Golden Living Center
1836 Gold St Redding, CA 96001
Citation Number: 230009706
Citation Date: 01/16/2014
Violation Date: 9/18/2012
Class: B
Penalty: $10,000


F329 483.25(1) Drug Regimen is Free from Unnecessary Drugs

Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used in excessive dose (including duplicate therapy); or for excessive duration; or without adequate monitoring; or without adequate indications for its use; or in the presence of adverse consequences which indicate the dose should be reduced or discontinued; or any combinations of the reasons above.

Based on a comprehensive assessment of a resident, the facility must ensure that residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

The facility failed to ensure Resident 1 was free of unnecessary drugs, when he received excessive doses of Ativan (lorazepam: a benzodiazepine medication used as an antianxiety agent, sedative-hypnotic, and anticonvulsant), was not adequately monitored for the excessive dose amount, and did not receive adequate supervision when his one on one (1:1) staff person (assigned to provide care only to the one resident, Resident 1, with never leaving sight of the resident) was reassigned. Resident 1 then suffered a subsequent fall which resulted with a fracture to his left (L) humerus (upper arm bone). Resident 1 was 78 years old, admitted to the facility on 1/13/12 with diagnoses that included dementia with behavioral disturbances and other persistent mental disorders.

During a record review on 10/3/12, Resident 1's "At Risk for Falls" care plan, dated 1/14/12, indicated he had an extensive fall history, impaired balance, poor safety awareness, and used medications that increased his fall risk.

Resident 1's physician's monthly order sheet for October 2012 showed 0.5 milligrams (mg) of Ativan was ordered every 6 hours, with an additional 0.5 mg Ativan ordered PRN (as needed) every 12 hours. Resident 1's orders included 0.5 mg of Risperdal (antipsychotic medication- reduces/calms the distortion and disorganization of a person's mental capacity) every night at bed time.

Resident 1's record included nurse Progress Notes, dated 9/16/12 at 9:46 pm, that read," ... DON (Director of Nursing) was called regarding residents behavior and (licensed nurse) was permitted to call in a 1 on 1 sitter (1:1 monitoring - a Certified Nurse Assistant to be assigned to provide care only to Resident 1 and never leaving sight of Resident 1) to be with resident at all times to ensure his and other residents safety ..."

Resident 1's nurse Progress Notes, dated 9/17/12 at 3:19pm, read, "Resident has more behaviors on the night shift then other times of the day, when there is less staff to redirect him."

Resident 1's nurse Progress Notes, dated 9/18/12 at 10:39 pm, indicated the following:

1. Resident 1 had a verbal confrontation with a resident and hit him with a cloth napkin at 6 pm;
2. At 6:15 pm, Resident 1 lunged at another resident and threatened her;
3. Resident 1 then attempted to slap a third resident in the face and ended up slapping her arm;
4. The nurse contacted Resident 1's physician for a "one time" order of 1 mg of Ativan "to calm his aggression;"
5. 1:1 care monitoring had to be provided to ensure everyone's safety; and
6. Resident 1 "was able to be calmed ... (Resident 1) slept for 1 and 1/2 hours, but was then up and wandering the facility. 1 on 1 care had to be provided to ensure the safety of everyone will continue to monitor."

A review of Resident 1's Medication Administration Records (MARs) for September 2012 showed documentation that he received the following doses of Ativan on 9/18/12: 0.5 mg Ativan at midnight between 9/17 and 9/18/12;
0.5 mg Ativan at 8 am;
0.5 mg Ativan at 12 noon;
0.5 mg Ativan at 6 pm;
0.5 mg Ativan PRN dose at 3:15pm; and
1.0 mg Ativan "one time" dose at 7:45pm, for a total of 3.5 mg Ativan in less than 20 hours.

In addition, on 9/18/12, Resident 1 received his bedtime dosage of 0.5 mg of Risperdal (a sedating medication given to assist with sleep and assist in reducing overall emotional/aggressive behaviors).

The manufacturer of Ativan states in the medication's package insert, that lorazepam (Ativan) "is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. ... The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient." The manufacturer does not state that lorazepam is useful in treating agitation associated with dementia.

In the CMS Interpretive Guidelines for 42 CFR 483.25(1), the American Geriatrics Society ( <http://www.>); American Medical Directors ( <>); American Society of Consultant Pharmacists ( <>) and other established professional groups are listed as sources of information related to precautions for medication uses in elderly patients. They have published a set of clinical practice guidelines for precautions related to "Potentially Inappropriate Medications in Older Adults," which is also referred to as the "Beer's Criteria List." This document (available at: < guidelines_recommendations/2012>) states that benzodiazepine medications (the family of medications that include Ativan) should only rarely be used in older adults because "(Older adults) have increased sensitivity to benzodiazepines and decreased metabolism of long-acting agents. In general, all benzodiazepines increase risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents in older adults .... Avoid benzodiazepines (any type) for treatment of insomnia, agitation, or delirium."

Lexicomp Online provides an extensive pharmaceutical reference database: At "Geriatric Lexi-Drugs": {http:l/ <http:l/> Information about lorazepam (Ativan) includes: Under "Warnings/Precautions"- "In older adults, benzodiazepines increase the risk of impaired cognition, delirium, falls, fractures, and motor vehicle accidents. Due to increased sensitivity in this age group, avoid use for treatment of insomnia, agitation, or delirium. (Beers Criteria)." Under "Special Geriatric (Elderly) Considerations" - "This medication is considered to be potentially inappropriate in this (elderly) patient population (Beers Criteria: Quality of evidencehigh; Strength of recommendation - strong)."

Resident 1's Progress Note, dated 9/19/12 at 12:53 am, stated the following: "Situation: resident (Resident 1) got up out of bed at 23:00 (11 pm) and had an unwitnessed fall in his doorway" "Background: resident had been agitated all shift - had several confrontations and was given scheduled and PRN (as needed) 0.5 mg Ativan and 1 mg 1 time dose of Ativan per MD" "Assessment: resident had pain to left shoulder and left hip - red mark behind left ear and left shoulder- VS (vital signs) were unavailable to (SIC) due to resident refusing" "Response: MD was called - no response- called DON (Director of Nursing)- got approval to send (Resident 1) to acute (general acute care hospital)."

The following Progress Note, dated 9/19/12 at 4:33 am, stated the following: "Pt (patient) returned from (acute hospital) ER at 0400 (4 am) ... pt (patient) has a fractured Left humerus (arm bone) from fall earlier. Pt came back with order for pain meds but was medicated with norco (a combination of the narcotic hydrocodone and acetaminophen [Tylenol] used for pain relief) at hospital before returning ..."

There was no documented evidence that a CNA (Certified Nursing Aid) or other staff member was assigned, to care only for Resident 1 and to keep visual contact of Resident 1 at all times for his safety, when he sustained the fall, on 9/18/12 at 11 pm.

The facility's "Verification of Investigation" report (a typed summary, in the resident's record provided by the facility to the surveyor; reports the facility's investigation into details leading up to and including Resident 1 's fall and post fall care), dated 9/19/12 with times listed 6:01 thru 6:17pm, stated," ... Contributing Factors ... " - (Resident 1) has a diagnosis of dementia with behaviors ... " "Immediate Resident Protection Initiated: ... (Resident 1) was put on 1 on 1 staff assignment with a CNA. MD (Physician) was notified of the situation and gave an order for a one tie (SIC: time) dose of Ativan 1 mg PO (by mouth) to be given ... At 7:45pm the Ativan was given per the MD order and the 1 on 1 assignment continued .... " It also stated, "Around 11 :00 pm resident was found on the floor in the doorway of his room 1 0 feet away from where (Licensed Nurse) was at nurses station." The reports do not comment about how the fall at 11 pm could have been "unwitnessed" with a CNA assigned to be with him (1:1) at all times.

A review of Resident 1's Physical Therapy "Progress Notes," dated 9/21/12 at 2 pm, read, "Physical Therapy Screen reveals that fall was not due to prominent balance deficits, but rather due to compromised balance from medication (Ativan) given to resident for agitation ..."

On 10/3/12 at 3:30 pm, the facility's Pharmacist (RPh) was interviewed about Resident 1 's Ativan dosing on 9/18/12. RPh stated, daily "doses between 2.0 and 2.5 mg could contribute to falls and over-sedation," and confirmed that "Ativan doses greater than 2.0 mg do contribute to a lack of coordination."

On 10/3/12 at 3:48 pm, the DON stated that due to staffing, the sitter was pulled at the beginning of night shift (10 pm to 6 am - The CNA who had been assigned to provide safety to Resident 1 had been taken away from Resident 1's (1:1) observation and care, and reassigned elsewhere in the facility, because there was not sufficient staff in the facility to meet all of the care needs of the residents). The 1:1 CNA had been removed even though the nurse's notes (mentioned earlier from 9/18/12 at 10:39 pm) indicated Resident 1 had slept for 1 & 1/2 hours after the medication was given and then was up again wandering the facility with the 1:1 CNA accompanying him.

On 1/8/13 at 4:45 pm, the facility's Medical Director, who is Resident 1's attending medical doctor (MD) was interviewed about the one time dose of 1 mg of Ativan, on 9/18/12. He stated that facility staff had informed him that Resident 1 was agitated and aggressive towards staff and was difficult to control. MD stated "Ativan does affect balance and could have contributed to (Resident 1's) fall."

Therefore, the facility failed to ensure Resident 1 did not receive excessive doses of Ativan, a medication that is recognized by the AMDA and Lexicomp:

1. to be potentially inappropriate in the geriatric population;

2. to be ineffective and should not be used for the treatment of insomnia, agitation or delirium;

3. to make worse the risk factors and symptoms Resident 1 already had: impaired cognition, risk of falls and fractures;

4. was given in excess of the recommended maximum dose to be given to an adult of any age; and

5. For which the facility's Pharmacist and Medical Director had knowledge that the dose of Ativan given was excessive and could contribute to excess sedation, lack of motor coordination (stability on one's feet) and falls.

On 9/16/12, the facility established Resident 1 needed special observation and a plan was put in place to have a staff CNA assigned for 1:1 observation and care of Resident 1 to provide for his safety. Resident 1 most often displayed his need for supervision on the night shifts, and on the night shift of 9/18/12, a day when Resident 1 had received more than his usual amount of sedating medications, and far above the recommended doses, his 1:1 care provider was reassigned, leaving him vulnerable and unobserved. Subsequently Resident 1 did fall while not being observed, and as a result fractured his left humerus (upper arm bone).

This violation presented either imminent danger that death or serious harm would result or a substantial probability that death or serious physical harm would result.