ep. 22, 2010 4:57PM SMITH & ASSOCTATES No, 2130 STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. , Case No. 2010002674 VENICE HMA, LLC d/b/a HOME HEALTH SERVICES OF VENICE, 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, VENICE HMA, ULC d/bfa HOME HEALTH SERVICES OF VENICE (hereinafter “the Respondent”), pursuant to Sections 120,569 aud 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 FORTY ONE THOUSAND DOLLARS ($41,000.00) pursuant to Sections 400.474 and 400,484(2)(c), Florida Statutes (2009), based upon two (2) repeated Class Ill deficiencies and one (1) Class JI deficiency pursuant to Sections 400.474 and 400.484(2)(b), Florida Statutes (2009). 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 Filed October 5, 2010 9:16 AM Division of Administrative Hearings. 10 cep. 22 ZUIY 4. TPM OMIT & AOSQGLATto No. 2190 P. 120,60, Florida Statutes (2009); Chapters 408, Part II, and 400, Part TIL, Florida Statutes (2009), and Chapter 594-8, Florida Administrative Clode (2009). 3. Venue lies pursuant to Rule 28-106.207, Plorida 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 I, and Chapter 400, Part Ill, 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 212280961) located at 420. Tamiami Trail, Suite 304, Venice, Florida 34285, and was at all material times required to comply with the applicable federal and state regulations, statutes and rules governing home health agencies. COUNTS The Respondent Failed To Implement Treatment And Did Not Follow The Plan Of Care In Violation Of Section 400,487(2), Florida Statutes (2009), And Rule 59A-8,0215(2), Florida Administrative Code 6. The Agency re-alleges and incorporates by reference paragraphs one (1) through five (5). , 7, Pursuant to Florida law, when required by the provisions of Chapter 464; Part |, Part III, or Part V of Chapter 468; or Chapter 486, Florida Statutes (2009), 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 i cep 22. 2010 4:21PM OMTTH & ASSOCIATES No. 2130 =P. 12 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). 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 cave. Jf 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. 8 On or about September 17, 2007 through September 19, 2007, the Agency conducted a Relicensure Survey of the Respondent’s Facility, 9% Based on clinical record review and interviews with the home health agency staff, the organization failed to ensure that physicians were contacted to approve changes to their patient's plans of care for three (3) of twenty-five (25) patients reviewed, specifically Patient number eleven (11), Patient number thirteen (13), and Patient number seventeen (17), and failed to ensure treatments were administered only as ordered for one (1) of twenty-five (25) sample patients, specifically Patient number seven (7), and failed to ensure verbal orders were put in writing and included In the medical record for one (1) of twenty-five (25) sampled patients, ep, 22, 2010 4:52PM SMITH & ASSOCIATES No. 2130 P. 13 specifically Patient number seven (7). 10. Patient number eleven (11) was admitted to the home health agency on Noyember 29, 2006 and recertified on July 27, 2007 to September 24, 2007. Documentation in the clinical record for September 3, 2007 revealed the skilled nurse provided wound care to the sacrum without benefit of a physician's order. A further review of the record did not demonstrate any evidence the physician was notified of the need to change the Plan of Care for wound care treatments to date or at the time of review. 11. Patient number thirteen (13) was admitted to the home health agency on July 4, 2007, and the patient care was recertified on September 2, 2007. ‘(here is an order dated August 30, 2007 in the olinical record for nursing to inctease the nursing visits to two (2) times a week times for six 6) weeks,. The recertified plan of treatment dated September 2, 2007 ordered skilled nursing visit two (2) times a week for one (1) week. During the first week of the new ' certification period, the skilled nurse only visited one (1) time. There is no documented evidence in the chart that the physician was notified that one (1) visit was made rather than the two (2) visits that were ordered. The second week of care, the nurse visited two (2) times. There are no orders in the chart to cover the skilled nursing visit dated September 11, 2007 and September 13, * 2007, On September 18, 2007 at approximately 1:30 p.m., the Director of Nursing reviewed the findings and stated that apparently the nurse failed to carry the modified orders over to the recertification orders. “12, Patient. number seventeen (17) was admitted to the home health agency on ) September 13, 2007 with orders on the Plan of Care for skilled nursing to provide visits two (2) times per week for one (1) week (September 13, 2007) and two (2) times per week for three (3) weeks (September 17, 2007) PRN (as needed) visits for ostomy problems times three (3). A review of the clinical record revealed the nurse visited Patient number seventeen (17) on . ep. 22, 2010 4:52PM SMITH & ASSOCIATES No. 2130 P, September 13, 2007 for the start of care OASIS assessment and the next visit was made on September 17, 2007. A further review of the record revealed Patient number seventeen's (17) primary caregiver called the home health agency on September 14, 2007 and spoke with a muse who documented the following: "Unable to schedule visit today d/t conflicts. Spoke with pt/spouse by phone. Spouse independent w/wafer changes since last admission but pt has developed new problem w/leaking and bleeding from stoma. Instructed to contact MD ze: excessive bleeding over the weekend." On September 15, 2007, the following entry was documented: "Spoke with pt's spouse. States September 14 noted pt bleeding ftom stoma. Spouse states 0 bleeding noted today." No home visits were completed on September 14, 2007, September 15, 2007 or on September 16, 2007 to assess Patient number seventeen’s (17) actual stoma bleeding and alert the physician to any possible changes that suggest a need to alter the Plan of Care, Documentation also revealed the physician was not notified the nurse provided only one (1) visit during week one (1), or obtained any physician orders to cover the missed visit. Any interview with the administrative staff confirmed the nurse should have made an on-site assessment of Patient number seventeen’s (17) bleeding and notified the physician of the missed visit during week one (1), 13. A review of the clinical record for sample Patient number seven (7) revealed a Start of Care of August 17, 2007. The principal diagnosis was malignant neoplasm of the soft palate, Patient number seven (7) had a gastrostomy tube (tube placed in the stomach for feeding) inserted on August 16, 2007, The specific orders for the skilled nurse were to cleanse the tube insertion site with hydrogen peroxide, pat dry, and apply dressing. Patient number seven (7) was admitted to the hospital on August 26, 2007 and remained hospitalized until August 30, 2007. The home health ageney resumed services on August 31, 2007, 14, A review of the resumption of care orders dated August 31, 2007 did not reveal ep. 22 ZUI0 4:92PM OMIT & ASSOCTATES No. 2130 P15 any change in previously ordered treatment of the feeding tube insertion site. A review of the skilled nurse's notes dated September 3, 2007 from 12:20 p.m, to 1:20 p.m. revealed the nurse cleansed the stoma with hydrogen peroxide, applied triple antibiotic ointment, covered with dressing, and secured with tape. A complete review of the record failed to reveal the physician was contacted and approved the use of the antibiotic ointment to the site. 15. Aninterview with the administrator on September 19, 2007 at 10:30 a.m. revealed “the nurse had been out sick and had paperwork pending", 16. On September 19, 2007 the administrator provided a copy of a verbal order dated September 18, 2007 for August 31, 2007 authorizing the nurse to "cleanse with hydrogen peroxide, apply antibiotic cream (over the counter) as needed, dressing". The verbal order failed to specify which antibiotic cream to use. 17, The Respondent's act, omission or practice had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class Ill deficiency, Section 400.484(2)(c), Florida Statutes. 18, The Agenoy cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes, . 19. The Agency provided the Respondent with a mandatory corection date of October 19, 2007. 20, On or about October 19, 2007, the Agency conducted a Follow-Up by Desk Review of the Relicensure Survey of September 17, 2007 through September 19, 2007 of the Respondent’s facility and determined that the above referenced deficiency had not been corrected, 21. Based on clinical record review, the organization failed to ensure that physicians were contacted to approve changes to their patient's Plans of Care for two (2) of three (3) patients oep. ZZ. ZUIY 4c 9ZPM OMIT & ADOOGLATES No, 2130 P. reviewed, specifically Patient number twenty six (26), and Patient number twenty eight (28). 22, Patient number twenty six (26) was admitted to the home health agency on October 3, 2007 with a diagnosis of diabetic ulcer of’ the R foot with cellulitis and gangrene of the It Sth toe, and amputation of the R 5th toe. There wete physician orders for the skilled nurse to visit 3W4 plus 3PRN related to wound or dressing to wound (three (3) times a week for four (4) weeks and three (3) visits, as needed, related to wound ot dressing to the wound.) Documentation in the clinical record showed that there were skilled nursing visits to the patient on October 3, 2007; October 4, 2007; October 8, 2007; October 9, 2007; October 10, 2007, and October 13, 2007. There weve no -verbal orders in the record related to a change in the ordered visit pattern and the record did not demonstrate any evidence the physician was notified of the need to change the Plan of Care for wound care treatments to date or at the time of review. 23. Patient number twenty eight (28) was admitted to the home health agency on September 20, 2007 with a diagnosis of attention to colostomy. The physician's orders are for the skilled nurse to visit 2W1 beginning September 20, 2007 (twice a week for one (1) week), September 24, 2007 2W2 +3PRN (and beginning with September 24, 2007, twice a week for two (2) weeks plus six (6) visits as needed for ostomy problems). There is a verbal order dated October 8, 2007 in the clinical record for nursing to increase the nursing visits to twice a week - for one (1) week, During the first week of the certification period, the skilled nurse only visited once, There is no documented evidence in the chart that the physician was notified that one (1) visit was made xather than the two (2) visits that were ordered. 24. 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. 25. The Agency cited the Respondent for a Class III violation in accordance with 16 Sep, 22. 2010 4:52PM = SMITH & ASSOCIATES No. 2130 P17 Section 400.484(2)(c), Florida Statutes. 26. The Respondent was given a mandatory correction date of November 19, 2007. 27. ° On or about November 6, 2007, the Agency conducted a second Follow-Up by Desk Review of the Relicensure Survey of September 17, 2007 through September 19, 2007 of the Respondent's facility and determined that the above referenced deficiency had been corrected. 28. On or about January 4, 2010 through January 7, 2010, the Agency conducted a Relicensure Survey of the Respondent's Facility. ) 29. Based on record review, observation and interview, the home health agency failed to ensure each patient had an established plan of care which was followed and reviewed by a physician for nineteen (19) patients (Patients #34, #12, #25, #16, #15, #5, #8, #18, #22, #28, #36, #37, #14, #23, #24, #3, #11, #21 and #33), failed to ensure two (2) of the patients met the criteria for needing skilled services (Patients #8 and #9), and failed to ensure that the patients’ physicians were notified of changes in the patient's treatment plan for five (5) patients (Patient #5, #8, #18, #14 and #3), Violations were found in twenty (20) of forty (40) records which were reviewed. “30, A medical record review of Patient number thirty. four (34) on January 6, 2010, documented a Start of Care date of November 12, 2009. The patient's medical record did not provide documentation of a written plan of care, nor was there documentation the doctor was notified there was not a written plan of care for review of treatment orders to sign. 31. A medical record review of Patient number twelve (12) on January 5, 2010 noted a Start of Care date of November 13, 2009, The patient's medical record did not provide documentation of a writtan plan of care, nor was a notation of a plan of care sent to the doctor fot review, 32, A medical record review of Patient number twenty five (25) on January 6, 2010 cep. 24. 2ZUI0 4:92PM | oOMITH & ASSOCIATES No. 2130 =P. 18 revealed a Start of Care date December 2, 2009, The patient's medical record did not provide documentation of a written plan of care, nor was there documentation the doctor was notified there was not a written plan of care for review of treatment orders to sign. 33. A medical record review of Patient number sixteen (16) on January 6, 2010 revealed a Start of Care date December 20, 2009. The patient's medical record did not provide documentation of a written plan of care, nor was there documentation the doctor was notified ‘there was not a written plan of care for review of treatment orders to sign, 34, A medical record review of Patient number fifteen (15) on January 5, 2010 noted a Start of Care date October 5, 2009. The patient's medical record did not provide documentation of a written plan of care, nor was there documentation the doctor was notified there was not a written plan of care for review of treatment ordets to sign. 35, Patient number five (5) was admitted to the home health agency on January 29, 2009 with a recertification period of May 29, 2009 to July 27, 2009, and a principal diagnosis of "Disorders of Porphyrin’, a disease of the nervous system and skin, Per the Plan of Treatment, skilled nursing was to provide care and services as follows: one (1) time per week for (1) week beginning May 29, 2009, and on June 4, 2009 one (1) time per week for seven (7) weeks. A review of the clinical record on January 4, 2010, failed to include documentation of a visit having been completed during the work week of May 29, 2009 through May 31, 2009. There ‘was no explanation in the record as to why this visit was not completed as ordered or any indication the physician was notified and approved this change to the plan of treatment. 36, Patient number eight (8) was admitted to the home health agency on December 41, 2009, with a principal diagnosis of "Unspecified Late Effect.” Per the Plan of ‘Treatment, skilled nursing was to provide care and services as follows: one (1) time per day for five (5) days beginning on December 21, 2009, and on December 28, 2009 one (1) time per week for four (4) ven ZZ 2010 4:92PM SMITH & ASSOCIATES No. 2130 =P, 19 weeks, A review of the clinical record on January 5, 2010 failed to include documentation of three (3) visits having been completed during the work week of December 21, 2009 through December 27, 2009. A record review demonstrated visits were completed on December 21, 2009 and December 22, 2009, There was no explanation in the record.as to why these visits were not completed as ordered or any indication the physician was notified and approved this change to the plan of treatment, 37. Patient number eighteen (18) was admitted to the home health agency on December 25, 2009 with a principal diagnosis of "Cellulitis and Abscess." Per the Plan of Treatment, skilled nursing and physical therapy were to provide care and services, Physical therapy was to complete visits as follows: one (1) time per week for one (1) week. A review of the clinical record on January 5, 2010 failed to include documentation of a visit having been completed during the work week of December 25, 2009 through December 27, 2009. A record teview demonsirated a visit was completed on December 31, 2009, There was no explanation in the record as to why this visit was not completed as ordered or any indication the physician was notified and approved this change to the plan of treatment. 38 Patient number twenty two (22) was admitted to the home health agency on December 23, 2009 with a principal diagnosis of “Depression." A review of the clinical record on January 5, 2010 failed to include documentation of a Plan of Treatment having been initiated since the start of care and to date, nor was there documentation the doctor was notified there was a change in the initiation of the Plan of Treatment. 39. Patient number twenty eight (28) was admitted to the home health agency on ‘October 17, 2009 with a principal diagnosis of "CAD" (Coronary Artery Disease). A review of the clinical record on January 5, 2010 failed to include documentation of a Plan of Treatment having been initiated since the start of care and to date, nor was there documentation the doctor Sep. 22. 2010 4:52PM SMITH & ASSOCIATES No. 2130 P. 20 was notified there was a change in the initiation of the Plan of Treatment. 40. Patient nuraber thirty six (36) was admitted to the home health agency on December 3, 2009 with a principal diagnosis of "Scrotal Wound." A review of the clinical record on January 5, 2010 failed to include documentation of a Plan of Treatment having heen initiated since the start of care and to date, nor was there documentation the doctor was noted there was a change in the initiation of the Plan of Treatment. 41. Patient number thirty seven (37) was admitted to the home health agency on December 19, 2009 with a principal diagnosis of “Acute Cholecystitis with Sepsis." A review-of the clinical record on January 6, 2010 failed to include documentation of a Plan of Treatment having been initiated since the start of care and to date, nor was there documentation the doctor was notified there was a change in the initiation of the Plan of Treatment, 42. A review of documentation in the occupation therapy notes for Patient number fourteen (14) revealed the occupational therapist instructed and applied moist heat to the patient's hand on December 18, 2009. There were no physician's orders for this treatment to be utilized, 43, A review of the plan of treatment for Patient number fourteen (14) documented ~ the inclusion of orders for the home health aide to provide personal care, No aide visits were performed for Patient number fourteen (14) and thera was no notification to the physician of the feiture to follow the plan of treatment established by the physician. 44, Patient number iwenty three (23) was admitted to the home health agency's care on December 4, 2009. At the time of review on January 5, 2010, there was no plan of treatment , established for the care of this patient and thus there were no orders for care and services to be provided and how often care and services were to be provided. 45, Patient number twenty four (24) was admitted on December 10, 2009. At the time of review on January 5, 2010, there was no plan of treatment established for the care of this ° oep. 22, ZUG 4.95PM OMIT & ADSOCTATES No. 2130, P, patient for the types and frequencies for visits. The home health agency did not notify the physician to approve a change in the Plan of Care that specified the type and frequencies for visits, . 46. Patient number three (3) was admitted to the home health agency on August 8 2009, with a diagnosis of muscle weakness, The Plan of Care dated August 8, 2009, identified the need for a home health aide two (2) times a week for three (3) weeks to assist with bathing activities and personal hygiene, A review of the home health aide notes documented the home health aide visited the patient three (3) times the week of August 10, 2009 and made three (3) additional visits the following week. There was no documentation in the clinical record the physician was contacted and had approved the change in frequency and duration of the services. On January 5, 2010 at 10:00 am, the office staff reported that no additional information was available for Patient number three (3). 47, Patient number eleven (11) was admitted to the home health agency on July 24, 2009 with a Recertification period of November 21, 2009 to January 19, 2010, The diagnoses included, but were not limited to, Osteomyelitis (an infection in F bone) involving the ankle and foot and had a PICC line (peripherally insetted central catheter). A review of the Plan of Care dated November 21, 2009 documented specific orders for the skilled nurse to flush all the ports with ten (10) milliliters of Normal Saline and Heparin one-hundred (100) units, three (3) milliliters weekly. A review of the skilled nurse's notes revealed the nurse flushed the two (2) lumen of the peripherally inserted central catheter line with five (5) milliliter of Normal Saline on October 25, 2009, December 4, 2009 and December 30, 2009. There was no documentation the nurse flushed the peripherally inserted cental catheter line as ordeted on December 20, 2009. _ There was no documentation the physicion was notified of the change in the ordered Plan of Treatment. oep 22 2010 4.93PM OMIT & ASSOCTATES No. 2130 =P. 22 48. Patient number thirty three (33) was admitted to the home health agency on Angust 2, 2009 with a principal diagnosis of open wound of back. The patient was recertified for care on November 28, 2009. The recertification assessment documented the patient previously had a coceyx wound that was healed. On December 22, 2009, the physician from the wound care center issued orders for a newly identified wound on the coccyx to apply prisma border to the coccyx and change on Thursdays and Saturdays. The order was clarified on December 23, 2009 and read: "Coccyx prisma border, Apply prisma to coccyx wound, cover with mepilex border." A review of the nutse’s note dated December 28, 2009 revealed the coccyx wound measured 0.5 centimeters by 0.5 centimeter and the wound bed was pink. A review of the nurse's note dated December 31, 2009 failed to document the skilled nurse assessed the coceyx wound or cleaned the area as ordered, to apply prisma to coccyx wound and cover with mepilex border, The nurse's note dated January 2, 2010 did not contain documentation of the status of the wound or documentation the wound care was performed as per the physician's order, to apply prisma to coccyx wound and cover with mepilex border, There was no documentation the physician was notified of the order not being followed. 49. During various interviews with the administrator and Director of Clinical Practice throughout the survey process, it was reported the Plans of Treatment were not completed for all of patient clinical records. The administrator reported, "It was a documentation issue," She confirmed that she was unaware of exactly how many records failed to have a completed Plan of Treatment. She added, "When the Plans of ‘Treatment needed to be completed, the processor was not always able to get the record and then the processor moved on to the next patient's Plan of Treatment to be done." However, the Plan of Treatment that was missed and/or skipped was not always discovered as being incomplete. The findings were confirmed by the Director of Professional services on January 7, 2010 at 1:30 p.m. oep. £2 ZVIY 4.25PM OMELETTE & AooQULATto No. 2130 P. 23 50, Patient number eight (8) was admitted to the home health agency on December 21, 2009 with a principal diagnosis of "Unspecified Late Effects (ICD-9-CM 438.9)" and "Occlusion and Stenosis" (ICD-9-CM 433.11). Per the Plan of Treatment, skilled nursing was providing care and services with orders to administer Vitamin B12 1000 microgram (1 ml) daily times five (5) days then one (1) mi weekly, As per Medicare guidelines 40.1,2.4 - Administration of Medications, Vitamin B-12 injections would be a covered therapy only if it were reasonable and necessary to the treatment of the pertinent illness or injury. A review of the record on January 5, 2010 documented no diagnosis to support the skilled nursing administration of daily and subsequent weekly Vitamin B-12 injections, There was no documentation in the record that the nurse alerted the physician to this Jack of continued skilled nursing service and obtained guidance with possible orders to suggest a need to alter the plan of care and for this patient's condition. $1, Patient number nine (9) was admitted to the home health agency on December 5, 2009, with a principal diagnosis of "Encounter for Change OR" (ICD-9-CM 58.31). Per the Pian of Treatment, skilled nursing was providing wound care to the right buttocks. During a home visit and interview completed on January 5, 2010 with Patient number nine’s (9) permission, it was revealed the patient was no longer homebound. Patient number nine (9) reported as being able to drive "Ad lib" (at liberty) and going shopping in various stores. There was no documentation in the record that the nurse alerted the physician to this lack of continued skilled nursing service and obtained guidance with possible orders to suggest a need fo alter the plan of care and for this change/improvement in Patient number nine’s (9) condition. 52. 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. oep. 22, ZUIY 42 95PM | OMLTH & ASDOGTATES No. 2130 P24 33. The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes. 54. The Respondent’s deficient act, omission or practice constitutes a repeated Class IIT deficiency. Section 400.484(2)(c), Florida Statutes (2009). 55. Upon finding an uncorrected or repeated Class III deficiency, the agency shall impose an administrative fine not to exceed $1,000 for each osontrence ahd each day that the uncorrected or repeated deficiency exists pursuant to Section 400.484(2)(c), Florida Statute (2009). . 56. The Agency provided the Respondent with a mandatory cozrection date of February 7, 2010. ) WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, intends to impose an administrative fine against the Respondent in the amount of NINETEEN THOUSAND DOLLARS ($19,000.00) based upon nineteen (19) occurrences of a repeated Class IIT deficiency pursuant to Sections 400.474 and 400.484(2)(0), Florida Statutes (2009), COUNT II The Respondent Failed To Develop 4 Plan Of Care That Was Complete And Accurate In Violation Of Section 400.487(2), Florida Statutes (2009), And Rule 59A-8.0215(1), Florida Administrative Code 37. ‘The Agenoy re-alleges and incorporates by reference paragraphs one (1) through five (5). 58. Pursuant to Florida law, when required by the provisions of Chapter 464; Part I, Part II, 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 oep. 22, ZUG GioarM OMI TH & ASOOCTATES No. 2130 P25 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 teviewed, 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), ) , Purguant 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 shal{ 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. 59, Qn or about September 17, 2007 through September 19, 2007, the Agency conducted a Relicensure Survey of the Respondent’s Facility. . 60. Based on record review and administrative staff interview, the home health agency failed to develop a complete and accurate Plan of Care for three (3) of twenty five (25) sampled patients, specifically Patient number seven (7), Patient number ten (10), and Patient number seventeen (17. This is evidenced by inaccurate allergy information for sample Patient number seven (7), failure to include wound vac instructions for sample Patient number ten (10), and failure to include oxygen on the plan of care for sample Patient number seventeen (17). dep. 22, 2010 4:53PM SMITH & ASSOCIATES No. 2130 P26 61. Sample Patient number seven (7) had a Start of Care date of August 17, 2007. A review of the intake sheet dated August 17, 2007 revealed the patient was allergic to heparin. A review of the Plan of Care dated August 17, 2007 revealed the patient had no known allergies. , 62, An interview with the administrator on September 19, 2007 at 10:00 a.m, revealed she would contact the skilled nurse who visited Patient number seven (7) and clarify the conflicting allergy information, 63. Sample Patient number ten (10) was admitted to the home health agency on "September 2, 2007. A review of the yerbal order written on the intake sheet dated August 31, 2007 and hospital orders from the physician dated September 1, 2007 documented orders for nutsing to provide wound vac care. A review of the Plan of Care failed to include any reference to wound vac care and physician orders. Documentation in the clinical nursing record indicated Patient number ten (10) had a wound vac in place with no nursing care having been provided fiom the Start of Care to date, or at time of review. 64. An interview with the administrator on September 19, 2007 at 10:00 a.m. reported the Primary Care Physician did not want anyone to touch the wound, but confinned the information as such should have been included in the Plan of Care. 65. Sample Patient number seventeen (17) was admitted to the home health agency on September 13, 2007. A review of the Plan of' Care for the cartfication period September 13, 2007'to November 11, 2007 did not include oxygen as a medication in section ten (10) and was, therefore, not reviewed or evaluated. 66. An interview with the administrator on September 19, 2007 at 10:00 am. confirmed the findings. 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 Ill deficiency. Section 400.484(2)(c), 7 Sep 22, 2010 4:53PM © SMITH & ASSOCIATES No, 2130 P, 27 Florida Statutes. 68, The Agency cited the Respondent for a Class If] violation in accordance with Section 400.484(2)(c), Florida Statutes. 69. The Agency provided the Respondent with a mandatory correction date of October 19, 2007. ) , 70. On or about October 19, 2007, the Agency conducted a Follow-Up by Desk Review of the Relicensure Survey of September 17, 2007 through September 19, 2007 of the Respondent's facility and determined that the above referenced deficiency had not been corrected, . 7\. Based on record review, the home health egency failed to develop a complete and accurate Plan of Care for one (1) of three (3) sampled patients, specifically Patient number twenty seven (27). This is evidenced by inaccurate allergy information for sample Patient number twenty seven (27). 72. Sample Patient number twenty seven (27) had a Start of Care date of Ootober 6, 2007, A review of the consultation record from Venice Regional Medical Center, which was included. in the patient's home health care tecord, revealed that Patient number twenty seven (27) was allergic to codeine, morphine sulfate, and vereparai A review of the Plan of Care dated October 6, 2007 revealed Patient number twenty seven (27) had an allergy to verapamil only. 73, The Respondent's act, omission or practice, had an indirect, adverse effect on the health, safety, or security of a patient constituting a Class IIL deficiency. Section 400.484(2)(c), Florida Statutes, ) 74, The Agency cited the Respondent for a Class III violation in accordance with Section 400.484(2)(c), Florida Statutes, 75, The Respondent was given amandatory correction date of November 19, 2007. ep. 22, 2010 4:53PM SMITH & ASSOCIATES No. 2130 P. - 76. On or about November 6, 2007, the Agency conducted a second Follow-Up by Desk Review of the Relicensure Survey of September 17, 2007 through September 19, 2007 of the Respondent’s facility and determined that the above referenced deficiency had been corrected. 77, On or about January 4, 2010 through January 7, 2010, the Agency conducted a Relicensure Survey of the Respondent’s Facility. 78. Based on record review and interview, the home health agency failed to develop a ‘Plan of Care that includes all appropriate items required for fourteen (14) of forty (40) patients reviewed, specifically Pationts #12, #15, #16, #22, #23, #24, #25, #34, #36, #37, #20, #3, #8 and #14. 79, Patient number #12 had a start of care date of November 13, 2009; Patient #15 had a start of care date of October 5, 2009; Patient #16 had a start of care date of December 20, * 2009; Patient #22 had a start of care date of December 23, 2009; Patient #23 had a start of care date of December 4, 2009; Patient #24 had a start of care date of December 10, 2009, Patient #25 had a start of care date of December 2, 2009, Patient #34 had a start of care date of November 12, 2009; Patient #36 had a start of care date of December 3, 2009; Patient #37 had a start of care date of December 19, 2009 and Patient #20 had a start of care date of November 20, 2009, At the time of record review from January 4, 2010 through January 7, 2010, these patients had no plan of treatment established, 80. Administrative staff agreed on January 7, 2010 at 12:45 p.m, there was no plan of treatment established for Patients #12, #15, #16, #22, #23, #24, #25, #34, #36, #37, and #20 that specified all clinical services would be implemented only in accordance with a plan of care established by a physician's written orders, 81. Patient number three (3) was admitted to the home health agency on August 9, 19 28 06D. 24 LZUIV 47 04TM ONL TN & ADOUGTATES No. 2130 P29 2009 with a diagnosis of muscle weakness. A review of the Home Health Certification and Plan of Care for August 8, 2009 to October 6, 2009, Section 10, Medications Name/Strength/Form/Frequency/Route listed Patient number three’s (3) current medications, including: Primidone 250 milligrams 1 tablet by mouth daily and Alprazolam 25 milligrams daily by mouth as needed. Per the Lexi-Comp's Dmg Reference Handbook, 12th edition, Alprazolam is dispensed in tablets of 0.25 milligram, 0.5 milligram, 1 milligram or 2 milligrams and the usual maximum dosage is 4 milligrams. A review of the Medication profile, dated August 8, 2009, documented the correct dosage and frequency of the Primidone was Primidone 250 milligrams 1/2 tablet by mouth twice a day. The skilled nurse.failed to correctly identify and include the proper dosage in the Plan of Care. 82. Patient ttumber eight (8) was admitted to the home health agency on December 21, 2009, with a principal diagnosis of "Unspecified Late Rffects" (ICD-9-CM 438.9) and other pertinent diagnosis of "Occlusion and Stenosis (ICD-9-CM 433.11) as a Medicare patient, Orders for skilled jursing included administration of Vitamin B-12 injections 1 milliliter (ml) daily times five (5) days, then one (1) ml weekly for four (4) weeks. Per Medicare guidelines, these diagnoses would not be considered as supporting documentation for the administration of . these injections to be provided and accepted ag reasonable and a necessary care and service, with specific goals to be achieved while providing skilled nursing services. 8. A review of Patient number fourteen’s (14) plan of teeatment dated December 15, 2009 documented ihe patient had medication ordered of Digoxin 125 mg (milligrams) 1 tablet daily. Observation during a home visit on January 5, 2010 at approximately 9:30 a.m. revealed the patient's medication dosing was actually Digoxin 1s meg (micrograms), The nurse did not assure the medication dosing was accurate on the plan of treatment for Patient number fourteen (14), A review of the plan of treatment noted the goals on the plan of treatment for nursing did 20 oe 22, 2UIY 4. 04rM OMIT & ADDOCTATES No, 2130 P. not reflect any of the care the nurse was providing in the area of wound care. There was one (1) nursing goal and this was related to a goal to prevent further falls. The Plan of Treatment available to staff for teview was not reflective of the care ordered or the observed care provided to Patient number fourteen (14). 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 It 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 Respondent's deficient act, omission or practice constitutes a repeated Class Ill deficiency. Section 400.484(2)(c), Florida Statutes (2009). 87. Upon finding an uncortected or repeated Class Ill 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). 88, ‘The Agency provided the Respondent with a mandatory correction date of February 7, 2010. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, intends to impose an administrative fine against the Respondent in the amount of FOURTEEN THOUSAND DOLLARS ($14,000.00) based upon fourteen (14) occurrences of a repeated Class TI deficiency pursuant to Sections 400.474 and 400.484(2)(c), Florida Statutes (2009). 21 30 oep. 22. ZUIU 42 947M OMI TH & ADSOUTAT ES No. 2130) P. 3I COUNT DIT ' The Respondent Failed To Ensure The Registered Nurse Was The Case Manager In Violation Of Section 400.484(2)(b), Florida Statutes (2009), Aud Rule $9A-8.008(1), Florida Administrative Code : 89. The Agency re-alleges and incorporates by. reference paragraphs one (1) through five (5). 90. Pursuant to Florida law, the agency shall impose fines for various classes of deficiencies in accordance with the following schedule, A Class II deficiency is any act, omission, or practice that has a direct adverse effect on the health, safety, or security of a patient, Upon finding a class II deficiency, the agency shall impose an administrative fine in the amount of $5,000 for each occurrence and each day that the deficiency exists, Section 400,484(2)(b), Florida Statutes (2009), Pursuant to Florida law, in oases of patients requiring only nursing, or in cases requiring nursing and physical, respiratory, occupational or speech therapy services, or nursing - and dietetic and nutrition services, the agency shall provide case management by a licensed registered nurse directly employed by the agency. Rule 59A-8.008(1), Florida Administrative Code. 91, On or about January 4, 2010 through January 7, 2010, the Agency conducted a Relicensure Survey of the Respondent's Facility. 92. Based on observation, record review and administrative interview, it was determined the home health agency failed to ensure the Registered Nurse was the case manager and furnished services that required substantial and specialized skill for four (4) of forty (40) records reviewed, specifically Patient number five (5), Patient number fourteen (14), Patient number twenty eight (28), and Patient nurnber thirty seven (37). 93, The home health agency's failure to ensure the Registered Nurse provided case 22 ep. ZZ. ZUIV SG lO4rm ONL IT & AOoQULATES No, 2130) PL 32 management and fimished registered nursing services that required specialized and substantial skill has caused harm and adversely affected the patients cited. This failure also resulted in the home health agency's inability to ensure the provision of quality health care was maintained in 4 sate environment and assured the quality of care; treatment and services had not been compromised. 94. Patient number five (5) was admitted to the home health agency on January 29, 2009, with a recertification period from May 29, 2009 to July 27, 2009. Skilled nursing was to visit the patient once pet week for one (1) week effective May 29, 2009 and once per week for seven (7) weeks effective June 4, 2009. A review of the record on January 4, 2010 the skilled furse documented on May 24, 2009, during the recertification in the Outcome and Assessment Information Set (OASIS), the presence of a one (1) centimeter (om) "Slit" observed on. the patient's coccyx area, On June 10, 2009, the nurse documented reviewing the wound oare procedure with Patient number five’s (5) mother without any competency assessmentevaluation or return demonstration. On June 18, 2009, the nurse documented the following: "Coccyx area is becoming worse and has an area of unstageable slough about 1 cm x 3/4 cm in irregular shape" with no documentation of the physician notified of this change in condition. On June 25, 2009, July 3, 2009 and July 9, 2009 there was na documentation of the wound care. Without any skilled nursing observation and/or wound measurements, medical staff would not know if the wound had progressed or declined. Documentation in the record for May 24, 2009 and July 20, 2009 noted the nurse counseled Patient number five (5) to "Tum self." On July 24, 2009 the nurse documented in the sixty (60) day summary as follows: "...R hip Stage II 3 cm Lx 1.5 em W x 0 depth Coccyx: Stage IV 3.5 em L x 1.5 om Wx1 om D..." Documentation on July 27, 2009, Patient number five (5) went to the hospital emergency department and was discharged from the hore health agency ‘services on July 28, 2009. The documentation concluded the 23 yep 2e ZUIV GiO4rM OMI In & ADOUGIAT EO No. 2130 P. coceyx wound progressed ftom a Stage II on May 24, 2009 to a Stage IV on July 24, 2009, without the Registered Nurse documenting that appropriate assessments and interventions had been performed to prevent causing Patient number five (5) ham. The home health agency failed to ensure the Registered Nurse provided care and services in a safe environment and assured the quality of care, treatment and services had not been compromised. , 95. Ih an interview with the administrator and Director of Ctinical Services, on January 4, 2009, at approximately 2:00 p.m., these findings were confirmed. The administrator teported the nurse should have done more and the documentation was "remiss", 96. Patient number fourteen (14) was admitted to the home health agency's care on December 15, 2009, with diagnoses of congestive heart failure and diabetes, history of fall, and diabetic leg ulcer, A review of the initial nursing evaluation done on December 15, 2009, noted Patient number fourteen (14) was at high tisk related to nutition due to diabetes, the wound, and the use of diuretics, There was no nursing teaching or training related to nutrition: in the record, There was no evaluation of Patient number fourteen’s (14) dietary intake, ot the types of foods the patient was eating. On December 24, 2009, there was documentation indicating Darvocet N was added to Patient number fourteen’s (14) medication regimen to assist with pain control. There was no evaluation by the nurse of the effectiveness of the pain management for Patient number fourteen (14), a 97. . Patient number twenty eight (28) was admitted to the home health agency's care on October 17, 2009, with subsequent recertification periods and included diagnoses of Coronary Artery Disease, post op (Postoperative) wounds LLE (Left Lower Bxtremity), Diabetes Mellitus Type If, Peripheral Vascular Disease, and skin tear right elbow. A review of the clinical record, on January 5, 2010, documented a wound on the left heel area and that Patient number twenty eight (28) is independent with care. During a home visit, completed on January 6, 2010, with 24 33 oep, Zh ZVIV GIOSTM OMT IT & AOOULTAT EO No. 2130 P. patient's permission, the Registered Nurse was observed to complete wound care to the right inner thigh at the knee present since the start of care on Octobat 17, 2009. There was no nursing teaching or training related to this issue in the record. There was no evaluation of the patient's ability to perform wound right thigh wound care. There was no documentation the nurse communicated with the physician that Patient number twenty eight (28) had progressed to the point where it was no longer reasonable and necessary to continue services because the patient's needs had been met adequately by the home health agency and Patient number twenty eight (28) could be discharged. The Registered Nurse failed to provide the specialized skill in assessing the need for continued nursing care and services and notifying the physician of the improvement in the patient's condition, 98, Patient number thirty seven (37) was ‘admitted to the home health agency's cate, on December 19, 2009, with diagnoses of acute cholecystitis with sepsis, subphrenic abscess, acute rena] failure, atrial fibrillation with rapid ventricular response ~ new to coumadin. Orders included skilled nursing to provide visits for instructions on disease process including medications and draw Prothrombin Ratio (PR) and International Normalized Ratio (INR), blood test for coumadin and coagulation time, as ordered, A review of the record on January 6, 2010, documented in the musing notes, dated December 31, 2009, for wound care to abdomen having been completed with documentation that orders received from the physician on that date. A review of the record failed to include any documentation of a written physician's order for skilled nursing to provide this wound care from December 31, 2009 to January 7, 2010. During a home visit completed on January 7, 2010, with patient's permission, the nurse was observed to perform this wound care to the abdomen by cleansing the navel area with nonmal saline, applying skin prep to the swrounding tissue with silver powder in the wound base, and Mepilex border to wound area without the benefit of a written physician's order. The nurse was then observed to 25 34 vep, fi 2ZViIV GiDGPM — OMLIA & AOOUULAILO No. 2130 F, return all the supplies used/unused for the wound care to the nurse's agency bag and then leave the home. 99. In an interview with the administrator and Dixector of Clinical Services, at 1:30 pan. the administrator confirmed the nurse "Should not have done that” and agreed it was a breach of an infection control procedure. ) 100. The Respondent's act, omission, or practice had a direct adverse effect on the health, safety, or security of a patient and constituted a Class It violation in accordance with Section 400,484(2)(b), Florida Statutes (2009). 101, Upon finding a Class I deficiency, the Agency shall impose an administrative fine in the amount of five thousand dollars ($5,000.00) per occurrence pursuant to Section 400.484(2)(b), Florida Statutes (2009). WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration intends to impose an administrative fine against the Respondent in the amount of EIGHT THOUSAND DOLLARS ($8,000.00) based on a Class II deficiency pursuant to Sections 400.474 and 400.484(2)(b), Florida Statutes (2009). CLAIM FOR RELIEF WHEREFORE, the Petitionér, State of Florida, Agency for Health Care Administration, respectfully requests the Court to enter 4 final order granting the following relief against the Respondent: 1. Make findings of fact and conclusions of law in favor of the Agency. 2. Jmpose an administrative fine against the Respondent in the amount of FORTY ONE THOUSAND DOLLARS ($41,000.00). 26 3) OEP. ££ ZVIN Si OGTM | OMIT & AOOVVIAILO No. 2130) oP. 38 3. Enter any other relief that this court deems just and appropriate. Respectfully submitted this 5 \s¥day of fa. b pant , 2010, Qe dnte Men. Andrea M, Lang, Assistant General Cf{insel 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) 335-1253 NOTICE THE RESPONDENT 1S 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 NOTONED THAT IT HAS THE RIGHT TO RETAIN AND BE REPRESENTED BY AN ATTORNEY IN THIS MATTER. SPECIFIC OPTIONS FOR ADMINISTRATIVE ACTION ARE SET OUT JN 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 BINAL 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) 412-3630. 27 Vue Lee L£VIV Te DDT OWT & AVOVVIAILS No. £190 CERTIFICATE OF SERVICE [HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form has been served to: Brenda 8, Gurst, Administrator, Venice HMA, LLC d/b/a Home Health Services of Venice, 420 Tamiami Trail, Suite 304, Venice, Florida 34285, by U.S. Certified Mail, Retum Receipt No. 7009 1680 0001 8777 2025, and C T Corporation System, Registered Agent for Venice HMA, LLC d/b/a Home Health Services of Venice, 1200 Pine Island Road, Plantation, Florida 33324, by U.S. Certified Mail, Retum Receipt No. 7009 , 2010. 1680 0001 87772018, this 84s day of Doce gic Copies furnished to: Andrea M. Lang, Assistant General Cobasel Plorida Bar No. 0364568 Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C Fort Myers, Florida 33901 Telephone: (239) 335-1253 Brenda 8. Gurst, Administrator Venice HMA, LLC d/b/a Home Health Services-of Venice 420 Tamiami Trail, Suite 304 Andrea M. Lang, Assistant General Counsel Agency for Health Care Administration Office of the General Counsel 2295 Victoria Avenue, Room 346C. Venice, Florida 34285 Fort Myers, Florida 3390] (U.S. Certified Mail) ‘| Unteroffice Mail) CT Corporation System. Harold Williams Registered Agent for Field Office Manager Venice HMA, LLC Agency for Health Care Administration d/b/a Home Health Services of Venice 1200 South Pine Island Road Plantation, Florida 33324 (U.S. Certified Mail) 2295 Victoria Avenue, Room 340A Fort Myers, Florida 3390] (Interoffice Mail) 28 roof

Docket for Case No: 10-009442

Orders for Case No: 10-009442