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9909 MEDICAL CENTER DRIVE

ROCKVILLE, MD null

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

The hospital failed to ensure that the use of restraint or seclusion was carried out in accordance with valid orders of a physician or other licensed practitioner when in 3 of 6 records reviewed (patient #2, 3, and 4), restraints were initiated based on orders that (1) did not indicate the reason for restraint, (2) did not indicate the type of restraint, and (3) failed to establish that telephone orders were signed in a timely manner as evidenced by:

Patient #2 was a 77 year-old male admitted to Adventist Rehabilitation Hospital at 1909 on 11/10/2009, with cognitive deficits secondary to a closed head injury related to a motor vehicle accident. Patient #2 had a history of hypertension and diabetes mellitus. The record showed that patient #2 demonstrated confusion, agitation, poor insight, and poor judgment during this length-of-stay. The anti-psychotic medications Risperdal, Ativan, and Haldol were utilized in management of patient #2's behavioral needs, and patient #2 was placed into restraints at times during this length-of-stay.

The record for patient #2 revealed twenty orders for restraint use for wrist restraints, lap belt, and/or side rails (11/10, 11/11, and every day from 11/20 through 12/07 (18 consecutive days). Of these twenty orders, 1 order had no reason for restraint documented and 3 were did not indicate the type of restraint to be applied. Additionally, twelve of these twenty orders were telephone orders that did not indicate the time the physician signed off that he checked and authorized the order.

Patient #3 was a 64 year-old female admitted to Adventist Rehabilitation Hospital on 11/12/2009 with chronic lower back pain secondary to advanced spinal stenosis. The discharge summary in the record revealed that patient #3 experienced both confusion and disorientation, with an inability to follow commands, and the record revealed that patient #3 was placed into restraints at times during this length-of-stay.

Patient #3's record revealed 12 orders authorizing restraint usage for the use of a lap belt and/or enclosure bed. Of these 12 orders for restraint, 2 were not valid because no type of restraint was documented in the order, and 9 did not indicate the time the physician signed the order.

Patient #4 was a 61 year-old male admitted to Adventist Rehabilitation Hospital on 12/16/2009 with mobility impairment, status-post cerebral vascular accident with right hemiparesis, aphasia, and dysphagia. Patient #4 also had a history of diabetes mellitus. The discharge summary in the record revealed that patient #4 experienced both confusion and severe agitation at times during this length-of-stay; and the record revealed that patient #4 was placed into restraints at times during this length-of-stay.

Patient #4's record revealed 6 orders authorizing restraint usage (12/17, 12/18, 12/19, 12/20, 12/21, and 12/22). These included the use of lap belt, enclosure bed and hand mitts. One of these 6 orders for restraint (12/21) was not a valid order because (1) no reason for the restraint use was entered, and (2) no type of authorized restraint was entered into the order. Four of these 6 orders for restraints were not valid because there was no time entered to validate when the physician reviewed and confirmed that the order was complete and accurate.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

In 3 of 6 records reviewed (patients #2, 3, and 4) the hospital failed to ensure that restraints were discontinued at the earliest possible time as evidenced by:

Patient #2 was a 77 year-old male admitted to Adventist Rehabilitation Hospital at 1909 on 11/10/2009, with cognitive deficits secondary to a closed head injury related to a motor vehicle accident. Patient #2 had a history of hypertension and diabetes mellitus. The record showed that patient #2 demonstrated confusion, agitation, poor insight, and poor judgment during this length-of-stay. The anti-psychotic medications Risperdal, Ativan, and Haldol were utilized in the management of patient #2's clinical needs during this length-of-stay; and patient #2 was placed into restraints at times during this length-of-stay.

The record for patient #2 revealed twenty orders for restraint use for wrist restraints, lap belt, and/or side rails (11/10, 11/11, and every day from 11/20 through 12/07 (18 consecutive days). In 14 of these 20 orders, flow-sheet data entered on the same order-sheet forms, showed that patient #2 was quiet, calm, and/or cooperative at times, but restraints were not ended.

In 4 of the 14 order flow-sheets where patient #2 was noted at times as quiet, calm and/or cooperative, the assessment indicating if release criteria had been met, was noted as N/A (not applicable) and in the remaining 10 flow-sheets the documentation indicated that criteria for release was not met, despite the fact that patient #2 was quiet, calm and/or cooperative. Further, a note entered into the record by a nurse practitioner (NP) indicated that patient #2 was in wrist restraints "despite having sitter in the room." The NP recorded that the record "finds patient having periods of agitation during which he believes he is being attacked/ hurt other periods, patient very calm and pleasant ... patient currently responding in a conversant and pleasant manner ... " The NP concluded that patient #2 "does not need to be in restraint when he is calm."

Patient #3 was a 64 year-old female admitted to Adventist Rehabilitation Hospital on 11/12/2009 with chronic lower back pain secondary to advanced spinal stenosis. The discharge summary in the record revealed that patient #3 experienced both confusion and disorientation, with an inability to follow commands during this length-of-stay; and the record revealed that patient #3 was placed into restraints at times during this length-of-stay.

Patient #3's record revealed 12 orders authorizing restraint usage for the use of a lap belt and/or enclosure bed. Documentation revealed that in 5 of these 12 time frames of restraint use, patient #3 was documented as quiet, calm, and/or cooperative at times, but restraints were not ended at these times.

Patient #4 was a 61 year-old male admitted to Adventist Rehabilitation Hospital on 12/16/2009 with mobility impairment, status post cerebral vascular accident with right hemiparesis, aphasia, and dysphagia. Patient #4 had a history of diabetes mellitus. The discharge summary in the record revealed that patient #4 experienced both confusion and severe agitation at times during this length-of-stay; and the record revealed that patient #4 was placed into restraints at times during this length-of-stay.

Patient #4's record revealed 6 orders authorizing restraint usage (12/17, 12/18, 12/19, 12/20, 12/21, and 12/22). These orders authorized the use of a lap belt, enclosure bed and/or hand mitts. Documentation revealed that in 4 of these time frames when patient #4 was under orders for restraint use, he was documented as quiet, calm, and/or cooperative at times, but restraints were not ended at these times. As was also true with patient #2, in one of these 4 periods of restraint use (on 12/18) the record revealed that patient #4 was both assigned a sitter and he was quiet, calm and cooperative (from 1400 through 1700). Nonetheless, despite both the presence of a sitter and his documented calm behavior, restraint use was not ended.

DELIVERY OF DRUGS

Tag No.: A0500

The hospital failed to ensure that drugs were prescribed, distributed, and administered in accordance with accepted standards of practice when two Fentanyl Duragesic patches were prescribed, distributed, and administered, without the record demonstrating that the patient had been determined to be opioid tolerant as evidenced by:

Patient #1 was a 19 year-old female admitted to Adventist Rehabilitation Hospital for physical rehabilitation on 12/17/2009 after sustaining multiple injuries in a motor vehicle accident. Patient #1 was prescribed a 12 mcg transdermal Fentanyl Duragesic patch at 1730 on 10/17, and it was placed (administered) at 1830 on the same date. Additionally patient #1 was prescribed Ultram (Tramadol) 50 mg by mouth every 8 hours, and Vicodin 5 mg by mouth every 4 hours as needed for breakthrough pain. On 12/18/2009 patient #1 ' s dose for the Fentanyl Duragesic patch was increased to 25 mcg and her dose for Vicodin was also increased to 5/500 times 2, by mouth, every 6 hours. No evidence was found that the patient was opioid tolerant at the time the Fentanyl patch was prescribed on 12/17 or at the time the dose was doubled on 12/18. The standard of care for prescription and administration of Fentanyl Duragesic patches requires that completed and documented assessment/evaluation establishes that the patient is opioid tolerant before these patches can be prescribed or administered.

Detailed information including the definition for opioid tolerance is available in the Food and Drug Administration published advisory (last updated 07/2009) which can be found online at .