STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, O T ~ 3 a{ Petitioner, vs. Case Nos. 2007006220 (Fines.) 2007006222 (Cond.) MELBOURNE TERRACE RCC, LLC, d/b/a MELBOURNE TERRACE REHABILITATION CENTER, Respondent. / ADMINISTRATIVE COMPLAINT Who, a COMES NOW the Agency for Health Care Administration (hereinafter “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against MELBOURNE TERRACE RDD, LLC, d/b/a MELBOURNE TERRACE REHABILITATION CENTER, (hereinafter “Respondent”), pursuant to §§120.569 and 120.57 Florida Statutes (2006), and alleges: NATURE OF THE ACTION This is an action to change Respondent’s licensure status from Standard to Conditional commencing April 12, 2007 and ending April 23, 2007, and impose an administrative fine in the sum of ten thousand dollars ($10,000.00) and a survey fee of six thousand dollars ($6,000.00) for a total assessment of sixteen thousand dollars ($16,000.00), based upon Respondent being cited for one State Class I deficiency. JURISDICTION AND VENUE 1. The Agency has jurisdiction pursuant to §§ 120.60 and 400.062, Florida Statutes (2006). 2. Venue lies pursuant to Florida Administrative Code R. 28-106.207. PARTIES 3. The Agency is the regulatory authority responsible for licensure of nursing homes and enforcement of applicable federal regulations, state statutes and rules governing skilled nursing facilities pursuant to the Omnibus Reconciliation Act of 1987, Title IV, Subtitle C (as amended), Chapter 400, Part II, Florida Statutes, and Chapter 59A-4, Florida Administrative Code. 4. Respondent operates a 120-bed nursing home, located at 251 Florida Avenue, Melbourne, FL 32901, and is licensed as a skilled nursing facility license number 13400962. 5. Respondent was at all times material hereto, a licensed nursing facility under the licensing authority of the Agency, and was required to comply with all applicable rules, and statutes. COUNT I 6. The Agency re-alleges and incorporates paragraphs one (1) through five (5), as if fully set forth herein. 7. That pursuant to Florida law, an intentional or negligent act materially affecting the health or safety of residents of the facility shall be grounds for action by the agency against a licensee. § 400.102(1)(a), Florida Statutes (2006). 8. That Florida law provides that all licensees of nursing home facilities shall adopt and make public a statement of the rights and responsibilities of the residents of such facilities and shall treat such residents in accordance with the provisions of that statement. The statement shall assure each resident the following...the right to receive adequate and appropriate health care and protective and support services, including social services; mental health services, if available; planned recreational activities; and therapeutic and rehabilitative services consistent with the resident care plan...the right to be free from mental and physical abuse, corporal punishment, extended involuntary seclusion, and from physical and chemical restraints... § 400.022, Florida Statutes (2006). 9. That on or about April 12, 2007, the Agency conducted a Complaint Survey (CCR#2007003928) at Respondent’s facility. 10. That based upon observation, interview, the review of manufacturer documentation, and the review of records, Respondent intentionally or negligently failed to follow manufacturer's instructions for assembly, use, and maintenance of a shower chair, endangering the safety of one (1) of four (4) sampled residents, causing the resident to fall, sustain a subdural hematoma, and die. 11. That the Petitioner’s representative reviewed the Respondent’s records regarding resident number one (1) during the survey completed on April 12, 2007 and noted as follows: a. That the resident fell in the doorway of the shower room on March 27, 2007 at approximately 10:15 AM; b. That while being transported to the shower on said date and time, the upper portion of the shower chair in which the resident was being transported became detached and the chair fell backward; c. That the resident hit her/his head and sustained a hematoma of four (4) centimeters (cm.) by four (4) cm. and the resident was sent to the emergency room at 5:00 PM on March 27, 2007; d. That the resident was diagnosed with an acute subdural hematoma, became comatose and died on March 29, 2007 at 03:30 AM., almost two days after the fall. 12. That the Petitioner’s representative reviewed the admitting hospital’s records regarding resident number one (1) during the survey completed on April 12, 2007 and noted as follows; a. That the resident was admitted on March 27, 2007 at 5:51 PM; b. That the Emergency Room triage documentation indicated a primary diagnosis as: "Subarachnoid hemorrhage;" c. That the results of a CT scan without contrast were noted as follows: "Findings - There is a large acute subdural hematoma along the right convexity measuring up to 2 cm in greatest thickness. It exerts significant mass-effect on the underlying brain with right-to-left midline shift and subfalcine herniation. This is measured approximately 1 cm. There is also subdural blood along the left occipital bone with mass effect on the left cerebellar hemisphere, subdural hemorrhage layering along the tantorium and smaller right convexity subdural hematoma anteriorly measuring approximately 1 cm in thickness;" d. That the History and Physical of the patient documented that the patient had: "nausea, vomiting and headache after . . . fall in the shower this morning . . . and hit... head with laceration and hematoma... . The patient was placed under observation;” e. That a physician consult of the patient, written on March 27, 2007 stated: "The brain is quite squeezed and [s/he] is becoming comatose . . . . does not respond to voice .... I told the caregiver that [s/he] was on Coumadin and I could not perform operation [and that] it would be futile to do so...;” f. That The Discharge Summary stated: "The patient was admitted on 3/27 after fall in the shower and has found to have subarachnoid brain bleed . . . . prognosis is extremely poor on admission. [S/he] was admitted to PCU and review of records from Organ and Tissue Donation inquiry reveals that patient expired on 3/29/07 at 03:30 AM". 13. That the Petitioner’s representative interviewed Respondent’s administrator on April 12, 2007 who indicated as follows: a. That when resident number one (1) fell on March 27, 2007, the pull bar to the shower chair came off the chair while the Certified Nursing Assistant (CNA) was holding the pull bar; b. That it was later discovered that some screws were omitted during the assembly of the involved shower chair; c. That the chair in question had been assembled in December of 2006. 14. That the Petitioner’s representative observed the subject shower chair on April 12, 2007 and noted a label on the pull bar, the component that became detached during the accident, which read: "This pipe must be secured with screws before use". 15. That the Petitioner’s representative interviewed Respondent’s East wing unit manager on April 12, 2007 who indicated that on March 27, 2007, after the occurrence of the resident’s fall, at least the top-most two screws on each side of the above-examined chair were not present. 16. That the Petitioner’s representative interviewed Respondent’s assistant maintenance manager on April 12, 2007 who indicated as follows: a. That he was one of the two people who assembled the subject chair; b. That the chair involved in the incident came assembled except for the pull bar and wheels; c. That screws were in a package and that some screws remained unused after assembly; d. That he felt that, at the time of assembly, if the top piece (pull bar) were to somehow come off the chair, there was no way in which the patient could fall; e. That he did not put the top two screws in when assembling the chair. 17. That the Petitioner’s representative interviewed the Respondent’s supply director on April 12, 2007 who indicated as follows: a. That she was the other staff member involved in the subject chair’s assembly; b. That the shower chair had been recently ordered and that when it came in, the Respondent’s assistant maintenance director put it together with her help; c. That on the back top bar of the chair, the pull bar, were six screws; d. That there were no instructions for the placement of the other four screws; e. That the chairs come fully assembled, except for the pull bar; f. That these screws were taped with instructions that only discussed the top two screws; g. That neither the assistant maintenance director nor she put any of these screws into the chairs; h. That the assistant maintenance director had informed her that there was no need to install the screws because he claimed that the chairs were tightly fitted together and they would be all right. 18. That the Petitioner’s representative reviewed the documentation that the facility secured from the supplier of the subject chair and noted the following: regarding “Assembly of Chair Back:” a. “° Assembly of Chair Back’ ‘Insert push bar assembly on the two vertical pipes and push down to bottom stops. The tight fit may require tapping the corner tees with a rubber mallet or wood block to assure proper seating. Install two #6 X % screws in the pre-drilled holes;" b. These instructions refer to the top bar, the component described above as the "pull bar:" c. "Operating Instructions" included instructions stating that the chair must be assembled in accordance to the instructions that were enclosed and that the device was to be utilized solely within a shower room reading “...transfer user into the chair in the shower room.” 19. That the Respondent failed to comply with manufacturer’s instructions in Respondent’s failure to: a. Follow the assembly instructions requiring the assembly regarding the screws in the device; b. Follow the manufacturer’s instructions regarding use in which the chair was to be utilized within the confines of the shower room exclusively and not as a mechanism for the transport of persons to and or from the shower. 20. That the Petitioner’s representative interviewed the Respondent’s administrator, risk manager and the director of nursing on April 12, 2007 who indicated as follows: a. That after the resident's fall, Respondent immediately made sure that the top screws were inserted in the pull bar areas of the involved chair and another chair of the same type that had been received by the facility at the same time from the manufacturer, per the manufacturer's instructions; b. That temporary suspensions were issued for the two employees who had assembled the chair as above referenced as well as the suspension of the certified nursing assistant involved in the resident’s fall; c. That there was an initiation of a requirement that all equipment that requires assembly and is designated for patient use be examined by the Respondent’s plant manager prior to the equipment’s utilization; d. That the involved employees who assembled the shower chairs received education regarding following instructions in equipment assembly and complying with the newly implemented procedure of having the plant manager inspect new devices upon their return to work; e. That following the fall of resident number one (1), all shower room equipment was examined to make sure that the equipment was properly assembled; f. That Respondent’s plant manager will conduct a monthly review of all patient equipment. 21, That the Petitioner’s representative noted on April 12, 2007 that shower chairs as involved in the fall and fatal injury to resident number one (1) were still being used by Respondent to transport residents to and from shower rooms despite the manufacturer’s direction that the same was an inappropriate utilization of the medical device. 22. That Respondent has a duty to utilize medical devices in accord with there intended use and to ensure that the same are in proper condition for the intended use. 23. That the failure to properly assemble and utilize the shower chair is a failure to provide protective and support services to residents as required by law. 24. That the Respondent intentionally or negligently acted in a manner materially affecting the health and safety of residents who utilize shower chairs as follows: a. The failure to follow assembly instructions for the medical device; b. The failure to utilize the medical device solely for its intended use, i.e. in the shower; c. The utilization of the medical device intended for use solely in the shower as a device for resident transport to and from shower areas; d. The utilization of an improperly and incompletely assembled medical device in the care and services of resident number one (1) resulting in the resident’s fall, the infliction of a head injury, and the resident’s ultimate death. 25. That the same is a breach of the Respondent’s statutory duty’s to protect its residents and to provide necessary protective and support services. 26. The Agency determined that this deficient practice presented a situation in which immediate corrective action was necessary because Respondent’s non-compliance had caused, or was likely to cause, serious injury, harm, impairment, or death to a resident receiving care in Respondent's facility and cited Respondent with a State Class I deficiency. 27. The Agency provided Respondent with the mandatory correction date for this deficient practice of April 14, 2007. WHEREFORE, the Agency seeks to impose an administrative fine in the amount of $10,000.00 against Respondent, a skilled nursing facility in the State of Florida, pursuant to §§ 400.23(8)(a) and 400.102, Florida Statutes (2006). COUNT II 28. The Agency re-alleges and incorporates paragraphs one (1) through five (5) and Count I as if fully set forth herein. 29. Respondent has been cited for one (1) State Class I deficiency and therefore is subject to a six (6) month survey cycle for a period of two years and a survey fee of $6,000 pursuant to Section 400.19(3), Florida Statutes (2006). WHEREFORE, the Agency intends to impose a six (6) month survey cycle for a period of two years and impose a survey fee in the amount of $6,000.00 against Respondent, a skilled nursing facility in the State of Florida, pursuant to Section 400.19(3), Florida Statutes (2006). COUNT II 30. The Agency re-alleges and incorporates paragraphs one (1) through five (5) and Count I of this Complaint as if fully set forth herein. 31. Based upon Respondent’s one cited State Class I deficiency, it was not in substantial compliance at the time of the survey with criteria established under Part II of Florida Statute 400, or the rules adopted by the Agency, a violation subjecting it to assignment of a conditional licensure status under § 400.23(7)(b), Florida Statutes (2006). WHEREFORE, the Agency intends to assign a conditional licensure status to Respondent, a skilled nursing facility in the State of Florida, pursuant to § 400.23(7), Florida Statutes (2006) commencing April 12, 2007 and ending April 23, 2007. 2 Respectfully submitted this (cL day of July, 2007. Agéncy for Health Care Admin. 525 Mirror Lake Drive, 330G St. Petersburg, FL 33701 727.552.1525 (office) DISPLAY OF LICENSE Pursuant to § 400.23(7)(e), Fla. Stat. (2005), Respondent shall post the most current license in a prominent place that is in clear and unobstructed public view, at or near, the place where residents are being admitted to the facility. Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes. Respondent 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. All requests for hearing shall be made to the attention of: The Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Bldg #3, MS #3, Tallahassee, Florida, 32308, (850) 922-5873. RESPONDENT IS FURTHER NOTIFIED THAT A REQUEST FOR HEARING MUST BE RECEIVED WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT OR WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has open served by USS. Certified Mail, Return Receipt No: 7004 1350 0004 2776 1328 on July / 2, 2007 to: Meghan Jeanne Wilson, Administrator, Melbourne Terrace Rehab Center, 251 Florida Ave., Melbourne, FL 32901 and by U.S. Mail to CT Corp System, Reg. Agent, 1200 South Pine Island Road, Plantation, FL 33324. Copies furnished to: Meghan Jeanne Wilson, Administrator Melbourne Terrace Rehab Center 251 Florida Avenue Melbourne, Florida 32901 (U.S. Certified Mail) Joel Libby Field Office Manager Hurston South Tower 400 W. Robinson, Suite $309 Orlando, FL 32801 (U.S. Mail) CT Corp System, Registered Agent Melbourne Terrace Rehab Center 1200 South Pine Island Road Plantation, Florida 33324 (U.S. Mail) Thomas J. Walsh, II, Esquire Senior Attorney Agency for Health Care Admin. 525 Mirror Lake Dr, 330G St. Petersburg, Florida 33701 (Interoffice) 11

Docket for Case No: 07-003627