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STATE OF FLORIDA

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I AGENCY FOR HEALTH CARE ADMINISTRATION

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STATE OF FLORIDA, AGENCY FOR

HEALTH CARE ADMINISTRATION,

·Petitioner,

. vs. Case Nos. 2011000688

2011000689

ROYAL OAK NURSING CENTER, LLC d/b/a·

ROYAL OAK NURSING CENTER,

Respondent.

ADMINISTRATIVECOMPLAINT

COMES NOW the Agency for Health Care Administration (hereinafter "Agency''), by

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and fh;rough the undersigned counsel, and files this·Administrative Complaint against Royal Oak

_ Nursu:ig Center, LLC d/b/a Royal Oak Nursing Center, (hereinafter "Respondent'1, pursuant to

§§120.569 and 120.57 Florida Statutes (2 10), an alleges:

NATURE OF THE ACTION

This is an action to chan e Respondent's licensure status from standard to conditional commencing December 17, 2010 and ending January 17, 2011,° to impose an adrnimstrative fine in the·amount of twenty thousand dollars ($20,009.00), to impose a six month survey cycle, and assess a survey fee of six thousand dollars ($6,00.0.00), based upon Respondent being cited for two (2) Isolated State Class I deficiencies.

JURISDICTION AND VENUE

1. The Agency has jurisdiction pursuant to§§ 120.60 and 4.00.062, Florida Statutes (2010).

   
   

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   Filed April 13, 2011 4:12 PM Division of Administrative Hearings

   
   

2. Venue lies pursuant to Florida Administrative Code R. 28106.207.

   
   

   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 N,·Subtitle C (as amended), Chapters 400, Part II, and 408, Part II, Florida Statutes, and Chapter 59A-4, Florida

. Administrative Code.

4. Respondent operates a 120-bed nursing home, located at 37300 Royal Oak Lane, Dade City, Florida, 33525 and is licensed as a skilled nursing facility license number 14840962.

·S. 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!

1. The Agency re-alleges and incorporates paragraphs one (1) through five (S), as if fully set

   forth herein.

   
   

2. That pursuant to Florida law, all physician orders shall be followed as prescri9ed, and if not followed, the reason shall be recorded on the resident's medical record during that shift. Rule 59A-4.107(5), Florida Administrative Code.

3. ·That pursuant to Florida law, each facility shall adopt procedures that assure the accurate . acquiring, receiving, dispensing, and ·administeri of all drugs and biologicals, to meet the needs of each resident. Rule 59A-4.l12(1), Florida Administrative Code.

4. That based on observation, the review of records, and interview, Respondent failed to follow physician orders as prescribed and or failed to assure the accurate administration of all

   
   

   drugs and biologicals to three (3) of sixteen (16) sampled residents, said failures being contrary

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     J · . to the mandates of law.

     
     

5. That Petitioner's representative reviewed Respondent's records related to resident number three (3) during the survey and noted ·as follows:

   1. The facility face sheet records that the resident was admitted to the facility on August 25, 2010 after a hospitaljzation;

   2. The face sheet documented multiple diagnoses including: Chronic Airway Obstruction; Dementia; Chronic Ischemic (low blood flow) Heart Disease; ppor Cerebral. Vascular Accident (CVA) (stroke); Old Myocardial Infarction (heart attack); Chronic Kidney Disease, stage three; Diabetes and Diverticulitis of colon; .

   3. A copy of Do Not Resuscitate (DNR) order, signed by the resident and the resident's physician on September 9, 2010 was in the record;

   4. A physician's order dated September 9, 2010 at 2:20 p.m. directs the resident

      
      

      · to be sent to the emergency room for an evaluation of 11 • • • decreased 02

      
      

      . (oxygen);"

      
      

   5. The resident returned to the facility on September 12, 2010 with the fol owing admission orders: "Accept all transfer orders; Cou.madin 2.5 mg every Tuesday, Thursday, Saturday and Sunday; Coumadin 5 mg every Monday, Wednesday and Friday; sliding scale insulin coverage; and respiratory nebulizer treatments. every four hours as needed.11

   6. A printed laboratory report dated November 22, 2010 at 12:45 p.m. reflected

      
      

      the facility received Prothrombin Time/International Normalized Ratio (PT/INR) lab values: PT; 60.7, Verified by repeat. INR: 6.7;

      
      

   7. On November 22, 2010 at 1:30 p.m., the physician visited the resident and the physician's progress notes read: "Having loos_e BM since a.m. (Total of 4). INR is 6.7. Ciprofloxin 250 mg BID. x five d9ses for right lower lobe infiltrate... 11 and also noted the resident had a Clostridium Difficile infection;

   8. A physician's order dated November 22, 2010 was received for Warfarin (Coumadin): HOLD until next PT /INR results, which was scheduled for November 29, 2010;

   9. The above referenced physician's order is not reflected on the resident's

      November 2010 medication observation record by Respondent's staff licensed practical nurse ni.Unbei one (1};

      J• The resident's November 2010 medication observation record reflects that on

      _ -November 22,- 2010 at 5:00 p.m. Coumadin 2 mg was administered to the resident by Respondent's licensed practical nurse number two (2);

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      1. The resident's November 2010 medication observation record reflects that on November 23, 2010 at 5:00 p.m. Coumadin 2 mg was again administered to the resident by Respondent's licensed practical nurse number two (2);

         1. The resident's November 2010 medication observation record reflects that on November 24, 2010 at' 5 00 p.m. Coumadin 2 mg was again administered to the resident by Respondent's licensed practical nurse number three (3);

      1. A November 23, 2010 9;00 p.m. nurse's note documents that the resident was incontinent but there was no documentation of bloody stools;

      2. A November 24, 2010 2:00 p.m. nurse's note records that the loose stools continued with no mention of blood in the stool;

      3. A November 25, 2010 1:00 p.m. nurse's note records loose stools continued

         
         

         with no mention of blood present;

         
         

      4. A note of November 24, 2010, no time specified, reflects the nurse practitioner visited;

      .q. In the progress note, the nurse practitioner reported the resident had one loose stool that morning with a question of blood and mucus observed;

      1. The exam rev ed the abdomen to be ''.. , soft, benign, with vague complaints

         . of discomfort. I.I

      2. The resident's November 2010 medication observation record reflects that on November 25, 2010 at 5:00 p.m. the Coumadin 2 mg was held due to."rectal bleeding" as noted by Respondent's licensed practical nurse five (5);

      3. The residen.fs November 2010 medication observation record reflects that on November 26, 2010 at 5:00 p.m. the Coumadin 2 mg was again held due to

         •irectal bleeding11 as noted by Respondent's licensed practical nurse number

         five (5);

         
         

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      4. The resident's November 2010 medication observation record reflects that on November 27, ·2010 at 5:00 p.m. the Coumadin 2 mg was again held due to "rectal bleeding" as noted by Respondent's licensed practical nurse five (5);

      5. A nurse's notes by licensed practical nurse number five (5) dated November 25, 2010 at 7:00 p.m. documented, 11Dark, loose maroon colored stool...," the physician was called, and the note stated "otherwise stable.11

      6. At 8:00 p.m. on November 25, 2010? another nurse wrote th.at she attempted to cali the physician two times and was awaiting a return call, and n_oted that the resident had a poor appetite, low fluid intake, the skin wann and dry, and the temperature was 97.7;

         
         

         1. Absent from the record was any further documentation regarding attempts at physician contact or any telephone orders regarding this contact;

         2. Nursing notes of November 26, 2010 from 1he 11:00 p.m. through 7:00 a.m.' shift record that the resident continued to have loose stools;

         3. These notes reflect that vital signs were noted to be cq.anged, with no values recorded, and the resident complained of "not feeling well."

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      aa. Oxygen saturation level was documented at 96%;

      bb. · Absent from these notes was any documentation that the resident's physician

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      being notified of.the resident's·observed condition;

      cc. . A November 27, 2010 note documents that on said date at 11:45 a.m. the

      hurse called the physician;

      
      

      dd. At 11:50 a.m. on November 27, 2010, a nurse's note reflects that the doctor on. call was contacted and Stat orders for a Complete Blood Count (CBC) and a Basic Metabolic Panel (BMP) were obtained;·

      ee. At·12:tO p.m. on November 27, 2010, a nurse's note reflects that licensed practical nurse number two (2) noted that the resident continued to have blood in the stool and had a small amount of bloody emesis (vomit);

      ff. At 2:23 p.m. on November 27, 2010,·the lab reported a stool sample tested positive for C. Difficile toxin;

      gg. At 10:30 p.m. on November 27, 2010, the nurse's notes stated that the CBC and BMP lab results were reported and attempts were made to contact the physician at 7:00 pm., 8:00 p.m.t 8;45 p.m., and 10 p.m.

      hh. There was no documentation of attempts to notify the Respondent's directol' of nurses of the concerns regarding the physician contact;

      
      

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      There was no documentation of blood in.the stool;

      
      

      At 10:40 p.m. on November 27, 2010, the physician called and was informed

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      of the lab results and orders were received for: Flagyl 500 mg three times

      daily.and IV fluids of Normal Saline at 100 cc per hour for 24 hours;

      
      

      ·11:00 p.m.. November 27, 2010 nurse's notes indicate the IV was started;·

      
      

      A nurse's note of November 28, 2010 at 2:00 a.ni. states the resident was

      weak but alert with no documentation of bloody stools;

      
      

      mm. A nurse's note of November 28, 2010 at 7:45 a.m. by licensed nurse number one (I) records that the resident was found 11 ... in a pool of blood from the

      . rectal area.11 The physician and family were called. Emergency Medical Services was_ called to send the :resident to the hospital.

6. That Petitioner's representative interviewed Respondent's director of nurses on December 15, 2010 regarding resident number three (3) and the director indicated as follows:

   1. Respondent's licensed practical nurse number one (1) was on duty on November 29, 2010 and reported to the director of nurses that the nurse had

      .been taking the record apart for resident number three (3) when the nurse n ticed that the order of November 22, 2010 directing that Coumadin be held from the resident had not been transcribed to the resident's medication administration record;

   2. Licensed practical nurse number one (1) was tenninated by Respondent on November 29,201O;

   3. Licensed practical nurse number two (2), who administered the Coumadin to the resident on November 22 and 23, 2010 was also terminated by Respondent;

      
      

   4. Nurse number four (4), a night nurse responsible for the twenty-four (24) hour

      chart check was terminated two (2) days later for not catching the error;

   5. The resident's physician was informed on November 29, 2010 around midmorning and he immediately cmne to the facility and discussed the issue with her, the assistant director of nursing, the risk manager, and the

administrator.

• 12. That Petitioner's representative interviewed Respondent's medical director and physician

  
  

  ·for resident number three (3) on December 15 through 17 2010 regarding resident number three

  
  

  1. and the physician indicate(fas follows:

     
     

     1. He had been the attending physician for the resident;

        
        

     2. • He was on vacation the week of November 22, 2010, but he co sulted with

the other physicians in the practice and everyone was aware of the multiple

co-morbidities of the resident; .

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· c. He was unaware of the facility's failure to hold the Coumadin until he was informed on November 19, 2010, midmorning, by Respondent's director of nurs ;

1. He cam tothe facility to evaluate the record and the error;

2. He was aware of the termination of three (3) nurses;

3. He signed the resident's Death Certific te and provided a copy;

   
   

4. The primary cause of death was: Multiple Medical Problems of Aged with the secondary underlying issues of: Gastrointestinal Bleed (GI Bleed); Colostrium Difficile, Colitis, Diabetes Mellitus (DM), Coronary Artery Disease (CAD) and Chronic Kidney Disease (CKD);

   
   

5. During a review of the Death Certificate for resident number three (3) during

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the interview, he confirmed that GI - Bleed was listed as a secondary

underlying medical issue;

1, The physii;ian called his office and spoke with his partners during the

interview, and the physicians and nurse practitioner verified the facility did

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not verbalize concerns about rectal bleeding, but just the diarrhea;

j. The physicians in the pr_actice, including the nurse practiti ner, stated to him. that they did not have knowledge of the three additional doses of Coumadin and were treating the resident for the C. Difficile colitis and a lung infection.

1. That Petitioner's representative interviewed Respondent's assistant director of nmses during the survey regarding resident number three (3) who indicated that she was notified of the

   resident's transfer hut received .no follow up information and was informed of the resident' death on November 19, 2010 atarolllld 7:00 a.m..

2. That Petitioner's representative reviewed the · emergency medical services record contained in the hospital records of resident number three (3) and noted as follows:

   1. The ambulance arrived at the facility on November 28, 2010 at 7:56 a. .• nine (9} minutes after notification by the facility;

   2. The Chief Complaint was listed as: Respiratory Distress, Severe;

      
      

   3. The airway was noted as "Partially obstructed-Blood,1' and breathing was..

      
      

      ·tabored;

   4. Blood/Fluid loss was estimated at less than 100 cc.

3. Petitioner'-s re entative reviewed the hospital emergency room Initial Assessment Form contained in the hospital records of resident number three (3) and noted as follows:

   
   

   1. The Brief Assessment section stated that the resident was "found by the

      i nursing home staff hemorrhaging from the rectum and mouth.11

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   2. The resident was in an agonal cardiac rhythm and not breathing upon arrival

      
      

   3. The exam timed at 8:13 a.m. stated that the resident had _a high lNR and continued to receive Coumadin at the facility;

   4. · There was no ocumentation on the ER record of the presence of blood;

      
      

   5. The Clinical Impression was: DOA, (dead on arrival);

      
      

   6. The physician pronounced the time of death as 8:1S a.m.

4. That Petitioner's representative reviewed Respondent's records related to resident

   · nwnber fourteen (14) during the survey and noted follows:

   
   

   1. Per the facility face sheet, the res dent was admitted to the facility on January

      .30, 2009;

      
      

   2. Admitting diagnoses listed included: weakness, vascular disease, chronic heart disease, congestive heart failure (CHF), acute embolism (blood clot) and long tenn and current use of anticoagulants;

   3. · The resident's November 2010.medication administration record documented the resid t received.: Warfarin (Cournadin) 2.5 mg daily at·5:00 p.m.

   4. A lab report dated November 22, 2010 read as follows: PT: 56.2, verified by repeat INR: 6.1. Therapeutic range listed as 2.0 to 3.0. The bottom ofth lab slip contained a hand written note 1111/23/10 Coumadin on hold till INR <3.11 The report was signed, but illegible;

   5. A nurse's note of-November 22, 2010 at 12:00 p.m. provided the physician was notified and a telephone order was received to hold Warfarin 2.5 mg until

      
      

      
      

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      the INR was less than(<) 3 and continued "PT/INR scheduled to be rechecked

      
      

      Thursday 11/25/10."

      
      

      A November 22, 2010 12:00 p.m. telephone physician's order stated,

      
      

      . 11 arfarin 2.5 mg po daily is to be held until INR is <3. PT/INR scheduled to be rechecked on Thursday 11/25/10.11 ·

      g. The resident's November 2.010 medication administration record documented the_resident's Warfarin was held on November 22, 23, and 24, 2010 however the Warfarin was docwnented as given on November 25, 26, 27, 28, and 29,

      2010;

      
      

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      Absent from the record was any lab results for a PT/INR result of November 25, 2010;

      · A November 29, 2010 PT/INR test result reflected PT: 29.0, INR: 2.6

      A hand written note on the report stated· the results were called to the

      
      

      physician I s assistant (PA);

      
      

      k. No new orders were documented as obtained.

5. That Petitioner's representative interviewed Re·spondent's nurse caring for resident numbl';r fourteen (14) on November 22, 2010 who indicated as follows:

   1. She was unaware of the labs not being done on November 25, 2010;

.b. She checked the calendar and found that November 25, 2010 was a hol day

. and only stat labs were to be done;

1. She did not inform the physician of that finding;

   
   

2. She was unaware until now that the Coumadin was restarted on November 25,

   
   

   .2010 without the labs ordered by the physician;

   
   

   
   

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3. At the time she wrote the order she thought that the resident received ro tine, twice weekly PT/INR levels and Thursday, November 25, 2010 would have been the next test.

'18. Th.at the nurse above referenced and Respondent's director of nurses confinne that Coumadin (Warfarin) 2.5 mg, daily at 5:00 p.m., was restarted for resident numbei: fourteen (14) on November 25, 2010 without the ordered laboratory results or a physicians order to do so.

1. . That Petitioner's representative reviewed Respondent's records related to resident number four (4) during the survey and noted as follows:·

   1. Per the facility face sheet, the resident was admitted to the facility on· November 19, 2010;

   2. Admitting diagnoses included: Late effects of CVA (stroke), Dementia, Unspecified cerebral ischemia (loss of circulation the ·brain), Atrial Fibrillation, Diabetes with circulation diSQrder, Hypertension, and Congestive Heart Failure. (CHF);

   3. A physician's telephone order dated November 20 201O at 7:45 a.m. read "Warfarin (Coumadin) 2.5 mg po, QD (daily)."

   4. On November 24, 2010 at 10:26 a.m. a lab r the following: PT: 36.9 and INR: 3.9.

   5. A hand written notation at the bottom of the lab report stated: "11/24/10·

      
      

      Coumadin decreased (indicated·by downward arrow) to 2.0,,.

      
      

   6. The numbers were written over the initial value of 2.5.

      
      

   7. · . The note was not signed nor was a date and time written;

      
      

   8. A November 24, 2010 physician's telephone order, no time specified, stated to decrease the Coumadin to 2.0 mg daily at 5:00 p.m.

      
      

   9. The Registered Nurse in charge signed the order;

      
      

   10. The resident>s November 2010 medication administration records refle that on November 24, 2010 at 5:00 p.m. Cownadin (Warfarin) 2.5 mg· was recorded as given by Respondent's licensed practical nurse number four (4);

   11. A nurse's note dated November 24, 2010, at 8:30 p m. recorded an order was

       received to decrease-the Coumadin to 2.0 mg at 5 p.m. daily;

       
       

       1. The note was.signed-by Respondent's registered nurse charge nurse;

          . m. There was no·documentation regarding what time the physician contacted

          regarding the abnonnal lab values;

          
          

          1. A November 26, 2010 nurse's note of 3:00 P· ·. documented that the resident

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             was rest.ing quietly and refused to eat breakfast and lunch intake was 20%; •· .

             
             

          2. A November 26, 2010 ·nurse's note of 5:00 p.m. stated that the aide _was unable to hear the blood pressure;

          3. The physician was called;

             
             

          4. At 6:00 p.m., the physician's assistant returned the call and requested the resident be sent to the hospital for evaluation;

          5. The note said the family requested comfort measures only (CMO);

             
             

          6. The physician's assistant was informed of the resident's declining condition;

             
             

          7. On November 29, 2010 at 12:01 a.m., a nurse's notes revealed that she was called to the room to find the resident had n pulse or respirations;

          8. The physician and family was notified;

             
             

          9. A_ November 29, 2010 1:40 a.m. nurse's note indicated that the body was

          
          

          released to the funeral home.

          
          

2. That Petitioner,s representative interviewed Respondent'-s licensed practical nurse

   -1 number four (4) who was caring for resident. number four (4) during the survey and the nurse

   I indicated as follows:

   1. She was on duty on November 24,-2010 and administered Coumadin 2.5 mg. to the resident;

   2. · After the medication was given she becam aware of the elevated clotting lab values;

   3. She spoke with the Physician's Assistant (PA) after the medication was given and he was a · of the increased dose of Couniadin 2.5 mg given on November 24, 2010;.

   4. The physician'·s assistant stated to begin the decreased dose of Cownadin 2.0

      mg.

      
      

      e; She did not write the order to start the dose change on November 25, 2010.

3. That Petitioner's representative interviewed during the survey the physician's. assistanf who was aring for resident number four (4) who indicated as follows:

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   1. He was aware of the resident receiving Coumadin 2.5 mg on November 24,

      
      

      2010;

      
      

      - b. He gave the order to begin the decreased dose on November 25, 2010; •

      c. There was no indication of bleeding prior to the resident's death.

      
      

4. That the above reflects Respondent's failure to ensure that all physician orders- be

   • followed as prescribed and, if not followed, recording the reason therefore in Respondent's multiple incidents of failing to follow physician's orders related to ticoagulant therapies for three (3) identified residents, said failures constituting significant medication errors resulting in life threatening complications for the residents.

     
     

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5. That the Agency determined that these failures relate to a situation in which immediate corrective action is necessary because the facility's noncompliance has caused, or is likely to cause, se1ious injury, hann, impainnent, or death to a resident receiving care in a facility and cited this deficient practice as an Isolated State Class I deficiency.

WHEREFOREt the Agency seeks to impose an administrative fine in the amount of ten thousand dollars ($10,000.00) against Responden1, a skilled nursing facility in the State of Florida, pursuant to§ 400.23(8)(a), Florida Statutes (2010).

COUNT II

. 24. The Agency re-alleges and incorporates paragraphs one (!)-through five (5), as if fully set forth

· herein.

• 25. . That pursuant to Florida law, all licensees of nursing homes facilities shall adopt and µ,a.ke 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 right to receive adequate and appropriate health care and protective and support services, including · social services; mental health ser:vices, if available; planned recreational activities; and therapeutic and·

:i'(lhabilitative services consistent with the resident care plan, with established and recognized practice standards within the community, and with rules as adopted by the agency. § 400.022(1) (1), Fla. Stat. (2010).

1. That based upon the review of records, interview, and observation Respondent failed to

   
   

   provide 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, w.ith established and recognized practice

   standards withiJ:i the community for three (3) of sixteen (16) sampled residents, the same being contrazy

   to law.

   
   

2. That Petitioner's representative reviewed Respondent's records related to resident

   number three (3) d ing the survey and noted as follows:

   
   

   1. The facility face sheet records that the resident was admitted to the facility on August 45, 2010 after a hospitalization;

   2. The face sheet documenied multiple diagnoses including·: Chronic Airway

      
      

      Obstruction; . Dementia; Chronic IschemiQ (low blood flow) Heart Disease; prior Cerebral Vascular Accident (CVA) (stroke); Old Myocardial Infarction (heart attack); Chronic Kidney Disease, stage three; Diabetes and Diverticulitis of colon;

   3. A copy of a Do Not Resuscitate (l?N_R) order, signed by the resident and the resident's physician on September 9, 2010 was in the record;

   4. . . A physician's order dated September 9, 2010 at 2:20 p.m. directs the resident

      to be sent to the emergency room for an evaluation of 11 • • • decreased 02

      
      

      
      

   5. The resident returned to the facility on September·12, 2010 with the following admission orders: ''Accept all transfer orders; Coumadin 2.5 mg every Tuesday, Thursday, Saturday and Sunday; Coumadin S mg every Monday, Wednesday and Friday; sliding scale insulin coverage; and respiratory nebulizer treatments every four hours as needed.11

   6. A physician progress note dated November 1, 2010 stated that the INR was

      
      

      2.2 and the resident was taking Coumadin 2 mg daily;

      
      

   7. The physician noted one bowel movement per day. There was no mention of bloody movements;

   8. A November 2, 2010 monthly nursing summary report revealed that the

      
      

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      resident was alert with occasional confusion and forgetfulness, was described as continent, and page six of the summary stated "no loose stools in the past few.weeks.11

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   9. A .progress note of November 8, 2010 by a second physician.who visited the resident note that the resident had four loose stools since the morning, no

      · time specified on the note, and that it "smells like C: Diff."

      j, Under the "Plan" section, the physician wrote: Stool for C.Diff; Warfarin 2

      mg daily; Metrogyl (Flagyl) 500 mg three time daily (used to treat a C.Diff infection), and Lactobacillus, one capsule twice daily.

      k. November_ 8, 2010 lab results were: PT: 30.5; INR 2.8 with the lab report

      stating that the1NR therapeutic range was 2.0 to 3.0; -

      
      

      1. The physician noted on the lab report to continue the present dose of Coumadin, 2 mg.

      m; A nurse practitioner's progress note of November 15, 2010 indicated that the

      resident had a low-grade fever and vomiting and stated that the resident had "crackles right lung base."

      1. Intravenous medications were ordered;

         
         

      2. The labs of that day were: PT: 32.1; INR 3.0;

         
         

      3. The lab report contained a hand written note to continue Coumadin 2 mg.

      
      

      . q. On November 16, 2010, the nurse practitioner visited the resident and noted that the resident had "a few crackles1' in the right lung base and under the "Impression'' section, item #3, wrote "Pulmonary Embolism, On Coumadin. INR 3 0 today" with item #6 stating a history of C. Diff colitis;

      1. There was no documentation of bloody stools;

         
         

      2. A printed laboratory report dated November 22, 2010 at 12:45 p.m. reflected the facility received Prothrombin Timeflntemational Nonnalized Ratio (PT/INR) lab values: PT: 60.7, Verified by repeat. INR: 6.7

      3. On November 22, 20IO at 1:30 p.m., the physician visited the resident and the physician's -progress notes read: "Having loose BM since a.m. (fotal of 4). INR is 6.7. Ciprofloxin 250 mg BID x five doses for right lower lobe infiltrate... " and also noted the resident had a Clostridium Difficile infection;

      4. . A physician's order dated November 22, 2010 was received for Warfarin (Coumadin): HOLD until next PT /JNR. results, which was scheduled for November 29, 2010;

      5. The above referenced physician's order is not reflected on the resident's November 2010 medication observation record by Respondent's staff licensed practical nurse numb one (1);

      6. The resident's November 2010 medication observation record reflects that on November .22, 2010 at 5:00 p.m. Coumadin 2 mg was administered to the

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      i . resident by Respondent's licensed practical nurse number two (2);

      i x. The resident's November 2010.medication observation record reflects that on

      · November 23, 2010 at 5:00 p.m. Coumadin 2 mg was again administered to the resident by Respondent's licensed practical nurse number two (2);

      y. The resident's November 2010 medication observation record reflects that on November 24, 2010 at 5:00 p.m. Coumadin 2 mg was again administered to the resident by Respondent's licen_sed practical nurse number three (3);

      · z. A November 23, 2010 9:00 p.m. nurse's note documents that the resident was

      incontinent but there was no documentation of bloody stools;

      
      

      
      

      aa. A November 24, 2010 2:00 p.m. nurse's note records that the loose stools continued with no mention of blood in the stool;

      bb. A November 25, 2010 1:00 p.m. nurse's note records loose stoqls continued with no mention of blood present;

      cc. A note of November 24, 2010, no time specified, reflects the nurse

      
      

      _practitioner visited;

      dd. In the progress note, the nurse practitioner reported the resident had one loose

      stool that morning with a question of blood and mucus observed;

      ee. The exam revealed the abdomen to be 11••• soft, benign, with vague complaints

      of discomfort."

      
      

      ff. The resident's November 2010 medication observation record reflects that on

      _ November 25, 2010 at 5:0Q p.m. the Cownadin 2 mg was held due to ''rectal bleeding" as noted by Respondenf s licensed practical nurse five-(5);

      gg. The resident's Nov mber 2010 medication observation rec_oni"reflects that on November 26, 2010 at 5:00 p;m. the Coumadin 2 mg was again held due to 11rectal bleeding11 as noted by Respondent's licensed practical nurse number five (S);

      hh. The resident's November 2010 medication observation record reflects that on November 27, 2010 at 5:00 p.m. the Coumadin 2 mg was agam held due to "rectal bleedi g11 as noted by Respondent's licensed practical nurse- five (5);

      ii. A nurse's notes by licensed practical nurse number five (5) dated November 25, 2010 at 7:00 p.m. documented, "Dark, loose maroon colored stool...," the phyid ian was called, and the note stated "otherwise stable.11 ·

      jj. At 8:00 p.m. on November 25, 2010, another nurse wrote that she attempted.

      
      

      to call the physician two times and was awaiting a retµm call, and noted that the resident had a poor appetite, low fluid intake, the skin warm and dry, arid the temperature was 97.7;

      kk. Absent :from the record was any further documentation regarding attempts at physician contact or any telephone orders regarding this contact;

      11. Nursing not of November 26, 2010 from the 11: 0 p.m: through 7:00 a.m.

      shift record that the resident continued to have loose stools;

      mm. These notes reflect that vital signs were noted to be change·ct, with no values

      
      

      1 . recorded, and the resident complained of " at feeling well.11

      nn. Oxygen saturation level was documented at 96%;

      oo. Absent from the notes was any documentation that the resident's physician being notified of the· ident's observed condition;·

      j.

      I pp. A November 27, 2010 note documents that on said date at 11:45 a.m. the

      i

      nurse called the physician;

      
      

      qq. At 11:50 a.m. on November 27, 2010, a nurse's note reflects·that the doctor on call was contacted and Stat orders for a Complete Blood Count (CBC) arid a Basic Metabolic Panel (BMP) were obtained;

      rr. At 12:1.0 p.m. on November 27, 2010, a nurse1s note reflects that licensed practical nurse number two (2) n te that the resident continued to have blood in the stool and had a small amount of bloody emesis (vomit);

      ss. At 2:23 p.m. on November 27, 201-0, the lab reported a stool sample tested

      positive for C. Difficile toxin;

      
      

      t·t.

      At 10:30 p,m. on November 27,2010, the nurse's notes stated that the CBC and BMP lab results were reported and attempts were made to contact the

      
      

      · physician at 7:00 pm., 8:00 p.m., 8:45 p.m., and·10 p.m.

      
      

      uu. There was no docwnentation of attempts to notify the Respondent's director

      
      

      of nurses of the concerns regaraing the physician contact;

      
      

      vv.. There was no documentation of blood in the stool;

      l

      i ww. At 10:40 p.m. on November 27, 2010, the physician called and was informed of the lab results and orders were received for: Flagyl 500 mg three times daily and IV fluids of Normal Saline at 100 cc per hour for 24 hours;

      xx. 11:00 p.m. November 27, 2010 nurse's notes indicate the IV was started;

      . yy. A nurse's note of November 28, 2010 at 2:00 a.m. states the resident was

      weak but alert with no documentation of bl ody stools;

      
      

      zz. A nurse's npte of November 28, 2010 at 7:45 a.m. by licensed nurse number one (1) records that the resident was found 11 ... in a pool of blood from the rectal area." The physician and family were called. Emergency Medical Services was called to send the resident to the hospital.

3. The Respondenf s assistant director of nurses indicated to Petitioner's representative that she was notified of the transfer bu1 received no follow up information and was informed of the death of resident number three (30 on November 29, 2010 at around 7:00 a.m.

4. That . Petitioner's •representative reviewed the emergency medical services record

   contained in the hospital records of resident number three (3) and noted as follows:

   1. The ambulance arrived at the facility on November 28, 2010 at 7:56 a.m., nine

      
      

      (9) minutes after notification by the facility;

      
      

   2. The Nature of the Call was listed as Respiratory Distress;

      
      

   3. The Chief Complaint was listed as: Respiratory Distress, Severe;

      
      

      . !i

      
      

   4. The airway was noted as "Partially obstructed-Blood,." and breathing was labored;

   5. Blood/Fluid loss was estimated at less than 100 cc.

      f. There was no documentation of continued rectal bleeding in the emergency medical services record.

      
      

5. Petitioner's representative reviewed the hospital emergency room Initial Assessment Fonn contained in the hospital records of resident number three (3) and noted as follows

   1. The Brief Assessment section stated that the resident was· "found by the

      
      

      nursing home staff hemo1Thaging from the rectum and mouth."

      . .

   2. The resident was in an agonal cardiac rhythm and not breathing upon arrival;

      
      

   3. The Chief Complaint was listed as·Cardiac Arrest pre-hospital; ·

   4. The exam timed at 8:13 a.m. stated that the resident had a high INR and continued to receive Coumadin at the facility;

      · e. There was no documentation on the ER record of the presence of blood;

      
      

      1. The Clinical Impression was: DOA, (dead on arrival);

         
         

      2. The physician pronounced the time of death as 8:15 a.m.

      . .

6. That Petitioner,s representative interviewed Respondent•s_medical director and physician

   
   

   for resident nrun"\,er three (3) on ember 15 through 17, 20IO regarding· resident number three

   · (3) and the physician indicated as follows:

   
   

   1. He had been the attending physician for the resident;

      
      

   2. He was on vacation the -week of November 22, 2010, but he consulted with the other physicians in the practice and everyone was aware of the multiple co"morbidities of the resident;

      
      

      -I

   3. He was unaware of the facility's failure to hold the Coumadin until he was

      J

      informed on November 19, 2010, midmorning, by Respondent's director of

      
      

      ! nurse;

      l

      I

      d.

      i e.

      He came to the facility to evaluate the record and the error; He was aware of the termination of three (3) nurses;

      1. He signed the residerit's Death Certificate and provided a.copy;

         
         

      2. The primary cause of death was: Multiple Medical Problems of Aged with the secondary underlying issues of: Gastrointestinal Bleed (GI Bleed); Colostrium Difficile, Colitis, Diabetes Mellitus (DM), Coronary Artery Disease (CAD) and Chronic Kidney Disease (CKD);-

      3. During a review of the Death Certi:ficate·for resident number three (3) during tJ:ie interview, he confinned that GI Bleed was listed as a_ secondary underlying medical issue;

      4. The physician called his office and spoke with ·his partners during the int ew, and the physicians and nurse practitioner verified the facility did not verbalize concerns about rectal bleeding, but just the diarrhea;

      J. The physicians in the practice, including the nurse practitioner, stated to him that they did not have knowledge of the three additional doses of Coumadin and were treating e resident for the C. Difficile colitis and a lung infection.

7. Th t Petitioner>s representative interviewed Respondent's director of nurses on December 15, 2010 regarding resident number three (3) and the director indicated as follows:

   1. She became aware of a medication error related to Coumadin not being held and the death of the resident on November 19, 2010 at about 9:30 a.m.

      
      

   2. .Respondent's licepsed practical nurse number one (1) was on duty on

      November 29, 2010 and reported to the director of nur_ses that the nurse had

      .J

      been taking the record apart for resident number three (3) when tb.e nurse

      noticed that the order of November 22, 2010 directing that Coumadin be held from the resident had not been transcribed to the resident's medication administration record;

   3. The nurse initially_ stated that she did not find the order; .

      
      

   4. The director then showed nurse number one 91) the order that nurse number one (1) had written on November 22, 2010;

   5. Licensed p ical nurse number one (1) was tenninated by Respondent on.

      November 29, 2010;·

   6. The director then "f?egan the adverse incident investigation;

   7. Licensed practical nurse number two·c2) , who administered the Coumadin to the resident on November 22 and 23; 2010 was also terminated by Respondent;

   8. Nurse number four (4), a night nurse responsible for the twenty-four (24) hour

      chart check was terminated two (2). days later for not catching the error;

   9. The resident's physician, who is also Respondent's edical director, was informed on. November 29, 2010 around midmorning and he immediately came to the facility discussed the issue with her, the assistant director of nursing, the risk manager, and the administrator;

   10. On December 1, 2010, all licensed staff was educated Ol). anticoagulant therapy, lab values, and signs and symptoms of side effects and provided a sign-in sheet representing all but two (2) staff members;

       
       

   11. Of the two (2) who had not attended, one (10 worked once every six (6) weeks and had been notified by phone to report to work early to complete the

       education before assuming duty and the other nurse ork.ed every other weekend and had. been told to report for _work early on the next scheduled day for training. The nurse had not-worked for Respondent since December 1, 2010.

8. Th.at P titioner's representative reviewed Respondent's records related to resident number fourteen (14) during the swvey and noted as follows: ·

   1. Per the·facility face sheet, the resident was admitted to the facility on January

      
      

      
      

   2. Admitting diagnoses listed included:·weakness, vascular disease,- chronic heart disease, congestive heart failure (CHF) acute embolism (blood clot) and long term and current use of anticoagulants;

   3. The resident's November 2010 medication administration record documented the resident received: Warfarin (Coumadin) 2,5 mg daily at 5:00 p.m.

   4. A lab report dated November 22, 2010 read as follows: PT: 56.2, verified by repeat INR: 6.1. Therape1:1tic range listed as 2.0 to 3.0. The bottom of the lab slip contained a hand written note "11/23/10 Coumadin on hold till INR <3.11 the report was signed, but illegible;

   5. A nurse's note of November 22, 2010 at 12:00_p.m. provided the physician was notified and a telephone order was received to hold Warfarin 2.5 mg until the INRwas less than(<) 3 and continued "PT/INR scheduled to be rechecked Thursday 11/25/10."

      --

      
      

   6. A November 22, 2010 12:00 p.m. telephone physician's order stated, "Warfarin 2.5 mg po daily is to be held until INR is <3. PT/INR scheduled to be rechecked on Thursday 11/25/10.11

   7. The resident's November 2010 medication administration record documented

      
      

      the resident's Warfarin Vl!as held on November 22, 23, and 24, 2010 however

      
      

      the Warfarin was documented as given on November 25, 26, 27, 28, and 29,

      
      

      2010;

      
      

   8. Absent from the record was any lab results for a PT/INR result of November 25,. 2010;

   9. A November 29, 2010 PT/INR test result reflected PT: 29.0, INR: 2.6

      
      

   10. A hand written note on the report· stated the results were called to the

       . '

       physician 1 s assistant (PA);

       
       

   11. No new orders were documented as obtained.

       
       

9. That Petitioner's representative interviewed Respondent's nurse caring for resident

   
   

   number fourteen (14) on November 22, 2010 who indicated as follows:

   
   

   1. She was unaware of the labs not being done on November 25, 201O;

      
      

   2. She checked the calendar and found that November 25, 2010· was a holiday and only stat labs were to be done;

   3. She did not inform the physician of that fin<:ting;

   4. She was unaware until now that the Coumadin was restarted on November 25,

      
      

      · 2010 without the labs ordered by the physician;

      
      

   5. At the time she wrote the order she thought that the resident received routine, twice weekly PT/INR levels and Thursday, November 25, 2010 would have been the next test. .

I

I

l

J

1

-I

J

·1, .

.; .

• 35.·. That the nurse above referenced and Respondent's director of nurses confirmed that

Coumadin (Warfarin) 2.5 mg, daily at 5:00 p:m., was restarted for resident n ber fourteen (14) on November 2 2010 without the ordered laboratory results or a physicians order to do so.

36. That Petitioner's representative reviewed Respondent's records related to resident number four (4) during the survey and noted as follows:

.a. Per the facility face. sheet, the resident was admitted to the facility .on

November 19, 2010;

1. Admitting· diagnoses included: Late effects of CVA (stroke), Dementia, Unspecified cerebral ischemia (loss of, circulation the brain), Atrial Fibrillation, Diabetes with circulation disorder, Hypertension, and Congestive Heart F lure (CHF);

2. A physician's telephone order dated November 20, 2010 at 7:45 a.m. read

   
   

   11Warfarin(Coumadin) 2.5 mg po, QD (daily)."

   
   

3. On November 24, 2010 at 10:26 a.m. a l b reported the following: PT: 36 9 and INR: 3.9.

4. A hand written notation at the bottom of the lab report stated: "11/24/10 Co adin decreased (indicated by downward arrow) to 2.0".

5. ·The numbers were written over the initial value of2.5.

   
   

6. The note was not signed nor was a date and time written;

7. ·A November 24, 2010 physician's telephone order, no time specified, stated to decrease the Coumadin to 2.0 mg daily at 5:00 p.m.

8. The Registered Nurse in charge signed the order;

   
   

   j;" The resident's November 2010 medication administration records reflects that

   -1 on November 24, 20,10 at 5:00 p.m.. Coumadin (Warfarin) 2.5 mg was

   recorded as given by Respondent's licensed practical nurse number four (4);

   1. A nurse's note dated November 24, 2010, at 8:30 p.m. recorded an order was received to decrease the Coumadin-to 2.0 mg at 5 p.m. daily;.

      1. The note was signed by Respondent"s J,"egistered nurse charge nurse;

1. There was no documentation regarding what time the physician was contacted

   regarding the abnon;nal lab values;

2. A November 26, 2010 nurse's note of 3:00 p.m. documented that the resident

   was resting quietly and refused to eat breakfast and lmtch intake was 20%;

3. ·A November 26. 2010 nurse's note of 5:00 p.m. stated that the aide was unable to hear the blood pressure;

4. The physician was called;

5. At 6:00 p;m., the physician's assistant returned the call and requested the resident be sent to the hospital for evaluation;

   ,

6. The note said the family requested comfort measures only (CMO);

7. The physician's assistant was informed of the resident's declining condition;

8. On November 28, 2010 a nurse9s note;no time specified, recorded that the resident took no medications that day, there were no complaints of pain, and the staff provided comfort measures only;

9. The note stated the resident was incontinent, but there was no mention of blood in the stool;

10. On November 29, 2010 at 12:01 a.m., a nurse's notes revealed that she was called to the room to find the resident had no pulse or respirations;

    
    

    
    

    . 37,

11. The physician and family was notified;

1. A November 29, 2010 1:40 a.m. nurse's note indicated that the body was released to the funeral home.

   That Petitioner's representative interviewed Respondent's licensed practical nurse

   
   

   number four (4) who was caring for resident number four (4) during the survey and the nurse

   
   

   indicated as follows:

   
   

   1. She was on duty on November 24, 2010 and administered Coumadin 2.5 mg.

      
      

      t<? the resident;

      . b. After the medication was given she became aware of the eievated clotting lab

      
      

      values;

      
      

      1. She spoke with the Physician's Assistant (PA) after the medication was given and he was aware of the increased dose of Coumadin 2.5 mg given on November 24, 2010;

      2. Tlie physician's assistant stated to begin the decreased dose of Coumadin 2.0 .

         .mg.

      3. She did not write the order to start the dose change on November 25, 2010.

      
      

      1. 1bat Petitioner's representative interviewed during the survey the physician's assistant

         
         

         who was caring for resident number four (4) who indicated as follows:

         
         

         1. He was aware of the resident receiving Coumadin 2.5 mg on November 24, 2010;

         2. He gave the order to begin the decreased dose on November 25, 2010;

            
            

         3. There was no indication of bleeding prior to the resident's death.

            
            

      2. That The above reflects Respondent's failure to ensure its residents receive adequate and

         
         

         appropriate health care and protective and support services, including social services; mental health

         
         

         servi if available; planned ·recreational activities; and therapeutic and rehabilitative services

         
         

         i consistent with the resident care plan, with established and recognized practice standards within the

         j commwiity due to, including but not-limited to, Respondent's failure to:

         i a. Ensure regularly scheduled testing for the evaluation of anticoagulant therapies are

         I conduoted;

         j

   2. Ensure that laboratory results are appropriate y reviewed and monitored to assure .

      therapeutic goals are maintained;

      
      

   3. Ensure that physician's order for medication are appropriately _transcribed and

      implemented;

      
      

   4. The provision of anticoagulant therapy me ications, a significant medication · error, after the medication had been discontinued by the phys1cian;

   5. The failure to monitor for symptoms of co1}1J)lications related to anticoagulant

therapies.

1. That the Agency detennined that these failures relate to a situation in which immediate corrective action is necessary because the facility's noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident receiving care in a facility and cited this deficient practice as an Isolated State Class I deficiency.

   WHEREFORE, the Agency seeks to impose an administrative fine in the amount of ten thousand dollars ($10,00.00) against Respondent, a skilled nursing facility in the State of Florida, pursuant to§ 400.23(8)(a), Florida Statutes (2010).

   
   

   COUNT III

   
   

   1

   i

   j

2. . The Agency re alleges and incorporates paragraphs one (1) through five (5) and Cowits I and II as if fully set forth herein.

3. Respondent has be cited for two (2) State Class I deficiencies and therefore is subject to a six (6) month survey cycle for a period of two years and a survey fee of six thousand dollars ($6,000) pursuant to Section 400.19(3), Florida Statutes (2010).

   1

   .! .

   ..

   I

   WHEREFORE, the Agency intends to impose a six (6) month survey cycle for a period of two years and impose a survey fee in the amount of six thousand dollars ($6,000.00) against Respondent, a skilled nursing facility in the State of Florida1 pursuant to Section 400.19(3), Florida Statutes (2010).

   COUNTIV

   
   

4. · The Agency rewalleges and incorporates paragraphs one (1) through five (5) and Counts I and II of this Complaint as if fully set forth herein.

5. Based upon Respondent's two (2) cited State Class I deficiencies, it was not in substantial compliance at the time of the survey with criteria established under Part II of Florida Statute 400, or the rule13 adopted by the Agency, violation subjecting it to assignment of a conditi01,1al licensure status under§ 400.23(7)(a), Florida Statutes (2010) commencing December 17, 2010 and ending January l lt 2011· .

WHEREFORE, the Agency intends to assign a conditional licensure status to Respondent, a skilled nursing facility in the State of Florida, pursuant to § 400.23(7), Florida Statutes (2010) co encing December 17, 2010.

Respectl\llly submitted thi,te:::March,2011.

·.lit\Olmas J. Walsh II, Esquire la. Bar. No. 566365

Agency for Health Care Admin. 525 Mirror Lake Drive, 330G St. Petersburg, FL 33701 727.552.1947 (office)

DISPLAY OF LICENSE

Pursuant to§ 400.23(7)(e), Fla. Stat (2009), Respondent shall post the most current license in a prominent pla that is in clear and unobstructed public view, at or near, the place where residents are being admitted to the facility.

Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes. Respondent has the right to retain, and be represented by an attorney . in this matter. Specific options for administrative action are set out in the attached ;Election of Rights.

All requests for hearh;tg shall be made to the attention of: The Agency Cler Agency for Health

Care Admlnlstration, 2727 Mahan Drive, Bldg #3, MS #3, Tmiahassee, Florida, 32308, (850)

922 5873.

RESPONDENT IS FURTHER NOTIFIED THAT A REQUEST FOR HEARlNG MUST BE

·RECEIVED WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT OR WILL RESULT 1N 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 b_eefserved by

U.S. Certified Mail, Return Receipt No: 7008 0500 0002 1975 3243 on MarchLL . 2011 to

NRAI Services, Inc., Registered Agent for Royal Oak Nursing Center, LLC, 5 lS"East Park Avenue, Tallahassee, FL 32301, and by U.S. Mail to Anita E. Howard) Administrator, Royal

j Oak Nursing Center, 37300 Royal Oak Lane, Dade City, FL 33525.

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Copies furnished to:

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Docket for Case No: 11-001750