STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION bv-iKY STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. ; Case No. 2008002356 ARC BAHIA OAKS, INC., d/b/a BAHIA OAKS LODGE, Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (“Agency”), by and through the undersigned counsel, and files this Administrative Complaint against ARC BAHIA OAKS, INC., d/b/a BAHIA OAKS LODGE (“Respondent” or “Respondent Facility”), pursuant to Sections 120.569 and 120.57, Florida Statutes (2007), and alleges: NATURE OF THE ACTION This is an action to impose an administrative fine in the sum of five hundred dollars ($500.00) based upon one cited uncorrected State Class III deficiency pursuant to Section 429.19(2)(c), Florida Statutes (2007). JURISDICTION AND VENUE 1. The Agency has jurisdiction pursuant to Sections 20.42, 120.60, and 429.07, and Chapter 408, Part II, Florida Statutes (2007). 2. Venue lies pursuant to Florida Administrative Code R. 28-106.207. PARTIES 3. The Agency is the regulatory authority responsible for licensure of assisted living facilities and enforcement of all applicable state statutes and rules governing assisted living facilities pursuant to Chapter 408, Part II, and Chapter 429, Part I, Florida Statutes, and Chapter 58A-5 Florida Administrative Code. 4. Respondent operates a 100-bed assisted living facility located at 2186 Bahia Vista Street, Sarasota, Florida 34239, and is licensed as an assisted living facility, license number 7099. 5. Respondent was at all times material to the allegations of this complaint a licensed facility under the licensing authority of the Agency, and was required to comply with all applicable rules and statutes. COUNT I 6. The Agency re-alleges and incorporates paragraphs one (1) through five (5), as if fully set forth in this count. 7. Rule 58A-5.0185(5)(b), Florida Administrative Code, requires: 58A-5.0185 Medication Practices. Pursuant to Sections 429.255 and 429.256, and this rule, facilities holding a standard, limited mental health, extended congregate care, or limited nursing services license may assist with the self-administration or administration of medications to residents in a facility. A resident may not be compelled to take medications but may be counseled in accordance with this rule. (1) SELF ADMINISTERED MEDICATIONS. (a) Residents who are capable of self-administering their medications without assistance shall be encouraged and allowed to do so. (b) If facility staff note deviations which could reasonably be attributed to the improper self-administration of medication, staff shall consult with the resident concerning any problems the resident may be experiencing with the medications; the need to permit the facility to aid the resident through the use of a pill organizer, provide assistance with self-administration of medications, or administer medications if such services are offered by the facility. The facility shall contact the resident's health care provider when observable health care changes occur that may be attributed to the resident's medications. The facility shall document such contacts in the resident's records. (3) ASSISTANCE WITH SELF-ADMINISTRATION. (a) For facilities which provide assistance with self-administered medication, either: a nurse; or an unlicensed staff member, who is at least 18 years old, trained to assist with self-administered medication in accordance with Rule 58A-4.0191, F.A.C., and able to demonstrate to the administrator the ability to accurately read and interpret a prescription label, must be available to assist residents with self- administered medications in accordance with procedures described in Section 429.256, F.S. (b) Assistance with self-administration of medication includes verbally prompting a resident to take medications as prescribed, retrieving and opening a properly labeled medication container, and providing assistance as specified in Section 429.256(3), F.S. In order to facilitate assistance with self-administration, staff may prepare and make available such items as water, juice, cups, and spoons. Staff may also return unused doses to the medication container. Medication, which appears to have been contaminated, shall not be returned to the container. (c) Staff shall observe the resident take the medication. Any concerns about the resident's reaction to the medication shall be reported to the resident's health care provider and documented in the resident's record. (4) MEDICATION ADMINISTRATION. (a) For facilities which provide medication administration a staff member, who is licensed to administer medications, must be available to administer medications in accordance with a health care provider's order or prescription label. (b) Unusual reactions or a significant change in the resident's health or behavior — shall be documented in the resident's record and reported immediately to the resident's health care provider. The contact with the health care provider shall also be documented in the resident's record. (5) MEDICATION RECORDS. (b) The facility shall maintain a daily medication observation record (MOR) for each resident who receives assistance with self-administration of medications or medication administration. A MOR must include the name of the resident and any known allergies the resident may have; the name of the resident's health care provider, the health care provider's telephone number; the name, strength, and directions for use of each medication; and a chart for recording each time the medication is taken, any missed dosages, refusals to take medication as prescribed, or medication errors. The MOR must be immediately updated each time the medication is offered or administered. (6) MEDICATION STORAGE. AND DISPOSAL. (a) In order to accommodate the needs and preferences of residents and to encourage residents to remain as independent as possible, residents may keep their medications, both prescription and over-the-counter, in their possession both on or off the facility premises; or in their rooms or apartments, which must be kept locked when residents are absent, unless the medication is in a secure place within the rooms or apartments or in some other secure place which is out of sight of other residents. However, both prescription and over-the-counter medications for residents shall be centrally stored if: 1. The facility administers the medication; 2. The resident requests central storage. The facility shall maintain a list of all medications being stored pursuant to such a request; 3. The medication is determined and documented by the health care provider to be hazardous if kept in the personal possession of the person for whom it is prescribed; 4. The resident fails to maintain the medication in a safe manner as described in this paragraph; 5. The facility determines that because of physical arrangements and the conditions or habits of residents, the personal possession of medication by a resident poses a safety hazard to other residents; or 6. The facility's rules and regulations require central storage of medication and that policy has been provided to the resident prior to admission as required under Rule 58A-5.0181, F.A.C. (b) Centrally stored medications must be: 1. Kept in a locked cabinet, locked cart, or other locked storage receptacle, room, or area at all times; 2. Located in an area free of dampness and abnormal temperature, except that a medication requiring refrigeration shall be refrigerated. Refrigerated medications shall be secured by being kept in a locked container within the refrigerator, by keeping the refrigerator locked, or by keeping the area in which refrigerator is located locked; 3. Accessible to staff responsible for filling pill-organizers, assisting with self- administration, or administering medication. Such staff must have ready access to keys to the medication storage areas at all times; and 4. Kept separately from the medications of other residents and properly closed or sealed. (7) MEDICATION LABELING AND ORDERS. (a) No prescription drug shall be kept or administered by the facility, including assistance with self-administration of medication, unless it is properly labeled and dispensed in accordance with Chapters 465 and 499, F.S., and Rule 64B16- 28.108, F.A.C. If a customized patient medication package is prepared for a resident, and separated into individual medicinal drug containers, then the following information must be recorded on each individual container: 1. The resident's name; and 2. Identification of each medicinal drug product in the container. (b) Except with respect to the use of pill organizers as described in subsection (2), no person other than a pharmacist may transfer medications from one storage container to another. (c) If the directions for use are "as needed" or "as directed," the health care provider shall be contacted and requested to provide revised instructions. For an "as needed" prescription, the circumstances under which it would be appropriate for the resident to request the medication and any limitations shall be specified; for example, "as needed for pain, not to exceed 4 tablets per day." The revised instructions, including the date they were obtained from the health care provider and the signature of the staff who obtained them, shall be noted in the medication record, or a revised label shall be obtained from the pharmacist. (d) Any change in directions for use of a medication for which the facility is providing assistance with self-administration or administering medication must be accompanied by a written medication order issued and signed by the resident's health care provider, or a faxed copy of such order. The new directions shall promptly be recorded in the resident's medication observation record. The facility may then place an "alert" label on the medication container which directs staff to examine the revised directions for use in the MOR, or obtain a revised label from the pharmacist. (e) A nurse may take a medication order by telephone. Such order must be promptly documented in the resident's medication observation record. The facility must obtain a written medication order from the health care provider within 10 working days. A faxed copy of a signed order is acceptable. (f) The facility shall make every reasonable effort to ensure that prescriptions for residents who receive assistance with self-administration of medication or medication administration are filled or refilled in a timely manner. (g) Pursuant to Section 465.0276(5), F.S., and Rule 64F-12.006, F.A.C., sample or complimentary prescription drugs that are dispensed by a health care provider, must be kept in their original manufacturer's packaging, which shall also include the practitioner's name, the resident's name for whom they were dispensed, and the date they were dispensed. If the sample or complimentary prescription drugs are not dispensed in the manufacturer's labeled package, they shall be kept in a container that bears a label containing the following: 1. Practitioner's name; 2. Resident's name; 3. Date dispensed; 4. Name and strength of the drug; 5. Directions for use; and 6. Expiration date. (h) Pursuant to Section 465.0276(2)(c), F.S., before dispensing any sample or complimentary prescription drug, the resident's health care provider shall provide the resident with a written prescription, or a fax copy of such order. (8) OVER THE COUNTER (OTC) MEDICATIONS. (a) A stock supply of OTC medications for multiple resident use is not permitted in any facility. (b) Non-prescription over-the-counter drugs, when centrally stored, shall be labeled with the resident's name, and the manufacturer's label with directions for use shall be kept with the medication. (c) When an over-the-counter medication is prescribed by a health care provider, the medication becomes a prescription medication and shall be managed in accordance with prescription medication under this rule. 8. On January 2-3, 2008, the Agency conducted a Biennial Survey of the Respondent facility. 9. Based on observation, interview, and record review, the facility failed to ensure that three (3) of eight (8) residents, “Residents #2, #5 and #8,” had Medication Observation Records (“MORs”) that were accurate, complete and contained the information required by Rule 58A-5.0185, Florida Administrative Code. Specifically, 9.1. for Resident #2 the Respondent Facility failed to document its contact with Resident 2's health care provider when observable health care changes occur that may be attributed to the resident's medications and failed to centrally store and label Resident #2’s over-the-counter vitamins. 9.2. for Residents #5 and #8 the Respondent Facility failed to update the MOR each time medication is offered or administered as to whether the medication is taken, refused, missed or whether there is a medication error. 10. On 1/02/08 at 9:45 a.m., during a tour with the Executive Director (ED) on the third floor, Resident #2 was observed to have several medications sitting on a microwave in Resident #2’s room. The medications were Centrum tablets, B-12 and C-1000 mg tablets. The resident then retrieved from Resident #2’s walker two bottles of Lutein, an eye vitamin with minerals. The resident then stated that one of the bottles of Lutein had Flax Seed Oil tablets in them, and that she had put the medication in the Lutein bottle because the bottle was smaller than the Flax Seed Oil bottle. The resident stated that she doesn't remember when she started taking the over-the-counter medications. 11. —_In an interview with the Executive Director on 1/02/08 at 10:10 a.m., the Executive Director stated that residents are evaluated by the facility to see if they are capable of self-administration of their own medications. The Executive Director stated that Resident #2 was evaluated as an “assist with [Resident #2’s] medication,” meaning that Resident #2 required assistance with self-administration of medications. 12, Record review of Resident #2's chart at around 10:35 a.m., revealed that the “ resident’s “extensive medication management box” was checked "yes." The evaluation was dated 4/1/06. The Executive Director stated that the medication evaluation done on 4/1/06 was the most current and up-to-date evaluation. The Executive Director stated when the box is checked "yes" the facility has determined that the resident needs supervision with self- administration of the resident’s medications. Further record review of Resident #2's chart revealed there is no order from the attending physician for the resident to self-administer Centrum tablets, B-12, C-1000 mg and Flax Seed oil. Review of Resident #2's MOR revealed the Centrum tablets, B-12, C-1000 mg and Flax Seed oil are not listed. 13. Further review of Resident #2's MOR for December 2007 revealed Lortab 5/500 mg tablet, to be taken 1 tablet by mouth every 6 hours as needed for pain, was documented as having been given 32 tablets. Further review of Resident #2's MOR for December 2007 revealed the resident was also given Colace 100 mg capsule for 6 consecutive days, December 12th thru 17th, and then, again, on the 20th and the 31st of 2007 for constipation. 14. The Drug Information Handbook for Nursing 2007 edition list Lortab 5/500 mg tablets as 5 mg Hydrocodone bitartrate and 500 mg of acetaminophen is used for relief of moderate to severe pain and is classified as a controlled medication. One of the adverse reactions listed for the medication is constipation. 15. In an interview with the Executive Director on 1/02/08 at 10:30 a.m., the Executive Director stated there is no facility policy requiring a facility staff member signing the MOR to also record for an "as needed medication" what time the medication was given, how much of the medication was given, and the effectiveness of the medication. 16. Interview on 1/02/08 at 11:15 a.m., with the Wellness Director (WD) stated there is no facility policy requiring staff to document the time and effectiveness of an “as-needed” medication. The Wellness Director stated that the facility only documents by “exception,” when there is a change in the resident’s condition. The Wellness Director stated one of the side effects of Lortab is constipation, and Lortab could have been a contributing factor for the observable health care change in the resident causing the resident to have to receive Colace 100 mg for 6 consecutive days. There is no documentation in Resident #2's record that addresses the Respondent Facility’s contact with Resident #2’s health care provider as to the observable health care change which occasioned the Resident’s receiving Colace for 6 consecutive days for constipation, or on the December 2007 MOR. 17. Review of Resident #5's MOR on 1/02/07, revealed on each of December 13th, 16th, and 28th for the medication Colace 100 mg, to be administered daily, the space on the MOR to indicate the administration of the 5 p.m. dose was unsigned and blank. The MOR for the Simvastatin 40 mg daily 9:00 p.m. dose was not signed and was blank. Similarly, the MOR for daily administration of Combigan Opthal eye drops for December 16th and 29" showed that the 9:00 p.m. dose was not signed and was blank for both days. 18. Review of Resident #8's MOR on 1/03/08 at 10:00 a.m., revealed that the 5:00 p.m. dose of Lortab 5/500 mg for December 3, 2007, was not signed and was blank. 19. On 1/03/08 at 10:15 a.m., the Weliness Director admitted to the Agency surveyor that the MORs should have been signed, and there should be no blank areas on residents’ MORs without an explanation for Residents #5, and #8. 20. The Agency determined that the Respondent Facility’s failure to ensure that three (3) of eight (8) residents had Medication Observation Records (“MORs”) that were accurate, complete and contained the information required by Rule 58A-5.0185, Florida Administrative Code was related to the personal care of the residents that indirectly or potentially threatened the health, safety, or security of the residents and cited Respondent for a State Class III deficiency. 21. The Agency provided Respondent with a mandatory correction date of February 3, 2008. 22. On February 11, 2008, the Agency conducted a re-visit to the Biennial Survey of the Respondent. 23. Based on record review, the facility failed to ensure that two (2) of three (3) residents, “Residents #10 and #11,” had Medication Observation Records (“MORs”) that were accurate, complete and contained the information required by Rule 58A-5.0185, Florida Administrative Code. Specifically, 23.1. for Resident #10 the Respondent Facility failed to record if the February 2, 2008, dosage of Trimethoprim was missed due to a failure to refill the prescription or whether the medication was refused by Resident #10, and failed to record that Resident #10 had actually received the medication on February 2, 3, and 5, 2008. 23.2. For Resident #11 the Respondent Facility failed to ensure that the MOR was accurately updated for each time medications were taken or refused. 24. On 2/11/08, review of the Medication Observation Record (MOR) for Resident #10 revealed a listing for Trimethoprim 100mg one tablet daily for 30 days every other month to 10 be given in the month of February 2008. On 2/2/08, 2/3/08 and 2/5/08, the doses were circled as not being given. The documentation on the back of the MOR for 2/2/08 stated "Med not here", and for 2/5/08 it read "Med not available". There was no explanation for the 2/3/08 dose in regards to why the dose was circled as not given. 25. Interview with the Interim Wellness Director and the Executive Director at 11:10 a.m., revealed that Resident #10’s medication had actually been in the medication dispensing system but the Medication Tech did not realize it was there until later and initially documented incorrectly on the MOR, without later making corrections, when she realized she had given the medication. 26. _—_ Interview at 11:14 a.m., with the Medication Tech revealed she had actually given the medication but failed to correct the incorrect documentation on the MOR. 27. Documentation provided by the Executive Director revealed the medication arrived at the Respondent Facility from the pharmacy on January 30, 2008 and was available for the resident when it was to be administered beginning on 2/1/08. 28. On 2/11/08, review of the MOR for Resident #11 revealed orders for Prevident 5000 Plus Cream, “apply as directed or brush twice daily at 9:00 a.m. and 5:00 p.m.,” for Singulair 10 mg, “one tablet by mouth at bedtime 9:00 p.m.,” for Xalatan 0.005%, “instill one drop in left eye at bedtime 9:00 p.m.,” and for Salex 6% Cream, “apply to bilateral feet at bedtime until all samples are gone.” 29. Further review of the MOR for Resident #11 revealed: 29.1. on 2/1/08 and 2/8/08 the 5:00 p.m. dose of Prevident 5000 Plus Cream were blank with no initials as being given or refused 29.2. on 2/9/08 the 9:00 p.m. doses of Singulair 10mg, Xalatan 0.005% one il drop, and Salex 6% Cream were blank with no initials that the medication had been given or refused. 30. Interview with the Interim Wellness Director at 11:30 a.m., revealed he had no knowledge as to why the medication had not been initialed as given. He stated the person that omitted the signature was not currently at work, and he was unable to verify as to why the MOR had not been initialed. 31. The Agency determined that during the January 2-3, 2008, survey and again during the February 11, 2008, survey the Agency had identified Respondent Facility’s deficient practice of failing to maintain Medication Observation Records for residents that were accurate, complete and contained the information required by Rule 58A-5.0185, Florida Administrative Code. Hence, this deficient practice is an uncorrected deficiency for purposes of § 429.19(2)(c), Florida Statutes. 32. The Agency determined that this deficient practice of Respondent Facility’s failure to ensure that two (2) of three (3) residents, “Residents #10 and #11,” had Medication Observation Records (“MORs”) that were accurate, complete and contained the information and record of contacts required by Rule 58A-5.0185, Florida Administrative Code, was related to the personal care of the resident that indirectly or potentially threatened the health, safety, or security of the resident and cited Respondent for an uncorrected State Class III deficiency. 33. The Agency provided Respondent with a mandatory correction date of March 10, 2008. WHEREFORE, the Agency intends to impose an administrative fine in the amount of $500.00 against Respondent, an assisted living facility in the State of Florida, pursuant to Section 429.19(2)(c), Florida Statutes (2007). 12 fo Respectfully submitted this 20 day of March, 2008. \ wo rd, James H. Harris, Esq. FW. Bar. No. 817775 Assistant General Counsel Agency for Health Care Administration 525 Mirror Lake Drive, 330H St. Petersburg, FL 33701 727-552-1435 Facsimile: 727-552-1440 Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes. Respondent has the right to retain, and be represented by an attorney in this matter. Specific options for administrative action are set out in the attached Election of Rights. All requests for hearing shall be made to the Agency for Health Care Administration, and delivered to Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Bldg #3,MS #3, Tallahassee, FL 32308;Telephone (850) 922-5873. RESPONDENT IS FURTHER NOTIFIED THAT THE FAILURE TO REQUEST A HEARING WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT WILL RESULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form have been served by U.S. Certified Mail, Return Receipt No. 7007 1490 0001 6907 5442 to Mary Jo Harper, Administrator, Bahia Oaks Street, 2186 Bahia Vista Street, Sarasota, Florida 34239, and by U.S. Certified Mail, Return Receipt No. 7007 1490 0001 6907 5244 to CT Corporation System, Registered Agent, Bahia Oaks Lodge, 1200 S. Pine Island Rd., Plantation, FL 33324, on March LO , 2008. es H. Harris sistant General Counsel 13 Copies furnished to: Mary Jo Harper, Administrator Bahia Oaks Lodge 2186 Bahia Vista Street Sarasota, Florida 34239 (U.S. Certified Mail) CT Corporation System Registered Agent Bahia Oaks Lodge 1200 South Pine Island Rd. Plantation, FL 33324 (USS. Certified Mail) David Day/Kriste Mennella Field Office Manager 2295 Victoria Ave., Room 340 Ft. Myers, Florida 33901-3884 (U.S. Mail) James H. Harris, Esq. Agency for Health Care Administration 525 Mirror Lake Drive, 330H St. Petersburg, Florida 33701 (nteroffice) 14 SENDER: COMPLETE THIS SECTION ®@ Complete item S12, and 3. Also complete item 47 fed Delivery is desired. @ Print your name and address on the reverse so that we can returf the Gard to you. @ Attach this card to the back of the mailpiece, Or on the front if space permits. 1. Article Addressed to: COMPLETE THIS SECTION ON DELIVERY Ze Xd -_ B. Received by (Printed Name: a D. Is delivery address different from item 1?. 0 Yes If YES, enter delivery address below: [1 No Mary Jo Harper, Administrator Bahia Oaks Lodge 2186 Bahia Vista Street » Tr Cotiee Ma Ci expres mat Sarasota, Florida 34239 C1 Registered 1 Return Receipt for Merchandise 0 An enna ee O insured Mall ~= 1.6.00, nog ge 4. Restricted Delivery? (Extra Fee) 0 Yes 2. Articles Cranst 7007 1499 O001 &907 S4y4a 2006002354, 1 PS Form 3811, February 2004 Domestic Return Receipt 102595-02-M-1540

Docket for Case No: 08-001814