STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, OK NSO Petitioner, Case No. 2008003254 vs. AL INVESTORS SARASOTA, LLC, d/b/a BENEVA PARK CLUB, Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the Agency For Health Care Administration (the “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against AL INVESTORS SARASOTA, LLC, d/b/a BENEVA PARK CLUB, (“Respondent” or “Respondent Facility”), pursuant to §§ 120.569, and 120.57, Fla. Stat. (2007), and alleges: NATURE OF THE ACTION This is an action to impose an administrative fine in the amount of twenty-five thousand dollars ($25,000.00) and a survey fee of five hundred dollars ($500.00) or such other relief as this tribunal may determine, based upon five cited State Class I deficiencies pursuant to § 429.19(2)(a), Fla. Stat. (2007). JURISDICTION AND VENUE 1. The Agency has jurisdiction pursuant to Sections 20.42, 120.60, and 429.07, and Chapter 408, Part II, Florida Statutes (2007). 2. Venue lies pursuant to Fla. Admin. Code R. 28-106.207. PARTIES 3. The Agency is the regulatory authority responsible for licensure of assisted living facilities and enforcement of all applicable state statutes and rules governing assisted living facilities pursuant to Chapter 408, Part II, and Chapter 429, Part I, Florida Statutes, and Chapter 58A-5 Florida Administrative Code. 4, Respondent operates a 120-bed assisted living facility located at 743 S. Beneva Road, Sarasota, Florida 34232, and is licensed as an assisted living facility providing limited nursing services, license number 6563. 5. Respondent was at all times material to this complaint a licensed: facility under the licensing authority of the Agency, and was required to comply with all applicable rules and statutes. COUNT I 6. The Agency realleges and incorporates paragraphs 1 through 5, as if fully set forth in this. count. 7. Section 429.07(3)(c), Florida Statutes (2007), provides: (c) A limited nursing services license shall be issued to a facility that provides services beyond those authorized in paragraph (a) and as specified in this paragraph. 2. Facilities that are licensed to provide limited nursing services shall maintain a written progress report on each person who receives such nursing services, which report describes the type, amount, duration, scope, and outcome of services that are rendered and the general status of the resident's health. ... , 3. A person who receives limited nursing services under this part must meet the admission criteria established by the agency for assisted living facilities. When a resident no longer meets the admission criteria for a facility licensed under this part, arrangements for relocating the person shall be made in accordance with s. 429.28(1)(k), unless the facility is licensed to provide extended congregate care services. 8. Rule 58A-5.031, Florida Administrative Code, requires: (2) RESIDENT CARE STANDARDS. (a) A resident receiving limited nursing services in a facility holding only a standard and limited nursing license must meet the admission and continued residency criteria specified in Rule 58A-5.0181, F.A.C. (c) Limited nursing services may only be provided as authorized by a health care provider's order, a copy of which shall be maintained in the resident's file. (d) Facilities licensed to provide limited nursing services must employ or contract with a nurse(s) who shall be available to provide such services as needed by residents. The facility shall maintain documentation of the qualifications of nurses providing limited nursing services in the facility's personnel files. (e) The facility must ensure that nursing services are conducted and supervised in accordance with Chapter 464, F.S., and the prevailing standard of practice in the nursing community. (3) RECORDS. (a) A record of all residents receiving limited nursing services under this license and the type of service provided shall be maintained. (o) Nursing progress notes shall be maintained for each resident who receives limited nursing services. (c) A nursing assessment conducted at least monthly shall be maintained on each resident who receives a limited nursing service. 9. Section 464.003(3), Florida Statutes (2007), defines: (3) (a) "Practice of professional nursing" means the performance of those acts requiring substantial specialized knowledge, judgment, and nursing skill based upon applied principles of psychological, biological, physical, and social sciences which shall include, but not be limited to: 1. The observation, assessment, nursing diagnosis, planning, intervention, and evaluation of care; health teaching and counseling of the ill, injured, or infirm; and the promotion of wellness, maintenance of health, and prevention of illness of others. 2. The administration of medications and treatments as prescribed or authorized by a duly licensed practitioner authorized by the laws of this state to prescribe such medications and treatments. 10. Rule 58A-5.0185(1) (b), Florida Administrative Code, requires: (ob) If facility staff note deviations which could reasonably be attributed to the improper self- administration of medication, staff shall consult with the resident concerning any problems the resident may be experiencing with the medications; the need to permit the facility to aid the resident through the use of a pill organizer, provide assistance with self- administration of medications, or administer medications if such services are offered by the facility. The facility shall contact the resident's health care provider when observable health care changes occur that may be attributed to the resident's medications. The facility shall document such contacts in the resident's records. 11. On February 21-22, 2008, the Agency conducted a complaint survey (CCR# 2008002010) of Respondent Facility. 12. Based on a review of 11 clinical records and interview with administrative staff, the facility staff failed to contact the resident’s health care provider for observable health care changes from medications for 3 of the 11 sampled residents, “Resident #2, #4, and #11.” Specifically, for Resident #2 there was no notification to Resident #2’s health care provider of the sudden significant bleeding from the socket of a missing tooth following a physician-ordered increase in Coumadin and of PT/INR test results showing excessive levels; for Resident #4 the staff failed to notify the resident’s physician post-hospitalization regarding a change in the resident’s Coumadin dosage by the hospital resulting in a sub-therapeutic dosage of medication used to prevent clotting; for Resident #11 there was a failure to report an elevated laboratory result to a resident’s health care provider, thus placing the resident at risk for bleeding. 13. Resident #2 was admitted to the facility with diagnoses of a fracture humerus, dislocated hip, hypertension, edema, hernia, coronary artery disease, congestive heart failure, depression, and elevated cholesterol in November of 2005. 13.1. Review of Resident #2’s Medication Observation Record revealed that Resident #2 was to take 4 mg of Coumadin daily from February 1 through February 15, 2007. 13.2. On February 16, 2007, Resident #2 was started on a regime of 6 mg of Coumadin per day, with PT/INR laboratory testing to be administered on Wednesday, February 21, 2007. 13.3. PT/INR testing is a commonly accepted method of monitoring Coumadin levels in a patient’s blood. Elevated levels of Coumadin can cause excess or fatal bleeding, while low levels of Coumadin can fail to prevent fatal clotting or strokes. 13.4. On February 17, 2007, Resident #2 was observed by the staff of Respondent Facility to be bleeding from the socket of a missing tooth. Despite the application of pressure and gauze packing, the wound continued to bleed off and on throughout the afternoon. 13.5. Given the 50% increase in Coumadin daily dosage, Resident #2’s observed bleeding on February 17, 2008, was an observable health care change. However, Respondent Facility’s staff did not report this observable health care change to Resident #2’s health care provider, and, instead, at 3:05 p.m. on February 18, 2007, the Respondent Facility received permission to delay Resident #2’s PT/INR testing until Thursday, February 22, 2007. 13.6. Following PT/INR testing on February 21, 2007, Resident #2 was determined to have an INR of greater than 10.0 and a PT of 89.7, and upon viewing Resident #2’s mouth Respondent Facility’s staff determined that Resident #2 continued to actively bleed from the area of Resident #2's mouth where a tooth was missing. 13.7. At 11:15 p.m. on February 21, 2007, Resident #2 was transported to a hospital by an ambulance. 13.8. It was noted on Resident #2's MOR (Medication Observation Record), that the resident received Vitamin K, 5 mg, every evening on 2/22/07, 2/23/07, and 2/24/07. Vitamin K is commonly administered to lower PT and INR levels. 13.9. On 2/22/07, the PT/INR test result was elevated with PT at greater than 100, and the INR was greater than 10.0. 13.10. On February 23, 2007, the nursing progress notes for Resident #2 indicated at 10:00 p.m. "Order received stop vitamin K, stop warfarin (the generic of Coumadin), PT/INR on Monday STAT (‘as quickly as possible’).” However, there was no documentation in the resident’s record to indicate that laboratory testing was done on February 26, 2007, Monday, as ordered. 13.11. On February 27, 2007, Resident #2’s health care provider ordered that Resident #2 receive Coumadin 2 mg daily and that Resident #2 be given PT/INR testing in one week. However, this medication was not started by the nurse until 3/8/07, over a week later than ordered. The explanation on the back of the MOR was "Rx (prescription) on order." There was no indication in the record that the physician was notified of the failure to begin the ordered lower dosage in a timely manner. 13.12. The next lab report in Resident #2’s chart was dated 2/28/07. At that time, the PT test result was 18.4 and the INR was 1.27. There is no record indication that Resident #2’s health care provider was notified of the results, or that nursing assessment was commenced. 13.13. Laboratory tests were drawn on March 7, 2007, and March 9, 2007. The results were a PT of 16.3 with an INR of 1.06 on the 7 and on the 9** a PT of 15.5 and INR of -99. Nursing notes indicate that these results were sent to Resident #2’s health care provider on March 9. 13.14. On March 7, 2007, Resident #2’s health care provider ordered that Resident #2 receive Coumadin 2 mg daily and that a PT/INR test was to be drawn on 3/8/07. There was no evidence of the results of a March 8, 2007, test in the resident's record. 13.15. On 3/13/07, the Home Health Agency's copy of the order from Resident #2’s health care provider indicated there was to have been a PT/INR test drawn in 1 week. The Coumadin dose was to continue at 2 mg. per day. There were no laboratory results in the resident’s record indicating laboratory work during the week of March 18 through 24, 2007. 13.16. On 3/30/07, Resident #2’s health care provider ordered PT/INR and BMP (chemistry blood work) laboratory testing be done. The testing was done on 4/4/07, with the results indicating a PT/INR ratio of 22.6/1.70. There is no indication in Resident #2’s file that Resident #2’s health care provider was notified of the results, or that nursing assessment was commenced. 13.17. On 5/17/07, the PT result was 19.9, with an INR of 1.42. These results were sent to Resident #2’s health care provider. 13.18. On 6/29/07, the PT was 36.3, and the INR was 3.35. For this test, the PT was twice the therapeutic level, but there is no indication in Resident #2’s record that Resident #2’s health care provider was contacted, or that nursing assessment was commenced. 13.19. On 7/2/07, there was a physician's order for a repeat of the PT/INR in 1 week to 10 days. However, there were no results of any blood work for the July 9 to July 12 time span located in Resident #2’s resident record. 13.20. Interview with the Residence Director on 2/21/08 at 4:30 p.m., revealed that the Respondent Facility did not have any other lab reports available for Resident #2, other than those lab reports found by the Agency surveyor in Resident #2’s file. 13.21. Interview with Resident #2’s physician and Advanced Registered Nurse Practitioner on 2/22/08 at 8:30 a.m., revealed the July tests were ordered through "their" lab, but the physician and Advanced Registered Nurse Practitioner were unsure why the tests were not completed. 13.22. On 7/31/07, Resident #2’s health care provider ordered an additional PT/INR test. There was no documentation in the record indicating this test was performed. 13.23. On 8/13/07, the progress notes indicated the resident's blood pressure was low at 96/46, as the Home Health Agency reported to the resident's health care provider. It was decided to send the resident to the Emergency Room (ER). The resident refused transport. There was no further monitoring documented for this 10 resident until the next day. 13.24. On 8/14/07, there were multiple medication changes, but not the Coumadin. There was no documentation of the status of the resident. 13.25. On 8/16/07, the documentation in the progress notes indicated the resident was bleeding from the mouth, multiple bruises was noted on the resident's body. The physician was notified by Resident #2’s home health agency that Resident #2’s INR was greater than 10.0. The resident was sent to the Emergency Room (ER) at 8:00 a.m. At 2:00 p-m., the resident returned from the Emergency Room. Lab work found in the record from the hospital indicated PT was 97.2 with and INR of 12.04. At 3:45 p.m., the Nurse noted the resident was having “frank red blood” seeping from Resident #2’s mouth in a “scant amount.” The resident's blood pressure was 94/66. The doctor and the ARNP were notified, and the resident was taken to the Emergency Room. The resident refused to return to the hospital. At 7:00 p.m., the resident had no further bleeding. At 11:00 p.m. the resident's blood pressure was 120/46. 13.26. On 8/17/07, the resident was noted to be "short of breath," receiving oxygen, and weak. The resident's color was pale, and speech was more garbled. The Home Health Agency Nurse indicated to the staff member that 11 Resident #2 had blood in the resident’s stool. The resident was sent to the Emergency Room. At that time, the resident was admitted to the hospital. The facility later received word that the resident expired while in the hospital. 14, Initial review of Resident #4's clinical record revealed the resident was taking Coumadin 5 mg, alternating with 2.5 mg every other day. 14.1. Further review of the clinical record revealed Resident #4 went to the hospital on 1/15/08 for a cardiac catheterization. The resident remained in the hospital until 1/18/08. 14.2. Upon return to the facility, there was an instruction sheet from the hospital labeled "discharge instructions." This was not a signed physician's order. Among the instructions was for the resident to take Coumadin 2.5 mg every other day. There was no documentation in Resident #4’s file showing an order from a physician clarifying for the facility if this was the dosage Resident #4’s physician wanted for this resident. 14.3. A review of the Medication Observation Record (MOR) revealed that Resident #4 received the 2.5 mg dosage throughout the rest of January of 2008. Further review of the February MOR revealed the resident had a new order 12 written in the MOR, the resident was to receive 5 mg every other day, alternating with 2.5 mg every other day. The resident received the first dosage of 5 mg on 2/20/08. There was no physician's order in the record for this change in dosage. 14.4. The above was confirmed with the Resident Service Director on 2/21/08 at 1:15 p.m. 15. Resident #11 received Coumadin therapy of 3 mg on Sunday and 6 mg every other day of the week. 15.1. A laboratory test showed that Resident #11 had a prothrombin time (PT) dated 1/4/08 of 44.3 (normal 14.1- 17.1 seconds) and an INR (International Normalized Ratio) of 3.17. 15.2. The results of the PT/INR test dated January 4, 2008, for Resident #11 were above the therapeutic range for this resident. There was no physician notification of this issue until 1/8/08. 16. The Agency determined that the deficient practice of failing to contact the resident's health care provider when observable health care changes occur that may be attributed to the resident's medications was related to the operation and maintenance of the facility, or to the personal care of the resident, which the Agency determined presented an imminent danger to the resident or a substantial probability that death 13 or serious physical or emotional harm would result and cited the Respondent for a State Class I deficiency. 17. Pursuant to § 429.19(2)(a), Florida Statutes (2007), the Agency is authorized to impose a fine in an amount not less than five thousand dollars ($5,000.00) and not exceeding ten thousand dollars ($10,000.00) for each State Class I deficiency. 18. The Agency provided Respondent with a mandatory correction date of February 29, 2008. WHEREFORE, the Agency intends to impose an administrative fine in the amount of $5,000.00 against Respondent, an assisted living facility in the State of Florida, pursuant to Section 429.19(2) (a), Florida Statutes (2007), or such further relief as this tribunal deems just. COUNT II 19. The Agency realleges and incorporates paragraphs 1 through 5 and 7, 8, and 9, as if fully set forth in this count. 20. Rule 58A-5.0182(1), Florida Administrative Code, provides: 58A-5.0182 Resident Care Standards. An assisted living facility shall provide care and services appropriate to the needs of residents accepted for admission to the facility. (1) SUPERVISION. Facilities shall offer personal supervision, as appropriate for each resident, including the following: 14 (b) Daily observation by designated staff of the activities of the resident while on the premises, and awareness of the general health, safety, and physical and emotional wellbeing of the individual. (d) Contacting the resident's health care provider and other appropriate party such as the resident's family, guardian, health care surrogate, or case manager if the resident exhibits a significant change; ... (e) A written record, updated as needed, of any significant changes as defined in subsection 58A- 5.0131(33), F.A.C., any illnesses which resulted in medical attention, major incidents, changes in the method of medication administration, or other changes which resulted in the provision of additional services. 21. On February 21-22, 2008, the Agency conducted a complaint survey (CCR# 2008002010) of Respondent Facility. 22. Based on a review of 11 clinical records, interview with facility administrative staff, and interview with a physician and an Advanced Registered Nurse Practitioner (“ARNP”), the facility failed to ensure that nursing services were conducted and supervised in accordance with Chapter 464, Florida Statutes, and with the prevailing standard of practice in the nursing community by failing to ensure that there was effective communication and coordination of care between the facility, the physician, the ARNP, and the Home Health Agencies involved in the care of residents for 5 of 11 residents reviewed, “Residents #2, #3, #4, #7 and #8.” This lack of 15 communication resulted in a failure of the Respondent Facility to ensure that residents’ health care providers were alerted to the need for critical laboratory tests in accord with the prevailing standard of practice in the nursing community, failure to ensure that critical laboratory tests were performed as ordered, and that such tests were evaluated, and responded to in a manner to ensure that residents received medication in a safe manner, thus placing residents receiving Coumadin at risk for hemorrhage and possible death and causing Resident #3 to not receive an ordered test to determine the need for oxygen. 23. Prevailing standards of practice in the nursing community require that a nurse alert a resident’s health care provider if periodic Prothrombin (PT) and International Normalized Ratio (INR) testing are not being performed on a resident who is receiving Coumadin therapy. As part of the standard of practice in the nursing community, a nurse is aware of the dangers of bleeding due to excessively high test levels of PT and INR, and-a nurse is aware of the dangers of failure to preventing clotting and strokes from excessively low test levels of PT and INR. 24. Review of Resident #2’s Medication Observation Record revealed that Resident #2 was to take 4 mg of Coumadin daily from February 1 through February 15, 2007. 16 24.1. Review of the lab work in the record of Resident #2, revealed the result of a Prothrombin (PT) test dated 2/15/07, was 13.9 (normal 14.1-17.1 seconds) and International Normalized Ratio (INR) was 0.85 (normal therapeutic range 2-3). 24.2. On 2/18/07, the next entry indicated it was a late entry for 2/16/07: "New order received for Coumadin increase to 6 mg QD [daily] (noted on MOR right away). PT/INR on Wed. Make sure resident is taking Coumadin medication.” 24.3. Review of the MOR (Medication Observation Record) revealed that on 2/16/07, Resident #2 started on 6 mg a day. 24.4. On February 17, 2007, the progress notes for Resident #2 stated: "Began shift with (resident name) bleeding from socket of a missing tooth. Pressure applied via gauze. Area bled off and on through afternoon in minimal amounts once pressure applied." There was no evidence that Resident #2’s health care provider was notified of this bleeding episode in accord with prevailing standards in the nursing community. 24.5. On 2/18/07, a Home Health Agency Nurse documented that Resident #2’s physician gave permission to draw Resident #2’s blood on Thursday instead of Wednesday. 17 24.6. The next lab test drawn was a PT of 89.7 seconds and an INR of greater than 10.0 on 2/21/07. Critical laboratory values were identified by the blood drawing lab as a PT of greater than 35 seconds, and an INR of greater than 7.0. 24.7. On 2/21/07, four (4) days after Resident bleeding was first discerned, documentation in the progress notes indicated that Resident #2’s health provider had been called by the testing laboratory report Resident #2’s INR of 12.2, and that it "had previously been brought to this writer's attention resident had been bleeding from gums -- on inspecti the gum-moderate amount of dried blood appearance b left side lip and jaw, and mouth. Resident stated had been bleeding from an extraction at area." The resident was transferred to the Emergency Room (ER) #2'Ss nursing care to just that the on of elow the gum at 11:15 a.m. At 2:33 p.m., the resident returned from the Emergency Room (ER). 24.8. It was noted on Resident #2's MOR (Medica Observation Record), that the resident received Vit 5 mg every evening on 2/22/07, 2/23/07, and 2/24/07 Vitamin K is commonly administered to lower PT and levels. 18 tion amin K, INR 24.9. On 2/22/07, the PT result was greater than 100 and the INR was greater than 10.0. 24.10. The progress notes indicated on 2/23/07, at 10:00 p.m. "Order received stop vitamin K, stop warfarin [the generic of Coumadin], PT/INR on Monday STAT [‘as quickly as possible’].” However, there was no documentation in the ‘resident’s record to indicate that laboratory testing was done on February 26, 2007, Monday, as ordered. 24.11. On February 27, 2007, Resident #2’s health care provider ordered that Resident #2 receive Coumadin 2 mg daily and that Resident #2 be given PT/INR testing in one week. However, this medication was not started by the nurse until 3/8/07, over a week later than ordered. The explanation on the back of the MOR was "Rx (prescription) on order." There was no indication in the record that the physician was notified of the failure to begin the ordered lower dosage at the time ordered. 24.12. The next lab report in Resident #2’s chart was dated 2/28/07. At that time, the PT was 18.4 and the INR was 1.27. There is no record indication that Resident #2’s health care provider was notified of the results, or that nursing assessment was commenced. 24.13. Laboratory tests were drawn on March 7, 2007, and March 9, 2007. The results were a PT of 16.3 with an INR 19 of 1.06 on the 7 and on the 9° a PT of 15.5 and INR of -99. Nursing notes indicate that these results were sent to Resident #2’s health care provider on March 9. 24.14. On March 7, 2007, Resident #2’s health care provider ordered that Resident #2 receive Coumadin 2 mg daily and that a PT/INR test was to be. drawn on 3/8/07. There was no evidence of the results of a March 8, 2007, test in the resident’s record. 24.15. On 3/13/07, the Home Health Agency's copy of the order from Resident #2’s health care provider indicated there was to have been a PT/INR test drawn in 1 week. The Coumadin dose was to continue at 2 mg. per day. There were no laboratory results in the resident’s record indicating laboratory work during the week of March 18 through 24, 2007. 24.16. On 3/30/07, Resident #2’s health care provider ordered PT/INR and BMP (chemistry blood work) laboratory testing be done. The testing was done on 4/4/07, with the results indicating a PT/INR ratio of 22.6/1.70. There is no indication in Resident #2’s file that Resident #2’s health care provider was notified of the results, or that nursing assessment was commenced. 24.17. On 5/17/07, the PT result was 19.9, with an INR of 1.42. These results were sent to Resident #2’s health 20 care provider. 24.18. On 6/29/07, the PT was 36.3, and the INR was 3.35. For this test, the PT was twice the therapeutic level, but there is no indication in Resident #2’s record that Resident #2’s health care provider was contacted, or that nursing assessment was commenced. 24.19. On 7/2/07, there was a physician's order for a repeat of the PT/INR in 1 week to 10 days. However, there were no results of any blood work for the July 9 to July 12 time span located in Resident #2’s resident record. 24.20. Interview with the Resident Services Director on 2/21/08 at 4:30 p.m., revealed that the Respondent Facility did not have any other lab reports available for Resident #2, other than those lab reports found by the Agency surveyor in Resident #2’s file. 24.21. Interview with Resident #2’s physician and Advanced Registered Nurse Practitioner on 2/22/08 at 8:30 a.m., revealed the July tests were ordered through "their" lab, but the physician and Advanced Registered Nurse Practitioner were unsure why the tests were not completed. 24.22. On 7/31/07, Resident #2’s health care provider ordered an additional PT/INR test. There was no documentation in Resident #2’s record indicating that the PT/INR test was performed. 21 24.23. On 8/13/07, the progress notes indicated the resident's blood pressure was low at 96/46, as the Home Health Agency reported to the resident's health care provider. It was decided to send the resident to the Emergency Room (ER). The resident refused transport. There was no further monitoring documented for this resident until the next day. 24.24. On 8/14/07, there were multiple medication changes, but not the Coumadin. There was no documentation of the status of the resident. 24.25. On 8/16/07, the documentation in the progress notes indicated the resident was bleeding from the mouth, multiple bruises was noted on the resident's body. The physician was notified by Resident #2’s home health agency that Resident #2’s INR was greater than 10.0. The resident was sent to the Emergency Room (ER) at 8:00 a.m. At 2:00 p.m., the resident returned from the Emergency Room. Lab work found in the record from the hospital indicated PT was 97.2 with and INR of 12.04. At 3:45 p.m., the Nurse noted the resident was having “frank red blood” seeping from Resident #2’s mouth in a “scant amount.” The resident's blood pressure was 94/66. The doctor and the ARNP were notified, and the resident was taken to the Emergency Room. The resident refused to return to the hospital. At 7:00 22 p.m., the resident had no further bleeding. At 11:00 p.m. the resident's blood pressure was 120/46. 24.26. On 8/17/07, the resident was noted to be "short of breath," receiving oxygen, and weak. The resident's color was pale, and speech was more garbled. The Home Health Agency Nurse indicated to the staff member that Resident #2 had blood in the resident’s stool. The resident was sent to the Emergency Room. At that time, the resident was admitted to the hospital. The facility later received word that the resident expired while in the hospital. 25. During the tour of the facility on 2/21/08 at approximately 10:00 a.m., Resident #3 was identified as being on oxygen. The resident wanted the oxygen discontinued, saying that it was "too expensive" to pay the resident’s portion of the oxygen charge. The resident further stated the resident’s doctor had ordered a test a long while ago to determine if the oxygen was still needed. 25.1. A review of Resident #3’s file showed a physician's order dated 2/4/08 for a pulse oximetry to be performed for Resident #3 without the oxygen and at night. 25.2. At the time of the survey on 2/21/08, the test had not been performed. 23 25.3. Interview with the Resident Services Director on 2/22/08 at 11:25 a.m., revealed she was unsure of the reason the pulse oximetry test was not performed. She further indicated there were problems with the resident's insurance and a co-payment the insurance company required. However, the Resident Services Director did confirm that the chart did not contain documentation of the insurance issues or notification to the physician or other appropriate party of the insurance issues. 26. Record review of Resident #4’s resident record revealed the resident was admitted to the facility on 4/6/07. At the time of admission, the health assessment form, Agency form 1823, revealed the resident was taking Coumadin. At the time of admission, the resident was taking 2.5 mg of Coumadin every other day, alternating with 5 mg of Coumadin every other day. Further review of the record revealed there were no routine orders for blood work to check the levels of Coumadin. There was only one PT and INR laboratory report dated 2/15/08 in Resident #4’s resident record. At that time the result was a PT of 14 (normal 13-17) and .94 (therapeutic level 2-3). 26.1. Interview with the Resident Services Director on 2/21/08 at 5:15 p.m., indicated blood work was not ordered, so it was not done. The Resident Services Director indicated her belief that it was not the facility's 24 responsibility to remind the physician or the Advanced Registered Nurse Practitioner (ARNP) of the possible need for blood work for a resident. The Resident Services Director further indicated it was her belief that the Resident Services Director’s responsibility was only to ensure that the resident received the resident’s ordered medications. 26.2. Further review of the clinical record revealed Resident #4 went to the hospital on 1/15/07 for a cardiac catheterization. The resident remained in the hospital until 1/18/07. Upon return to the facility, there was an instruction sheet from the hospital labeled "discharge instructions." This was not a signed physician's order. Among the instructions was for the resident to take Coumadin 2.5 mg every other day. There was no order from a health care provider clarifying for the facility if this was the dosage the physician wanted for this resident. In accord with prevailing standards of practice in the nursing community, this daily dosage of 2.5 mg of Coumadin was abnormally low, and not a usual dosage for the medication. A review of the Medication Observation Record (MOR) revealed the resident received this lower dosage throughout the rest of January of 2008. Further review of the February MOR revealed the resident had a new order hand- 25 written in the MOR, the resident was to receive 5 mg every other day, alternating with 2.5 mg every other day. The resident received the first dosage of 5 mg on 2/20/08. There was no health care provider's order in the record for this change in dosage. There was no documentation in the progress notes about this issue. 26.3. This lack of a health care provider’s order was confirmed with the Resident Services Director on 2/21/08 at 1:15 p.m. 27. Resident #7 was receiving Coumadin since admission to the Respondent Facility on April 4, 2006. 27.1. Review of the clinical record of Resident #7 revealed an order dated 5/24/07 to Pesume Coumadin, to test the Prothrombin Time/International Normalized Ratio (PT/INR) daily, and to maintain the PT/INR ratio at 2 - 3. 27.2. However, Resident #7’s file contains no daily lab work noted on the clinical record. 27.3. On 8/9/07, there was a note to a Home Health Agency from Resident #7’s physician indicating the INR was 1.27 and to continue Coumadin 2.5 mg Monday, Wednesday, Friday, and to provide 3 mg of Coumadin each day of the rest of week. The physician ordered that the home health agency recheck PT/INR the next Wednesday, August 15, 2007. 26 27.4. The resident’s file also contained physician's orders on Home Health Agency letterhead indicating Coumadin doses, and change orders dated 8/16/07, 9/11/07, 9/27/07, 11/15/07, 12/7/07, and 1/25/08. However, there were no lab reports related to these orders except as noted below. 27.5. On 9/27/07, the order included the INR result of 1.95, instructions to continue the same dosage of the Coumadin, (the Resident was taking 2.5 mg on Monday Wednesday and Friday, and 3 mg the rest of the week) and recheck of the PT/INR in 1 month. There was no documentation of any results of blood work for October in Resident #7’s record. 27.6. On 11/15/07, the order from the Home Health Agency’s health care provider included an increase in the dosage to Coumadin 3 mg every day and for the Home Health Agency to recheck the PT/INR in 1 week. There was no indication in the resident’s record that the one week check was performed. 27.7. On 12/7/07, the documentation indicated to continue Coumadin and for the Home Health Agency to recheck the blood in 2 weeks. There were no results in the resident’s record to indicate that this laboratory work was performed. 27 27.8. On 1/25/08, the next documentation of laboratory testing was again on Home Health Agency letterhead and included the results of the INR of 2.2, and the dosage was to continue the same. 27.9. Interview with the Resident Services Director on 2/21/08 at 5:17 p.m., revealed that the residents who are tested for blood work from the Home Health Agency providing blood work to Resident #7 are not always Home Health Agency patients. At times the Home Health Agency sends nurses into the facility to act as phlebotomists and draw the blood. When this is done, the Resident Services Director opined that the Home Health Agency is not providing Home Health Care. The Resident Services Director stated that it cannot be determined when the Home Health Agency is active as a Home Health Agency and when the agency is active as phlebotomists. She further indicated the Home Health Agency in either of its roles does not always tell the Respondent Facility the results of any lab work they perform while visiting the resident. She stated she is not always aware of the orders for the blood work. 28. Resident #8 was admitted to the facility on 4/13/07. 28.1. On the initial health assessment dated 4/13/07, there were physician's orders for Prothrombin Time/International Normalized Ratio (PT/INR) to be done 28 every Monday and Thursday. 28.2. The initial laboratory results noted on the resident’s record were dated 5/31/07. There were no prior testing results in Resident #8’s file. The last laboratory results noted in the resident record were on 1/25/08, and none since then through the date of the Agency survey on February 22, 2008. 28.3. Interview with the Resident Services Director on 2/21/08, revealed the missing tests were not completed. 29. The Respondent Facility failed to ensure that nursing services were conducted and supervised in accordance with Chapter 464, Florida Statutes, and with the prevailing standard of practice in the nursing community by: 29.1. For Resident #2, failing to promptly assess and communicate to Resident #2’s health care provider Resident #2's gum bleeding on February 17, 2007; failing to timely implement health care provider’s order for laboratory testing on February 26, on March 8, during the week of March 18 through March 24, during the period from July 9 to July 12, and July 31, 2007; failing to notify Resident #2’s health care provider that ordered lower level of Coumadin dosage was not implemented until over one week after the lower level was ordered; and failing to promptly notify Resident #2’s health care provider and commence nursing 29 assessment due to abnormal laboratory results on February 28, April 4, and June 29. 29.2. For Resident #3, failing to promptly implement Resident #3’s health care provider’s order for pulse oximetry or to promptly notify Resident #3’s health care provider or appropriate others as to problems with implementing the health care provider’s order. 29.3. For Resident #4, failing to notify Resident #4’s health care provider that although Resident #4 was receiving Coumadin therapy, no periodic testing of Resident #4 had been ordered; failing to timely notify Resident #4’s health care provider when Respondent Facility changed Resident #4’s dosage of Coumadin without an order from a health care provider, but pursuant to a hospital discharge instruction sheet; and by failing to obtain a written order from Resident #4’s health care provider to restore Resident #4’s Coumadin dosage to pre-hospitalization levels. 29.4. For Resident #7, failing to implement Resident #7’s health care provider’s order for daily PT/INR testing; failing to ensure that a home health agency timely implemented Resident #7’s health care provider's order for PT/INR testing on Wednesday, August 15, 2007; and failing to notify Resident #7’s health care provider that although Resident #7 was receiving Coumadin therapy, no periodic 30 testing of Resident #7 had been ordered for October, November, and December of 2007. 29.5. For Resident #8, failing to implement regular and timely PT/INR testing twice-weekly as ordered by Resident #8’s health care provider. 30. The Agency determined that the deficient practice of failing to ensure that nursing services were conducted and supervised in accordance with Chapter 464, Florida Statutes, and with the prevailing standard of practice in the nursing community was related to the operation and maintenance of the facility, or to the personal care of the resident, which the Agency determined presented an imminent danger to the resident or a substantial probability that death or serious physical or emotional harm would result and cited the Respondent for a State Class I deficiency. 31. Pursuant to § 429.19(2) (a), Florida Statutes (2007), the Agency is authorized to impose a fine in an amount not less than five thousand dollars ($5,000.00) and not exceeding ten thousand dollars ($10,000.00) for each violation. 32. The Agency provided Respondent with a mandatory correction date of February 29, 2008. WHEREFORE, the Agency intends to impose an administrative fine in the amount of $5,000.00 against Respondent, an assisted living facility in the State of Florida, pursuant to Section 31 429.19(2) (a), Florida Statutes (2007), or such further relief as this tribunal deems just. COUNT III 33. The Agency re-alleges and incorporates paragraphs 1 through 5, and 7, 8, and 9, as if fully set forth in this count. 34. Rule 58A-5.0182(1), Florida Administrative Code, provides: 58A-5.0182 Resident Care Standards. An assisted living facility shall provide care and services appropriate to the needs of residents accepted for admission to the facility. (1) SUPERVISION. Facilities shall offer personal supervision, as appropriate for each resident, including:- the following: (b) Daily observation by designated staff of the activities of the resident while on the premises, and awareness of the general health, safety, and physical and emotional wellbeing of the individual. (d) Contacting the resident's health care provider and other appropriate party such as the resident's family, guardian, health care surrogate, or case manager if the resident exhibits a significant change; (e) A written record, updated as needed, of any significant changes as defined in subsection 58A- 5.0131(33), F.A.C., any illnesses which resulted in medical attention, major incidents, changes in the method of medication administration, or other changes which resulted in the provision of additional services. 32 35. On February 21-22, 2008, the Agency conducted a complaint survey (CCR# 2008002010) of Respondent Facility. 36. Based on a review of 11 clinical records, interview with facility administrative staff, and interview with a physician and an Advanced Registered Nurse Practitioner (“ARNP”), the facility failed to ensure daily observation by designated staff of the activities of the residents while on the premises, and awareness by staff of the general health, safety, and physical and emotional wellbeing of the residents for 5 of 11 residents reviewed, “Residents #2, #3, #4, #7 and #8.” This failure resulted in a lack of communication with residents’ health care providers and home health agencies, including a failure of the Respondent Facility to ensure that residents’ health care providers were alerted to the need for critical laboratory tests in accord with the prevailing standard of practice in the nursing community, failure to ensure that critical laboratory tests were performed as ordered, and that such tests were evaluated, and responded to in a manner to ensure that residents received medication in a safe manner, thus placing residents receiving Coumadin at risk for hemorrhage and possible death and causing Resident #3 to not receive an ordered test to determine the need for oxygen. 37. Prevailing standards of practice in the nursing community require that a nurse observe and alert a resident’s 33 health care provider if periodic Prothrombin (PT) and International Normalized Ratio (INR) testing are not being performed on a resident who is receiving Coumadin therapy. As part of the standard of practice in the nursing community, a nurse is aware of the dangers of bleeding due to excessively high test levels of PT and INR, and a nurse is aware of the dangers of failure to preventing clotting and strokes from excessively low test levels of PT and INR. 38. Review of Resident #2’'s Medication Observation Record revealed that Resident #2 was to take 4 mg of Coumadin daily from February 1 through February 15, 2007. 38.1. Review of the lab work in the record of Resident #2, revealed the result of a Prothrombin (PT) test dated 2/15/07, was 13.9 (normal 14.1-17.1 seconds) and International Normalized Ratio (INR) was 0.85 (normal therapeutic range 2-3). 38.2. On 2/18/07, the next entry indicated it was a late entry for 2/16/07: "New order received for Coumadin increase to 6 mg QD [daily] (noted on MOR right away). PT/INR on Wed. Make sure resident is taking Coumadin medication.” 38.3. Review of the MOR (Medication Observation Record) revealed that on 2/16/07, Resident 42 started on 6mga day. 34 38.4. On February 17, 2007, the progress notes for Resident #2 stated: "Began shift with (resident name) bleeding from socket of a missing tooth. Pressure applied via gauze. Area bled off and on through afternoon in minimal amounts once pressure applied." There was no evidence that Resident #2’s health care provider was notified of this bleeding episode in accord with prevailing standards in the nursing community. 38.5. On 2/18/07, a Home Health Agency Nurse documented that Resident #2’s physician gave permission to draw Resident #2’s blood on Thursday instead of Wednesday. 38.6. The next lab test drawn was a PT of 89.7 seconds and an INR of greater than 10.0 on 2/21/07. Critical laboratory values were identified by the blood drawing lab as a PT of greater than 35 seconds, and an INR of greater than 7.0. 38.7. On 2/21/07, four (4) days after Resident #2’s bleeding was first discerned, documentation in the nursing progress notes indicated that Resident #2’s health care provider had been called by the testing laboratory to report Resident #2’s INR of 12.2, and that it "had just previously been brought to this writer's attention that the resident had been bleeding from gums -- on inspection of the gum-moderate amount of dried blood appearance below 35 left side lip and jaw, and mouth. Resident stated the gum had been bleeding from an extraction at area." The resident was transferred to the Emergency Room (ER) at 11:15 a.m. At 2:33 p.m., the resident returned from the Emergency Room (ER). 38.8. It was noted on Resident #2's MOR (Medication Observation Record), that the resident received Vitamin K, 5 mg every evening on 2/22/07, 2/23/07, and 2/24/07. Vitamin K is commonly administered to lower PT and INR levels. 38.9. On 2/22/07, the PT result was greater than 100 and the INR was greater than 10.0. 38.10. The progress notes indicated on 2/23/07, at 10:00 p.m. "Order received stop vitamin K, stop warfarin [the generic of Coumadin], PT/INR on Monday STAT [*as quickly as possible’].” However, there was no documentation in the resident’s record to indicate that laboratory testing was done on February 26, 2007, Monday, as ordered. 38.11. On February 27, 2007, Resident #2’s health care provider ordered that Resident #2 receive Coumadin 2 mg daily and that Resident #2 be given PT/INR testing in one week. However, this medication was not started by the nurse until 3/8/07, over a week later than ordered. The explanation on the back of the MOR was "Rx (prescription) 36 on order." There was no indication in the record that the physician was notified of the failure to begin the ordered lower dosage at the time ordered. 38.12. The next lab report in Resident #2’s chart was dated 2/28/07. At that time, the PT was 18.4 and the INR was 1.27. There is no record indication that Resident #2’s health care provider was notified of the results, or that nursing assessment was commenced. 38.13. Laboratory tests were drawn on March 7, 2007, and March 9, 2007. The results were a PT of 16.3 with an INR of 1.06 on the 7 and on the 9°" a PT of 15.5 and INR of .99. Nursing notes indicate that these results were sent to Resident #2’s health care provider on March 9. 38.14. On March 7, 2007, Resident #2’s health care provider ordered that Resident #2 receive Coumadin 2 mg daily and that a PT/INR test was to be drawn on 3/8/07. There was no evidence of the results of a March 8, 2007, test in the resident’s record. 38.15. On 3/13/07, the Home Health Agency's copy of the order from Resident #2’s health care provider indicated there was to have been a PT/INR test drawn in 1 week. The Coumadin dose was to continue at 2 mg. per day. There were no laboratory results in the resident’s record indicating laboratory work during the week of March 18 through 24, 37 2007. 38.16. On 3/30/07, Resident #2’s health care provider ordered PT/INR and BMP (chemistry blood work) laboratory testing be done. The testing was done on 4/4/07, with the results indicating a PT/INR ratio of 22.6/1.70. There is no indication in Resident #2’s file that Resident #2’s health care provider was notified of the results, or that nursing assessment was commenced. 38.17. On 5/17/07, the PT result was 19.9, with an INR of 1.42. These results were sent to Resident #2’s health care provider. 38.18. On 6/29/07, the PT was 36.3, and the INR was 3.35. For this test, the PT was twice the therapeutic level, but there is no indication in Resident #2’s record that Resident #2’s health care provider was contacted, or that nursing assessment was commenced. 38.19. On 7/2/07, there was a physician's order for a repeat of the PT/INR in 1 week to 10 days. However, there were no results of any blood work for the July 9 to July 12 time span located in Resident #2’s resident record. 38.20. Interview with the Resident Services Director on 2/21/08 at 4:30 p.m., revealed that the Respondent Facility did not have any other lab reports available for Resident #2, other than those lab reports found by the Agency 38 surveyor in Resident #2’s file. 38.21. Interview with Resident #2’s physician and Advanced Registered Nurse Practitioner on 2/22/08 at 8:30 a.m., revealed the July tests were ordered through "their" lab, but the physician and Advanced Registered Nurse Practitioner were unsure why the tests were not completed. 38.22. On 7/31/07, Resident #2’s health care provider ordered an additional PT/INR test. There was no documentation in Resident #2’s record indicating that the PT/INR test was performed. 38.23. On 8/13/07, the progress notes indicated the resident's blood pressure was low at 96/46, as the Home Health Agency reported to the resident's health care provider. It was decided to send the resident to the Emergency Room (ER). The resident refused transport. There was no further monitoring documented for this resident until the next day. 38.24. On 8/14/07, there were multiple medication changes, but not the Coumadin. There was no documentation of the status of the resident. 38.25. On 8/16/07, the documentation in the progress notes indicated the resident was bleeding from the mouth, multiple bruises was noted on the resident's body. The physician was notified by Resident #2’s home health agency 39 that Resident #2’s INR was greater than 10.0. The resident was sent to the Emergency Room (ER) at 8:00 a.m. At 2:00 p.-m., the resident returned from the Emergency Room. Lab work found in the record from the hospital indicated PT was 97.2 with and INR of 12.04. At 3:45 p.m., the Nurse noted the resident was having “frank red blood” seeping from Resident #2’s mouth in a “scant amount.” The resident's blood pressure was 94/66. The doctor and the ARNP were notified, and the resident was taken to the Emergency Room. The resident refused to return to the hospital. At 7:00 p.m., the resident had no further bleeding. At 11:00 p.m. the resident's blood pressure was 120/46. 38.26. On 8/17/07, the resident was noted to be "short of breath," receiving oxygen, and weak. The resident's color was pale, and speech was more garbled. The Home Health Agency Nurse indicated to the staff member that Resident #2 had blood in the resident’s stool. The resident was sent to the Emergency Room. At that time, the resident was admitted to the hospital. The facility later received word that the resident expired while in the hospital. 39. During the tour of the facility on 2/21/08 at approximately 10:00 a.m., Resident #3 was identified as being on oxygen. The resident wanted the oxygen discontinued, saying 40 that it was "too expensive" to pay the resident’s portion of the oxygen charge. The resident further stated the resident’s doctor had ordered a test a long while ago to determine if the oxygen was still needed. 39.1. A review of Resident #3’s file showed a physician's order dated 2/4/08 for a pulse oximetry to be performed for Resident #3 without the oxygen and at night. 39.2. At the time of the survey on 2/21/08, the test had not been performed. 39.3. Interview with the Resident Services Director on 2/22/08 at 11:25 a.m., revealed she was unaware of the reason the pulse oximetry test was not performed. She further indicated there were problems with the resident's insurance and a co-payment the insurance company required. However, the Resident Services Director did confirm that the chart did not contain documentation of the insurance issues or notification to the physician or other appropriate party of the insurance issues. 40. Record review of Resident #4’s resident record revealed the resident was admitted to the facility on 4/6/07. At the time of admission, the health assessment form, Agency form 1823, revealed the resident was taking Coumadin. At the time of admission, the resident was taking 2.5 mg of Coumadin every other day, alternating with 5 mg of Coumadin every other 41 day. Further review of the record revealed there were no routine orders for blood work to check the levels of Coumadin. There was only one PT and INR laboratory report dated 2/15/08 in Resident #4’s resident record. At that time the result was a PT of 14 (normal 13-17) and .94 (therapeutic level 2-3). 40.1. Interview with the Resident Services Director on 2/21/08 at 5:15 pem., indicated blood work was not ordered, so it was not done. The Resident Services Director indicated her belief that it was not the facility's responsibility to remind the physician or the Advanced Registered Nurse Practitioner (ARNP) of the possible need for blood work for a resident. The Resident Services Director further indicated it was her belief that the Resident Services Director’s responsibility was only to ensure that the resident received the resident’s ordered medications. 40.2. Further review of the clinical record revealed Resident #4 went to the hospital on 1/15/07 for a cardiac catheterization. The resident remained in the hospital until 1/18/07. Upon return to the facility, there was an instruction sheet from the hospital labeled "discharge instructions." This was not a signed physician's order. Among the instructions was for the resident to take Coumadin 2.5 mg every other day. There was no order from a 42 health care provider clarifying for the facility if this was the dosage the physician wanted for this resident. In accord with prevailing standards of practice in the nursing community, this daily dosage of 2.5 mg of Coumadin was abnormally low, and not a usual dosage for the medication. A review of the Medication Observation Record (MOR) revealed the resident received this lower dosage throughout the rest of January of 2008. Further review of the February MOR revealed the resident had a new order hand- written in the MOR, the resident was to receive 5 mg every other day, alternating with 2.5 mg every other day. The resident received the first dosage of 5 mg on 2/20/08. There was no health care provider's order in the record for this change in dosage. There was no documentation in the progress notes about this issue. 40.3. This lack of a health care provider’s order was confirmed with the Resident Services Director on 2/21/08 at 1:15 p.m. 41. Resident #7 was receiving Coumadin since admission to the Respondent Facility on April 4, 2006. 41.1. Review of the clinical record of Resident #7 revealed an order dated 5/24/07 to resume Coumadin, to test the Prothrombin Time/International Normalized Ratio (PT/INR) daily, and to maintain the PT/INR ratio at 2 - 3. 43 41.2. However, Resident #7's file contains no daily lab work noted on the clinical record. 41.3. On 8/9/07, there was a note to a Home Health Agency from Resident #7’s physician indicating the INR was 1.27 and to continue Coumadin 2.5 mg Monday, Wednesday, Friday, and to provide 3 mg of Coumadin each day of the rest of week. The physician ordered that the home health agency recheck PT/INR the next Wednesday, August 15, 2007. 41.4. The resident’s file also contained physician's orders on Home Health Agency letterhead indicating Coumadin doses, and change orders dated 8/16/07, 9/11/07, 9/27/07, 11/15/07, 12/7/07, and 1/25/08. However, there were no lab reports related to these orders except as noted below. 41.5. On 9/27/07, the order included the INR result of 1.95, instructions to continue the same dosage of the Coumadin, (the Resident was taking 2.5 mg on Monday Wednesday and Friday, and 3 mg the rest of the week) and recheck of the PT/INR in 1 month. There was no documentation of any results of blood work for October in Resident #7's record. 41.6. On 11/15/07, the order from the Home Health Agency’s health care provider included an increase in the dosage to Coumadin 3 mg every day and for the Home Health Agency to recheck the PT/INR in 1 week. There was no 44 indication in the resident’s record that the one week check was performed. 41.7. On 12/7/07, the documentation. indicated to continue Coumadin and for the Home Health Agency to recheck the blood in 2 weeks. There were no results in the resident’s record to indicate that this laboratory work was performed. 41.8. On 1/25/08, the next documentation of laboratory testing was again on Home Health Agency letterhead and included the results of the INR of 2.2, and the dosage was to continue the same. 41.9. Interview with the Resident Services Director on 2/21/08 at 5:17 p.m., revealed that the residents who are tested for blood work from the Home Health Agency providing blood work to Resident #7 are not always Home Health Agency patients. At times the Home Health Agency sends nurses into the facility to act as phlebotomists and draw the blood. When this is done, the Resident Services Director opined that the Home Health Agency is not providing Home Health Care. The Resident Services Director stated that it cannot be determined when the Home Health Agency is active as a Home Health Agency and when the agency is active as phlebotomists. She further indicated the Home Health Agency in either of its roles does not always tell the 45 Respondent Facility the results of any lab work they perform while visiting the resident. She stated she is not always aware of the orders for the blood work. 42. Resident #8 was admitted to the facility on 4/13/07. 42.1. On the initial health assessment dated 4/13/07, there were physician's orders for Prothrombin Time/International Normalized Ratio (PT/INR) to be done every Monday and Thursday. 42.2. The initial laboratory results noted on the resident’s record were dated 5/31/07. There were no prior testing results in Resident #8’s file. The last laboratory results noted in the resident record were on 1/25/08, and none since then through the date of the Agency survey on February 22, 2008. 42.3. Interview with the Resident Services Director on 2/21/08, revealed the missing tests were not completed. - 43. The Respondent Facility failed to failed to ensure daily observation by designated staff of the activities of the residents while on the premises, and awareness by staff of the general health, safety, and physical and emotional wellbeing of the residents for 5 of 11 residents reviewed by: 43.1. For Resident #2, failing to promptly assess and communicate to Resident #2’s health care provider Resident #2’s gum bleeding on February 17, 2007; failing to timely 46 implement health care provider’s order for laboratory testing on February 26, on March 8, during the week of March 18 through March 24, during the period from July 9 to July 12, and July 31, 2007; failing to notify Resident #2’s health care provider that ordered lower level of Coumadin dosage was not implemented until over one week after the lower level was ordered; and failing to promptly notify Resident #2’s health care provider and commence nursing assessment due to abnormal laboratory results on February 28, April 4, and June 29. 43.2. For Resident #3, failing to promptly implement Resident #3’s health care provider’s order for pulse oximetry or to promptly notify Resident #3’s health care provider or appropriate others as to problems with implementing the health care provider’s order. 43.3. For Resident #4, failing to notify Resident #4’s health care provider that although Resident #4 was receiving Coumadin therapy, no periodic testing of Resident #4 had been ordered; failing to timely notify Resident #4’s health care provider when Respondent Facility changed Resident #4’s dosage of Coumadin without an order from a health care provider, but pursuant to a hospital discharge instruction sheet; and by failing to obtain a written order from Resident #4’s health care provider to restore Resident 47 #4’s Coumadin dosage to pre-hospitalization levels. 43.4, For Resident #7, failing to implement Resident #7’s health care provider’s order for daily PT/INR testing; failing to ensure that a home health agency timely implemented Resident #7’s health care provider’s order for PT/INR testing on Wednesday, August 15, 2007; and failing to notify Resident #7’s health care provider that although Resident #7 was receiving Coumadin therapy, no periodic testing of Resident #7 had been ordered for October, November, and December of 2007. 43.5. For Resident #8, failing to implement regular and timely PT/INR testing twice-weekly as ordered by Resident #8’s health care provider. 43.6. For each Resident receiving Coumadin therapy, the Resident Services Director’s admission that the Respondent Facility is generally unaware of when blood testing is administered to the residents. 44. The Agency determined that the deficient practice of failing to ensure that there are daily observations of the activities of the residents and awareness of the general health, safety, and physical and emotional wellbeing of the residents was related to the operation and maintenance of the facility, or to the personal care of the residents, which the Agency determined presented an imminent danger to the residents or a 48 substantial probability that death or serious physical or emotional harm would result and cited the Respondent Facility for a State Class I deficiency. 45. Pursuant to § 429.19(2) (a), Florida Statutes (2007), the Agency is authorized to impose a fine in an amount not less than five thousand dollars ($5,000.00) and not exceeding ten thousand dollars ($10,000.00) for each violation. 46. The Agency provided Respondent with a mandatory correction date of February 29, 2008. WHEREFORE, the Agency intends to impose an administrative fine in the amount of $5,000.00 against Respondent, an assisted living facility in the State of Florida, pursuant to Section 429.19(2) (a), Florida Statutes (2007), or such further relief as this tribunal deems just. COUNT_IV 47. The Agency re-alleges and incorporates paragraphs 1 through 5, and 7, 8, 9, 23, 24 and 25, as if fully set forth in this count. 48. Rule 58A-5.0182(1)(d), Florida Administrative Code, requires: An assisted living facility shall provide care and services appropriate to the needs of residents accepted for admission to the facility. (1) SUPERVISION. Facilities shall offer personal supervision, as appropriate for each resident, including the following: 49 (d) Contacting the resident's health care provider and other appropriate party such as the resident's family, guardian, health care surrogate, or case manager if the resident exhibits a significant change; 49. Rule 58A-5.0131(33), Florida Administrative Code, defines: (33) "Significant change" means a sudden or major shift in behavior or mood, or a deterioration in health status such as unplanned weight change, stroke, heart condition, or stage 2, 3, or 4 pressure sore. Ordinary day-to-day fluctuations in functioning and behavior, a short-term illness such as a cold, or the gradual deterioration in the ability to carry out the activities of daily living that accompanies the aging process are not considered significant changes. 50. On February 21-22, 2008, the Agency conducted a complaint survey (CCR# 2008002010) of Respondent Facility. 51. Based on a review of 11 clinical records and interview with administrative staff the facility failed to ensure the physician was contacted appropriately when there were significant changes in the resident's condition resulting in hospitalization for Resident #2. 52. As set forth above, on February 17, 2007, Resident #2 was observed to have bled in observable amounts throughout the afternoon following a fifty percent (50%) increase in Coumadin dosage. This is a “significant change” as defined by Rule 58A- 5.0131(33), Florida Administrative Code. 53. As set forth above, on February 17, 2007, Resident #2 experienced a significant change which was not reported to 50 Resident #2’s health care provider until four (4) days later, on February 21, 2007, and nursing progress notes never indicate that any other appropriate party such as the resident's family, guardian, health care surrogate, or case manager were notified. 54. The Agency determined that the deficient practice of failing to contact the resident’s health care provider and other appropriate party if the resident exhibits a significant change was related to the operation and maintenance of the facility, or to the personal care of the resident, which the Agency determined presented an imminent danger to the resident or a substantial probability that death or serious physical or emotional harm would result and cited the Respondent for a State Class I deficiency. 55. Pursuant to § 429.19(2)(a), Florida Statutes (2007), the Agency is authorized to impose a fine in an amount not less than five thousand dollars ($5,000.00) and not exceeding ten thousand dollars ($10,000.00) for each violation. 56. The Agency provided Respondent with a mandatory correction date of February 29, 2008. WHEREFORE, the Agency intends to impose an administrative fine in the amount of $5,000.00 against Respondent, an assisted living facility in the State of Florida, pursuant to Section 429.19(2) (a), Florida Statutes (2007), or such further relief as this tribunal deems just. 51 COUNT V 57. The Agency re-alleges and incorporates paragraphs 1 through 5, 7 through 10, 20 through 24, and 26 though 29, as if fully set forth in this count. 58. Section 429.28, Florida Statutes (2007), provides: (1) No resident of a facility shall be deprived of any civil or legal rights, benefits, or privileges guaranteed by law, the Constitution of the State of Florida, or the Constitution of the United States as a resident of a facility. Every resident of a facility shall have the right to: (a) Live in a safe and decent living environment, free from abuse and neglect. (b) Be treated with consideration and respect and with due recognition of personal dignity, individuality, and the need for privacy. (j) Access to adequate and appropriate health care consistent with established and recognized standards within the community. (3) (a) The agency shall conduct a survey to determine general compliance with facility standards and compliance with residents' rights as a prerequisite to initial licensure or licensure renewal. (b) In order to determine whether the facility is adequately protecting residents' rights, the biennial survey shall include private informal conversations with a sample of residents and consultation with the ombudsman council in the planning and service area in which the facility is located to discuss residents! experiences within the facility. (e) The agency may conduct complaint investigations as warranted to investigate any allegations of noncompliance with requirements required under this part or rules adopted under this part. (4) The facility shall not hamper or prevent residents from exercising their rights as specified in this section. 52 59. “Neglect” is defined at § 415.102(15), Florida Statutes (2007): (15) "Neglect" means the failure or omission on the part of the caregiver or vulnerable adult to provide the care, supervision, and services necessary to maintain the physical and mental health of the vulnerable adult, including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services, which a prudent person would consider essential for the well-being of a vulnerable adult. The term "neglect" also means the failure of a caregiver or vulnerable adult to make a reasonable effort to protect a vulnerable adult from abuse, neglect, or exploitation by others. "Neglect" is repeated conduct or a single incident of carelessness which produces or could reasonably be expected to result in serious physical or psychological injury or a substantial risk of death. 60. A Limited Nursing Services survey for an Assisted Living Facility was conducted on 1/22/07 though 1/23/07 in conjunction with a Biennial survey at Respondent Facility. 60.1. Based on observation, review of the resident handbook, resident concerns, and review of the standards of practice in the community, the facility failed to comply with the Resident's Bill of Rights for 1 of 9 sampled residents, “Resident #4,” and for 1 of 10 random sampled residents, “Resident #18,” as evidenced by: 1) Staff standing to feed Resident #18 in the dining room, violating Resident #18’s right to be treated with consideration and respect and with due recognition of personal dignity, individuality, and the need for privacy; 2) The resident’s 53 handbook states all doors are locked at night, but in fact the doors are not locked; violating residents’ rights to live in a safe and decent living environment; 3) Residents did not receive adequate housekeeping services for the past 2 weeks, violating residents’ rights to live in a safe and decent living environment; and 4) The facility failed to provide medication as ordered for Resident #4, violating Resident #4’s right to have access to adequate and appropriate health care consistent with established and recognized standards within the community. 60.2. Observation on 1/23/07 at approximately 12:30 p.m. in the small dining room, a staff member was observed to stand to feed Resident #18, during the entire meal. 60.3. Review of the facility handbook revealed the facility states the entrance door is to be locked at 8:00 p-m. and all the exit doors are to be locked at night. 60.4. During a review of the physical plant, the Agency surveyor observed that the entrance and exit doors are all open and do not alarm if anyone leaves at any time of the day or night. 60.5. During a tour of the facility on 1/22/07 at approximately 10:00 a.m. several residents voiced concerns about the housekeeping services. The residents' stated 54 that for the past 2 weeks the hall ways were not being kept clean. 60.6. Interview with the Administrator on 1/23/07 at approximately 1:00 p.m. revealed the head of the housekeeping department has been out ill. 60.7. Review of Resident #4's January 2007 Medication Observation Record (MOR) revealed a listing for Ativan 0.5 mg (1) tab by mouth 3 times a day as needed. Review of the physician orders revealed there was no order for the Ativan. Further review of the MOR revealed the resident was receiving Depakote 125 mg twice a day. Review of the physician orders revealed there was no order for the Depakote. 60.8. Interview with the Resident Care Director on 1/23/07 at approximately 10:30 a.m. revealed the staff had used the physician's recommendations on the admission summary to the hospital as the order for the medications. 60.9. The Agency determined that this deficient practice was related to the operation and maintenance of the Facility, or to the personal care of Respondent Facility’s residents, and indirectly or potentially threatened the physical or emotional health, safety, or security of the Facility residents. 55 60.10. The Agency cited the Respondent Facility for a Class III violation in accordance with Section 429.19(2) (c), Florida Statutes (2006). 60.11. The Agency provided a mandated correction date of February 23, 2007. 60.12. During a follow-up survey of the Respondent Facility on March 21, 2007, this deficient practice was found to have been corrected. 61. On February 21-22, 2008, the Agency conducted a complaint survey (CCR# 2008002010) of Respondent Facility. 62. Residents #2, #4, #7, #8, and #11, as identified in the February 21-22, 2008, survey, are “vulnerable adults” as defined by § 415.102(26), Florida Statutes (2007): (26) "Vulnerable adult" means a person 18 years of age or older whose ability to perform the normal activities of daily living or to provide for his or her own care or protection is impaired due to a mental, emotional, long-term physical, or developmental disability or dysfunctioning, or brain damage, or the infirmities of aging. 63. Home Health Agency staff and staff of. Respondent Facility providing direct care and services to Residents #2, #4, #7, #8, and #11 are “caregivers” as defined by § 415.102(4) and (8), Florida Statutes (2007): (4) "Caregiver" means a person who has been entrusted with or has assumed the responsibility for frequent and regular care of or services to a vulnerable adult on a temporary or permanent basis and who has a commitment, agreement, or understanding with that person or that person's guardian 56 that a caregiver role exists. "Caregiver" includes, but is not limited to, relatives, household members, guardians, neighbors, and employees and volunteers of facilities as defined in subsection (8). For the purpose of departmental investigative jurisdiction, the term "caregiver" does not include law enforcement officers or employees of municipal or county detention facilities or the Department of Corrections while acting in an official capacity. (8) "Facility" means any location providing day or residential care or treatment for vulnerable adults. The term "facility" may include, but is not limited to, any hospital, state institution, nursing home, assisted living facility, adult family-care home, adult day care center, residential facility licensed under chapter 393, adult day training center, or mental health treatment center. 64. Based on a review of 11 clinical records and interviews with the facility administrative staff the Respondent Facility hampered or prevented 5 residents from exercising their rights to be free from neglect or to have access to adequate and appropriate health care consistent with established and recognized standards within the community, or both. 64.1. Specifically, Residents #2, #4, #7, #8, and #11, who were receiving Coumadin therapy, as set forth above, did not receive nursing care and services in accord with prevailing standards of practice in the nursing community. 64.2. Pursuant to Rule 58A-5.031, Florida Administrative Code, Respondent Facility had a duty to employ or contract with nurses as needed by residents and also had a duty to ensure that nursing services provided to Residents #2, #4, #7, #8, and #11 were conducted and 57 supervised in accordance with Chapter 464 and with the prevailing standards of practice in the nursing community. 64.3. As set forth more specifically above, Respondent Facility failed to employ or contract with nurses needed by residents, since the nurses employed by, or contracting with, the Respondent Facility failed or omitted to provide needed medical services, or Respondent otherwise failed or omitted to provide to Residents #2, #4, #7, #8, and #11 the medical services that Residents #2, #4, #7, #8, and #11 needed to maintain their physical health, or Respondent Facility failed to take reasonable efforts to protect Residents #2, #4, #7, #8, and #11 from neglect. 65. Based on a review of 11 clinical records and interviews with the facility administrative staff, the Respondent Facility hampered or prevented 5 residents from having access to adequate and appropriate health care consistent with established and recognized standards within the community. 65.1. Specifically, Residents #2, #4, #7, #8, and #11, who were receiving Coumadin therapy, as set forth above, did not receive nursing care and services in accord with prevailing standards of practice in the nursing community. 65.2. Pursuant to Rule 58A-5.031, Florida Administrative Code, Respondent Facility had a duty to employ or contract with nurses as needed by residents and 58 also had a duty to ensure that nursing services provided to Residents #2, #4, #7, #8, and #11 were conducted and supervised in accordance with Chapter 464 and with the prevailing standards of practice in the nursing community. 65.3. As set forth more particularly above, Respondent Facility’s failure to employ or contract with nurses as needed by residents or to ensure that nursing services provided to Residents #2, #4, #7, #8, and #11 were conducted and supervised in accordance with Chapter 464 and with the prevailing standards of practice in the nursing community, hampered or prevented Residents #2, #4, #7, #8, and #11 from exercising their rights to have access to adequate and appropriate health care consistent with established and recognized standards within the community. 66. A review of the drug insert for Coumadin therapy revealed the "Dosage and administration of Coumadin must be individualized for each patient according to the particular patient's PT/INR (Prothrombin Time/International Normalized Ratio) response to the drug.” 67. Under Laboratory Control "The PT should be determined daily after the administration of the initial dose until PT/INR results stabilize in the therapeutic ranges." "Intervals between subsequent PT/INR determinations should be based upon physician's judgment of the patient's reliability and response 59 to Coumadin in order to maintain the individual in the therapeutic range." "Acceptable intervals for PT/INR determinations are normally within the range of 1 to 4 weeks after a stable dosage has been determined.” 68. Moreover, Respondent Facility made no effort to manage the administration of Coumadin within Respondent Facility: To obtain a list of all residents taking Coumadin, the facility staff had to individually read each resident's MOR (Medication Observation Records). There was no knowledge of which residents were to have blood work and were taking this medication. 69. Interview with the Resident Services Director on 2/21/08 at 5:15 p.m., displayed a complete lack of Respondent Facility’s understanding of its duties to residents. The Resident Services Director indicated that blood work was not ordered so it was not done, regardless of the prevailing standard of practice in the nursing community for Coumadin administration. The Resident Services Director indicated a belief that it was not the facility's responsibility to remind the physician or the Advanced Registered Nurse Practitioner (ARNP) of the possible need for blood work. The Resident Services Director further indicated her belief that it was her responsibility only to ensure the resident received the ordered medications. 60 70. The February 22, 2008, violation constitutes a repeat violation of the January 22-23, 2007, violation, pursuant to applicable law, and should be taken into consideration in determining the applicable penalty pursuant to § 429.19, Florida Statutes (2007). 71. The Agency determined that the deficient practice of hampering or preventing residents from exercising their right to be free from neglect, or hampering or preventing residents from exercising their right to have access to adequate and appropriate health care consistent with established and recognized standards within the community, or both, were related to the operation and maintenance of the facility, or to the personal care of the resident, which the Agency determined presented an imminent danger to the resident or a substantial probability that death or serious physical or emotional harm would result and cited the Respondent for a State Class I deficiency. 72. Pursuant to § 429.19(2) (a), Florida Statutes (2007), the Agency is authorized to impose a fine in an amount not less than five thousand dollars ($5,000.00) and not exceeding ten thousand dollars ($10,000.00) for each violation. 73. The Agency provided Respondent with a mandatory correction date of February 29, 2008. 61 WHEREFORE, the Agency intends to impose an administrative fine in the amount of $5,000.00 against Respondent, an assisted living facility in the State of Florida, pursuant to Section 429.19(2) (a), Florida Statutes (2007), or such further relief as this tribunal deems just. COUNT VI 74, The Agency re-alleges and incorporates paragraphs one (1) through five (5) and Counts I through V, as if fully set forth in this count. 75. Pursuant to Section 429.19(7), Florida Statutes (2007), in addition to any administrative fines imposed, the Agency may assess a survey fee, equal to the lesser of one half of a facility’s biennial license and bed fee or $500, to cover the cost of conducting an initial complaint investigation that results in the finding of a violation that was the subject of the complaint. 76. On or about February 21-22, 2008, the Agency conducted a complaint investigation at the Facility which resulted in the finding of a violation that was the subject of the complaint to the Agency. 77. Pursuant to Section 429.19(7), Florida Statues (2007), such a finding subjects the Respondent to a survey fee equal to the lesser of one half of the Respondent’s biennial license and bed fee or $500.00. 62 78. Respondent is therefore subject to a complaint survey fee of five hundred dollars ($500.00), pursuant to Section 429.19(1), Florida Statutes (2007), in addition to the fine applicable to the violations found. WHEREFORE, the Agency intends additionally to impose a survey fee of five hundred dollars ($500.00) against Respondent, an assisted living facility in the State of Florida, pursuant to Section 429.19(7), Florida Statutes (2007). Respectfully submitted this S- of April, 2008. Ma es H. Harris a. Bar. No 817775 Counsel for Petitioner Agency for Health Care Administration 525 Mirror Lake Drive, 330H St. Petersburg, Florida 33701 727.552.1535 (office) 727.552.1440 (fax) 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 Agency for Health Care Administration, and delivered to Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Bldg #3,MS #3, Tallahassee, FL 32308;Telephone (850) 922-5873. RESPONDENT IS FURTHER NOTIFIED THAT THE FAILURE TO REQUEST A HEARING WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. 63 CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been served by U.S. Cerfified Mail, Return Receipt No. 7007 1490 0001 6907 5251 on , 2008 to Cheryl Veech, Administrator, Beneva Park Club, 743 S. Beneva Road, Sarasota, Florida 34232 and by U.S. Mail to CT Corporation System, Registered Agent, Beneva Park Club, 1200 South Pine Island Road, Plantation, Florida 33324. Copies furnished to: Ones. 2 es H. Harris, Esquire’ Akgistant General Counsel Cheryl Veech Administrator Beneva Park Club 743 S. Beneva Road Sarasota, Florida 34232 (U.S. Certified Mail) CT Corporation System Registered Agent Beneva Park Club 1200 South Pine Island Rd. Plantation, FL 33324 (U.S. Mail) David Day/Kriste Mennella Field Office Manager 2295 Victoria Ave., Room 340 Ft. Myers, Florida 33901-3884 (U.S. Mail) James H. Harris, Esq. Agency for Health Care Admin. 525 Mirror Lake Drive, 330H St. Petersburg, FL 33701 (Interoffice) 64 SENDER: COMPLETE THIS SECTION COMPLETE THIS SECTION ON DELIVERY Bel Agent A. Signature ge J “TC /ee Bh | AA JA. AetMul op Ol Addressee . Date of Delivery BE es/ox D. Is delivery address different from itam 12 Cl Yes if YES, enter delivery address below: CI 'No 1. Article Addressed to: Cheryl Veech, Administrator Beneva Park Club 743 S. Beneva Road 3, Service Type 7 O Certified Mal O Exp Mail Sarasota, Florida 34232 Creat Open. ve ipt for Merchandise Cl insured Mail =] C.0.D. 4. Restrictad Nek.» “tra Fea) O ves ve Aa £5907 5ea51 as } PS Form 3811, February 2004 Domestic Return Receipt. 102595-02-M-1540

Docket for Case No: 08-002150