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Based on the findings of this survey it was determined that the hospital had not met the requirements of the Condition of Patient Rights as evidenced by the following deficient practices:

The hospital failed to:
1. Provide the Important Message from Medicare as noted in A117;
2. Allow a patient to participate in care planning and provide informed consent as noted in A130 and A 131;
3. Ensure that restraints were only utilized for the safety of the patients, staff and others as noted in A154;
4. Ensure that seclusion was used only for the management of violent or self destructive behavior as noted in A162 ;
5. Ensure that restraint and seclusion was ordered by a physician as noted in A168;
6. Ensure that restraints were discontinued at the earliest possible time as noted in A174; and
7. Provide an evaluation by a physician or other trained licensed professionals within one hour of the initiation of restraints as noted in A179.

Based on a review of 40 open and 15 closed records, it was determined that the hospital consistently fails to provide recipients with notification of their discharge rights via " An Important Message from Medicare " (IM).
Medical records staff members failed to identify that the required notifications were missing from closed records and failed to notify Quality Assurance or any other department that could have rectified the deficient practice. Specifically:

1. Six out of seven open records of Medicare recipients (patients #10, 11, 14, 15, 17, and 18) reviewed by Surveyor #2 contained no "Important Message" notifications.

2. Ten of 15 closed records reviewed belonged to recipients. These 10 patients (#50, 51, 53, 54, 56, 58, 59, 61, 62, and 64) accounted for 14 inpatient stays lasting longer than four days during 2010. Of these 28 possible instances for making the required patient notification of discharge rights, only four notifications were made.

Based on review of policies, procedures and 40 open records, in 1 of 40 open records reviewed the hospital failed to honor patient #89's right to participate the development and implementation of his care plan when the hospital failed to provide him interpretive services as evidenced by:

Patient #89 was an 88 year old male who presented to the Emergency Department at Shady Grove Adventist Hospital (SGAH) on 8/10/10 with a chief complaint of headache and left sided numbness. The patient's medical history included high cholesterol, gastric reflux (a weakened esophageal sphincter allows gastric acids to back up into the esophagus and throat causing indigestion and heartburn), hypertension (high blood pressure), and atrial fibrillation (a common cardiac arrythmia or rapid irregular heart rhythm). The patient was admitted with a diagnosis of subdural hematoma (also known as subdural hemorrhage or SDH, brain injury in which blood accumulates within the brain causing symptoms similar to a stroke).

The hospital patient rights sheet that is provided to patients at admission, under item #4 states that patients have the right to " have access to interpretive services; when necessary and appropriate, to prevent language barriers from hampering your care, for the hearing or visually impaired, to access to appropriate audiovisual aids."

Patient #88 spoke Farci and did not speak English. The record showed that staff repeatedly relied on family to interpret for him during this length of stay, which lasted from 08/10 through 08/30.

Based on review of policies, procedures, and 40 open medical records, in 1 of 40 medical records reviewed, the hospital failed to ensure that provision of care was in accordance with the fully informed consent of the patient as evidenced by:

Patient #89 was an 88 year old male who presented to the Emergency Department at Shady Grove Adventist Hospital (SGAH) on 8/10/10 with a chief complaint of headache and left sided numbness. The patient's medical history included high cholesterol, gastric reflux (a weakened esophageal sphincter allows gastric acids to back up into the esophagus and throat causing indigestion and heartburn), hypertension (high blood pressure), and atrial fibrillation (a common cardiac arrythmia or rapid irregular heart rhythm). The patient was admitted with a diagnosis of subdural hematoma (also known as subdural hemorrhage or SDH, brain injury in which blood accumulates within the brain causing symptoms similar to a stroke).

The record showed that patient #89 spoke Farci and he did not speak any English. On admission (8/11/10) a registered nurse completed a screening regarding advance directives for patient #89. The record indicated that patient #89 did not have an Advance Directive and the nurse checked the box which stated: " Patient does not want to make an advance directive at this time and verbalizes understanding that the absence of an advance directive prevents hospital staff from knowing wishes. " The patient was alert and oriented and there was no indication he had appointed a surrogate decision-maker. However, throughout the medical record, documentation including progress notes, nursing notes, and consents, revealed that pertinent information regarding patient #89's plan of care was discussed with his son, daughter, son-in-law, granddaughter, and friend. For example, 1 consent for surgery was signed by patient #89's son on 8/11. The form included a note indicating unable to give consent but the son signed off that "he has given consent verbally." The next line stated the procedure was explained to me, and I am authorized to consent for him "I am his son." A second consent, witnessed by 2 nurses, was not obtained from the patient but was obtained on 8/28/10 via telephone.

Patient #89 was able to make his own decisions. No determination was made that he was incapacitated and no surrogate decision maker was identified. By failing to provide interpretive services, the hospital failed to inform the patient of risks and benefits of each procedure, and failed to obtain an appropriate informed consent for his medical treatment.

In 9 of 10 records reviewed from the security restraint log (patients #70, 71, 72, 73, 74, 76, 77, 78, and 79) the hospital failed to ensure that restraints were not utilized as a means of staff convenience and/or failed to ensure that restraints were only imposed to ensure the immediate physical safety of the patient, a staff member, or others. For example:

1. Patient #70 was a 25 year-old male registered at 1815 on 08/28/2010. The physician ED record showed that he presented frustrated, hostile, agitated, and intoxicated.

The record revealed that patient #70 went into restraints on arrival. Documented rationales for restraint included that patient #70 tried to leave the unit, he " wandered aimlessly, " and he was "constantly getting out of bed." From approximately 1830 until 2300 patient #1 remained in restraints even though the record showed he was calm. Restraints were not removed until 2257, shortly before a 2311 nursing note stated that transportation home was being arranged.

2. Patient #73 was a 31 year-old male who was brought in to the SGAH ED on Emergency Petition at 2353 on 08/17. Security logged that they placed patient #73 into 4-point restraints at 2345 which was on his arrival. The record showed that at 2351 patient #73 was moved to the Emergency Psychiatric Treatment Unit, a separate section of the ED.

A nursing note entered at 0022 described patient #73 as having been agitated with "violent behavior" on arrival but his behavior on arrival was not described and furthermore, the nurse documented that at the time of this note patient #73 was already calm. Initiation of restraints was not justified by the given documentation and once he had calmed, restraints were not ended.. Three hours later at 0332 while noted as calm and cooperative, patient #73 was "downgraded" to 2-point restraint.

At 0415 the order for restraints expired but restraints still continued, The exact time restraints ended could not be determined. Security indicated restraints ended at 0420, nursing indicated the restraints ended at 0509, but observation sheets continued until 0545 without documenting that restraints ended prior to 0545. Although it could not be determined exactly when restraints ended, it was substantiated that staff maintained him in restraints without justification for nearly his entire visit without sufficient clinical justification.

3. Patient #76 was a 31 year-old female registered at the ED at 1607 on 08/08. The Emergency Physician Record showed a chief complaint of suicidal thoughts, suicide attempt and agitation. The record showed that she went to the EPTU at 1639. Patient #76 was placed into 4-point restraint after she refused to stay in her room and repeatedly came to the nursing station. Security was called at 1732 to speak with patient #76 about staying in her room, and the record revealed that when she came out again she was placed into restraints. At 1800 an order for restraints was entered. The nursing note indicated that the patient was screaming and yelling, "up at RN station, refusing to go back to room, security called, MD notified, patient placed in 2-point restraints, order signed by MD." Screaming, yelling, and refusing to be secluded are not acceptable criteria for initiation of restraints, yet the MD authorized the order at 1800. Patient #76 stayed in restraints for more than 2 hours after this unjustifiable initiation. Restraints ended at 2012.

Based on review of 1 of 10 records selected from the hospital security restraint log, the hospital failed to ensure that seclusion was used only for the management of violent or self-destructive behavior as evidenced by:

Patient #76 was a 31 year-old female registered at the ED at 1607 on 08/08. The Emergency Physician Record showed a chief complaint of suicidal thoughts, suicide attempt and agitation. The record showed that she went to the EPTU at 1639.

A 1730 nursing note stated that " patient continues to come to the nursing station asking for pain meds for her hand, MD notified, patient given Motrin, patient is very up and down with her emotions, patient crying and then laughing, patient states I'm very anxious, MD notified, patient given meds." (Ativan 1 mg by mouth was given.) The next nursing note at 1732 stated "Security called to speak to patient about staying in room." Involuntary confinement of a patient in a room is seclusion and requires and order.

The next nursing note indicated that the patient was screaming and yelling, "up at RN station, refusing to go back to room, security called, MD notified, patient placed in 2-point restraints, order signed by MD." Screaming, yelling, and refusing to be secluded are not acceptable criteria for initiation of restraints. Together, contacting security to talk to the patient about staying in her room and then placing her in restraints when she left her room, evidences that this was seclusion of the patient.

In interview, hospital leadership reported that the hospital does not use seclusion and therefore has no policies and procedures related to the use of seclusion. However, lacking any policies or procedures related to the use of seclusion, patient #76 was secluded by staff without sufficient justification, without any order, and without appropriate assessment. When patient #76 came out of the room where staff were attempting to seclude her, staff requested and received an order to place patient #76 in restraint because she refused to stay in her room.

Review of 10 records from the hospital security restraint log revealed 3 of 10 records (patients #72, 73, and 76) where the hospital failed to ensure that the use of restraint and seclusion was in accordance with the order of a physician or other licensed practitioner responsible for the care of the patient as specified under 482,12-c and authorized to order restraint or seclusion by hospital policy in accordance with State law. For example:

1. Patient #72 was a 25 year-old male patient registered at 0040 on 08/25. The Physician Emergency Record revealed a clinical impression of altered mental status, luekocytosis, and urinary tract infection. The record also showed patient #72 was confused, agitated, and difficult to medically evaluate.

At 0046 security logged that within minutes of his arrival patient #72 was taken to ED room 4B and placed in 4-point restraints. A nursing note at 0108 stated that patient #72 had been combative on arrival, but no description of the actual behavior justifying restraints was recorded. The behavior was only described as "agitated, angry, combative, defensive, hostile, and uncooperative, with poor insight and poor judgment." No order was found in the record, and no face-to-face evaluation was completed within 1 hour of initiation of restraint use. Patient #72 remained in restraint without an order until 0545, minutes before discharge from the unit at 0606.

2. Patient #73 was a 31 year-old male who was brought in to the SGAH ED on Emergency Petition at 2353 on 08/17. Security logged that they placed patient #73 into 4-point restraints at 2345 which was on his arrival. The record showed that at 2351 patient #73's room was changed to EPTU 1. The EPTU is an enclosed and locked area of the ED that provides a calmer environment for behavioral health patients separated from the main ED.

At 0015 an order for restraint was entered into the record. By 0415 when the order expired, no face to face assessment had been completed and patient #73 remained in restraints without any renewal order. The record failed to demonstrate exactly when restraints ended. Security logged restraints ended at 0420, nursing documented restraints ended at 0509, and observation sheets showed patient #73's restraint observations continued until 0545. Thus, it could not be determined exactly when restraints ended. Nonetheless it was substantiated that patient #73 went into restraints and remained in restraints for nearly his entire visit and the use of restraints extended beyond the time specified in the order.

3. Patient #76 was a 31 year-old female registered at the ED at 1607 on 08/08. The Emergency Physician Record showed a chief complaint of suicidal thoughts, suicide attempt and agitation. The record showed that she went to the EPTU at 1639.

Staff secluded patient #76 without an order and when she failed to abide by the seclusion, she was placed into restraints. A 1730 nursing note stated that " patient continues to come to the nursing station asking for pain meds for her hand, MD notified, patient given Motrin, patient is very up and down with her emotions, patient crying and then laughing, patient states I'm very anxious, MD notified, patient given meds." (Ativan 1 mg by mouth was given.) The next nursing note at 1732 stated "Security called to speak to patient about staying in room." The next nursing note indicated that the patient was screaming and yelling, "up at RN station, refusing to go back to room, security called, MD notified, patient placed in 2-point restraints, order signed by MD." Involuntary confinement of a patient in a room is seclusion and requires and order but no order was obtained for this episode of seclusion.

In 9 of 10 records reviewed, the hospital failed to ensure that restraint usage was discontinued at the earliest possible time as evidenced by:

During onsite survey, 10 records were selected from the hospital ' s security restraint log. Based on review of these 10 records, 9 of 10 patients (70, 71, 72, 73, 74, 76, 77, 78, and 79) remained in restraints after they ceased to be an imminent threat to self or others. In 6 of these 10 records (patients 70, 71, 72, 73, 77, and 79) the patients remained in restraints until it was time to prepare them for discharge. For example:

1. Patient #70 was a 25 year-old male registered in the ED at 1815 on 08/28/2010. The physician ED record showed that he presented frustrated, hostile, agitated, and intoxicated. He was triaged at 1819 as an ESI 3 (a triage scale where 1 is most urgent and 5 is least)

At 1820 a nursing note indicated that the patient refused to let the RN take his temperature. At 1826 security staff logged that patient #70 had been brought in by police with alcohol intoxication. At 1826 security staff logged that patient #70 was placed into 2-point restraints after stating that he intended to leave and that he wished he were dead. The nursing rationale for restraint initiation was entered at 1907 and indicated that restraints were applied because patient #70 was "wandering aimlessly" and "constantly getting out of bed" and therefore he was placed in 4 point restraint. A 1924 nursing note stated, skin intact, restraints intact, and patient calm. The record demonstrated no justification to initiate restraints and after the patient had calmed, there was no justification to continue restraints. At 2210 restraints were noted as checked. Restraints did not end until 2257, which was shortly before a 2311 nursing note stated that transportation home was being arranged.

2. Patient #72 was a 25 year-old male patient registered at 0040 on 08/25. The Physician Emergency Record revealed a clinical impression of altered mental status, luekocytosis, and urinary tract infection. The record also showed patient #72 was confused, agitated, and difficult to medically evaluate.

Within minutes of his arrival, at 0046 security logged that patient #72 was taken to ED room 4B and placed in 4-point restraints. A nursing note at 0108 stated that patient #72 had been combative on arrival, but the record contained no description of the actual behavior justifying restraints. Behavior was only described as "agitated, angry, combative, defensive, hostile, and uncooperative, with poor insight and poor judgment."

At 0139 nursing indicated that patient #72 was "more relaxed" after administration of both Haldol and Ativan. At 0218 patient received Versed for conscious sedation for a spinal tap. Observation sheets indicated that even then patient remained in 4-point restraints and no other documentation showed restraints ended. At 0358 a decision was made to admit patient to critical care. At 0415 the order for restraints expired but restraint use still continued. Both the security log and observation sheet showed that patient #72 was still in restraints until 0545, which was again, shortly before discharge. The record showed he was discharged via stretcher at 0606. Patient #72 remained in 4-point restraints for nearly his entire ED visit, which was nearly 5 hours, without sufficient justification, without an order, without a face-to-face evaluation, and without substantive nursing assessment documented..

3. Patient #74 was a 39 year-old male who presented with depression and intoxication. He was brought in by police and was registered in the ED at 2359 on 08/13. Within minutes, at 0005, security logged that patient #74 had been placed into 4-point restraints. Documentation of the specific behavior justifying restraint was not recorded in the medical record. No face-to-face evaluation was completed. Observation sheets revealed that patient #74 was quiet, calm, and/or asleep at every 15-minute check, from 0115 until 0245, but restraints did not end until 0245.

In 10 of 10 records reviewed (patients #70 through #79), the hospital failed to ensure that patients were seen within 1 hour after initiation of restraints to evaluate (1) the patient's immediate situation, (2) the patient ' s reaction to the intervention; (3) the patient ' s medical and behavioral condition; and (4) the need to continue or terminate the restraint or seclusion as evidenced by:

During onsite survey, 10 records were selected from the hospital ' s security restraint log. Based on review of these 10 records, in every instance when patients went into restraint they were not seen and evaluated face to face within 1 hour as required.

Based on observation and interview during onsite review of outpatient services, it was determined that the hospital's QAPI program failed to monitor or measure any quality indicators for the outpatient infusion center.

In an interview with the infusion center's director on 9/1/10, it was determined that, while the infusion center does monitor some quality indicators such as adverse medication reactions, no results are reported up through the hospital's QAPI program, and there is no guidance or leadership extended from the hospital's QAPI department to the infusion center. This situation was later confirmed by the Vice President for Quality.

In 1 of 10 records selected from the hospital security restraint log, the hospital failed to ensure that all patient medical record entries were be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures as evidenced by:

During onsite survey, 10 records were selected from the hospital ' s security restraint log for review. In 1 of these 10 records (patient #70), on 08/28 at 1850, the record revealed that a physician signed and dated a blank order for restraints, and thus it was delegated to staff to determine all parameters of the order. The order found by the Surveyor on 08/31 remained a signed and dated but otherwise blank order for restraint in the medical record.

A review of 15 closed records revealed two verbal orders that were not promptly signed by the ordering physician. Patient #58 had a verbal order written on 6/26/10 that was signed on 7/19/10. Patient # 59 had a verbal order written on 7/1/10 that was signed on 7/19/10. The review also identified 3 verbal orders that had not been signed at all. Patient #56 had a verbal order noted by the nurse on 7/2/10, patient #60 had a verbal order noted by the nurse on 6/26/10, and patient #64 had a verbal order noted by the nurse on 7/2/10.

Review of 15 closed records revealed revealed one record with a history and physical exam signed six weeks after it was dictated and a second record missing a history and physical (H&P) exam.

Patient #60 was admitted to the hospital on 6/23/10 and had a H&P dictated on that day. It was not signed by the physician until 8/6/10. The closed medical record for patient #64 was missing the H&P altogether and the discharge summary had been dictated on 8/30/10, almost two months after the discharge on 7/9/10.

All of the closed records were for discharges more than 30 days prior to the survey and all should have been closed and complete. The medical record staff failed to identify these deficiencies prior to closing the records.

In 2 of 8 open surgical-patient records reviewed, the hospital failed to ensure that an operative report describing techniques, findings, and tissues removed or altered were written or dictated immediately following surgery and signed by the surgeon, as evidenced by:
The hospital system for documenting operative reports includes the physician completing a paper report and then that report is transcribed into the electronic record. In 2 of 8 medical records reviewed on 8/30/2010 there were no hard copies of the operative reports nor were the dictated reports electronically signed.
1. Patient #80 was a 47 year old male admitted to Shady Grove Adventist Hospital (SGAH) on 8/22/10 for removal of bone stimulator and treatment for infection. When reviewed on 8/30/10, there was no paper copy of the operative report in the medical record and the transcribed electronic report was not signed.
2. Patient #81 was a 84 year old male admitted to SGAH on 8/26/10 for subdural hematoma requiring surgery. When reviewed on 8/30/10, there was no paper copy of the operative report in the medical record and the transcribed electronic report was not signed.