EXHIBIT Ay tabbies" STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, ! Petitioner, vs. Case No.: 2014000180 SPRING LAKE NC, LLC d/b/a SPRING LAKE REHABILITATION CENTER, Respondent. / i ADMINISTRATIVE COMPLAINT | COMES NOW the Agency for Health Care Administration (hereinafter “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against Spring lake NC, LLC d/b/a Spring Lake Rehabilitation Center (hereinafter “Respondent”), pursuant to §§120.569 and 120.57 Florida Statutes (2013), and alleges: NATURE OF THE ACTION This is an action to change Respondent’s licensure status from Standard to Conditional commencing December 3, 2013, and ending December 30, 2013, and to impose an administrative fine in the amount of ten thousand dollars ($10,000.00) based on one Class I deficiencies, and to impose survey fees of six thousand dollars ($6,000.00) with a two (2) year survey. JURISDICTION AND VENUE 1. The Agency has jurisdiction pursuant to §§ 120.60 and 400,062, Florida Statutes (2013). 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), Chapters 400, Part Il, and 408, Part Il, Florida Statutes, and Chapter 59A-4, Florida Administrative Code. 4. Respondent operates a (120) bed nursing home, located at 1540 6" Street NW, Winter Haven , Florida, 33881 and is licensed as a skilled nursing facility license number 15110961. 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 (5), as if fully set forth herein. 7. Pursuant to Florida law, all licensees of nursing homes 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 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, with established and recognized practice standards within the community, and with tules as adopted by the agency. § 400.022(1)(), Fla. Stat. (2013). 8. That Florida law provides the following: “‘Practice of practical nursing’? means the performance of selected acts, including the administration of treatments and medications, in the care of the ill, injured, or infirm and the promotion of wellness, maintenance of health, and prevention of illness of others under the direction of a registered nurse, a licensed physician, a licensed osteopathic physician, a licensed podiatric physician, or a licensed dentist. A practical nurse is responsible and accountable for making decisions that are based upon the individual’s educational preparation and experience in nursing.” § 464.003(19), Fla. Stat. (2012). 9. On December 3, 2013, the Agency completed a complaint survey of the Respondent’s facility. 10, Based on resident record review, interviews with facility nursing staff, the Attending Physician, Medical Director, facility Administration and review of the facility ' s policies and procedures related to Anticoagulant Therapy the facility failed to provide adequate monitoring of Coumadin, for one of twenty residents, consistent with recognized monitoring standards for an anticoagulant. Based on a review of all current residents receiving Coumadin within the facility and one closed record of a resident receiving Coumadin one of twenty sampled residents (Resident #1) did not have the appropriate monitoring required for Coumadin Therapy. Resident #1 was receiving 3 mg of Coumadin daily at 5 PM without adequate monitoring of the high risk medication. The physician did not order a PT/INR (Protime/International Normalizing Ratio; a measure of blood clotting time) during the resident ' s admission. Also, the nurses administered the medication without regard to the required laboratory test and failed to contact the physician regarding the laboratory tests. Resident #1 developed elevated liver enzymes, and then developed an acute Gastrointestinal Bleed related to " Coagulopathy secondary to Coumadin " and severe anemia. Per facility audits, nineteen current residents receiving Coumadin were potentially affected. The actions of the medical and nursing staff who administered the high risk anticoagulant mediation and failed to order the necessary laboratory tests to monitor the clotting times that subsequently led to the resident ' s acute gastrointestinal bleed, coagulopathy and severe anemia resulted in the findings of Immediate Jeopardy existing in the facility as of 11/6/13. The Immediate Jeopardy was removed on 12/3/13 at 5:50 PM and the scope and severity was reduced toa "D." 11. Review of the Hospital History and Physical dated 11/23 revealed Resident #1 was admitted to the hospital for abdominal pain, elevated liver enzymes. While in the ER, the resident was also diagnosed with renal failure and guaiac positive stools (blood in the stool). The INR was supratherapeutic. The family gave consent for blood transfusions and blood pressure support. The resident received 10 mg of Vitamin K in the emergency room as an antidote to the Coumadin. Her blood pressure was 85/43. The physician 's impression was " 1, GI Bleed 2. Coagulopathy secondary to Coumadin 3. Severe Anemia." The plan was to admit to the ICU and transfuse Fresh Frozen Plasma and 2 units of packed red blood cells. The resident ' s prognosis was poor. Per a family interview on 12/5/13 at 11.35 AM, the resident was transfused with 2 units of Fresh Frozen Plasma and 4 Units of Packed Red Blood Cells. She stated that the resident 's kidneys ' did not regain function and she was unable to remove the excess fluid from the transfusions (potentially 2 extra liters of fluid). Because the resident could not remove the fluid, the excess fluid caused an exacerbation of her underlying Congestive Heart Failure which in turn caused respiratory distress and then her death. 12, Review of the hospital records obtained on 12/2/13 from the hospital revealed Resident #1‘ s PT on 11/22/13 was >120 seconds and the " INR was not done " due to the lack of clotting. The therapeutic range for the Prothrombin time indicated for clot prevention is 9-12.5 seconds and a therapeutic INR is between 2.0 and 3.5. The resident ' s hemoglobin level was 5.3 g/dL, normal range is 11.3-15.6 g/dL. Both lab values (the PT and the hemoglobin) were critical lab values that required immediate intervention. 13. During an interview on 12/5/13 at 11:35 AM, Resident #1 ' s family member stated that Resident #1 was admitted to the facility for rehabilitation services and was supposed to be discharged home. She also stated that the resident did not have any previous history of gastrointestinal bleeding and developed an acute bleed at the facility. 14, The facility admitted Resident #1 on 11/6/13 with diagnoses including Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, Anemia and Atrial Fibrillation. The resident was admitted to the facility for Short Term Sub Acute Care. The resident was receiving Physical and Occupational Therapy for function and strengthening. 15. Review of the Hospital History and Physical, dated 10/29/13, revealed the resident was receiving Aspirin 81 mg daily and Pradaxa 75 mg twice daily for anticoagulation. The resident ' s Aspirin and Pradaxa were discontinued in the hospital and she was started on Coumadin as a new therapy. Review of the hospital laboratory data revealed a PT/INR was collected on 11/5 with a result of 1.8. On 11/6 the PT/INR was 2.4 indicating an upward trend, however still within therapeutic range (between 2.0 and 3.5). 16. Review of Wittkowsky, Ann, The American Society of Health System Pharmacists, Chapter 24 Warfarin, page 358 revealed: " The intensity of warfarin therapy is monitored by evaluation of the Prothrombin time (PT), expressed as the INR ..." Table 24.7 summarizes the Frequency of INR Monitoring and Patient Assessment. If the initiation of the therapy utilized the flexible initiation method, then after administration of the first dose of Warfarin/Coumadin, monitor the INR daily through day four of administration. If utilizing the average daily dosing method, monitor the INR every 3-5 days until the INR is greater than the lower limit of the desired therapeutic range then within 1 week. After hospital discharge: if the patient is stable, monitor the INR within 3-5 days, if the patient is unstable monitor the INR within 1-3 days. During the first month of treatment, monitor the INR at least weekly. The routine follow up for an INR ofa medically unstable is every 1-2 weeks. 17. Review of the Geriatric Dosage Handbook 12" Edition 2007, pg. 1179, Initiation of Oral Anticoagulation With Warfarin revealed: " Dosing of warfarin (Coumadin) must be individualized according to patient response to the drug as indicated by the INR..." " Step 1. Obtain baseline INR. Begin therapy with warfarin with a dose of 2-5 mg per day with dosage adjustments based on results of INR determinations." " Step 2. Day that INR is stabilized in the therapeutic range: Check INR daily. Adjust warfarin dose based on the results of INR determinations. Patients stabilized in the therapeutic range: Intervals between subsequent INR determinations should be based upon the physician ' s judgment of the patient ' s reliability and response to warfarin in order to maintain the individual within therapeutic range. Acceptable intervals for INR determinations are normally within the range of 1-4 weeks after a stable dosage has been determined. Most patients are satisfactorily maintained on warfarin at a dose of 2-10 mg daily. " 18. Review of the Admission Minimum Data Set, dated 11/19/ 13, revealed the resident scored a 15/15 on her Brief Interview for Mental Status indicating no cognitive impairment. No behaviors were coded during the assessment window. The resident required extensive one to two person assistance with all activities of daily living except eating. The resident was coded as continent of bowel and bladder. 19. Review of the Admission Orders dated 11/6/13 revealed the resident was prescribed Coumadin 3 mg daily. There were no orders for a PT/INR upon admission or during her admission to the facility. 20. Review of the facility 's policy entitled " Anticoagulant Therapy " with a copyright date of 2008 revealed the Purpose of the policy was " To effectively monitor residents receiving anticoagulant therapy and reduce the risk of bleeding by maintaining therapeutic blood levels in accordance with physician orders." Under Procedure, Item 3. " Confirm with the physician the desired INR/PT testing schedule and therapeutic range at the time of the anticoagulant therapy order. Item 11 revealed " Document lab results, current dosage and physician orders on Anticoagulant Therapy Flow Sheet." 21. Review of the Attending Physician's "PT/INR Protocol " given to the facility in 2012 revealed: " All new admissions who are on Coumadin, you must use the Anticoagulant MAR " (no longer valid with eMAR). " Category A- New admissions- if the resident doesn ' t come with a current PT/INR, you are to write an order to be done the next day." "Category B -New admissions- if the resident does come with a current (the day of admission) PT/INR result, then you are to write an order for PT/INR to be done 4 days after admission. You must document the results of the PT/INR that were present on admission in your admission note." " Once you determine what category the resident goes under then. You must write an order for PT/INR to be done weekly from the last date of the PT/INR. " 22. — Review of the Care Plan dated 11/6/13 revealed a problem area related to bleeding and anticoagulant use with approaches including " labs as ordered, notify MD of lab results out of expected range, check PT/INR prior to administering anticoagulant medication, observe for unusual bleeding, blood in stool or urine ..., encourage, remind and assist to avoid activities that may cause injury and encourage and assist as needed to use soft toothbrush ... " Facility staff however, did not make any attempt to contact the physician for PT/INR orders in accordance with the plan of care. 23, Review of the Narrative Nurses Notes revealed the resident was admitted on 11/6/13 and was alert and oriented times three and required moderate 1-2 person assistance with her activities of daily living. The facility nurses did not document the resident ' s admitting PT/INR lab on the admission note. The resident reported diarrhea upon admission. Review of the nurses ' note dated 11/22/13 at 3:57 PM revealed, " at approx(imately). 2:30 PM, MD (Medical Doctor) responded to page and instructed to send pt (patient) out to (local hospital) non-emergent for eval(uation) pt has abnormal lab values, c/o (complains of) diarrhea and nausea and blood in stool from hemorrhoids. Pt has yellow tinged skin. Contacted sister to inform of pts condition. Pts skin is warm, dry and intact. Redness to inner buttocks, Pts family members requested to be sent by emergency 911, so 911 was called. Will wait with pt until EMS (Emergency Medical Services) arrives. " 24. Review of the daily Clinical Nursing Assessments revealed between 11/7-11/18/13 there was no documentation of resident reported pain or blood in the resident's stool. Her skin was normal in appearance. On 11/19/13 the resident had " hemorrhoids and blood when having BM. “No pain was reported on 11/19/13. On 11/20 the resident did not report any pain and did not have any rectal bleeding. On 11/20 the resident did not report any pain and did not have any rectal bleeding. On 11/21 the resident was assessed with normal vital signs, no complaints of pain, no rectal bleeding and was alert and oriented times three. On 11/22/13 the resident was assessed at 2:25 PM. Her vital signs were 97.8 degrees (temperature), 99 heart beats per minute, 24 respirations per minute, 110/70 blood pressure, her pulse oximetry was 94% and her pain level was a 7/10. Her pain was noted to be generalized and she was medicated. The resident was alert and oriented times three and was verbally coherent. The resident ' s urine was amber in ,color. The resident last had a bowel movement on 11/22/13 and was noted to have bright red blood " from hemorrhoids. MD paged." The resident's skin was jaundiced. There was no documented evidence that the nursing staff attempted to contact the attending physician to obtain orders for a PT/INR. 25. Review of the Transfer Form dated 11/22/13 revealed the resident was transferred to the ER for abnormal labs, jaundice, diarrhea and nausea. 26. | When an order for Coumadin is entered into the computer the lab box for the INR must be checked in order for the nurse to document the lab value in the eMAR prior to administering the medication. Review of the Medication Administration Record revealed Resident #1 received 3 mg of Coumadin daily at 5 PM between 11/6/13 and 11/21/13. She was discharged prior to her 11/22/13 dose. The eMAR did not include the lab box for the entry of the INR lab value. The nurses that administered the Coumadin at 5 PM were Employees D, E, F (LPNs). 27. Record review revealed the resident did not have an Anticoagulation Flow sheet. The flow sheet was utilized by the facility for tracking and trending the PT/INR, current Coumadin dose and adjustments and physician and responsible party notification per facility protocol. 28. Review of the Physician ' s Orders included on 11/11/13 the resident was placed on fluid restriction of 2 liters per day. On 11/14 the resident had a CMP (Comprehensive Metabolic Panel) and BNP (B-Type Naturetic Peptide, used to measure fluid volume) was ordered. On 11/18/13 the resident had a CMP ordered and her Lipitor was discontinued as well as her Lasix was increased due to an increase in her liver enzymes and a decrease in her kidney function. On 11/20/13 an order was obtained for a BNP and a CMP, the resident 's liver and kidney functions were still compromised. On 11/22/13 an order was obtained to send the resident to the ER (emergency room). There were no orders for a PT/INR. 29. Review of the Physician ' s Progress Notes revealed the resident was " doing ok" on 11/18/13. On 11/21/13 the resident was "doing ok." There was no documented evidence the physician addressed the resident ' s Coumadin administration or lack of a PT/INR. 30. Review of the laboratory data dated 11/19/13 revealed the resident ' s renal and liver functions were elevated. The lab data dated 11/22/13 and received by the facility at 11:37 AM revealed the resident ' s renal and liver functions were elevated. No PT/INRs were obtained or ordered. A resident with elevated renal and liver function is indicative of kidney and liver failure. Medications are broken down by the liver and excreted through the kidneys, when either of the organs is not functioning appropriately; the medication accumulates in the body causing increased medication levels and potentially harmful side effects. In addition, one of the functions of the liver is the production of blood clotting factors that Coumadin directly inhibits. If the liver functions are compromised and not producing the clotting factors, the Coumadin effects could also intensify (i.e. increased bleeding times.) 31. During an interview on 12/2/13 10:05 AM the Pharmacy Consultant, stated that he completed a 100% audit of all residents currently in house once a month. He stated that he routinely checked for drug interactions, irregularities, unnecessary medications and reviews labs. He also stated that for a resident receiving Coumadin, he would check the PT/INRs. He stated that if no labs were in the chart he would request a PT/INR from the physician. He stated that he was last in the facility on 11/14/13. 32. Review of the 11/14/13 Pharmacy Consultant Recommendations revealed Resident #1 was reviewed with no recommendations for a PT/INR were requested. 33. During a follow up interview on 12/2/13 at 11:10 AM, the Pharmacy Consultant stated that he " must have seen the hospital INR" and " it must have been within limits." He stated that there was no literature that defined how often a PT/INR should be collected and stated that he was not aware of any facility policy regarding anticoagulation therapy. He stated that he was not aware of Resident #1 's Attending Physician ' s PT/INR protocol. 34, During an interview on 11/27/13 at 11:30 AM the attending physician stated that he assessed the resident frequently related to her co-morbid conditions, He stated that he was monitoring her for her increased liver enzymes. The physician stated that he thought her elevated liver enzymes were a result of the Lipitor and he discontinued the Lipitor. He stated that on 11/22/13 he was called and it was reported that she was pale. He stated that the resident was sent to the ER due to her abnormal labs. Lab work was completed at the hospital and she was anemic. He also stated that she had blood in her stool. The physician confirmed she was on Coumadin and that she had a high PT at the hospital; " greater than 120 seconds." He stated again that the resident was in liver failure, He also stated that the elevated liver enzymes could have been a contributing factor to the increased PT/INR. He confirmed that no orders were written or obtained for a PT/INR and no labs were collected for the PT/INR. He also confirmed facility staff did not contact him for lab orders regarding the PT/INR. He stated that he had a written protocol for when to order PT/INRs and the facility staff were supposed to follow his protocol. 35. During an interview on 11/27/13 at 3:05 PM the Medical Director stated he saw the resident in the hospital on 11/22 and she had a GI Bleed, Acute Renal Failure and Respiratory failure. The " PT/INR was very elevated" and she received FFP (Plasma) and Vitamin K. The Medical Director was asked regarding the facility ' s policy on PT/INR lab draws. He stated that it was up to the attending physician to set his own protocols. He stated that he checked his residents every Monday and Thursday. He also stated that " everyone should be checked when they come in and every three to four days. " He stated that if the PT/INR was stable " it was ok to check every week." If the resident required a dosage change, then " check the INR every three to four days." He stated that the nurses would be responsible for contacting the physician for the PT/INR orders. He also stated the nurses should have called the doctor and asked what the plan is for checking the PT/INR for Resident #1. He stated a resident that was newly started on Coumadin should have had PT/INR checked in one week or less from admission, He stated that Resident #1 was a " system failure." The Medical Director stated that he was the Medical Director of the facility and did not have specific contact with the resident prior to 11/22. He also stated that the facility did not have any specific policy regarding the frequency of PT/INR draws, however he stated again that it should be done at least weekly if stable and more frequently if warranted. . 36. During an interview on 11/27/13 at 11:47 AM Employee A (CNA) stated she routinely cared for Resident #1. She stated the resident was continent but would not get up to go to the bathroom. She had diarrhea one day. The resident had bright red blood in the toilet. The resident stated that she had hemorrhoids. Employee A reported the bleeding to the nurse. The nurse (Employee B) came in and looked at the resident. She stated that the resident did not have any pain. The CNA stated that the resident was later sent to the ER. 37. During an interview on 11/27/13 at 12 PM with Employee B (LPN) and Employee G (LPN Unit Manager), Employee B stated that she cared for Resident #1 and had noticed some jaundice, abnormal labs and diarrhea; she paged the doctor and he ordered a non-emergent transfer. However, the family insisted on 911. Called 911 and the resident left via ambulance. She stated the resident hadn ' t left by end of shift, but she left around 3:30 PM with the EMS personnel. The LPN stated that the resident had blood from hemorrhoids, and she could visibly see the hemorrhoids. The resident also complained of her rectum hurting. She did not have any other complaints of pain. The LPN stated that she first paged the doctor around lunch time with | I I | t | i the abnormal labs and he said he would come and see her. The unit manager notified the sister. The sister arrived and agreed that she was yellow. The sister called her daughter around 2 PM, and she was coming in the 30 minutes and requested the doctor send her to the ER. She paged the doctor back, assessed the resident again, and her vital signs were stable, the resident was not hurting and was alert and oriented. The physician said to send her out non-emergently. The DON (Director of Nurses) met with the niece around 3 PM and she wanted the resident sent out via 911. The DON notified the unit manager to call the doctor and request to send 911. The LPN called the physician back and he agreed to 911 transport. 911 was called and the resident left via stretcher at approximately 3:30 PM. The nurse stated that the resident was receiving Coumadin at 5 PM daily. She stated that the attending physician specialized his care for each patient. She stated that the other attending physician ' s in the facility would order PT/INRs based on admission and were typically drawn on Mondays and Thursdays. She stated that the resident did not have any PT/INRs drawn or ordered. She stated that if a PT/INR was not ordered, the nurses would notify the doctor that the PT/INR not scheduled and get them scheduled. She stated that Employee C (Desk Nurse on East) takes care of all of the attending physician 's orders. Employee C was the liaison between facility nurses and the physician. She stated that the attending physician preferred to go through one nurse (Employee C) for all of his orders. 38. During an interview on 11/27/13 at 12:15 PM with Employee C (Desk Nurse) and the DON, Employee C stated that she acted as a liaison between the doctors and the staff. She stated that she attempted to group the issues and the labs and make one phone call a day to the physician if possible and get the information together for rounds. She stated: that the attending physician was in the facility 3-4 times per week. The attending physician gave his orders to Employee C and she entered the items into the computer. She stated the labs were typically routine with Coumadin and some of the doctors had Monday and Thursday standing orders for labs. However, Resident #1 ' s attending physician ordered his own labs for his residents. If a resident had a PT/INR completed in the hospital then the attending physician decided when the next one would be completed. She stated that it was unknown if anyone asked the physician regarding the INR. The DON stated that attending physician could be difficult and liked to order his own labs. He also stated that the physician " individualized care" to each resident. The DON also stated that the attending physician had a guideline with when to order the PT/INR that was written up "a while back. " 39. During an interview 11/27/13 at 3:36 PM Employee D (LPN) stated that she routinely worked the 3-11 shift and: was responsible for administering Coumadin to the residents. She stated Resident #1 was on 3 mg of Coumadin and the medication was given during the evening med pass. The nurse confirmed no PT/INRs were ordered or drawn. She stated that the attending physician ordered his own labs. She stated that this physician was " very strict regarding his patients." She stated that she didn't question him " because he was a stickler. " She also stated that he had a strong personality. The nurse stated again that she didn ' t question the physician regarding the lack of a PT/INR and confirmed that she administered the medication to the resident. The nurse also confirmed that she did not inform the unit manager or the DON of the lack of PT/INRs. 40. During an interview on 11/27/13 at 3:47 PM Employee E (LPN Evening Supervisor) Stated that the resident was alert and oriented, diabetic, on Coumadin. The resident had hemorrhoids. Employee E confirmed that she administered Coumadin to Resident #1 at 5 PM. Employee E stated that she didn ' t see any PT/INR ' s on the chart and stated that the attending physician ordered his own labs. She stated that it was " not unusual to not have an order for a PT/INR. "She stated that she checked the PT/INRs prior to administering. However, confirmed again that the resident did not have a PT/INR and she administered the medication to the resident. She also confirmed that she didn ' t inform anyone (Physician, Unit Manager, Director of Nurses or the Medical Director) of the lack of PT/INRs. She stated that the attending physician only went through one person (Employee C) and he had a certain way he liked things done. Employee E also confirmed she didn't speak with Employee C regarding orders for a PT/INR. 41. During an interview on 12/2/13 at 11:45 AM Employee F (LPN) stated that she typically worked the weekend evening shift and was trained to document " see chart " and not the actual lab value on the eMAR. She stated that she did not ever check the PT/INR since she worked the weekends. Surveyor informed DON and he stated he expected the nurses to check the PT/INR prior to Coumadin administration. 42. During an interview on 11/27/13 at 12:50 PM the DON (Director of Nurses), stated that Resident #1 's attending physician " was very difficult to deal with and he created an aura of no one to question him." The DON stated that the attending physician was monitoring her liver enzymes. The resident was jaundiced. The attending physician was informed again of the labs and ordered the resident out to the hospital non-emergently. The resident was stable with no active signs of bleeding. The DON called the unit and got the resident out 911 per the family's request. The DON stated that he did not see the resident but had the unit manager go assess her. The resident was admitted to the hospital (he stated he was informed on 11/23 of her admission). The resident was admitted with a possible a GI bleed. The DON was informed on 11/25/13 of the resident ' s hospital course. The DON stated that he " looked into the issue." Review and discussion of the DON ' s review of the incident revealed: the PT/INR was last done on 11/6 while at the hospital. The resident was receiving Coumadin 3 mg. She was on Pradaxa in the hospital and resident didn ' t want to be on Pradaxa and she was switched to Coumadin during the most recent admission. No further PT/INRs were drawn. The DON stated that there was " no rhyme or reason for his (the attending physician ' s) orders. " 43. Review of the in-service documentation revealed 14 direct care nursing staff were not in- serviced including one of the three nurses that administered the Coumadin without notifying the physician of the lack of an INR. (Employee E). 44, During an interview on 12/2/13 at 1 PM the ADON, confirmed the 14 staff members who were not educated, including one of the nurses involved in the incident. She stated that she did not have any plans for additional education related to anticoagulant therapy. 45. The facility implemented the following measures which resulted in the removal of the Immediate Jeopardy on 12/3/13 at 5:50 PM. The measures included: All current residents on Coumadin have been sampled with no additional resident identified with any concerns. All residents have orders for Coumadin, orders for PT/INRs that were collected routinely, a Coumadin Flow sheet, and an Anticoagulant Care Plan. 46. During an interview on 12/3/13 at 9:30 AM the Director of Nurses stated that 100% current staff members were educated on 12/2/13 per the ADON. Four PRN staff members were terminated due to not working within 3 months. Three have been removed from the schedule until the in-service has been completed. 47. An audit was conducted on 12/2/13 of all residents receiving Coumadin. All residents had a PT/INR collected on 12/2/13 per physician ' s orders. All residents had current Coumadin Flow Sheets, all residents had a provider signature of the lab result and all residents had a current anticoagulant care plan. The PT/INRs and the Coumadin Flow Sheets were validated on 12/3/13 by the survey team. 48. Review of the Lab Data collected on 12/2/13 on all residents receiving Coumadin revealed no resident had a supratherapeutic INR (greater than 3.5). 49. On 12/3/13 all nurses on the first and second shift of all three units were interviewed. The nurses were able to articulate the facility ' s physician order guidelines pertaining to the PT/INR. They were able to state all residents had orders for PT/INRs to be drawn either on Mondays or Mondays and Thursdays. They also stated that the each resident had a Coumadin Flow Sheet. All of the nurses were able to describe the signs and symptoms of a high PT/INR (i.e. bleeding). The nurses also stated that they were would contact the physician regarding an abnormal lab value. The nurses stated that they would contact the physician for lab orders if no PT/INR was available for review and had not been ordered. The eMAR system has now been revised to include a hard stop on the lab entry prior to initialing the Coumadin as given. 50. The Agency determined that this deficient practice presents a situation in which immediate corrective action is necessary because the facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident receiving care in a facility, and cited Respondent with a patterned Class I deficient practice. WHEREFORE, the Agency seeks to impose an administrative fine in the amount of ten thousand dollars ($10,000.00) against Respondent, a skilled nursing facility in the State of Florida, pursuant to § 400.23(8)(a), Florida Statutes (2013). Count I 51. | The Agency re-alleges and incorporates paragraphs one (1) through five (5), and Count I of this Complaint as if fully recited herein. 52. Based upon Respondent’s one cited State Class I deficiencies, 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)(a), Florida Statutes (2012). 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 (2013) commencing December 3, 2013, and ending December 30, 2013. COUNT Il 53. The Agency re-alleges and incorporates paragraphs one (1) through five (5), and Counts I and II of this Complaint as if fully recited herein. 54. That Respondent has been cited with one (1) State Class I deficiencies and therefore is subject to a six (6) month survey cycle for a period of two years and a survey fee of six thousand dollars ($6,000) pursuant to Section 400.19(3), Florida Statutes (2012). 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 six thousand dollars ($6,000.00) against Respondent, a skilled nursing facility in the State of Florida, pursuant to Section 400.19(3), Florida Statutes (2013). Respectfully submitted this 17 day of April, 2014. _/s/JohnEliotBradley John Bradley, Esquire Fla. Bar. No. 92277 Agency for Health Care Admin. 525 Mirror Lake Drive, 330G St. Petersburg, FL 33701 727.552.1947 (office) 727.552.1440 (facsimile) John.Bradley@ahca.myflorida.com DISPLAY OF LICENSE Pursuant to § 400.23(7)(e), Fla. Stat. (2011), 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) 412-3630. 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 THEREBY CERTIFY that a true and correct copy of the foregoing has been served by USS. Certified Mail, Return Receipt No: (7010 0780 0001 9835 7387) on April 17, 2014, to Trentino Manco, Spring Lake Rehabilitation Center, 1540 6" Street NW, Winter Haven, Florida, 33861. John Eliot Bradley John Eliot Bradley, Esquire Copy furnished to: Pat Caufman, Field Office Manager, Agency for Health Care Admin. Bernard Hudson, Long Term Care Unit Manager, Agency for Health Care Admin. 19 USPS.com® - USPS Tracking™ English Customer Service USPS Mobile BAUSPSCOM Quick Tools Ship a Package USPS Tracking™ ponents — _ | https://tools.usps.com/go/TrackConfirmAction|input.action?tRef=qt&tLc=0&tLabels=70... 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Docket for Case No: 14-002469