STATE OF FLORIDA 4 AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, yZ q . (S ty S 7] o. < AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Fraes No. 2008012330 FLORIDA HEALTH SCIENCES CENTER, INC., d/b/a TAMPA GENERAL HOSPITAL, Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW the Petitioner, State of Florida, Agency For Health Care Administration (“hereinafter the Agency”), by and through its undersigned counsel, and files this Administrative Complaint against the Respondent, Florida Health Sciences Center, Inc., d/b/a Tampa General Hospital (“hereinafter the Respondent”), pursuant to Sections 120.569 and 120.57, Florida Statutes (2008), and alleges as follows: NATURE OF THE ACTION This is an action to impose an administrative fine against a hospital in the amount of thirty two thousand dollars ($32,000.00). JURISDICTION AND VENUE 1. The Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2008). 2. The Agency has jurisdiction over the Respondent pursuant to Sections 20.42 and 120.60, and Chapters 395, Part I, and 408, Part II, Florida Statutes (2008). 3. Venue lies pursuant to Rule 28-106.207 Florida Administrative Code. PARTIES 4. The Agency is the licensing and regulatory authority that oversees hospitals in the state of Florida and enforces the applicable federal and state regulations, statutes and rules that govern such facilities. Chs. 395, Part I, 408, Part II, Fla. Stat. (2008), Ch. 59A-3, Fla. Admin. Code. The Agency may deny, revoke, and suspend any license issued to a hospital, or impose an administrative fine, for a violation of the Health Care Licensing Procedures Act, the authorizing statutes or applicable rules. §§ 408.813, 408.815, 408.831, 395.003, 395.1041, 395.1065, Fla. Stat. (2008). 5. The Respondent was issued a license by the Agency (License Number 4044) to operate an 877-bed hospital located at 2 Columbia Drive, Tampa, Florida 33606 (hereinafter “the Facility”), and was at all times material required to comply with the applicable federal and state regulations, statutes and rules. COUNT I (Tag 120 The Respondent Failed To Ensure That Nursing Staff Assessed, Planned, Intervened And Evaluated Patients In Violation Of F.A.C. 59A-3.2085 6. The Agency re-alleges and incorporates by reference paragraphs 1 through 5. 7. Under Florida law, each hospital shall be organized and staffed to provide quality nursing care to each patient. Where a hospital’s organizational structure does not havea nursing department or service, it shall document the organizational steps it has taken to assure that oversight of the quality of nursing care provided to each patient is accomplished. Fla. Admin. Code R. 59A-3.2085(5). 8. Under Florida law, each hospital shall document the relationship of the nursing department to other units of the hospital by an organizational chart, and each nursing department 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. Establishment 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. Each hospital shall employ a registered nurse on a full time basis who shall have the authority and responsibility for managing nursing services and taking ail reasonable steps to assure that a uniformly optimal level of nursing care is provided throughout the hospital. Fla. Admin. Code R. 59A-3.2085(5)(a). 9. Under Florida law, the registered nurse shall be responsible for ensuring that a review and evaluation of the quality and appropriateness of nursing care is accomplished. The review and evaluation shall be based on written criteria, shall be performed at least quarterly, and shall examine the provision of nursing care and its effect on patients. Fla. Admin. Code R. 59A- 3.2085(5)(b). 10. Under Florida law, the registered nurse shall ensure that education and training programs for nursing personnel are available and are designed to augment nurses’ knowledge of pertinent new developments in patient care and maintain current competence. Cardiopulmonary resuscitation training shall be conducted as often as necessary, but not less than annually, for all nursing staff members who cannot otherwise document their competence. Fla. Admin. Code R. 59A-3.2085(5)(c). 11. Under Florida law, each 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. Fla. Admin. Code R. 59A-3.2085(5)(d). 12. Under Florida law, 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. Fla. Admin. Code R. 59A-3.2085(5)(e). 13. Under Florida law, all rehabilitation, psychiatric, and substance abuse programs provided by hospitals shall provide to the patient: (a) An evaluation upon referral; (b) Establishment of goals; (c) Development of a plan of treatment, including discharge planning, in coordination with the referring individual and rehabilitation staff, and after discussion with the patient and family; (d) Regular and frequent assessment, performed on an interdisciplinary basis, of the patient’s condition and progress, and of the results of treatment; (e) Maintenance of treatment and progress records; and (f) At least a quarterly assessment of the quality and appropriateness of the care provided. Fla. Admin. Code R. 59A-3.278(1)(a)-(f). 14. Under Florida law, the scope of services offered, and the relationship of the rehabilitation, psychiatric or substance abuse program to other hospital units, as well as ail supervisory relationships within the program, shall be defined in writing. Responsibility for the performance of clinical services also shall be clearly defined. Delegation of authority within the program shall be specified in job descriptions and in organizational plans. Written policies and procedures to guide the operation of the rehabilitation program shall be developed and reviewed at least annually, revised as necessary, dated to indicate the time of last revision, and enforced. Fla. Admin. Code R. 59A-3.278(3). 15. Under Florida law, there shall be a current written plan of care for each patient receiving rehabilitative, psychiatric or substance abuse services. The plan shall state the diagnosis, and problem list when appropriate, pertinent to the rehabilitation or treatment process; precautions necessitated by the patient’s general medical condition or other factors; the short- term and long-term goals of the treatment program; and require monthly or more frequent review of the patient’s progress.. The medical record and the written plan shall evidence a team approach, with participation of the professional and administrative staffs, the patient, and, as appropriate, the patient’s family. The medical record shall document the written instructions given to the patient and the family concerning appropriate care after discharge from the hospital. 59A-3.278(4). 16. Under Florida law, all rehabilitation, psychiatric, and substance abuse programs provided by hospitals shall provide to the patient: (a) An evaluation upon referral; (b) Establishment of goals; (c) Development of a plan of treatment, including discharge planning, in coordination with the referring individual and rehabilitation staff, and after discussion with the patient and family; (d) Regular and frequent assessment, performed on an interdisciplinary basis, of the patient’s condition and progress, and of the results of treatment; (ec) Maintenance of treatment and progress records; and (f) At least a quarterly assessment of the quality and appropriateness of the care provided. Fla. Admin. Code R. 59A-3.278(1)(a)-(f). 17. Under Florida law, the scope of services offered, and the relationship of the rehabilitation, psychiatric or substance abuse program to other hospital units, as well as all supervisory relationships within the program, shall be defined in writing. Responsibility for the performance of clinical services also shall be clearly defined. Delegation of authority within the program shall be specified in job descriptions and in organizational plans. Written policies and procedures to guide the operation of the rehabilitation program shall be developed and reviewed at least annually, revised as necessary, dated to indicate the time of last revision, and enforced. Fla. Admin. Code R. 59A-3.278(3). 18. Under Florida law, there shall be a current written plan of care for each patient receiving rehabilitative, psychiatric or substance abuse services. The plan shall state the diagnosis, and problem list when appropriate, pertinent to the rehabilitation or treatment process; precautions necessitated by the patient’s general medical condition or other factors; the short- term and long-term goals of the treatment program; and require monthly or more frequent review of the patient’s progress. The medical record and the written plan shall evidence a team approach, with participation of the professional and administrative staffs, the patient, and, as appropriate, the patient’s family. The medical record shall document the written instructions given to the patient and the family concerning appropriate care after discharge from the hospital. 59A-3.278(4). 19. On or about August 14, 2008, the Agency conducted a complaint survey of the Respondent and its Facility (CCR# 2008009559/FL00039557). 20. Based upon observation, interviews, and a review of the Facility’s policies and procedures, documentation, and clinical records, it was determined that the Respondent failed to ensure the nursing staff did not assess, plan, intervene, and evaluate the nursing care for seven (#1, #4, #6, #3, #5, #7, #8) of nine psychiatric patients reviewed. This practice caused harm to two psychiatric patients and potential harm to other psychiatric patients. Patient #1 21. According to Patient #1's psychiatric evaluation admission form dated July 18, 2008, the Patient was admitted from the Emergency Room with a chief complaint of suicidal ideation. 22. The Patient also had a history of self-mutilation and a prior suicide attempt. 23. The documentation showed a long history of a borderline personality disorder as well as ongoing depression. 24. — The Patient had been Baker Acted by the emergency room physician. 25. According to admission nursing documentation dated July 18, 2008, at 11:30 p.m., the Patient was admitted with suicidal ideation and a history that included self-mutilation, a prior suicide attempt and depression. 26. The information showed that the Patient had told the emergency room staff that he or she had hid razors and pills inside of personal products and that the Patient stated that he or she would kill himself or herself on the psychiatric unit (7F). 27. The documentation indicated that the Patient stated that he or she was suicidal and could not contract for safety. 28. The Patient was placed on suicide precautions. 29. A review of the Inpatient Suicide Risk Assessment and Evaluation dated July 18, 2008, at 10:00 p.m., noted that the Patient was suicidal and could not contract for safety. 30. A review of Verbal Telephone Psychiatric physician orders dated July 19, 2008, at 12:30 a.m., revealed instructions to place the Patient on suicide precaution and an observation level of safety checks every fifteen minutes. 31. Nursing documentation dated July 19, 2008, at 10:00 p.m., showed that the Patient was having fleeting suicidal thoughts. 32. Psychiatric physician documentation dated July 20, 2008, indicated that the Patient had fantasies about self-injurious thoughts and suicidal ideation, but contracted for safety. 33. Nursing documentation dated July 20, 2008, at 2:11 p.m., noted that the Patient was focused on ways of hurting himself or herself. 34. Psychiatric physician documentation dated July 21, 2008, noted that the Patient continued to be suicidal, denied intent, but fantasized about ways to kill himself or herself. 35. A review of the every fifteen minute safety check log noted that from 6:30 p.m. until 8:00 p.m., the Patient was in his or her room. 36. Nursing documentation dated July 21, 2008, at 10:00 p.m., indicated that at the beginning of the 3-11 shift, the Patient denied suicide ideation and was later noted to be walking in and out of his or her room frequently. 37. | The documentation showed that at 8:16 p.m. the Patient was found slumped over with a sheet around his or her neck and attached to the closet door. 38. A review of the code sheet documentation dated July 21, 2008, at 8:20 p.m., revealed that the Patient was resuscitated, transferred to the Intensive Care Unit, and expired on July 22, 2008, at 5:51 a.m. 39. A review of the Inpatient Suicide Risk Assessment and Evaluation dated July 21, 2008, at 8:10 a.m., noted that the Patient indicated the presence of suicidal thoughts. 40. Documentation at 3:30 p.m. noted that the Patient denied any suicidal thoughts because he or she was in a safe place. 41. A review of the clinical record and an interview with the Vice President of Patient Care Services, Unit Manager, and Risk Management Specialist, on August 13, 2008, at approximately 4:10 p.m., revealed no further documentation regarding the Inpatient Suicide Risk Assessment and Evaluation for July 19-20, 2008. 42. A review of the policy and procedure Suicide Prevention Protocol #TX-18, dated July 2008, revealed instructions to complete the suicide assessment on admission and twice a day if a patient was determined to be at risk. 43. The instructions stated to consult with the physician, begin close observation, obtain a physician order, and accompany the patient in non monitored areas. 44. A review of the policy and procedure titled "Levels of Observation on the Psychiatric Unit " L-1, dated February 2007, did not reveal any evidence of what type of patients are to be considered for the different levels of observation. 45. A review of the policies and procedures as well as the clinical records did not reveal any evidence of the Inpatient Suicide Risk Assessment Evaluation being completed on July 19-20, 2008. 46. The review also did not reveal any evidence that the Patient was assessed for the need of a higher level of observation despite ongoing suicidal thoughts, a pertinent history from the time of admission to the time of the incident, and thoughts of hurting himself or herself. Patient #4 47. According to Patient #4's admission documentation, the Patient was admitted to the psychiatric unit (7F) from the emergency room on June 21, 2008. 48. The documentation revealed that the Patient had been Baker Acted and was confused. 49. During an interview with the Patient's psychiatrist on August 13, 2008, at 1:45 p.m., it was noted that the Patient was assessed as a low risk for suicide and was on every fifteen minutes safety checks. 50. A review of the admission orders dated June 21, 2008, at 7:00 p.m., revealed that the Patient was to be on every fifteen minute safety checks. 51.. A review of the fifteen minute observation log for the fifteen minute safety checks on July 4, 2008, at 6:15 am., 6:30 am., 6:45 am. and 7:00 am., did not reveal any documentation that the fifteen minute safety check had been conducted. 52. During an interview with the Nurse Unit Manager of the psychiatric unit (7F) on August 13, 2008, at approximately 1:00 p.m., it was revealed that the log was to be documented every fifteen minutes to account for patient safety. 53. A review of the progress notes dated July 22, 2008, at 10:30 p.m., revealed that the Patient was assessed for an alteration in his or her thought process. 54. The Patient was out on the unit, but did not attend group therapy. 55. . The Patient requested to be moved to a different room because his or her roommate had gastrointestinal distress and the room smelled bad. 56. The Patient was noted to be moved to a different room. 57. During an interview with the Nurse Unit Manager of psychiatric unit 7F on August 13, 2008, at approximately 1:00 p.m., it was revealed that Patient #4 was moved to a room where a previous patient had hung himself or herself from a closet door with a bed sheet on July 21, 2008, at approximately 8:15 p.m. 58. During an interview with the Vice President of Patient Services on July 13, 2008, at approximately 1:00 p.m., it was revealed that all of the patients on the unit were given a debriefing after the July 21, 2008, suicide on 7F. 59. A review of the Patient #4’s clinical record revealed no documentation of an assessment of the Patient's feelings or thought process with respect to transferring to the room the July 21, 2008, suicide, approximately 44 hours earlier. 60. A review of the progress notes dated July 22, 2008, at 10:30 p.m., revealed that the Patient came out of the new room and asked if he or she could sleep in the haliway because he or she was too afraid to sleep in the new room. 61. The Patient was noted as sleeping in the hallway during the night of July 22, 2008. 62. A review of the fifteen minute observation checks revealed that the Patient 10 returned to the room on July 23, 2008, at 7:45 a.m., from the dining room. 63. The Patient was observed by the staff to be in the Patient's room until 9:45 a.m. 64. During an interview with the Patient's psychiatrist on August 13, 2008, at approximately 1:45 p.m., it was revealed that the Patient was responding. 65. The psychiatrist was in the process of discharge planning and the Patient was to be discharged to a Short Term Residential Treatment Center (SRT). 66. The interview of the psychiatrist revealed that the Patient was excited on July 23, 2008, at 8:15 p.m., during the psychiatrist's assessment and conversation about the placement to SRT. 67. A review of the progress notes dated July 23, 2008, at 10:30 a.m., by a mental health technician (MHT) revealed that the Patient reported being excited about the pending discharge to a SRT. 68. A review of the fifteen minute observation safety checks dated July 23, 2008, at 4:15 p.m., revealed that the Patient was observed eating the dinner meal. 69. The 4:30 p.m. documentation showed a code was being performed on the Patient. 70. A review of the nursing notes dated July 23, 2008, at 4:20 p.m., revealed that the nurse entered the Patient's room to return clothes that another patient had taken out of the room. 71. The nurse and a mental health technician entered the room and saw a pair of pajama pants torn and a knot tied in one piece. 72. The documentation noted they looked at the bathroom door and saw a very large knot between the top of the bathroom door and the ceiling. 73. The nurse then pushed the bathroom door slightly and discovered Patient hanging behind the door. 74. Acode was called and cardiopulmonary resuscitation (CPR) was started. 11 75. A review of the code sheet dated July 23, 2008, revealed that the time of arrival to be 4:52 p.m. 76. It was noted that the Patient was transferred to Intensive Care Unit (ICU) on July 23, 2008, at 5:16 p.m., and subsequently expired at 11:34 p.m.. 77. During an interview with the Nurse Unit Manager (7F) on August 13, 2008, at approximately 1:00 p.m., it was revealed the mental health technician told the nurse that a fifteen minute observation safety check of the patient was observed at 4:30 p.m. and that the Patient was lying on the bed in a green shirt. 78. The Unit Manger revealed that the mental health technician failed to document the time on the observation check list sheet. 79. The Unit Manager further revealed that a nurse from the floor, during the code, entered the number 21, representing a code on the observation check list in the next blank area of the observation check list. 80. The time was noted to be 4:30 p.m. 81. The code sheet indicated that the time of arrival of the code team was 4:52 p.m., a delay of 32 minutes from initial discovery at 4:20 p.m. 82. During the interview, the Unit Manager revealed there was a discrepancy in the times on the fifteen minute observation safety check list, the nursing notes, and code sheet. 83. The interview and a review of the documentation revealed that the physician order for every fifteen minute checks was not implemented on July 4, 2008, and potentially was not conducted on July 23, 2008, due to the discrepancies in documentation. 84. The interview and a review of the documentation revealed no evidence of an assessment of the Patient prior to the room change where another patient had attempted suicide, and the Patient had knowledge of the attempted suicide and felt afraid. 12 Patient #6 85. During a tour of Psychiatric Unit 7F on August 14, 2008, from approximately 6:50 a.m. to 8:40 a.m., an observation revealed that Patient #6 was asleep in a recliner adjacent to the nursing station and that a patient care technician sitting in a chair by the recliner recording variable timed safety checks of the Patient. 86. A review of Patient #6's medical record revealed a physician order dated August 13, 2008, at 5:10 p.m., for constant visual observation. 87. A review of the physician and nursing documentation did not reveal any evidence of the Patient being assessed for individual needs related to sleeping in the hallway. Patients #3, #5, #7 and #8 88. An observation of the dining room on the Psychiatric Unit 7F on August 14, 2008, from approximately 6:50 a.m. to 8:40 a.m. revealed Patients #3, #5, #7, and #8 sitting in chairs at a table, heads down on the table, appearing to be asleep. 89. _A patient care technician was recording variable timed safety checks of the four patients. 90. A review of Patient #3's medical record revealed a physician order dated August 13, 2008, at 11:00 a.m., to maintain constant visual observation. 91. A review of the routine safety check form dated August 14, 2008, revealed that checks were documented from 12:00 a.m. to 6:30 a.m. by the patient care technician observed sitting in the hallway by Patient #6. 92. The documentation indicated that the Patient was brought to the dining room at 6:30 a.m. 93. A review of Patient #5's medical record revealed a physician order dated August 13, 2008, to make patient 1:1. 13 94, A review of the routine safety check form dated August 14, 2008, revealed that checks were documented from 12:00 a.m. to 7:15 a.m. by the patient care technician observed sitting in the hallway by Patient #6. 95. The documentation indicates the Patient was brought to the dining room at 7:00 am. 96. A review of Patient #7's medical record revealed a physician order dated August 13, 2008, at 3:40 p.m., to begin constant observation. 97. A review of the routine safety check form dated August 14, 2008, revealed that checks were documented from 12:00 a.m. to 6:30 am. by the patient care technician observed sitting in the hallway by Patient #6. 98. The documentation indicates that the Patient was brought to the dining room at 6:40 a.m. 99. A review of Patient #8's medical record revealed a physician order dated August 13, 2008, at 7:00 p.m., to place the Patient on constant visual observation. 100. A review of the routine safety check form dated August 14, 2008, revealed that checks were documented from 12:00 a.m. to 6:30 a.m. by the patient care technician observed sitting in the hallway by Patient #6. 101. The documentation indicates that the Patient was brought to the dining room at 6:30 a.m. 102. A review of the physician and nursing documentation for Patients #3, #5, #7, and #8, did not reveal any evidence of the Patients being assessed for individual needs related to sleeping in the hallway. Sanctions 103. Under Florida law, the Agency may impose an administrative fine, not to exceed 14 $1,000 per violation, per day, for the violation of any provision of Chapter 395, Part I, or Chapter 408, Part Il, or the applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine. § 395.1065(2)(a), Fla. Stat. (2008). 104. Under Florida law, as a penalty for any violation of Chapter 408, Part II, the authorizing statutes, or the applicable rules, the Agency may impose an administrative fine. Unless the amount or aggregate limitation of the fine is prescribed by authorizing statutes or applicable rules, the Agency may establish criteria by rule for the amount or aggregate limitation of administrative fines applicable to this part, authorizing statutes, and applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine. For fines imposed by final order of the Agency and not subject to further appeal, the violator shall pay the fine plus interest at the rate specified in Section 55.03, Florida Statutes, for each day beyond the date set by the Agency for payment of the fine. § 408.813, Fla. Stat. (2008). WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully seeks an administrative fine against the Respondent in the amount of seven thousand dollars ($7,000.00). COUNT I (Tag 121 The Respondent Failed To Have Sufficient Number of Qualified Registered Nurses On Duty At All Times To Provide Nursing Care And Facilitate Appropriate Intervention By Nursing, Medical Or Other Hospital Staff Members In Violation Of F.A.C. 59A-3.2085(5)(f) 105. The Agency re-alleges and incorporates by reference paragraphs 1 through 5. 106. Under Florida law, a sufficient number of qualified registered nurses shall be on duty at all times to give patients the nursing care that requires the judgment and specialized skills of a registered 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 15 hospital staff members. Fla. Admin. Code R. 59A-3.2085(5)(f). 107. On or about August 14, 2008, the Agency conducted a complaint survey of the Respondent and its Facility (CCR# 2008009559/FL00039557). 108. Based upon observation, interviews, and a review of clinical records, it was determined that the Respondent failed to ensure that its nursing service had an adequate number of licensed registered nurses and other personnel to provide the necessary care and services to psychiatric patients for 7 or 9 patients (Patient #1, #4, #6, #3, #5, #7, #8). This practice does not ensure that patient goals and the highest level of practicable well-being are maintained. 109. During a tour of Psychiatric Unit 7F on August 14, 2008, an observation from approximately 6:50 a.m. to 8:40 a.m. revealed a 22 bed unit with a census of 18 patients. 110. The staff for the 11-7 night shift consisted of two registered nurses, two mental health technicians and two patient care technicians. 111. The Agency re-alleges and incorporates by reference paragraphs 85 through 102 set forth above. 112. A review of the shift assignment sheet for the 11-7 shift on August 13, 2008, indicated that a patient care technician was assigned to Patients #3, #6, #7, #8, a registered nurse was assigned to Patient #5, and a mental health technician was assigned to relieve the patient care technician for break. 113. During an interview with the registered nurse on August 14, 2008, at approximately 11:20 a.m., it was revealed that Patients #3, #5, #6, #7, and #8 beds were moved to the hallway to enable the patient care technician to observe all five patients while they slept. 114. A review of the routine safety check forms for all five patients noted that the mental health technician assigned to relieve the patient care technician documented the safety checks at 2:45 a.m. and 3:00 a.m., noting that the patients were in the hallway asleep. 16 115. An observation of Patients #3, #5, #7, and #8 on August 14, 2008, showed that they waited in the dining room with their heads down on the table, appearing to sleep, until the breakfast trays arrived at 7:35 a.m. This was a wait of over an hour for three of four patients. | 116. During an interview with the registered nurse on August 14, 2008, at 11:20 a.m., revealed that the five Patients requiring constant visual observation or 1:1 supervision are kept together in the hallway for sleeping and are brought to the dining room to wait together to efficiently utilize staff assignments. Sanctions 117. Under Florida law, the Agency may impose an administrative fine, not to exceed $1,000 per violation, per day, for the violation of any provision of Chapter 395, Part I, or Chapter 408, Part II, or the applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine. § 395.1065(2)(a), Fla. Stat. (2008). 118. Under Florida law, as a penalty for any violation of Chapter 408, Part II, the authorizing statutes, or the applicable rules, the Agency may impose an administrative fine. Unless the amount or aggregate limitation of the fine is prescribed by authorizing statutes or applicable rules, the Agency may establish criteria by rule for the amount or aggregate limitation of administrative fines applicable to this part, authorizing statutes, and applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine. For fines imposed by final order of the Agency and not subject to further appeal, the violator shall pay the fine plus interest at the rate specified in Section 55.03, Florida Statutes, for each day beyond the date set by the Agency for payment of the fine. § 408.813, Fla. Stat. (2008). WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully seeks an administrative fine against the Respondent in the amount of one thousand dollars ($1,000.00). COUNT III (Tag 208 The Respondent’s Governing Body Failed To Ensure The Conduct of the Hospital As A Functioning Institution In Violation Of F.A.C. 59A-3.272(1) 119. The Agency re-alleges and incorporates by reference paragraphs 1 through 5. 120. Under Florida law, the licensee shall have a governing body responsible for the conduct of the hospital as a functioning institution. Fla. Admin. Code R. 59A-3.272(1). 121. Under Florida law, adherence to patient rights, standards of care, and examination and placement procedures provided under Part I of Chapter 394, Florida Statutes, shall be a condition of licensure for hospitals providing voluntary or involuntary medical or psychiatric observation, evaluation, diagnosis, or treatment. § 395.003(5)(a), Fla. Stat. (2008). Each patient shall receive services, including, for a patient placed under Section 394.4655, Florida Statutes, those services included in the court order, which are suited to his or her needs, and which shall be administered skillfully, safely, and humanely with full respect for the patient's dignity and personal integrity. Each patient shall receive such medical, vocational, social, educational, and rehabilitative services as his or her condition requires in order to live successfully in the community. § 394.459(4)(a), Fla. Stat. (2008). 122. Under Florida law, facilities shall develop and maintain, in a form accessible to and readily understandable by patients and consistent with rules adopted by the department, the following: 1. Criteria, procedures, and required staff training for any use of close or elevated levels of supervision, of restraint, seclusion, or isolation, or of emergency treatment orders, and for the use of bodily control and physical management techniques. 2. Procedures for documenting, monitoring, and requiring clinical review of all uses of the procedures described in subparagraph 1. and for documenting and requiring review of any incidents resulting in injury to patients. 3. A system for investigating, tracking, managing, and responding to complaints by persons receiving services or individuals acting on their behalf. § 394.459(4)(b), Fla. Stat. (2008). 123. On or about August 14, 2008, the Agency conducted a complaint survey of the Respondent and its Facility (CCR# 2008009559/FL00039557). 124. Based upon observation, interviews, and a review of the Facility’s policies and procedures, Environment of Care committee meeting minutes, Facility documentation, and clinical records, it was determined that the Facility’s governing body did not ensure that care and services were provided in a safe environment and met the needs of its psychiatric patients. 125. The Agency re-alleges and incorporates by reference Count I and Count II. 126. During an interview with the Vice President Patient Care Services and the Unit Manager on August 13, 2008, at approximately 1:55 p.m., and again on August 14, 2008, at approximately 11:35 a.m., it was revealed that staff had been instructed to increase observation of the patients after the first suicide. 127. The interviews noted there had been no change in policy implemented, no form changes, and no formal time plan for the increased observation to take place or instructions of how the increased observation was to take place. 128. A review of Patient #4's record did not show any evidence of increased frequent rounds from the evening of July 21, 2008, to the time of the attempted suicide during the early evening of July 23, 2008. 129. During an interview with the Vice President of Patient Care Services, the Unit Manager, and the Unit Clinician on August 14, 2008, at approximately 11:35 a.m., it was noted that a formal in-service about suicide was presented for the staff on August 7, 2008, to August 10, 2008, approximately sixteen days after the first suicide. 130. A review of the Facility documentation indicated that 17 of 137 direct care staff 19 members had attended the formal in-service after two hanging deaths on the unit within 44 hours of each other. 131. A review of the Facility documentation dated July 30, 2008, revealed that two patients had attempted suicide on the Psychiatric Unit (7F) and subsequently expired. 132. A review of the documentation for both Patients revealed no evidence of an investigation or an analysis being conducted. 133. A review of the Facility documentation dated July 30, 2008, 2008, indicated that the feasibility of video monitoring was to the assessed, an environmental assessment would be conducted, and that the feasibility of changing the every fifteen minute observation. checks protocol to a more variable system. 134. During an interview with the Director of Risk Management on August 13, 2008, at approximately 5:30 p.m., the Facility would not disclose the root cause analysis/investigation that had been performed, other pertinent investigation information surrounding the two deaths, or the plan of action developed or being developed. 135. During an interview with the Vice President of Patient Care Services, the Director of Risk Management and the Psychiatric Unit Manager, on August 14, 2008, at approximately 11:35 a.m., a review of information read by the Vice President of Patient Care Services from a summary sheet, there was no evidence of the video surveillance study being completed, results of an environmental assessment, or a new written protocol for the a more variable fifteen minutes observation check 136. During an interview with the Vice President of Patient Care Services and the Director of Risk Management on August 14, 2008, at approximately 11:30 a.m., it was indicated that the Facility would not disclose the investigation that was conducted or action plan that was implemented. 20 137. During the exit conference on August 14, 2008, at approximately 4:30 p.m., the Director of Performance Improvement provided a computerized copy of a form of a brief analysis of the incidents. 138. _A review of the Facility documentation that was presented during the survey and interviews did not show evidence of the Facility conducting a comprehensive root cause analysis such as for staffing, personnel involved, environment, physician orders observation level, etc. or implementing a plan of action to ensure patient safety and well being after the first or second suicides on July 21, 2008, or July 23, 2008, in the same room on the same unit. 139. There was no evidence of the Facility ensuring patient safety after the incident and a delay of implementing safety approaches after the second incident. Sanction 140. Under Florida law, the Agency may impose an administrative fine, not to exceed $1,000 per violation, per day, for the violation of any provision of Chapter 395, Part I, or Chapter 408, Part II, or the applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine. § 395.1065(2)(a), Fla. Stat. (2008). 141. Under Florida law, as a penalty for any violation of Chapter 408, Part II, the authorizing statutes, or the applicable rules, the Agency may impose an administrative fine. Unless the amount or aggregate limitation of the fine is prescribed by authorizing statutes or applicable rules, the Agency may establish criteria by rule for the amount or aggregate limitation of administrative fines applicable to this part, authorizing statutes, and applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine. For fines imposed by final order of the Agency and not subject to further appeal, the violator shall pay the fine plus interest at the rate specified in Section 55.03, Florida Statutes, for each day beyond the date set by the Agency for payment of the fine. § 408.813, Fla. Stat. (2008). 21 WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully seeks an administrative fine against the Respondent in the amount of twenty four thousand dollars ($24,000.00). CLAIM FOR RELIEF . WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully seeks a final order that: 1. Makes findings of fact and conclusions of law in favor of the Agency. 2. Imposes an administrative fine against the Respondé the total amount of thirty two thousand dollars ($32,000.00). 3. Orders any other relief authorized by law thg Respectfully submitted on this 16th day of Dees 3 Thomas M. Hoele: \Sénior Attorney Florida Bar No. 709311 Office of the General Counsel Agency for Health Care Administration 525 Mirror Lake Drive North, Suite 330 St. Petersburg, Florida 33701 Telephone: (727) 552-1439 Facsimile: (727) 552-1440 NOTICE The Respondent is notified that it/he/she has the right to request an administrative hearing pursuant to Sections 120.569 and 120.57, Florida Statutes. If the Respondent wants to hire an attorney, it/he/she has the right to be represented by an attorney in this matter. Specific options for administrative action are set out in the attached Election of Rights form. The Respondent is further notified if the Election of Rights form is not received by the Agency for Health Care Administration within twenty-one (21) days of the receipt of this Administrative Complaint, a final order will be entered. The Election of Rights form shall be made to the Agency for Health Care Administration and delivered to: Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Mail Stop 3, Tallahassee, FL 32308; Telephone (850) 922-5873. 22 CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form have been served to: Carl Heaberlin, R.N., Registered Agent, Tampa General Hospital, 2 Columbia Drive, Davis Islands, Tampa, Florida 326 Mail, Return Receipt Requested 7007 1490 0001 6979 1694 and Copies furnished to: Carl Heaberlin, R.N., Registered Agent Tampa General Hospital 2 Columbia Drive, Davis Islands Tampa, Florida 33606 - (U.S. Certified Mail) James Kennedy, Esquire ; Buchanan, Ingersoll & Rooney, P.C. 401 East Jackson Street, Suite 2500 Tampa, Florida 33602-5236 (U.S. Mail) Florida Bar No. 7093 11 Office of the General Counsel Agency for Health Care Administration 525 Mirror Lake Drive North, Suite 330 St. Petersburg, Florida 33701 Telephone: (727) 552-1439 Facsimile: (727) 552-1440 Agency for Health Care Administration The Sebring Building, Fourth Floor 525 Mirror Lake Drive North St. Petersburg, Florida 33701 (Interoffice Mail) Thomas M. Hoeler, Senior Attorney Office of the General Counsel Agency for Health Care Administration 525 Mirror Lake Drive North, Suite 330 St. Petersburg, Florida 33701 (Interoffice Mail) 23 B06,,by U.S. Certified andey Kennedy, Esquire, 500, Tampa, Florida Patricia R. Caufman, Field Office Manager item 4 if Restricted Delivery is desired. @ Print your name and address on the reverse so that we can return the card to you. ™ Attach this card to the back of the mailpiece, or on the front if space permits. ™ Complete items 1, 2, ana 3. Also complete 1. Article Addressed to: Carl Heaberlin, R.N., Reg. Agent Tampa General Hospital 2 Columbia Drive, Davis Islands Tampa, Florida 33606 PS Form 3811, February 2004 7007 L450 o001 6979 1644 Domestic Return Receipt 3. Service Type $KCertified. Mait O Registered Ja Return Receipt for Merchandise O Insured Mail O Express Mail Ocop. to2596-02-M1640

Docket for Case No: 09-000357