BS oth STATE OF FLORIDA Sot AGENCY FOR HEALTH CARE ADMINISTRATION -z,.. © “a OS, ae fet A % EE, A, ot “EG STATE OF FLORIDA, AGENCY FOR Bam, we HEALTH CARE ADMINISTRATION, Oe AHCA No.: 2006005528 4 Petitioner, Return Receipt Requested: ; 7002 2410 0001 4235 0487 Vv. 7002 2410 0001 4235 0494 7002 2410 0001 4235 0500 Db 3900 MIAMI BEACH HEALTHCARE GROUP, LTD., d/b/a AVENTURA HOSPITAL AND MEDICAL CENTER. Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the State of Florida, Agency for Health Care Administration (hereinafter “AHCA”), by and through the undersigned counsel, files this administrative complaint against Miami Beach Healthcare Group, Ltd. d/b/a Aventura Hospital and Medical Center (hereinafter “Aventura Hospital and Medical Center”) pursuant to 28-106.111 Florida Administrative Code (2005), and Chapter 120, Florida Statutes (2005) hereinafter alleges: NATURE OF THE ACTION 1. This is an action to impose an administrative fine in the amount of $13,500.00 pursuant to Section 395.1065(2) (a) Florida Statutes (2005). JURISDICTION AND VENUE 2. This court has jurisdiction pursuant to Section 120.569 and 120.57 Florida Statutes (2005), and Chapter 28-106 Florida Administrative Code (2005). 3. Venue lies in Miami-Dade County pursuant to 120.57 Florida Statutes (2005), and Chapter 28, Florida Administrative Code (2005). PARTIES 4. AHCA is the enforcing authority with regard to hospital licensure law pursuant to Chapter 395, Part I, Florida Statutes (2005) and Rules 59A-3 Florida Administrative Code (2005). 5. Aventura Hospital and Medical Center is a hospital facility located at 20900 Biscayne Boulevard, Aventura, Florida 33180 and is licensed under license number 4430 pursuant to Chapter 395, Part I, Florida Statutes (2005), and Chapter 59A-3 Florida Administrative Code (2005). 6. A complaint investigation survey was conducted at the hospital from May 18, 2006 to May 25, 2006. As a result of the findings of the survey, an Immediate Order of Moratorium on Elective Admissions was imposed on the facility on May 26, 2006. The moratorium was lifted effective June 1, 2006. ie) 7. As a result of the complaint investigation survey conducted from May 18, 2006 to May 25, 2006, the hospital was cited with five (5) deficiencies as set forth in this administrative complaint. COUNT I AVENTURA HOSPITAL AND MEDICAL CENTER FAILED TO PROVIDE FREEDOM FROM RESTRAINTS CONSISTENT WITH THE RIGHTS OF MENTALLY ILL PERSONS OR PATIENTS. 592R-3.254(4), FLORIDA ADMINISTRATIVE CODE (PATIENT RIGHTS AND CARE) 8. AHCA re-alleges and incorporates paragraphs (1) through (7) as if fully set forth herein. 9. An unannounced visit and a complaint investigation survey was conducted at the facility from May 18, 2006 to May 25, 2006. Based on interview, facility policy and procedure, and clinical record review, it was determined that the facility failed to provide freedom of restraints consistent with the rights of mentally ill persons or patients for 1 of 8 (#1,) sampled patients. The findings include the following. 10. Review of the clinical record for sampled patient #1 revealed admission to the facility on 3-28-06 for cellulitis of the foot and mental retardation. The emergency room physician's history and physical stated that the patient was alert and oriented to person, place, and time with remote and recent memory intact. Review of the medication administration record revealed that the patient received Haldol 5 mg IM on 3-28-06 at 1539. The physician and triage nurse had documented that the patient was allergic to Haldol prior to administration. 11. The triage nurse documented on 3-28-06 that the patient was combative in the emergency room and Klonopin .5 mg was administered at 2130 by mouth. Prior to admission to the hospital the documented psychoactive medications sampled patient #1 was receiving were as follows: Risperdal 2mg by mouth twice a day for psychosis, Restoril 30 mg one by mouth at hour of sleep, Klonopin .5 mg by mouth twice a day (3pm and 9pm), Depakane 500 mg by mouth 3 times a day, and Depakote ER 500 mg one by mouth three times a day for Bipolar Disorder. The physician's orders were for 1:1 sitter, cardiac diet, Respirdal 2 mg twice daily, Clonazepam 0.5 mg twice daily (3pm and 9pm). 12. On 3-28-06, there were case management notes which revealed that the patient was continent. The patient can transfer with assistance and barely tolerates activity. There is no documentation revealing that the facility attempted to inquire about pre-admission information to meet the needs. of the patient prior to restraint use. Nurses’ notes did not reveal any periods of relief from the restraints. The documentation did not reveal assessment of sampled patient #1’s behaviors to determine if the cause could be alleviated through clinical interventions prior to drug intervention. 13. On 3-28-06 the nurses notes revealed that the skin integrity was red/broken and adult briefs were on and restraints, and a 1:1 sitter. Review of the restraint order did not reveal the patient was on bilateral foot restraints. 14. On 3-29-06 at 0200 the physician ordered Ativan 2 mg IV q 4hrs prn for agitation and Rocephin 1 gm IM q 24 hours. Physician ordered Dilaudid 2 mg Im q 3 hours prn at 0115. Restraint order on 3-29-06 revealed patient is at risk for falls, aggressiveness and restlessness noted. Soft cuff bilateral restraints and a vest were ordered to "prevent accidental injury from movement." The patient was placed in restraints on 3-29-06 at 2200. There was an additional order for Clonazepam .5 mg three times a day which supersedes the previous order. 15. On 3-30-06 at 0800 the physician ordered restraints due to "high risk for falls” and documented that it was necessary “to prevent accidental injury from movement.” Soft cuff bilateral restraints and a vest were ordered to "prevent accidental injury from movement." There is no nursing documentation indicating that the patient was moving about putting/him her at risk for accidental injury. ui 16. On 3-30-06 at 1935 there was an order for Thorazine 25 mg Im (intramuscular) q (every) 4 hours for agitation and increase Zyprexa to 10 mg every 4 hours by mouth. Psychiatry documented on 3-30-06 and 3-31-06 that the patient was agitated and combative. Prior to restraint use the nursing staff did not assess sampled patient #1 behaviors to determine if the cause could be alleviated through clinical interventions prior to restraint use nor were less intrusive interventions documented. 17. The patient received medication Ativan 2 mg for agitation on 3-30-06 at 1525 and was documented as being in physical restraints to include a vest and bilateral wrist restraints in addition to a 1:1 sitter. Nursing documented that the patient’s skin integrity was red/broken and adult briefs were on. There is no documentation revealing that the facility attempted to inquire about pre-admission information to include history of falls, or past behaviors, or interventions to meet the needs of the patient. On 3-30-06 the patient received Ativan 2 mg IM given for agitation, and a 1:1 sitter. 18. On 3-31-06 at 0800 the physician ordered restraints due to "high risk for falls” and documented that it was necessary “to prevent accidental injury from movement." Soft cuff bilateral restraints and a vest was ordered to "prevent accidental injury from movement." There is no nursing documentation indicating that the patient was moving about putting/him her at risk for accidental injury. 19. On 3-31-06 at the patient was still in physical restraints at 0600, adult brief on, skin integrity, broken and red, and a 1:1 sitter. On 3-31-06 at 0800 breath sounds were decreased. There was no documentation by nursing staff that the physician was contacted. 20. On 3-31-06 at 0800 patient was still in a physical restraint, skin was red, broken and adult brief was on, Ativan 2 mg IM was given, and a 1:1 sitter. On 3-31-06 at 1232 a nurse's note revealed that the patient is continent. On 3-31-06 at 1705 the patient was documented as being in physical restraints, skin red/broken and diaper on, Ativan 2 mg IM was given, and a 1:1 sitter. 21. On 4-1-06 at 0500 there was an order for restraints initiated by the registered nurse for preventive accidental injury from movement, not signed by the physician. There is no nursing documentation indicating that -the patient was moving about putting/him her at risk for accidental injury. 22. On 4-1-06 at 2310 the patient was still in physical restraints and the skin turgor was tenting, skin character ecchymotic, and there was draining from the ulcer. The patient was documented in adult briefs, breath sounds were wheezing, Ativan 2 mg IM was given, and a 1:1 sitter. The physician increased the Thorazine to 50 mg by mouth twice a day and 50 mg every 4 hours as needed for agitation and hold if sedated. 23. There were no physician orders for the use of physical restraints, bilateral wrist restraints and vest for sampled patient #1 on 4-1-06, 4-2-06, or 4-3-06. The facility’s current policy and procedure for restraint usage stated that "an order will be obtained prior to the application of a restrained. The nurse documented on 4-1-06 at 0800 and 2130 and 4-2-06 at o511 and 0800 that sampled patient #1’s physician restraint” orders were checked and the Registered Nurse answered yes. There were no documented physician's orders for the use of restraints on the aforementioned dates. 24. On 4-2-06 the physician ordered Lasix 20 mg IV now and in the morning in addition to KCL 10 mg P.O. now. at 2:30. On 4-2-06 at 0024 the breath sounds documented indicated wheezing, patient had sputum in yellow thick coloring, SPO2 was 96%. The patient was physically restrained with a vest and bilateral wrist restraints with a 1:1 sitter. 25. On 4-2-06 at 0139 patient was in the aforementioned physical restraints and there was an order placed for "Out of Bed activities to chair with assistance." On 4-2-06 at 0447 patient was given Ativan 2 mg IM for agitation and was on restraints, and a 1:1 sitter. On 4-2-06 at 0530 the patient was in diapers, bilateral wrist restraints and vest and breath sounds rales. 26. On 4-2-06 the wound care nurse assessed the patient for the integrity of the ulcer. On 4-2-06 at 0800 patient assessment was combative, pupils were sluggish, restraints were on bilateral wrist, feet and vest. On 4-2-06 at 2200 the patient remained in restraints, no vitals taken as per physician order q 4 hours. 27. On 4-2-06 at 1400 the patient had rhonchi breath sounds as per documentation. On 4-2-06 at 1800 the patient remained in a vest restraint and bilateral wrist restraints with a 1:1 sitter. 28. At this time the patient was documented by nursing staff as having developed bilateral lower edema with loss of dorsalis pedis palpable pulses. Nurse's notes did not reveal any communication with physician. On 4-2-06 at 2000 there was drainage with the color of serosanguineous, adult briefs, Ativan 2 mg IM for agitation and restraints, and a 1:1 sitter. 29. On 4-2-06 the respiratory breath sounds were decreased bilaterally. Pupils were sluggish. On 4-2-06 at 2024 the breath sounds were decreased bilaterally, with drainage from ulcer. 30. On 4-3-06 at 0200, nursing documentation evidenced that Dilaudid 2mqg was administered, patient physically restrained bilateral wrist restraints and vest and 1:1 sitter by side. At 0220 patient was given Ativan 2 mg IV and Dilaudid 2 mg (route unknown). At 0330 patient was found cold and not breathing. The code was not initiated until 5 minutes later as per nursing and physician documentation. Patient was pronounced dead at 0346. Patient expired while in restraints. 31. Nursing failed to document turning and positioning for 3-29-06, 3-30-06, 4-1-06, 4-2-06 and 4-3-06. Nursing failed to document the removal of sampled patient #1 bilateral wrist restraints for assessment and/or range of motion as per facility restraint policy on the following dates: on 4-1-06 at 0800, 1000,1552,1600 and 2130 hours; on 4-2-06 at 2000; and on 4-3-06 at 0200 hours. . 32. The only nursing documentation description of patient #1's behaviors in the clinical record throughout hospitalization included agitation and combativeness. There was no documentation that other measures or interventions were attempted to allay the patient’s symptoms other than physical and chemical restraint usage. 33. Interview by telephone on 5-25-06 at 10:30 am with the nursing assistant about patient #1 revealed that he/she was with the patient twice. The first time as per interview was on 3-31-06 from 7 PM to 7 am on 4-1-06. The sitter stated that the patient had a vest tied to the bed and wrist and ankle 10 restraints also tied to the bed. The patient was at a low incline (20 to 30 degree). The patient was turned only to change the diaper that he/she was wearing. The patient was then returned to the position on his/her back. The patient coughed and snored loudly. The cough was loose and in the patient's position, he/she was unable to cough anything out. The patient was continually trying to sit up. 34. Clinical record review did not reveal that the physician's order included bilateral ankle restraints. 35. Further interview with the sitter revealed that the second time the sitter was with the patient was on 4-2-06 from 7 PM until the patient expired on 4-3-06 at 3:30 am. The patient was positioned on his/her back the entire shift, except to change the diaper. The patient continued to cough. The patient was continually trying to sit up and get off the bed. The physician came to see the patient between 8 and 8:30 PM. The physician stated in front of the sitter that he was going to order Lasix IV and potassium by mouth to help the patient's breathing. The sitter confirmed that the medications were not given to the patient by the nurse before he/she expired. 36. Interview with the Guardian of sampled patient #1 on 5-23-06 at 3:35 pm revealed that the facility did not notify him/her that restraints were going to be implemented. Patient was ambulant and continent. 37. Review of the current policy and procedure for "Standards of Nursing Practice” encourages improvement of nursing care through the revision of nursing care plans; delivers nursing care based upon the nursing care plan as evidenced by effectual documentation; recognizes, reports and documents signs and symptoms of complications with accompanying action to correct or prevent further negative change, within the scope of nursing practice or as directed by physician; recognizes reports and documents changes in behavioral patterns with accompanying action to correct or prevent further negative change, within the scope of nursing practice or directed by physician; performs treatment procedures in compliance with hospital and nursing service policies and procedures; and administers medications and intravenous therapy in compliance with hospital and nursing service policies and procedures. 38. Review of the current policy and procedure for "Skin Integrity" revealed that the policy is used for prevention and/or treatment and is essential upon the initial nursing assessment. Upon subsequent re-assessment, the nurse will identify and implement the appropriate plan of care and protocol. The nurse will contact wound care services. 39. Review of the current policy and procedure for "Assessment /Reassessment" revealed that this was initiated as to define the scope of assessment by each discipline in the 12 assessment and reassessment process; to provide same standard of care 24 hours per days 7 days per week; and to provide on- going, relevant data pertaining to the patient's biophysical, psychological, and environmental, throughout the continuum of care. The routine reassessment of the patient's status includes a system review every shift. The reassessment process is ongoing throughout the patient's course of hospitalization and involves the interdisciplinary team based on the identified needs of the patients. 40. Review of the current policy and procedure for "Restraint" revealed that the patient has the right to be free from restraints of any form that are not medically necessary or are used as convenience. There is a physical restraint and _ chemical restraint. The order will be obtained prior to application of restraint. Immediately after the application of restraints for acute medical and surgical care, the RN will assess the patient for levels of distress, agitation. The use of restraints should be frequently evaluated and ended at the earliest possible time based on the assessment and reevaluation of the patient's condition. 41. The RN who is responsible for the patient’s care determines if the patient meets the criteria set for discontinuation of the restraint. Within 1 hour following the application of seclusions or restraint for behavior management, 13 an MD will conduct a face to face evaluation to determine the appropriateness of the application of restraint for behavioral management. If unable to contact physician must contact ED physician on duty. For risk prevention, close observation may be provided. 42. Review of the current policy and procedure for "Patient Rights" revealed that the patient, including the guardian, has the right to expect reasonable continuity and access to care. The non-discriminatory policy states that quantity and quality of services to patient will be given. The patient has the right to personal safety within the confines of the hospital. 43. Interview with the Director/VP compliance officer on 5-18-06 at 11:00 am revealed that the facility was aware of the non-compliance and are actively correcting the issues. 44, Interview with the Chief Executive Officer on 5-18-06 at 4:00 pm revealed that there are administrative changes occurring at the moment and the facility is expeditiously intending to remove any non-compliance. The reorganization should not take much longer. The administration had initiated plans for the 6‘ floor south tower, but clearly the plans are not working. Therefore, the closure of the unit is imminent. There is a governing board meeting occurring in the week of the 5-22-06 and the facility will be implementing a revised 14 restraint policy, there is a new Risk Manager commencing employment in the same week. The Registered Nurse on the unit of sampled patient #1 was terminated. The CEO confirmed the findings. 45. Based on the foregoing, Aventura Hospital and Medical Center violated 59A-3.254(4), Florida Administrative Code (2005), which warrants an assessed fine of $6,000.00 ($1,000.00/day for 6 days). COUNT IIT AVENTURA HOSPITAL AND MEDICAL CENTER FAILED TO PROVIDE A REASSESSMENT OF PATIENT’S CARE NEEDS AND HEALTH STATUS. RULE 59A-3.2085(5) (b), FLORIDA ADMINISTRATIVE CODE (NURSING SERVICE) 46. AHCA re-alleges and incorporates paragraphs (1) through (7) as if fully set forth herein. 47. An unannounced visit and a complaint investigation survey were conducted at the facility from May 18, 2006 to May 25, 2006. Based on observation, interview, facility policy and procedure, and clinical record review, it was determined that the facility failed to provide reassessing of patient's care needs as well as patient's health status and response to interventions for 5 of 8 (#1 ,#5 ,#6 ,#7 ,#8) sampled patients. The findings include the following. 48. Review of the clinical record for sampled patient #1 revealed admission to the facility on 3-28-06 for cellulitis of the foot and mental retardation. The emergency room physician's history and physical stated that the patient was alert and oriented to person, place, and time with remote and recent memory intact. Review of the medication administration record revealed that the patient received Haldol 5 mg IM on 3-28-06 at 1539. 49. The physician and triage nurse had documented that the patient was allergic to Haldol prior to administration. The triage nurse documented on 3-28-06 that the patient was combative in the emergency room and Klonopin .5 mg was administered at 2130 by mouth. Prior to admission to the hospital, the documented psychoactive medications sampled patient #1 was receiving were as follows: Risperdal 2mg by mouth twice a day for psychosis, Restoril 30 mg one by mouth at hour of sleep, Klonopin .5 mg by mouth twice a day (3pm and 9pm), Depakane 500 mg by mouth 3 times a day, and Depakote ER 500 mg one by mouth three times a day for Bipolar Disorder. The physician's orders were for 1:1 sitter, cardiac diet, Respirdal 2 mg twice daily, Clonazepam 0.5 mg twice daily (3pm and 9pm). 50. On 3-28-06 there were case management notes which revealed that the patient was continent, the patient can transfer with assistance and barely tolerates activity. There 16 is no documentation revealing that the facility attempted to inquire about pre-admission information to meet the needs of the patient prior to restraint use. Nurses’ notes did not reveal any periods of relief from the restraints. The documentation did not reveal assessment of sampled patient #1 behaviors to determine if the cause could be alleviated through clinical interventions prior to drug intervention. On 3-28-06 the nurses notes revealed that the skin integrity was red/broken and adult briefs were on and restraints, and a 1:1 sitter. Review of the restraint order did not reveal the patient was on bilateral foot restraints. 51. On 3-29-06 at 0200 the physician ordered Ativan 2 mg Iv q 4hrs prn for agitation and Rocephin 1 gm IM q 24 hours. Physician ordered Dilaudid 2 mg Im q 3 hours prn at 0115. Restraint order on 3-29-06 revealed patient is at risk for falls, aggressiveness and restlessness noted. Soft cuff bilateral restraints and a vest were ordered to "prevent accidental injury from movement." The patient was placed in restraints on 3-29-06 at 2200. There was an additional order for Clonazepam .5 mg three times a day which supersedes the previous order. 52. On 3-30-06 at 0800 the physician ordered restraints due to "high risk for falls” and documented that it was necessary to prevent accidental injury from movement. Soft cuff 17 bilateral restraints and a vest were ordered to "prevent accidental injury from movement." There is no nursing documentation indicating that the patient was moving about putting/him her at risk for accidental injury. 53. On 3-30-06 at 1935 there was an order for Thorazine 25 mg Im (intramuscular) q (every) 4 hours for agitation and increase Zyprexa to 10 mg every 4 hours by mouth. Psychiatry documented on 3-30-06 and 3-31-06 that the patient was agitated and combative. Prior to restraint use, the nursing staff did not assess sampled patient #1’s behaviors to determine if the cause could be alleviated through clinical interventions prior to restraint use nor were less intrusive interventions documented. 54. The patient received medication Ativan 2 mg for agitation on 3-30-06 at 1525 and was documented as being in physical restraints to include a vest and bilateral wrist restraints in addition to a 1:1 sitter. Nursing documented that the patient’s skin integrity was red/broken and adult briefs were on. There is no documentation revealing that the facility attempted to inquire about pre-admission information to include history of falls, or past behaviors, or interventions to meet the needs of the patient. On 3-30-06 the patient received Ativan 2 mg IM given for agitation, and a 1:1 sitter. 55. On 3-31-06 at 0800 the physician ordered restraints due to "high risk for falls” and documented that it was necessary “to prevent accidental injury from movement." Soft cuff bilateral restraints and a vest were ordered to "prevent accidental injury from movement." There is no nursing documentation indicating that the patient was moving about putting/him her at risk for accidental injury. 56. On 3-31-06 at the patient was still in physical restraints at 0600, adult brief on, skin integrity, broken and red, and a 1:1 sitter. On 3-31-06 at 0800 breath sounds were decreased. There was. no documentation by nursing staff that the physician was contacted. On 3-31-06 at 0800 patient was still in a physical restraint, skin was red, broken and adult brief was on, Ativan 2 mg IM was given, and a 1:1 sitter. On 3-31-06 at 1232 a nurse's’ note revealed that the patient is continent. On 3-31-06 at 1705 the patient was documented as being in physical restraints, skin red/broken and diaper on, Ativan 2 mg IM was given, and a 1:1 sitter. 57. On 4-1-06 at 0500 there was an order for restraints initiated by the registered nurse for preventive accidental injury from movement, not signed by the physician. There is no nursing documentation indicating that the patient was moving about putting/him her at risk for accidental injury. 58. On 4-1-06 at 2310 the patient was still in physical restraints and the skin turgor was tenting, skin character ecchymotic, and there was draining from the ulcer. The patient was documented in adult briefs, breath sounds were wheezing, Ativan 2 mg IM was given, and a 1:1 sitter. The physician increased the Thorazine to 50 mg by mouth twice a day and 50 mg every 4 hours as needed for agitation and hold if sedated. 59. There were no physician orders for the use of physical restraints, bilateral wrist restraints and vest for sampled patient #1 on 4-1-06, 4-2-06, or 4-3-06. The facility’s current policy and procedure for restraints usage stated that "an order will be obtained prior to the application of a restraint.” The nurse documented on 4-1-06 at 0800 and 2130 and on 4-2-06 at 0511 and 0800 that sampled patient #1'’s physician restraint orders were checked, and the Registered Nurse answered yes. There were no documented physician's orders for the use of restraints on the aforementioned dates. 60. On 4-2-06 the physician ordered Lasix 20 mg IV now and in the morning in addition to KCL 10 mg P.O. now at 2:30. On 4-2-06 at 0024 the breath sounds documented indicated wheezing, patient had sputum in yellow thick coloring, SPO2 was 96%. The patient was physically restrained with a vest and bilateral wrist restraints with a 1:1 sitter. 61. On 4-2-06 at 0139 patient was in the aforementioned physical restraints and there was an order placed for "Out of Bed activities to chair with assistance." On 4-2-06 at 0447 patient was given Ativan 2 mg IM for agitation and was on restraints, and a 1:1 sitter. On 4-2-06 at 0530 the patient was in diapers, bilateral wrist restraints and vest and breath sounds rales. 62. On 4-2-06 the wound care nurse assessed the patient for the integrity of the ulcer. On 4-2-06 at 0800 patient assessment was combative, pupils were sluggish, restraints were on bilateral wrist, feet and vest. On 4-2-06 at 2200 the patient remained in restraints, no vitals taken as per physician order q 4 hours. 63. On 4-2-06 at 1400 the patient had rhonchi breath sounds as per documentation. On 4-2-06 at 1800 the patient remained in a vest restraint and bilateral wrist restraints with a 1:1 sitter. At this time the patient was documented by nursing staff as having developed bilateral lower edema with loss of dorsalis pedis palpable pulses. Nurse's notes did not reveal any communication with physician. On 4-2-06 at 2000 there was drainage with the color of serosanguineous, adult briefs, Ativan 2 mg IM for agitation and restraints, and a 1:1 sitter. 64. On 4-2-06 the respiratory breath sounds were decreased bilaterally. Pupils were sluggish. On 4-2-06 at 2024 the breath sounds were decreased bilaterally, with drainage Erom ulcer. 65. On 4-3-06 at 0200, nursing documentation evidenced Dilaudid 2mg was administered, patient physically restrained, bilateral wrist restraints and vest and 1:1 sitter by side. At 0220 patient was given Ativan 2 mg IV and Dilaudid 2 mg (route unknown). At 0330 patient was found cold and not breathing. The code was not initiated until 5 minutes later as per physician and nursing documentation. Patient was pronounced dead at 0346. Patient expired while in restraints. 66. Nursing failed to document turning and positioning for 3-29-06, 3-30-06, 4-1-06, 4-2-06 and 4-3-06. Nursing failed to document the removal of sampled patient #1 bilateral wrist restraints for assessment and/or range of motion as per facility restraint policy on the following dates: on 4-1-06 at 0800, 1000, 1552, 1600 and 2130 hours; on 4-2-06 at 2000; and on 4-3-06 at 0200 hours. 67. The only nursing documentation description of patient #1's behaviors in the clinical record throughout hospitalization included agitation and combativeness. There was no documentation that other measures or interventions were Nw is) attempted to allay the patient’s symptoms other than physical and chemical restraint usage. 68. Interview by telephone on 5-25-06 at 10:30 am with the nursing assistant about patient #1 revealed that he/she was with the patient twice. The first time as per interview was on 3-31-06 from 7 PM to 7 am on 4-1-06. The sitter stated that the patient had a vest tied to the bed and wrist and ankle restraints also tied to the bed. The patient was at a low incline (20 to 30 degree). The patient was turned only to change the diaper that he/she was wearing. The patient was then returned to the position on his/her back. The patient coughed and snored loudly. The cough was loose and in the patients' position, he/she was unable to cough anything out. The patient was continually trying to sit up. 69. Clinical record review revealed that the physician's order did not include bilateral ankle restraints. 70. Further interview with the sitter revealed that the second time the sitter was with the patient was on 4-2-06 from 7 PM until the patient expired on 4-3-06 at 3:30 am. The patient was positioned on his/her back the entire shift, except to change the diaper. The patient continued to cough. The patient was continually trying to sit up and get off the bed. The physician came to see the patient between 8 and 8:30 PM. The physician stated in front of the sitter that he was going 23 to order Lasix IV and potassium by mouth to help the patient's breathing. The sitter confirmed that the medications were not given to the patient by the nurse before he/she expired. 71. Review of the clinical record review of sampled patient #5 the restraints were ordered on 5-15-06. The restraints are to be used as needed or prn basis as per physician order on 5-15-06. There was no justification filled out as to the reason for use of restraints on the patient. From 5-15-06 at 1140, 5-16-06 at 1140, 5-17-06 at 0700, 5-18-06 0400 there were orders for restraint usage in addition to the Risperdal .25 mg q 4 hrs which was never administered, according to a review of the nurse's notes. On 5-20-06 the restraint immobilization care was conducted but the patient had already been on restraints since 5-14-06. Further review of the record did not reveal any documentation of positioning while in restraints or relief. 72. Further review on 5/25/06 of the clinical record for sampled patients #1 and #5 revealed there was no evidence of documentation regarding the care or monitoring of the patients in restraints in the sampled patients’ clinical records and nurse's notes. The notes document that the restraints were checked by the nurses. The notes do not indicate that the restraints were loosened for a time or removed for a time or that the patient was observed for resistance to the restraints. 24 There was no documentation of repositioning the patients while in restraints. There was no evidence of nursing care plans for the sampled patients found in the clinical records. 73. A tour of the 6 floor was conducted on 5-18-06 at 9:00 am which revealed that there was one patient with restraints on the unit. The nurse had recently removed the restraints for sampled patient #5. Sampled patient #5 was visibly touching his/her wrists with a facial grimace. A family member was present and stated that he/she does not like the restraints and would watch his/her relative. The relative was concerned about leaving his/her relative in the facility. The surveyor inquired by interview if 1:1 sitter had been provided, relative stated no, the relative did not know he/she could request for assistance when he/she goes home. 74. Review of the clinical record for sampled patient #5 evidences that the patient was admitted to the facility on 5-4- 06 for pneumonia/UTI. On 5-5-06 the patient was transferred to IcU with change in mental status. On 5-5-06 the patient was intubated. On 5-7-06 the patient had an NG (nasal gastric) tube for feeding. On 5-7-06 the X-ray revealed that the patient had Pleural Effusion and there were no nursing notes with appropriate intervention in the clinical record. On 5-8-06 the patient was extubated and had a swallow evaluation which the patient failed. On 5-9-06 the patient had a PEG tube placed at 25 2000 with enteral feeding Glucerna started. The patient was started on Risperdal .25 mg xl stat, q 4 hrs.and nurses notes and the MAR (medication administration record) did not reveal the medication as being administered. 75. The restraints were ordered on 5-15-06. The restraints are to be used as needed or prn basis. There was not justification filled out for the reason to use restraints on the patient. From 5-15-06 at 1140, 5-16-06 at 1140, 5-17-06 at 0700, 5-18-06 0400 there were orders for restraint usage in addition to the Risperdal .25 mg q 4 hrs (according to a review of the nurse's notes). The patient was not connected to any life sustaining machinery. The patient is contracted and is cognitively impaired to time, place and person x1. 76. The restraint order for 5-18-06 at 0400 was initiated by the attending registered nurse. The nurse filled out the information where the physician must sign and stated that it was approved via telephone by the physician. On 5-20-06 the patient developed a Stage I decubitus while hospitalized. 77. On 5-23-06 and X-ray report revealed the patient had bilateral lung infiltrates. On 5-25-06 the patient was taken to the Intensive Care Unit for respiratory failure and intubated. 78. Further interview with the CNO on 5-18-06 at 1:00 PM on the 6 floor unit revealed that sampled patient #5 was not receiving the least restrictive measures for the restraints. 26 The patient was not connected to any life sustaining course of treatment. The Charge nurse failed to contact the physician to request that an order for 1:1 sitter in exchange for the wrist restraints as per the facility policy. The attending nurse wrote telephone orders as per the physician on 5-18-06 at 0400 am. The policy for standards of nursing practice and the assessment and reassessment facility policy were not followed. The CNO confirmed the findings. 79. Interview with the charge nurse on 5-18-06 at 1:20 PM revealed that the physician had not been contact for sampled patient #5 for the use of least restrictive measures of restraints. The patient was with a relative, was observed not to be attached to Jlife sustaining machinery, was on psychotropic medication, and the attending nurse did not request for a 1:1 sitter to reduce the restraint use. The reassessment to evaluate the patient's response to intervention to meet the needs of the patient was not conducted. 80. A second tour was conducted in the Intensive Care Unit (ICU) on 5-25-06 from 2:30 PM to 3:00 PM by the Director of Quality Management, ICU Nurse Manager, and the Risk Manager. During the tour of the ICU it was observed that 3 patients (#6, #7, and #8) were restrained with bilateral wrist restraints. The patients were positioned on their backs. 81. Observation of sample patient #6 on 5-25-06 at 2:30 PM revealed that the patient was positioned in the bed on his/her back. The patient was unresponsive. The patient had bilateral wrist restraints tied to the bed. There was no family present to interview. The patient had a diagnosis of infarction while undergoing a cardiac procedure in the Cardiac Catheterization unit. 82. Observation of sample patient #7 on 5-25-06 at 2:35 PM revealed that the patient was flat in bed on his/her back with bilateral wrist restraints tied to the bed. The patient was unresponsive. Surveyor interviewed the family at the bedside of sample patient #7 and the family stated that the patient had been on his/her back in the bed in the Icu, restrained at the wrists, for 6 to 7 days. The adult child of the patient stated that the patient had not been repositioned during the times that he/she had been visiting the patient. The family had been allowed to stay with the patient for 10 consecutive hours each day. The spouse of the patient confirmed the information. The patient had a diagnosis of pleural effusion. 83. Observation of sample patient #8 on 5-25-06 at 2:45 PM revealed that the patient was flat in bed on his/her back with bilateral wrist restraints tied to the bed. The patient was unresponsive. Interview with the family at the bedside of 28 sample patient #8 revealed that the patient had been on his/her back in the bed in the ICU, restrained at the wrists, for several days. The spouse of the patient stated that the patient had not been repositioned off his/her back and was restrained at the wrists. Two adult children of the patient confirmed the information., The patient had a diagnosis of respiratory failure. 84. Further review of the clinical record for sampled patients #1, 5, 6, 7, 8, revealed there was no evidence of documentation regarding the care or monitoring of the patients in restraints in the sampled patients’ clinical record and nurse's notes. The notes document that the restraints were checked by the nurses. The notes do not indicate that the restraints were loosened for a time or removed for a time or that the patient was observed for resistance to the restraints. There was no documentation of repositioning the patient while in restraints. There was no evidence of nursing care plans for the sampled patients found in the clinical record 85. The hospital's current policy and procedure for "Standards of Nursing Practice" encourages improvement of nursing care through the revision of nursing care plans; delivers nursing care based upon the nursing care plan as evidenced by effectual documentation; recognizes, reports and documents signs and symptoms of complications with accompanying 29 action to correct or prevent further negative change, within the scope of nursing practice or as directed by physician; recognizes, reports and documents changes in behavioral patterns with accompanying action to correct or prevent further negative change, within the scope of nursing practice or directed by physician; performs treatments procedures in compliance with hospital and nursing service policies and procedures; administers medications and intravenous therapy in compliance with hospital and nursing service policies and procedures. 86. Review of the current policy and procedure for "Skin Integrity” revealed that the policy is used for prevention and/or treatment and is essential upon the initial nursing assessment. Upon subsequent re-assessment, the nurse will identify and implement the appropriate plan of care and protocol. The nurse will contact wound care services. 87. Review of the current policy and procedure for "“Assessment/Reassessment" revealed that this was initiated as to define the scope of assessment by each discipline in the assessment and reassessment process; to provide same standard of care 24 hours per days 7 days per week; and to provide on going, relevant data pertaining to the patient's biophysical, psychological, and environmental, throughout the continuum of care. The routine reassessment of the patient's status include 30 a system review every shift. The reassessment process is ongoing throughout the patient's course of hospitalization and involves the interdisciplinary team based on identified needs of the patients. 88. Review of the current policy and procedure for "Restraint" revealed that the patient has the right to be free from restraints of any form that are not medically necessary or are used as convenience. There is a physical restraint and chemical restraint. The order will be obtained prior to application of restraint. Immediately after the application of restraints for acute medical and surgical care, the RN will assess the patient for levels of distress, agitation. The use of restraints should be frequently evaluated and ended at the earliest possible time based on the assessment and reevaluation of the patient's condition. The RN who is responsible for the patients care determines if the patient meets the criteria set for discontinuation of the restraint. 89. Within 1 hour following the application of seclusion or restraint for behavior management, an MD will conduct a face to face evaluation to determine the appropriateness of the application of restraint for behavioral management. If unable to contact physician must contact ED physician on duty. For risk prevention, close observation may be provided. 31 90. Review of the current policy and procedure for "Patient Rights" revealed that the patient, including the guardian, has the right to expect reasonable continuity and access to care. The non-discriminatory policy states that quantity and quality of services to patient will be given. The patient has the right to personal safety within the confines of the hospital. 91. Interview with the Director/VP compliance officer on 5-18-06 at 11:00 am revealed that the facility was aware of the non-compliance and were actively correctirig the issues. The facility had designated a new Risk Manager and employment would not’ begin until 5-22-06. 92. Interview with the Director of Quality Management on 5-25-06 at 2:45 PM confirmed that no changes had been executed since the problem of restraints had been identified on 5-18-06. 93. Based on the foregoing, Aventura Hospital and Medical Center violated 59A-3.2085(5) (b), Florida Administrative Code (2005), which warrants an assessed fine of $3,000.00 (6 days at $500.00/day) . COUNT IIT AVENTURA HOSPITAL AND MEDICAL CENTER FAILED TO ASSIGN NURSING CARE SERVICES TO MEET THE INDIVIDUAL NEEDS oF THE PATIENTS. RULE 59A-3.2085(5) (e)1.- 3., FLORIDA ADMINISTRATIVE CODE (NURSING SERVICE) 94. AHCA re-alleges and incorporates paragraphs (1) through (7) as if fully set forth herein. 95. An unannounced visit and a complaint investigation survey were conducted at the facility from May 18, 2006 to May 25, 2006. Based on observation, interview, facility policy and procedure, and clinical record review, it was determined that the facility failed to assign nursing care services to meet the individual needs of the patient for 2 of 8 (#1, #5) sampled patients. The findings include the following. 96. Review of the clinical record for sampled patient #1 revealed admission to the facility on 3-28-06 for cellulitis of the foot and mental retardation. The emergency room physician's history and physical stated that the patient was alert and oriented to person, place, and time with remote and recent memory intact. Review of the medication administration record revealed that the patient received Haldol 5 mg IM on 3-28-06 at 1539. The physician and triage nurse had documented that the patient was allergic to Haldol prior to administration. ‘The triage nurse documented on 3-28-06 that the Patient was 33 combative in the emergency room and Klonopin .5 mg was administered at 2130 by mouth. Prior to admission to the hospital the documented psychoactive medications sampled patient 1 was receiving were as follows: Risperdal 2mg by mouth twice a day for psychosis, Restoril 30 mg one by mouth at hour of sleep, Klonopin .5 mg by mouth twice a day (3pm and 9pm), Depakane 500 mg by mouth 3 times a day, and Depakote ER 500 mg one by mouth three times a day for Bipolar Disorder. The physician's orders were for 1:1 sitter, cardiac diet, Respirdal 2mg twice daily, Clonazepam 0.5 mg twice daily (3pm and 9pm). 97. On 3-28-06 there were case management notes which revealed that the patient was continent, the patient can transfer with assistance and barely tolerates activity. There is no documentation revealing that the facility attempted to inquire about pre-admission information to meet the needs of the patient prior to restraint use. Nurses’ notes did not reveal any periods of relief from the restraints. The documentation did not reveal assessment of sampled patient #1's behaviors to determine if the cause could be alleviated through clinical interventions prior to drug intervention. On 3-28-06 the nurses notes revealed that the skin integrity was red/broken and adult briefs were on and restraints, and a 1:1 sitter. Review of the restraint order did not reveal the patient was on bilateral foot restraints. 34 98. On 3-29-06 at 0200 the physician ordered Ativan 2 mg IV gq 4hrs prn for agitation and Rocephin 1 gm IM q 24 hours. Physician ordered Dilaudid 2 mg Im q 3 hours prn at 0115. Restraint order on 3-29-06 revealed patient is at risk for falls, aggressiveness and restlessness noted. Soft cuff bilateral restraints and a vest were ordered to "prevent accidental injury from movement". The patient was placed in restraints on 3-29-06 at 2200. There was an additional order for Clonazepam .5 mg three times a day which supersedes the previous order. 99. On 3-30-06 at 0800 the physician ordered restraints due to "high risk for falls" and documented that it was necessary “to prevent accidental injury from movement." Soft cuff bilateral restraints and a vest were ordered to "prevent accidental injury from movement." There is no nursing documentation indicating that the patient was moving about putting/him her at risk for accidental injury. 100. On 3-30-06 at 1935 there was an order for Thorazine 25 mg Im (intramuscular) q (every) 4 hours for agitation and increase Zyprexa to 10 mg every 4 hours by mouth. Psychiatry documented on 3-30-06 and 3-31-06 that the patient was agitated and combative. Prior to restraint use the nursing staff did not assess sampled patient #1 behaviors to determine if the cause could be alleviated through clinical interventions prior to 35 restraint use nor were less intrusive interventions documented. 101. The patient received medication Ativan 2 mg for agitation on 3-30-06 at 1525 and was documented as being in physical restraints to include a vest and bilateral wrist restraints in addition to a 1:1 sitter. Nursing documented that the patient’s skin integrity was red/broken and adult briefs were on. There is no documentation revealing that the facility attempted to inquire about pre-admission information to include history of falls, or past behaviors, or interventions to meet the needs of the patient. On 3-30-06 the patient received Ativan 2 mg IM given for agitation, and a 1:1 sitter. 102, On 3-31-06 at 0800 the physician ordered restraints due to "high risk for falls” and documented that it was necessary “to prevent accidental injury from movement." Soft cuff bilateral restraints and a vest were ordered to "prevent accidental injury from movement." ‘There is no nursing documentation indicating that the patient was moving about putting/him her at risk for accidental injury. On 3-31-06 at the patient was still in physical restraints at 0600, adult brief on, skin integrity, broken and red, and a 1:1 sitter. on 3-31-06 at 0800 breath sounds were decreased. There was no documentation by nursing staff that the physician was contacted. 36 103. On 3-31-06 at 0800 patient was still in a physical restraint, skin was red, broken and adult brief was on, Ativan 2 mg IM was given, and a 1:1 sitter. On 3-31-06 at 1232 a nurse's note revealed that the patient is continent. On 3-31-06 at 1705 the patient was documented as being in physical restraints, skin red/broken and diaper on, Ativan 2 mg IM was given, and a 1:1 sitter. 104. On 4-1-06 at 0500 there was an order for restraints initiated by the registered nurse for preventive accidental injury from movement, not signed by the physician. There is no nursing documentation indicating that the patient was moving about putting/him her at risk for accidental injury. ‘ 105. On 4-1-06 at 2310 the patient was still in physical restraints and the skin turgor was tenting, skin character ecchymotic, and there was draining from the ulcer. The patient was documented in adult briefs, breath sounds were wheezing, Ativan 2 mg IM was given, and a 1:1 sitter. The physician increased the Thorazine to 50 mg by mouth twice a day and 50 mg every 4 hours as needed for agitation and hold if sedated. 106. There were no physician orders for the use of physical restraints, bilateral wrist restraints and vest for sampled patient #1 on 4-1-06, 4-2-06, and 4-3-06. The facility's current policy and procedure for restraint usage stated that "an order will be obtained prior to the application 37 of a restraint”. The nurse documented on 4-1-06 at 0800 and 2130 and 4-2-06 at 0511 and 0800 that sampled patient Hits physician restraint orders were checked and the Registered Nurse answered yes. There were no documented physician's orders for the use of restraints on the aforementioned dates. 107. On 4-2-06 the physician ordered Lasix 20 mg IV now and in the morning in addition to KCL 10 mg P.O. now at 2:30. On 4-2-06 at 0024 the breath sounds documented indicated wheezing, patient had sputum in yellow thick coloring, SPO2 was 96%. The patient was physically restrained with a vest and bilateral wrist restraints with a 1:1 sitter. 108. On 4-2-06 at 0139 patient was in the aforementioned physical restraints and there was an order placed for "Out of Bed activities to chair with assistance." On 4-2-06 at 0447 patient was given Ativan 2 mg IM for agitation and was on restraints, and a 1:1 sitter. On 4-2-06 at 0530 the patient was in diapers, bilateral wrist vrestraints and vest and breath sounds rales. 109. On 4-2-06 the wound care nurse assessed the patient for the integrity of the ulcer. On 4-2-06 at 0800 patient assessment was combative, pupils were sluggish, restraints were on bilateral wrist, feet and vest. On 4-2-06 at 2200 the patient remained in restraints, no vitals taken as per physician order q 4 hours. 38 110. On 4-2-06 at 1400 the patient had rhonchi breath sounds as per documentation. On 4-2-06 at 1800 the patient remained in a vest restraint and bilateral wrist restraints with a 1:1 sitter. At this time the patient was documented by nursing staff as having developed bilateral lower edema with loss of dorsalis pedis palpable pulses. Nurse's notes did not reveal any communication with physician. On 4-2-06 at 2000 there was drainage with the color of serosanguineous, adult briefs, Ativan 2 mg IM for agitation and restraints, and a l:1 sitter. On 4-2-06 the respiratory breath sounds were decreased bilaterally. Pupils were sluggish. On 4-2-06 at 2024 the breath sounds were decreased bilaterally, with drainage from ulcer. iil. On 4-3-06 at 0200 nursing documentation evidenced that Dilaudid 2mg was administered, patient physically restrained bilateral wrist restraints and vest and 1:1 sitter by side. At 0220 patient was given Ativan 2 mg IV and Dilaudid 2 mg (route unknown). At 0330 patient was found cold and not breathing. The code was not initiated until 5 minutes later as per nursing and physician documentation. Patient was pronounced dead at 0346. Patient expired while in restraints. 112. Nursing failed to document turning and positioning for 3-29-06, 3-30-06, 4-1-06, 4-2-06 and 4-3-06. Nursing failed to document the removal of sampled patient #1 bilateral wrist restraints for assessment . and/or range of motion as per 39 facility restraint policy on the following dates: on 4-1-06 at 0800, 1000,1552,1600 and 2130 hours; on 4-2-06 at 2000; and on 4-3-06 at 0200 hours. 113. The only nursing documentation description of patient #1's behaviors in the clinical record throughout hospitalization included agitation and combativeness. There was no documentation that other measures or interventions were attempted to allay the patient’s symptoms other than physical and chemical restraint usage. 114. Interview by telephone on 5-25-06 at 10:30 am with the nursing assistant about patient #1 revealed that he/she was with the patient twice. The first time as per interview was on 3-31-06 from 7 PM to 7 am on 4-1-06. The sitter stated that the patient had a vest tied to the bed and wrist and ankle restraints also tied to the bed. The patient was at a low incline (20 to 30 degree). The patient was turned only to change the diaper that he/she was wearing. The patient was then returned to the position on his/her back. The patient coughed and snored loudly. The cough was loose and in the patient's position, he/she was unable to cough anything out. The patient was continually trying to sit up. 115. Clinical record review did not reveal that the physician's order included bilateral ankle restraints. 40 116. Further interview with the sitter revealed that the second time the sitter was with the patient was on 4-2-06 from 7 PM until the patient expired on 4-3-06 at 3:30 am. The patient was positioned on his/her back the entire shift, except to change the diaper. The patient continued to cough. The patient was continually trying to sit up and get off the bed. The physician came to see the patient between 8 and 8:30 PM. The physician stated in front of the sitter that he was going to order Lasix IV and potassium by mouth to help the patient’s breathing. The sitter confirmed that the medications were not given to the patient by the nurse before he/she expired. 117. Interview with the Guardian of sampled patient #1 on 5-23-06 at 3:35 pm revealed that the facility did not notify him/her that restraints were going to be implemented. Patient was ambulant and continent. 118. A tour of the 6™ floor was conducted on 5-18-06 at 9:00 am which revealed that there was one patient with restraints on the unit. The nurse had recently removed the restraints for sampled patient #5. 119. Observation of sampled patient #5 revealed that the patient was visibly touching his/her wrists with a facial grimace. A family member was present and stated that he/she does not like the restraints and would watch his/her relative. The relative was concerned about leaving his/her relative in 41 facility. The surveyor inquired by interview if 1:1 sitter had been provided, relative stated no, the relative did not know he/she could request for assistance when he/she goes home. 120. Review of the clinical record for sampled patient #5 the patient was admitted to the facility on 5-4-06 for pneumonia/UTI. On 5-5-06 the patient was transferred to Icu with change in mental status. On 5-5-06 the patient was intubated. On 5-7-06 the patient had an NG tube for feeding. On 5-7-06 the X-ray revealed that the patient had Pleural Effusion and no nursing notes for appropriate intervention were in the clinical record. On 5-8-06 the patient was extubated and had a swallow evaluation which the patient failed. On 5-9-06 the patient had a PEG tube placed at 2000 and enteral feeding Glucerna was started. The patient was started on Risperdal .25 mg xl stat, q 4 hrs and nurses notes and the medication administration record do not document that the medication was administered. 121. The physical restraints were ordered on 5-15-06. The restraints are to be used as needed or prn basis. There was no justification filled out for the reason to use restraints on the patient. From 5-15-06 at 1140, 5-16-06 at 1140, 5-17-06 at 0700, 5-18-06 0400 there were orders for restraint usage in addition to the Risperdal .25 mg q 4 hrs according to review of the nurse's notes. 122. The patient was not connected to any life sustaining machinery. The patient is contracted and is cognitively impaired to time, place and person x1. The restraint order for 5-18-06 at 0400 was initiated by the attending registered nurse. The nurse filled out the information where the physician must sign and stated that it was approved via telephone by the physician. On 5-20-06 the patient developed a Stage I decubitus while be hospitalized. 123. On 5-23-06 and X-ray report revealed the patient had bilateral lung infiltrates. On 5-25-06 the patient was taken to the Intensive Care Unit for respiratory failure and intubated. 124. Further review on 5/25/06 of the clinical record for sampled patients #1 and #5 revealed there was no evidence of documentation regarding the care or monitoring of the patients in restraints in the sampled patients’ clinical record and nurse's notes. The notes document that the restraints were checked by the nurses. The notes do not indicate that the restraints were loosened for a time or removed for a time or that the patient was observed for resistance to the restraints. There was no. documentation of repositioning the patient while in restraints. There was no evidence of nursing care plans for the sampled patients found in the clinical records. 125. Interview with the charge nurse on 5-18-06 at 1:20 PM revealed that the physician had not been contacted for sampled 43 patient #5 for the use of least restrictive measures of restraints. The patient was with a relative, was observed not to be attached to life sustaining machinery, was on psychotropic medication, and the attending nurse did not request for a 1:1 sitter to reduce the restraint use. The attending nurse did not request which considerations needed to be taken to meet the needs of the patient. No education was provided by the charge nurse to the attending registered nurse for the individual needs of sampled patient #5. 126. Review of the chart of sample Patient #1 with the Director of Quality Management and the ICU Nurse Manager on 5- 25-06 revealed that there was no evidence of monitoring of the patient while in the vest restraint and the restraints of the wrists and ankles. i127. Interview by telephone on 5-25-06 at 10:30 am with the nursing assistant that was placed with sample patient #1 as a sitter revealed that the sitter was with the patient twice. The first time was on 3-31-06 from 7 PM to 7 am on 4-1-06. The sitter stated that the patient had a vest tied to the bed and wrist and ankle restraints also tied to the bed. The patient was at a low incline (20 to 30 degree). The patient was turned only to change the diaper that he/she was wearing. The patient was then returned to the position on his/her back. The patient coughed and snored loudly. The cough was loose and in the 44 patients' position, he/she was unable to cough anything out. The patient was continually trying to sit up. 128. Further interview with the sitter revealed that the second time the sitter was with the patient was on 4-2-06 from 7 PM until the patient expired on 4-3-06 at 3:30 am. The patient was positioned on his/her back the entire shift, except to change the diaper. The patient continued to cough. The patient was continually trying to sit up and get off the bed. The physician came to see the patient between 8 and 8:30 PM. The physician stated in front of the sitter that he was going to order Lasix IV and potassium by mouth to help the patients breathing. The sitter confirmed that the medications were not given to the patient by the nurse before he/she expired. 129. Review of the current policy and procedure for "Standards of Nursing Practice" revealed encourages improvement of nursing care through the revision of nursing care plans; delivers nursing care based upon the nursing care plan as evidenced by effectual documentation; recognizes, reports and documents signs and symptoms of complications with accompanying action to correct or prevent further negative change, within the scope of nursing practice or as directed by physician; recognizes reports and documents changes in behavioral patterns with accompanying action to correct or prevent further negative change, within the scope of nursing practice or directed by 45 physician; performs treatments procedures in compliance with hospital and nursing service policies and procedures; and administers medications and intravenous therapy in compliance with hospital and nursing service policies and procedures. 130. Review of the current policy and procedure for "Skin Integrity" revealed that the policy used for prevention and/or treatment is essential upon the initial nursing assessment. Upon subsequent re-assessment, the nurse will identify and implement the appropriate plan of care and protocol. The nurse will contact wound care services. 131. Review of the current policy and procedure for "Assessment/Reassessment" revealed that this was initiated as to define the scope of assessment by each discipline in the assessment and reassessment process; to provide same standard of care 24 hours per days 7 days per week; and to provide on going, relevant data pertaining to the patient's biophysical, psychological, and environmental, throughout the continuum of care. The routine reassessment of the patient's status include a system review every shift. The reassessment process is ongoing throughout the patient's course of hospitalization and involves the interdisciplinary team based the on identified needs of the patients. 132. Review of the current policy and procedure for "Restraint" revealed that the patient has the right to be free 46 from restraints of any form that are not medically necessary or are used as convenience. There is a physical restraint and chemical restraint. The order will be obtained prior to application of restraint. Immediately after the application of restraints for acute medical and surgical care, the RN will assess the patient for levels of distress, agitation. 133. The use of restraints should be frequently evaluated and ended at the earliest possible time based on the assessment ‘and reevaluation of the patient's condition. The RN responsible for the patient's care determines if the patient meets the criteria set for discontinuation of the restraint. 134. Within 1 hour of following the application of seclusion or restraint for behavior Management, an MD will conduct a face to face evaluation to determine the appropriateness of the application of restraint for behavioral Management. If unable to contact physician must contact ED physician on duty. For risk prevention you may provide close observation. 135. Interview with the Director/vP compliance officer on 5-18-06 at 11:00 am revealed that the facility was aware of the non-compliance and were actively correcting the issues. The facility had designated a new Risk Manager and employment would not begin until 5-22-06. 47 136. Interview with the Director of Quality Management on 5-25-06 at 2:45 PM confirmed that no changes had been executed since the problem of restraints had been identified on 5-18-06. 137. Based on the foregoing, Aventura Hospital and Medical Center violated 59A-3.2085(5) (e)1.- 3., Florida Administrative Code (2005), which warrants an assessed fine of $3,000.00 (6 days at $500.00/day). COUNT IV AVENTURA HOSPITAL AND MEDICAL CENTER FAILED TO ADMINISTER MEDICATION AS ORDERED BY THE PHYSICIAN RULE 59A-3.2085(2), FLORIDA ADMINISTRATIVE CODE (PHARMACY) 138. AHCA re-alleges and incorporates paragraphs (1) through (7) as if fully set forth herein. 139. An unannounced visit and a complaint investigation survey were conducted at the facility from May 18, 2006 to May 25, 2006. Based on observation, interview, facility policy and procedure, and clinical record review, it was determined that the facility failed to administer medication as ordered by the physician for 2 of 8 (#1, #5) sampled patients. The findings include the following. 140. Review of the clinical record for sampled patient #1 revealed that on 3-28-06 at 1539 the patient was administered 48 Haldol 5 mg intramuscular (IM) in the Emergency Room as per the medication administration record. Review of the nursing documentation and the physician's history and physical revealed that the patient was allergic to Haldol. There was no documentation that the facility staff intervened after the administration of the Haldol. On 4-2-06 at 8:30 pm the physician ordered Lasix 20 mg IV now and in the morning in addition to KCL 10 mg p.o. due to the chest congestion/rales of the patient. Review of the nurses’ notes revealed that the medication was not administered. On 4-3-06, the medication administration record revealed that the registered nurse administered Klonopin img at 2218 and Ativan 2 mg IV and Dilaudid 2 mg (route of Dilaudid not documented) . The nurses’ notes revealed that the patient was unresponsive at 0325. The code was called and the team arrived approximately at 0330. The patient was pronounced dead at 0346. 141. Review of the clinical record for sampled patient #5 revealed that on 5-14-06 there were orders for Risperdal .25 mg q 4 hrs. Review of the nurses’ notes reveals that the medication was not administered. Further review of the clinical record on 5-25-06 revealed that the medication administration record showed that the medication was not administered as the physician ordered. 49 142. Based on the foregoing, Aventura Hospital and Medical Center violated 59A-3.2085(2), Florida Administrative Code (2005), which warrants an assessed fine of $1,000.00 (1 day at §1,000.00/day) COUNT V AVENTURA HOSPITAL AND MEDICAL CENTER FAILED: TO NOTIFY OF ANY DEATHS THAT OCCUR UNEXPECTEDLY WHILE A PATIENT IS RESTRAINED. SECTION 395.0197(7), FLORIDA STATUTES (FIFTEEN (15) DAY REPORTS) 143. AHCA re-alleges and incorporates paragraphs (1) through (7) as if fully set forth herein. 144. An unannounced visit and a complaint investigation survey were conducted at the facility from May 18, 2006 to May 25, 2006. Based on interview, facility policy and procedure, and clinical record review, it was determined that the facility failed to notify any deaths that occurs unexpectedly while a patient is restrained for 1 of 8 (#1) sampled patients. The findings include the following. 145. Review of external submission of the report of death in restraints did not reveal sampled patient #1 on the state report. Review of the incident reporting system on 5-18-06 at 10:03 am revealed that sampled patient #1 was included. 50 146. Review of the clinical record for sampled patient #1 shows that the patient was admitted to the facility on 3-28-06 for cellulitis and mental retardation. At 2200 patient was given Ativan 2 mg and Dilaudid 2 mg. At 0330 patient was found cold and not breathing, and the code was not initiated until five minutes later. Patient was pronounced dead at 0346. Patient expired while in restraints. 147. Interview by telephone on 5-25-06 at 10:30 am with the nursing assistant that was placed with sample patient #1 as a sitter revealed that the sitter was with the patient twice. The first time was on 3-31-06 from 7 PM to 7 am on 4-1-06. The sitter stated that the patient had a vest tied to the bed and wrist and ankle restraints also tied to the bed. The patient was at a low incline (20 to 30 degree). The patient was turned only to change the diaper that he/she was wearing. The patient was then returned to the position on his/her back. The patient coughed and snored loudly. The cough was loose and in the patients' position, he/she was unable to cough anything out. The patient was continually trying to sit up. There was no physician's order for bilateral ankle restraints. 148. Further interview with the sitter revealed that the second time the sitter was with the patient was on 4-2-06 from 7 PM until the patient expired on 4-3-06 at 3:30 am. The patient was positioned on his/her back the entire shift, except 31 to change the diaper. The patient continued to cough. The patient was continually trying to sit up and get off the bed. The physician came to see the patient between 8 and 8:30 PM. The physician stated in front of the sitter that he was going to order Lasix IV and potassium by mouth to help the patient’s breathing. The sitter confirmed that the medications were not given to the patient by the nurse before he/she expired. 149. The facility policy and procedure for "Sentinel Event” is defined as an unexpected occurrence involving the death or serious physical or psychological injury, or the risk thereof. Death due to restraints is defined by the facility as a sentinel event whether physical or pharmacologic. 150. Review of the current policy and procedure for "Patient Safety Plan" revealed the potential for unanticipated adverse occurrences affecting patients in all aspects of care/services provided within the organization. The policy defines adverse occurrences in care and services to include restraint. The frequency and appropriateness of utilization of restraints, and/or death or injury secondarily to restraint use is defined as an adverse occurrence. 151. Interview with the Risk Management employee on 5-18- 06 at 11:15 am revealed that the facility was still performing the root cause and analysis and the department has been without a Director for a period amount of time and he/she had been 52 handling all issues. The Risk management employee confirmed the findings of lack of physician signature on 2 restraint orders initiated by the nurse for sampled patient #1. The RM employee was not aware about submission within the 15 day time frame. 152. Interview with the Director/VP compliance officer on 5-18-06 at 11:00 am revealed that the facility was aware of the non-compliance and were actively correcting the issues. The facility had designated a new Risk Manager and employment would not begin until 5-22-06. The VP stated that he/she thought that the facility had more time to investigate an adverse incident. The Director and CNO confirmed the findings. 153. Based on the foregoing, Aventura Hospital and Medical Center violated Section 395.0197(7), Florida Statutes (2005), which warrants an assessed fine of $500.00. CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida Agency for Health Care Administration requests the following relief: 1. Make factual and legal findings in favor of the Agency on Counts I, II, III, IV, and V. 2. Assess against Aventura Hospital and Medical Center an administrative fine of $13,500.00 for the violations cited above. This complaint investigation survey also resulted in an 33 imposition of an Immediate Order of Moratorium on Elective Admissions. 3. Assess costs related to the investigation and prosecution of this matter, if applicable. 4, Grant: such other relief as the court deems is just and proper. Respondent is notified that it has a right to request an administrative hearing pursuant to Sections 120.569 and 120.57, Florida Statutes (2005). 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 the Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, MS #3, Tallahassee, Florida 32308. RESPONDENT IS FURTHER NOTIFIED THAT THE FAILURE TO RECEIVE A REQUEST FOR A HEARING WITHIN TWENTY-ONE (21) DAYS OF RECEIPT 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. firrte, D heap ave ourdes A. Naranjo, Esq. Florida Bar No.: 997315 Assistant General Counsel Agency for Health Care Administration 8350 N.W. 52 Terrace - #103 Miami, Florida 33166 34 Copies furnished to: Harold Williams Field Office Manager Agency for Health Care Administration 8355 N. W. 53 Street Miami, Florida 33166 (Interoffice Mail) Jean Lombardi Agency for Health Care Administration Finance and Accounting 2727 Mahan Drive, Mail Stop #14 Tallahassee, Florida 32308 (Interoffice mail) Hospital Program Office Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #31 Tallahassee, Florida 32308 (Interoffice mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true copy hereof was sent by U.S. Mail, Return Receipt Requested to Heather Rohan, Chief Executive Officer, Aventura Hospital and Medical Center, 20900 Biscayne Boulevard, Aventura, Florida 33180; Miami Beach Healthcare Group, Ltd., P. O. Box 750, Nashville, Tennessee, 37202; CT Corporation System, 1200 South Pine Island Road, Plantation, Florida 33324 on this Jo day of 2006. [er ele, Grbereupp urdes A. Naranjo, Esq. 35 —_ SENDER: COMPLETE THIS SECTION COMPLETE THIS SECTION ON DELIVERY = Complete items 1, 2, and 3. Also complete Ag re a 7 item 4 if Restricted Delivery is desirad., x ("9 ! Titans sent U.S. Postal Servicer l@ Print your name and address on the reverse ; so that we can retim the card to you. B, Received by ( Printad! Nama) afe of Dilivg CERTI FIED MAIL», REC @ Attach this card to the back of the mailptece, Who (Domestic Mail Only; No insurance ci or on the front if space permits. D,, 's delivery address different from item 197’ EI Yee rorcellvery information visit our website 4 Article Addressed to: it YES, enter delivery address below: C].No OFFICIAL © lg Ed Heaahar Mohan I Cortiflad Fee jarvica Type : 1 Certified Mail 1 Express Mall 1F-Registered Return Receipt for Merchandise. Cinsured Mat =O c.0.0.; tricted Delivery? (Extra Fea) “ D Yes Ratum Reclept Fea (Endorsement Required) Restricted Dalivery Fea (Endorsement Required) Total Postage & Fees rant Toy iy C) a ~2ACPRO3-2-0085 + al Ad ranster irom service label): i: i toothy 8.0500 Procaume. | {PS Form 3811, August 2001 Domestic Retum Recelpt " i ten Chinen, Ch Oa “ PS Form 3800, June 2002 TAA DLL 2 - SENDER? COMPLETE THIS SECTION COMPLETE THIS SECTION ON DELIVERY a Complete itams 4, 2, and 9. Also complete A. Signature. “ : item 4 if Restricted Delivary is desired, 2 _A CJ Agent @ Print your name and address on the feverse xX ¥ ; 3 So that we can return the card to you, Fl Adresses 7002 2440 o001 4235 4a? Rohan [One 7002 2420 OO01 4235 048 ‘Siraat, Apt Wi pep © Attach this card to the backer to mailpiece, 3 Resehved by (Printed Name) [6 Data of Davary U.S. Postal Servicer OF on the front if space permits, ‘ zx CERTIFIED MAIL. R 1. Anlicla Addressed to: D. Is delivery address differant from item 1? O Yes oo PGES an Er Only; No Insuranc} if YES, enter delivery addrpss below: CT No fo] . in Me cunt Wealth CONe - Kp aS m “he om or ru " ° { ar EB —— q Cortiad Fe | o ones Fee 7 Express Malt “Tl endarsomant neat eee aes ies pt for Merchandise ; a7 CI Restreted Dalivery Fea H a (Endorsement Required) Ol Yes fu fu a ‘ B Complete items 1, 2, and 3. Also complete . item 4 if Restricted Delivery Is desired, . | CERTIFIED MAI Lm RECEI tint Your name and address on the reverse Addressee { | i | | | | So that we can return the card to you, . Atiach this card to the back of the mailpieco, 2, Date at Delivery For delivery information visit our website at OF on the front if space permits, 2-tF TOGA LL (1 amcteacaesseaw: Ey apis ciferent fom item? CT Yes Oo E E IWYBS, ent? delivery address below: CO No Postage Certified Fea ‘atum Raciept Fee {Enddrsement Required) Rastrictad Dellvery Fae (Endorsement Alaquired) - 8. 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Docket for Case No: 06-002900