/11. ‘Physician's order, dated 9/15/11 at-9:00 a.m., included an order to transfer the child to the other hospital. A review of the clinical record revealed there was no Certification and Consent to Transfer present in the record. 52, On 9/16/11 at 6:00 p.m., the Pediatric Nurse Manager reviewed the clinical record for Patient #13 and confirmed that the Certification and Consent to Transfer was not present in the medical. record. 53. Patient #13%s attending physician was interviewed via telephone on 9/16/11 at 6:35 p.m. She stated she remembered - reviewing and signing.the form; however, she did not know what happened to. the ‘form afterwards. . 54. Patient #5 was interviewed in the patient's room at 11:40 a.m. on 9/16/11. The patient was to be discharged from the orthopedic surgery unit later that day. 55. On 9/16/11 at approximately 11:15 a.m. an interview was conducted with Patient #5's nurse, who stated. the patient was to be discharged with physical therapy rehabilitation at home. . 56. Patient #5 confirmed to the, Agency’s surveyor that he was being discharged that day, and the patient knew he was to receive physical therapy services at home. The patient did not Page 20 of 26 know what agency would be providing the physical therapy services, or when the services were scheduled to begin. 57. A review of Patient #5's physician's order. confirmed the patient was discharged home with physical therapy. Further review of the patient's chart found that the chart failed to note what physical therapy providers were offered to the patient. There was no documentation to indicate exactly when physical therapy would begin, only that the social worker was to coordinate physical therapy services. 58. ‘The Agency’s surveyor conducted an interview with Respondent’s Risk Manager on 9/16/11 at approximately 5:30 p.m. The Risk Manager confirmed that there was no documentation of when home physical therapy would begin for Patient #5. . 59, Pediatric Patient #3 was admitted to Respondent's pediatric unit on 4/9/11 and discharged on 4/22/11. The Agency’s surveyor reviewed Respondent’s Physician Medication Discharge Order form for Patient #3 which was signed and dated, but did not note the time, by a physician and which indicated three new medications were ordered for Patient #3. Review of the Nursing Discharge Medication Teaching Sheet, date and time non-legible, also showed the three new medications. For the first medication, PrednisoLONE, the label on the box indicating ‘whether or not to continue the medication at home was not checked; the section to insert the time the next dose was due Page 21 of 26 ~~ { , was blank. For the second medication, Iron Sulfate, the label on the box showed that the not~to-continue-at-home box was circled; the section to insert the time the next dosé was due was blank. For the third medication, Amlodipine, the label on ‘the box that indicated whether the patient was to continue the medication at home or not was not checked; the section to insert | the time the next dose was due was blank; the form was not complete and parts were not legible. The partial and incompléte medication labels had the potential for the infant to receive the medications at the wrong time or not at all. | 60. The above recited facts show that Respondent violated H ; Rule 59A-3.254 (2) (a)-(d), Florida Administrative Code, by failing to follow Respondent’ s policy and procedure on discharge planning for four of sixteen patients whose care was reviewed by the Agency - Patients #1, #3, #13 and #5. 61, The above cited deficiency subjects the Respondent Facility to the imposition of an, administrative penalty in a sum not to exceed one thousand dollars ($1,000.00) per violation per day. § 395.1065(2) (a) Florida Statutes. WHEREFORE, the Petitioner, state of Florida, Agency for Health. Care Administration, requests that this tribunal impose an administrative fine against the Respondent in the total _amount of $2,000.00, or such other relief as this tribunal deems just. Page 22 of 26 COUNT IZI H0402 62. The Agency re-alleges and incorporates by reference paragraphs 1 through 5. 63. Statutes 395.0197, Florida Statutes, requires: (1) Every licensed facility shall, as a part of its administrative functions, establish an internal risk Management program that iricludes all of the following components: . (a) The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents to patients. (4) The agency shall‘ adopt rules governing the establishment of internal risk management programs to meet the needs of individual licensed facilities. Each internal risk management program shall include the use of incident reports to be filed with an individual of responsibility who is competent in risk management techniques in the employ of each licensed facility, such as an insurance coordinator, or who is retained by the licensed facility as a consultant. The individual responsible for the risk management program shall have free access to all medical records of the licensed facility. The incident reports are part of the workpapers of the attorney defending the licensed facility in litigation relating to the licensed facility and are subject to discovery, but are not admissible as evidence in court. A person filing an incident report is not subject to civil suit by virtue of such incident report. As a part of each internal risk management program, the incident reports shall be used to develop categories of incidents which identify problem areas. Once identified, procedures shall be adjusted to correct the problem areas. (5) For purposes of reporting to the agency pursuant to this section, the term ‘adverse incident” means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which: (a) Results in one of the following injuries: 1. Death; 2. Brain or spinal damage; 3. Permanent disfigurement; Page 23 of 26 ~~ 4. Fracture or dislocation of bones or joints; 5. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility; 6, Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or 7. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident; : (b): Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise ‘unrelated to the patient's diagnosis or medical condition; (c) Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to. the patient and documented through the informed- consent process; or ; . . (d) Was a procedure to remove unplanned foreign objects remaining from a surgical procedure, 64. Based on the Agency’s surveyor’s review of Respondent’s records and interviews with members of Respondent’s staff, the Agency determined that Respondent! s risk manager failed to conduct an adequate investigation and analysis following the death of 1 patient, Patient #1, of 16 patients, whose death occurred within 24 hours of transfer from the facility. This practice does not ensure identification of problems related to patient care. 65. Patient #1's Certification and Consent to Transfer dated 4/26/11 revealed that Patient #1, a child, was transferred by basic life transport to a skilled nursing facility Page 24 of 26 we approximately 5 hours away from Respondent! s hospital on 4/26/11. . 66. The Agency’s surveyor conducted an interview with the Risk manager on 9/16/11 at approximately 11:00 a.m. The Respondent facility had been notified on 4/27/11 that Patient #1. had a cardiac arrest and expired earlier that day. The Risk Manager stated that Respondent’ s attending pediatrician and the Pediatric Nurse Manager had reviewed the record and found no concerns related to physician or nursing care. The interview revealed there was no evidence of an investigation having been initiated. . 67. The above recited facts show that Respondent violated Statutes 395.0197(1) (a), Florida Statutes, by failing to conduct an adequate investigation and analysis following the death of a patient, whose death occurred within 24 hours of transfer from the facility.’ . 68. The above cited deficiency subjects the Respondent Facility to the imposition of an administrative penalty in a sum not to exceed one thousand dollars ($1,000.00) per violation per day. § 395.1065(2) (a) Florida Statutes. WHEREFORE, the Petitioner, State of Florida, Agency for Health care Administration, requests that this tribunal impose an administrative fine against the Respondent in the total amount of $1,000.00, or such other relief as this tribunal deems Page 25 of 26 ee just. NOTICE OF RIGHTS Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes. Respondent has the right to retain, and be : represented by an attorney in this matter. Specific options for administrative action are set out in the attached Election of Rights. : All requests for hearing shall be made to the Agency for Health Care Administration, and delivered to Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Bldg #3, MS #3, Tallahassee, FL 32308, whose telephone number is 850-412-3630. RESPONDENT IS FURTHER NOTIFIED THAT THE FAILURE TO REQUEST A HEARING WITHIN 21 DAYS OF RECHIPT OF THIS COMPLAINT WILL, RESULT “IN AN ADMISSION OF THE FACTS ALLEGED IN. THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been served to: Ronald Alan Hytoff, Chief Executive Officer, Tampa General Hospital, P.O. Box 1289, Tampa, FL 33601, by U.S. Certified Mail, Return Receipt No. 7003 1010 0001 3600 3128, and to Carl Heaberlin, R.N., as Registered Agent for Tampa General Hospital, P.O. Box 1289, Tampa, FL 33601, on February Bb, 2012. Assistant General Counsel Agency for Health Care Administration 525 Mirror Lake Drive, 330D St. Petersburg, FL 33701 727-552-1944 Facsimile 727-552-1440 Copy furnished to: Pat Caufman, FOM Page 26 of 26 Ronald Alan Hytoff - i Chief Executive Officer ‘Tampa General Hospital 'Po. Box 1289 (Tampa, FL 33601 i 9 COMPLETE THIS S fat ON ORLIVERY

Docket for Case No: 12-001261