STATE OF FLORIDA DIVISION OF ADMINISTRATIVE HEARINGS STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, DY ‘ Dy () > Petitioner, vs. Case No. 2008006693 CLEARVIEW MANOR, INC., d/b/a CLEARVIEW MANOR, Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (“Agency”), by and through the undersigned counsel, and files this Administrative Complaint against CLEARVIEW MANOR, INC., d/b/a CLEARVIEW MANOR (“Clearview,” “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 one thousand dollars ($1,000.00) based upon one cited twice uncorrected State Class III deficiency pursuant to Sections 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 regulations, 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 15-bed assisted living facility located at 1080 South Clearview Avenue, Tampa, Hillsborough County, Florida 33629, and is licensed as an assisted living facility, license number 9643. 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. Pursuant to Florida law, an assisted living facility shall provide care and services appropriate to the needs of residents accepted for admission to the facility. Rule 58A-5.0182, Florida Administrative Code. Specifically, with regard to the administration of medication, Rule 58A-5.0185(3), (4), and (5), Florida Administrative Code, provide: (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 S8A-5.0191, 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. . (c) Medication administration includes the conducting of any examination or testing such as blood glucose testing or other procedure necessary for the proper administration of medication that the resident cannot conduct himself and that can be performed by licensed staff. (5) MEDICATION RECORDS. (a) For residents who use a pill organizer managed under subsection (2), the facility shall keep either the original labeled medication container; or a medication listing with the prescription number, the name and address of the issuing pharmacy, the health care provider's name, the resident's name, the date dispensed, the name and strength of the drug, and the directions for use. (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. 8. Rule 58A-5.0182(7), Florida Administrative Code, requires: (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)... (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. © 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. 9. On November 20, 2007, the Agency completed Complaint Survey CCR #2007013093 of the Clearview facility. 91. Based on record review, observation, and interviews, the administrator did not ensure that the facility had maintained a daily medication observation record (MOR) for each resident who receives assistance with self-administration of medications or medication administration for four (4) -- Residents #1, #3, #6 and #9 -- out of seven (7) sampled residents who received assistance with self-administration of medication. 9.2. During a comparison of the medications and review of the MOR's for November 2007, Resident #1's MOR had a line through the “Januvia 100 mg T and the Diavan 320 mg T - 1T po QD (one tablet by mouth everyday) (in the morning)” from 11/17/07 to 11/19/07, rather than any initials or other notation as to administration on each day. 9.3. During an interview at approximately 1:01 p.m. on November 20, 2007, the Clearview administrator stated, "Yes", when he was shown that a line that had been scratched through the dates, rather than initialed to indicate that the medications were given. The Administrator further stated at approximately 1:02 p.m. on November 20, 2007, "The old Administrator, I guess, did it [scratched through the dates rather than initialing that the medications had been given] for this [Resident #1] resident.” 9.4, During a continued review of the bubble packs filled on 11/05/07 for Resident #3, Resident #3 was to have received Benztropine (Cogentin) “1 mg T- 1T po BID” (one tablet by mouth twice a day). However, the November 2007 MOR had a line through the MOR for the Benztropine from 11/16/07 to 11/19/07, rather than any initials or other notation as to administration on each day. 9.5. During an interview at approximately 1:01 p.m. on November 20, 2007, the administrator stated, "Yes", when he was shown the line that had been scratched through the 4 dates rather than initialed as given. The administrator further stated at approximately 1:02 p.m. on November 20, 2007, "The old administrator, I guess, did it [scratched through the four dates rather than initialing that the Benztropine had been given] for this resident [Resident #3].” 9.6. During review, Resident #6's MOR for November 2007 had a scratch through three days from 11/17/07 through 11/19/07 for the following five medications: Potassium CL 10 meq T - 2T po QD (two tablets by mouth every day); Wellbutrin XL 300 mg T - 1 T po QD (one tablet by mouth every day); Prozac 40 mg C - 1 C po QD, at 8:00 a.m., per the MOR: Zantac 150 mg T - 1T po BID; Synthroid 50 mcq T - 1T po QD. 9.7. During further record review, Resident #6's MOR for November 2007 had a scratch through four days from 11/16/07 through 11/19/07 for four other medications: Enablex 7.5 mg T - 1T po QD at HS (one tablet by mouth at night or bedtime); Geodon 80 mg C - 2C po QD at HS; Risperdal 4 mg T - 2T po QD at HS; Depakote 500 mg - 1 at PM, per the MOR. 9.8. During a record review, Resident #9's medication observation record (MOR) indicated that Resident #9 was to receive Depakote 500 mg (1) 3 X daily at 8:00 a.m.; 12:00 noon and at 6:00 p.m. However, the November 2007 MOR had a line through the MOR for the Depakote 8:00 a.m. dose from 11/17/07 to 11/18/07 and an “O” under 11/19/07. The 12:00 noon and the 6:00 p.m. doses had a line through the MOR from 11/16/07 through 11/18/07 and an “O” under the 11/19/07 square, rather than any initials or other notation as to. administration. 9.9. Resident #9 had two other medications -- Benztropine T - 1 mg 3 X daily and Clonazepen .Smg (1/2) 2 X daily -- that were not initialed as given or otherwise annotated as to administration. The 8:00 a.m. dose of Benztropine was not initialed, but only had a line through the dates from 11/17/07 through 11/18/07 and an O under 11/19/07. The 12:00 noon dose was last initialed as given on 11/09/07 and blank from 11/10/07 through 11/19/07. The Clonazepen 8:00 a.m. and 6:00 p.m. doses were not initialed as given from 11/17/07 to 11/18/07 and an “O” was entered under 11/19/07, rather than any initials or other notation as to administration. 10. The Agency determined that this deficient practice of failure to maintain accurate and updated Medication Observation Records 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 Clearview for a State Class III deficiency. Specifically, a line drawn through several dates on the MOR indicates a complete disregard for the MOR system and indicates that either no record was kept for the entire period with a belated entry made for drugs that may or may not have been administered, or that the line was drawn in anticipation of drug administration, either case being a violation of the requirement to maintain a contemporaneous record of drug administration. 11. The Agency provided Respondent with a mandatory correction date of December 20, 2007. 12. On January 22, 2008, the Agency conducted a follow-up to the Complaint Survey (CCR #2007013093) of the Respondent. 12.1 Based on observation, record review and interview, the Clearview facility failed to ensure that the daily medication observation records (MORs) were up-to-date for 2, Residents #3 and #5, of the 5 sampled residents who received assistance with self- administration of medication. 12.2 Record review of the 01/08 MOR for Resident #3 revealed the following entries: Geodon, 60 mg, 1 tablet by mouth 2 times daily. Geodon, 80 mg, 1 tablet by mouth 2 times daily Depakote, 500 mg, 3 tablets by mouth daily at bedtime. Depakote, 500 mg, 3 tablets by mouth daily in the morning. 12.3 Observation conducted 01/22/08 at 9:45 a.m. of the medication bubble packs for Resident #3 revealed no package of Geodon, 60 mg. A medication bubble pack that was present was labeled Geodon, 80mg, labeled, “take 2 capsules by mouth in the evening.” A second bubble pack of Geodon, 80 mg, was also found for Resident #3 labeled, “take 1 capsule by mouth every morning.” 12.4 Observation conducted on 01/22/08 at 9:45 a.m. of the medication bubble packs for Resident #3 revealed three (3) medication bubble packs for Depakote: a medication bubble pack for Depakote, 500 mg, labeled, “3 tablets by mouth daily at bedtime;” a second pack for Depakote, 500 mg, labeled, “3 tablets by mouth daily in the morning;” and a third Depakote, 500 mg, labeled, “take 3 tablets by mouth 2 times a day;” this latter package of medication was not identified on the MOR. 12.5 Record review of the 01/08 MOR for Resident #5 revealed an entry for Diphenhydromine, 30mg tablet, to be taken 1 capsule by mouth in the evening. Observation conducted on 01/22/08 at 9:45 of the medication bubble pack revealed a label for Diphenhydromine, 50mg capsule, 1 capsule by mouth in the evening. 12.6 Interview conducted on 01/22/08 with Carl, a staff member, confirmed that the medication labels for Geodon, Depakote, and Diphenhydromine did not match the entries on the MOR and that a clarification would have to be obtained. 12.7 The Agency determined that this deficient practice of failure to maintain accurate and updated Medication Observation Records 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 Clearview for an uncorrected State Class III deficiency. 13. | The Agency provided Respondent Clearview with a mandatory correction date of February 22, 2008. 14. On May 12, 2008, the Agency conducted a second follow-up to the Complaint Survey (CCR #2007013093) of the Respondent. 14.1. Based on observation, record review and interview, the facility failed to ensure that the daily medication observation records (MORs) for 3 residents — Residents #1, #2, and #3 — were up-to-date, from a sample of 5 residents who received assistance with self-administration of medication. 14.2. Record review of Resident #1's Health Assessment, dated 01/07/08, ~ revealed a list of the following prescriptions: Trazodone, 50mg, 1 by house at bedtime Benadryol, 50 mg, | tab 2 times a day Ibuprofen, 800mg, | tab as needed Respitol, 3mg, 2 daily. 14.3. Record review of Resident #1's 5/08 MOR revealed a list of the following medications: Ibuprofen, 800mg, take 1 tablet by mouth 3 times a day as needed. Trazodone, 50mg, tab take 1 tablet by mouth daily at bedtime. Risperdal, 3mg tab, take 1 tablet by mouth twice daily. Benadryl, 50mg capsule, take 1 tablet by mouth twice daily Diphenhydramine, 50 mg tab, take 1 capsule by mouth twice a day. 14.4. Observation conducted on 05/12/08 at approximately 10:00 a.m. revealed a prepackaged medication labeled Risperdal, 4mg. Interview conducted on 05/12/08 with Charlene, who identified herself as the acting Administrator, revealed that according to Charlene, a nurse had visited the facility on or about 05/09/08 and this nurse had changed out (took the old packages and brought new ones) Resident #1's medications; however, no updated list of medications was available for review, and the Risperdal dosage did not match what was identified on the 5/08 MOR. 14.5. Record review of Resident #2's Health Assessment, dated 03/18/08, revealed a list of the following prescriptions: Diphenhydramine/benadryl, 50mg, 1 tab every evening Prolixin decamote, 25 mg, every 2 weeks DDAVP, 0.2mg, 1 tablet at bedtime Norvasc, 5mg, | tablet every day Altace, 10mg, | tablet every day Trileptal, 300mg, 1 tablet every a.m. and 2 tablets every evening Klonopin, 0.5mg, 1 tablet by mouth three times a day HCTZ, 25mg, | tablet every day Cogentin, .l1mg every evening. 14.6. Record Review of Resident #2's 5/08 MOR revealed a list of the following medications: Ramipril, 10mg tab Seroquel, 200mg tab take entire package by mouth every morning Depakote ER, 500mg tab Amlodipine, S5mg tab take entire package by mouth every morning Clonazepam, 0.5mg tab take entire package by mouth every morning Desmopressin, 0.2mg tab Seroquel, 200mg. tab Benztopine, Img tab Diphenhydramine, 50mg tab take entire package by mouth at bedtime Depakote ER, 500mg. tab give entire package by mouth at bedtime Clonazepam, 0.5mg tab, give entire package by mouth at bed time. 14.7. Observations conducted 05/12/08 at approximately 10:45 a.m. of Resident #2's medications revealed prepackaged/labeled medications. The surveyor noted that the labels did not include Seroquel for the a.m. dosage and the p.m. dosage of Seroquel was for 400mg; the Clonzepam .5mg was prepackaged and labeled only for bedtime dosage. 14.8. Interview conducted on 05/12/08 at approximately 10:45 a.m. with Charlene, acting Administrator, revealed that no updated physician orders were available to cross reference the medications identified on the MORs. Charlene stated that “the nurse” had brought pre-packaged medications for the facility on or about 05/09/08 and the prepackaged medications did not match the MORs. 14.9. Record review of Resident #3's medication observation record revealed the medication, Metformin HCL 500mg tablet, take1 tablet by mouth once daily in the morning was being given at 8:00 AM. However, the label on the bubble pack read “Metformin HCL 500 mg tablet, take 1 tablet twice a day.” 14.10. When interviewed on 5/12/08 at approximately 10:30 AM, Charlene, the acting administrator, stated she would give the medication as it was stated on the label of the medication, not what is on the medication observation record. When interviewed on 5/15/08 at approximately 11:30 AM. Resident #3 confirmed that her/his medication was given to her/him twice a day before meals. 14.11. The Agency determined that this deficient practice of failure to maintain accurate and updated Medication Observation Records 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 Clearview for a State Class III deficiency. 15. The Agency provided Respondent Clearview with a mandatory correction date of June 12, 2008. 16. The November 20, 2007, deficiency being uncorrected on January 22, 2008, and the January 22, 2008, deficiency being uncorrected on May 12, 2008 -- the May 12, 2008, deficiency constitutes grounds for a twice uncorrected State Class III deficiency as defined by law. WHEREFORE, the Agency intends to impose an administrative fine in the amount of $1,000.00 against Respondent Clearview, an assisted living facility in the State of Florida, pursuant to Section 429.19(2)(c), Florida Statutes (2007). 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. 11 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 foregoing has been served by U.S. Certified Mail, Return Receipt No. 7007 1490 0001 6979 1113 on May 23 _, 2008 to Kevin S. Kladakis, Registered Agent, Clearview Manor, 4008 Sevilla St., Tampa, FL 33629 and by U.S. Certified Mail, Return Receipt No. 7007 1490 0001 6979 1120 to Administrator, Clearview Manor, 1080 S. Clearview Avenue, Tampa, FL 33629. \ wan ; James H. Harris, Esquire ASgistant General Counsel Copies furnished to: Kevin S. Kladakis, Registered Agent Administrator Clearview Manor Clearview Manor 4008 Sevilla Street 1080 S. Clearview Avenue Tampa, FL 33629 (U.S. Certified Mail) Tampa, FL 33629 (U.S. Certified Mail) Kathleen Varga James H. Harris, Esq. Facility Evaluator Supervisor 525 Mirror Lake Dr., 4" Floor St. Petersburg, Florida 33701 (Interoffice) Peter J. Molinelli, Esq. Sheila K. Nicholson, Esq. Quintairos Prieto Wood & Boyer, P.A. 4905 W. Laurel St., Ste 200 Tampa, Florida 33607-3883 (U.S. Mail, courtesy copy) Agency for Health Care Admin. 525 Mirror Lake Drive, 330H St. Petersburg, FL 33701 (Interoffice) USPS - Track & Confirm Page 1 of 1 SERVICEs Home | Help | Sign In Track & Confirm Search Results Label/Receipt Number: 7007 1490 0001 6979 1120 Status: Delivered Track & Confirm Enter Label/Receipt Number. Your item was delivered at 12:07 PM on May 24, 2008 in TAMPA, FL 33629. NotHication Options Track & Confirm by email Get current event information or updates for your item sent to you or others by email. { Ge» } Site Map, Contact Us Forms Gov't Services Jobs Privacy Policy, Terms of Use National & Premier Accounts Copyright© 1999-2007 USPS. All Rights Reserved. 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Docket for Case No: 08-002902