STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case No. 2009010010 GENTIVA HEALTH SERVICES (CERTIFIED), INC. d/b/a GENTIVA HEALTH SERVICES, 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, GENTIVA HEALTH SERVICES (CERTIFIED), INC. d/b/a GENTIVA HEALTH SERVICES (hereinafter “the Respondent”), pursuant to Sections 120.569 and 120.57, Florida Statutes (2009), and alleges as follows: NATURE OF THE ACTION This is an action to impose an administrative fine against a home health agency in the amount of THIRTEEN THOUSAND DOLLARS ($13,000.00) pursuant to Sections 400.474 and 400.484(2)(c), Florida Statutes (2009), based upon four (4) repeat Class III deficiencies. JURISDICTION AND VENUE 1. This Court has jurisdiction over the subject matter pursuant to Sections 120.569 and 120.57, Florida Statutes (2009). 2. The Agency has jurisdiction over the Respondent pursuant to Sections 20.42 and 120.60, Florida Statutes (2009); Chapters 408, Part II, and 400, Part WWI, Florida Statutes (2009), 1 Filed March 31, 2010 3:54 PM Division of Administrative Hearings. and Chapter 59A-8, Florida Administrative Code (2009). 3. Venue lies pursuant to Rule 28-106.207, Florida Administrative Code (2009). PARTIES 4. The Agency is the licensing and regulatory authority that oversees home health agencies in Florida and is responsible for the enforcement of the applicable federal and state regulations, statutes and rules governing home health agencies pursuant to Chapter 408, Part II, and Chapter 400, Part III, Florida Statutes (2009), and Chapter 59A-8, Florida Administrative Code. The Agency may deny, revoke, or suspend a license, or impose an administrative fine, for violations as provided for by Sections 400.474 and 400.484, Florida Statutes (2009), and Rules 59A-8.003 and 59A-8.0086, Florida Administrative Code. 5. The Respondent was issued a license by the Agency to operate a home health agency in Florida (License Number 20874096) located at 5050 Tamiami Trail N., Unit B, Naples, Florida 34103, and was at all material times required to comply with the applicable federal and state regulations, statutes and rules governing home health agencies. COUNT I The Respondent Failed To Ensure That The Registered Nurse Provided Patient Care InA Prudent Manner As Ordered As Evidenced By A Lack Of Documentation To Denote . Wound Care In Violation Of Rule 59A-8.0095(3)(a), Florida Administrative Code 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 7. Pursuant to Florida law; a registered nurse shall be currently licensed in the state, pursuant to Chapter 464, Florida Statutes (2008), and be the case manager in all cases involving nursing 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 594-8.0095(3)(a), Florida Administrative Code. 8. On or about February 1, 2007, the Agency conducted a Licensure Survey of the Respondent’s Facility. 9, Based on a record review of three (3) of twenty-five (25) patients, specifically - Patient number seventeen (17), Patient number twenty (20) and Patient number twenty-two (22), the home health agency failed to ensure the registered nurse is the case manager for all care provided; ensure the registered nurse is responsible for all documentation in the clinical record; and assure the registered nurse assessed patient condition changes or deviations for the plan of care with progress reports made to the physician as needed. 10. A review of Patient number seventeen’s (17) record conducted on January 31, 2007 revealed the patient was admitted to the home health agency on December 28, 2006 with . diagnoses that include, but are not limited to Diabetes, Nephritis, and Congestive Heart Failure. The Physician orders for certification period December 28, 2006 to February 25, 2007 included, but were not limited to, medications for blood sugar control, "Starlix 120mg three (3) times a day by mouth with food if blood sugar is above 120, and Starlix 60 mg daily before meals by mouth if blood sugar is below 120" and "Blood glucose monitoring and testing with physician ordered range from 80-120." 11. A review of the Nursing notes from home visits did not include any results of blood sugars or any assessments of blood sugar levels and the use of the ordered Starlix doses. There was a section on the home visit flow sheet for applicable lab/finger sticks, values are to be noted. These sections were blank. 12. Nursing notes from the initial home visit dated December 28, 2007 indicated the paramedics were on site when the nurse arrived. The note indicated Patient number seventeen (17) had a blood sugar level of 72, was given glucose, and recovered. 13. A nursing note dated January 4, 2007 described Patient number seventeen (17) as alert, oriented to family, self and place, however, "does not know time due to lack of schooling." During this same visit the patient was taught medication management and verbalizes understanding. 14. The niece, who is the caregiver, "stated there were two (2) prescriptions to be picked up and one was an injection" The niece left to get the medication. The nurse noted the medication profile would be updated when the niece returned from the pharmacy. There was no further documentation regarding the injection. 15. In an interview with the Director of Nursing on January 31, 2007 at approximately 11:00 a.m., she confirmed the record was lacking significant documentation. 16. A review of the clinical record for sample Patient number twenty (20) revealed a start of care of January 7, 2007. The medication regimen for the patient included Lasix 20 milligrams by mouth daily; Toprol XL 25 milligrams by mouth daily; and Isordil 10 milligrams by mouth daily. 17. A review of the skilled nurse's note dated January 18, 2007 revealed documentation of a blood pressure of 94/50 sitting position, 90/60 lying down and 110/60 standing after walking. The skilled nurse further documented:" Blood pressure was low..." 18. On January 22; 2007 during the skilled visit, the nurse documented the following blood pressure; 94/50 sitting and 96/60 after walking. 19. _A further review of the nurse's note revealed that the skilled nurse provided the patient with the following instructions; " blood pressure checks: daily record, report to MD (Medical Doctor) blood pressure lower than 90/60 or higher than 160/90...Knowledgeable of when to report blood pressure to physician... Daughter with patient today agrees to check blood pressure daily." 20. In addition, during the visit dated January 29, 2007, the skilled nurse documented: _ "Emphasized the importance of self monitoring blood pressure and heart rate... report abnormals..." 21. There was no documentation in the record that the patient or family member was instructed and demonstrated competency on the technique for monitoring blood pressure or heart rate. 22. Per Nursing 2007 Drug Handbook; Lippincott, Williams, and Wilkins; Publishers, Toprol (metroprolol succinate) is a selective beta-blocker cardiac medication with an adverse reaction listed for the cardiovascular system as "Hypotension.” Lasix (furosemide) is a potent loop-diuretic medication with adverse reactions listed for the cardiovascular system as “Orthostatic Hypotension.” Isordil (isosorbide dinitrate) is a coronary artery vasodilator, nitrate, and hypotensive medication that have drug-drug interactions with other hypertensives causing a potential for an increased hypotensive effect. All these medications have listed as a nursing consideration to monitor blood pressures frequently and teach the patient to change position cautiously to avoid increased dizziness. . 23. An interview with the Director of Clinical services on February 1, 2007 at 9:45 a.m. confirmed the findings. 24. A review of Patient number twenty-two’s (22) record conducted on January 31, 2007 revealed the patient was admitted to the home health agency on December 15, 2006 with diagnoses that included but were not limited to Congestive Heart Failure, Hypertension, and Malaise/Fatigue. The Physician orders for the certification period December 15, 2006 to February 12, 2007, included but were not limited to skilled nursing to provide the following: (1) "wound care..."; (2) "instruct patient to weigh self daily and notify physician of weight variation of two (2) to three (3) pounds in twenty-four (24) hours”; and (3) "notify physician of respiratory ranges and measure oxygen saturation levels at every visit and report when less than. 92%." 25... A record review revealed a physician's interim order dated December 18, 2006 for the skilled nurse to perform dressing changes to bilateral lower extremities twice a week for five (5) weeks with three (3) PRN (as needed) visits for wound complications. The skilled nurse visited Patient number twenty-two (22) on December 18, 2006, December 21, 2006, December 25, 2006, December 27, 2006, January 2, 2007, and January 4, 2007. There was no evidence in the nurse's notes of any wound assessment/condition documentation during those visits. On January 8, 2007, a wound care specialist was ordered to visit the patient to assess the wounds and perform wound care. | 26. Per the home health agency's Policy Manual 3-5 Assessment - General Information number six (6) included the following: "All patients with open wounds will have a wound assessment documented weekly or with each skilled nursing visit when the frequency is less than once per week and as necessary unless the wound is covered by a non-removable dressing." 27. A further record review revealed the patient was instructed to self weigh daily at the start of care. However, the clinical record lacked documented evidence the skilled nurse assessed the patient's weight at each visit to possibly notify the physician of any weight variation of two (2) to thrée (3) pounds within twenty-four (24) hours. 28. Nurse's notes for December 25, 2006; January 8, 2007; January 11, 2007; January 12, 2007; January 15, 2007; January 19, 2007, and January 22, 2007 failed to include any oxygen saturation levels for the skilled nurse to assess the patient's respiratory status. 29. These findings were verified by administrative staff and confirmed the lack of assessment and documentation did not meet professional standards and agency policy and procedures. 30. The Respondent’s act, omission or practice had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes. 31. The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes. 32.. The Agency provided the Respondent with a mandatory correction date of March 3, 2007. 33. On or about May 14, 2007 through May 15, 2007, the Agency conducted a Follow-Up Survey of the Annual Licensure Survey of February 1, 2007 of the Respondent's facility and determined that the above referenced deficiency had not been corrected. 34. Based on clinical record review and direct care staff interview, the home health agency failed to ensure the Registered Nurse was the Case Manager and coordinated care for one (1) of five (5) active sample patients, specifically Patient number one (1). This is evidenced by failure to maintain liaison with physician and dialysis center for sample Patient number one (1) and promptly notify the physician of significant weight loss. 35. A review of the clinical record for sample Patient number one (1) revealed a start of care date of April 4, 2007. The diagnosis included, but was not limited to, colon cancer, Diabetes Mellitus type Il and End Stage Renal Disease. Patient number one (1) underwent dialysis three (3) times a week. 36. A review of the Start of Care comprehensive assessment dated April 4, 2007 © revealed the patient had a Udall Catheter to the right upper chest for dialysis. 37. A review of the skilled nurse's notes from April 5, 2007 to April 26, 2007 revealed the following: On April 11, 2007, the skilled nurse documented Patient number one’s (1) weight to be 157 pounds. On April 13, 2007, the weight was documented to be 154 pounds. On April 23, 2007, the skilled nurse documented:" weight 150: losing weight daily." 38. | There was no evidence in the record that the skilled nurse notified the physician of the significant findings. 39. In addition, there was no documented evidence the skilled nurse contacted the dialysis center in an effort to obtain the pre and post dialysis weight in order to effectively manage the care of Patient number one (1). 40. A further review of the record revéaled on April 26, 2007 at 1:35 p.m., the occupational therapist documented Patient number one’s (1) temperature to be 103.1 degrees. The nurse was contacted and instructed the patient's wife to call the dialysis center for the fever. 41. At 4:40 p.m. on April 26, 2007, the skilled nurse visited the patient and documented a temperature of 100.8 and the patient was sent to the emergency room for possible infection of the Udall catheter. ) 42. There was no documentation in six (6) of the eight (8) skilled nurse's notes reviewed from April 4, 2007 to April 26, 2007 that the skilled nurse assessed the catheter site for signs and symptoms of complications, including infection, In addition, there was no clear documentation in the clinical record of coordination with the dialysis center regarding the.care of the catheter. 43. The above was confirmed by the Director of Clinical Services on April 14, 2007 in an interview at 11:00 a.m. 44. An interview with the Skilled Nurse on April 15, 2007 at 10:45 a.m. confirmed she didn't contact the physician or the dialysis center regarding the patient's weight loss. She further revealed the Udall catheter was the responsibility of the dialysis center and would never "touch" it. She stated she could not document any conversation with the dialysis center for fear of duplication of services. 45. The Respondent’s act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes. 46. The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes. 47. The Agency provided the Respondent with a mandatory correction date of June 14, 2007. | 48. | Onor about June 21, 2007, the Agency conducted a second Follow-Up Survey of the February 1, 2007 Annual Licensure Survey of the Respondent’s facility and determined that the above referenced deficiency had been corrected. 49. On or about July 13, 2009 through July 16, 2009 the Agency conducted a Relicensure Survey of the Respondent’s Facility. 50. Based on record review, staff interview and review of the home health agency's policies and procedures for wound care and infection control, it was determined the Registered Nurse failed to ensure adequate case management for two (2) of twenty-five (25) sampled patients, specifically Patient number sixteen (16) and Patient number eighteen (18). This is evidenced by: Failure of the nurse to consistently document the appearance and depth of the abdominal wound of Patient number sixteen (16) and failure of the nurse to follow proper infection control techniques during wound care for Patient number eighteen (18). 51. A record review on July 14, 2009 revealed Patient number sixteen (16) was admitted to the home health agency with diagnoses including, but not limited to, small bowel closure and debility. The start of care was May 30, 2009, related to an open wound to the patient's abdomen. | 52. A review of the plan of care dated May 30, 2009 revealed nursing assessment and care to Patient number sixteen’s (16) wound to the abdomen to be performed three (3) times a week. The wound was to be cleansed with normal saline, covered with calcium alginate and a foam dressing and secured with tape. . 53. A review of the OASIS (Outcome and Assessment Information Set) dated, May 30, 2009 revealed a mid abdominal wound measuring 7.5 cm x 6.0 cm with scant amount of serosanguinous drainage; edges rounded. The depth of the wound was not measured. 54. A review of the skilled nursing note dated June 1, 2009 revealed abdominal wound measurements of 7.5 cm (L) x 5.2 cm (W). The nurse indicated the wound had a small amount of tan colored discharge; however, the nurse did not document the appearance of the wound itself. 55. On June 3, 2009 a Wound Assessment Addendum was completed which measured the abdominal wound at 9.5 cm x 5.7 cm and a depth of .4 cm's. A-comprehensive description of the wound was completed. 56. A review of the skilled nursing note of June 5, 2009 revealed abdominal wound measurements by the nurse of 7.0 cm x 5.0 cm; however, she did not measure the depth of the wound nor was there any assessment of the wound's appearance. 10 57. A further review of the skilled nursing notes for the dates of June 7, 2009 and June 9, 2009 revealed the nurse measured the length and width of the abdominal wound, however, the depth of the wound was not measured. 58. On June 11, 2009, a comprehensive wound assessment was completed which revealed the wound measured 7.5 x 5.0 and 0.1 cm. A detailed description of the wound was documented. ) 59. A review of the skilled nursing notes for the dates of June 13, 2009 through June 22, 2009 and from June 29, 2009 through July 3, 2009 revealed the length and width of the abdominal wound were measured; however, the depth of the wound was not measured, There was no documentation to support an assessment of the wound's appearance. 60. A review of the home health agency's policies and procedures for wound care- assessment and documentation reveals the components of a complete wound. assessment which include location, size, appearance and drainage. The procedure indicated the company standard is to use linear measurement in three (3) dimensions; document longest head-to-toe length by widest perpendicular width by deepest vertical depth in centimeters and for shallow wounds, approximate depth. The wound base is to be described as well as wound margins which should include width and location using a "Clock face." 61. The nurse failed to consistently measure the wound's depth and failed to consistently assess and document the appearance of the wound after each treatment. 62. An interview with the home health agency administrator, who is a Registered Nurse, on July 15, 2009 at 3:45 p.m., revealed the facility's policy is to measure the patient's wounds at least once a week and to assess the appearance of the wound during each treatment. The administrator stated the nurse consultant for wound care was the nurse who performed the comprehensive assessment of Patient number sixteen’s (16) wound on June 3, 2009 and June 11, 2009, not the nurse who was treating the wound. She stated the nurse treating the wound-should have measured the depth of the wound when she measured the length and width. The administrator stated when the wound was measured the depth should be measured as appropriate. She confirmed the nurse failed to measure and assess the wound according to the home health agency's policies and procedures for wound care. 63. Patient number eighteen (18) had a start of care date of September 4, 2008 with a principal diagnosis of pressure ulcers to the hips. 64. During the home visit on July 15, 2009 at 11:00 a.m., the Licensed Nurse was observed cleaning Patient number eighteen’s (18) wounds. After sanitizing her hands with alcohol gel, the nurse took a pair of clean gloves, and blew on the gloves before applying them. The nurse started the wound care with the contaminated gloves. The nurse removed the soiled dressing from the patient's right hip and sacral ulcer using the same gloves. The nurse cleaned the right hip ulcer with wound cleanser without changing gloves. The nurse then proceeded to clean the sacral ulcer, using the same soiled gloves. The nurse asked the patient's spouse to help with the wound care and pass the clean gauze to her. The patient's spouse replied that he/she didn't have any gloves on to which the nurse replied, "its ok". The nurse allowed the spouse to handle the clean gauze with bare hands without washing or sanitizing hands. Several times during the wound care, the Licensed Nurse was observed readjusting her glasses and her hair with the gloves on and continued with the wound care. 65. On July 15, 2009 at 11:45 a.m., an interview was held with the skilled nurse at the completion of the wound care. The nurse confirmed the breeches of infection control. 66. A review of the home health agency's policy and procedure for clean technique 12 dressings revealed the nurse should remove gloves after removing the soiled dressing, cleanse hands with soap and water or a waterless hand cleanser and apply new sterile gloves. 67. The Respondent’s act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class II deficiency. Section 400.484(2)(c), Florida Statutes (2009). 68. The Respondent’s deficient act, omission or practice constitutes a repeated Class II deficiency. Section 400.484(2)(c), Florida Statutes (2009). 69. Upon finding an uncorrected or repeated Class III deficiency, the agency shall impose an administrative fine not to exceed $1,000 for each occurrence and each day that the uncorrected or repeated deficiency exists pursuant to Section 400.484(2)(c), Florida Statute (2009). 70. The Agency provided the Respondent with a mandatory correction date of August 16, 2009. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Adtinistration, respectfully requests the Court to impose an administrative fine against the Respondent in the amount of TVO THOUSAND DOLLARS ($2,000.00) based upon two (2) occurrences of a repeated Class III deficiency pursuant to Sections 400.474 and 400.484(2)(c), Florida Statutes (2009). | COUNT If The Respondent Failed To Implement Care And Did Not Follow The Plan Of Treatment In Violation Of Section 400.487(2), Florida Statutes (2008) 71. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 72. Pursuant to Florida law, when required by the provisions of Chapter 464; Part I, 13 ’ Part Il, or Part V of Chapter 468; or Chapter 486, 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 (2009). 73. Onor about February 1, 2007, the Agency conducted a Licensure Survey of the Respondent’s Facility. 74. — Based on record review and interviews, the home health agency failed to follow the plan of treatment orders for seven (7) of twenty-five (25) sampled patients, specifically Patient number thirteen (13), Patient number ten (10), Patient number eighteen (1 8), Patient number seventeen (17), Patient number twenty-two (22), Patient number twenty-three (23), and Patient number twenty-four (24). 75. Patient number twenty-two (22) was admitted to the home health agency on December 15, 2006. A review of the clinical record revealed a physician modification order written on January 9, 2007 for skilled nursing to provide services "daily for dressing changes and wound care." The clinical record lacked evidence the skilled nurse completed the required daily visits. on January 9, 2007; January 16, 2007; January 18, 2007; January 20, 2007; January 21, 2007, and January 23, 2007. Per the Physician's Plan of Care for the certification period of December 15, 2006 to February 12, 2007, skilled nursing was to “instruct the patient to weigh self daily and notify physician of weight variation of two (2) to three (3) pounds in twenty-four (24) hours" and "measure O2 saturation every visit." In the initial assessment, the skilled nurse documented Patient number twenty-two (22) was instructed to weigh self daily. However, the clinical record lacked evidence that the skilled nurse also instructed the patient to notify the physician of any weight variation of two (2) to three (3) pounds in twenty-four (24) hours. Documentation further lacked evidence the skilled nurse measured the required O. saturation at each completed visit on January 8, 2007; January 11, 2007; January 12, 2007; January 15, 2007; January 19, 2007 and January 22, 2007. Per the Physician's Plan of Care for the certification period of December 15, 2006 to February 12, 2007, physical therapy was to provide services "0 times one (1) week for one (1) week and two (2) times per week for four (4) weeks - frequency effective December 16, 2006 (2w4)." A review of the clinical record revealed for the week for December 23, 2006 through December 29, 2006, and January 6, 2007 through January 12, 2007 physical therapy completed only one (1) visit during each of those weeks instead of the two (2) visits required. A further review of the clinical record revealed the physical therapist completed a visit on January 18, 2007 to discharge the patient from physical therapy services without benefit of a physician's order for this extra visit. There was no evidence in the record of a physician's order changing the service frequency or plan of care. The administrative staff verified these findings with no explanation given for the lack of documentation in the clinical record. 76. A record review for Patient number seventeen (17) on January 31, 2007 whose diagnosis included, but were not limited to, diabetes for which the patient was receiving oral medication. The physician's orders and the plan of care revealed a goal was to maintain the blood sugar between 80-120. A review of the Nursing Notes since the admission date of December 28, 2006 did not contain any blood sugar levels or the compliance with the ordered medication for diabetes. 77. Areview of the clinical record for sample Patient number thirteen (13) revealed a start of care date of January 22, 2007 with an admitting diagnosis of Chronic Airway Obstruction. The specific orders for the skilled nurse included to measure Oxygen saturation on admission and as needed and report when less than 90%. A review of the skilled nurse's note dated January 24, 2007 revealed an oxygen saturation of 86% with oxygen on at two (2) liters. A further review of the nurse's note revealed that after laying down resting with oxygen set at two (2) liters, the oxygen saturation level remained at 89%. 78. Patient number twenty-four (24) was admitted on January 10, 2007 with a diagnosis of Chronic Airway Obstruction. Skilled nursing visits were ordered twice a week for four (4) weeks. A review of the clinical record reveals that the nurse visited twice a week the first two (2) weeks of care. The third week only one (1) skilled nursing visit was made on January 27,2007. 79. Jn an interview with the administrator on January 31, 2007 at approximately 10:15 a.m. she stated she would run a visit transaction report to verify the dates of and number of skilled nursing visits made to the patient. She later stated that the transaction report showed that the nurse did not make any additional visits the third week of care. 80. Patient number twenty-three (23) was admitted on January 6, 2007 with a diagnosis of aftercare following surgery. Home health aide visits were ordered twice a week for three (3) weeks. A review of the clinical record reveals that the home health aide failed to make any visits during the second week of care. 81. A review of the record revealed Patient number ten (10) was admitted to services 16 on January 3, 2007 with diagnoses that included, but were not limited to, Abnormality of Gait, History of Falls, and Debility. Physician's orders included, but were not limited to the following: "Skilled Nursing to provide the following: "Musculoskeletal Interventions, Respiratory Interventions, Pain Management Interventions, and Medication Management.” A review of the clinical record revealed the skilled nurse documented wound care had been provided to left forearm skin tears on January 9, 2007, January 12, 2007, and January 16, 2007 without benefit of a physician's order. 82. A review of the record revealed Patient number eighteen (18) was admitted to services on January 11, 2007 with diagnoses that included, but were not limited to, aftercare following joint surgery, total knee replacement, and therapeutic drug monitoring. Physician's orders included, but were not limited to the following: "Skilled Nursing - PT/INR via VP (venipuncture) or fingerstick 2 x weekly." Per the home health agency administrative staff, the- physician has a protocol for adjusting the coumadin dosages per the INR lab values. A review of the clinical record revealed a protocol sheet for the Coumadin changes per the INR lab values. This protocol was signed by the physician on March 10, 2006 and not specific for Patient number eighteen (18) and current certification period. A further review of the Clinical Notes documented for January 18, 2007, January 22, 2007, and January 25, 2007 revealed the skilled nurse instructed Patient number eighteen (18) to adjust the Coumadin dosage without the benefit of a valid physician's order. 83. These findings were verified by administrative staff and confirmed the protocol was not specific for Patient number eighteen (18) and current certification period, 84. The Respondent’s act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes. 85. The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes. 86. The Agency provided the Respondent with a mandatory correction date of March 3, 2007. 87. On or about May 14, 2007 through May 15, 2007, the Agency conducted a Follow-Up Survey of the Annual Licensure Survey of February 1, 2007 of the Respondents facility and determined that the above referenced deficiency had not been corrected.’ 88. Based on a record review and interviews, the home health agency failed to follow the plan of treatment orders for one (1) of six (6) sampled patients, specifically Patient number five (5). 89. A review of the clinical record for sample Patient number five (5) revealed a start of care of March 20, 2007 with a certification period from March 20, 2007 to May 18, 2007. The diagnoses included abnormality of gait and decubitus to lower back. 90. The Plan of Care included orders for the skilled nurse to visit the patient twice a week for one (1) week to: "Implement and instruct medication regimen, including dosage, side effect, name, route, frequency, desired action and adverse reactions. Assess medication compliance/medication set up.” 91. The plan of care did not include any orders for treatment of the lower back decubitus ulcer. 92. A review of the nurse's note dated March 23, 2007 revealed the skilled nurse washed wound to coccyx with soap and water, dried well and applied Duoderm patch. 93. On March 28, 2007, the skilled nurse documented instructing the patient's spouse on dressing change with skin prep. 94, An interview with the Director of Clinical Services on May 15, 2007 at approximately 11:15 a.m. revealed the nurse used the LifeSmart Care protocol for pressure ulcer as part of the Plan of Care to treat Patient number five’s (5) lower back wound. 95. There was no evidence in the record that the physician was contacted and approved the use of the protocol for the wound care. 96. The findings were confirmed by the Director of Clinical Services on May 15, 2007 at approximately 11:15 am. 97. A further review of the Plan of Care revealed orders for Physical Therapy to visit the patient twice a week for one (1) week, then three (3) times a week for three (3) weeks, 98. A review of the case communication forms revealed the physical therapist failed to visit the patient on March 26, 2007 and March 27, 2007 and then on April 4, 2007 and April 6, 2007. The reason for the missed visits was documented as "Physical Therapist was sick." 99, There was no documented evidence the home health agency attempted to reschedule the missed visits, or notified the physician of the alteration in the plan of care. 100. An interview with the Director of Clinical Services on April 15, 2007 at approximately 12:30 p.m. confirmed the findings. 101. The Respondent’s act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes. 102. The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes. 103. The Agency provided the Respondent with a mandatory correction date of June _ 19 14, 2007. 104. On or about June 21, 2007, the Agency conducted a second Follow-Up Survey of the February 1, 2007 Annual Licensure Survey of the Respondent’s facility and determined that the above referenced deficiency had been corrected. 105. On or about July 13, 2009 through July 16, 2009 the Agency conducted a Re- licensure Survey of the Respondent's facility. 106. Based on clinical record reviews and interviews, the home health agency failed to ensure care and treatments were administered as ordered by the physician. This is evidenced by Nurse's failure to clarify specific treatment orders for abdominal wound care for Patient number sixteen (16). Failure to provide wound care to pressure sores for Patient number eighteen (18) as ordered by the physician. Failure to provide care that followed the plan of treatment in seven (7) of twenty-five (25) cases, specifically Patient number two (2), Patient number four (4), Patient . number eight (8), Patient number fifteen (15). Patient number eighteen (18), Patient number twenty-one (21) and Patient number twenty-two (22). 107. A record review on July 14, 2009 revealed Patient number sixteen (16) was admitted to the home health agency with diagnoses including, not limited to, small bowel closure and debility. The start of care was May 30, 2009 related to an open wound to the patient's abdomen. 108. A review of the plan of care dated May 30, 2009 revealed nursing assessment and care to the patient's wound to the abdomen to be performed three (3) times a week. The wound was to be cleansed with normal saline; covered with calcium alginate and a foam dressing and secured with tape. 109, The record reflects ongoing wound care to the patient's abdominal wound through 20 July 3, 2009. On July 3, 2009, a communication from the nurse to the physician included, "Continue SN (Skilled Nursing) visits 3 x w (three times a week) for wound care." However, the nurse failed to specifically document what treatment to the wound would be provided. 110. An interview with the home health agency administrator, who is a Registered Nurse, on July 15, 2009, at 3:45 p.m. confirmed the order was not specific and should have reflected what treatment to the patient's wound should have been provided. 111. Patient number eighteen (18) was admitted to the home health agency on September 4, 2008, with a principal diagnosis of pressure ulcer to the hips. A review of the Home Health Certification and Plan of Care.dated June 29, 2009 revealed a specific wound care otder for each ulcer. Wound care to the left hip ulcer: Cleanse with normal saline, apply hydrogel to granulated area, apply Santyl to necrotic tissue, apply skin prep to peri-wound skin, cover with non adherent dressing and secure with Mefix tape. Wound care to the right hip ulcer: Cleanse with normal saline; may apply Skin Prep or Hydrocolloid to periwound skin PRN (as needed); Fill cavity with foam; Cover with bioclusive drape. 112. During the home visit on July 15, 2009 at 11:00 a.m., the Licensed Nurse was observed to cleanse both wounds with skin integrity wound cleanser which contained the following ingredients: purified water, sorbitol cocoamphodiacetate. The nurse did not apply the Hydrogel to the granulated area of the left hip ulcer. After cleaning the ulcer, the nurse applied Santyl to necrotic area and instructed the spouse to apply Nystatin cream to the periwound area. 113. An interview with the Licensed Nurse on July 15, 2009 at 11:45 a.m. confirmed the observation and confirmed the physician's orders were not followed for the wound care. A complete review of the record on July 15, 2009 at 12:00 p.m. failed to reveal an order for the use of Nystatin cream. 21 114. Patient number two (2) was admitted to the home health agency on December 2, 2008 with a certification period of January 31, 2009 to March 31, 2009. A review of the record ‘on July 14, 2009 revealed Physical Therapy and Occupational Therapy services were being provided. The home health agency had orders to provide Physical Therapy three (3) times per week for four (4) weeks. A review of the scheduled visits revealed Physical Therapy completed only two (2) visits during the week of February 7, 2009 to February 13, 2009 with no explanation in the record for the missed visit. There was no indication the physician was notified and approved the change in the plan of care. 115. Patient number four (4) was admitted to the home health agency on February 9, 2009. A review of the record on July 15, 2009 revealed Skilled Nursing, Physical Therapy (PT), Speech Therapy (ST), Social Service (MSW), and Occupational Therapy (OT) services were being provided. The home health agency had orders dated February 23, 2009 to provide Speech Therapy once per week for four (4) weeks. A review of the scheduled visits revealed Speech Therapy completed a visit on February 25, 2009, and missed the weeks of February 28, 2009 to March 3, 2009 and March 4, 2009 to March 10, 2009, for a total of eighteen (18) days with no explanation in the record for the missed visits. There was no indication the physician was ever notified and approved the change in the plan of care. A missed visit note was written for March 13, 2009 with notification to the physician for an additional eight (8) days before a Speech Therapy visit was completed on March 20, 2009. 116. Areview of Patient number eight’s (8) medical records was conducted on July 14, 2009. Patient number eight (8) has a start date of May 27, 2009. The home health agency has telephone orders from June 22, 2009 to provide home health aide services twice a week for one (1) week. Documentation in the clinical record revealed the week of June 21, 2009. Only one (1) 22 home health aide service was provided, not two (2) as ordered. 117. An interview with the administrator on July 16, 2009 at 9:15 a.m. revealed there was no additional information in the home health agency's system to substantiate a reason for the missed visit. 118. Patient number fifteen (15) was admitted to the home health agency on June 13, 2009, with skilled nursing providing services three (3) times per week for two (2) weeks, twice per week for two (2) weeks, and once per week for two (2) weeks. A review of the clinical record on July 14, 2009 revealed orders in the Plan of Care for the patient to "Weigh self daily and notify physician of gain of 2 Ibs." 119. During a home visit conducted on July 14, 2009, Patient number fifteen (15) was asked if the weights were being done with a reply of, "No." A review of the skilled nurse documentation for the visits completed to that date (nine (9) visits total) did not include any reference to weight documentation and/or having been completed as ordered. There was no indication the physician was ever notified and approved the change in the plan of care. 120. Patient number eighteen (18) was admitted to the home health agency on September 4, 2008, with a principal diagnosis of pressure ulcer to the hips. A review of the Home Health Certification and Plan of Care dated June 29, 2009, revealed specific wound care orders for each ulcer. Wound care to the left hip ulcer: Cleanse with normal saline, apply hydrogel to granulated area, apply Santyl to necrotic tissue, apply skin prep to peri-wound skin, cover with non adherent dressing and secure with Mefix tape. Wound care to the right hip ulcer: Cleanse with normal saline; May apply Skin Prep or Hydrocolloid to periwound skin PRN; Fill cavity with foam; Cover with bioclusive drape. 121. During the home visit on July 15, 2009 at 11:00 a.m., the Licensed Nurse was 23 observed to cleanse both wounds with skintegrity wound cleanser (purified water, sorbitol cocoamphodiacetate). The nurse did not apply the Hydrogel to the granulated area of the left hip ulcer. 122. Aninterview with the licensed nurse on July 15, 2009 at 11:45 a.m. confirmed the observation and confirmed the physician's orders were not followed for the wound care. 123. Patient number twenty-one (21) was admitted to the home health agency on March 28, 2009, with a certification period of May 27, 2009 to July 25, 2009. A review of the record on July 15, 2009 revealed skilled nursing services were being provided for wound care. Wound care to the lower leg ulcers: Cleanse with soap and water, apply Solosite and Prisma, gauze, rolled gauze, secure with tape to left and right ulcers. A review of the skilled nursing note dated June 29, 2009 revealed the nurse used wound wash (purified water, sorbitol cocoamphodiacetate) without the benefit of a physician's order. 124. An interview with the administrator on July 15, 2009 at 11:45 a.m. confirmed soap and water and wound wash were not interchangeable and should not have been used without an order. 125. Patient number twenty-two (22) was admitted to the home health agency on March 6, 2009, with a certification period of July 4, 2009 to September 1, 2009. A review of the record on July 15, 2009, revealed Skilled Nursing services were being provided for wound care once a week for nine (9) weeks. A review of the clinical record revealed a missed visit note dated July 13, 2009, with the following entry: "Scheduling miscommunication, Patient was not seen week of July 4, 2009 through July 10, 2009.” Documentation revealed the physician had not approved this change in the plan of care. A review of the schedule for the skilled nurse assigned to Patient number twenty-two (22) for the week of Saturday July 11, 2009 to Friday July 17, 24 2009 did not include this patient's name for a scheduled visit to be completed as ordered. There was no documentation in the record as to who had completed the physician ordered weekly wound care (week of July 4, 2009 through July. 10, 2009) or when the next visit would be completed. 126. The Respondent’s act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes (2009). 127. The Respondent’s deficient act, omission or practice constitutes a repeated Class III deficiency. Section 400,484(2)(c), Florida Statutes (2009). 128. Upon finding an uncorrected or repeated Class III deficiency, the agency shall impose an administrative fine not to exceed $1,000 for each occurrence and each day that the uncorrected or repeated deficiency exists. Section 400.484(2)(c), Florida Statute (2009). . 129, The Agency provided the Respondent with a mandatory correction date of August 16, 2009. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to impose an administrative fine against the Respondent in the amount of EIGHT THOUSAND DOLLARS ($8,000.00) based upon eight (8) occurrences of a repeated Class III deficiency pursuant to Sections 400.474 and 400.484(2)(c), Florida Statutes (2009). COUNT I The Respondent Failed To Ensure Effective Communication And Coordination Of Care In Violation Of Section 400.487(6), Florida Statutes (2009) 130. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). 25 131. Pursuant to Florida law, home health service agreements; physician's, physician assistants, and advanced registered nurse practitioner's treatment orders; patient assessment, establishment and review of plan of care; provision of services; orders not to resuscitate.-- The skilled care services provided by a home health agency, directly or under contract, must be supervised and coordinated in accordance with the plan of care. Section 400.487(6), Florida Statutes (2008), 132. On or about February 1, 2007, the Agency conducted a Licensure Survey of the Respondent’s Facility. 133. Based on observations during a home visit, interview, and clinical documentation review, the home health agency failed to ensure that care was coordinated for one (1) of twenty- five (25) patients, specifically Patient number fourteen (14), by not communicating physician's orders to a nurse making a first visit to the patient. 134. Patient number fourteen (14) was admitted to the home health agency on January 28, 2007 following a total knee replacement. Nursing and physical therapy are ordered for the patient, During a home visit on January 30, 2007 at approximately 9:00 a.m., the nurse was observed asking why Patient number fourteen (14) had a dressing on his/her left shin. The patient responded that he/she did not know what caused the need for the dressing there. The nurse replied that she would like to take the dressing off to see what was under it. Patient number fourteen (14) stated that the dressing was last changed by the admission nurse using supplies from the hospital. 135. The nurse removed the dressing and cleansed the wound, which resembles a skin tear from adhesive tape, and applied a clean dressing. The nurse also asked about two (2) steri strips on the shin just above the left ankle. Patient number fourteen (14) responded that he/she 26 did not know why they were there. The nurse advised that Patient number fourteen (14) leave them in place until they fall off. 136. A review of the clinical record revealed a physician's order dated January 28, 2003 containing orders for the nurse to provide wound care three (3) times a week by cleansing the wound with normal, saline, applying xeroform, and covering with Mepilex border. 137. In an interview with the administrator on January 31, 2007 she stated that the nurse should have been informed of orders and the patient status by the admission nurse, prior to making a visit to Patient number fourteen (14). The administrator stated that she does not understand how communication broke down. 138. The Respondent’s act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes. 139. The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes. 140. The Agency provided the Respondent with a mandatory correction date of March 3, 2003. 141. On or about May 14, 2007 through May 15, 2007, the Agency conducted a Follow-Up Survey of the Annual Licensure Survey of February 1, 2007 of the Respondent’s facility and determined that the above referenced deficiency had been corrected. 142. On or about July 13, 2009 through July 16, 2009 the Agency conducted a Relicensure Survey of the Respondent’s facility. 143. Based on a review of clinical records, and interviews with administrative staff, the home health agency did not ensure effective coordination and communication between services 27 providing care to two (2) of twenty-five (25) patients reviewed, specifically Patient number eleven (11) and Patient number twenty-two (22). 144. Patient number eleven (11) was admitted to the home health agency on June 9, 2009 with a diagnosis of aftercare healing of the hip. The patient had other pertinent diagnoses including, but not limited to, End Stage Renal Disease. Patient number eleven (11) received dialysis treatment three (3) times a week at a local outpatient dialysis center. A review of the Plan of Care revealed the home health agency provided nursing, physical therapy and occupational therapy services to Patient number eleven (11). The Plan of Care revealed documentation that the patient's nutritional requirement was a regular diet. 145. During the home visit on July 14, 2009 at 11:00 a.m., it was revealed Patient number eleven (11) had been on a low potassium diet prior to the admission to the home health agency. Patient number eleven (11) further revealed that he/she had regular laboratory blood tests at the dialysis center and diet changes were made according to the laboratory result. The patient maintained documentation of the laboratory results at home and followed the instructions provided by the dialysis center. A complete review of the record failed to reveal any documentation of communication between the dialysis center and the home health agency to support the objectives listed in the Plan of Care. 146. An interview with the administrator on July 14, 2009 at 12:30 p.m. revealed the office is supposed to do a case communication that shows coordination of care between the home health agency and the dialysis center. The administrator added that the nurse "Should know better." A further review of the record revealed on July 1, 2009, the nurse documented in her note that Patient number eleven (11) had been taking Dilaudid for two (2) weeks and was having problems with bowel functions. The nurse further noted that she would contact the physician on 28 July 6, 2009 if Patient number eleven (11) was not more regular. The last bowel movement was on June 30, 2009 and Patient number eleven (11) felt like he/she was not emptying the bowels completely. 147. On July 8, 2009, two (2) missed visits were in the record indicating Patient number eleven (11) had refused both the skilled nurse's visit and the physical therapist's visit. The missed visit note from the therapist indicated that Patient number eleven (11) was constipated and very upset. In the "Notification" section of the missed visit note, a box was checked indicating the physician vas notified via fax. There was no other documentation in the record indicating a follow up to the initial faxed message to the physician. 148. On July 14, 2009 at 11:00 a.m., during the home visit, the Physical Therapist revealed on July 8, 2009 she did not contact the physician herself but had communicated to the nurse that Patient number eleven (11) was on the toilet, crying due to the pain from the bowels. 149. On July 14, 2009 at 12:30 p.m. an interview was held with the administrator. She revealed the home health agency did not have any documentation indicating they had followed up with the physician regarding Patient number eleven’s (11) complaint. The administrator stated that it looked like the licensed nurse did not follow up on this problem. 150. Patient number twenty-two (22) was admitted to the home health agency on March 6, 2009 with diagnoses that included, but were not limited to the following: Pressure Ulcers and Anoxic Brain Damage. A review of the clinical record on July 15, 2009 revealed the patient was receiving nursing care from the home health agency for wound care. Patient number twenty-two (22) was being provided care from a dialysis center three (3) times per week. There was no evidence in the record indicating the home health agency and the dialysis ‘center communicated about coordination of care for Patient number twenty-two (22) with regard to this 29 patient's wound, possible changes in the dietary requirements related to wound healing, and how to best to meet the needs of this patient. A further review of the clinical record for sample Patient number twenty-two (22) revealed a skilled nurses case communication note dated June 25, 2009, to the physician with the following documentation: "After review of medicines - Parent reports administering Lamotrigine (anticonvulsant) 225 mg in a.m. and 150 mg. in p.m. However, orders read Lamotrigine 150 mg. in a.m. and 100 mg in p.m. Please advise Parent." A review of the clinical record failed to include any documentation that the nurse communicated with the physician and followed-up with regard to the correct anticonvulsant medication dose. 151. The Respondent's act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes (2009). 152. The Respondent’s deficient act, omission or practice constitutes a repeated Class Ill deficiency. Section 400.484(2)(c), Florida Statutes (2009). 153. Upon finding an uncorrected or repeated Class III deficiency, the agency shall impose an administrative fine not to exceed $1,000 for each occurrence and each day that the uncorrected or repeated deficiency exists. Section 400.484(2)(c), Florida Statute (2009). 154. The Agency provided the Respondent with a mandatory correction date of August 16, 2009. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to impose an administrative fine against the Respondent in the amount of TWO THOUSAND DOLLARS ($2,000.00) based upon two (2) occurrences of a repeated Class III deficiency pursuant to Sections 400.474 and 400.484(2)(c), Florida Statutes (2009). 30 COUNT IV The Respondent Failed To Develop A Plan Of Care That was Complete And Accurate In Violation Of Rule 59A-8.0215(1), Florida Administrative Code 155. The Agency re-alleges and incorporates by referencé paragraphs one (1) through five (5). 156. Pursuant to Florida law, a plan of care shall be established in consultation with the physician, physician assistant, or advanced registered nurse practitioner, pursuant to Section 400.487, Florida Statutes (2009), and the home health agency staff who are involved in providing the care and services required to carry out the physician, physician assistant, or advanced registered nurse practitioner’s treatment orders. The plan must be included in the clinical record and available for review by all staff involved in providing care to the patient. The plan of care shall contain a list of individualized specific goals for each skilled discipline that provides patient care, with implementation plans addressing the level of staff who will provide care, the frequency of home visits to provide direct care and case management. Rule 59A- 8.0215(1), Florida Administrative Code. 157. On or about February 1, 2007, the Agency conducted a Licensure Survey of the Respondent’s Facility. 158. Based on record review and interview with the administrator, the home health agency failed to ensure that the physician's Plan of Care was specific, complete, and accurate for one (1) of twenty-five (25) patients reviewed, specifically Patient number eighteen (18). 159. .A review of the record revealed Patient number eighteen (18) was admitted to services on January 11, 2007 with diagnoses that included, but were not limited to, Aftercare following Joint Surgery, Total Knee Replacement, and Therapeutic Drug Monitoring. Physician's orders included but not limited to the following: "PT/INR via VP (venipuncture) or 31 fingerstick 2 x weekly." 160. Per the agency administrative staff, the physician has a protocol for adjusting the coumadin dosages per the INR lab values. 161. The-Plan of Care did not include this Coumadin protocol under number ten (10) "Medications: Dose/Frequency/Route" and failed to include these directions to the skilled nurse under number twenty-one (21) "Orders for Disciplines and Treatments..."were included Home Health Aide: twice a week for four (4) weeks". No other orders or directions are provided to indicate what the Skilled Nurse was to instruct the patient on "Medication Compliance/Med Set- up." 162. These findings were verified by administrative staff and confirmed the Plan of Care was incomplete and did not contain all the documentation necessary to provide appropriate cate. 163. The Respondent’s act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes (2006). 164. The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes. 165. The Agency provided the Respondent with a mandatory correction date of March 3, 2007. 166. On or about May 14, 2007 through May 15, 2007, the Agency conducted a Follow-Up Survey of the Annual Licensure Survey of February 1, 2007 of the Respondent’s facility and determined that the above referenced deficiency had not been corrected. 167. Based on record review and interview with the administrator, the home health 32 ‘ agency failed to ensure that the physician's Plan of Care was specific, complete, and accurate for one (1) of six (6) patients reviewed, specifically Patient number five (5). 168. A review of the clinical record for sample Patient number five (5) revealed a start of care of March 20, 2007 with a certification period from March 20, 2007 to May 18, 2007. The diagnoses included abnormality of gait and decubitus to lower back. 169. The Plan of Care included orders for the skilled nurse to visit Patient number five (5) twice a week for one (1) week to: "Implement and instruct medication regimen, including dosage, side effect, name, route, frequency, desired action and adverse reactions. Assess medication compliance/medication set up." 170. The plan of care did not include any orders for treatment of the lower back. decubitus ulcer. . 171. Areview of the nurse's note dated March 23, 2007 revealed the skilled nurse washed wound to coccyx with soap and water, dried well and applied Duoderm patch. 172. On March 28, 2007, the skilled nurse documented instructing Patient number five’s (5S) spouse on dressing change with skin prep. 173. Aninterview with the Director of Clinical Services on May 15, 2007 at approximately 11:15 a.m. revealed the nurse used the LifeSmart Care protocol for pressure ulcer as part of the Plan of Care to treat Patient number five’s (5) lower back wound. 174. There was no evidence in the record that the physician was contacted and approved the use of the protocol for the wound care. 175. ‘The findings were confirmed by the Director of Clinical Services on May 15, 2007 at approximately 11:15 a.m. 176. The Respondent’s act, omission or practice, had an indirect, adverse effect on the 33 health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes. 177. The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes. 178. The Agency provided the Respondent with a mandatory correction date of June 14, 2007. 179. Onor about June 21, 2007, the Agency conducted a second Follow-Up Survey of the February 1, 2007 Annual Licensure Survey of the Respondent’s facility and determined that the above referenced deficiency was corrected. 180. On or about July 13, 2009 through July 16, 2009 the Agency conducted a Re- licensure Survey of the Respondent’s Facility. 181. Based on record review and interview, the home health agency failed to develop a Plan of Care that includes all appropriate items required for one (1) of twenty-five (25) patients reviewed, specifically Patient number eleven (11). 182. Patient number eleven (11) had a start of care date of June 9, 2009 with a principal diagnosis of aftercare following hip surgery. Other pertinent diagnoses included, but were not limited to End Stage Renal Disease. A review of the Plan of Care dated June 5, 2009 tevealed Patient number eleven (11) had a dialysis access which is maintained at outpatient dialysis center. The Plan of Care did not specify the type or location of the dialysis access site. This pertinent information is necessary to ensure home health agency personal are familiar with the type and location of access site (fistula, graft or catheter) and ensure access area is free of signs and symptoms of infection and complications. A further review of the Plan of Care revealed Patient number eleven’s (11) nutritional requirement was a regular diet. 34 183. During the home visit on July 14, 2009 at 11:00 a.m. Patient number eleven (11) and spouse revealed the patient had been adhering to a diabetic diet and a low potassium diet due to the end stage renal disease status. Patient number eleven’s (11) spouse revealed that they get the diet modification information from the dialysis center according to the laboratory blood results drawn at the dialysis center. 184. The Respondent’s act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class III deficiency. Section 400.484(2)(c), Florida Statutes (2009). 185. The Respondent’s deficient act, omission or practice constitutes a repeated Class Ill deficiency. Section 400.484(2)(c), Florida Statutes (2009). . 186. Upon finding an uncorrected or repeated Class III deficiency, the agency shall impose ari administrative fine not to exceed $1,000 for each occurrence and each day that the uncorrected or repeated deficiency exists. Section 400.484(2)(c), Florida Statute (2009). 187. The Agency provided the Respondent with a mandatory correction date of August 16, 2009. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to impose an administrative fine against the Respondent in the amount of ONE THOUSAND DOLLARS ($1,000.00) based upon one (1) occurrence of a repeated Class III deficiency pursuant to Sections 400.474 and 400.484(2)(c), Florida Statutes (2009). CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter a final order granting the following relief against the 35 Respondent: 1. Make findings of fact and conclusions of law in favor of the Agency. 2. Impose: an administrative fine against the Respondent in the amount of THIRTEEN THOUSAND DOLLARS ($13,000.00). 3. Enter any other relief that this court deems just and appropriate. Respectfully submitted this ce day of __ (Viar-eda , 2010. Andrea M. Lang, Assistant General Cbuhsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Telephone: (239) 338-3203 NOTICE JHE RESPONDENT IS NOTIFIED THAT IT HAS THE RIGHT TO REQUEST AN ADMINISTRATIVE HEARING PURSUANT TO SECTIONS 120.569 AND 120.57, OF THE FLORIDA STATUTES. THE RESPONDENT IS FURTHER NOTIFIED THAT IT HAS THE RIGHT TO RETAIN AND BE REPRESENTED BY AN ATTORNEY IN THIS MATTER. SPECIFIC OPTIONS FOR ADMINISTRATIVE ACTION ARE SET OUT IN THE ATTACHED ELECTION OF RIGHTS FORM. THE RESPONDENT IS FURTHER NOTIFIED IF THE ELECTION OF RIGHTS FORM IS NOT RECEIVED BY THE AGENCY FOR HEALTH CARE ADMINISTRATION WITHIN TWENTY-ONE (21) DAYS OF THE RECEIPT OF THIS ADMINISTRATIVE COMPLAINT, A FINAL ORDER WILL BE ENTERED. THE ELECTION OF RIGHTS FORM SHALL BE MADE TO THE AGENCY FOR HEALTH CARE ADMINISTRATION AND DELIVERED TO: AGENCY CLERK, AGENCY FOR HEALTH CARE ADMINISTRATION, 2727 MAHAN DRIVE, BLDG 3, MAIL STOP 3, TALLAHASSEE, FLORIDA 32308; TELEPHONE (850) 922-5873. 36 CERTIFICATE OF SERVICE LHEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form has been served to: Karen Marie Walsh, Administrator, Gentiva Health Services (Certified), Inc. d/b/a Gentiva Health Services, 5050 Tamiami Trail N., Unit B, Naples, ’ Florida 34103, by U.S. Certified Mail, Return Receipt No. 7008 1140 0003 8889 1271, and Blumberg Excelsior Corporate Services, Inc., Registered Agent for Gentiva Health Services (Certified), Inc. d/b/a Gentiva Health Services, 515 East Park Avenue, Tallahassee, Florida 32301, by U.S. Certified Mail, Return Receipt No. 7008 1140 0003 8889 1288, this bck day of — Macy _,2010. Andrea M. Lang, Assistant General Counsel Florida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Telephone: (239) 338-3203 Copies furnished to: Karen Marie Walsh, Administrator ~ | Andrea M. Lang, Assistant General Counsel Gentiva Health Services (Certified), Inc. Agency for Health Care Administration d/b/a Gentiva Health Services Office of the General Counsel 5050 Tamiarni Trail N., Unit B 2295 Victoria Avenue, Room 346C Naples, Florida 34103 Fort Myers, Florida 33901 (U.S. Certified Mail) Blumberg Excelsior Corporate Services, Inc. | Harold Williams Registered Agent for ~ Field Office Manager Gentiva Health Services (Certified), Inc. Agency for Health Care Administration d/b/a Gentiva Health Services 2295 Victoria Avenue, Room 340A 515 East Park Avenue Fort Myers, Florida 33901 Tallahassee, Florida 32301 (Interoffice Mail) (U.S. Certified Mail) __L _| 37 COMPLETE THIS SECTION ON DELIVERY 2, and 3, Also complete « ‘A:Slgnature Delivery:ts desired. dress on the reverse © Agent Dl Addressee C. Date of Dellvery Recalved by (Printed Namgy {s delivery addtess different from item 17° Cl Yes If YES, enter delivery address below: CI No 3. Service Tre ; *. .Cenitied ait’ Express Mall fay Registered’ 1) Retum Recelpt for Merchandise ‘ Clingured Mali C1 c.0.p. 4. Restricted pele? (Extra Fee) (Transter from service label) * All . ; PS Form 3811, February 2004 Domestic Return Recelpt 102505-02-M-1840_

Docket for Case No: 10-001728