STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. . Case No. 2011006275 GALENCARE, INC., d/b/a NORTHSIDE HOSPITAL, . Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW the Petitioner, the State of Florida’s Agency For Health Care Administration (“the Agency”), and files this administrative complaint against the Respondent, Galencare, ‘Inc., d/b/a Northside Hospital (the “Respondent” or “Respondent: Facility”), pursuant to Sections 120.569 and 120.57, Florida Statutes, and alleges as follows: NATURE OF THE ACTION This is an action to impose an administrative fine against a hospital in the amount of fourteen thousand dollars ($14,000.00) pursuant to Section 395.1065, Florida Statutes. JURISDICTION AND VENUE Le: The Agency has jurisdiction over the Respondent pursuant to Sections 20.42 and 120.60, Florida Statutes, Chapters 408, Parts I and II, and 395, Part I, Florida Statutes, and Chapter 59A-3, Plorida Administrative Code. Page 1 of 14 Filed July 12, 2011 1:03 PM Division of Administrative Hearings i i i | ' i | | | | 2. Venue lies pursuant to Rule 28-106.207, Florida Adihinistrative Code. PARTIES 3, The Agency licenses and regulates hospitals in Florida and enforces the applicable federal and state regulations and statutes governing hospitals pursuant to Chapter 408, Parts I and II, Florida Statutes, Chapter 395, Part I, Florida Statutes, -and Chapter 59A-3, Florida Administrative Code. The Agency may deny, revoke, suspend a license, or impose an administrative fine against a hospital, for the violation of any provision of Chapter 395, Part I, Florida Statutes, or any rule adopted under that chapter. 4. the Respondent was issued a license by the Agency to operate a’ 288-bed hospital, ‘license number 4224, located at 6000 Forty-Ninth Street, North, St. Petersburg, Florida 33709. 5. At all times material to the allegations of this complaint, Respondent was required to comply with all applicable federal and state regulations and statutes. - COUNT I HO0120 6. The Agency: re-alleges and incorporates by reference paragraphs 1 through 5. 7. Rule 59A-3,.2085(5), Florida Administrative Code, requires: (5) Nursing Service. Each hospital shall be organized and staffed to provide quality nursing care to each Page 2 of 14 patient. ... (a) Each hospital shall document the relationship of the nursing department to other units of the hospital by an organizational chart, and each nursing department shall have a written organizational plan that delineates lines of authority, accountability and communication. The nursing department shall assure that the following nursing management functions are fulfilled: 1. Review and approval of policies and procedures that relate to qualifications and employment of nurses. 2. Establishment of standards for nursing care and mechanisms for evaluating such care. 3. Implementing approved policies of the nursing department. 4. Assuring that a written evaluation is made of the performance of registered nurses and ancillary nursing personnel at the end of any probationary period and at a defined interval thereafter. 5. Each hospital shall employ a registered nurse on a full time basis who shall have the authority and responsibility for managing nursing services and taking all reasonable steps to assure that a uniformly optimal level of nursing care is provided throughout the hospital. (d) Each hospital shall develop written standards of nursing practice and related policies and procedures to define and describe the scope and conduct of patient care provided by the nursing staff. These policies and procedures shall be reviewed at least annually, revised as necessary, dated to indicate the time of the last review, signed by the responsible reviewing authority, and enforced. {e) The nursing process of assessment, planning, intervention and evaluation shall be documented. for each hospitalized patient from admission through discharge. 1. Each patient’s nursing needs shall be assessed by a registered nurse at the time of admission or within the period established by each facility’s policy. 2. Nursing goals shail be consistent with the therapy prescribed by the responsible medical practitioner. 3. Nursing intervention and patient response, and patient status on discharge from the hospital, must be noted on the medical record. (f) A sufficient number of qualified registered nurses shall be on duty at all times to give patients the Page 3 of 14 nursing care that requires the judgment and specialized skills of a registered nurse, and shall be sufficient to ensure immediate availability of a registered nurse for bedside care of any patient when needed, to assure prompt recognition of an untoward change in a patient’s condition, and to facilitate appropriate intervention by nursing, medical or other hospital staff members. (g) Each Class I and Class II hospital shall have at least one licensed registered nurse on duty at all times on each floor or similarly titled part of the hospital for rendering patient care services. 8. On May 17, 2011, the Agency conducted a complaint survey of the Respondent Facility. 9. Based on the Agency’s surveyor’s observations, review of Respondent's records and interviews with Respondent’ s personnel, the Agency’s surveyors concluded that Respondent failed to implement nursing goals consistent with the therapy prescribed by each patient’s responsible medical practitioner, as set forth in the physician’s plan of care, for 13 of the 19 patients whose care by Respondent was reviewed - Patients #1, #2, #3, #6, #7, #8, #9, #10, #11, #12, #14, #15, and #16. 10. Patient #8 was admitted to the Respondent facility on 3/12/11 with the diagnosis of renal failure. Review of consulting nephrologist orders revealed an order for daily weights on 3/13/11. Review of nursing documentation revealed that Patient #8's daily weight was not recorded from 3/16/11 through 3/21/11 and on 3/23/11 and 3/24/11. 11. The Director of Quality confirmed the lack of documentation of Patient #8’s weight, during an interview with Page 4 of 14 the Agency’s surveyors on 5/17/11 at approximately 11:00 a.m. 12. Patient #15 was admitted to the Respondent facility on 5/16/11 with the diagnosis of Ischemic Stroke. A review of the physicians’ orders dated 5/16/11 at 2:50 p.m. revealed an order , to lavage, wash out, the right ear. The Agency’s surveyor’s review of a progress note dated 5/17/11 at 10:30 a.m. noted "floor staff did not lavage ear as ordered.” 13, An interview was conducted on 5/17/11 at approximately 11:30 a.m. with unit charge nurse during the review of Patient #15’s clinical record. When questioned why the lavage had not been done, the charge nurse stated the order needed to be clarified as to what solution to use. There was no documentation in the clinical record stating why the lavage was not done, or that the physician had been notified to clarify the order. . 14: Patient #1 was admitted to the Respondent facility with mild diverticulitis, inflammation of the diverticula or -small outpouchings along the wall of the colon, and renal insufficiency. 15. Patient #1’s physician's ordered an antineutrophil cytoplasmic antibody (“ANCA”) test to be done. Review of the medical record revealed an ANNA test, to detect autoimmune diseases, was performed instead of the ANCA that was ordered. 16. Patient #2 was admitted to the Respondent facility on Page 5 of 14 Ne ~~ 12/30/10 with the diagnosis of patent foramen ovale, a defect in the wall between the heart's two upper chambers that can allow unfiltered.blood to bypass the lungs and circulate through the body. The Agency’s surveyor’s review of physicians’ orders showed an order for a random urinary sodium test to be done on 1/4/11. However, the Agency's surveyor’s review of laboratory results revealed no evidence that the test had been performed. 17. Patient #3 was admitted to the Respondent facility on 1/4/11 with the diagnosis of chronic renal insufficiency. The Agency’s surveyor’s review of physicians’ orders revealed an ‘order for a urinalysis with microscopic examination and an ionized calcium test on 1/22/11. The Agency’s surveyor’s review of laboratory results revealed no documentation that the test had been performed. 18, Patient #6 was admitted to the Respondent facility on 1/31/11 with the diagnosis of acute renal insufficiency. Réview of the medical record revealed an order for ionized calcium on 2/1/11. The Agency’s surveyor’s review of the laboratory results for Patient #6 revealed no documentation that the test was performed. 19. Patient #7 was admitted to the Respondent facility with the diagnosis of hematuria, blood in the urine. The Agency’s surveyor’s review of physicians’ orders for Patient #7 revealed an order for a urinalysis with microscopic examination Page 6 of 14 and a random urinary sodium and creatinine testing. However, the Agency’s surveyor’s review of the laboratory results for Patient #7 revealed that the tests had not been performed. 20. Patient #9 was admitted to the Respondent facility on 3/9/11 with the diagnosis of alcohol abuse and chronic obstructive pulmonary disease. The Agency’s surveyor’s review of physicians’ orders revealed that Respondent wag instructed to repeat the urinalysis with a random urinary sodium, creatinine and potassium testing. However, the Agency’s surveyor’ 8 review of the laboratory results for Patient #9 revealed there was no documentation that the tests had been performed. ) 21. Patient #10 was admitted to the Respondent facility on 3/18/11. The Agency’s surveyor’s review of physicians’ orders dated 3/22/11 at 8:30 p.m. reveal that Respondent was instructed to perform a potasium and-magnesium testing “tonight.” However, the Agency’s surveyor’s review of the laboratory result for Patient #10 revealed that the potassium and magnesium testing were not done on 3/22/11 as ordered, 22. Patient #11 was admitted to the Respondent facility on 3/29/11 with the diagnosis of renal insufficiency. The Agency's surveyor’ s review of physicians’ orders revealed an order to obtain a repeat urinalysis with microscopic examination on 4/4/11. However, the Agency’s surveyor’s review of laboratory results for Patient #11 revealed no documentation that the test Page 7 of 14 had been performed, 23. Patient #12 was admitted to the Respondent facility on 3/11/11. The Agency's surveyor’s review of physicians’ orders for Patient #12 revealed an order for a random urinary sodium and creatinine testing on 3/19/11 at 9:00 p.m. However, the Agency’s surveyor’s review of the laboratory results revealed no documentation that the testing had been performed. 24. Patient #14 was admitted to the Respondent facility on 5/10/11. The Agency's surveyor’ s review of physicians’ orders dated 5/10/11 revealed an order which instructed Respondent to obtain a urinalysis with culture and sensitivity on 5/10/11. Review of the laboratory results revealed no documentation that the test was completed. 25. Patient #16's past medical history included dialysis and end-stage renal disease. Physician's orders for Patient #16 dated 5/15/11 at 4:15 p.m. revealed an order that Respondent ‘take daily weights, test serum phosphorus on blood already in lab ~ this purported to be a 2™ order, initially ordered on 5/14/11 - and perform an ionized calcium testing. Review of the nursing documentation revealed the daily weights were not started until 5/17/11, 2 days after the order was written. Review of physician's orders for 5/14/11 revealed no order for a serum phosphorous written on that date, but Respondent’s records contained no documentation of an attempt to clarify this Page 8 of 14 discrepancy. 26. The Agency’ s surveyor’s interview with the nurse involved with Patient #16's care was conducted on 5/17/11 at approximately 4:30 p.m, The nurse stated he had received a telephone order from the physician for the serum phosphorous, but was busy and failed to write the order. 27, The Agency’s surveyor conducted a review of the laboratory results on 5/17/11 with Respondent’s Quality Manager seeking the ionized calcium results for Patient #16. The Quality Manager was unable to locate the results of the ionized calcium testing. An interview was conducted on 5/17/11 at approximately 2:00 p.m. with Respondent’s Charge Nurse, after thorough review of the clinical record, the Agency’s surveyor’s findings of no order and no testing were confirmed. 28. During interview with the Agency’s surveyors on 5/17/11 at approximately 6:00 p.m., the Director of Quality Management confirmed no evidence: could be found related to the above findings as to Patients #1, #2, #3, #6, #7, #8, #9, #10, #11, #12, #14, #15, and #16. 29, The above recited facts show that Respondent violated Rule 59A-3.2085, Florida Administrative Code, by failing to implement nursing goals consistent with the therapy prescribed by each patient’s responsible medical practitioner, as set forth in the physician’s plan of care, for 13 of the 19 patients whose Page 9 of 14 care by Respondent was reviewed. 30. The above cited deficiencies subject the Respondent Facility to the imposition of an administrative penalty in a sum not to exceed one thousand dollars ($1,000.00) per violation per day. § 395,1065(2) (a) Florida Statutes. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, requests that this tribunal impose an administrative fine against the Respondent in the total amount of $13,000.00, or such other relief as this tribunal deems just. COUNT Ti HO094 31. The Agency re-alleges and incorporates by reference paragraphs 1 through 5, 32. Rule 59A-3.2085(2), Florida Administrative Code, requires: (2) Pharmacy. Each hospital shall develop and monitor procedures to assure the proper use of medications. Such procedures shall address prescription and ordering, preparation and dispensing, administration, and patient monitoring for medication effects. For purposes of providing medication services, each Class I and Class II hospital shall have on the premises, and each Class III hospital shall have on the premises or by contract, a pharmacy, pharmaceutical department or service, or similarly titled unit, and, when applicable, shall present evidence that it holds a current institutional or community pharmacy permit under the provisions of the Florida Pharmacy Act, Chapter 465, F.S. (e) The pharmacist shall review each order before dispensing the medication, with the exception of situations in which a licensed independent practitioner Page 10 of 14 aed ~~ with appropriate clinical privileges controls : prescription ordering, preparation and administration of medicine. The pharmacist shall verify the order with the prescriber when there is a question. (f) All medications shall be prepared and dispensed consistent with applicable law and rules governing professional licensure and pharmacy operation and in accordance with professional standards of pharmacy practice. (g) A medication profile shall be developed and Maintained by the pharmacy department for each patient and shall be available to staff responsible for the patient's care. The medication profile shall include. at least the name, birth date, sex, pertinent health problems and diagnoses, current medication therapy, medication allergies or sensitivities, and potential drug or food interactions. (h) The hospital shall develop and implement a process for providing medications when the pharmacy is closed that ensures adequate control, accountability, and the, appropriate use of medications. (i) The hospital shall ensure there is an adequate and proper supply of emergency drugs within the pharmacy and in designated areas of the hospital. (j) Receipt, distribution and administration of controlled drugs are documented by the pharmacy, nursing service and other personnel, to ensure adequate control and accountability. in accordance with state and federal law. (k). The hospital shall ensure that the administration of drugs shall take place in accordance with written policies, approved by the professional staff and designed to ensure that all medications are administered safely and efficiently. (1) Each hospital’s pharmacy shall be directed by a licensed pharmacist, who may supervise satellite pharmacies, and who may be hired ona contract basis. The director of the hospital pharmacy, or other licensed pharmacists who are properly designated, shall be available to the hospital at all times, whether on duty or on call. (m) Administration of drugs shall be undertaken only upon the orders of authorized members of the professional staff, where the orders are verified before administration, the patient is identified, and the dosage and medication is noted in the patient’s chart or medical record. Page 11 of 14 aed ~~ 33. On May 17, 2011, the Agency conducted a complaint survey of the Respondent Facility. 34. Based on the Agency’s surveyor’s observations, review of Respondent's records and interviews with Respondent’s personnel, the Respondent failed to administer medications as ordered by each patient’s physician for 1 patient, Patient #4, of 19 patients whose care was reviewed by the Agency's surveyors, This practice does not provide for effective medication therapy. 35. Patient #4 was admitted to the Respondent facility on 1/18/11 with the diagnosis of acute renal insufficiency. 36. Review of physicians’ orders for Patient #4 revealed an order for Decadron 10 milligrams intravenously prior to the administration of Ferrlecit. 37, However, the Agency's review of the Medication Administration Record for Patient #4 revealed the medication was not administered, or alternative administered by not noted, 38. The above recited facts show that Respondent violated Rule 59A-3.2085, Florida Administrative Code, by failing to follow Patient #4’s physician’s medication order, or alternatively by not documenting having followed Patient #4’s physician’s medication order, Either way, the physician had no way to ascertain if the ordered regime was effective. 39. The above cited deficiency subjects the Respondent - Page 12 of 14 Facility to the imposition of an administrative penalty in a sum not to exceed one thousand dollars ($1,000.00) per violation per day. § 395.1065(2) (a) Florida Statutes. WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, requests that this tribunal impose an administrative fine against the Respondent in the total amount of $1,000.00, or such other relief as this tribunal deems just. NOTICE OF RIGHTS Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes. Respondent has the right to retain, and be represented by an attorney in this matter. Specific options for administrative action are set out in the attached Election of Rights. All requests for hearing shall be made to the Agency for Health Care Administration, and delivered to Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Bldg #3, MS #3, Tallahassee, FL 32308, whose telephone number is 850-412-3630. RESPONDENT IS FURTHER NOTIFIED THAT THE FAILURE TO REQUEST A HEARING WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT. AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the foregoing has been served to: Stephen J. Daugherty, Chief Executive Officer, Northside Hospital, 6000 Forty-Ninth Street, North, St. Petersburg, Florida 33709, by U.S. Certified Mail, Page 13 of 14 Return Receipt No. 7003 1010 0001 3600 4828, and to Galencare, Inc., One Park Plaza, Legal Department, Nashville, TN 37203, on June (7 , 2011. es H, Harris, Esq. » Bar. No. 817775 Assistant General Counsel Agency for Health Care Administration 525 Mirror Lake Drive, 330D St. Petersburg, FL 33701 727-552-1944 Facsimile 727-552-1440 Copy furnished to: , Pat Caufman, FOM Page 14 of 14 STATE OF FLORIDA _? AGENCY FOR HEALTH CARE ADMINISTRATION RE: Galencare, Inc., d/b/a Northside Hospital CASE NO, 2011006275 ELECTION OF RIGHTS This Election of Rights form is attached to a proposed action by the Agency for Health Care Administration (AHCA). The title may be Notice of Intent to Impose a Late Fee, Notice of Intent to Impose a Late Fine or Administrative Complaint. ; Your Election of Rights must be returned by mail or by fax within 21 days of the day you receive the attached Notice of Intent to Impose a Late Fee, Notice of Intent to Impose a Late Fine or Administrative Complaint, If your Election of Rights with your selected option is not received by AHCA within twenty- one (21) days from the date you received this notice of proposed action by AHCA, you will have given up your right to contest the Agency’s proposed action and a final order will be issued. (Please use this form unless you, your attorney or your representative prefer to reply according to Chapter120, Florida Statutes (2006) and Rule 28, Florida. Administrative Code.) PLEASE RETURN YOUR ELECTION OF RIGHTS TO THIS ADDRESS: ' Agency for Health Care Administration Attention: Agency Clerk 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308. Phone: 850-412-3630 Fax: 850-921-0158. PLEASE SELECT Y 1 OF THESE 3 OPTIONS OPTION ONE (1) I admit to the allegations of facts and law contained in the Notice of Intent to Impose a Late Fine or Fee, or Administrative Complaint and I waive my right to object and to have a hearing. { understand that by giving up my right to a hearing, a final order will be issued that adopts the proposed agency action and imposes the penalty, fine or action. OPTION TWO (2) LT admit to the allegations of facts contained in the Notice of Intent to Impose a Late Fee, the Notice of Intent to Impose a Late Fine, or Administrative Complaint, but I wish to be heard at an informal proceeding (pursuant to Section 120.57(2), Florida Statutes) where 1 may submit testimony and written evidence to the Agency to show that the proposed administrative action is too severe or that the fine should be reduced. OPTION THREE (3)___—s« I dispute the allegations of fact contained in the Notice of Intent to Impose a Late Fee,. the Notice of Intent to Impose a Late Fine, or Administrative Complaint, and I request a formal hearing (pursuant to Subsection 120.57(1), Florida Statutes) before an Administrative Law Judge appointed by the Division of Administrative Hearings. PLEASE NOTE: Choosing OPTION THREE (3), by itself, is NOT sufficient te obtain a formal hearing. You also must file a written petition in order to obtain a formal hearing before the Division of Administrative Hearings under Section 120,57(1), Florida Statutes. Jt must be received by the Agency Clerk at the address above within 21 oxy of your receipt of this proposed administrative action. The request for formal hearing must conform to the requirements of Rule 28-106,2015, Florida Administrative Code, which requires that it contain: 1. Your name, address, and telephone number, and the name, address, and telephone number of your representative or lawyer, if any. 2. The file number of the proposed action. 3, A statement of when you received notice of the Agency’s proposed action. 4. A statement of all disputed issues of material fact. If there are none, you must state that there are none. Mediation under Section 120.573, Florida Statutes, may be available in this matter if the Agency ' agrees, License type: (ALF? nursing home? medical equipment? Other type?) Licensee Name: __License number: Contact person: Name Title Address: Street and number City Zip Code Telephone No. Fax No. Email(optional) Thereby certify that I am duly authorized to submit this Notice of Election of Rights to the Agency for Health Care Administration on behalf of the licensee referred to above. Signed: Date: Print Name: Title: Late fee/fine/AC ] COMPLETE THIS SECTION ON £) VERY W YEB, enter calvary areas below: ;Stephen J. Daugherty, iChief Executive Officer iNorthside Hospital . 16000 Forty-Ninth Street, North . ‘St. Petersburg, FL 33709 i . , a CO insured Mall : i : pee . _ [4 Reetncted poten? (nm Fae Dee." Ps Form'3814, February 2004 | Domeetio Return Receipt os 8-02-1640

Docket for Case No: 11-003382