AGENCY FoR HEALTH CARE ADMINISTRATION, 06-1583 Petitioner, AHCA No.; 2006001924 Return Receipt Requested: v. 7002 2410 0001 4234 8491 7002 2410 0004 4234 8507 HIGH TECH Home HEALTH, INC., d/b/a HIGH TECH HomE HEALTH, INC., Respondent, / ADMINISTRATIVE COMPLAINT COMES Now the Agency. for Health Care Administration Inc., a/b/a High Tech Home Health, Inc. (hereinafter “High Tech Home Health, Inc.”), Pursuant to Chapter 400, Part Iv, and Section 120.60, Florida Statutes (2005), and herein alleges; NATURE OF THE ACTION Te ACTION 1. This ig an action to impose a Moratorium on the admission of new Patients, and an administrative fine of $35,000.00 Pursuant to Section 400.484, Florida Statutes for the Protection of the public health, Safety anq welfare, JURISDICTION AND VENUE ER SND VENUE 2. AHCA has jurisdiction Pursuant. to Chapter 400, Part Iv, Florida Statutes, 3. ° Venue lies in Palm Beach County pursuant to Rule 28.106.207, Florida Administrative Code. PARTIES 4. AHCA is the regulatory authority responsible for licensure and enforcement of all applicable statutes and rules governing home health agencies, pursuant to Chapter 400, Part IV, Florida Statutes and Chapter 59A-8 Florida Administrative Code. 5. High Tech Home Health, Inc. operates a home health agency located at 4360 North Lake Boulevard, Suite #214, in Palm Beach Garden, Florida 33410. High Tech Home Health, Inc. is licensed as a home health agency under license number 20470096. High Tech Home Health, Inc. was at call times material hereto a licensed facility under the licensing authority of AHCA and was required to comply with all applicable rules and statutes. COUNT I HIGH TECH HOME HEALTH, INC. FAILED TO CONDUCT AN ONGOING QUALITY ASSURANCE PROGRAM TO ENSURE THAT THE PLAN OF CARE ORDERED BY A PHYSICIAN WAS FOLLOWED FOR 8 OF 10 PATIENTS Section 400.487 (2), Florida Statutes, and/or Rule 59A-8.0095(2) (c), Florida Administrative Code (Personnel) CLASS I VIOLATION 6. AHCA re-alleges and incorporates Paragraphs (1) through (5) as if fully set forth herein, 7. During the complaint investigation (#2006001388) conducted on 02/27/06 through 03/03/06 and based on interview and clinical record review, it was determined that the Director of Nursing failed to conduct an ongoing quality assurance program to ensure that the plan of care ordered by a physician was followed for 8 of lo sampled patients (Patient #1, #3, #4, #5, #6, #7, #8 and #10) resulting in placing the residents at imminent risk of death, disablement or permanent injury. 8. The failure of the Registered Nurse to follow the physician's orders for Patient #3, who was receiving multiple anticoagulants. The patient had physician's orders for daily PT/INR to monitor the anticoagulant medication level. Patient #3 was hospitalized within a week of admission to the agency. The diagnosis on admission to the hospital was Coumadin toxicity and abdominal muscle hematoma. The patient died on 08/18/05. The final primary pathological diagnosis by the medical examiner was anticoagulation toxicity. The cumulative effect of these failures resulted in a crisis situation in which the residents are at imminent risk of death, disablement or permanent injury. (a) Request was made during the entrance conference on 03/02/06 at 9:15 am, with the Director of Professional Services (DPS), for Quality Assurance meeting minutes and the agency grievance log. The DPS stated during an interview on 03/02/06 at 9:15 am that the administrator would be in shortly. The DPS further stated during an interview on 03/02/06 at 9:15 am, "I will field it (complaints), take care of it and call the patient. There has been no Quality Assurance (meetings) since I've been back (November 2005). It's supposed to be quarterly, reported in March, June, September and January. I haven't had time to do it. Should have been one (meeting) in January. The QA (quality assurance) Director left the first week in January. We have a new Director, hired in January. I have done chart reviews but Tf haven't put the data together." , (b) The administrator stated during an interview on 03/02/06 at 12:50 pm, "I became aware of the situation (of Patient #3) 2 weeks ago when I got a call from... (another State agency).... (previous DPS) never told me...(previous DPS) talked to the daughter..... (Licensed Practical Nurse) was the coordinator booking (scheduling) the case.... (Licensed Practical Nurse) not here right now. I know we have a complaint log." (c) The administrator asked the DPS if the previous director of Quality Assurance (QA) had been contacted to determine if he/she knew where the book was. (d) Review of the agency complaint log given to the surveyor at 1:30 pm revealed no evidence of documentation by the previous DPS of the conversation with the daughter of Patient #3. Further review of the agency Complaint Log revealed no evidence of documentation by the administrator or DPS regarding the situation of Patient #3 or any follow up to prevent further such incidents. Continued review of the documentation revealed the last documented entry was dated 10/31/05 regarding a nurse not being available. The present DPS stated during an interview on 03/02/06 at 1:30 pm ," I know there's one more I did on 01/11/06 about a nurse not showing up." (e) There was no evidence of documentation of any meetings between among the governing body, the group of professional personnel and the staff to reflect that the findings of the quality assurance program are used to improve services. There was no evidence of documentation that the administrator had investigated the allegations regarding Patient #3 upon being informed of the situation by the State agency, to prevent any further incidents from occurring. During the exit conference, the following day, 03/03/06 at approximately 9:30 am, the administrator asked the DPS if the Quality Assurance minutes had been located. No documentation was produced by the agency prior to the end of the survey. (£) Review of the clinical record for Patient #3 reveals documentation the patient was admitted to the agency on 08/07/05 with diagnoses inclusive of Closed Fracture of the Patella with Surgical Repair and Atrial Fibrillation. Continued review of the clinical record reveals documentation of a signed physician home health certification and plan of care (POC) that stated in part "SN eval +62 (visits) Lovenox (anticoagulant) img Bc (subcutaneous) until therapeutic Daily PT/INR (laboratory sample for determining anticoagulant effectiveness). Continued review of the plan of care revealed that the patient was also taking Coumadin (anticoagulant) 5mg by mouth daily. (g) The nurse's documentation reveals a blood draw was performed by the RN (registered nurse) on 08/09/05 and 08/11/05. Further review of the clinical record reveals that the patient is being seen twice daily by a RN and a Licensed Practical Nurse (LPN) for Lovenox injections. There is no evidence communication between these two nurses seeing the patient regarding the lack of daily blood draws. Documentation in the nurses notes by the RN reveal daily communications with ".... cM" (case Manager) regarding clarification of lab orders on 08/08/05, 08/09/05 and 08/10/05. On 8/11/05, the documentation reveals," ....CM states Tues (08/09/05) lab draw clotted: QOD (every other day) PT/INR." There is no evidence of documentation of a physician order to change the blood draw frequency. (h) Interview with the Director of Clinical Services on 02/27/06 at approximately 11:30 am reveals that --.-CM is an LPN (licensed practical nurse) and routinely gives instructions, including physician orders, verbally to the RN (registered nurse). Interview on 02/27/06 at approximately 11:45 am with the RN providing the care to the patient revealed verbal orders from physicians are routinely received verbally from the LPN case Manager. The RN further stated although she/he was informed verbally of the daily PT/INR, there were no instructions in the patient’s home to determine the frequency of the blood draws and that he/she had nothing in writing. The RN continued to state during an interview on 2/27/06 at approximately 11:45 am that the laboratories that received specimens were not open on the weekend, therefore, the orders needed to be clarified to reflect the lack of services. During a phone call placed by the surveyor on 2/27/05 to the laboratory used for this patient, a lab employee stated the lab is open at 3 locations on Saturdays from 8-12 pm. One of the locations was noted to be in the same city as Patient #3. (i) The RN documents on 08/11/05 "PT/INR drawn." There is no evidence a specimen was brought to the lab on 08/11/05 in the clinical record. Phone calls to the lab on 02/27/06 revealed that the only specimens from this patient were received on 08/9/05 and 08/16/05. Continued review of the clinical record reveals that all the Lovenox injections were given in the abdomen. The patient was admitted to the hospital on 08/14/05 with a diagnosis of Coumadin toxicity, abdominal rectus muscle hematoma, and an INR of 9.5. The therapeutic level is between 2 and 3. 9. Review of the clinical record of Patient #1 revealed documentation of a physician's signed plan of care (POC) for start of care 05/28/05 with diagnoses of DVT (deep vein thrombosis) and Atrial Fibrillation. Further review of the POC reveals the patient was taking Coumadin amg (an anticoagulant) daily. Continued review of the clinical record reveals a physician's prescription dated 05/27/05 for PT/INR lab work for anticoagulation therapy to be done on 05/28/05 with results to be called physician. (a) Continued review of the clinical record revealed a Comprehensive Assessment and OASIS data set which documents a blood sample obtained on 06/01/05 by the Registered Nurse. Further review of the clinical record revealed no evidence of documentation that the Registered Nurse followed the physician's orders and informed the physician that the blood was not drawn on 05/28/05 as ordered. 10. Review of the clinical record of Patient #4 revealed documentation of a physician's plan of care for start of care 01/17/06 with diagnoses of Osteoarthrosis, a Revised Hip Replacement, and an Open Wound of Hip and Thigh. Review of the clinical record revealed the patient was discharged from the hospital with medications inclusive of Coumadin 2.5mg daily. Review of the Physician Hospital Order Sheet on the home health agency clinical record reveal physician orders dated 01/14/06 for PT/INR Q am (lab test for Coumadin monitoring every morning). There is no evidence of documentation in the clinical record that the Registered Nurse clarified whether the lab test should continue to be done daily or where the patient's lab work would be done. Interview with the LPN "care coordinator" on 03/02/06 at 11:10 am revealed, "The patient must have gone to the doctor to have it (PT/INR) done. It's not a skill. I'll call the nurse to see if (the nurse) checked on it." At 11:15 am, the LPN care manager stated: "The nurse said that (patient) went to the doctor for PT/INR". There was no evidence of documentation by the skilled nurse of clarification of the plan of care for Coumadin monitoring. 11. Review of the clinical record of Patient #5 reveals documentation of a signed physician's plan of care for start of care 01/18/06 with diagnoses of Osteoarthrosis, Partial Hip Replacement, Long term use of Anticoagulant, and Open Wound of Knee. Although the plan of care documentation revealed a diagnosis of Partial Hip Replacement, further review of the clinical record revealed the patient was discharged from the hospital for a Knee Replacement surgery. Continued review of the clinical record reveals the plan of care was approved and signed by the Registered Nurse and the Physician. Medications included Coumadin 7.5mg daily. Continued review of the clinical record revealed that orders for a PT/INR to be drawn on 01/19/06. According to the nursing note of 01/19/06, the Licensed Practical Nurse documents a blood draw of a PT/INR (used for Coumadin monitoring). Review of lab results performed on 01/19/06 revealed documentation of a PTT (partial prothrombin time) (used to monitor patients taking heparin). The lab document is stamped as faxed on 01/20/06. There is no documentation in the clinical record identifying who reviewed the lab work and/or faxed the results to the physician. There is no evidence in the clinical record whether the Registered Nurse alerted the physician to the error, and if the plan of care needed to be altered as a result of this error. 12. Review of the clinical record of Patient #8 revealed documentation of a signed physician's plan of care dated 01/29/05 with diagnoses of Atrial Fibrillation, Embolism and Thrombosis, and Debility. Review of the clinical record reveals a referral from the patient's 10 insurance company with the words written "never received orders." Another document From the hospital case management department referring the patient revealed "Discharge Home with HHC (home health care)." There are no signed verbal orders by the Registered Nurse for home health services. There is no evidence in the clinical record that orders for home care were clarified or requested by the Registered Nurse to the physician. Interview with the LPN (Licensed Practical Nurse) care coordinator on 03/02/06 at 12:25 pm who stated, "We as case Managers do the orders. These are all canned orders." There was no evidence of documentation that the agency had obtained specific orders for home care from a physician. 13. Review of the clinical record for Patient #6 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, open wound of knee/leg with wound debridement. Continued review of the clinical record documentation reveals a registered nurse signed and physician signed plan of care for skilled nursing services evaluation and daily to administer antibiotics intravenously and wound care every 3 days. Further review of the clinical record reveals "Physician's Verbal Orders" dated "1/9/06" which document, in part, CBC (complete blood count) with diff (differential). Vancomycin, trough on 1/12/06, then every Thursday thereafter." The signature on the verbal orders is illegible. Continued review of the clinical record documentation reveals a "physician's order" from the pharmacy dated 02/02/06 to, in part,"... Pharmacy to adjust Vancomycin per Vancomycin Jlevels..hold the Vancomycin tonight. Start Vancomycin 13 grams IV ( changed dosage) daily on Saturday 02/04/06..draw new peak and trough levels Monday and weekly including CBC with diff and fax results to .... (another physician). There is no evidence of documentation that a physician signed these orders or that the physician ordering home care services was informed of the change in orders. (a) Further review of the clinical record revealed that the patient had blood drawn for the laboratory work on 01/26/06, 02/09/06, 02/16/06 and 02/23/06. ‘The Licensed Practical Nurse (LPN) case manager acknowledged the lack of physician orders for the lab work during an interview on 03/02/06 and stated, "I don't know why there were no labs on the POC (plan of care). I don't know whose signature that is (on the verbal order). It's standard procedure to draw labs. I don't have a document for the standard procedure, ask the (Director of Professional Services). I have a standard procedure for a dry dressing. (b) The Registered Nurse who signed the poc acknowledged that it was his/her signature on the POC and stated during an interview on 03/02/06 at 10:40 am, "I don't see the orders for the labs (on the POC). I just sign the Poc to get it to the doctor to go out to the physician. I don't get all the information to put the POC together. I just get the nurse's sign up evaluation." There was no evidence of documentation or by interview that the skilled nursing services were furnished in accordance with the plan of care. 14. Review of the clinical record for Patient #7 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Atrial fibrillation with recent pacemaker placement and non insulin dependent diabetes mellitus. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 3 additional visits to, in part, "...Preparation and administration of insulin, proper technique for drawing up insulin/injection of insulin. Continued review of the POC reveals that the patient is currently taking, in part, Coumadin (blood thinner) and Metformin (oral anti hypoglycemic) .There was no evidence of documentation on the Poc that the patient was taking insulin. There was no evidence of documentation of physician orders specific to the monitoring of the anticoagulation therapy. The LPN case Manager stated during an interview on 03/02/06 at 12:25 pm," We as case managers do the orders. These are all canned 13. orders." The Registered Nurse signing the POC acknowledged that it was his/her signature on the POC during an interview on 03/02/06 at approximately 12 Noon and stated, "I made a mistake (leaving out specific orders for anticoagulation therapy). I just put in the numbers on the evaluation by the nurse. My number for that order (for the non insulin diabetic orders) says something different than what was printed out on the POC. I made a mistake." (a) Further review of the clinical record documentation reveals that the patient received only 1 additional visit and was last seen by the agency nurse on 01/25/06. Continued review of the "Flow sheet" dated 01/25/06 at 12 Noon, reveals documentation, in part,..." Believe PT (patient) had an episode of Atrial Fib. 4 am when patient became diaphoretic, very pale...symptoms resolved shortly. WNR (within normal range) at this time...Left chest wound from pacemaker placement sutures intact...also discussed diet with patient since patient not eating well....reported episode to MD. Seeing patient later today for blood work." Further review of the "Flow Sheet" reveals there is no evidence of a signature by the nurse. The LPN case manger acknowledged the documentation in the clinical record during an interview on 03/02/06 at 12:20 pm ‘and stated," The patient was discharged on 01/25/06. There was no more skill in the home. The patient was non- compliant. I 14 made the discharge sheet out now. On hindsight, the patient should not have been discharged. The nurse's note is not signed. It was an LPN. The DPS acknowledged the documentation in the clinical record during an interview on 03/02/06 between 12:15 pm and 12:25 pm and stated, "I agree the patient should not have been discharged. The nurse should have asked about the PT/INR (lab work)." There was no evidence of documentation or by interview that the skilled nursing services were furnished in accordance with the plan of care. 15. Review of the clinical record for Patient #10 reveals that the patient was admitted to the agency on 01/12/06 with diagnoses that included, in part, cellulitis and abscess abdominal wall and insulin dependent diabetes. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 7 times a week for 4 weeks "wound care as ordered." There was no evidence of documentation on the POC of any specific orders for wound care. Continued review of the clinical record revealed documentation of a hospital physician's order dated 1/11/06 for, in part, W-D (wet to dry dressing) with packing daily." The physician ordering the dressing changes was not the physician listed as the physician ordering the home care service. Further review of the clinical record reveals documentation that the registered nurse was performing dressing changes consisting of cleansing the wound with normal saline and then packing the wound with Iodoform gauze as of 01/14/06 daily through 01/16/06, then as of 01/20/06 through 01/26/06 and again as of 01/31/06 through 02/03/06. The LPN was performing the wound care as ordered by the hospital physician on 01/17/06 through 01/19/06, then as of 01/28/06, 01/30/06 and 01/31/06. There was no further documentation contained in the clinical record. The patient was listed as being an active patient per the agency's list. The DPS acknowledged the clinical record documentation during an interview on 03/02/06. There was no evidence of documentation or by interview that the skilled nursing services were furnished in accordance with the plan of care. 16. Based on the foregoing facts, High Tech Home Health, Inc. violated Section 400.487(2), Florida Statutes, and/or Rule 59A-8.0095(2)(c), Florida Administrative Code, herein classified as a Class I deficiency, which carries, in this case, an assessed fine of $5,000.00 and is also ground for the imposition of a Moratorium on new admissions. COUNT II HIGH TECH HOME HEALTH, INC. FAILED TO ASSURE THAT PROGESS REPORTS WERE MADE TO THE PHYSICIAN WHEN THE PATIENT'S CONDITION CHANGED AND OR THERE WERE DEVIATIONS FROM THE PLAN OF CARE Rule 59A~8.0095(3) (a), Florida Administrative Code (PERSONNEL ) 16 CLASS I VIOLATION 17. AHCA re~alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 18. During the complaint investigation (2006001388) and based on record review and interview the Registered Nurse failed to assure that progress reports were made to the physician when the patient's condition changed and or there were deviations from the plan of care for 8 of 10 sampled patients (Patient #1, #3, 44, #5, #6, #7, #8 and #10) xvesulting in placing the residents at imminent risk of death, disablement or permanent injury due to the Registered Nurse's failure to alert the physician of the lack of monitoring for Patient #3 who was receiving multiple anticoagulants and requiring daily blood samples to be drawn. 19. Patient #3 was hospitalized on 08/14/05 with diagnosis of Coumadin toxicity and abdominal muscle hematoma within a week of admission to the agency. The patient died on 08/18/05. The final primary pathological diagnosis was anticoagulation toxicity made by the Medical Examiner. The cumulative effect of these failures resulted in a crisis situation in which the health and safety of patients are at risk and places the residents at imminent risk of death, disablement or permanent injury. (a) Review of the clinical record for Patient #3 revealed documentation the patient was admitted to the agency on 08/07/05 with diagnoses inclusive of closed fracture of the patella with surgical repair and Atrial fibrillation. Continued review of the clinical record revealed documentation of a physician signed home health certification and plan of care that stated in part "SN evaluation +62 (visits) Lovenox (anticoagulant) img sec (subcutaneous) until therapeutic Daily PT/INR (laboratory sample for determining anticoagulant effectiveness) . Continued review of the plan of care revealed that the patient was also taking Coumadin (anticoagulant) 5mq by mouth daily. (b) Further review of the clinical record revealed documentation that the patient was seen by a Registered Nurse on 08/08/05 (10:30 am), with blood pressure at 126/76 and radial pulse at 76; Lovenox at 60mg was administered sc R abd (right abdomen) . On 08/08/05 (pm), documentation by the Licensed Practical Nurse (LPN) revealed blood pressure to he 106/60 and pulse 64. The blood pressure continued to range between 106/60 to 126/76 until 08/13/05. On 08/13/05, the LPN saw the patient at 8 am and had not documented a blood pressure. The radial pulse is 66. There is a crossed out reading of 90/60 on this visit note. The LPN also saw the patient on 08/13/05 at 7 pm and 18 documentation has the blood’ pressure at 90/60 and the radial pulse was 68. The patient complained of pain to the abdomen on a pain scale of 6 and about the same for the knee. There is no evidence in the clinical record that the vital sign information was communicated between the Registered Nurse and the LPN or that the physician was notified of the change in the patient's condition. . (c) The nurse's documentation revealed a blood draw was performed by the RN on 08/09/05 and 08/11/05. There is no evidence communication between the two nurses seeing the patient regarding the lack of daily blood draws. Documentation in the nurses notes by the RN reveal daily communications with ".... CM (case manager)" regarding clarification of lab orders on 08/08/05, 08/09/05 and 08/10/05. On 08/11/05, the documentation reveals ....CM states Tues (8/9/05) lab draw clotted: QOD (every other day) PT/INR." There is no evidence of a physician order to change the blood draw frequency. (d) Interview with the Director of Clinical Services on 02/27/06 at approximately 11:30 am revealed that," ....CM" is an LPN (licensed practical nurse) and routinely gives instructions, including physician orders, verbally to the RN (registered nurse). Interview on 02/27/06 at approximately 11:45 am with the RN providing the care to the patient revealed verbal orders from physicians are routinely received verbally from the LPN case manager. The RN further stated although he/she was informed verbally of the daily PT/INR, there were no instructions in the patient's home to determine the frequency of the blood draws and that he/she had "nothing in writing." (e) The RN further documents on 08/11/05 "PT/INR drawn." There is no evidence a specimen was brought to the lab on 08/11/05. Phone calls to the lab on 02/27/06 revealed the only specimens from this patient were received on 08/09/05 and 08/16/05. Lovenox injections were administered as ordered twice daily in the patient's abdomen by the home health agency skilled nurses. The patient was admitted to the hospital on 08/14/05 with a diagnosis of Coumadin toxicity, abdominal rectus muscle hematoma, and an INR of 9.5. The therapeutic level is between 2 and 3. There was no evidence of documentation that the Registered Nurse evaluated the patient's needs and promptly alerted the physician of the failure to follow the physician's orders. The Director of Professional Services stated during an interview on 03/02/06 at 9:15 am, "The case managers are all LPN's (Licensed Practical Nurses) ." 20. Review of the clinical record of Patient #1 revealed documentation of a physician's signed plan of care (POC) for start of care 05/28/05 with diagnoses of DVT (deep vein thrombosis) and Atrial fibrillation. Further review of the POC reveals the patient is taking Coumadin 2mg (an anticoagulant) daily. Further review of the clinical record reveals a physician's prescription dated 05/27/05 for PT/INR (lab work for anticoagulation therapy) to be done on 05/28/05 with results to be called to physician. (a) Continued review of the clinical record revealed a Comprehensive Assessment with OASIS data set which documented, in part that a blood sample was obtained on 06/01/05 by the Registered Nurse. Further review of the clinical record revealed no evidence of documentation that the Registered Nurse informed the physician that the blood was not drawn on 05/28/05 as ordered. 21. Review of the clinical record of Patient #4 revealed documentation of a physician's plan of care for start of care 01/17/06 with diagnoses of Osteoarthrosis, a Revised Hip Replacement, and an Open Wound of Hip and Thigh. Continued review of the clinical record revealed that the patient was discharged from the hospital with medications inclusive of Coumadin 2.5mg daily. Review of the Physician Hospital Order Sheet contained in the home health agency clinical record reveals physician orders dated 01/14/06 for PT/INR Q am (lab test for Coumadin monitoring every morning) . There is no evidence of documentation in the clinical record that the Registered Nurse clarified whether the lab test should continue to be drawn daily by the home health agency staff or where the patient's lab work would be done. During an interview with the LPN "care coordinator" on 03/02/06 at 11:10 am, the LPN care coordinator stated, "The patient must have gone to the doctor to have it (PT/INR) done. Tt's not a skill. I'll call the nurse to see if he/she checked on it". At 11:15 am, the LPN care manager stated during an interview, "The nurse said... (patient) went to the doctor for PT/INR". There was no evidence of documentation that the Registered Nurse had communicated with the physician regarding the blood work until the telephone call 03/02/06. 22. Review of the clinical record of Patient #5 revealed documentation of a signed physician's plan of care for start of care 01/18/06 with diagnoses of Osteoarthrosis, Partial Hip Replacement, Long term use of Anticoagulant, and Open wound of knee. Although the plan of care documentation revealed a diagnosis of Partial Hip Replacement, further review of the clinical record documentation revealed the patient was discharged from the hospital after a Knee Replacement surgery. Continued review of the clinical record revealed documentation the plan of care was approved and signed by . the Registered Nurse and the Physician. Medications included Coumadin 7.5mg daily. Further review of the clinical record reveals orders for a PT/INR to be drawn on 01/19/06. According to the nursing note of 01/19/06, the nN No Licensed Practical Nurse documented a blood draw of a PT/INR (used for Coumadin monitoring). Review of lab results documentation performed on 01/19/06 reveal a PTT (partial prothrombin time) result (used to monitor patients taking heparin). The lab document is stamped as faxed on 01/20/06. (a) There is no evidence of documentation in the clinical record identifying who reviewed the lab work and/or faxed the results to the physician. There is no evidence of documentation in the clinical record that the Registered Nurse alerted the physician to the lab error, and ensured the patient's Coumadin levels were therapeutic. 23. Review of the clinical record of Patient #8 revealed documentation of a signed physician's plan of care dated 01/29/05 with diagnoses of Atridl fibrillation, Embolism and Thrombosis and Debility. Review of the clinical record reveals documentation of a referral from the patient's insurance company with the words written "never received orders" written across the document. Another document, from the hospital case management department, referring the patient, stating: "Discharge Home with HHC (Home Health Care)." There is no evidence of documentation of signed verbal orders by the Registered Nurse for home health services. There is no evidence of documentation in the clinical record that orders for home care were clarified or requested by the Registered Nurse to the physician. Interview with the LPN care coordinator on 03/02/06 at 12:25 pm who stated, "We as case managers do the orders. These are all canned orders." 24. Review of the clinical record for Patient #6 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, open wound of knee/leg with wound debridement. Continued review of the clinical record documentation reveals a registered nurse signed and physician signed plan of care for skilled nursing services evaluation, and daily visits to administer antibiotics intravenously, and wound care every 3 days. Further review of the clinical record reveals "Physician's Verbal Orders" dated "1/9/06" which document, in part, CBC (complete blood count) with diff (differential). Vancomycin, trough on 1/12/06 then, every Thursday thereafter." The signature on the verbal orders is illegible. Continued review of the clinical record documentation reveals a “physician's order" from the pharmacy dated 02/02/06 to, in part,"... Pharmacy to adjust Vancomycin per Vancomycin levels..hold the Vancomycin tonight. Start Vancomycin 13 grams IV (changed dosage) daily on Saturday 02/04/06..draw new peak and trough levels Monday and weekly including CBC with diff and fax results to ....(mame of another physician). There is no evidence of documentation that a physician signed these orders or that the physician ordering home care services was informed of the change in orders. (a) Further review of the clinical record revealed that the patient had blood drawn for the laboratory work on 01/26/06, 02/09/06, 02/16/06 and 02/23/06. The Licensed Practical Nurse (LPN) case manager acknowledged the lack of physician orders for the lab work during an interview on 03/02/06 and stated, "I don't know why there were no labs on the POC (plan of care). I don't know whose signature that is (on the verbal order). It's standard procedure to draw labs. It doesn’t have a document for the standard procedure, ask to the (Director of Professional Services). I have a standard procedure for a dry dressing. (b) The Registered Nurse who signed the poc acknowledged that it was his/her signature on the POC and stated during an interview on 03/02/06 at 10:40 am, "I don't see the orders for the labs (on the POC). I just sign the Poc to get it to the doctor to go out to the physician. I don't get all the information to put the POC together. I just get the nurse's sign up evaluation." There was no evidence of documentation or by interview that the registered nurse re-evaluated the patient's nursing needs to assure that care was being provided as ordered. 25. Review of the clinical record for Patient #7 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Atrial fibrillation with recent pacemaker placement and non insulin dependent diabetes mellitus. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 3 additional visits to, in part, "...Preparation and administration of insulin..proper technique for drawing up insulin/injection of insulin. Continued review of the Poc reveals that the patient is currently taking, in part, Coumadin (blood thinner) and Metformin (oral anti hypoglycemic). There was no evidence of documentation on the Poc that the patient was taking insulin. There was no evidence of documentation of physician orders specific to the monitoring of the anticoagulation therapy. The LPN case manager stated during an interview on 03/02/06 at 12:25 pm," We as case managers do the orders. These are all canned orders." The Registered Nurse signing the POC acknowledged that it was his/her signature on the POC during an interview on 03/02/06 at approximately 12 Noon and stated, "I made a mistake (leaving out specific orders for anticoagulation therapy). I just put in the numbers on the evaluation by the nurse. My number for that order (for the non insulin Giabetic orders) says something different than what was printed out on the POC. I made a mistake." (a) Further review of the clinical record documentation reveals that the patient received only 1 additional visit and was last seen by the agency nurse on 01/25/06. Continued review of the "Flow sheet" dated 01/25/06 at 12 Noon, reveals documentation, in part,..." Believe PT (patient) had an episode of Atrial Fib. 4 am when patient became diaphoretic, very pale...symptoms resolved shortly. WNR (within normal range) at this time...Left chest wound from pacemaker placement sutures intact...also discussed diet with patient since patient not eating well....reported episode to MD. Seeing patient later today for blood work." Further review of the "Flow Sheet" reveals there is no evidence of a signature by the nurse. The LPN Case manger acknowledged the documentation in the clinical record during an interview on 03/02/06 at 12:20 pm and stated," The patient was discharged on 01/25/06. There was no more skill in the home. The patient was non-compliant. I made the discharge sheet out now. On hindsight, the patient should not have been discharged. The nurse's note is not signed. It was an LPN. The DPS acknowledged the documentation in the clinical record during an interview on 03/02/06 between 12:15 pm and 12:25 pm and stated, "I agree the patient should not have been discharged. The nurse should have asked about the PT/INR (\lab work)." There was no evidence of documentation or by interview that the registered nurse re-evaluated the patient's nursing needs to assure that care was being provided as ordered. 26. Review of the clinical record for Patient #10 reveals that the patient was admitted to the agency on 01/12/06 with diagnoses that included, in part, cellulitis and abscess abdominal wall and insulin dependent diabetes. Continued review of ‘the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 7 times a week for 4 weeks "wound care as ordered." There was no evidence of documentation on the POC of any specific orders for wound care. Continued review of the clinical record revealed documentation of a hospital physician's order dated 1/11/06 for, in part, W-D (wet to dry dressing) with packing daily." The physician ordering the dressing changes was not the physician listed as the physician ordering the home care service. Further review of the clinical record reveals documentation that the registered nurse was performing dressing changes which consisted of cleansing the wound with normal saline and then packing the wound with Iodoform gauze as of 01/14/06 daily through 01/16/06, then as of 01/20/06 through 01/26/06 and again as of 01/31/06 through 02/03/06. The LPN was performing the wound care as ordered by the hospital physician on 01/17/06 through 01/19/06, then as of 01/28/06, 01/30/06 and 01/31/06. There was no further documentation contained in the clinical record. The patient was listed as being an active patient per the agency's list. The DPS acknowledged the clinical record documentation during an interview on 03/02/06. There was no evidence of documentation or by interview that the registered nurse re- evaluated the patient's nursing needs to assure that care was being provided as ordered. 27. Based on the foregoing facts, High Tech Home Health, Inc. violated Rule 59A-8.0095(3) (a), Florida Administrative Code, herein classified as a Class I deficiency, which carries, in this case, an assessed fine of $5,000.00 and is also ground for the imposition of a Moratorium on new admissions. COUNT III HIGHT TECH HOMEHEALTH INC. FAILED TO RETAIN THE FULL RESPONSIBILITY FOR THE CARE GIVEN TO PATIENTS Rule 59A-8.0095(3), Florida Administrative Code CLASS I VIOLATION 28. AHCA re-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 29. During the complaint investigation (2006001388) and Based on interview and clinical record review, it was determined the Registered Nurse failed to retain the full responsibility for the care given to patients 8 of 10 sampled patients (Patient #1, #3, #4, $5, #6, #7, #8 and #10) resulting in placing the residents at imminent risk of 29 death, disablement or permanent injury due to the Registered Nurse's lack of supervision for Patient #3 receiving multiple anticoagulants and requiring daily blood samples and subsequently the hospitalization of Patient #3, within a week of admission to the home health agency, with diagnosis of Coumadin toxicity and abdominal muscle hematoma. The patient died on 08/18/05. The final primary pathological diagnosis of Patient #3 was anticoagulation toxicity made by the medical examiner. The cumulative effect of these failures resulted in a crisis situation in which the health and safety of patients are at risk and places the residents at imminent risk of death, disablement or permanent injury. 30. Review of the clinical record for Patient #3 revealed documentation the patient was admitted to the agency on 08/07/05 with diagnoses inclusive of Closed Fracture of the Patella with Surgical Repair and Atrial Fibrillation. Continued review of the clinical record revealed documentation of a signed physician home health certification and plan of care that stated in part ' SN evaluation +62 (visits) Lovenox (anticoagulant) 1mg sc (subcutaneous) until therapeutic Daily PT/INR (laboratory sample for determining anticoagulant effectiveness) . Continued review of the plan of care revealed that the 30 patient was also taking Coumadin (anticoagulant) 5mg by mouth daily. (a) Further review of the clinical record revealed documentation that the patient was seen by a Registered Nurse on 08/08/05 (10:30 am),with blood pressure at 126/76 and radial pulse at 76; Lovenox at 60mg was administered sc R abd (right abdomen). On 08/08/05 (am), documentation by the Licensed Practical Nurse (LPN) revealed blood pressure to be 106/60 and pulse 64. The blood pressure continued to range between 106/60 to 126/76 until 08/13/05. On 80/13/05, the LPN saw the patient at 8 am and did not document a blood pressure. The radial pulse is 66. There is a crossed out reading of 90/60 on this visit note. The LPN also saw the patient on 08/13/05 at 7 pm and has the blood pressure at 90/60 and the radial pulse was 68. The patient complained of pain to the abdomen on a pain scale of 6 and about the same for the knee. There is no evidence in the clinical vrecord that vital sign information was communicated between the Registered Nurse and the LPN. 31. Review of the agency's policy for Coordination of Care revealed, in part, that the coordination of patient care shall be guided by written criteria in order to assure continuity of services. The policy further states that staff will maintain regular communication with other Agency staff 31 members and the Supervisory Staff and that this will be accomplished through: (a) Daily verbal communication with the Supervisory Staff. (b) Reporting significant changes in patient's medical condition verbally and communication documents. . (c) Interdisciplinary communication documents. (a) Interdisciplinary verbal communications. 31. Interview with the Director of Professional Services (DPS) on 02/27/05 at approximately 11:30 am revealed there were no written communication logs kept in the office and information is communicated verbally to the staff providing care. The DPS further stated that the staff is expected to document in their visit notes any ‘communication to the office or with other staff members providing care to the patient. There was no evidence of documentation in the clinical record that the agency staff providing care to Patient #3 had coordinated services effectively to ensure that the patient's blood level was therapeutic to prevent the risk of anticoagulation toxicity. The nurse's documentation revealed a blood draw was performed by the RN on 08/09/05 and 08/11/05. There is no evidence of communication between the .two nurses visiting the patient regarding the lack of daily blood draws. Documentation in the nurses notes by the RN reveal daily communications with ".... CM" (case manager) regarding clarification of lab orders on 08/08/05, 08/09/05 and 08/10/05. On 08/11/05, the documentation reveals," ....CM states Tues (08/09/05) lab draw clotted: QOD (every other day) PT/INR." There was no evidence of documentation of a physician order to change the blood draw frequency to every other day. 32. Interview with the Director of Professional Services on 02/27/06 at approximately 11:30 am revealed that -...the CM is an LPN and routinely gives instructions, including physician orders, verbally to the RN. Interview on 02/27/06 at approximately 11:45 am with the RN providing the care to the patient revealed verbal orders from physicians are routinely received verbally from the LPN case Manager. The RN further stated although he/she was informed verbally of the daily PT/INR, there were no instructions in the patient's home to determine the frequency of the blood draws and that he/she had "nothing in writing." The RN continued to state during an interview on 02/27/06 at approximately 11:45 am that the laboratories that received specimens were not open on the weekend, ‘therefore, the orders needed to be clarified to reflect the lack of services. During a phone call placed by the surveyor on 02/27/05 to the laboratory used for this patient, a lab employee stated the lab is open at 3 locations on Saturdays 33 from 8-12 pm . One of the locations was noted to be in the same city as Patient #3. 33. The RN documents on 08/11/05 "PT/INR drawn." There is no evidence a specimen was brought to the lab on 08/11/05 in the clinical record. Phone calls to the lab on 02/27/06 revealed that the only specimens from this patient were received on 08/09/05 and 08/16/05. Lovenox injections were administered as ordered twice daily in the patient's abdomen by the home health agency skilled nurses. The patient was admitted to the hospital on 08/14/05 with a diagnosis of Coumadin toxicity, abdominal rectus muscle hematoma, and an INR of 9.5. The INR therapeutic level is between 2 and 3. 34. Review of the clinical record of Patient #1 revealed documentation of a physician's signed Plan of Care (POC) for start of care 05/28/05 with diagnoses of DVT (deep vein thrombosis) and Atrial Fibrillation. Continued review of the POC revealed the patient is taking Coumadin amg (an anticoagulant) daily. Further review of the clinical record reveals a physician's prescription dated 05/27/05 for PT/INR lab work for anticoagulation therapy to be done on 05/28/05 with results to be called physician. (a) Continued review of the clinical record revealed a Comprehensive Assessment and OASIS data set which documented, in part, a blood sample was obtained on 06/01/05 34 by the Registered Nurse. Further review of the clinical record revealed no evidence of documentation that the Registered Nurse coordinated services and informed the physician that the blood was not drawn on 05/28/05 as ordered. 35. Review of the clinical record of Patient #4 revealed documentation of a physician's plan of care for Start of care 01/17/06 with diagnoses of Osteoarthrosis, a Revised Hip Replacement, and an Open Wound of Hip and Thigh. Continued review of the clinical record revealed the patient was discharged from the hospital with medications inclusive of Coumadin 2.5mg daily. Review of the Physician Hospital Order Sheet on the home health agency clinical record reveal physician orders, from another physician not the physician who ordered the home care services, dated 01/14/06 for PT/INR Q am (lab test for Coumadin monitoring every morning) . There is no evidence of documentation in the clinical record that the Registered Nurse clarified whether the lab test should continue to be done daily or where the patient's lab work would be done. Interview with the LPN "care coordinator" on 03/02/06 at 11:10 am revealed, "The patient must have gone to the doctor to have it (PT/INR) done. It's not a skill. I'll call the nurse to see if he/she checked on it." At 11:15 am, the LPN care manager stated "The nurse said...(patient) went to the doctor for 35 his PT/INR." There was no evidence of documentation that the Registered Nurse coordinated the patient's care and informed the LPN care coordinator of these findings until 03/02/06. 36. Review of the clinical record of Patient #5 revealed documentation of a signed physician's plan of care for start of care 01/18/06 with diagnoses of Osteoarthrosis, Partial Hip Replacement, Long term use of Anticoagulant, and Open wound of Knee. Although the plan of care documentation reveals a diagnosis of Partial Hip Replacement, further review of the clinical record revealed the patient was discharged from the hospital for a Knee Replacement surgery. Continued review of the clinical record revealed the plan of care was approved and signed by the Registered Nurse and the Physician. Medications included Coumadin 7.5mg daily. Continue review of the clinical record, revealed orders for a PT/INR to be drawn on 01/19/06. According to the nursing note of 01/19/06, the Licensed Practical Nurse documented a blood draw of a PT/INR (used for Coumadin monitoring). Review of the documentation of lab results performed on 01/19/06 revealed documentation of PTT (partial prothrombin time) (used to monitor patients taking heparin). The lab document is stamped as faxed on 01/20/06. There is no evidence of documentation in the clinical record identifying who reviewed the lab work and/or 36 faxed the results to the physician. There is no evidence of documentation in the clinical record whether the Registered Nurse alerted the physician to the lab error, and how any further blood draws would be coordinated to ensure the patient's Coumadin levels were therapeutic. 37. Review of the clinical record of Patient #8 revealed documentation of a signed physician's plan of care dated 01/29/05 with diagnoses of Atrial fibrillation, Embolism and Thrombosis, and Debility. Review of the clinical record revealed a referral from the patient's insurance company with the words written "never received orders". Another document from the hospital case management department, referring the patient, stated "Discharge Home with HHC (Home Health Care) ." There is no evidence of documentation of signed verbal orders by the Registered Nurse for home health services to start. There is no evidence of documentation in the clinical record that orders for home care were clarified or requested by the Registered Nurse to the physician. Interview with the LPN care coordinator on 03/02/06 at 12:25 pm who stated, "We as case managers do the orders. These are all canned orders." 38. Review of the clinical record for Patient #6 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Open Wound of Knee/Leg with Wound Debridement. Continued review of the 37 clinical record documentation reveals a Registered Nurse and Physician signed plan of care for skilled nursing services evaluation and then daily to administer antibiotics intravenously and wound care every 3 days. Further review of the clinical record reveals "Physician's Verbal Orders" dated "1/9/06" which document, in part, CBC (complete blood count) with diff (differential). Vancomycin trough 1/12/06 then every Thursday thereafter." The signature on the verbal orders is illegible. Continued review of the clinical record documentation reveals a physician's order from the pharmacy dated 02/02/06 to, in part,"... Pharmacy to adjust Vancomycin per Vancomycin levels..hold the Vancomycin tonight. Start Vancomyein 13 grams IV (changed dosage) daily on Saturday 02/04/06..draw new peak and trough levels Monday and weekly including CBC with diff and fax results to .(another named physician). There is no evidence of documentation that a physician signed these orders or that the physician ordering home care services was informed of “the change in orders. (a) Further review of the clinical record revealed that the patient had blood drawn for the laboratory work on 01/26/06, 02/09/06, 02/16/06 and 02/23/06. The Licensed Practical Nurse (LPN) case manager acknowledged the lack of physician orders for the lab work during an interview on 03/02/06 and stated, "I don't know why there's 38 no labs on the POC (plan of care). I don't know whose signature that is (on the verbal order). It's standard procedure to draw labs. I don't have a document for the standard procedure, ask the (Director of Professional Services). I have a standard procedure for a dry dressing. (b) The Registered Nurse who signed the Ppoc acknowledged that it was his/her signature on the POC and stated during an interview on 03/02/06 at 10:40 am, "ZI don't see the orders for the labs (on the POC). I just sign the POC to get it to the doctor to go out to the physician. I don't get all the information to put the POC together. I just get the nurse's sign up evaluation." There was no evidence of documentation in the clinical record that the Registered Nurse and agency staff had coordinated the patient's plan of care to reflect that the physician ordering the home care was aware of the blood laboratory work being drawn on the patient. 39. Review of the clinical record for Patient #7 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Atrial Fibrillation with recent Pacemaker Placement and Non Insulin Dependent Diabetes Mellitus. Continued review of the clinical record documentation reveals a Registered Nurse signed plan of care (POC) for skilled nursing evaluation and 3 additional visits to, in part, "...Preparation and 39 administration of insulin, proper technique for drawing up insulin/ injection of insulin. Continued review of the Poc reveals that the patient is currently taking, in part, Coumadin (blood thinner) and Metformin (oral anti hypoglycemic) .There was no evidence of documentation on the Poc that the patient was taking insulin. There was no evidence of documentation of physician orders specific to the monitoring of the anticoagulation therapy. The LPN case Manager stated during an interview on 03/02/06 at 12:25 pm ," We as case managers do the orders. These are all canned orders." (a) The Registered Nurse signing the POC acknowledged that it was his/her signature on the POC during an interview on 03/02/06 at approximately 12 Noon and stated, "I made a mistake (leaving out specific orders for anticoagulation therapy). I just put in the numbers (of pre- typed orders) on the evaluation by the nurse. My number for that order (for the non insulin diabetic orders) says something different than what was printed out on the POC. I made a mistake." (c) Further review of the clinical record documentation reveals that the patient received only 1 additional visit and was last seen by the agency nurse on 01/25/06. Continued review of the "Flow sheet" dated 01/25/06 at 12 Noon, reveals documentation, in part,..." 40 Believe PT (patient) had an episode of Atrial Fib. 4 am when patient became diaphoretic, very pale...symptoms resolved shortly. WNR (within normal range) at this time...Left chest wound from pacemaker placement sutures intact...also discussed diet with patient since patient not eating well....reported episode to MD. Seeing patient later today for blood work." Further review of the "Flow Sheet" reveals there is no evidence of a signature by the nurse. The LPN case manger acknowledged the documentation in the clinical record during an interview on 03/02/06 at 12:20 pm and stated," The patient was discharged on 01/25/06. There was no more skill in the home. The patient was non-compliant. I made the discharge sheet out now. On hindsight, the patient should not have been discharged. The nurse's note is not signed. It was an LPN. The DPS acknowledged the documentation in the clinical record during an interview on 03/02/06 between 12:15 pm and 12:25 pm and stated, "I agree the patient should not ‘have been discharged. The nurse should have asked about the PT/INR (lab work)." There was no evidence of documentation of liaison between the registered nurse, the physician and agency staff to coordinate services effectively and safely to the patient. 40. Review of .the clinical record for Patient #10 reveals that the patient was admitted to the agency on 01/12/06 with diagnoses that included, in part, cellulitis 41 and abscess abdominal wall and insulin dependent diabetes. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 7 times a week for 4 weeks "wound care as ordered." There was no evidence of documentation on the POC of any specific orders for wound care. Continued review of the clinical record revealed documentation of a hospital physician's order dated 1/11/06 for, in part, W-D (wet to dry dressing) with packing daily." The physician ordering the dressing changes was not the physician listed as the physician ordering the home care service. Further review of the clinical record reveals documentation that the registered nurse was performing dressing changes consisting cleansing the wound with normal saline and then packing the wound with Iodoform gauze as of 01/14/06 daily through 01/16/06, then as of 01/20/06 through 01/26/06 and again as of 01/31/06 through 02/03/06. The LPW was performing the wound care as ordered by the hospital physician on 01/17/06' through 01/19/06, then as of 01/28/06, 01/30/06 and 01/31/06. There was no further documentation contained in the clinical record. The patient was listed as being an active patient per the agency's list. There was no evidence of documentation of supervision by the registered nurse to coordinate the wound care. The DPS acknowledged the clinical record documentation during an interview on 03/02/06. There was no evidence of documentation of liaison between the Registered Nurse, the physician and agency staff. 41. Based on the foregoing facts, High Tech Home Health, Inc. violated Rule 59A-8.0095(3), Florida Administrative Code, herein classified as a Class I deficiency, which carries, in this case, an assessed fine of $5,000.00 and is also grounds for the imposition of a Moratorium on new admissions. COUNT IV HIGH TECH HOMEHEALTH INC. FAILED TO ENSURE THAT THE PLAN OF CARE ORDERED BY A PHYSICIAN WAS FOLLOWED FOR 8 PATIENTS Section 400.487(2), Florida Statutes (TREATMENT ORDERS) CLASS I VIOLATION 42. AHCA re-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 43. During the complaint investigation (2006001388) and based on interview and clinical record review, it was determined the agency failed to ensure that the plan of care ordered by a physician was followed for 8 of 10 sampled patients (Patient #1, #3, #4, #5, #6, #7, #8 and #10) resulting in placing the residents at imminent risk of death, disablement or permanent injury due to the Registered Nurse's failure to follow the physician's orders for Patient #3 receiving multiple anticoagulants and requiring daily 43 blood samples and subsequently the hospitalization of Patient #3, within a week of admission to the agency, with diagnoses of Coumadin toxicity and abdominal muscle hematoma. The patient died on 08/18/05. The final primary pathological diagnosis by the medical examiner was of anticoagulation toxicity. The cumulative effect of these failures resulted in a crisis situation in which the health and safety of patients are at risk and places the residents at imminent risk of death, disablement or permanent injury. 44. Review of the clinical record for Patient #3 reveals documentation the patient was admitted to the agency on 08/07/05 with diagnoses inclusive of Closed Fracture of the Patella with Surgical Repair and Atrial Fibrillation. Continued review of the clinical record reveals documentation of a signed physician home health certification and plan of care (POC) that stated in part "SN evaluation +62 (visits) Lovenox (anticoagulant) img sc (subcutaneous) until therapeutic Daily PT/INR (laboratory sample for determining anticoagulant effectiveness) . Continued review of the plan of care revealed that the patient was also taking Coumadin (anticoagulant) 5mg by mouth daily. (a) The nurse's documentation reveals a blood draw was performed by the RN (registered nurse) on 08/09/05 and 08/11/05. Further review of the clinical record reveals 44 that the patient is being seen twice daily by a RN and a Licensed Practical Nurse (LPN) for Lovenox injections. There is no evidence of communication between these two nurses seeing the patient regarding the lack of daily blood draws. Documentation in the nurses notes by the RN reveal daily communications with ".... CM" (case manager) regarding clarification of lab orders on 08/08/05, 08/09/05 and 08/10/05. On 8/11/05, the documentation reveals," ....CM states Tues (08/09/05) lab draw clotted: QOD (every other day) PT/INR." There is no evidence of documentation of a physician order to change the blood draw frequency. (b) Interview with the Director of Clinical Services on 02/27/06 at approximately 11:30 am reveals that ....CM is an LPN (licensed practical nurse) and routinely gives instructions, including physician orders, verbally to the RN (registered nurse). Interview on 02/27/06 at approximately 11:45 am with the RN providing the care to the patient revealed verbal orders from physicians are routinely received verbally from the LPN case manager. The RN further stated although she/he was informed verbally of the daily PT/INR, there were no instructions in the patient’s home to determine the frequency of the blood draws and that he/she had nothing in writing. The RN continued to state during an interview on 2/27/06 at approximately 11:45 am that the laboratories that received specimens were not open on the 4S weekend, therefore, the orders needed to be clarified to reflect the lack of services. During a phone call placed by the surveyor on 2/27/05 to the laboratory used for this patient, a lab employee stated the lab is open at 3 docations on Saturdays from 8-12 pm. One of the locations was noted to be in the same city as Patient #3. (c) The RN documented on 08/11/05 "PT/INR drawn." There was no evidence a specimen was brought to the lab on 08/11/05 in the clinical record. Phone calls to the lab on 02/27/06 revealed that the only specimens from this patient were received on 08/9/05 and 08/16/05. Continued review of the clinical record reveals that all Lovenox injections were given in the abdomen. The patient was admitted to the hospital on 08/14/05 with a diagnosis of Coumadin toxicity, abdominal rectus muscle hematoma, and an INR of 9.5. The therapeutic level is between 2 and 3. 45. Review of the clinical record of Patient #1 revealed documentation of a physician's signed plan of care (PoC) for start of care 05/28/05 with diagnoses of DVT (deep vein thrombosis) and Atrial Fibrillation. Further review of the POC reveals the patient was taking Coumadin amg (an anticoagulant) daily. Continued review of the clinical record reveals a physician's prescription dated 05/27/05 for PT/INR lab work for anticoagulation therapy to be done on 05/28/05 with results to be called physician. 46 (a) Continued review of the clinical record revealed a Comprehensive Assessment and OASIS data set which documents a blood sample obtained on 06/01/05 by the Registered Nurse. Further review of the clinical record revealed no evidence of documentation that the Registered Nurse followed the physician's orders and informed the physician that the blood was not drawn on 05/28/05 as ordered. 46. Review of the clinical record of Patient #4 revealed documentation of a physician's plan of care for start of care 01/17/06 with diagnoses of Osteoarthrosis, a Revised Hip Replacement, and an Open Wound of hip and Thigh. Review of the clinical record revealed the patient was discharged from the hospital with medications inclusive of Coumadin 2.5mg daily. Review of the Physician Hospital “Order Sheet on the home health agency clinical record reveal physician orders dated 01/14/06 for PT/INR Q am (lab test for Coumadin monitoring every morning). There is no evidence of documentation in the clinical record that the Registered Nurse clarified whether the lab test should continue to be done daily or where the patient's lab work would be done. Interview with the LPN "care coordinator" on 03/02/06 at 11:10 am reveals, "The patient must have gone to the doctor to have it (PT/INR) done. It's not a skill. I'll call the nurse to see if .. (the nurse) checked on it." At 47 11:15AM, the LPN care manager stated "The nurse said ... (patient) went to the doctor for PT/INR". There was no evidence of documentation by the skilled nurse of clarification of the plan of care for Coumadin monitoring. 47. Review of the clinical record of Patient #5 reveals documentation of a signed physician's plan of care for start of care 01/18/06 with diagnoses of Osteoarthrosis, Partial Hip Replacement, Long term use of Anticoagulant, and Open Wound of Knee. Although the plan of care documentation reveals a diagnosis of Partial Hip Replacement, further review of the clinical record revealed the patient was discharged from the hospital for a Knee Replacement surgery. Continued review of the clinical record reveals the plan of care was approved and signed by the Registered Nurse and the Physician. Medications included Coumadin 7.5mg daily. Continued review of the clinical record reveals orders for a PT/INR to be drawn on 01/19/06. According to the nursing note of 01/19/06, the Licensed Practical Nurse documents a blood draw of a PT/INR (used for Coumadin monitoring) . Review of lab’s results performed on 01/19/06 revealed documentation of a PTT (partial prothrombin time) (used to monitor patients taking heparin). The lab document is stamped as faxed on 01/20/06. There is no documentation in the clinical record identifying who reviewed the lab work and/or faxed the results to the physician. There is no 48 evidence in the clinical record whether the Registered Nurse alerted the physician to the error, and if the plan of care needed to be altered as a result of this error. 48. Review of the clinical record of Patient #8 revealed documentation of a signed physician's plan of care dated 01/29/05 with diagnoses of Atrial Fibrillation, Embolism and Thrombosis, and Debility. Review of the clinical record reveals a referral from the patient's insurance company with the words written "never received orders." Another document from the hospital case management department referring the patient reveals "Discharge Home with HHC (home health care)." There are no signed verbal orders by the Registered Nurse for home health services. There is no evidence in the clinical record that orders for home care were clarified or requested by the Registered Nurse to the physician. Interview with the LPN (Licensed Practical Nurse) care coordinator on 03/02/06 at 12:25PM who stated, "We as case managers do the orders. These are all canned orders." There was no evidence of documentation that the agency had obtained specific orders for home care from a physician. 49. Review of the clinical record for Patient #6 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Open Wound of Knee/Leg with Wound Debridement. Continued review of the 49 clinical record documentation reveals a registered nurse and physician signed plan of care for skilled nursing services evaluation and daily to administer antibiotics intravenously and wound care every 3 days. Further review of the clinical record reveals "Physician's Verbal Orders" dated "1/9/06" which documented, in part, CBC (complete blood count) with diff (differential). Vancomycin trough on 1/12/06 then every Thursday thereafter." The signature on the verbal orders is illegible. Continued review of the clinical record documentation reveals a "physician's order" from the pharmacy dated 02/02/06 to, in part,"... Pharmacy to adjust Vancomycin per Vancomycin levels..hold the Vancomycin tonight. Start Vancomycin 13 grams IV (changed dosage) daily on Saturday 02/04/06..draw new peak and trough levels Monday and weekly including CBC with diff and fax results to ....( another physician). There was no evidence of documentation that a physician signed these orders or that the physician ordering home care services was informed of the change in orders. (a) Further review of the clinical record revealed that the patient had blood drawn for the laboratory work on 01/26/06, 02/09/06, 02/16/06 and 02/23/06. The Licensed Practical Nurse (LPN) case manager acknowledged the lack of physician orders for the lab work during an interview on 03/02/06 and stated, "I don't know why there 50 were no labs on the POC (plan of care). I don't know whose signature that is (on the verbal order). It's standard procedure to draw labs. I don't have a document for the standard procedure, ask the (Director of Professional Services). I have a standard procedure for a dry dressing." The Registered Nurse who signed the POC acknowledged that it was his/her signature on the POC and stated during an interview on 03/02/06 at 10:40 AM, "I don't see the orders for the labs (on the POC). I just sign the POC to get it to the doctor to go out to the physician. I don't get all the information to put the POC together. I just get the nurse's sign up evaluation." 50. Review of the clinical record for Patient #7 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Atrial Fibrillation with recent Pacemaker Placement and Non Insulin Dependent Diabetes Mellitus. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 3 additional visits to, in part, "...Preparation and administration of insulin, proper technique for drawing up insulin/ injection of insulin. Continued review of the poc reveals that the patient is currently taking, in part, Coumadin (blood thinner) and Metformin (oral anti hypoglycemic). There was no evidence of documentation on the 31 Poc that the patient was taking insulin. There was no evidence of documentation of physician orders specific to the monitoring of the anticoagulation therapy. The LPN case Manager stated during an interview on 03/02/06 at 12:25 pm ," We as case managers do the orders. These are all canned orders." The Registered Nurse signing the POC acknowledged that it was his/her signature on the POC during an interview on 03/02/06 at approximately 12 Noon and stated, "I made a Mistake (leaving out specific orders for anticoagulation therapy). I just put in the numbers on the evaluation by the nurse. My number for that (pre-typed) order (for the non insulin diabetic orders) says something different than what was printed out on the POC. I made a mistake." (a) Further review of the clinical record documentation reveals that the patient received only 1 additional visit and was last seen by the agency nurse on 01/25/06. Continued review of the "Flow sheet" dated 01/25/06 at 12 Noon, reveals documentation, in part... “Believe PT (patient) had an episode of Atrial Fib. 4 am when patient became diaphoretic, very pale...symptoms resolved shortly. WNR (within normal range) at this time...Left chest wound from pacemaker placement sutures intact...also discussed diet with patient since patient not eating well....reported episode to MD. Seeing patient later today for blood work." Further review of the "Flow Sheet" reveals there is no evidence of a signature by the nurse. The LPN case manger acknowledged the documentation in the clinical record during an interview on 03/02/06 at 12:20 pm and stated," The patient was discharged on 01/25/06. There was no more skill in the home. The patient was non- compliant. I made the discharge sheet out now. On hindsight, the patient should not have been discharged. The nurse's note is not signed. It was an LPN. The DPS acknowledged the documentation in the clinical record during an interview on 03/02/06 between 12:15 pm and 12:25 pm and stated, "I agree the patient should not have been discharged. The nurse should have asked about the PT/INR (lab work) ." 51. Review of the clinical record for Patient #10 reveals that the patient was admitted to the. agency on 01/12/06 with diagnoses that included, in part, Cellulitis and Abscess Abdominal Wall and Insulin Dependent Diabetes. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 7 times a week for 4 weeks “wound care as ordered." There was no evidence of documentation on the POC of any specific orders for wound care. Continued review of the clinical record revealed documentation of a hospital physician's order dated 1/11/06 for, in part, W-D (wet to dry dressing) with packing daily." The physician ordering the dressing changes was not the 33 physician listed as the physician ordering the home care service. Further review of the clinical record reveals documentation that the registered nurse was performing dressing changes consisting cleansing the wound with normal saline and then packing the wound with Iodoform gauze as of 01/14/06 daily through 01/16/06, then as of 01/20/06 through 01/26/06 and again as of 01/31/06 through 02/03/06. The LPN was performing the wound care as ordered by the hospital physician on 01/17/06 through 01/19/06, then as of 01/28/06, 01/30/06 and 01/31/06. There was no further documentation contained in the clinical record. The patient was listed as being an active patient per the agency's list. The DPS acknowledged the clinical record documentation discrepancies during an interview on 03/02/06. 52. Based on the foregoing facts, High Tech Home Health, Inc. violated Section 400.487(2), Florida Statutes, herein classified as a Class I deficiency, which carries, in this case, an assessed fine of $5,000.00 and is also grounds for the imposition of a Moratorium on new admissions. COUNT V HIGH TECH HOME HEALTH INC. FAILED TO ENSURE THAT SKILLED NURSING SERVICES WERE COORDINATED EFFECTIVELY FOR 8 PATIENTS Section 400.487(6), Florida Statutes (PLAN OF CARE) CLASS I VIOLATION 54 53. AHCA re-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein, 54. During the complaint investigation (2006001388) and based on interview and clinical record review, it was determined the agency failed to ensure skilled nursing services were coordinated effectively for 8 of 10 sampled patients (Patient #1, #3, #4, $5, 6, #7, #8 and #10) resulting in placing the residents at imminent risk of death, disablement or permanent injury due to the Registered Nurse's lack of supervision for Patient #3 receiving multiple anticoagulants and requiring daily blood samples and subsequently the hospitalization of Patient #3, within a week of admission to the home health agency, with diagnosis of Coumadin toxicity and abdominal muscle hematoma. The patient died on 08/18/05. Final primary pathological diagnosis was of anticoagulation toxicity made by the medical examiner. The cumulative effect of these failures resulted in a crisis situation in which the health and safety of patients are at risk and places the residents at imminent risk of death, disablement or permanent injury. 55. Review of the clinical record for Patient 3 revealed documentation the patient was admitted to the agency on 08/07/05 with diagnoses inclusive of Closed Fracture of the Patella with Surgical Repair and Atrial Fibrillation. Continued review of the clinical record 55 revealed documentation of a signed physician home health certification and plan of care that stated in part ' SN evaluation +62 (visits) Lovenox (anticoagulant) img sc (subcutaneous) until therapeutic Daily PT/INR - (laboratory sample for determining anticoagulant effectiveness) . Continued review of the plan of care revealed that the patient was also taking Coumadin (anticoagulant) Smg by mouth daily. (a) Further review of the clinical record revealed documentation that the patient was seen by a Registered Nurse on 08/08/05 (10:30 am), with blood pressure at 126/76 and radial pulse at 76; Lovenox at 60mg was administered sc R abd (right abdomen). On 08/08/05 (PM), documentation by the Licensed Practical Nurse (LPN) revealed blood pressure to be 106/60 and pulse 64. The blood pressure continued to range between 106/60 to 126/76 until 08/13/05. On 08/13/05, the LPN saw the patient at 8 am and did not document a blood pressure. The radial pulse “is 66. There is a crossed out reading of 90/60 on this visit note. The LPN also saw the patient on 08/13/05 at 7 pm and has the blood pressure at 90/60 and the radial pulse was 68. The patient complained of pain to the abdomen on a pain scale of 6 and about the same for the knee. There is no evidence in the clinical record that vital sign information was communicated between the Registered Nurse and the LPN. 56 . 56. Review of the agency's policy for Coordination of Care revealed, in part, that the coordination of patient care shall be guided by written criteria in order to assure continuity of services. The policy further states that staff will maintain regular communication with other Agency staff members and the Supervisory Staff and that this will be accomplished through: (a) Daily verbal communication with the Supervisory Staff (b) Reporting significant changes in patient's medical condition verbally and communication documents. (c) Interdisciplinary communication documents. (ad) Interdisciplinary verbal communications. 57. Interview with the Director of Professional Services (DPS) on 02/27/05 at approximately 11:30 am revealed there is no written communication logs kept in the office and information is communicated verbally to the staff providing care. The DPS further stated that the staff is expected to document in their visit notes any communication to the office or with other staff members providing care to the patient. There was no evidence of documentation in the clinical record that the agency staff providing care to the patient had coordinated services effectively to ensure that the patient's blood level was therapeutic to prevent the risk of anticoagulation toxicity. 57 58. The nurse's documentation revealed a blood draw was performed by the RN on 08/09/05 and 08/11/05. There is no evidence communication between the two nurses visiting the patient regarding the lack of daily blood draws. Documentation in the nurses notes by the RN reveal daily communications with ".... CM" (case manager) regarding clarification of lab orders on 08/08/05, 08/09/05 and 08/10/05. On 08/11/05, the documentation reveals," ....CM states Tues (08/09/05) lab draw clotted: QOD (every other day) PT/INR." There is no evidence of documentation of a physician order to change the blood draw frequency to every other day. 59. Interview with the Director of Professional Services on 02/27/06 at approximately 11:30 am revealed that ....CM is an LPN and routinely gives instructions, including physician orders, verbally to the RN. Interview on 02/27/06 at approximately 11:45 am with the RN providing the care to the patient revealed verbal orders from physicians are routinely received verbally from the LPN case manager. The RN further stated although he/she was informed verbally of the daily PT/INR, there were no instructions in the patient's home to determine the frequency of the blood draws and that he/she had "nothing in writing." The RN continued to state during an interview on 02/27/06 at approximately 11:45 am that the laboratories that received specimens were 58 not open on the weekend, therefore, the orders needed to be clarified to reflect the lack of services. During a phone call placed by the surveyor on 02/27/05 to the laboratory used for this patient, a lab employee stated the lab is open at 3 locations on Saturdays from 8-12 pm. One of the locations was noted to be in the same city as Patient #3. 60. The RN documents on 08/11/05 "PT/INR drawn." There is no evidence a specimen was brought to the lab on 08/11/05 in the clinical record. Phone calls to the lab on 02/27/06 revealed that the only specimens from this patient were received on 08/09/05 and 08/16/05. Lovenox injections were administered as ordered twice daily in the patient's abdomen by the home health agency skilled nurses. The patient was admitted to the hospital on 08/14/05 with a diagnosis of Coumadin toxicity, abdominal rectus muscle hematoma, and an INR of 9.5. The INR therapeutic level is between 2 and 3. 61. Review of the clinical record of Patient #1 revealed documentation of a physician's signed Plan of Care (POC) for start of care 05/28/05 with diagnoses of DVT (deep vein thrombosis) and Atrial Fibrillation. Continued review of the POC revealed the patient is taking Coumadin "omg (an anticoagulant) daily. Further review of the clinical record reveals a physician's prescription dated 05/27/05 for 59 PT/INR lab work for anticoagulation therapy to be done on 05/28/05 with results to be called physician. (a) Continued review of the clinical record revealed a Comprehensive Assessment and OASIS data set which documented, in part, a blood sample was obtained on 06/01/05 by the Registered Nurse. Further review of the clinical record revealed no evidence of documentation that the Registered Nurse coordinated services and informed the physician that the blood was not drawn on 05/28/05 as ordered. 62. Review of the clinical record of Patient #4 revealed documentation of a physician's plan of care for start of care 01/17/06 with diagnoses of Osteoarthrosis, a Revised Hip Replacement, and an Open Wound of Hip and Thigh. Continued review of the clinical record revealed the patient was discharged from the hospital with medications inclusive of Coumadin 2.5mg daily. Review of the Physician Hospital Order Sheet on the home health agency clinical record reveal physician orders, from another physician not the physician who ordered the home care services, dated 01/14/06 for PT/INR Q am (lab test for Coumadin monitoring every morning) . There is no evidence of documentation in the clinical record that the Registered Nurse clarified whether the lab test should continue to be done daily or where the patient's lab work would be done. Interview with the LPN 60 "care coordinator" on 03/02/06 at 11:10 am revealed, "The patient must have gone to the doctor to have it (PT/INR) done. It's not a skill. I'll call the nurse to see if he/she checked on it." At 11:15AM, the LPN care manager stated "The nurse said...(patient) went to the doctor for his PT/INR." There was no evidence of documentation that the Registered Nurse coordinated the patient's care and informed the LPN care coordinator of these findings until 03/02/06. 63. Review of the clinical record of Patient #5 revealed documentation of a signed physician's plan of care for start of care 01/18/06 with diagnoses of Osteoarthrosis, Partial Hip Replacement, Leng term use of Anticoagulant, and Open wound of Knee. Although the plan of care documentation reveals’ a diagnosis of Partial Hip Replacement, further review of the clinical record revealed the patient was discharged from the hospital for Knee Replacement surgery. Continued review of the clinical record revealed the plan of care was approved and signed by the Registered Nurse and the Physician. Medications included Coumadin 7.5mg daily. The continue review of the clinical record, revealed orders for a PT/INR to be drawn on 01/19/06. According to the nursing note of 01/19/06, the Licensed Practical Nurse documented a blood draw of a PT/INR (used for Coumadin monitoring). The review of the 61 documentation of lab results performed on 01/19/06 revealed documentation of PTT (partial prothrombin time) (used to monitor patients taking heparin). The lab document is stamped as faxed on 01/20/06. There is no evidence of documentation in the clinical record identifying who reviewed the lab work and/or faxed the results to the physician. There is no evidence of documentation in the clinical record whether the Registered Nurse alerted the physician to the lab error, and how any further blood draws would be coordinated to ensure the patient's Coumadin levels were therapeutic. 64. Review of the clinical record of Patient #8 revealed documentation of a signed physician's plan of care dated 01/29/05 with diagnoses of Atrial fibrillation, Embolism and Thrombosis, and Debility. Review of the clinical record revealed a referral from the patient's insurance company with the words written "never received orders". Another document from the hospital case. management department, referring the patient, stated "Discharge Home with HHC (Home Health Care) ." There -is no evidence of documentation of signed verbal orders by the Registered Nurse for home health services. There is no evidence of documentation in the clinical record that orders for home care were clarified or requested by the Registered Nurse to the physician. Interview with the LPN care coordinator on 03/02/06 at 12:25PM who stated, "We as case managers do the orders. These are all canned orders." 65. Review of the clinical record for Patient 46 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Open Wound of Knee/Leg with Wound Debridement. Continued review of the clinical record documentation reveals a Registered Nurse and Physician signed plan of care for skilled nursing services evaluation and then daily to administer antibiotics intravenously and wound care every 3 days. Further review of the clinical record reveals "Physician's Verbal Orders" dated "1/9/06" which document, in part, CBC (complete blood count ) with diff (differential). “Vancomycin trough on 1/12/06 then every Thursday thereafter." The signature on the verbal orders is illegible. Continued review of the clinical record documentation reveals a physician's order from the pharmacy dated 02/02/06 to, in part,"... Pharmacy to adjust Vancomycin per Vancomycin levels..hold the vancomycin tonight. Start Vancomycin 13 grams IV ( changed dosage) daily on Saturday 02/04/06..draw new peak and trough levels Monday and weekly including CBC with diff and fax results to ....( another physician). There is no evidence of documentation that a physician signed these orders or that the physician ordering home care services was informed of the change in orders. 63 66. Further review of the clinical record revealed that the patient had blood drawn for the laboratory work on 01/26/06, 02/09/06, 02/16/06 and 02/23/06. The licensed Practical Nurse (LPN) case manager acknowledged the lack of physician orders for the lab work during an interview on 03/02/06 and stated, "I don't know why there were no labs on the POC (plan of care). I don't know whose signature that is (on the verbal order). It's standard procedure to draw labs. I don't have a document for the standard procedure, ask to (Director of Professional Services). I have a standard procedure for a dry dressing. 66. The Registered Nurse who signed the POC acknowledged that it was his/her signature on the POC and stated during an interview on 03/02/06 at 10:40 AM, "I don't ‘gee the orders for the labs (on the POC). I just sign the POC to get it to the doctor to go out to the physician. I don't get all the information to put the POC together. I just get the nurse's sign up evaluation." There was no evidence of documentation in the clinical record that agency staff had coordinated the patient's plan of care to reflect that the physician ordering the home care was aware of the blood laboratory work being drawn on the patient. 67. Review of the clinical record for Patient #7 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Atrial 64 Fibrillation with recent Pacemaker Placement and Non Insulin Dependent Diabetes Mellitus. Continued review of the clinical record documentation reveals a Registered Nurse signed plan of care (POC) for skilled nursing evaluation and 3 additional visits to, in part, "...Preparation and administration of insulin proper technique for drawing up insulin/ injection of insulin. Continued review of the Poc reveals that the patient is currently taking, in part, Coumadin (blood thinner) and Metformin (oral anti hypoglycemic). There was no evidence of documentation on the Poc that the patient was taking insulin. There was no evidence of documentation of physician orders specific to the monitoring of the anticoagulation therapy. The LPN case manager stated during an interview on 03/02/06 at 12:25 pm," We as case managers do the orders. These are all canned orders." 68. The Registered Nurse signing the POC acknowledged that it was his/her signature on the POC during an interview on 03/02/06 at approximately 12 Noon and stated, "I made a mistake (leaving out specific orders for anticoagulation therapy). I just put in the numbers (of pre-typed orders) on the evaluation by the nurse. My number for that order (for the non insulin diabetic orders) says something different than what was printed out on the POC. I made a mistake." 65 (a) Further review of the clinical vrecord documentation reveals that the patient received only 1 additional visit and was last seen by the agency nurse on 01/25/06. Continued review of the "Flow sheet" dated 01/25/06 at 12 Noon, reveals documentation, in part,..." Believe PT (patient) had an episode of Atrial Fib. 4 am when patient became diaphoretic, very pale...symptoms resolved shortly. WNR (within normal range) at this time...Left chest wound from pacemaker placement sutures intact...also discussed diet with patient since patient not eating well....reported episode to MD. Seeing patient later today for blood work." Further review of the "Flow Sheet" reveals there is no evidence of a signature by the nurse. The LPN case manger acknowledged the documentation in the clinical record during an interview on 03/02/06 at 12:20 pm and stated, “The patient was discharged on 01/25/06. There was no more skill in the home. The patient was non- compliant. I made the discharge sheet out now. On hindsight, the patient should not have been discharged. The nurse's note is not signed. It was an LPN”. The DPS acknowledged the documentation in the clinical record during an interview on 03/02/06 between 12:15 pm and 12:25 pm and stated, "I agree the patient should not have been discharged. The nurse should have asked about the PT/INR (lab work) ." There was no 66 evidence of documentation of liaison between agency staff to coordinate services effectively and safely to the patient. 69. Review of the clinical record for Patient #10 reveals that the patient was admitted to the agency on 01/12/06 with diagnoses that included, in part, cellulitis and abscess abdominal wall and insulin dependent diabetes. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 7 times a week for 4 weeks "wound care as ordered." There was no evidence of documentation on the POC of any specific orders for’ wound care. Continued review of the clinical record, revealed documentation of a hospital physician's order dated 1/11/06 for, in part, W-D (wet to dry dressing) with packing daily." The physician ordering the dressing changes was not the physician listed as the physician ordering the home care service. Further review of the clinical record reveals documentation that the registered nurse was performing dressing changes consisting of cleansing the wound with normal saline and then packing the wound with Iodoform gauze as of 01/14/06 daily through 01/16/06, then as of 01/20/06 through 01/26/06 and again as of 01/31/06 through 02/03/06. The LPN was performing the wound care as ordered by the hospital physician on 01/17/06 through 01/19/06, then as of 01/28/06, 01/30/06 and 01/31/06. There was no further 67 documentation contained in the clinical record. The patient was listed as being an active patient per the agency's list. There was no evidence of documentation of supervision by the registered nurse to coordinate the wound care. The DPS acknowledged the clinical record documentation during an interview on 03/02/06. There was no evidence of documentation of liaison between agency staff. 70. Based on the foregoing facts, High Tech Home Health, Inc. violated Section 400.487(6), Florida Statutes, herein classified as a Class I deficiency, which carries, in this case, an assessed fine of $5,000.00 and is also grounds for the imposition of a Moratorium on new admissions. COUNT VI HIGH TECH HOME HEALTH INC. FAILED TO DEVELOP A PLAN OF CARE, IN CONSULTATION WITH THE PHYSICIAN AND AGENCY STAFF CARING FOR THE PATIENT THAT WAS AVAILABLE FOR REVIEW BY ALI STAFF PROVIDING CARE TO THE PATIENT FOR 8 PATIENTS. Rule 59A-8.0215(1), Florida Administrative Code (PLAN OF CARE) CLASS I VIOLATION 71. AHCA e-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 72. During the complaint investigation (2006001388) and based on record review and interview, it was determined that the agency failed to develop a plan of care, in consultation with the physician and agency staff caring for the patient that was available for review by all staff 68 providing care to the patient for 8 of 10 sampled patients (Patient #1, #3, #4, #5, #6, #7, #8 and #10). The cumulative effect of these systemic problems and failures resulted in a crisis situation in which the health and safety of the agency's patients are at risk and placed the residents at imminent risk of death, disablement or permanent injury. 73. Review of the clinical record for Patient #3 revealed documentation the patient was admitted to the agency on 8/7/05 with diagnoses inclusive of Closed Fracture of the Patella with Surgical Repair and Atrial Fibrillation. Continued review of the clinical record revealed documentation of a signed physician home health certification and plan of care that stated in part ' SN eval +62 (visits) Lovenox (anticoagulant) img sc (subcutaneous) until therapeutic Daily PT/INR (laboratory sample for determining anticoagulant effectiveness). Continued review of the plan of care revealed that the patient was also taking Coumadin (anticoagulant) 5mqg by mouth daily. Review of the plan of care of Patient #3 dated 08/07/05 and signed by the Registered Nurse and the Physician revealed the patient's Nutritional requirements were identified as Regular/Cardiac. There is mo evidence of a dietary recommendations or ‘restrictions associated with anticoagulant therapy. Further review of the plan of care revealed the absence of orders for implementation of safety 69 measures to protect against injury while taking anticoagulants. 74. Review of the clinical record of Patient #1 revealed documentation of a physician's signed plan of care for start of care 05/28/05 with diagnoses of DVT (deep vein thrombosis) and Atrial Fibrillation taking Coumadin amg (an anticoagulant) daily. (a) Review of the plan of care of Patient #1 dated 05/28/05 and signed by the Registered Nurse and the Physician revealed the patient's Nutritional requirements were identified as Lo Na (low sodium). There is no evidence of a dietary recommendations or restrictions associated with anticoagulant therapy. Further review of the plan of care revealed the absence of orders for implementation of safety measures to protect against injury while taking anticoagulants. 75. Review of the clinical record of Patient #4 revealed documentation of a physician's plan of care for start of care 01/17/06 with diagnoses of Osteoarthrosis, a Revised Hip Replacement, and an Open Wound of Hip and Thigh. Purther review of the clinical record revealed the patient was discharged from the hospital with medications inclusive of Coumadin 2.5mg daily. There is no evidence of a dietary recommendations or restrictions associated with anti- coagulant therapy on the plan of care. Further review of 70 the plan of care revealed the absence of orders for implementation of safety measures to protect against injury while taking anticoagulants. There igs no indication on the plan of care how the patient's Coumadin level will be monitored. 76. Review of the clinical record of Patient #5 revealed documentation of a signed physician's plan of care for start of care 01/18/06 with diagnoses of Osteoarthrosis, Partial Hip Replacement, Long term use of Anticoagulant, and Open Wound of Knee. Although the plan of care documentation revealed a diagnosis of Partial Hip Replacement, further review of the clinical record revealed the patient was discharged from the hospital for a Knee Replacement Surgery. There was no evidence of a dietary recommendations or restrictions associated with the anticoagulant therapy that the patient is receiving. 77. Review of the clinical record of Patient #8 revealed documentation of a plan of care dated 01/29/05 with diagnoses of Atrial Fibrillation, Embolism and Thrombosis, and Debility. Review of the clinical record revealed a referral from the patient's insurance company with the words written "never received orders." Another document from the hospital case management department referring to the patient stated, "Discharge Home with HHC (home health care) ." There were no signed verbal orders by the Registered Nurse for 71 home health services. There is no evidence in the clinical’ record that orders for home care were clarified or requested by the Registered Nurse to the physician. Interview with the LPN care coordinator on 03/02/06 at 12:25 pm who stated, "We as case managers do the orders. These are all canned orders." There is no evidence the plan of care was developed in consultation with the physician. 78. Review of the clinical record for Patient #6 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Open Wound of Knee/Leg with Wound Debridement. Continued review of the clinical record documentation reveals a registered nurse and physician signed plan of care for skilled nursing services evaluation and daily visits to administer antibiotics intravenously and wound care every 3 days. Further review of the clinical record reveals "Physician's Verbal Orders" dated "1/9/06" which document, in part, CBC (complete blood count) with diff (differential). Vancomycin trough on 1/12/06 then every Thursday thereafter." The signature on the verbal orders is illegible. Continued review of the clinical record documentation reveals a "physician's order" from the pharmacy dated 02/02/06 to, in part,"... Pharmacy to adjust Vancomycin per Vancomycin levels..hold the Vancomycin tonight. Start Vancomycin 13 grams IV ( changed dosage) daily on Saturday 02/04/06..draw new peak and trough levels Monday and weekly including CBC with diff and fax results to ....(another physician). There is no evidence of documentation that a physician signed these orders or that the physician ordering home care services was informed of the change in orders. (a) Further review of the clinical record revealed that the patient had blood drawn for the laboratory work on 01/26/06, 02/09/06, 02/16/06 and 02/23/06. The Licensed Practical Nurse (LPN) case manager acknowledged the lack of physician orders for the lab work during an interview on 03/02/06 and stated, "I don't know why there were no labs on the POC (plan of care). I don’t know whose signature that is (on the verbal order). It's standard procedure to draw labs. I don't have a document for the standard procedure ask to (Director of Professional Services). I have a standard procedure for a dry dressing." The Registered Nurse who signed the POC acknowledged that it was his/her signature on the POC and stated during an interview on 03/02/06 at 10:40 am, "I don't see the orders for the labs (on the POC). I just sign the POC to get it to the doctor to go out to the physician. I don't get all the information to put the POC together. I just get the nurse's sign up evaluation." 79. Review of the clinical record for Patient #7 reveals that the patient was admitted to the agency on 73 01/21/06 with diagnoses that included, in part, Atrial Fibrillation with recent Pacemaker Placement and Non Insulin Dependent Diabetes Mellitus. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 3 additional visits to, in part, "...Preparation and administration of insulin proper technique for drawing up insulin/injection of insulin. Continued review of the Poc reveals that the patient is currently taking, in part, Coumadin (blood thinner) and Metformin (oral anti hypoglycemic) .There was no evidence of documentation on the PoC that the patient was taking “insulin. There was no evidence of documentation of physician orders specific to the monitoring of the anticoagulation therapy. The LPN case manager stated during an interview on 03/02/06 at 12:25 pm," We as case managers do the orders. These are all canned orders." The Registered Nurse signing the POC acknowledged that it was his/her signature on the POC during an interview on 03/02/06 at approximately 12 Noon and stated, "I made a mistake (leaving out specific orders for anticoagulation therapy). I just put in the numbers on the evaluation by the nurse. My number for that (pre-typed) order (for the non insulin diabetic orders) says something different than what was printed out on the POC. I made a mistake." 74 (a) Further review of the clinical record documentation reveals that the patient Yeceived only 1 additional visit and was last seen by the agency nurse on 01/25/06. Continued review of the "Flow sheet" dated 01/25/06 at 12 Noon, reveals documentation, in part,..." Believe PT (patient) had an episode of Atrial Fib. 4 am when patient became diaphoretic, very pale...symptoms resolved shortly. WNR (within normal range) at this time...Left chest wound from pacemaker ‘placement sutures intact...also discussed diet with patient since patient not eating well....reported episode to MD. Seeing patient later today for blood work." Further review of the "Flow Sheet" reveals there is no evidence of a signature by the nurse. The LPN case manger acknowledged the documentation in the clinical record during an interview on 03/02/06 at 12:20 pm and stated," The patient was discharged on 01/25/06. There was no more skill in the home. The patient was non- compliant. I made the discharge sheet out now. On hindsight, the patient should not have been discharged. The nurse's note is not signed. It was an LPN. The DPS acknowledged the documentation in the clinical record during an interview on 03/02/06 between 12:15 pm and 12:25 pm and stated, "I agree the patient should not have been discharged. The nurse should have asked about the PT/INR (lab work) ." 75 80. Review of the clinical record for Patient #10 reveals that the patient was admitted to the agency on 01/12/06 with diagnoses that included, in part, Cellulitis and Abscess Abdominal Wall and Insulin Dependent Diabetes. Continued review of the clinical record documentation reveals a registered nurse signed the plan of care (POC) for skilled nursing evaluation and 7 times a week for 4 weeks "wound care as ordered." There was no evidence of documentation on the POC of any specific orders for wound care. Continued review of the clinical record revealed documentation of a hospital physician's order dated 1/11/06 for, in part, W-D (wet to dry dressing) with packing daily." The physician ordering the dressing changes was not the physician listed as the physician ordering the home care service. Further review of the clinical record reveals documentation that the registered nurse was performing dressing changes consisting cleansing the wound with normal saline and then packing the wound with Iodoform gauze as of 01/14/06 daily through 01/16/06, then as of 01/20/06 through 01/26/06 and again as of 01/31/06 through 02/03/06. The LPN was performing the wound care as ordered by the hospital physician on 01/17/06 through 01/19/06, then as of 01/28/06, 01/30/06 and 01/31/06. There was no further documentation contained in the clinical record. The patient was listed as being an active patient per the agency's list. The DPS 76 acknowledged the clinical record documentation discrepancies during an interview on 03/02/06. 80. Based on the foregoing facts, High Tech Home Health, Ine. violated Rule 59A-8.0215(1), Florida Administrative Code, herein classified as a Class I deficiency, which carries, in this case, an assessed fine of $5,000.00 and is also grounds for the imposition of a Moratorium on new admission. COUNT VII HIGH TECH HOME HEALTH INC. FAILED TO ENSURE THAT CLINICAL RECORDS CONTAINED CURRENT AND PAST CLINICAL DATA TO REFLECT EFFECTIVE INTERCHANGE, REPORTING, MINUTES OF CARE CONFERENCES, AND COORDINATION OF PATIENT CARE FOR SKILLED NURSING SERVICES FOR 8 PATIENTS. Section 400.491(1), Florida Statutes (CLINICAL RECORDS) CLASS I VIOLATION 81. AHCA re-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 82. During the complaint investigation (2006001388) and based on interview, observation and clinical record review, it was determined the agency failed to ensure the clinical record contained current and past clinical data to reflect effective interchange, reporting, minutes of case conferences, and coordination of patient care for skilled nursing services for 8 of 10 sampled patients (Patient #1, #3, #4, $5, #6, #7, #8 and #10) resulting in placing the residents at imminent risk of death, disablement or 77 permanent injury due to the Registered Nurse's lack of supervision for Patient #3 receiving multiple anticoagulants and requiring daily blood samples and subsequently the hospitalization of Patient #3, within a week of admission to the home health agency, with diagnosis of Coumadin toxicity and abdominal muscle hematoma. The patient died on 08/18/05. Final primary pathological diagnosis of anticoagulation toxicity was made by the medical examiner. The cumulative effect of these failures resulted in a crisis situation in which the residents are placed at imminent risk of death, disablement or permanent injury. 83. Observation on 03/02/06 at 10:20 am, accompanied by the Director of Professional Services and another surveyor, revealed two medical records personnel filing documents in the medical records room. Further observation revealed multiple large stacks of documents with the top of one being a nurse's "flow sheet" dated 01/02/06. During an interview with the medical records clerk on 03/02/06 at 10:20 am, the medical records clerk stated that medical records was, “one week behind in filing" but "for large groups, HMO's we are two months to one week behind in filing." 84. Review of the clinical record for Patient #3 revealed documentation that the patient was admitted to the agency on 08/07/05 with diagnoses inclusive of Closed 78 Fracture of the Patella with Surgical Repair and Atrial Fibrillation. Continued review of the clinical record revealed documentation of a signed physician home health certification and plan of care that stated in part, “SN evaluation +62 (visits) Lovenox (anticoagulant) img se (subcutaneous) until therapeutic Daily PT/INR (laboratory sample for determining anticoagulant effectiveness) . Continued review of the plan of care revealed that the patient was also taking Coumadin (anticoagulant) 5mg by mouth daily. (a) Further review of the clinical record revealed documentation that the patient was seen by a Registered Nurse on 08/08/05 (10:30 am), with blood pressure at 126/76 and radial pulse at 76; Lovenox at 60mq was administered sc R abd (right abdomen). On 08/08/05 (PM), documentation by the Licensed Practical Nurse (LPN) revealed blood pressure to be 106/60 and pulse 64. The blood pressure continued to range between 106/60 to 126/76 until 08/13/05. On 80/13/05, the LPN saw the patient at 8AM and did not document a blood pressure. The radial pulse is 66. There is a crossed out reading of 90/60 on this visit note. The LPN also saw the patient on 08/13/05 at 7PM and has the blood pressure at 90/60 and the radial pulse was 68. The patient complained of pain to the abdomen on a pain scale of 6 and about the same for the knee. There is no 79 evidence in the clinical record that vital sign information was communicated between the Registered Nurse and the LPN. Review of the agency's policy for Coordination of Care revealed, in part, that the coordination of patient care shall be guided by written criteria in order to assure continuity of services. The policy further states that staff will maintain regular communication with other Agency staff members and the Supervisory Staff and that this will be accomplished through: a. Daily verbal communication with the Supervisory Staff. b. Reporting significant . changes in patient's medical condition verbally and communication documents. c. Interdisciplinary comminication documents. d. Interdisciplinary verbal communications. 85. Interview with the Director of Professional Services (DPS) on 02/27/05 at approximately 11:30 am revealed there is no written communication logs kept in the office and information is communicated verbally to the staff providing care. The DPS further stated that the staff is expected to document in their visit notes any communication to the office or with other staff members providing care to the patient. There was no evidence of documentation in the clinical record that the agency staff providing care to the patient had coordinated services effectively to ensure that 80 the patient's blood level was therapeutic to prevent the risk of anticoagulation toxicity. 86. The nurse's documentation revealed a blood draw was performed by the RN on 08/09/05 and 08/11/05. There is no evidence of communication between the two nurses visiting the patient regarding the lack of daily blood draws. Documentation in the nurses notes by the RN reveal daily communications with ".... CM" (case manager) regarding clarification of lab orders on 08/08/05, 08/09/05 and 08/10/05. On 08/11/05, the documentation reveals," ....CM states Tues (08/09/05) lab draw clotted: QoD (every other day) PT/INR." There is no evidence of documentation of a physician order to change the blood draw frequency to every other day. 87. Interview with the Director of Professional Services on 02/27/06 at approximately 11:30 am revealed that -...-CM is an LPN and routinely gives instructions, including physician orders, verbally to the RN. Interview on 02/27/06 at approximately 11:45 am with the RN providing the care to the patient revealed verbal orders from physicians are routinely received verbally from the LPN case manager. The RN further stated although he/she was informed verbally of the daily PT/INR, there were no instructions in the patient's home to determine the frequency of the blood draws and that he/she had "nothing in writing." The RN continued 81 to state during an interview on 02/27/06 at approximately 11:45 am that the laboratories that received specimens were not open on the weekend, therefore, the orders needed to be clarified to reflect the lack of services. During a phone call placed by the surveyor on 02/27/05 to the laboratory used for this patient, a lab employee stated the lab is open at 3 locations on Saturdays from 8-12 pm. One of the locations was noted to be in the same city as Patient #3. The RN documents on 08/11/05 "PT/INR drawn." There is no evidence a specimen was brought to the lab on 08/11/05 in the clinical record. Phone calls to the lab on 02/27/06 revealed that the only specimens from this patient were received on 08/09/05 and 08/16/05. Lovenox injections were administered as ordered twice daily in the patient's abdomen by the home health agency skilled nurses. The patient was admitted to the hospital on 08/14/05 with a diagnosis of Coumadin toxicity, abdominal rectus muscle hematoma, and an INR of 9.5. The INR therapeutic level is between 2 and 3. 88. Review of the clinical record of Patient #1 revealed documentation of a physician's signed Plan of Care ( POC) for start of care 05/28/05 with diagnoses of DVT (deep vein thrombosis) and Atrial Fibrillation. Continued review of the POC revealed the patient is taking Coumadin 2mg (an anticoagulant) daily. Further review of the clinical record reveals a physician's prescription dated 05/27/05 for PT/INR lab work for anticoagulation therapy to be done on 05/28/05 with results to be called physician. (a) Continued review of the clinical record revealed a Comprehensive Assessment and OASIS data set which documented, in part, a blood sample was obtained on 06/01/05 by the Registered Nurse. Further review of the clinical record revealed no evidence of documentation that the Registered Nurse coordinated services and informed the physician that the blood was not drawn on 05/28/05 as ordered. 89. Review of the clinical record of Patient #4 revealed documentation of a physician's plan of care for start of care 01/17/06 with diagnoses of Osteoarthrosis, a Revised Hip Replacement, and an Open Wound of Hip and Thigh. Continued review of the clinical record revealed the patient was discharged from the hospital with medications inclusive of Coumadin 2.5mg daily. Review of the Physician Hospital Order Sheet on the home health agency clinical record reveal physician orders, from another physician not the physician who ordered the home care services, dated 01/14/06 for PT/INR Q am (lab test for Coumadin monitoring every morning) . There is no evidence of documentation in the clinical record that the Registered Nurse clarified whether the lab test should continue to be done daily or where the patient's lab work would be done. Interview with the LPN 83 "Care coordinator" on 03/02/06 at 11:10 am revealed, "The patient must have gone to the doctor to have it (PT/INR) done. It's not a skill. I'll call the nurse to see if he/she checked on it." At 11:15 am, the LPN care manager stated "The nurse said...(patient) went to the doctor for his PT/INR." There was no evidence of documentation that the Registered Nurse coordinated the patient's care and informed the LPN care coordinator of these findings until 03/02/06. 90. Review of the clinical record of Patient #5 revealed documentation of a signed physician's plan of care for start of care 01/18/06 with diagnoses of Osteoarthrosis, Partial Hip Replacement, Long term use of Anticoagulant, and Open wound of Knee. Although the plan of care documentation reveals a diagnosis of Partial Hip Replacement, further review of the clinical record revealed the patient was discharged from the hospital for Knee Replacement surgery. Continued review of the clinical record revealed the plan of care was approved and signed by the Registered Nurse and the Physician. Medications included Coumadin 7.5mg daily. Continue review of the clinical record reveal orders for a PT/INR to be drawn on 01/19/06. According to the nursing note of 01/19/06, the Licensed Practical Nurse documented a blood draw of a PT/INR (used for Coumadin monitoring) . Review of the documentation of lab results performed on 84 01/19/06 revealed documentation of PTT (partial prothrombin time) (used to monitor patients taking heparin). The lab document is stamped as faxed on 01/20/06. There is no evidence of documentation in the clinical record identifying: who reviewed the lab work and/or faxed the results to the physician. There is no evidence of documentation in the clinical record whether the Registered Nurse alerted the physician to the Lab error, and how any further blood draws would be coordinated to ensure the patient's Coumadin levels were therapeutic. 91. Review of the clinical record of Patient #8 revealed documentation of a signed physician's plan of care dated 01/29/05 with diagnoses of Atrial fibrillation, Embolism and Thrombosis, and Debility. Review of the clinical record revealed a referral from the patient's insurance company with the words written "never received orders". Another document from the hospital case management department, referring the patient, stated "Discharge Home with HHC (Home Health Care)." There is no evidence of documentation of signed verbal orders by the Registered Nurse for home health services. There is no evidence of documentation in the clinical record that orders for home care were clarified or requested by the Registered Nurse to the physician. Interview with the LPN care coordinator on 85 03/02/06 at 12:25PM who stated, "We as case managers do the orders. These are all canned orders." 92. “Review of the clinical record for Patient #6 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Open Wound of Knee/Leg with Wound Debridement. Continued review of the clinical record documentation reveals a Registered Nurse and Physician signed plan of care for skilled nursing services evaluation and then daily to administer antibiotics intravenously and wound care every 3 days. Further review of the clinical record reveals "Physician's Verbal Orders" dated "1/9/06" which document, in part, CBC (complete blood count) with diff (differential). Vancomycin trough 1/12/06 then, every Thursday thereafter." The signature on the verbal orders is illegible. Continued review of the clinical record documentation reveals a physician's order from the pharmacy dated 02/02/06 to, in part,"... Pharmacy to adjust Vancomycin per Vancomycin levels hold the Vancomycin tonight. Start Vancomycin 13 grams Iv (changed dosage) daily on Saturday 02/04/06..draw new peak and trough levels Monday and weekly including CBC with diff and fax results to . (another physician). There ig no evidence of documentation that a physician signed these orders or that the physician ordering home care services was informed of the change in orders. 86 (a) Further review of the clinical record revealed that the patient had blood drawn for the laboratory work on 01/26/06, 02/09/06, 02/16/06 and 02/23/06. The Licensed Practical Nurse (LPN) case manager acknowledged the lack of physician orders for the lab work during an interview on 03/02/06 and stated, "I don't know why there were no labs on the POC (plan of care). I don't know whose signature that is (on the verbal order). It's standard procedure to draw labs. I don't have a document for the standard procedure, ask the (Director of Professional Services). I have a standard procedure for a dry dressing. The Registered Nurse who signed the POC acknowledged that it was his/her signature on the POC and stated during an interview on 03/02/06 at 10:40 am, "I don't see the orders for the labs (on the POC). I just sign the PoC to get it to the doctor to go out to the physician. I don't get all the information to put the POC together. I just get the nurse's sign up evaluation." There was no evidence of documentation in the clinical record that agency staff had coordinated the patient's plan of care to reflect that the physician ordering the home care was aware of the blood laboratory work being drawn on the patient. 93. Review of the clinical record for Patient #7 reveals that the patient was admitted to the agency on 01/21/06 with diagnoses that included, in part, Atrial 87 Fibrillation with recent Pacemaker Placement and Non Insulin Dependent Diabetes Mellitus. Continued review of the clinical record documentation reveals a Registered Nurse signed plan of care (PoC) for skilled nursing evaluation and 3 additional visits to, in part, "...Preparation and administration of insulin proper technique for drawing up insulin/ injection of insulin. Continued review of the PoC reveals that the patient is currently taking, in part, Coumadin (blood thinner) and Metformin (oral anti hypoglycemic) .There was no evidence of documentation on the Poc that the patient was taking insulin. There was no evidence of documentation of physician orders specific to the monitoring of the anticoagulation therapy. The LPN case manager stated during an interview on 03/02/06 at 12:25 pm," We as case managers do the orders. These are all canned orders." 94. The Registered Nurse signing the POC acknowledged that it was his/her signature on the POC during an interview on 03/02/06 at approximately 12 Noon and stated, "I made a mistake (leaving out specific orders for anticoagulation therapy). I just put in the numbers (of pre-typed orders) on the evaluation by the nurse. My number for that order (for the non insulin diabetic orders) says something different than what was printed out on the POC. I made a mistake." 88 (a) Further review of the clinical record documentation reveals that the patient received only 1 additional visit and was last seen by the agency nurse on 01/25/06. Continued review of the "Flow sheet" dated 01/25/06 at 12 Noon, reveals documentation, in part,..." Believe PT (patient) had an episode of Atrial Fib. 4 am when patient became diaphoretic, very pale...symptoms resolved shortly. WNR (within normal range) at this time...Left chest wound from pacemaker placement sutures intact...also discussed diet with patient since patient not eating well....reported episode to MD. Seeing patient later today for blood work." Further review of the "Flow Sheet" reveals there is no evidence of a signature by the nurse. The LPN case manger acknowledged the documentation in the clinical record during an interview on 03/02/06 at 12:20 pm and stated," The patient was discharged on 01/25/06. There was no more skill in the home. The patient was non-compliant. I made the discharge sheet out now. On hindsight, the patient should not have been discharged. The nurse's note is not signed. It was an LPN. The DPS acknowledged the documentation in the clinical record during an interview on 03/02/06 between 12:15 pm and 12:2pmPM and stated, "I agree the patient should not have been discharged. The nurse should have asked about the PT/INR (lab work)." There was no 89 evidence of documentation of liaison between agency staff to coordinate services effectively and safely to the patient. 95. Review of the clinical record for Patient #10 reveals that the patient was admitted to the agency on 01/12/06 with diagnoses that included, in part, cellulitis and abscess abdominal wall and insulin dependent diabetes. Continued review of the clinical record documentation reveals a registered nurse signed plan of care (POC) for skilled nursing evaluation and 7 times a week for 4 weeks "wound care as ordered." There was no evidence of documentation on the POC of any specific orders for wound care. Continued review of the clinical record revealed documentation of a hospital physician's order dated 1/11/06 for, in part, W-D (wet to dry dressing) with packing daily." The physician ordering the dressing changes was not the physician listed as the physician ordering the home care service. Further review of the clinical record reveals documentation that the registered nurse was performing dressing changes consisting cleansing the wound with normal saline and then packing the wound with Iodoform gauze as of 01/14/06 daily through 01/16/06, then as of 01/20/06 through 01/26/06 and again as of 01/31/06 through 02/03/06. The LPN was performing the wound care as ordered by the hospital physician on 01/17/06 through 01/19/06, then as of 01/28/06, 01/30/06 and 01/31/06. There was no further documentation 90 contained in the clinical record. The patient was listed as being an active patient per the agency's list. There was no evidence of documentation of supervision by the registered nurse to coordinate the wound care. The DPS acknowledged the clinical record documentation during an interview on 03/02/06. There was no evidence of documentation of liaison between agency staff. 96. Based on the foregoing facts, High Tech Home Health, Inc. violated Section 400.491(1), Florida Statutes, herein classified as a Class I deficiency, which carries, in this case, an assessed fine of $5,000.00 and is also grounds for the imposition of a Moratorium on new admissions. CLAIM FOR RELIEF WHEREFORE, the Agency requests the Court to order the following relief: 1. Enter a judgment in favor of the Agency for Health Care Administration against High Tech Home Health, Inc. on Counts I through VII. 2. Assess against High Tech Home Health, Inc. an administrative fine of $35,000.00 on Counts I through VII, and a Moratorium on new admissions for the violations cited above. 3. Assess costs related to the investigation and prosecution of this matter, if applicable. 91 4. Grant such other relief as the court deems is just and proper on Counts I through VII. Respondent is notified that it has a right to request an administrative hearing pursuant to Sections 120.569 and 120.57, Florida Statutes. 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 the Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, MS #3, Tallahassee, Florida 32308. RESPONDENT IS FURTHER NOTIFIED THAT THE FAILURE TO RECEIVE A REQUEST FOR A HEARING WITHIN TWENTY-ONE (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. Nelson E. Rodney, Es, Assistant General Counsel Agency for Health Care Administration 8355 N.W. 52 Terrace - #103 Miami, Florida 33166 Copies furnished to: Diane Reiland Field Office Manager Agency for Health Care Administration 1710 Bast tiffany Drive, Suite 100 West Palm Beach, Florida 3407 (Interoffice Mail) Jean Lombardi Finance and Accounting Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 (Interoffice Mail) Home Health Agency Unit Program Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 (Interoffice Mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished by U.S. Certified Mail, Return Receipt Requested to Mimi K. larkin, Administrator, High Tech Home Health Inc. 4360 North Lake Boulevard, Suite #214, Palm Beach Garden, Florida 33410, and to Mimi K. Larkin, Registered Agent, 1 Sheldrake Lane, Palm Beach Gardens, Florida 33418 on this 15 aay of Mach , 2006. Moo 93

Docket for Case No: 06-001583