Citation Number: 030005797
Citation Date: 1/16/2009
Violation Date: 8/21/2008
Class: AA
Penalty: $ 100000

F157 Notification of Changes - 483.10 (b) (11) A facility must immediately inform the resident; consult with the resident's physician; and if known, notify the resident's legal representative or an interested family member when there is an accident involving the resident which results in injury and has the potential for requiring physician intervention; a significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental, or psychosocial status in either life threatening conditions or clinical complications); a need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment); or a decision to transfer or discharge the resident from the facility as specified in 483.12(a).

The facility must also promptly notify the resident and, if known, the resident's legal representative or interested family member when there is a change in room or roommate assignment as specified in 483.15(e)(2); or a change in resident rights under Federal or State law or regulations as specified in paragraph (b)(1) of this section.

The facility must record and periodically update the address and phone number of the resident's legal representative or interested family member.

F329 Unnecessary Drugs - 483.25(I) 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.

On 6/03/08, an unannounced visit was made to the facility to investigate complaint #CA00151848 regarding Resident A's death after sustaining an acute injury to the rib cage/chest area on 8/20/07. The Department determined that the facility failed to:

1. Ensure that Resident A did not receive an excessive dose of pain medication that caused adverse consequences and failed to

2. Consult with the MD for oxygen therapy when Resident A's respiratory status became compromised and failed to consult with the MD regarding reconsideration of the need to transfer the resident to the acute care hospital in light of the facility's inability to provide adequate care to alleviate the resident's severe pain without adversely affecting his respiratory status.

Resident A was an 83 year old admitted to the facility on 5/30/03 with a history of dementia, BPH (benign prostate hypertrophy), hypertension, anxiety, and insomnia. Review of the 6/6/07 MDS (minimum data set; an assessment tool) indicated that Resident A had memory problems and some mood/behavioral problems. Resident A was able to perform some of his activities of daily living with supervision or limited assistance and required extensive assistance for others (dressing, toilet use, and bathing).

Review of the 6/4/03 Physician's Orders Concerning Life Sustaining Treatment and Intensity of Care indicated that no CPR (cardio-pulmonary-resuscitation) was to be performed and it was to be determined if there was to be no transfer to acute hospital for terminal conditions. This document did not speak to an acute medical condition or injury.

According to the facility report, Resident A sustained a fall while being ambulated with assistance on 8/20/07. He stumbled and fell hitting his chest area on the footboard of the bed. Resident A was not transferred to the acute hospital for suspected injuries of his left chest/rib cage and instead was kept in the nursing facility with physician's orders to treat the pain. Review of the Physician's Discharge Summary signed on 9/6/07 by MD 2 indicated that Resident A expired on 8/21/07 and the discharge diagnosis included blunt abdominal/chest trauma.

Review of the 8/20/07 2:00 p.m. Nurse's Notes indicated the following: "CNA changing resident. Resident fell forward hitting left chest on corner of bed frame. Also received large skin tear to left hand. MD and RP (responsible party) notified. Resident appears nauseated. Skin color is pale ashened. Medical director (MD 1) in house to see resident." At 7:00 p.m. the nurse's notes indicated the following: "resident now resting quietly - pain is increased with movement. Assisted up in wheelchair for dinner - skin pale, cool, and clammy with movement."

Review of the 8/20/07 (4:00 p.m.) telephone Physician's Orders indicated the following medication order: "Roxanol 20mg (milligram)/ml (milliliter) [30ml = 1 fluid ounce], 1/4 ml oral every 4 hours as needed for moderate pain, 1/2 ml oral every 4 hours as needed for severe pain, and 1 ml oral every 4 hours as needed for very severe pain."

Review of the 8/20/07 2:55 p.m. Physician's Progress Notes done by PA (Physician Assistant) 2 documented that Resident A's left lower ribs and the left upper quadrant of abdomen were tender to palpation (touch). Resident A's skin was moist, pale, and diaphoretic (moist from perspiration). It was also noted that Resident A had rib and abdominal pain after the fall and PA 2 notified and discussed with the RP her findings.

During a telephone interview on 6/3/08 at 11:45 a.m., MD 1 was asked by the surveyor to describe what happened on 8/20/07 when Resident A's sustained a fall with injury. MD 1 stated that he did not witness Resident A's fall, however he was asked to see the resident because he was in the facility. MD 1 stated that Resident A complained of severe pain and his blood pressure was low. MD 1 stated "I suggested that we attempt to keep Resident A comfortable in the facility and look at the whole person. Medication was appropriate for pain control (Roxanol ordered previously by MD 2)."

During a telephone interview on 6/3/08 at 1:20 p.m. PA 2 stated that she called the RP and communicated to her that Resident A could have a pulmonary/abdominal injury because when she pushed on the ribs it was tender. PA 2 stated that the RP wanted to keep Resident A in the facility.

On 6/3/08 at 1:30 p.m., CNA 4 was interviewed regarding Resident A's fall with an injury. CNA 4 stated that he was getting ready to change Resident A before the fall on 8/20/07. CNA 4 said "I was near Resident A's doorway and communicated to the resident what I was going to do. He was facing me near his bed and turned around, or spun around to turn away from me. His feet caught somewhere, or it was the way he turned. He fell, face forward on top of the bed frame (foot board) on his ribs. I heard something crack or crunch, and I immediately called the charge nurse. He (Resident A) broke out in a sweat and turned really pale. MD 1 was paged and the charge nurse came into the room."

During a telephone interview on 6/5/08 at 10:45 p.m., RN 1 stated that Resident A was cared for by her during the night shift on 8/20/07 (11 p.m.) through 8/21/07 (7:00 a.m.). RN 1 stated that Resident A received the pain medication Roxanol (morphine sulfate) 20 mg/1 ml for severe pain to his rib cage area at 12:00 a.m. and again at 4:00 a.m. (total of 40 mg). At 5:30 a.m. staff re-positioned Resident A because he complained of severe pain. RN 1 stated that MD 2 was called at 6:45 a.m. and notified of Resident A's condition (complaints of severe pain and low oxygenation levels) and new medication orders were obtained for Roxanol. During a second telephone interview on 10/8/08 at 1:20 p.m., RN 1 stated that she "could not remember if Resident A was using oxygen" during her shift, however she stated that Resident A's "medical condition was worse when she received him, so oxygen should have been ordered prior to her shift."

Review of the 8/21/07 nurse's note documentation during the night shift indicated that Resident A was medicated at 12:00 a.m. and 4:00 a.m. with Roxanol 1 ml (20 mg) each time (total of 40 mg) for severe pain to the rib cage area. The documentation indicated the following: "Resident yelling and screaming with severe pain facial expressions." The documentation also indicated that at 6:45 a.m. MD 1 was called to notify him of Resident A's condition which included severe pain and an oxygenation saturation of 70% (normal 95 - 100%). There was no indication in the documentation that nursing initiated treatment with oxygen or consulted with the physician regarding the need for oxygen.

The 8/21/07 (7:00 a.m.) physician's orders indicated that a telephone order was made by MD 2 as follows: "Change Roxanol dose order to: Roxanol 20mg/ml 0.5 ml orally every 1 hour PRN (as needed) mild pain, Roxanol 20mg/1ml 0.75 ml orally every 1 hour PRN for moderate pain, Roxanol 20mg/ml 1 ml orally every 1 hour as needed for severe pain." There was no indication that the physician ordered supplemental oxygen therapy for Resident A's low oxygenation level (70%) or that staff consulted with the MD regarding the need for oxygen, or reconsideration of the need to transfer Resident A to the acute care hospital.

Review of the 8/21/07 nurse's notes documentation (late entry) indicated that at 7:00 a.m. Resident A was thrashing in bed, moaning, grimacing, and guarding the left side of his abdomen. Roxanol 1 milliliter (ml) was given orally (20 mg). At 8:00 a.m. Resident A was still thrashing in bed, moaning, had facial grimacing, and guarding/grabbing the left side of abdomen. A second dose of Roxanol 1 milliliter was given orally (20 mg). Resident A received a total of 40 mg of Roxanol in one hour (from 7:00 a.m. to 8:00 a.m.).

There was no indication in the documentation that oxygenation levels were being monitored or that oxygen therapy was being administered to Resident A. At 8:30 a.m. an ambulance was called to transfer Resident A to the acute hospital at the family's request. At 8:50 a.m. the ambulance service arrived and Resident A had shallow breathing at 4 breaths per minute (normal respiration rate is 12-20 breaths per minute for an adult at rest) until his breathing stopped at 8:50 AM. Emergency response personnel pronounced Resident A dead at that time. Resident A's body was released to the mortuary at 10:20 a.m.

During interview on 6/3/08 at 10:55 a.m. LN 3 stated that she saw Resident A 2-3 times that morning on 8/21/07 and knew he had worsening symptoms. LN 3 stated that she was aware of the situation and the type of pain medication being used to treat Resident A's pain. LN 3 stated that the RP had changed her mind about sending Resident A to the emergency department on 8/21/07 morning and emergency response personnel were called to transfer Resident A.

During interview on 6/2/08 at 11:02 a.m. Resident A's RP stated that a physician never called her to communicate to her how severe Resident A's injuries were until a nurse called her on 8/21/07 at approximately 7:30 a.m. The RP stated that she "did not understand the reason why Resident A was not transferred to the acute hospital if his injuries were that severe."

Review of the Physician Orders indicated that Resident A did not take any narcotic/opioid medications routinely or PRN (as needed) as part of his drug regimen before the 8/20/07 fall injury, except for the medication Tylenol 325 mg 2 tabs orally every 4 hours as needed for pain or headache. The Tylenol was originally ordered on 2/24/05. Resident A was not taking narcotic medication on a regular basis or for long periods of time.

Review of the Medication Administration Record indicated that Resident A received the following doses of the narcotic medication Roxanol within a 12 hour period: 10 mg oral at 8:10 p.m. (8/20/07), 20 mg oral at 12:00 a.m. (8/21/07), 20 mg oral at 4:00 a.m. (8/21/07), 20 mg oral at 7:05 a.m. (8/21/07), and 20 mg oral at 8:05 a.m.

According to Lexi-Comp Drug Information Handbook for Nursing (8th edition, 2007), "An opioid-containing analgesic regimen should be tailored to each resident's needs and based upon the type of pain being treated (acute versus chronic), the route of administration, degree of tolerance for opioids (naive versus chronic user, age, weight, and medical condition. May cause respiratory depression; use with caution in residents (particularly elderly or debilitated) with impaired respiratory function". (Warning/Precautions, page 843). "Dosing for adults in acute pain (moderate to severe): Oral: Prompt release formulations: Opiate-na9 ve: [unable to tolerate high doses without adverse reactions or/and side effects] 10 mg every 3 to 4 hours as needed; residents with prior opiate exposure may require higher initial doses: usual range 10-30 mg every 3-4 hours as needed". (Dosing, page 844). These doses are recommended for young healthy adults.

According to Saunders Medical Surgical Nursing (2nd edition, Ignatavicius, Workman, Mishler, page 767), "After chest wall contusion, rib fractures are the next most common injury to the chest wall. Rib fractures most frequently result from direct blunt trauma to the chest, usually with involvement of the fifth through ninth ribs. Direct force applied to the ribs tends to fracture them and drive the bone ends into the thorax. Thus, there is a potential for intrathoracic (within the thorax or chest) injury, such as pneumothorax (a collection of air or gas in the pleural cavity) or pulmonary contusion. Pneumothorax is almost invariably present if ribs one through four are fractured. The client usually experiences pain with movement and splints the chest defensively. Thoracic splinting results in impaired ventilation and inadequate clearance of tracheobronchial secretions. Potent analgesia that causes respiratory depression is avoided".

Review of the official 8/28/07 "Certificate of Death" from the County of Placer indicated that Resident A's 8/21/07 cause of death was due to 1) Respiratory Arrest 2) Multiple Rib Fractures and 3) Mechanical Fall.

Review of the 8/20/07 Nursing Care Plan called "Patient fall with injury to left chest" indicated that nursing interventions to administer oxygen to Resident A were not included as part of the nursing actions and approaches for this problem. The 8/21/07 Weekly Nursing Summary completed after Resident A's fall indicated that oxygen was not being administered. The Respiratory section (#12) was left blank and a "N/A" (not applicable) was written by nursing. The Changes in Medication This Week section (#20) indicated that Resident A was on the medication Roxanol as needed for pain after a fall.

According to Saunders Medical Surgical Nursing (2nd edition, Ignatavicius, Workman, and Mishler) "Hypoxemia is defined as a PaO2 (Partial Pressure of Oxygen in Arterial Blood) of 55 mmHg (millimeter of mercury) or less with an oxygen saturation of 85% or less (page 677). The nurse may consider results lower than 91% (and certainly below 86%) an emergency, necessitating immediate treatment. If the SaO2 (oxygen saturation) is below 85% the body's tissues have a difficult time becoming oxygenated. A SaO2 of less than 70% is life-threatening (page 630)."

During a telephone interview on 10/7/08 at 10:20 a.m. the DON stated that a physician's order is required to administer oxygen and she could not find one in the documentation from the time of Resident A's initial injury (8/20/07) until the time of his death (8/21/07). The DON explained that oxygen use and oxygenation saturation levels are documented in the nurse's notes. If oxygen was administered to Resident A, it would have been documented in the clinical record.

A review of the facility's policy and procedure called "Oxygen Therapy" (undated) was done on 10/7/08. The policy indicated the following: "Purpose: To deliver supplemental oxygen to aid the relief of tissue hypoxia and hypoxemia (decreased oxygen). It is the policy of this facility that oxygen therapy is administered as ordered by the physician or as an emergency measure until a physician order can be obtained. Documentation: 1. Date and time oxygen therapy is in use, if intermittent, 2. Oxygen flow rate and device being used, 3. Assessment of resident's response to therapy, 4. Document oxygen saturation levels per physician order and physician notification of unusual readings."

Resident A received a total dose of 40 mg of Roxanol on 8/21/07, between 7:05 a.m. and 8:05 a.m. (within 1 hour) in the absence of oxygen therapy when it was known by the physicians and staff that he had sustained a traumatic rib cage/chest injury and had an oxygenation saturation recorded at 70% (normal 95%-100%) at 6:45 a.m. and 76% at 8:20 a.m. The rib cage/chest injury, low oxygenation levels, and high dose of the narcotic medication placed Resident A at high risk for developing respiratory depression and respiratory arrest. There was no indication that the physician ordered oxygen treatment for Resident A or that nursing administered oxygen treatment according to facility policy to assist Resident A with his declined respiratory status until an order could be obtained. There was no indication that the facility attempted to obtain other treatment options or a higher level of care for Resident A even though he had sustained an acute injury and the care provided by the facility was inadequate to relieve the excruciating pain that he suffered. The RP indicated that if she had known how severe Resident A's condition was, she would have wanted Resident A to be transferred to the hospital immediately for care.

The Department determined that the facility failed to:

1. Ensure that Resident A did not receive an excessive dose of pain medication that cause adverse consequences, considering Resident A's respiratory function was compromised due to an acute rib/chest injury. Resident A sustained an acute rib cage/chest injury and an excessive dose of a narcotic pain medication was continued in the presence of adverse consequences.

2. Consult with the MD for oxygen therapy when Resident A's respiratory status became compromised and his oxygenation saturation levels were documented to be at 70% and 76%. The facility also failed to administer oxygen as indicated in the facility's policy to aid the relief of tissue hypoxia or hypoxemia on an emergency basis until an order from the MD could be obtained, and failed to provide or arrange for adequate care to relieve the resident's excruciating pain.

These failures resulted in Resident A suffering excruciating, unrelieved pain for a period of approximately 21 hours following an acute abdominal injury, while receiving an excessive dose of a narcotic pain medication (Roxanol, which was used in the presence of adverse consequences), developing respiratory arrest and expiring approximately 50 minutes after receiving a total dose of 40 mg of the narcotic medication Roxanol (Morphine Sulfate) within a one hour period. Resident A received a total of 90 mg of Roxanol between 8/20/07 (8:10 p.m.) and 8/21/07 (8:05 a.m.). Nursing staff did not consult with the MD for supplemental oxygen to treat Resident A's low oxygenation levels or reconsideration of the need to transfer the Resident to the acute care hospital.

These violations presented either (1) imminent danger that death or serious harm to the patients or residents of the long-term health care facility would result there from, or (2) substantial probability that death or serious physical harm to patients or residents of the long-term health care facility would result there from and were a direct proximate cause of Resident A's death.