STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, v. AHCA No. 2018000134 License No. 25 PRY, INC., d/b/a GOOD SAMARITAN File No. 11910275 RETIREMENT HOME, Provider Type: Assisted Living Facility Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW the Petitioner, State of Florida, Agency for Health Care Administration (“the Agency”), by and through the undersigned counsel, and files this Administrative Complaint against the Respondent, PRY, Inc., d/b/a Good Samaritan Retirement Home (“the Respondent”), pursuant to Sections 120.569 and 120.57, Florida Statutes (2017), and alleges: NATURE OF THE ACTION This is an action to impose an administrative fine of $20,000.00 against the Respondent based upon one class I violation and two class II violations.! PARTIES 1. The Agency is the licensing and regulatory authority that oversees assisted living facilities in Florida and enforces the applicable state statutes and rules governing such facilities. Ch. 408, Part II, Ch. 429, Part I, Fla. Stat. (2017); Ch. 58A-5, Fla. Admin. Code. The Agency may deny, revoke, and suspend any license issued to an assisted living facility and impose an administrative fine for a violation of the Health Care Licensing Procedures Act, the authorizing | Subsequent to the issuance of an Emergency Suspension Order, the Respondent surrendered it license to operate this assisted living facility. But for the surrender of the license, the Administrative Complaint would have sought license revocation. statutes or applicable rules. §§ 408.813, 408.815, 429.14, 429.19, Fla. Stat. (2017). In addition to licensure denial, revocation, or suspension, or any administrative fine imposed, the Agency may assess a survey fee against an assisted living facility. § 429.19(7), Fla. Stat. (2017). 2 The Respondent was issued a license by the Agency to operate an assisted living facility (“the Facility”) and was at all times material required to comply with the applicable statutes and rules governing assisted living facilities. The Respondent’s license to operate this assisted living facility was suspended by the Agency through an Emergency Suspension Order that was issued on December 19, 2017. Thereafter, the Respondent surrendered this license to the Agency. COUNT I Assistance with Self-Administration of Medication 3. Under Florida law, (3) ASSISTANCE WITH SELF-ADMINISTRATION. (a) Any unlicensed person providing assistance with self administration of medication must be 18 years of age or older, trained to assist with self administered medication pursuant to the training requirements of Rule 58A- 5.0191, F.A.C., and must be available to assist residents with self-administered medications in accordance with procedures described in Section 429.256, F.S. and this rule. (b) In addition to the specifications of Section 429.256(3), F.S., assistance with self-administration of medication includes verbally prompting a resident to take medications as prescribed. (c) In order to facilitate assistance with self-administration, trained staff may prepare and make available such items as water, juice, cups, and spoons. Trained staff may also return unused doses to the medication container. Medication, which appears to have been contaminated, must not be returned to the container. (d) Trained staff must observe the resident take the medication. Any concerns about the resident’s reaction to the medication or suspected noncompliance must be reported to the resident’s health care provider and documented in the resident’s record. (e) When a resident who receives assistance with medication is away from the facility and from facility staff, the following options are available to enable the resident to take medication as prescribed: 1. The health care provider may prescribe a medication schedule that coincides with the resident’s presence in the facility; 2. The medication container may be given to the resident, a friend, or family member upon leaving the facility, with this fact noted in the resident’s medication record; 3. The medication may be transferred to a pill organizer pursuant to the requirements of subsection (2), and given to the resident, a friend, or family member upon leaving the facility, with this fact noted in the resident’s medication record; or 4, Medications may be separately prescribed and dispensed in an easier to use form, such as unit dose packaging; (f) Assistance with self-administration of medication does not include the activities detailed in Section 429.256(4), F.S. 1. As used in Section 429.256(4)(h), F.S., the term “competent resident” means that the resident is cognizant of when a medication is required and understands the purpose for taking the medication. 2. As used in Section 429.256(4)(i), F.S., the terms “judgment” and “discretion” mean interpreting vital signs and evaluating or assessing a resident’s condition. Fla. Admin. Code R. 58A-5.0185(3). 4. On or about 12/15/17, the Agency conducted a survey of the Facility. 5. Based on observation and interview, the Facility failed to document in resident records significant changes in the resident’s health, specifically medication refusals, and report these changes immediately to the health care provider for 5 of 6 residents (Resident #1, #2, #3, #4, and #5). 6. On 12/15/17, a record review was conducted on Resident #1’s Medication Observation Record (MOR). Resident #1°s MOR indicated that, from 12/1/17-12/15/17, Resident #1 had refused the following medications: Amlodipine Besylate 10 mg (refused eight doses), Aspirin 81 mg (refused eight doses), Levothyroxine 25 mg (refused eight doses), Lisinopril 20 mg (refused 19 doses), Metoprolol tartrate 25 mg (refused 12 doses), Diclofenac 75 mg (refused 22 doses), Quetiapine Fumarate 200 mg (refused 17 doses), Lorazepam .5 mg (refused 18 doses), and Temazepam 15 mg (refused 10 doses). 7. On 12/15/17, a record review was conducted on Resident #1’s MOR. During the record review, no documentation was found in Resident #1’s MOR showing that Resident #1’s primary care physician or family was contacted regarding any of the medication refusals mentioned above. 8. On 12/15/17 at 1:36 PM, an interview was conducted with Facility’s Staff A. In reference to Resident #1 refusing medication, Staff A stated, “staff notified the Manager and Owner of the Resident refusing [Resident #1’s] medication, but she only documented the refusal information on the back of the medication record and did not write it on the Resident’s observation log that she reported it to management.” Staff A stated that she was not sure if the Manager or Owner had contacted the physician or Resident #1’s family when Resident #1 refused Resident #1’s medication earlier in December. Staff A stated that the doctor visits the Facility to provide care and treatment on occasion, but she was not sure of the last visit. There is no documentation on file related to physician visits to the Facility for either November or December. When asked about an incident on 12/15/17, involving Resident #1 being sent to the hospital via emergency medical services, Staff A stated that Resident #1’s son was called due to Resident #1’s decline and behavior. Resident #1’s son told staff to call 911 for medical attention, so they did. Staff A stated, “Resident had not been eating or taking [Resident #1’s] medication for several days.” Staff A stated that information regarding Resident #1 not eating was not documented in the staff communication log, which is kept in the Administrator’s office. 9. On 12/15/17 at 3:07 PM, an interview was conducted with the Facility’s Administrator. The Administrator stated that he is new to the Facility and is unaware of the location of resident files. The Administrator also said that he is unaware of the communication logbook. Further, the Administrator said that he is unaware of how changes in medication orders are handled and whether or not the physician was notified concerning Resident #1’s refusal of medication. 10. On 12/15/17 at 5:15 PM, an interview was conducted with the Facility’s Owner. The Owner stated, “I have been through three administrators and I don’t know where anything is. I have to call my son.” The Owner stated that the doctor conducts visits to the Facility monthly, but did not know when specifically. When asked for supporting documentation, she stated, “I don’t have any because it’s not written down.” When asked for the location of the observation logbook, she stated, “I have to call and ask my son.” When asked for supporting documentation of notifications made to Resident #1’s primary care physician and family regarding Resident #1’s refusing medication multiple time between 12/1/17-12/15/17, she stated, “I am not aware of any documentation. I will call and ask my son.” The Owner said that all that information should have been written down, but she does not know where and that she would have to look for it. 11. On 12/15/17, a record review was conducted on Resident #2’s MOR. Resident #2’s MOR showed that, between 12/1/17-12/15/17, Resident #2 had 25 documented refusals for Metformin HCL 500 mg (take one tablet by mouth two times a day). 12. On 12/15/17, a record review was conducted on Resident #2’s file. During the record review, no documentation was found in Resident #2’s file showing if Resident #2’s primary care physician or family were notified regarding Resident #2’s refusal of medication. 13. On 12/15/17 at 1:45 PM, an interview was conducted with Facility Staff A. During the interview Staff A stated that the only documentation of Resident #2’s medication refusals for December 2017 was made under the nurses modification notes on the back of Resident #2’s MOR. Staff A stated that there is no other documentation of Resident #2’s medication refusals. Staff A stated, “The refusals were brought to the attention of the Administrator and Manager and she is not sure if they notified the primary care physician or the Resident’s family.” 14. On 12/15/17 at 5:25 PM, an interview was conducted with the Facility’s Owner. The Owner said that she does not know if the primary care physician or family had been contacted about Resident #2’s medication refusals. She stated that she had been through many administrators and had no idea where the documentation is located to verify if contact had been made. 15. On 12/15/17, a record review was conducted on Resident #3’s file. During this record review documentation was found showing that, between 12/2/17-12/12/17, Resident #3 had 14 documented refusals for Nystatin 100,000 (apply to affected area two times per day). There were also ten doses that had not been documented on Resident #3’s MOR, despite the requirement that each dose be recorded on the MOR. 16. On 12/15/17, a record review was conducted on Resident #3’s file. During the record review, no documentation was found in Resident #3’s file showing if Resident #3’s primary care physician or family were notified regarding Resident #3’s refusal of medication. 17. On 12/15/17 at 1:53 PM, an interview was conducted with Facility Staff A. Concerning Resident #3’s medication refusals during December 2017, Staff A stated, “The Resident’s refusal of medication was not documented on any other form than the MOR. The refusals were brought to the attention of the Administrator and Manager. I am not sure if they notified the primary care physician or the Resident’s family.” 18. On 12/15/17 at 5:25 PM, an interview was conducted with the Facility’s Owner. The Owner said that she does not know if the primary care physician or family had been contacted about Resident #3’s medication refusals. She stated that she had been through many administrators and had no idea where the documentation is located to verify if contact had been made to notify Resident #3’s doctor or family. 19. On 12/15/17, a record review was conducted on Resident #4’s MOR. Resident #4’s MOR showed that, on 12/10/17, Resident #4 had refused Resident #4’s morning dose of the following medications: Clopidogrel 75 mg (take one tablet by mouth once a day), Escitalopram 20 mg (take one tablet by mouth once a day), Ferrous Sulfate EC 325 mg (take one tablet by mouth once a day), Lisinopril 2.5 mg (take one tablet by mouth in the morning), Pantoprazole SOD DR 40 mg (take one tablet by mouth daily), Vitamin D2 5,000 unit (take one capsule by mouth once a day), and MAPAP 325 (take one tablet by mouth twice a day). 20. On 12/15/17 at 2:07 PM, an interview was conducted with Facility Staff A. Regarding Resident #4’s medication refusals during December 2017, Staff A stated that the refusals were documented under the nurse’s medication notes on the back of Resident #4’s MOR. Staff A stated, “The refusal of medication was not placed on any other form regarding the refusals. The refusals were brought to the attention of the Administrator and Manager. I am not sure if they notified the primary care physician or the Resident’s family.” 21. On 12/15/17 at 5:25 PM, an interview was conducted with the Facility’s Owner. The Owner said that she does not know if the primary care physician or family had been contacted about Resident #4’s medication refusals. She stated that she had been through many administrators and had no idea where the documentation is located to verify if contact had been made to notify Resident #4’s doctor or family. 22. On 12/15/17, a record review was conducted on Resident #5’s MOR. Resident #5°s MOR showed that, between 12/1/17-12/15/17, Resident #5 had documented refusals of the following medications: 8 AM dose of Fexofenadine HCL 180 mg (take one tablet by mouth daily) and 8 AM dose of Gabapentin 600 mg (take one tablet by mouth three times daily). There was no documentation on Resident #5’s MOR for the 12 PM dose of Gabapentin 600 mg (take one tablet by mouth three times daily). This section of Resident #5’s MOR was blank, despite the requirement that each dose be recorded on the MOR. Resident #5’s MOR showed that, between 12/1/17-12/13/17, Resident #5 had documented refusals for the 8 PM dose of Metoprolol Tartrate 25 mg (take one tablet by mouth twice daily). During the record review of Resident #5’s file, no documentation of doctor orders or observation notes were found. 23. On 12/15/17 at 2:16 PM, an interview was conducted with Facility Staff A. Regarding Resident #5’s medication refusals during December 2017, Staff A stated that the refusals were documented under the nurse’s medication notes on the back of Resident #5’s MOR. Staff A stated, “The refusal of medication was not placed on any other form regarding the refusals. The refusals were brought to the attention of the Administrator and Manager. I am not sure if they notified the primary care physician or the Resident’s family.” 24. = On 12/15/17 at 5:25 PM, an interview was conducted with the Facility’s Owner. The Owner said that she does not know if the primary care physician or family had been contacted about Resident #5’s medication refusals. She stated that she had been through many administrators and had no idea where the documentation is located to verify if contact had been made to notify Resident #5’s doctor or family. 25. On 12/18/17 at 11:13 AM, an interview was conducted with the Office Manager of Resident #5’s primary care physician’s office. The Office Manager stated that, as of today, no one from the Facility had notified the office that Resident #5 had been refusing Resident #5’s medication since 12/1/17. She stated that that is a concern and she would notify the physician immediately. She also said that she would contact the Facility as to the physician’s response to this concern. 26. The Respondent’s actions, or inactions, constitute a class I violation. 27. Class “I” violations are those conditions or occurrences related to the operation and maintenance of a facility or to the care of clients which the agency determines present an imminent danger to the clients of the provider or a substantial probability that death or serious physical or emotional harm would result therefrom. § 429.19(2)(a), Fla. Stat. (2017). Remedy 28. Under Florida law, as a penalty for any violation of this part, authorizing statutes, or applicable rules, the Agency may impose an administrative fine. § 408.813(1), Fla. Stat. (2017). 29. Under Florida law, In addition to the requirements of part II of chapter 408, the agency shall impose an administrative fine in the manner provided in chapter 120 for the violation of any provision of Part I of Chapter 429, part II of chapter 408, and applicable rules by an assisted living facility, for the actions of any person subject to level 2 background screening under s. 408.809, for the actions of any facility employee, or for an intentional or negligent act seriously affecting the health, safety, or welfare of a resident of the facility. § 429.19(1), Fla. Stat. (2017). 30. Under Florida law, Each violation of Part I of Chapter 429 and adopted rules shall be classified according to the nature of the violation and the gravity of its probable effect on facility residents. The agency shall indicate the classification on the written notice of the violation as follows: Class “TI” violations are defined in s. 408.813. The agency shall impose an administrative fine for a cited class I violation in an amount not less than $5,000 and not exceeding $10,000 for each violation. § 429.19(2)(a), Fla. Stat. (2017). WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, seeks to impose an administrative fine of $10,000.00 against the Respondent. COUNT Il Medication Records S1. Under Florida law, (5) MEDICATION RECORDS. (a) For residents who use a pill organizer managed in subsection (2), the facility must 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 must maintain a daily medication observation record (MOR) for each resident who receives assistance with self-administration of medications or medication administration. A medication observation record 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 medication observation record must be immediately updated each time the medication is offered or administered. (c) For medications that serve as chemical restraints, the facility must, pursuant to Section 429.41, F.S., maintain a record of the prescribing physician’s annual evaluation of the use of the medication. Fla. Admin. Code R. 58A-5.0185(5). 32. Onor about 12/15/17, the Agency conducted a survey of the Facility. 33. Based on record review, interview, and observation, the Facility failed to maintain an accurate and up to date MOR for 2 of 6 residents (Resident #1 and #4). 34. On 12/15/17, a record review was conducted on Resident #1’s MOR. Resident #1’s MOR indicated that, from 12/1/17-12/15/17, Resident #1 had refused the following medications: Amlodipine Besylate 10 mg, Aspirin 81 mg, Levothyroxine 25 mg, Lisinopril 20 mg, Metoprolol tartrate 25 mg, Diclofenac 75 mg, Quetiapine Fumarate 200 mg, Lorazepam .5 mg, and Temazepam 15 mg. 35. On 12/15/17, a record review was conducted on Resident #1’s file. No documentation was found showing that Resident #1’s primary care physician or family had been contacted regarding Resident #1’s refusal of medication. 36. On 12/15/17, a record review was conducted on Resident #1’s file. Documentation was found showing that Resident #1 was in the hospital from 12/2/17-12/4/17. 37. On 12/15/17, a record review was conducted on Resident #1’s file. The doctor’s orders found during this review did not completely match Resident #1’s MOR for multiple medications. Resident #1’s doctor’s order for Levothyroxine 25 mg with a start date of 11/21/17 take one tablet by mouth every morning one hour before breakfast. Resident #1’s MOR shows that Resident #1 is currently taking one tablet of Levothyroxine 25 mg daily at 8 AM, after 10 breakfast. Resident #1’s doctor’s order for Lorazepam .5mg take one tablet by mouth every 12 hours with a start date of 11/21/17. Resident #1’s MOR shows that Resident #1 is currently taking one tablet of Lorazepam .5 mg by mouth twice a day, at 8 AM and at 5 PM. Resident #1’s doctor’s order for Metoprolol Tartrate 25 mg take one tablet by mouth two times a day with a start date of 11/21/17. Resident #1°s MOR shows that Resident #1 is currently taking one tablet of Metoprolol Tartrate 50 mg two times a day, unless Resident #1’s BR is less than 60 or Systolic Blood Pressure is less than 100. Resident #1’s doctor’s order for Loperamide 2 mg take one capsule by mouth four times daily as needed with a start date of 11/21/17. Resident #1’s MOR shows that Resident #1 is currently taking one capsule of Loperamide 2 mg by mouth every six hours as needed. Resident #1 had no doctor’s order on file for Temazepam 15 mg, despite it being listed on Resident #1°’s MOR. 38. On 12/15/17 at 1:36 PM, an interview was conducted with Facility Staff A. When asked about Resident #1, Staff A stated that she was not aware that Resident #1’s medications (Lorazepam, Metoprolol, Loperamide, and Levothyroxine were changed on 11/21/17. Staff A stated that all doctor orders go to the Administrator and they make the necessary changes or updates to the medication record and then update the medical technologists as to the changes to include the start date and/or discharged medication, if any. Staff A stated, “If the Administrator or Manager does not notify the staff of medication changes, there is no way that staff would have known of the orders.” In reference to Resident #1’s medication refusals, Staff A stated, “staff notified the Manager and Owner of Resident refusing [Resident #1°s] medication, but she only documented the information on the back of the medication record and did not note it on [Resident #1’s] observation log that she reported it to management.” Staff A said that she was not sure if the Manager or Owner contacted Resident #1’s physician or family during the earlier part of December. She said that the doctor visits the Facility to provide care and treatment on 11 occasion, but she was not sure of the date of his last visit. No documentation is on file related to physician’s visits to the Facility for the month of November and December. Regarding the incident with Resident #1 going to the hospital via emergency medical services, Staff A said that Resident #1’s son was called due to Resident #1’s decline and Resident #1’s son told staff to call 911 for medical attention, so they did. Staff A stated, “Resident had not been eating or taking [Resident #1’s medication] for many days. Information regarding Resident not eating was not put in staff communications logbook. The communications logbook is kept in the Administrator’s office.” 39. On 12/15/17 at 3:07 PM, an interview was conducted with the Facility’s Administrator. The Administrator stated, “I am new here and unaware of the location of resident files, the communication logbook, how changes in medication orders are handled, and if the physician was notified of the five resident medication refusals prior to the notification made today by the son of [Resident #1] to call 911 for his [parent]. I will contact the Owner to address those questions for you because I’m still learning this Facility.” 40. On 12/15/17 at 5:15 PM, an interview was conducted with the Facility’s Owner. The Owner stated, “I have been through three administrators and I don’t know where anything is. I have to call my son.” The Owner said that the doctor conducts visits to the Facility monthly, but she does not know when. When asked for any supporting documentation, she stated, “I don’t have any because it’s not written down.” When asked for the location of the observation logbook, she stated, “I have to call and ask my son.” When asked for supporting documentation of notification made to Resident #1’s primary care physician and family in regards to Resident #1’s refusals of medication from 12/1/17-12/15/17, she stated, “I am not aware of any documentation. I will call and ask my son.” The Owner said that all of the information should have been written down, but she does not know where and she has to look for it. 12 41. On 12/15/17, a record review was conducted on Resident #4’s MOR and file. Resident #4’s MOR listed Mirtazapine 30 mg take one tablet by mouth at bedtime. Resident #4’s file contained a doctor’s order dated 11/27/17 ordering a decrease in Mirtazapine to 15 mg. However, as of 12/15/17, Resident is still receiving the 30 mg dose. 42. On 12/15/17 a record review was conducted on Resident #4’s MOR and file. Resident #4’s file contained a doctor’s order to start Melatonin 5 mg. However, Resident #4’s MOR shows that Resident #4 did not receive Melatonin until 12/8/17. 43, On 12/15/17 a record review was conducted on Resident #4’s MOR and file. No other documentation was located in Resident #4’s file to show compliance with Resident #4 receiving each of the following medications: Clopidogrel 75 mg, Escitalopram 20 mg, Ferrous Sulfate EC 325 mg, Lisinopril 2.5 mg, Pantoprazole 40 mg, Vitamin B12 250 mcg, Vitamin D2 5,000 units, Mapap 325 mg, Fenofibrate 160 mg, and Pravastatin NA 20 mg. 44. On 12/15/17 at 2:07 PM, an interview was conducted with Facility’s Staff A. In regards to Resident #4’s medication refusals during December 2017, Staff A said that documentation was made under the nurse’s medication notes on the back of Resident #4’s medication record. Staff A stated, “The refusal of medication was not placed on any other form regarding the refusals. The refusals were brought to the attention of the Administrator and Manager. I am not sure if they notified the primary care physician or the Resident’s family.” Staff A said that she was not aware that Resident #4 had a change in medication on 11/27/17 because the Administrator did not update the medication record or notify the staff. She said that she can only go by what the medication records say when assisting with the self-administration of medication. 45. On 12/15/17, Staff A was observed discussing the medication changes with the Facility’s Administrator, but he is unaware of the changes and cannot locate the needed 13 information. He stated that he would call the Facility’s Owner for assistance to address the issue. 46. On 12/15/17 at 5:25 PM, an interview was conducted with the Facility’s Owner. The Owner stated that she does not know if the primary care physician or family had been contacted about resident medication refusals. She stated that she has been through many administrators and has no idea where the documentation is located to verify if contacts were made to notify the doctor or the family as needed. 47. The Respondent’s actions, or inactions, constitute a class II violation. 48. Class "II" violations are those conditions or occurrences related to the operation and maintenance of a facility or to the personal care of residents which the agency determines directly threaten the physical or emotional health, safety, or security of the facility residents, other than class I violations. § 429.19(2)(b), Fla. Stat. (2017). Remedy 49. Under Florida law, as a penalty for any violation of this part, authorizing statutes, or applicable rules, the Agency may impose an administrative fine. § 408.813(1), Fla. Stat. (2017). 50. Under Florida law, In addition to the requirements of part II of chapter 408, the agency shall impose an administrative fine in the manner provided in chapter 120 for the violation of any provision of Part I of Chapter 429, part II of chapter 408, and applicable rules by an assisted living facility, for the actions of any person subject to level 2 background screening under s. 408.809, for the actions of any facility employee, or for an intentional or negligent act seriously affecting the health, safety, or welfare of a resident of the facility. § 429.19(1), Fla. Stat. (2017). si. Under Florida law, Each violation of Part I of Chapter 429 and adopted rules shall be classified according to the nature of the violation and the gravity of its probable effect on facility residents. The agency shall indicate the classification on the written notice of the violation as follows: Class “II” violations are defined in s. 408.813. The agency shall impose an administrative fine for a cited class IT violation in an amount not less than $1,000 and not exceeding $5,000 for each violation. § 429.19(2)(b), Fla. Stat. (2017). WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, seeks to impose an administrative fine of $5,000.00 against the Respondent. COUNT IIT Medication-Labeling and Orders 52. Under Florida law, (7) MEDICATION LABELING AND ORDERS. (a) The facility may not store prescription drugs for self-administration, assistance with self-administration, or administration 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 in the container. (b) Except with respect to the use of pill organizers as described in subsection (2), no individual 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 must 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 must 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, must be noted in the medication record, or a revised label must 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 or electronic copy of such order. The new directions must promptly be recorded in the resident’s medication observation record. The facility may then place an “alert” label on the medication container that directs staff to examine the revised directions for use in the medication observation record, 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 is must obtain a written medication order from the health care provider within 10 working days. A faxed or electronic copy of a signed order is acceptable. (f) The facility must 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 61N-1.006, 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 must 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 must 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 must provide the resident with a written prescription, or a faxed or electronic copy of such order. Fla. Admin. Code R. 58A-5.0185(7). 53. | Onor about 12/15/17, the Agency conducted a survey of the Facility. 54, Based on record review, interview, and observation, the Facility failed to promptly update changes in directions for use of medication on the MOR for 2 of 6 residents (Resident #1 and #4). 55. On 12/15/17, a record review was conducted on Resident #1’s MOR. Resident #1’s MOR indicated that, from 12/1/17-12/15/17, Resident #1 had refused the following medications: Amlodipine Besylate 10 mg, Aspirin 81 mg, Levothyroxine 25 mg, Lisinopril 20 mg, Metoprolol tartrate 25 mg, Diclofenac 75 mg, Quetiapine Fumarate 200 mg, Lorazepam .5 mg, and Temazepam 15 mg. 56. On 12/15/17, a record review was conducted on Resident #1’s file. No documentation was found showing that Resident #1’s primary care physician or family had been contacted regarding Resident #1’s refusal of medication. 57. On 12/15/17, a record review was conducted on Resident #1’s_ file. Documentation was found showing that Resident #1 was in the hospital from 12/2/17-12/4/17. 58. On 12/15/17, a record review was conducted on Resident #1’s file. The doctor’s orders found during this review did not completely match Resident #1’°s MOR for multiple medications. Resident #1’s doctor’s order for Levothyroxine 25 mg with a start date of 11/21/17 take one tablet by mouth every morning one hour before breakfast. Resident #1’°s MOR shows that Resident #1 is currently taking one tablet of Levothyroxine 25 mg daily at 8 AM, after breakfast. Resident #1’s doctor’s order for Lorazepam .Smg take one tablet by mouth every 12 hours with a start date of 11/21/17. Resident #1°s MOR shows that Resident #1 is currently taking one tablet of Lorazepam .5 mg by mouth twice a day, at 8 AM and at 5 PM. Resident #1’s doctor’s order for Metoprolol Tartrate 25 mg take one tablet by mouth two times a day with a start date of 11/21/17. Resident #1’s MOR shows that Resident #1 is currently taking one tablet of Metoprolol Tartrate 50 mg two times a day, unless Resident #1’s BR is less than 60 or Systolic Blood Pressure is less than 100. Resident #1’s doctor’s order for Loperamide 2 mg take one capsule by mouth four times daily as needed with a start date of 11/21/17. Resident #1’s MOR shows that Resident #1 is currently taking one capsule of Loperamide 2 mg by mouth every six hours as needed. Resident #1 had no doctor’s order on file for Temazepam 15 mg, despite it being listed on Resident #1’s MOR. 59. On 12/15/17 at 1:36 PM, an interview was conducted with Facility Staff A. When asked about Resident #1, Staff A stated that she was not aware that Resident #1’s medications (Lorazepam, Metoprolol, Loperamide, and Levothyroxine were changed on 11/21/17. Staff A stated that all doctor orders go to the Administrator and they make the necessary changes or updates to the medication record and then update the medical technologists as to the changes to 17 include the start date and/or discharged medication, if any. Staff A stated, “If the Administrator or Manager does not notify the staff of medication changes, there is no way that staff would have known of the orders.” In reference to Resident #1’s medication refusals, Staff A stated, “staff notified the Manager and Owner of Resident refusing [Resident #1’s] medication, but she only documented the information on the back of the medication record and did not note it on [Resident #1’s] observation log that she reported it to management.” Staff A said that she was not sure if the Manager or Owner contacted Resident #1’s physician or family during the earlier part of December. She said that the doctor visits the Facility to provide care and treatment on occasion, but she was not sure of the date of his last visit. No documentation is on file related to physician’s visits to the Facility for the month of November and December. Regarding the incident with Resident #1 going to the hospital via emergency medical services, Staff A said that Resident #1’s son was called due to Resident #1’s decline and Resident #1’s son told staff to call 911 for medical attention, so they did. Staff A stated, “Resident had not been eating or taking [Resident #1°s medication] for many days. Information regarding Resident not eating was not put in staff communications logbook. The communications logbook is kept in the Administrator’s office.” 60. On 12/15/17 at 3:07 PM, an interview was conducted with the Facility’s Administrator. The Administrator stated, “I am new here and unaware of the location of resident files, the communication logbook, how changes in medication orders are handled, and if the physician was notified of the five resident medication refusals prior to the notification made today by the son of [Resident #1] to call 911 for his [parent]. I will contact the Owner to address those questions for you because I’m still learning this Facility.” 61. On 12/15/17 at 5:15 PM, an interview was conducted with the Facility’s Owner. The Owner stated, “I have been through three administrators and I don’t know where anything is. 18 I have to call my son.” The Owner said that the doctor conducts visits to the Facility monthly, but she does not know when. When asked for any supporting documentation, she stated, “I don’t have any because it’s not written down.” When asked for the location of the observation logbook, she stated, “I have to call and ask my son.” When asked for supporting documentation of notification made to Resident #1’s primary care physician and family in regards to Resident #1’s refusals of medication from 12/1/17-12/15/17, she stated, “I am not aware of any documentation. I will call and ask my son.” The Owner said that all of the information should have been written down, but she does not know where and she has to look for it. 62. On 12/15/17, a record review was conducted on Resident #4’s MOR and file. Resident #4’s MOR listed Mirtazapine 30 mg take one tablet by mouth at bedtime. Resident #4’s file contained a doctor’s order dated 11/27/17 ordering a decrease in Mirtazapine to 15 mg. However, as of 12/15/17, Resident #4 is still receiving the 30 mg dose. 63. Surveyor contacted the prescribing physician to inquire about possible side effects due to Resident #4 still receiving the 30 mg dose of Mirtazapine. Surveyor left a message to return call to Surveyor, but Surveyor has yet to receive an answer. A recorded message stated that ail calls would be returned within 48 hours. 64. On 12/15/17 a record review was conducted on Resident #4’s MOR and file. Resident #4’s file contained a doctor’s order to start Melatonin 25 mg. However, Resident #4’s MOR shows that Resident #4 did not receive Melatonin until 12/8/17. 65. On 12/15/17 a record review was conducted on Resident #4’s MOR and file. No other documentation was located in Resident #4’s file to show compliance with Resident #4 receiving each of the following medications: Clopidogrel 75 mg, Escitalopram 20 mg, Ferrous Sulfate EC 325 mg, Lisinopril 2.5 mg, Pantoprazole 40 mg, Vitamin B12 250 meg, Vitamin D2 5,000 units, Mapap 325 mg, Fenofibrate 160 mg, and Pravastatin NA 20 mg. 19 66. On 12/15/17 at 2:07 PM, an interview was conducted with Facility’s Staff A. In regards to Resident #4’s medication refusals during December 2017, Staff A said that documentation was made under the nurse’s medication notes on the back of Resident #4’s medication record. Staff A stated, “The refusal of medication was not placed on any other form regarding the refusals. The refusals were brought to the attention of the Administrator and Manager. I am not sure if they notified the primary care physician or the Resident’s family.” Staff A said that she was not aware that Resident #4 had a change in medication on 11/27/17 because the Administrator did not update the medication record or notify the staff. She said that she can only go by what the medication records say when assisting with the self-administration of medication. 67. On 12/15/17, Staff A was observed discussing the medication changes with the Facility’s Administrator, but he is unaware of the changes and cannot locate the needed information. He stated that he would call the Facility’s Owner for assistance to address the issue. 68. On 12/15/17 at 5:25 PM, an interview was conducted with the Facility’s Owner. The Owner stated that she does not know if the primary care physician or family had been contacted about resident medication refusals. She stated that she has been through many administrators and has no idea where the documentation is located to verify if contacts were made to notify the doctor or the family as needed. 69. The Respondent’s actions, or inactions, constitute a class II violation. 70. Class "II" violations are those conditions or occurrences related to the operation and maintenance of a facility or to the personal care of residents which the agency determines directly threaten the physical or emotional health, safety, or security of the facility residents, other than class I violations. § 429.19(2)(b), Fla. Stat. (2017). 20 Remedy 71. Under Florida law, as a penalty for any violation of this part, authorizing statutes, or applicable rules, the Agency may impose an administrative fine. § 408.813(1), Fla. Stat. (2017). 72. Under Florida law, In addition to the requirements of part II of chapter 408, the agency shall impose an administrative fine in the manner provided in chapter 120 for the violation of any provision of Part I of Chapter 429, part II of chapter 408, and applicable rules by an assisted living facility, for the actions of any person subject to level 2 background screening under s. 408.809, for the actions of any facility employce, or for an intentional or negligent act seriously affecting the health, safety, or welfare of a resident of the facility. § 429.19(1), Fla. Stat. (2017). 73. Under Florida law, Each violation of Part I of Chapter 429 and adopted rules shall be classified according to the nature of the violation and the gravity of its probable effect on facility residents. The agency shall indicate the classification on the written notice of the violation as follows: Class “II” violations are defined in s. 408.813. The agency shall impose an administrative fine for a cited class II violation in an amount not less than $1,000 and not exceeding $5,000 for each violation. § 429.19(2)(b), Fla. Stat. (2017). WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, seeks to impose an administrative fine of $5,000.00 against the Respondent. CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida, Agency for Health Care Administration, respectfully seeks an order that: 1. Makes findings of fact and conclusions of law in favor of the Agency. 2s Imposes the remedy set forth above. 21 Respectfully Submitted, - ‘< (?, f / Lz Y Poe ae Carlton Enfinger, I, Cf Florida Bar No. 793450 / y "Ns Maurice T. Boetger, Assistant General Counsel Florida Bar No. 0125192 Office of the General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 7 Tallahassee, Florida 32308 Telephone (850) 412-3658 Facsimile (850) 513-0616 Email: carlton.enfinger@ahca.myflorida.com NOTICE Pursuant to Section 120.569, F.S., any party has the right to request an administrative hearing by filing a request with the Agency Clerk. In order to obtain a formal hearing before the Division of Administrative Hearings under Section 120.57(1), F.S., however, a party must file a request for an administrative hearing that complies with the requirements of Rule 28-106.2015, Florida Administrative Code. Specific options for administrative action are set out in the attached Election of Rights form. The Election of Rights form or request for hearing must be filed with the Agency Clerk for the Agency for Health Care Administration within 21 days of the day the Administrative Complaint was received. If the Election of Rights form or request for hearing is not timely received by the Agency Clerk by 5:00 p.m. Eastern Time on the 21st day, the right to a hearing will be waived. A copy of the Election of Rights form or request for hearing must also be sent to the attorney who issued the Administrative Complaint at his or her address. The Election of Rights form shall be addressed to: Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, Mail Stop 3, Tallahassee, FL 32308; Telephone (850) 412-3630, Facsimile (850) 921-0158. Any party who appears in any agency proceeding has the right, at his or her own expense, to be accompanied, represented, and advised by counsel or other qualified representative. Mediation under Section 120.573, F.S., is available if the Agency agrees, and if available, the pursuit of mediation will not adversely affect the right to administrative proceedings in the event mediation does not result in a settlement. 22 CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of the Administrative Complaint and Election of Rights form were served to the below named persons/entities by the method y designated on this he Wrsory of January, 2018. Florida Bar No. 793450 7 Maurice T. Boetger, Assistant General Counsel Florida Bar No. 0125192 Office of the General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 7 Tallahassee, Florida 32308 Telephone (850) 412-3658 Facsimile (850) 513-0616 Email: carlton.enfinger@ahca.myflorida.com Administrator | Helen Y. Romero, Registered Agent Good Samaritan Retirement Home Good Samaritan Retirement Home 507 SE Ist Ave. 1025 West Oak Ridge Road Williston, Florida 32696 Orlando, FL 32809 | (Certified U.S. Mail) (Certified U.S. Mail) 9489 0050 OOe? £039 O4L5 41 9449 oOF0 O27? £039 OF15 54 23 STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION Re: PRY, Inc., d/b/a Good Samaritan ACHA No. 2018000134 Retirement Home ELECTION OF RIGHTS This Election of Rights form is attached to an Administrative Complaint. It may be returned by mail or facsimile transmission, but_must_be received by the Agency Clerk within 21 days, by 5:00 pm, Eastern Time. of the day you received the Administrative Complaint. If your Election of Rights form or request for hearing is not received by the Agency Clerk within 21 days of the day you received the Administrative Complaint, you will have waived your right to contest the proposed agency action and a Final Order will be issued imposing the sanction alleged in the Administrative Complaint. (Please use this form unless you, your attorney or your representative prefer to reply according to Chapter120, Florida Statutes, and Chapter 28, Florida Administrative Code.) Please return your Election of Rights form to this address: Agency for Health Care Administration Attention: Agency Clerk 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308 Telephone: 850-412-3630 Facsimile: 850-921-0158 PLEASE SELECT ONLY 1 OF THESE 3 OPTIONS OPTION ONE (1) I admit to the allegations of fact and conclusions of law alleged in the Administrative Complaint and waive my right to object and to have a hearing. I understand that by giving up the right to object and have a hearing, a Final Order will be issued that adopts the allegations of fact and conclusions of law alleged in the Administrative Complaint and imposes the sanction alleged in the Administrative Complaint. OPTION TWO (2) I admit to the allegations of fact alleged in the Administrative Complaint, but wish to be heard at an informal proceeding (pursuant to Section 120.57(2), Florida Statutes) where I may submit testimony and written evidence to the Agency to show that the proposed agency action is too severe or that the sanction should be reduced. OPTION THREE (3) I dispute the allegations of fact alleged in the Administrative Complaint and request a formal hearing (pursuant to Section 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 to 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. It must be 24 received by the Agency Clerk at the address above within 21 days of your receipt of this proposed agency 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. The name, address, telephone number, and facsimile number (if any) of the Respondent. 2. The name, address, telephone number and facsimile number of the attorney or qualified representative of the Respondent (if any) upon whom service of pleadings and other papers shall be made. 3. A statement requesting an administrative hearing identifying those material facts that are in dispute. If there are none, the petition must so indicate. 4. A statement of when the respondent received notice of the administrative complaint. 5. A statement including the file number to the administrative complaint. Mediation under Section 120.573, Florida Statutes, may be available in this matter if the Agency agrees. Licensee Name: Contact Person: Title: Address: Number and Street City Zip Code Telephone No. Fax No. E-Mail (optional) I hereby certify that I am duly authorized to submit this Election of Rights form to the Agency for Health Care Administration on behalf of the licensee referred to above. Signed: Date: Printed Name: Title: 25 USPS.com® - USPS Tracking® Results Page | of 3 FAQs > (http://faq.usps.com/?articleld=220900) USPS Tracking’ Track Another Package + Remove X Tracking Number: 9489009000276039091 541 Expected Delivery on TUESDAY 16 2" soopmo Y Delivered January 16, 2018 at 1:54 pm Delivered, Left with individual WILLISTON, FL 32696 Get Updates \v Text & Email Updates Tracking History Product Information See Less A https://tools.usps.com/go/TrackConfirmAction?tRef=fullpage&tLco=2&text28777=&tLab... 01/31/2018 USPS.com® - USPS Tracking® Results Page | of 3 FAQs > (http://faq.usps.com/?articleld=220900) USPS Tracking’ Track Another Package + Tracking Number: 9489009000276039091558 Remove X Your item was delivered to an individual at the address at 12:40 pm on January 17, 2018 in ORLANDO, FL 32809. Y Delivered January 17, 2018 at 12:40 pm Delivered, Left with Individual ORLANDO, FL 32809 Get Updates \v Text & Email Updates Vv Tracking History Vv Vv Product Information See Less NA Can’t find what you’re looking for? Go to our FAQs section to find answers to your tracking questions. https://tools.usps.com/go/TrackConfirmAction?tRef-fullpage&tLco=2&text28777=&tLab... 01/31/2018

Docket for Case No: 18-002150