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Based on document reviews, interviews and observations, it was determined that the hospital did not obtain approval from New York State Department of Health, licensing agency, to provide or discontinue services as listed on the facility's Operating Certificate. Specifically, the facility did not obtain approval to provide services at 6 onsite locations, or to discontinue 2 onsite services and 2 offsite premises.

Findings include:

1. The facility failed to provide an up-to-date operating certificate that lists current services at its main campus and its offsite locations. During an interview conducted August 17, 2010 at approximately 10:30AM with the administrative staff, it was determined that the hospital no longer has the following services listed on the Operating Certificate dated 1/5/09: Primary Medical Care O/P, Audiology.

2. The off-site hospital extension clinics' services that are closed without supporting closure documentation are:
NO. WESTCHESTER FAMILY HEALTH PRACTICE
39 SMITH AVE
MT. KISCO, NY 10549

CARDIAC IMAGING OF YORKTOWN
2013 CROMPOUND RD
YORKTOWN HEIGHTS, NY 10598

3. The hospital currently provides Hospice, Infusion Center, Wound Care, Pain Management and Acute Care Dialysis services without the approval of the NYS Department of Health.

4. The hospital patient rooms 711, 731, and 751 were converted into storage rooms. One patient room from each of the three compartments on the floor had been changed into a storage room to keep the corridors clear. Three of the patient rooms on the 6th Floor and 4th Floor had been changed in a similar manner with one room per corridor being changed into a storage room. These converted storage rooms do not provide the required air exchanges. In addition there is no documentation that the facility submitted the required application nor received approval from the NYS Department of Health for the conversions.

Based on medical record reviews and interviews, it was determined that the facility did not develop policies and procedures specifically identifying and addressing medications used as restraints.

Findings include:

The Patient Care Services Policy "Restraints and Seclusion" only addresses physical restraints. When medications were used to address violent behavior, the facility failed to distinguish when a drug is considered a Restraint in the ED or inpatient unit. Medications were not considered Restraints when they were used as PRN or Stat orders or used during a "Code Purple" (Pt or visitor becomes agitated and is a danger to himself or others). This resulted in a failure to protect the patient from harm since parameters for monitoring the patient's medical status, including timeframes (blood pressure, pulse, and respirations) were not established.

In addition, since medications used to address violent behavior are not considered Medications used as Restraints, vital signs, face-to-face assessments by the physician, debriefing by the treatment team following the restraint, review and/or revision of the Care Plan, monitoring as to the effectiveness of the restraint, and documentation on the Restraint/Seclusion form, were not required.


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Examples include:

1. MR #23 revealed that on 7/10/2010 at 7:45PM, the nurse documented the patient continued with increased agitation. The patient had poor response to setting limits or redirection, became increasingly agitated, and shoved the copier towards the desk and nurse. Security was notified and the patient was escorted back to the quiet room (which is the Seclusion Room). She attempted to strike staff, kicked and scratched the nurse. The patient was given Haldol 2mg IM and Ativan 1mg IM at 7:20PM per PRN orders with minimal effect. A physician presented and was aware. The patient remained in the unlocked seclusion room. According to 24 hour Restraint Monitoring Flow sheet, 24 hour Restraint Monitoring started at 7:20PM and constant observation (CO) was maintained for safety.

A review of the Medication Administration Record, (MAR) revealed that PRN Ativan 1mg po q4hr PRN was given on 7/10/2010 at 6:05PM; PRN Ativan 1mg IM q 4hr and PRN Haldol 2mg IM q4hr were given on 7/10/2010 at 7:20PM, also.
Although the medications were used to address violent behavior, there were no vital signs taken, a face-to-face assessment by the physician, debriefing by the treatment team following the medication used as a restraint, no review and/or revision of the Care Plan, and no monitoring as to the effectiveness of the restraint, which is required if medications are used as restraints.

2. Review of MR #22 revealed that on 4/14/2010 at 10:31AM, the nurse documented the patient was agitated, verbally loud and resisting staff, Ativan 0.5mg PO and Risperdal 0.5mg PO q6hr PRN was given at 10:00AM with no effect. The patient continued to escalate and became physically assaultive, Geodon 10mg IM BID PRN at 10:26AM and Ativan 2mg IM q 4hr PRN were given at 10:27AM. The patient was placed in the "Quiet Room, (which is actually the Seclusion Room) to deescalate, CO was maintained, support was provided, and the patient was released at 1:30PM. Since the medications were used as restraints, there were no vital signs taken, a face-to-face assessment by the physician, debriefing, etc. as required for medications used as restraints.
Note: a review of the ED record for this patient revealed that the patient came to the ED on 4/13/10 and received Ativan 2mg IM for agitation. According to the MAR and nurses notes, on 4/13/2010 at 3:11AM, Ativan 2mg IM, one time was given in ED. There was no documented evidence vital signs and other monitoring was done for the medication used as restraint.

3. MR #10 revealed that on the MAR and according to in-patient medications, the patient received Ativan 1mg PO q4hr PRN on 6/28/10 at 8:47AM. At 11:00PM, the patient remains agitated, attempting to leave, rambling incoherently, 24hr restraint monitoring flow sheet was started. MD called and made aware of increase Pulse 95, increase agitation, and became aggressive. The patient's vitals at 8:08pm were BP 138/87, P 114, T 97.2F. The patient received Ativan 1mg q4hr PRN IM on 6/28/10 at 11:46PM. There was no evidence to indicate that the patient's vital signs were monitored further.
The physician orders on restraint/seclusion form started on 6/28/10 at 12:00AM for biting and scratching, & attempting to leave unit. The type of locked seclusion was for 4 hrs. The physician ordered Geodone 20mg IM, one time and was given at 12:06AM on 6/29/2010.

A psychiatrist progress note on 6/29/2010 at 1:50AM documented that "called to assess the patient for locked seclusion after she bit one staffer and scratched another. Upon encounter the patient is in quiet room,(actually the Seclusion Room), the patient was agitated, psychotic, praying for forgiveness, tangential, displaying poor impulse control, at several points longing for MD. The patient was given Ativan 1mg IM PRN at 11:46PM on 6/28/2010, Geodon 20mg IM at 12:06AM on 6/29/2010, and locked seclusion was maintained."
There is no documentation regarding monitoring of vital signs or other requirements for patient receiving meducations used as restraints.

4. MR #10 revealed that the nurse documented as follows: "the patient seemed upset after her parents left, she wanted to go home. She was escorted to her room, rested quietly in her bed for a short time, took her HS (bed time) meds and a PRN Seroquel, and then the patient collected all her clothes and left her room and she was stating she was going home. She went into the quiet room (which is the Seclusion Room), threw her clothes on the floor, suddenly jumped up screaming and lashing out, Geodone (dose not indicated in the notes) IM PRN given at 9:05PM, Bp 166/92, P116, and Ativan 1mg IM PRN given at 11PM on 6/28/2010. The patient became increasingly agitated, bit a staff member and scratched an RN. She was placed in locked seclusion. Geodone 20mg IM ONCE given at 0:06AM and calmed quickly.The seclusion room door was opened until 0:300AM, she started screaming, trying to bite and kick and scratched staff. Ativan 2 mg One Time PO at 1:30AM on 6/29/2010, Ativan 2mg po Once given at 3:22AM, placed in locked seclusion and she was resting quietly; the door was unlocked at 4:00AM, she was on CO status for safety and observation.

The nurses notes documented the patient was agitated, rushing at door and while she accepted po medication, she spit it out. "The patient accepted Haldol 5mg IM at 10:45AM, a psychiatrist present, the patient lying on mattress at this time; at 3:15pm, the patient was calm upon awaking, BP 115/69, Pulse 103."
There is no documentation regarding monitoring of vital signs or other requirements after the initial dose, for patient receiving medications used as restraints

5. MR #13 revealed that on 8/1/10 at 9:41AM, the Nurses notes documented that the patient was verbally abusive and verbalizing paranoid ideation, not following staff verbal redirection. The patient received Ativan 2mg IM q4hr PRN, and Haldol 5mg q4hr PRN IM.at 9:32AM, vitals were checked at 8:15AM BP 114/74, P86; at 10:11am BP 114/74. P86

On 8/1/2010 at 10:20AM, the nurse documented the patient continued to refuse direction, and cursing and calling staff, the patient also was putting on call light in her bathroom repeatedly, she is not in distress. On 8/1/10 at 1:48PM Behavioral Health 24 hr assessment by RN documented the patient was in extremely poor behavioral control today, cursing openly at staff, the above PRN was given; at 11:30AM the patient somewhat calmer and less aggressive.

On 8/4/10 Behavioral Health 24hr assessment at 0:28AM documented the patient spent most of the evening in her room, out once, very briefly for snack; She declined offer of 1:1, contracts for safety and did not take her HS meds; At 8:00AM and 9:22AM her vitals were BP 121/77, P76, R18;
at 5:55PM, the nurse documented the patient remained agitated, very paranoid, delusional, believes phone are bugged and she is not speaking with the right person on the phone, cursing loudly at staff. One time dose Haldol 5mg IM and Ativan 2mg IM at 3:30PM were given, and some agitation relieved.

On 8/13/2010 at 1:50PM, RN documented the patient went to court today. She is angry that she is mandated to take medications. There's no indication that this was care planned for. The patient continued to be verbally aggressive in the milieu and was unresponsive to redirection. She required and received Haldol 5mg IM and Ativan 1 mg IM, one time, at 1:16PM after refusing po medication. The patient continues to threaten staff verbally.

In all cases, either the patient had vitals taken initially when receiving medications used as restraints but did not have documentation regarding monitoring of vital signs or other requirements after the initial dose.

Based on a review of policy and procedures and from interview, the seclusion room is also being used as a quiet room to manage the behavioral patient, which is not the intent of the regulations.

Findings include:

A review of Policy for Quiet Room: Guidelines for the Use of Quiet Room, revealed that there is no Quiet Room designated in the policy and no procedure for its use. Interview with the Behavioral Health manager, Staff #6 on 8/16/10, revealed that the seclusion room is also being used as a quiet room for patients, who need some quiet time.

However, the intent of a quiet room is not being met when the seclusion room is used for this purpose. The quiet room is used to foster a calming environment versus the environment of padded walls and floor. The seclusion room is only to be used for the management of violent, self-destructive behavior. The Restraint and Seclusion Policy (Definitions C, 2)excludes the Seclusion Room as Seclusion when it's used as a Quiet Room, which is not acceptable.

The seclusion room does not provide a calming environment or the feeling a quiet room should foster, such as a patient's bedroom, sensory stimulation room, or lounge area. Therefore, the Quiet Room, does not meet the intent of the regulations.

Based on document review and staff interviews, the current structure of the hospital quality assurance program fails to assure that the Quality Improvement Committee receives, analyzes and reports on the status of all service lines, on an ongoing basis, and can measure the success of improvement measures.

Findings include:
1. According to the flow diagram of the NWH Board of Trustees, the Quality Improvement line receives reports from the Interdisciplinary Hospital committees/Service Lines, and the Medical Board Committees, and each meet independently monthly. According to interviews with the Medical Director, there is QI staff representation on all committees, however there is no documented evidence of their participation. Data was presented, analyzed and acted on, by the Quality Improvement Committee, which meets monthly.
In addition, other relevant indicators, such as housekeeping, dietary departments, and Environment of Care, Physical Environment, Mortality, Morbidity (MM) reviews, are not included in the Quality Improvement Program.

2. The 2010 NWH Quality Improvement Committee Reporting Agenda only lists the topics that have been pre-selected for review once a year, and represents Performance Improvement Projects instead of an ongoing review of all hospital services and systems. The Quality Assurance Performance Improvement Program (QAPI) review doesn't include within the year, all departments and services (including those services furnished under contract or arrangement). There's no documented evidence to indicate that problems were identified and Performance Improvement plans developed to address the problems as they arose in the Quality Improvement meeting minutes.

3. Review of the QAPI program and committee meeting minutes revealed that other inpatient and outpatient departments were not included in the hospital-wide QA Program, e.g Complaints, Incidents, Infusion Center, Dialysis Unit, Hospice Program, Dietary, Social Work, Occupational, Speech and Physical Therapy departments, Physical Environment and Maintenance.

4. The QAPI committee failed to address and analyze incidents, complaints and accidents, as well as negative patient care outcomes.
A review of the QAPI committee revealed that complaints that were initially closed were not finalized as to outcome.
The hospital failed to use the data that was collected to monitor the effectiveness and safety of each service and the quality of care provided in all areas including Incidents (Patient Safety), Complaints, Food and Nutrition and Housekeeping.

Based on a review of 18 physician credentialing records, two records lacked documented evidence that complete and thorough appraisals were conducted of the practitioners and their demonstrated competencies were evaluated prior to their reappointment of privileges.

Findings include:

1. Review of the credentialing file of Staff #32, a pathologist, revealed that the practitioner was reappointed in April 2009, but there was no documented evidence to show that his quality of work, patient outcomes and adherence to medical staff rules were reviewed and evaluated prior to his reappointment.

2. Review of the credentialing file of Staff #33, a radiologist, revealed that the practitioner was reappointed in April 2009, but there was no documented evidence to show that his quality of work, patient outcomes, and adherence to medical staff rules were reviewed and evaluated prior to his reappointment.

Based on electronic/ paper medical record reviews and staff interviews, the hospital did not demonstrate that it had a system of coding and indexing medical records that facilitates timely retrieval of medical records of patients in the computer in order to support medical care evaluation studies. This is evident in 5 of medical records reviewed with the staff using the computer. MR #4, 20, 21,25, and 27.

Findings include:
1. The medical record for the patient MR #21 was initially reviewed on 8/19/10 at 3:00PM with Staff #18 witnessed by Staff #10. During the review, the care plan for the patient related to Turning and Positioning could not be displayed. The staff sought the assistance of another staff that is more familiar with the software in use but could not display the information. It was therefore concluded that staff had not provided a care plan for the identified mobility problems of ADL, Gait, Decreased Activity level and a Braden score of 13.
2. On 8/20/10, the medical record for the patient MR #4 was reviewed with Staff #16 also witnessed by Staff #10. During the review, Staff #21 was able to display and print other documents needed to complete the chart review for the patient MR#4. Staff #21 was asked to access MR #21 to see if documents that could not be found on 8/19/10 were in the computer. Staff #21 was able to find and print the missing Turning and Positioning records for patient MR #21. It was therefore concluded that the information must have been in the computer all along but the staff did not have the knowledge to retrieve the information. Staff #10 stated that she understood the problems and was working on fixing them.
3. On 8/23/10 at 10:30AM, the medical record for patient MR #27 was reviewed with Staff #21 in the computer room. During the review, it was noted that MR #27 had reddened skin and a Braden score of 11 on the unit which was not identified in the ER but noted on admission to the unit. Staff #21 was prompted several times to look for care planning information related to this reddened skin in the computer and she responded that there was none after several search efforts. Staff #21 searched and could not find any related notes to Turning and Positioning as required by the patient. Staff #21 then stated: "It is so easy to put the information in. I can do it in a second". This statement was heard by both surveyors doing chart review in the room. At 12:15PM, it was concluded that the information related to Turning and Positioning was not recorded for the patient. A request was sent to Staff #10 to submit the facility policy on Patient Assessment and Care Planning on 8/23/10 at 12:20PM. On 8/23/10 at 2:30PM, Staff #21 presented documents related to Turning and Positioning for the patient MR #27. Staff #21 stated: "After you left, I searched and searched till I found the document".

Based on medical record review, it was determined that the facility did not ensure that all patient medical record entries were legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided.

Findings include:
1. During observation and review of medical records in the Nuclear Medicine and Nuclear Cardiology units on 8/16/2010 at 2:50PM, MR #5 and MR #6 revealed that "the participants in Time Out form" was not completed, with the name of the Surgeon, and the name of the Anesthesioloist.

2. During an observation and medical record review in the Medical/Surgical unit on 8/18/2010 at 2:15PM, MR #29 revealed that "Pre Procedure Time Out Process form" was not completed; Surgeon/Procedural Physician, Anesthesiologist name was not filled out in the "Participants in Time Out" section.

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Based on medical record review, it was determined that the facility did not ensure that all orders are dated, timed, and authenticated promptly by the ordering practitioner.

Findings include:

1. During observation and review of medical records in Medical/Surgical unit on 8/18/2010 at 2:15PM:
a. MR #29 revealed that the patient was on DNR, but DNR form
was not filled outl, including the signature.
b. MR #9 revealed that the Consent to Treatment form was not filled out.
c. MR #14 revealed that the Emergency Department Record Form (ED) filled out by the physician did not include the date and time the patient was treated.
d. MR #15 revealed that the Physician's Certification of the Consent to operation, special treatment or procedures form, was not filled out. The Physician's Signature and Date were left blank.

2. During medical record review in the Pediatric unit on 8/23/2010:
MR #30 revealed that the ED record was not filled out completely, by a physician. The day and time seen by a physician was not indicated; the Consent for Iodinated Contrast CT was not completed- date/time was not completed.

3. During observation and review of medical record in the Behavioral Unit:
for MR #23 revealed:
a. "The Physician Orders for Restraint/sSeclusion Form" was not completed. The date and Time for Physician Orders was not documented. The type of restraint was 4 point, start time, stop time of Duration of Use of Restraint was not documented, and MD/DO/NP signature section was not signed.
b. Emergency Admission (section 9.39 Mental Hygiene Law) on 7/10/10 was not completed; in the column for Date of Arrival at Hospital including Mo/Day/Yr was not filled out, signature of Staff Physician was not signed.

Based on observation and medical record review, it was determined that the facility did not ensure that medication records, are accurate and complete.

Finding includes:

During an observation in the Pediatric unit, 4west Pediatrics, medication room, the Pyxis shift change controlled drug discrepancy reporting during the PM shift was not performed. The records revealed that there were no entries for 7/15, 7/18, 7/20, 8/13, and 8/14/2010.

Based on observations and staff interviews, the hospital failed to ensure that drugs and biologicals that are outdated or mislabeled or otherwise unusable are removed from storage areas where they could be used for patient care.

Findings include:

1. Emergency Department (ED) - witnessed by Staff #8 on 8/16/10:
a. At 11:50AM a Tracheal tube introducer with the expiration date of 7/2009 was noted among the stored supplies.
b. At 12 midday, a blue top Vacutainer with the expiration date of 6/2010 was noted among the stored supplies.
c. An ultrasound equipment with inspection date of June /09. During interview Staff #9 confirmed that it was due for the yearly inspection.
d. At 12:10PM, a cabinet was noted with a broken handle in the Fast Track section of the ED.
2. Neonatal Intensive Care Unit on 8/16/10 witnessed by Staff #16:
a. 50 blue Vacutainer with the expiration date of 12/08 were found in the storage room at 1:50PM.
b. 39 blue Vacutainer with the expiration date of 11/09 were found in the storage room at 1:50PM.
c. At 2:50PM, 3 spinal needles with the expiration of 07/09 were found in the storage cabinet.
d. At 2:50PM, 1 spinal needle with the expiration of 10/09 was found in the storage cabinet.
e. At 2:50PM, 1 spinal needle with the expiration of 03/09 was found in the storage cabinet.
f. At 2:55PM, 3 Nutriline 2 Fr needle 22G with the expiration date of 08/09 were found in the storage cabinet.
g. At 3:00PM, 1 cotton umbilical tape 1/8 x 30" 2 strands with the expiration date of 1/05 was found in the wheel-able storage cabinet. The following were also found in the same cabinet:
1 BD safety glide syringe 1ml 25g 5/8 expired 04/09.
1 BD safety glide syringe 1ml 25g 5/8 expired 05/09.
1 vial of sterile water expired 7/1/06.
1 vial of sodium chloride expired 8/1/06
BBL culture swab expired 07/09.
h. At 3:25PM, the emergency box was opened and following expired items were found inside the cart:
2 blue Vacutainer with the expiration dates of 07/10.
2 purple Vacutainer with the expiration dates of 06/10.
2 green Vacutainer with the expiration dates of 06/10.
2 small stylet slick disposable endotracheal tubes with the expiration dates of 06/10

3. Operating Room (OR) - witnessed by Staff #11 on 8/17/10:
a. At 11:00AM, a 4.0 ethilon suture with the expiration date of 7/10 was found in the storage cabinet in OR #1.
b. At 11:00AM, a 4.0 vicryl suture with the expiration date of 7/10 was found in the storage cabinet in OR #1.
c. At 11:35AM, 2 stapler reload XR 30G with the expiration date of 01/08 were found in the storage cabinet in the clean storage area of the OR.
d. At 11:35AM, 1 stapler reload XR 30V with the expiration date of 09/09 was found in the storage cabinet in the clean storage area of the OR. During interview Staff #11 stated that the OR has 2 supply clerks whose job it is to remove expired items.
e. At 11:50AM, an Un-cuffed Tracheal Tube packet was noted opened with the Stylet introducer taken out and the packet was noted among the clean supplies. During interview Staff #12 stated that supplies taken into the OR are returned to the storage area if not used. The potential of contaminating the stored supplies with this practice was discussed with Staff #11 and 12.

4. Labor and Delivery (LD) -witnessed by Staff #10 on 8/17/10:
a. At 2:30PM, 12 unsheathed and dusty curved airway/tongue depressors were found in the crash cart.
b. 1 Ambu laryngeal mask with the expiration date of 8/08 was also found in the same crash cart.

5. Laboratory - witnessed by Staff #13 on 8/17/10:
a. Chemistry
At 3PM, 1 purple Vacutainer with the expiration of 9/09 was fund among the stored items.
b. Immunology
i) At 3:10PM, a mounting media with the expiration date of 9/30/09 was found among the stored items in use.
ii) At 3:11PM, a washing solution for GC Chlamydia was noted opened with no date of opening and no expiration date on the container. The solution was also dispensed with a pipette and was not a closed dispensing system.
iii) At 3:12PM a bottle of water for rinsing dated 8/12/10 and no projected expiration date was found on the work table area.
iv) A stain electrophoresis mixture last mixed date of 3/22/10 was noted in the work station.
v) A 1 gallon container of a stain mixture dated 10/12/08 was noted in the work area.
vi) A buffer solution mixed on 7/29/10 was noted in the work area.
vii) A C6 wash buffer dated 7/19/10 was noted in the work area.
viii) A Vitamin D wash dated 7/26/10 was noted in the work area.
ix) A PPS buffer with ANA dated 6/29/10 was noted in the work area.
At 3:45PM, Staff #13 was asked to submit a policy on mixed solutions/buffers used in the department. A review of the policy "Serum Protein Electrophoresis" dated 7/1/98 revised 7/2001 of the Immunology department stated on page 4, "Preparation of Reagents"; step 4 Label the container with the date prepared and the expiration date. The staff working in this area failed to follow the policy for ensuring the integrity of the mixtures and buffers used in the immunology area of the laboratory.

c. Microbiology - witnessed by Staff #13 on 8/18/10:
3 canisters of Ecolab Quick Care waterless foam hand sanitizers with the expiration dates of 7/10 were found in the storage area.

6. Radiology- witnessed by Staff #15 on 8/18/10:

a. Intervention Radiology
i) 25 vials of 10mls of 0.9% Sodium Chloride with the expiration dates of 7/10 were found in the storage cabinets.
ii) A BD safety glide 1ml 25G with the expiration date of 5/10 was found in the storage cabinet.
iii) 2 BBL culture swab with the expiration date of 6/10 was found in the storage cabinet.
iv) 4 unsheathed and dusty curved airway/tongue depressors were found in the crash
cart.
v) 2 Insyte Autoguard 18GA 1.16 inches with the expiration date of 06/04 were found in
the crash cart.
vi) 2 Insyte Autoguard 20GA 1.00 inches with the expiration date of 08/04 were found
in the crash cart.
b. Women ' s Stereotactic Room:
i) At 11:35AM, a bottle of 0.9 Na Cl 500cc was noted opened without date and time on the opened bottle.
c. Cat Scan Room:
i) At 11:50AM, a 2.0 Ethicon Silk sutures with the expiration date of 1/09 was found in the storage cabinet.
ii) Pediatric Emergency Crash Cart contained the following expired items:
1 Provent arterial blood sample kit with dry lithium with the expiration date of 11/04.
1 Provent arterial blood sample kit with dry lithium with the expiration date of 01/04.
1 Provent arterial blood sample kit with dry lithium with the expiration date of 07/04.
BD Insyte Autoguard 22GA 1.0 inches with the expiration date of 09/07.
BD Insyte Autoguard 22GA 1.0 inches with the expiration date of 01/09.
2 BD Insyte Autoguard 20GA 1.0 inches with the expiration date of 11/09.
d. MRI Staging

7. 6th Floor Medical/Surgical Unit -witnessed by Staff #17 on 8/18/10:
a. The supply cart in the Hemodialysis unit was noted dusty at 2:25PM.
b. Room 612 was noted with a nasal canula on the bed rail. There was no cover on the nasal canula nor was there a cover any where in the room for the canula when not in use.
c. Room 646 the patient was noted on IV infusion of 1000cc 0.9 Na Cl with no label on the bag of IV and no label on the main line.

8. 4th Floor Surgical Unit - witnessed by Staff #10 and #18 on 8/19/10:
a. At 10:35AM, in room 414 a nasal canula was noted hanging on the wall O2 pipe without being covered.
b. At 10:37AM, the emergency cart in the 4 South was noted with an Ambu laryngeal mask with an expiration date of 8/08.
c. At 10:40AM, in room 430 a nasal canula was noted hanging on the wall O2 pipe without being covered.
d. At 10:50AM, in room 434 a nasal canula was noted hanging on the wall O2 pipe without being covered. In addition a bottle of opened and not dated 1000cc 0.9 Na Cl was noted in the room.

9. During interview with Staff #20 on 8/19/10 at 2:30PM to 4PM it was revealed that Staff #20 relied on volunteers to monitor other staff for infection control compliance and that a volunteer is needed for the OR areas. On 8/20/10 Staff #20 stated that a volunteer to monitor the OR areas has been selected and the audit tool has been formulated. Staff #20 also stated that she performs environmental check once a month using ""GNYHA/UHF Clostridium Difficile Collaborative Environmental Check" form. This form failed to identify and monitor the environmental issues observed in various locations of the facility that shows breaches in infection control practices.


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10. During observation in ICU/CCU on 8/16/2010, the following outdated medications and biologicals were found, this was verified by Staff #10:
a.Travel Box for adult in Transport Emergency Box was not signed, and
One Epinephrine inj 1: 10,000 1 mg with an expiration date of 8/1/2010 was found in the Transport Emergency Box.
b. In the Ostomy care cart,
Four Povidine-Iodine Swabstick with an expiration date of 2/2009,
One bottle of Plain Packung Strip with an expiration date of 4/2009,
Three CMC/Alginate dressing - 4x4 with an expiration date of 6/2009(2) and 1/2010(1) were found.
c. In the Zoll-Ext. Pacer/Defibrillator for Cardioversion cart,
One Electro with an expiration date of 4/2006
One Benzoin tincture swabstick with an expiration date of 9/2006
d. In the Code Cart (CCU side), one suture removal kit with an expiration date of 9/2009
e. In the clean utility room, five BD Insyte Autoguard (Angiocath) 18 GA with expiration date of 11/2007 and 3/2010.

Based on observation, staff interview and review of the dietary policy and procedures, the facility failed to provide dietary and food services according to the current standards of practice.

Findings include:

During observation and inspection of the kitchen, cafeteria, and food service areas conducted on 8/16/10 through 8/23/10, staff interview and review of the dietary policies and procedures manual, the following items were noted:
1. During the observation of the kitchen on 8/19/10, two potentially hazardous cooked beef briskets were not cooled by an adequate method to ensure that every part of the beef brisket reached the required temperature within the mandated timeframe. According to Staff #22, the two beef briskets, weighing approximately 9 to 12 pounds each, were cooked on 8/18/10 and cooled whole in a portable reach-in refrigerator and then transferred to a walk-in refrigerator (Box #11).

On 8/19/10 at approximately 11:15AM, whole beef briskets were observed in the walk-in refrigerator. The temperature of the briskets ranged from 40 degrees F to 50 degrees F. The temperature log was requested and reviewed. The temperature log for the cooling of the beef brisket revealed that the temperature of the brisket after two hours of cooling was recorded at 100 degrees F. The temperature log did not contain a temperature recording at the 6 hour timeframe.

Review of the Hospital's Nutritional Services policy entitled, "Cooling and Storing Meats and Other Potentially Hazardous Foods," states that "To ensure food safety and prevent the occurrence of food safety and sanitation problems, roasted meats and other potentially hazardous foods must be cooled and stored according to established safe guidelines with internal cooling temperatures as follows: From 140 degrees F to 70 degrees within 2 hours; From 70 degrees to 41 degrees F within 4 hours." Therefore, potentially hazardous foods must be cooled from 140 degrees F to 41 degrees F within a total of 6 hours.

There was no evidence that the temperatures of the beef briskets cooked on 8/18/10, were monitored properly to assure that the rate of cooling met the standard of practice.

2. On 8/17/2010 during the lunch meal, under-cooked chicken was served in the cafeteria. A thermometer was not used to determine that the pieces of chicken obtained proper internal cooking temperatures. Staff #22 and #29 were made aware of the problem and developed a corrective action plan.

3. During the tour of the kitchen and cafeteria on 8/16/10, the rubber gaskets on the doors of some of the reach-in and walk-in refrigerators were in need of repair and/or were soiled.

4. During the tours of the kitchen on 8/16/10 and 8/19/10, single service containers (large plastic pickle containers) were observed in the freezers and refrigerators being reused to store soups, beef ragu and other leftover food items. The Hospital's policy and procedure entitled, "Infection Control in Nutritional Services," states "Disposable containers and utensils shall be discarded after one use." Therefore, single service containers must be discarded after using the item from the original container.

5. On 8/16/10, one of the doors to the outside loading dock, located at the main receiving area, was observed to contain gaps and openings to the outside and was not protected against the entrance of insects and rodents.

6. During the tour of the dietary areas on 8/16/10, cracked floor tiles were observed between the passageway of the kitchen and cafeteria.

7. On 8/16/10, coffee urns, that were clean and ready for use according to Staff #29, were observed with water and a dark liquid inside and were not being properly air-dried. All equipment is to be air-dried after sanitizing. On 8/19/10, this observation was corrected and the coffee urns were observed dry inside and being stored inverted.

8. On 8/16/10, garbage containers throughout the kitchen were observed uncovered when not in use. Garbage and refuse containers in food preparation and utensil washing areas are to be covered when not in use.

9. During the tour of the kitchen on 8/16/10, the hoods above the ovens and fryer contained excessive grease. The hospital's policy and procedure entitled, "Nutritional Services Department Safety," states "The Nutritional Services Department is responsible for washing filters, hoods, floors, walls and windows in the department." The hospital's policy and procedure entitled, "Preventative Maintenance," states "Vents and hoods are cleaned quarterly by Nutritional Services staff or an outside vendor."

10. During the tour of the kitchen on 8/16/10, food preparation sinks without indirect drains were observed. This observation was confirmed with Staff #2. The standard of practice states that there is to be no direct connection between the sewage system and any drains originating from sinks and equipment used for storage, preparation or processing of food or drink.

11. On 8/16/10, at least two sinks used for food preparation were observed without strainers. Furthermore, the pipe under the pot washing sink was leaking.

12. On 8/16/10, the concentration of the sanitizing solution in the buckets throughout the kitchen was checked using chemical test strips and was found to be excessively high. Chemicals used for sanitizing are not to have concentrations which will leave toxic residues on surfaces treated. On 8/19/10, the concentration of the sanitizing solution was checked again and found to be in an acceptable range. According to Staff #29, the sanitizing solution dispenser was recalibrated by an outside vendor.

13. On 8/16/10, artificial lighting fixtures located over the food storage area were observed not to be protected to prevent broken glass from falling into food.
14. The shelving in the walk-in meat refrigerator (#9) and the produce refrigerator (#10) was rusty and not easily cleanable.

15.a On 8/16/10, in the walk-in refrigerator (#11), tuna salad was labeled with a preparation date of 8/7/10 and a use by date of 8/14/10. The hospital's policy and procedure entitled, "Labeling and Storage of Food Supplies," states "At no time will expired food be stored in Nutritional Services refrigerators." This food item was immediately discarded.
b. On 8/19/10, in the walk-in refrigerator (#11), beef brisket was labeled with a preparation date of 8/19/10 and a use by date of 8/26/10. The hospital's policy and procedure entitled, "Storage and Use of Leftovers," states "Leftover items which are not frozen are held no longer than three days before they are used or disposed of." Therefore, the use by date of cooked food items stored in the refrigerator should be no more than three days after the preparation date.

16. The can opener contained excessive food residue and needed to be cleaned and sanitized,

Based on observations, record review and staff interview, the Condition of Physical Environment is not met since the facility failed to ensure that the hospital is constructed and maintained to ensure the safety of patients and staff as evidenced by the findings cited.

1. The facility failed to maintain a safe, sanitary, and comfortable environment for patients and staff. See A701

2. The facility did not meet the applicable provisions of the Life Safety Code. See A709

3. The facility failed to provide dietary and food services according to the current standards of practice. See A620

4. The Endoscopy Suite was not constructed and maintained to prevent the spread of infection. See A749

Based on observations and staff interview, the facility failed to maintain a safe, sanitary, and comfortable environment for patients and staff.

Findings include:

1. Based on observations made on 8/16, 8/17, 8/18 and 8/19/10 water fountains throughout the hospital were not maintained as they lacked adequate pressure or had no pressure at all.
2. On 8/17/10 at 10:53AM, the nurse call bell in the patient shower located on the 4th floor nursing floor was pulled by the surveyor and there was no response by nursing staff for than 3 minutes. In addition, the staff responder in the staff lounge room 442 did not annunciate audibly or visually.
3. On 8/17/10 a ceiling tile in soiled utility room 383 was noted stained and damp. Examination of the area above the ceiling tile revealed that a plumbing valve was leaking.
4. Review of the Building Management System (BMS) on the morning of 8/18/10 revealed that between 8/12/10 and 8/17/10 humidity in the nursery, NICU and operating rooms was outside the ASHE range of 20-60%. The BMS printout shows humidity above 60% at various times. There was no follow up documentation or work order to indicate that corrective action was taken.


27522

5.a.(1) On 8/17/2010 at 2:25PM in the Maternity unit, it was observed that there were multiple stained/damaged ceiling tiles. Specifically, there were 2 broken ceiling tiles and one stained ceiling tile, damp to the touch, located in the Maternity Sterile Corridor; 6 stained ceiling tiles in the Maternity Exit passageway; and there were 3 stained ceiling tiles and one water-stained ceiling light panel in the Maternity Soiled Utility Room.

5.a.(2) On 8/20/2010, further observation of the floor above (a Mechanical Room) revealed that there was a supply fan located above these tiles, and there was a large puddle around the base of this fan from condensation. (There was a drain present).

5.b. On 8/17/2010 at 11:30AM in the vicinity of Elevator 6 on the 6th floor, two water soaked ceiling tiles were observed.

(Note: If ceiling tiles are not replaced and stay humid/wet, they may harbor the growth of mold/fungi and contribute to environmental contaminants. Also, stained ceiling tiles need to be investigated for potential leaks above, as it may be an indication of a problem with the plumbing/sprinkler system or of insufficient insulation around the steam pipes supplying heat to the facility.)

6. On the morning of 8/23/2010 in stairwell #9, it was observed that there was a large puddle of water, as well as paint bubbling/peeling from the staircase walls and the floor. A smaller puddle of water was also observed in stairwell #3 that same morning.

(Note: These observations indicate that the stairwell is not smoke tight. Stairwell needs to be investigated for potential leaks, as leaks may be an indication that the concrete barrier surrounding the staircase has a penetration or is not sealed properly to prevent water from entering the space.)

7. On 8/18/2010 at 2:35PM, it was observed that the 1st floor cancer center Men's and Women's bathrooms did not have appropriately positioned emergency nursing call bell pull cords as required by AIA 7.32.G2. The emergency pull cords were wrapped around the support bars. This practice does not provide easy access to a patient who might collapse on the ground.

Findings # 5 - 7 were verified with Staff #2 at the time of observation, except for the observation of the Mechanical Room which was verified with Staff #1.

Based on observations, record reviews and staff interviews, it was determined that the facility did not meet the applicable provisions of the Life Safety Code, NFPA 101, 2000 edition.

Findings include:

During the survey of the facility from 08/16/10 to 08/23/10, Life Safety Code deficiencies were noted in multiple areas of the Code requirements and were cited under the following Fire/Life Safety Code tags:

K 17
K 18
K 20
K 21
K 29
K 33
K 50
K 52
K 62
K 67
K 72
K 76
K 106
K 130
K 135
K 144
K 145

Based on observations, record review and staff interview, the Condition of Infection Control is not met since the facility failed to ensure a sanitary environment and failed to develop an effective Infection Control Program as evidenced by the following:

1. The infection control officer failed to develop and implement an effective infection control program. The infection control officer did not develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. See A749

2. The facility failed to maintain a sanitary environment for patients and staff. See A701

3. The facility failed to provide dietary and food services according to the current standards of practice. See A620

Based on observations, interview and record review, the infection control officer failed to develop and implement an effective infection control program.
Findings include:
A. During a survey of Central Sterile Supply (CSS) on 8/20/10 at 11:40AM, it was noted that the area was not constructed and maintained to prevent the spread of infection.
1. There was no door in the doorway to separate the decontamination side of CSS from the hospital's dishwasher. In addition, there was no exhaust ventilation on the "dirty" side of CSS where surgical instruments undergo gross decontamination. Instead, there were two HVAC vents providing supply ventilation, i.e., positive flow. This would allow air from the decontamination area to flow through the open doorway towards the dishwasher where the hospital's supply of dishes are washed.
2. The pass-through window between decontamination and clean side was left open. This would allow air from the decontamination area, where only supply ventilation is provided, to flow towards the clean side of CSS.
3. There was a large gap at either side of a plastic curtain on the window of a second pass-through located between the dirty and clean sides of CSS.
4. The cart washer used to clean stainless carts, used for the transporting of clean instruments to the OR and for transporting dirty instruments from the OR, is located in the same room as the hospital's dishwasher.
5. The area at the back end of the cart washer pass-through was noted being used for storage of the cleaned stainless steel OR carts. Also noted stored in this same area, as part of the medical waste cart exchange program, were eight empty 1 cu. yd carts for medical waste, three empty 3 ' by 6 & ? ' transport cabinets for sharps cabinets and 5 unclean 1 cu.yd. carts for the collection of trash. The washed and cleaned stainless steel transport carts would have to move through all these items then past a collection of unused hospital beds on the other side of the wall in order to arrive at the dumbwaiter approximately 30 - 40 feet away.
6. The CSS policy does not indicate how the stainless steel carts will be moved from the cart washer, appropriately stored and then transported to the OR suite.
7. The air flow between the clean side of CSS and the adjacent corridor was negative rather than positive, allowing air flow from the corridor into the sterile processing area.
8. The ceiling tiles on the decontamination side of CSS were the acoustical type which are not washable and which contain cracks and fissure that may retain dirt and dust.

B. During a survey of Endoscopy Suite on 8/20/10 at 3:20 PM, it was noted that the area was not constructed and maintained to prevent the spread of infection.

Findings include:

1. Flow of instrumentation was not from the contaminated area to a clean area as there was only one room with the sink used for gross decontamination immediately adjacent to the scope cleaners.

2. The processing room lacked a handwashing sink and a work counter.

3. Interview with Staff #12 revealed that, after processing, the cleaned endoscopes are carried across the corridor (public) to the storage room on the other side.

4. Room where clean supplies and endoscopes stored was negative to the corridor rather than positive. The room was provided with two exhausts vents but no supply vents.
5. Clean and non-clean items were stored in the "clean" storage room. Cardboard shipping boxes and an Argon coagulator were also stored in this room.
6. There was no door to the closet in which the endoscopes were stored.
7. Two ceiling tiles in the "clean" storage were noted stained and still damp indicating the possibility of a leak.
8. The HVAC supply vent in the processing room was tested by facility staff and shown to provide 60 CFM supply or approximately 5 air changes rather than the 10 air changes required. There was a strong odor of glutaraldehyde in the room the main ingredient in the disinfectant used. The room temperature was tested by the facility and found to be an uncomfortable 76 degrees Fahrenheit.

9. Procedure room #2 was tested by staff and found to be positive to corridor rather than neutral or negative.
C. Based on environmental observation of the facility and staff interviews, the infection control officer did not develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

Findings include:

1. On 8/16/10 at 2:00PM, a sterile autoclave set for chest drain and sterile trach tubing were found on the work counter in 6th floor soiled utility.
2. On 8/16/10 at 2:15PM, a pink slimy material was noted on the chute of the ice machine in the 6th floor pantry. Encrusted grime noted on the tray under the chute. On 8/17/10 at 12:10PM, the chute of the ice machine in the 3rd floor pantry was noted grimy. These observations were confirmed by Staff #1.
3. During tours on 8/16 and 8/17, no separation was available between the storage room containing sterile supplies and the staff lounge. Sterile supplies included oxygen masks, nebulizers, specimen traps, masks, scalpels, and naso-gastric sump tube. Air flow between these sterile storage rooms and the corridor was negative rather than positive. In the 6th floor sterile room no supply ventilation was available as the thermostat was not working.
4. On 8/17/10 at 10:40AM, it was noted that there was no supply ventilation in the medication room on 4th floor (room 482).
5. On 8/17/2010 at 11:20AM, it was observed that patient rooms 711, 731, and 751 were converted into storage rooms. During concurrent interview, Staff #2 stated that one patient room from each of the three compartments on the floor had been changed into a storage room to keep the corridors clear. He also stated that the smoke barriers on floors 4 through 7 were identical, and that 3 of the patient rooms on the 6th Floor and 4th Floor had been changed in a similar matter with one room per corridor being changed into a storage room. In interview with Staff #1 these converted storage rooms are provided with approximately 50 CFM supply ventilation. This would provide approximately 2 air changes per hour rather than the minimum 4 air changes per hour required
6. On 8/17/10 at 12:10PM, it was noted that soiled utility room 383 was not provided with exhaust ventilation. Flow of air for infection control is required to be negative instead it was positive. Flow of air was from the soiled room into the nursing unit corridor.
7. On 8/18/10 at 11:20AM, the door to the Janitor's closet in the back corridor of the OR was prevented from closing due to a housekeeping cart too large for the room.
8. On 8/18/10 at 11:30AM, the surveyor observed that the anesthesia work room, containing sterile items for the ORs, was being used as an entry way to the operating rooms. Interview with the OR charge nurse confirmed that surgeons and other staff members generally enter the ORs by coming from the pre-op holding area, the anesthesia storage room and then into the ORs.
9. On 8/18/10 at 12:10PM, no water was available at 2 of the 5 faucets at the scrub sink opposite OR #5. No water was available at 1 of 5 faucets at the scrub sink opposite OR #8. The bank of scrub sinks adjacent to OR #9 were not available for use because of the large amount of storage in front of the sink bank.
D. Based on observations and staff interview, the facility did not ensure separation between clean and dirty supplies.

Findings include:

1. On 8/17/2010 at 2:00PM, it was observed that Room 388 had equipment positioning devices stored in the clean storage room and mixed with miscellaneous sterile equipment.

2. On 8/17/2010 at 2:15PM, it was observed that the Sterile Corridor of the Maternity Unit had 2 metal file cabinets containing files that did not pertain to the area. These were stored in a clean corridor, and these cabinets are not considered clean. There was also one stained ceiling tile which was damp to the touch that was located directly above the sterile delivery set.

The Maternity exit corridor had a cart that stored dirty instruments, and a rolling cart which held sealed sterile supplies. This is an infection control issue. These carts also blocked egress out of that specific area.

3. On 8/18/2010 at 3:00PM, it was observed that on the 1st floor of the Cancer center there was a sharps container that was located directly over a bookshelf filled with magazines and books.

4. All findings were verified with Staff #2 at the time of the observation.


26259

E. Based on observations and staff interviews, the infection control officer did not develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

Findings include:

1. During interview with Staff #20 on 8/19/10 at 2:30PM, it was revealed that Staff #20 relied on volunteers to monitor other staff for infection control compliance.

Further interview on 8/20/10, Staff #20 stated that a volunteer to monitor the OR areas has been selected and the audit tool has been formulated. Staff #20 also stated that she performs environmental checks once a month using " GNYHA/UHF Clostridium Difficile Collaborative Environmental Check " form. However, the form failed to identify and monitor the environmental issues observed in various locations of the facility that shows breaches in infection control practices.

Examples of breaches in infection control practices include but are not limited to:
1. Staff in the OR restocking items taken into the OR in the storage area when the items have been opened, parts taken and remaining item and package returned to stock.
2. Dusty and unwrapped airway/tongue depressors noted in crash carts throughout the facility.
3. Hanging used uncovered nasal canula on O2 delivery pipes.
4. Not dating IV lines
5. Not dating open bottles of solutions.
6. Having expired items available in storage areas
7. Not having an effective tool to monitor the patient care environment for potential infection control risk issues.
8. Relying only on covert observers to identify infection control breaches in practice without the benefit of immediate re-education of staff to prevent repeat occurrences.
9. Not observing staff practices in critical risks area of the facility such as the ORs.

2a. A review of the infection control data for the facility showed that for Hip Replacements surgeries performed, the facility posted a 4.8% infection rate in Category 1 Risk Index compared to 1.88% mean observed rates in other facilities. Thus putting the facility in the 90th percentile with only 10% of other facilities doing better than the facility.

b. Similarly, the facility is in the 90th percentile performance group for Category 1 Risk Index for Colon surgeries with the facility having a year to date infection rate of 11.6% per /100 procedures performed compared to a mean average at similar facilities of 5.59%.
c. These data have not resulted in a critical review of the OR staff practices by Staff #20 as she stated on 8/19/10 during interview that she has not visited the OR to review the practices there. On 8/20/10, Staff #20 stated at 2:20PM that she has just identified a staff to do covert observations in the OR area. During the interview Staff #20 also denied knowlege of the source of the data found in the Infection Control binder which rated the infection rates by surgeons. This document was not identified with the facility's name.
d. The facility failed to review the Infection rate by surgeons, by OR room and by staff assisting with the procedures to identify the infection sources and did not demonstrate that appropriate infection control measures were put into place to reduce the rate of infections.

Based on review of medical record #9 and hospital protocol, the hospital, a designated stroke center, failed to provide emergency services within acceptable standards of practice. Furthermore, based on review of medical record #9, the hospital transferred the patient to a higher level of care without an express written certification signed by the emergency department physician. Also, there was no documented evidence in medical record #9 showing that the risks and benefits of the hospital transfer were explained to the patient or other legally responsible person.

Findings include:

1) According to medical record #9, the 62 year old male patient presented to the hospital's emergency department on June 16, 2010 at 2001 with recent and sudden onset of possible stroke symptoms, flaccid on right side and right sided facial droop. At 2005, the patient was examined by an emergency department (ED) physcian and the patient underwent diagnostic tests to determine the cause of the patient's symptoms and course of treatment. The "Emergency Physician Record/Acute Stroke Assessment HIH Stroke Scale" form signed by the ED physician stated that the results of the "CT Head" was "interpreted by a radiologist" and found to be "normal." Based on the results of the diagnostic tests, including a non-contrast CT of the head, and the ED physician's examination and evaluation, the ED physician's clinical impression was that the patient was having a non-hemorrhagic cerebral vascular accident (stroke). At 2046, the ED physician ordered and at 2111, the ED physician administered Tenecteplase (TNK). According to the hospital's Primary Stroke Center Protocol, the Tissue Plasminogen Activator (TPA), Alteplase, should have been administered to treat the non-hemorrhagic stroke, instead of TNK. The Emergency Physician Record/Progress Notes state, "Pt was given TNKase as a cardiac protocol inadvertently as opposed to TPA."
The non-contrast head CT scan was performed on 6/16/10 at 2006. Review of the report of the Head CT scan revealed that there was "No acute intracranial hemorrhage or mass effect." This report of the CT scan of the head was electronically signed by a radiologist on 6/17/10 at 0746. The hospital's stroke protocol states that the non-contrast brain CT scan must be interpreted by a radiologist. However, there is no documented evidence in the medical record that shows that a radiologist interpreted and signed the report of the brain CT scan prior to 6/17/10 at 0746.
A neurology consult was conducted of Patient #9 in the Emergency Department on 6/16/10 at approximately 2100. The neurology consult states, "A CT scan of the brain shows no evidence of hemorrhage or ischemic stroke." The consultant neurologist's "Impression: Likely acute and large left middle cerebral artery ischemic infarct in this patient with a history of recurring atrial fibrillation, now again in sinus rhythm, after the adminstration of 3 mg of Warfarin two days ago and 2 mg of Warfarin yesterday." The consultant neurologist's plan states that the ED physician administered Tenecteplase. This drug was administered rather than TPA." Review of the Consent for Special Treatment states, "I hereby authorize" the ED physician and the neurologist " to perform the following operation/procedure upon me: TNKase Administration, 'clot busting drug', for acute stroke. The consent form was signed by both the ED physician and the patient's wife, a legally responsible person, on 6/16/10 at 2110.

2) Review of medical record #9 revealed there is no documented evidence available to show that the emergency department physician signed a certification that, based upon the information available on 6/16/10 at 2301 (the time of transfer), the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the patient. Furthermore, there is no documented evidence available that the risks and benefits of the transfer were explained to the patient or a legally responsible person acting on the patient's behalf (spouse).