STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case No. 2014010390 ACE HOMECARE LLC d/b/a ACE HOMECARE, 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, ACE HOMECARE LLC d/b/a ACE HOMECARE (hereinafter “the Respondent”), pursuant to Sections 120.569 and 120.57, Florida Statutes (2013), and alleges as follows: NATURE OF THE ACTION This is an administrative action against a home health agency to impose an administrative fine in the amount of SIXTY THOUSAND DOLLARS ($60,000.00) pursuant to Section 400.484(2)(a), Florida Statutes (2013) based on four (4) Class I deficiencies. JURISDICTION AND VENUE 1, This Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2013). 2. The Agency has jurisdiction over the Respondent pursuant to Sections 20.42 and 120.60, Florida Statutes (2013); Chapters 408, Part II, and 400, Part II, Florida Statutes (2013), and Chapter 59A-8, Florida Administrative Code. 1 3. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code. PARTIES 4. The Agency is the licensing and regulatory_authority that_oversees_home_health agencies and enforces the applicable federal and state statutes, regulations and rules governing home health agencies. Chapter 408, Part IT, and Chapter 400, Part III, Florida Statutes (2013), and Chapter 59A-8, Florida-Administrative Code. The Agency is authorized to deny, revoke, or suspend a license, or impose an administrative fine for violations as provided for by Sections 400.474, and 400.464, Florida Statutes (2013), and Rules 59A-8.003 and 59A-8.0086, Florida Administrative Code. 5. The Respondent was issued a license by the Agency (License No. 299991018) to operate a home health agency located at 5268 Summerlin Commons Way, Unit 504, Fort Myers, Florida 33907, and was at all material times required to comply with the applicable federal and state statutes, regulations and rules for home health agencies. COUNTI The Respondent Failed To Ensure The Quality Assurance Information Was Utilized To Improve Services In Violation Of Rule 59A-8.0095(2)(e), Florida Administrative Code 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 7. Pursuant to Florida law, the director of nursing shall establish and conduct an ongoing quality assurance program. The program shall include at least quarterly, documentation of the review of the care and services of a sample of both active and closed clinical records by the director of nursing or his or her delegate. The director of nursing assumes overall responsibility for the quality assurance program. The quality assurance program is to assure that: 1. The home health agency accepts patients whose home health service needs can be met by the home health agency; 2. Case assignment and management is appropriate, adequate, and consistent with the plan of care, medical regimen and patient needs. Plans of care are individualized based on the patient’s needs, strengths, limitations and goals; a 3. Nursing and other services provided to the patient are coordinated, appropriate, adequate, and consistent with plans of care. 4. All services and outcomes are completely and legibly documented, dated and signed in the clinical service record; 5. The home health agency’s policies and procedures are followed; 6. Confidentiality of patient data is maintained; and 7, Findings of the quality assurance program are used to improve services. Rule 59A-8.0095(2)(e), Florida Administrative Code. 8. On or about January 6, 2014 through January 10, 2014, the Agency conducted a Relicensure Survey of the Respondent's facility. 9. Based upon clinical record review, interview and policy review, the Home Health Agency's Director of Clinical Services (DCS) and/or Alternate Director of Clinical Services (ADCS) failed to implement the policy in place for clinical record review. The DCS and ADCS attend the Administrator/Director of Clinical meeting and monthly Professional Advisory meeting and is aware of a concern with hospital readmission rates. The Home Health Agency failed to ensure records for patients transferred to the hospital were included in the monthly record reviews. The failure in tracking and trending hospitalization rates alone and failing to review care being provided places all patients at risk for receiving substandard quality of care, serious illness, injury or even death. The ADCS was informed of actual harm occurring on day 4 of the survey, there was no immediate action taken to prevent future occurrences. 10. Procedure revised January 2009 documents the process as follows: At least quarterly, a random sampling of 10% of annual unduplicated admissions of medical records will 3 be selected for review by representation from all disciplines. This sampling will contain all disciplines offered by the Agency and current and discharged records to determine whether established policies are followed in furnishing services directly_or-under-arrangement—Minutes of each meeting will document the discipline-specific participants, findings of record reviews and reporting to the Professional Advisory Committee. The medical record documentation will be reviewed. The results of the review will be combined into a summary report. The results will be analyzed through the performance improvement committee and presented to the Board of Directors, Professional Advisory Committee and Appropriate Agency staff. 11. Record review indicators for data and information contained within the record include: Plan of care; following established Agency policy; timeliness; legibility of documentation; quality, consistency, clarity, accuracy and completeness; services rendered and need for continued care. 12. The clinical record review process will review and evaluate patient/client care to identify and analyze the use of staff and services necessary to render care in compliance with the Agency's policies. This will include evaluation of prevailing professional standards, including their necessity, appropriateness, adequacy, and effectiveness. Identified concerns in the area of quality of care or patient safety will be referred to the appropriate person for action. The routine examination of previous review findings will be utilized to determine focus and assure quality of patient/client care. 13. Staff compliance with hand-off communication is monitored through utilization review/record review of "Case conferences involving all disciplines involved in care," "60 day summary report completed/copy to MD," "Record reflects appropriate MD notification." Staff compliance with medication reconciliation is monitored through utilization/record review of "Mediation profile updated with changes." 14. During an interview with the assistant director of clinical services, who has been 4 in charge of the Lee office since September, 2013, during the course of the survey to include 1/9/14 around 9 a.m. she said the process for record review has changed. She said since she has been in the office the clinical record_review_process_is_that-each_of the-clinical_coordinators ——_____—— randomly selects records to be audited. She said they do not write down the names of patient records that have been audited. She said after they audit the record, the tool is placed back into the medical record and that is why she is unable to know the number of records audited and/or what patients have been audited. She said for patients that have been transferred to the hospital the process is as follows: The staff member who is aware of the patient being admitted to the hospital calls the clinical coordinators/marketing staff. The clinical coordinator then places the patients name on a white board and calls the admitting hospital to inform the case manager it is * "their patient." A transfer to the hospital is completed. The patients name is taken off of the board if the patient is re-admitted to the home health agency or the certification period runs out. She said the records of patients transferred to an acute care setting are not routinely audited. 15. There is no indication a record review for Patient #6 was completed after being transferred to a higher level of care. There is no indication a record review for Patient #4 was > completed after being transferred to a higher level of care. A lack of coordination of care, skilled staff not following the physician directed plan of care and multiple staff not alerting the physician of changes in the patient’s condition contributed to Patient #4 and Patient #6 being transferred to an acute care setting. 16. During a phone interview on 1/13/14 around 1:45 p.m., the owner said if there are issues with clinical staff not following the plan of care or coordinating care, a variance would be completed and appropriate action plans would be put into place. It does not appear that variances are compiled or evaluated for trends, A review of the Professional Advisory Committee Meeting dated October 13, 2013 documents 10 current patients were discussed. Due to limitations, the follow-up discussion regarding evaluation and recommendations for care coordination among the 5 team for patient care will be deferred for next meeting in the 1st quarter 2014. i 17. During an interview with the alternate director of clinical services during most of i the day on 1/9/14 it was difficult to obtain inf ion related to the Quality Improvement Process. Upon exit of the facility around 3:00 p.m. on 1/9/14 the alternate director of clinical | services was informed regarding identification of harm for Patient #6. It was requested that upon entrance back at the facility on 1/10/14 a final attempt at obtaining information regarding the Quality Improvement Process would be discussed. Upon entrance into the facility on 1/10/14 a final interview was obtained in an attempt to understand the Quality Improvement Process. 18. The Respondent’s act, omission, or practice that results in a patient's death, disablement, or permanent injury, or places a patient at imminent risk of death, disablement, or permanent injury and constitutes a Class I violation in accordance with Section 400.484(2)(a), Florida Statutes (2013). 19. Upon finding a Class I deficiency, the agency shall impose an administrative fine in the amount of $15,000.00 for each occurrence and each day that the deficiency exists pursuant to Section 400.484(2)(a), Florida Statutes (2013). : WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration intends to impose an administrative fine against the Respondent in the amount of FIFTEEN THOUSAND DOLLARS ($15,000.00) based upon a Class I deficiency pursuant to Section 400.484(2)(a), Florida Statutes (2013). COUNT II ; The Respondent Failed To Ensure That The Patients Received Skilled Nursing Services In Accordance With The Physician’s Written Plan Of Care And Was Responsible For The Clinical Records Of Patients Receiving Nursing Care In Violation Of Rule 59A- 8.0095(3)(a), Florida Administrative Code 20. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 21. Pursuant to Florida law, a registered nurse shall be currently licensed in the state, 6 pursuant to Chapter 464, Florida Statutes, and be the case manager in all cases involving nursing i or both nursing and therapy care. Be responsible for the clinical record for each patient receiving , nursing care; and assure that progress reports are-made-to the physician for patients receiving ] nursing services when the patient’s condition changes or there are deviations from the plan of care. Rule 59A-8.0095(3)(a), Florida Administrative Code. 22. Onor about January 6, 2014 through January 10, 2014, the Agency conducted a Relicensure Survey of the Respondent's facility. 23. Patient #6 is a 92 year old who was admitted to the Home Health Agency for an initial Certification on 6/4/13 with a primary diagnosis of Acute Chronic and Systemic Heart Failure. Patient #6 was recertified for Skilled Nursing Services on 8/3/13 with a primary diagnosis of Hypertension. A review of the Orders Discipline and Treatments documented "Report signs and symptoms of respiratory complications/hypoxia, Report weight gain of 3 Ibs. or more in one day or 5 lbs. in one week." 24. A review of the Goals for the certification period of 8/3/13 through 10/1/13 noted "Patient had an open wound all areas are healed." 25. A review of the Skilled Nursing Visit Note dated 7/11/13 documented Patient #6's weight was 165 Ibs. and the patient had a trace of edema in the right lower extremity. On 7/16/13 Patient #6 was seen in physician's office and patient’s weight was documented at 168 lbs. 26. A review of the Outcome and Assessment Information Set (OASIS) Assessment dated 7/30/13 documented the patient's weight was 166 lbs. A review of the Medication Profile noted Patient #6 was receiving the diuretic Lasix 20 milligrams (mg) daily. A review of the Skilled Nursing Visit Note dated 8/5/13 revealed no documentation of the patient's weight. Patient #6's oxygen situation was 97% on room air and the patient had +1 edema bilaterally. 27. A review of the Skilled Nursing Visit Note dated 8/13/13 revealed no documentation of Patient #6's weight. There was an increase in the patient's edema noted at +2 7 bilaterally. The nurse documented the assessment of the patient's lung sounds as being diminished. The nurse documented the patient has developed a raised blister to the Left Lower Extremity. 28. A review of the Patient Summary Note dated 8/14/13 noted the problem/current status of Patient #6 as "Small Blister to Left Lower Extremity." The form is not signed by the patient's physician. 29. A review of the Skilled Nursing Visit Note dated 8/16/13 revealed no documentation of the patient's weight. Patient #6 was noted as having +2 edema bilaterally with diminished breath sounds. 30. A review of the Skilled Nursing Visit Note dated 8/17/13 revealed no documentation of the patient's weight. The Registered Nurse (RN) documented Patient #6 has developed a blister on the Right Lower Extremity and a Licensed Practical Nurse (LPN) supervisory visit is documented by the RN. The RN instructed Patient #6 to elevate his/her leg. The nurse notes "Will follow up on Monday." The nurse documented the patient's current functional limitation as "weakness," There is no documentation on the form the physician was notified of Patient #6 having fluid overload. 31. On 8/17/13 a Verbal Order Confirmation documented "Additional Skilled Nursing Visits on 8/17/13 and 8/18/13 to perform wound care. Patient has a new wound to right ower leg. Additional 3 as needed skilled nursing visits for wound care/dressing dislodgement." There is no documentation the physician was notified Patient #6 is having weeping edema with weakness. 32. A review of the Skilled Nursing Visit Note dated 8/18/13 revealed no documentation of the patient's weight. The LPN documents Patient #6 has diminished breath sounds and has difficulty breathing at rest. The LPN documents respirations are 22. The LPN treated blisters on both of the resident's lower extremities. These blisters can be attributed to 8 weeping edema which is a sign of fluid overload. The nurse instructed the patient to elevate his/her lower extremities. There is no documentation on the form the physician was notified of Patient #6 having fluid overload. 33. A review of the Skilled Nursing Visit Note dated 8/24/13 documented Patient #6 had +2 edema bilaterally with diminished breath sounds and respirations of 22 at rest. The LPN documented the patient becomes short of breath when ambulating less than 20 feet. The LPN documented the patient's right lower extremity is draining serosaguanous fluid. This is known as weeping edema which is a clear sign of fluid overload. The nurse documents "Patient is short of breath on exertion has used inhaler. Skilled nursing instructed in slow deep breaths relaxing in chair now." No weight was obtained on 8/24/13 on Patient #6. There is no documentation on the form the physician was notified of the patient having fluid overload. 34. A review of the Skilled Nursing Visit Note dated 8/27/13 documented Patient #6 had edema bilaterally to the lower extremities. The LPN documents the patient becomes short of breath when ambulating less than 20 feet. There is no weight obtained on the patient. There is no oxygen saturation noted on the patient. The LPN documented Patient #6 has a blister on his right lower extremity draining serosanganous fluid. The LPN then documents wound care to both lower extremities and instructs the patient "to maintain dry and intact." There is no documentation of any contact with the physician of the patient having fluid overload. 35. A review of the "Skilled Nursing Visit Note" dated 8/30/13 noted the LPN documented Patient #6 has edema bilaterally to the lower extremities. The LPN documents the patient is short of breath at rest. The LPN noted "Patient is anxious and short of breath, skilled nursing instructed to deep breath relax in recliner with feet elevated." The LPN documented Patient #6's lower extremity is draining fluid which is a clear sign of fluid overload. There is no weight obtained on the patient. There is no documentation on the form the physician was notified of the patient having fluid overload. 36. A review of the Skilled Nursing Visit Note dated 9/2/13 noted the LPN documented bilateral edema that has an intact blister with serous fluid. The LPN documented Patient #6 is short of breath at r ith dimini wreath sound. The LPN documented "Skilled nursing instructed elevate legs when sitting, ambulation with walker." There is no weight obtained on the patient. There is no documentation on the form the physician was notified of Patient #6 having fluid overload. 37. A review of the Skilled Nursing Visit Note dated 9/5/13 noted the Registered Nurse (RN) documented Patient #6 has bilateral edema with shortness of breath with activities of daily living. The RN documented the patient's oxygen saturation is 92% and respirations are 20. ‘The RN noted "Patient is very anxious today. Very short of breath. Wanting to put shoes on even though short of breath." There is no weight obtained on Patient #6. A supervisory visit for the LPN is completed by the RN. There is no patient teaching documented on the form. There is no documentation on the form the physician was notified of Patient #6 having fluid overload. 38. A verbal order confirmation dated 9/8/13 and signed by the physician on 9/10/13 documented "Skilled nursing ...Continuation of wound care and Skilled nursing assessment." There is no documentation the physician was notified Patient #6 was having shortness of breath at rest with weeping edema. There is no documentation on the form the physician was notified of the patient having fluid overload. 39. A review of History of Present Illness, a note made by Patient #6's physician during a visit dated 9/10/13 at 7:19 a.m. documented the patient's weight was 190 Ibs. Patient #6 had gained 34 Ibs. in weight since being recertified on 7/30/13. The care plan was to inform the physician if the patient gained 3 Ibs. in a day or 5 Ibs. in a week. The physician notes "the patient is a 92 year old who presents for shortness of breath ..symptoms include Dyspnea, exercise intolerance, fatigue and weakness ...symptoms are relieved by rest.. Associated symptoms include weight gain and edema ...The patient is currently unable to do activities of daily living 10 ] ____a wheelchair and cant wal today and has gained a lot of weigh. suddenly..." and unable to do housework. Note for ‘shortness of breath' was accompanied by friend today, I can see the visible shortness of breath, especially when the patient tries to speak. Patient #6 is in 40. Areview of the emergency room physician's note dated 9/10/13 documented "The patient is a 92 year old who presents to the emergency department, sent from Dr's office for having elevated INR and also regained 26 Ibs. over the last month and a half. The patient has orthopnea, increasing leg swelling, generalized weakness ... Chest x-ray revealed cardiomegaly, congestive heart failure with bilateral pleural effusions ...." According to the note Patient #6 was transferred to the intensive care unit of the hospital. 41. The discharge note dated 9/25/13 documented "The patient is a 92 year old who was seen in the Emergency Department with a weight gain of 25 lbs. and an INR of 4.9, which was found in the Dr's office ...Patient was admitted to the Medical Service, diuresed, and placed on fluid restriction and was initially admitted to the intensive care unit." 42. During an interview on 1/8/13 at 1:30 p.m., the Alternate Director of Clinical Services verified the nurses should have documented Patient #6's weight on every visit either by asking the patient his/her weight or taking it themselves. The Director of Nursing verified the nurses should have notified the physician Patient #6 was having weeping edema and shortness of breath at rest. 43. During an interview on 1/9/13 at 11:00 am. RN / Staff C verified she had not obtained a weight on the patient. After reviewing her documentation on 9/5/13 she stated "The patient was very short of breath. I should have contacted the doctor." 44. During a telephone interview on 1/9/13 at 1:00 p.m. LPN / Staff B alleged she had taken Patient #6's weight, but failed to document the weights. She stated "the patient's weight would go up and come back down by the next visit." 45. Patient #10 is a 90 year old who was admitted to the Home Health Agency due to 11 a Cerebral Vascular Accident (CVA) and has a history of atrial fibrillation. 46. A review of the Physical Therapy Visit Note dated 12/18/13, written by Physical Therapist_(PT)/Staff H, documented_Patient_#10 had_a_heart_rate_of 112_-There_is_no documentation on the form there was any communication with skilled nursing regarding an abnormal heart rate. 47. A review of the Physical Therapy Visit Note dated 12/20/13 written by Staff H/PT documented Patient #6 had a Heart Rate of 113. The note documented there was a Conference with Skilled Nursing regarding "Patient Status." There is no documentation on the form that nursing was informed of the patient's abnormal heart rate. 48. A review of the Physical Therapy Visit Note dated 12/23/13 documented Patient #10's heart rate was 107. The documentation on the form shows Staff H noting a conference with Skilled Nursing regarding the patient's status. There is no documentation that nursing was informed the patient had an abnormally high heart rate. 49. A review of the Physical Therapy Visit Note dated 12/30/13 documented Staff H/PT documented Patient #10 had a heart rate of 104. The form noted a conference with Skilled nursing regarding "patient progress." There is no documentation nursing was informed of the patient's heart rate being abnormally high. 50. A review of the Physical Therapist Functional Reassessment dated 12/31/13 documented Staff H/PT recorded a heart rate of 112. There is no documentation on the form nursing was informed of the patient's abnormally high heart rate. 51. During an interview on 1/8/13 at 11:00 a.m., the Alternate Director of Clinical Services stated an apical heart rate greater than 100 should be reported to the medical doctor. She stated she sometimes wished the Physical Therapist would not take vital signs because they constantly fail to report abnormal findings to nursing. 52. During a telephone interview on 1/8/13 at.1:35 p.m., Staff H/PT verified the 12 - patient's heart rate was abnormally high and she generally took the heart rate while the patient was at rest. Staff H/PT stated she had notified Staff G/RN prior to the interview of the patient's | | | | high heart rate. She verified she had not documented this in detail on her therapy note. 53. During an interview on 1/9/13 at 9:30 am., Staff G/RN stated at first he was unaware of Patient #10 having an abnormally high heart rate. After telling him what Staff H had reported he stated "She did tell me (Patient #10) had a high heart rate. I told her (Patient #10) was no longer my patient and she should report this to the patient's nurse." Staff G verified he had never informed the physician Patient #10 had a high heart rate. 54. Patient #4 is 64 year old with a start of care date of 12/6/13. Patient #4 had a recent stroke with residual weakness and is under the care of skilled nursing and physical/ occupational therapy. The patient lives with a family member who assists with care. The patient is alert, oriented and able to make needs known. 55. Staff C completed the initial comprehensive assessment for Patient #4 on 12/6/14. Vital signs documented are apical pulse 66 and blood pressure 166/60. Nursing diagnosis and skilled nursing provided on 12/6/14 is weakness, left side. Patient to see primary doctor on "Wednesday-to call 911 if blood pressure elevated" patient to check blood pressure daily and report increase. 56. A review of the current Plan of Care documents to report variances as follows: Apical pulse greater than 100 or less than 60; Blood Pressure greater than 160/90 or less than 90/60; Respirations greater than 24 or less than 12. A Therapy note dated 12/13/13 documents the resident was feeling very tired after a doctor’s appointment and had to do a lot of walking. 57. A review of a nursing note dated 12/17/13 at 10:45 am. noted Staff C documented Patient #4's blood pressure to be 170/100 and a pulse of 120. The nurse documents the patient had therapy. There is no documentation Staff C took the vital signs again before leaving the home at 11:30 a.m. The nurse did not follow the physician directed plan of care for a 13 variance in the blood pressure and pulse. Staff C documents the patient was given high blood pressure medication (name unknown). Staff C completed the visit instructing the patient in ______ sodium content in food and to read about hypertension_and_stroke materials to help understand diet and disease process. 58. Staff E, a physical therapist, documented on a visit note dated 12/20/13 at 9:20 a.m., Patient #4's blood pressure is 141/100 and pulse is 118. The note documented the patient fatigues quickly with exercise and required frequent rest periods. There is no indication the therapist retook the patients vital signs. The therapist completed the session and left the patients home at 10:10 a.m. The physical therapist did not inform the nurse or the physician regarding the elevated blood pressure and pulse. 59. Staff F, an occupational therapist, documents on a visit note dated 12/20/13 at 12:31 p.m., Patient #4's blood pressure is 150/90 and pulse is 120. The therapist completed the visit and left the patients home at 1:12 p.m. There is no indication the therapist retook the patients’ vital signs or notified the nurse or physician regarding the elevated pulse. 60. Staff C, a registered nurse, documented on a visit note dated 12/20/13 time unknown. Patient #4's blood pressure is 160/90 with an apical pulse of 120. The nurse documents she instructed the patient a rapid heart rate over 100 is considered elevated. Patient #4 had no side effects-no Shortness of Breath (SOB) or weakness-instructed in effective circulation related to cardiac status. The nurse documents physician notified of elevated blood pressure and heart rate-to call caregiver back. There is no indication the nurse talked with the physician. The next day, 12/21/13, the physician called the patient and instructed to go to the emergency room. 61. Patient #4 was taken to the emergency room at the request of the Patient's primary physician and was admitted for a 7 day hospital stay for atrial flutter, a rapid irregular heartbeat. A review of the hospital record dated 12/21/13 documenting: The patient's Electrocardiogram (EKG) did confirm the presence of atrial flutter at an atrial rate of 220 -340 and a ventricular rate 14 of about 110. The note documented the patient describes being in a usual state of health, undergoing physical therapy for a recent stroke when the therapist noted vital signs to be elevated yesterday. Apparently _Patient_#4 was_tachycardic_and_hypertensive._Patient_#4’s primary care physician was notified and recommended the emergency department. Here in the emergency department, Patient #4 is noted to be tachycardic and quite hypertensive. Patient #4 has been started on Cardizem drip with adequate response as well as a dose of Digoxin. Patient #4 will be admitted with atrial flutter with a rapid ventricular response, appears to be new onset. 62. During an interview on 1/9/13 at 9:00 a.m. Staff C was asked if she had retaken Patient #4's blood pressure and pulse after documenting it to be high on 12/17/13, she said no, because the patient had just had physical therapy. When asked why she did not contact the physician as per the physician directed plan of care for the elevated blood pressure and pulse she said she used her judgment and did not panic with the first set of vital signs. Staff C said she has been doing this (home health) a long time and knows when to call the physician. She said when she went back for the next visit on 12/20/13 and the blood pressure and pulse was still elevated she called the doctor’s office. When asked if she was aware of the risk for the patient developing blood clots associated with atrial flutter and atrial fibrillation she said yes. Staff C stated she "goofed on this one." 63. Patient #9 goes to the Dialysis Center three times a week, Tuesday, Thursday and Saturday, for Hemodialysis. The Dialysis Center by regulatory requirement monitors pre-dialysis weight, post-dialysis weight, cardiovascular status to include hypertension, fluid status, medications, respiratory status and diet instruction. The patient is seen regularly by the Nephrologist at the Dialysis Center. The Registered Dietician instructs the patient on nutrition and diet based upon laboratory values. 64. Patient #9 has a start of care date of 3/6/2013. The patient has a primary diagnosis this recertification period, 12/31/13 through 2/28/13, of Congestive Heart Failure. Other 15 pertinent diagnoses include End Stage Renal Disease. 65. Staff J completed the recertification assessment on 12/26/13. There is no ___________ documentation the _nurse_contacted_the Dialysis_Center_to_coordinate_care._Skilled_services provided with the visit documents patient was educated on Lasix, to be taken only on non- dialysis days to reduce bilateral lower edema. There is no current physician order for the Lasix and it is not documented on the current plan of treatment. Nursing diagnosis included risk for fluid shift related to cardiomegaly, poor perfusion. Additional comments document patient has had 3 new medications, episodes of hypertension and a new symptom of bilateral lower edema. 66. A review of the plan of care documents Patient #9 to be on a regular diet, with no added salt, and no concentrated sweets. This is not a standard diet for dialysis patients. There is no documentation the nurse contacted the Dialysis Center to obtain the appropriate diet and/or fluid restriction. 67. A review of goals for the certification period of 12/31/31 through 2/28/13 include: Patient/caregiver will verbalize understanding of illness, medication action and schedule and s/s of complications related to illness to report to skilled nurse/physician by week 6. Patient/caregiver will verbalize understanding of emergent measures, infection control and safety by week 3. Patient/caregiver will verbalize the importance of compliance with diet/activities/medications in 5 visits. Patient/caregiver will verbalize understanding/knowledge of measures to relieve pain in 6 visits. Patient will verbalize/demonstrate pain level as acceptable in 7 visits. Patient will maintain skin integrity without complications or breakdown through certification period. Patient/caregiver will verbalize/demonstrate understanding of printed information given on CAD (coronary artery disease) in 9 weeks as evidenced by stating Definition of CAD; 2 warning Signs and Symptoms; Risk factors that can/cannot be Modified; Treatments and Medications. 68. Staff J completed a recertification assessment dated 10/30/13. The nursing 16 diagnosis documented at risk for injury related to hypo/hypertension, Osteoarthritis (OA), weakness, and unsteady gait. Additional comments include Patient #9 has had elevated blood pressure, poor appetite, complains of peripheral neuropathy (pain in legs related to diabetes and poor circulation), having trouble drawing up insulin, needs pen insulin system, no falls. There is no documentation during this recertification period reassessing the patient's ability to draw up the insulin or coordinating with the physician regarding an insulin pen. 69. A review of the care plan dated 11/1/13 through 12/30/13 documents the primary diagnosis to be Diabetes, DMII renal nutrition status uncontrolled. 70. A review of goals this certification period include Patient/caregiver will verbalize the importance of compliance with diet/activity/medications in 4 visits. Patient/caregiver will verbalize understanding /knowledge of measure to relieve pain in 6 visits. Patient/caregiver will verbalize/demonstrate pain level as acceptable in 7 visits. Patient will maintain skin integrity without complications or breakdown through certification period. Patient/Caregiver will verbalize understanding of measures to prevent falls in 3 visits. Patient/Caregiver will verbalize/demonstrate understanding of printed information given on DM (diabetes mellitus) in 9 _ weeks as evidenced by stating 3 s/s of hypo/hyperglycemia; stating importance of checking sugars daily and stating importance of proper disposal of needles. 71. Staff F, a licensed practical nurse, documented on 11/11/13 Patient #9 has pain in the right leg. Skilled teaching documented patient instructed to use heating pad 10-15 minutes, not direct heat to help relax muscles. There is no physician order for use of a heating pad for this patient and is contraindicated for a patient with diabetes and peripheral neuropathy. During an interview on 1/6/14 in the afternoon, the Alternate Director of Clinical Services confirmed this is not an appropriate intervention for the nurse to instruct. 72. Staff J documented on 11/27/13, Patient #9's FBS (fasting blood sugar- before eating) is 208. A review of the plan of care documents to report to the physician a random/FSBS 17 (fingers stick blood sugar) greater than 130 before meals. There is no indication this finding was reported to the physician. 73. Staff J, a registered nurse, documents on 12/12/13 a FBS of 200. There_is no indication the nurse notified the physician for the FBS greater than 130. Skilled teaching for pain management - heating pad and instructed no starches as noted in the book. 74, A review of the plan of care for the recertification period dated 9/2/13 through 10/31/13 documented Patient #9's primary diagnosis is Diabetes. (DMII Renal Nutrition status uncontrolled). 75. Staff K, a physical therapist, documented on 9/16/13 Patient #9 reported weakness and fatigue. The patient's blood glucose was 65. Patient was given 1 glass of orange juice and instructed to eat lunch. There is no indication the therapist notified the nurse, Dialysis Center or physician regarding the low blood sugar. Orange juice is contraindicated for dialysis patients. The nurse did not, as a part of the plan of care for a dialysis patient with diabetes, coordinate with the Dialysis Center or physician regarding an appropriate intervention for low blood sugar. 76. The Respondent’s act, omission, or practice that results in a patient's death, disablement, or permanent injury, or places a patient at imminent risk of death, disablement, or permanent injury and constitutes a Class I violation in accordance with Section 400.484(2)(a), Florida Statutes (2013). 77. Upon finding a Class I deficiency, the agency shall impose an administrative fine in the amount of $15,000.00 for each occurrence and each day that the deficiency exists pursuant to Section 400.484(2)(a), Florida Statutes (2013). WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration intends to impose an administrative fine against the Respondent in the amount of FIFTEEN THOUSAND DOLLARS ($15,000.00) based upon a Class I deficiency pursuant to Section 18 400.484(2)(a), Florida Statutes (2013). COUNT Ill The Respondent Failed To Follow The Plan Of Treatment As Ordered By The Physician In Violation Of Section 400.487(2), Florida Statutes (2013) And Rule 59A- 8.0215(2), Florida Administrative Code 78. The Agency re-alleges and incorporates by reference paragraphs one (1) through . five (5). 79. Pursuant to Florida law, when required by the provisions of Chapter 464; Part I, Part III, or Part V of Chapter 468; or Chapter 486, Florida Statutes, the attending physician, physician assistant, or advanced registered nurse practitioner, acting within his or her respective scope of practice, shall establish treatment orders for a patient who is to receive skilled care. The treatment orders must be signed by the physician, physician assistant, or advanced registered nurse practitioner before a claim for payment for the skilled services is submitted by the home health agency. If the claim is submitted to a managed care organization, the treatment orders must be signed within the time allowed under the provider agreement. The treatment orders shall be reviewed, as frequently as the patient's illness requires, by the physician, physician assistant, or advanced registered nurse practitioner in consultation with the home health agency. Section 400.487(2), Florida Statutes (2013). Pursuant to Florida law, home health agency staff must follow the physician, physician assistant, or advanced registered nurse practitioner’s treatment orders that are contained in the plan of care. If the orders cannot be followed and must be altered in some way, the patient’s physician, physician assistant, or advanced registered nurse practitioner must be notified and must approve of the change. Any verbal changes are put in writing and signed and dated with the date of receipt by the nurse or therapist who talked with the physician, physician assistant, or advanced registered nurse practitioner’s office. Rule 59A-8.0215(2), Florida Administrative Code. 80. On or about January 6, 2014 through January 10, 2014, the Agency conducted a Relicensure Survey of the Respondent’s facility. 81. Based on interview and record review, the Home Health Agency failed to follow the physician directed plan of care and accurately assess the weight for Patient #6, who had a known history of Congestive Heart Failure (CHF) and failed to notify patients physician of acute changes in patients condition for 4 of 12 patients surveyed, specifically Patient #6, Patient #10, Patient #4 and Patient #9, resulting in Patient #6 developing fluid overload with weeping edema and shortness of breath (SOB) and gaining approximately 32 lbs. in a 4 week period resulting in the patient being: hospitalized for 15 days and placed in the Intensive Care Unit with fluid overload. 82. Patient #6 is a 92 year old who was admitted to the Home Health Agency for an initial Certification on 6/4/13 with a primary diagnosis of Acute Chronic and Systemic Heart Failure. Patient #6 was recertified for Skilled Nursing Services on 8/3/13 with a primary diagnosis of Hypertension. A review of the Orders Discipline and Treatments documented "Report signs and symptoms of respiratory complications/hypoxia, Report weight gain of 3 lbs. or more in one day or 5 Ibs. in one week." 83. A review of the Goals for the certification period of 8/3/13 through 10/1/13 noted "Patient had an open wound all areas are healed." 84. A review of the Skilled Nursing Visit Note dated 7/11/13 documented Patient #6's weight was 165 Ibs. and the patient had a trace of edema in the right lower extremity. On 7/16/13 Patient #6 was seen in physician's office and patient’s weight was documented at 168 Ibs. 85. A review of the Outcome and Assessment Information Set (OASIS) Assessment dated 7/30/13 documented the patient's weight was 166 Ibs. A review of the Medication Profile noted Patient #6 was receiving the diuretic Lasix 20 milligrams (mg) daily. A review of the Skilled Nursing Visit Note dated 8/5/13 revealed no documentation of the patient's weight. 20 Patient #6's oxygen situation was 97% on room air and the patient had +1 edema bilaterally. 86.