STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION. , : — . : bh «> STATE OF FLORIDA, Ox SG So Sct, % ne AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, vs. Case No. 2008010444 GULF COAST HEALTH CARE ASSOCIATES, LLC, d/b/a Sea Breeze Health Care, Respondent / ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “Agency”), by and through the undersigned counsel, and files this Administrative Complaint against GULF COAST HEALTH CARE ASSOCIATES, LLC, d/b/a Sea Breeze Health Care (hereinafter “Respondent”), pursuant to §§120.569 and 120.57 Florida Statutes (2008), and alleges: NATURE OF THE ACTION This is an action to impose an administrative fine in the amount of $2,500.00, based upon Respondent being cited for one State Class II deficiency. JURISDICTION AND VENUE 1. The Agency has jurisdiction pursuant to §§ 120.60 and 400.062, Florida Statutes (2008). 2. Venue lies pursuant to Florida Administrative Code R. 28-106.207. . PARTIES 3. The Agency is the regulatory authority responsible for licensure of nursing homes and " enforcement of applicable federal regulations, state statutes and rules governing skilled nursing facilities pursuant to the Omnibus Reconciliation Act of 1987, Title IV, Subtitle C (as amended), Chapter 400, Part I, Florida Statutes, and Chapter 59A-4, Florida Administrative Code. 4. Respondent operates a 120-bed nursing home, located at 1937 Jenks Avenue, Panama City, Florida 32405, and is licensed as a skilled nursing facility (license # 11870961). 5. Respondent was at all times material hereto, a licensed nursing facility under the licensing authority of the Agency, and was required to comply with all applicable rules and statutes. COUNT I RESPONDENT’S FACILITY FAILED TO ENSURE THAT THE RESIDENTS RECEIVED ADEQUATE AND APPROPRIATE HEALTH CARE BY FAILING TO CHANGED INCONTINENT BRIEFS/PULL-UPS §§ 400.102(1) and 400.022(1)(), Florida Statutes (2008) ISOLATED CLASS II DEFICIENCY 6. The Agency re-alleges and incorporates paragraphs one (1) through five (5), as if fully set forth herein. 7. Florida law provides the following: Section 400.102(1), F.S., “In addition to the grounds listed in part II of chapter 408, any of the following conditions shall be grounds for action by the agency against a licensee: (1) An intentional or negligent act materially affecting the health or safety of residents of the facility...” Section 400.022(1)()), F.S.: “All licensees of nursing home facilities shall adopt and make public a statement of the rights and responsibilities of the residents of such facilities and shall treat such residents in accordance with the provisions of that statement. The statement shall assure each resident the following: The right to receive adequate and appropriate health care and protective and support services, including social services; mental health services, if available; planned recreational activities; and therapeutic and rehabilitative services consistent with the resident care plan, with established and recognized practice standards within the community, and with rules as adopted by the agency.” 8. That the Agency conducted an unannounced complaint investigation on August 7, 2008. 9. Based on observation, interview and record review the facility failed to ensure that the residents received adequate and appropriate health care by failing to change the residents’ incontinent briefs/pull-ups after soiling. The Respondent facility’s failure to change the residents’ soiled briefs led to skin breakdowns, specifically excoriations and skin rashes in groin areas. In an effort to cut cost, staff changed the brief/pull up infrequently and only when saturated for 4 of 14 sampled residents (residents #1,2,3,8). This resulted in harm for 3 of the 4 residents (residents #1,2,3) in the form of skin rashes from the exposure to urine. The findings include: 1. An observation of resident #2 during wound care on 8/7/08 at 10:15 A.M. revealed the resident's brief was soiled and that the resident had a Stage 3 pressure sore to the coccyx area. The wound had a thick brown drainage and a foul odor. During an interview with the resident on 8/7/08 at 2:00 P.M. he/she stated that he/she was told that the facility was rationing briefs and that he/she would receive only 2-3 briefs a day. The resident stated he/she had spoken with the staff about his/her concems with this new policy without a resolution. The resident had been told by the physician that it was important to stay clean and dry to prevent contamination of the Stage 3 pressure sore, but the resident also stated that when the aides come in to check him/her they said "you aren't that wet" because the line on the brief had not completely changed colors. The aides would not change the resident until the line on the brief had completely changed color. The resident stated he/she had developed an excoriation/rash to the groin area and the aide was applying a cream. A review of the medical record revealed the resident is care planned for moisture barrier cream. The resident's MDS with ARD of 6/13/08 stated the resident's cognition is "0"- no impairment. The care plan stated the resident was dependent for toileting and is a Quadriplegic. The resident's MDS stated the resident was 4/3 or dependent in toileting with 2 person assist. The pressure sore had only gotten worse over time — the resident’s skin grid revealed the Pressure Sore had not decreased in size since 7/9/08. A review of the medical record revealed on 7/31/08 the nurse documented the pressure sore was without an odor. Then, the pressure sore was observed on 8/7/08 with a foul odor. 2. An interview with resident #1 on 8/7/08 at 10:30 a.m. revealed that the resident had a Stage 4 pressure sore to the coccyx with a wound vac. The resident was incontinent of bowel and had a Foley catheter. The resident stated when he/she turns on his/her right side the catheter will back up and leak and he/she experiences occasional bladder spasms which result in bladder leaks. The resident required a brief for bowel incontinence and urine leakage. The resident stated he/she was told by facility staff that he/she could only have 3 briefs a day, which was not adequate for his/her needs. The resident complained the lack of frequent changing of the brief resulted in skin breakdown to the groin area. The resident pulled back the covers to expose the area. The resident's groin area was red with a powder over the area. He/She stated the facility had been applying a cream to the area but then stopped. The resident told the nurse he/she still required the cream but the nurse stated the cream was only for a 2 week time period. The facility had not provided any further treatment to the reddened area. The resident had contacted a family member which brought him/her a bottle of Gold Bond powder to place on the redden area. The resident stated the area itched and was painful. A review of the resident's medical record revealed the cream mentioned was an antifungal cream which had been ordered for 14 days. The Physician Order Sheet (POS) contained orders for a Zinc Oxide cream to use As Needed (prn), which had not been applied. However, the medical record contained no assessment of the resident's red and irritated area near the groin. The resident's Quarterly MDS with an assessment reference date of 5/9/08 stated the resident's cognition was "0"- no impairment. The resident's toileting was a 4/3, meaning total dependence with 2 person assist. A review of the resident's medical record revealed a slow healing Stage 4 with minimal improvement since 7/16/08. 3. An interview with Resident #3 on 8/7/08 at 10:35 a.m. stated when he/she asked for some.“pull-ups” two weeks ago he/she was told they were all gone, he/she stated that he/she has tried to wear just one a day, but that doesn't work. The.resident has a colostomy that sometimes leaks. He/She also stated that he/she tried the diapers instead of the pull ups, but the diapers fit differently, come loose and leak. The . limitation on pull ups caused the resident to have a rash in the groin area and caused “water blisters.” A second interview with resident #3 on 8/7/08 at 4:05 p.m. revealed that he/she had a colostomy and a suprapubic catheter. These will often leak and the resident wears a pull-up to prevent the soiling of his/her clothes and embarrassing accidents. The resident stated the facility notified him/her that he/she would not receive any more pull ups. The resident stated the staff had stated the pull-ups were too expensive. The resident had spoken with the nurses and DON about his/her concerns about not receiving the pull-ups. The resident stated when he does not wear the pull up the stool and/or urine will get on his skin and it causes skin breakdown. A review of the resident's Quarterly MDS with the assessment reference date of 5/8/08 the resident is coded as cognitively intact -"0"- no impairment. The resident’s toileting is 2/2, meaning limited assist with one person assistance. A review of the skin grid for resident #3 revealed the resident had a Stage 3 pressure sore to the left buttock. The wound had not changed in measurements since 6/18/08. The resident also had a Stage 2 pressure sore to the right buttock. The wound had not changed in measurements since 6/18/08. 4. During an interview with resident #8 on 8/7/08 at 10:40 a.m., the resident stated the facility staff had told her she could only have 3 briefs/pull ups a day, which was not adequate for her needs. The resident needed the brief to prevent soiling of her clothes and urine on her skin. The resident stated she wears briefs at night because of the difficulty with transferring from the bed to the wheelchair, then to the toilet. The resident stated she had occasional voiding accidents and required more than 3 briefs a day. 5. An interview on 8/7/08 at 9:45 a.m. with the LPN stated that on 8/3/08 the facility had run out of diapers/briefs. The facility began a new process this past week, in which the briefs are locked up. The facility had only one key to the closet. The key was kept locked up on the South Unit in the medication cart. 6. An interview on 8/7/08 at 12:20 P.M. with an aide on the North Unit stated the Director of Nursing (DON) and Unit Managers had stated the budget had been reviewed and the residents. were using too many briefs and that each resident was to have only two briefs per day. The briefs have a line on the outside which changes color when they are wet. The aide is not to change the brief until the line turns a dark blue. The aides are to leave the brief on the resident if it is only a “little blue”, which indicated the resident had urinated but the brief was not saturated. The aides now have to go to the nurse and request a brief each time one is needed. 7. An interview with the Supply Clerk on 8/7/08 at 10:00 a.m. stated a new process had been implemented for the distribution of briefs and pull ups. The briefs were kept locked in central supply. The closet is set up with shelves for each shift. The 7-3 shift shelf contained 7 medium briefs, 14 large briefs, and 24 extra large briefs - for a total of 45 briefs. The 3-11 shelf contained 10 medium briefs and there were zero briefs on the 11-7 shelf. The 10 briefs were not included in the 45 briefs available for the 7-3 shift. An observation of the central supply area, which is separate from the supply closet, revealed the following number of briefs: Medium- 6 packs (20 each for 120 briefs) Large- 1 pack (15 briefs) Extra- Large- 2 packs (15 each for 30 briefs) _For a total of 165 briefs. The Supply Clerk confirmed these were all of the briefs stocked in the facility. The clerk reviewed with me the total number of briefs in each pack and total briefs on hand for each size. The supply clerk confirmed there were no other storage places for the briefs. There were a total of 220 briefs in the facility at 10:00 A.M. The facility’s 802 Form stated that there were 42 residents incontinent of bladder and 48 incontinent of bowel. That would provide approximately 4.5 briefs per incontinent resident (220/48= 4.5) The facility had no other briefs and an order was not placed for more until after this interview and observation. That order would not be delivered until at least the next day, so that would be 4.5 briefs per resident for approximately the next 24 hours. 8. An interview with the Administrator on 8/7/08 at 2:45 p.m. revealed that the facility had identified in June 2008 that they were over budget in the purchasing of briefs and that measures were put in place to decrease the use of briefs. A review of the "Detail Statement of Operations" stated the facility was budgeted for $1.50 per resident per day. The facility had spent $1.61 per resident per day. The facility was 11 cents over budget per resident in June 2008. The DON stated that the distribution of the briefs had been changed to prevent staff from over using the briefs. The DON also stated that staff and residents had not been told they could only have 2-3 briefs a day. Instead the policy was that the briefs were designed to be changed every 4 hours instead of every 2 hours. The residents who "dribble" were only to be given 2-3 pull ups a day. The DON stated that the briefs have a color strip which changes when saturated and the resident can stay in the same brief until the brief is saturated. The surveyor questioned if the resident is allowed to stay in a brief which is soiled with Urine for up to 4 hours. The DON stated if the resident urinated one time then it "doesn't mean they need to be changed." The DON also stated that the brief would not be changed until the line had changed color completely and was saturated. The DON was asked what color the brief would change to if it was completely saturated and she stated that was not sure. The DON stated the product sales representative told the staff that the resident’s briefs did not have to be changed for 4 hours and that the facility was using these to decrease costs. The staff had been “in- serviced” informally on the decreased need to change the briefs. 9. In an interview with a CNA on the South Wing at approximately 9:35 a.m. on 8/7/08, she stated that she has worked at the facility for 5 months and recently there has not been enough staff, supplies or "anything for the residents". She stated that the - diapers are now limited. She said that the diapers used to be kept in residents' bathrooms for easy access along with a towel, to permit ease of care for the residents. Now, the diapers are kept in the locked clean linen room and the CNAs must get the key, as only 2 diapers are allowed to be in a resident room at a time. This causes the CNAs to have to go back and forth more often so they have less time to help people. . She further states that this is a recent limitation on diapers as announced by the DON in a meeting, where the DON also told the staff that the diapers were made to be urinated in 2-3 times and to not change the diaper if the color strip does not change color, even if the.staff know the resident’s diaper is wet. An interview with the DON on 8/7/08 at 3:35 p.m. provided the information pamphlet from Med-line, the company which manufactures the briefs. The DON was questioned on the specific brand the facility was using as the pamphlet discussed many different types of brief and pull ups. The DON stated she did not know the types of briefs/pull-ups that the facility was currently using but she obtained the information from the Supply Clerk. The briefs were Ultra Soft Plus Briefs and Protection Plus Disposable Protective Underwear and the information in the pamphlet did not support the briefs/pull-ups could be changed every 4 hours or when saturated. 10. A review of the Medline web-site (www.medline.com) on August7, 2080, did not provide information of the ability to leave the briefs on the resident for 4 hours. The company does advertise an overnight brief for residents where the "benefits of a good night's sleep might outweigh the risk of not being checked and changed every 2 hours." This brief was for residents on 2 or more diuretics, combative, or other behavior issues. The company guidelines stated if this brief was to be used the resident's care plan should specify the times and justification for the use of the brief. A review of the purchase orders for July and August revealed the facility is not purchasing these briefs. The care plans for resident's #1, 2, 3sand 8's did not include an assessment for the use of the briefs. The web-site provided guidelines for incontinence care which included an individualized assessment of the resident for the best incontinence product to meet the resident's individual needs. This would include an assessment of the resident's type of incontinence, such as, Urge Incontinence, Stress Incontinence, Mixed Incontinence, Overflow Incontinence, Functional Incontinence, and Transient Incontinence. After the facility determined the type of incontinence an assessment of the resident's voiding pattern would be completed to determine the best type of product which would meet the resident's continence needs. The facility did not demonstrate the residents were assessed for their individual incontinence needs prior to the facility wide change in use of the briefs. Pursuant to s. 400.022(1)(1), F.S., the Respondent has a legal duty to provide adequate and appropriate health care, specifically, providing adequate and appropriate health care requires meeting the residents’ bodily function needs. Adequate health care dictates that the services provide are sufficient to keep the resident clean and dry. Appropriate care requires that the residents’ individual needs be met, including the need to have dry briefs and pull-ups for residents with skin conditions which are exacerbated by prolonged contact with feces or urine. 11. The Respondent failed to fulfill its duty to provide adequate and appropriate health care when it failed to timely change the wet brief of resident #2 which exacerbated a rash when it failed to change the briefs of resident #1 frequently enough to prevent skin breakdown in the groin area, when it failed to apply Zinc Oxide cream to resident #1, when it failed to assess the reddened area near resident #1’s groin, when it failed to provide resident #3 with enough pull- ups to prevent skin rash, when it ran out of diapers and briefs on August 3, 2008, and when the facility instructed the staff not to change the briefs until the color completely changed. The Respondent’s failure materially affected the health of the residents in that the failure to appropriately change diapers and pull ups caused skin rashes and caused skin irritation because the affected residents all require assistance for toileting as assessed by the Respondent, ranging from limited assistance to total dependence and thus were at a greater risk for complications from unchanged soiled and wet diapers and pull ups. The residents could not retrieve clean diapers/pull ups or change their soiled or wet diapers/pull ups. The mobility limitations of the affectéd residents also prevented them from independently and adequately providing any medical treatment to the irritated skin areas. Therefore, the facility’s obligation to provide adequate care to these dependent residents to prevent skin rashes and irritation included timely and sufficient provision of assistance in changing diapers/pull ups and in providing the actual diapers/pull ups in sufficient quantity. The skin rashes and irritations would not have occurred to the extent that they did if the Respondent had provided adequate assistance in changing soiled diapers and an adequate supply of diapers. Also, the Respondent failed to appropriately treat the irritated areas. 12. Pursuant to s. 400.102(1), F.S., any intentional or negligent act that materially affects the health or safety of a resident is grounds for administrative action. The Respondent has been cited for multiple acts, international or negligent, that materially affected the health of its residents. The Agency has supported its citations with specific factual findings that support the alleged deficiencies. Therefore, the Agency’s requested relief should be granted. 13. The Agency provided Respondent with the mandatory correction date for this deficient practice of September 7, 2008. WHEREFORE, the Agency intends to impose an administrative fine in the amount of $2,500.00 against Respondent, a skilled nursing facility in the State of Florida, pursuant to §§ 400.23(8)(b) and 400.102, Florida Statutes (2008). CLAIM FOR RELIEF WHEREFORE, the State of Florida, Agency for Health Care Administration, respectfully requests that this court: (A) Make factual and legal findings in favor of the Agency on Count I; (B) Recommend an administrative fine against Respondent in the amount of $2,500 for Count I, an isolated Class II deficiency; (C) Respondent still owes an administrative fine in the amount of $5,000 due to a previous Final Order dated November 27, 2007 for an isolated Class II deficiency; . (D) Assess attorney’s fees and costs; and (E) Grant all other general and equitable relief allowed by law. Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes. Specific options for administrative action are set out in the attached Election of Rights form. All requests for hearing shall be made to. the attention of Richard Shoop, Agency Clerk, Agency for Health Care Administration, 2727 Mahan Drive, MS #3, Tallahassee, Florida 32308, (850) 922-5873. If you want to hire an attorney, you have the right to be represented by an attorney in this matter. 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. Respectfully submitted this Ga day of October, 2008. , Mark Hinely Fla. Bar.48084 ; Agency for Health Care Administration 2727 Mahan Drive, MS #3 Tallahassee, Florida 32308 850.922.5873 (office) 850.921.0158 (fax) 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. 7004 2890 0000 5526 8732 to: Facility Administrator Rodney C. Watford, Sea Breeze Health Care, 1937 Jenks Avenue, Panama City, Florida 32405, by U.S. Certified Mail, Return Receipt No. 7004 2890 0000 5526 8749 to: Owner Gulf Coast Health Care Associates, LLC, 10210 Highland Manor Drive, Suite 250, Tampa, Florida 33610, and by U.S. Certified Mail, Return Receipt No. 7004 2890 0000 5526 8756 to Registered Agent Corporation Service Company, 1201 Hays Street, Tallahassee, Florida 32301 on October 4, 2008: Mark Hinely Copy furnished to: Barbara Alford, FOM 8 CE MAIL. 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Docket for Case No: 08-005652