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Based on document review, interview, and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities of the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.13 Patient Rights. (Cross refer A115).

CFR 482.55 Emergency Services. (Cross refer A1100).

Based on observations and interviews with patients and staff, it was determined that the facility failed to protect and promote the rights of each patient.

Findings include:

1. The following patient rights were not provided for all patients:

a. Grievances. (Cross refer A123).

b. Informed consent. (Cross refer A131).

c. Advanced Directives. (Cross refer A132).

d. Personal Privacy. (Cross refer A143).

e. Care in a Safe Setting. (Cross refer A144).

Based on document review, it was determined that a written reply and/or resolution of all patient complaints/grievances was not provided to all patients with a complaint/grievance.

Findings include:

Reference #1: The "Complaint and Grievance Policy Issue NO. 831-200-005" states that "Patient grievances will be reviewed, investigated, and resolved within a reasonable time frame. On average, a time frame of 7 days for the provision of the response is appropriate. If the grievance will not be resolved, or if the investigation is not or will not be completed within 7 days, the patients will be so informed in writing."

1. On 7/1/10 at 1:30 PM, Staff #15 provided the requested patient complaint/grievance reports for patients MR #18, #19, #20, #21 and #22.
4 (four) of the 5 (five) reports lacked documentation that the patient was notified as to the status of the complaint within 7 days as required per the facility policy and procedure; Reference #1.

a. A patient complaint/grievance from Patient #18, was received at the facility on 6/2/10. A reply observed in the complaint/grievance report was written and dated on 6/28/10, 22 days after the receipt of the grievance.

b. A patient complaint/grievance from Patient #19, was received at the facility on 3/2/10. A reply observed in the complaint/grievance report was written and dated on 3/25/10, 23 days after the receipt of the grievance.

c. A patient complaint/grievance from Patient #20, was received at the facility on 3/4/10. A reply observed in the complaint/grievance report was written and dated on 3/18/10, 14 days after the receipt of the grievance.

d. A patient complaint/grievance from Patient #21, was received at the facility on 4/12/10. The requested written reply for this complaint/grievance was not provided for review. Staff #15 confirmed that a written reply is 3.5 months overdue and has not been written and/or sent for this complaint/grievance.

2. The above findings were confirmed by Staff #1 and Staff #15 on 7/1/10 at 2:15 PM.

Based on medical record review it was determined that the facility failed to obtain all patients' informed consent in 1 of 3 medical records reviewed for consents (Medical Record #33).

Findings include:

Reference #1: Facility Policy and Procedure titled 'Consent for Surgical, Diagnostic and Other Procedures- Issue No. 831-200-031' states "POLICY: 1) Written informed surgical, diagnostic and other procedures must be obtained prior to beginning any medical or surgical procedures or administration of anesthesia, except in emergencies. 2) The patient or his or her representative has the right to make informed decisions regarding his or her care. The patient's rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment..."

1. Review of Medical Record #33 indicated per dialysis flowsheets dated 6/7/10 and 6/9/10, that the patient received dialysis at the facility.

a. Review of the 'Consent for Surgical, Diagnostic, and Other Procedures' form, dated 6/7/10 in the 'Signature of practitioner or Clinical Practitioner' section, indicated the patient and/or the legally responsible person, did not sign the consent form for the "HD" (hemodialysis).

b. Review of the orders for dialysis dated and timed 6/7/10 1650 indicated a "yes admit" next to the 'Consent Obtained' section of the order form.

c. Review of the 'Consent to Treatment and Financial Payment' form dated and timed 6/7/10 2300 indicated " [illegible] pt. (patient) not responding."

d. Review of the face sheet indicated the patient's sister was the designated emergency contact person for the patient.

e. Review of the 'Initial Patient Assessment/Interdisciplinary Referral' form indicated the patient lived at home with her husband and he was her caregiver.

2. The facility did not obtain consent for Patient #33's dialysis treatments, as per the facility policy and procedure referenced above.

Based on medical record review, it was determined that the facility failed to implement its policy and procedure for advance directives.

Findings include:

Reference #1: Facility Policy and Procedure titled 'Advance Directives for Health Care Issue No. 831-200-071' states "... Procedure: ... 8) Nursing Assessment. (sic) The patient's nurse shall query the patient again about an Advance Directive during the initial assessment process. The patient's response shall be recorded in the appropriate Assessment form."

1. On 7/1/10, four closed medical records were reviewed in the presence of Staff #1 and Staff #22. As per Staff #1 and Staff #22, the nurses document their assessment for a patient's advance directive on the 'Initial Patient Assessment/Interdisciplinary Referral' form. Three of the four patients were admitted to the hospital. Medical Records #24, #27, and #30 lacked evidence of an assessment by the admitting nurse, on the 'Initial Patient Assessment/ Interdisciplinary Referral' form, for an advance directive.

A. Based on observations, staff interview and review of facility policy, it was determined that the facility failed to ensure that patients names are not disclosed in the emergency room waiting area.

Findings include:

1. On 6/29/10 at 12:55 PM, during observations made in the Emergency Department (ED) waiting area, in the presence of Staff #1, a patient's first and last name was announced thru the overhead speakers with a statement to go to the registration desk. Staff #3 confirmed that she called the patient by name, since there is no other system in place to locate patients in the waiting area.

2. On 6/29/10 at 1:00 PM, during observations made in the ED waiting area, in the presence of Staff #1, a patient's first and last name was called out with a statement to go to the examination room.

3. Staff #4 confirmed that she called the patient by name, since there is no other system in place to locate patients in the waiting area.

4. On 6/29/10 at 1:15 PM, ED patient privacy policies were requested for review.

a. On 6/30/10 at 2:00 PM, Staff #1 confirmed that the ED does not have established patient privacy policies and procedures to protect and not disclose the patients' names in the ED.

5. The above findings were confirmed by Staff #1 on 7/1/10 at 2:15 PM


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B. Based on medical record review, staff interview, a review of facility policies and procedures, and a review of pertinent documentation, it was determined that the facility failed to protect the patient's right to privacy.

Findings include:

Reference #1: Facility policy titled "Use of Personally-Owned Mobile Communication Devices/Recording Devices on University Premises" amended 5/15/07 states, "...Definitions A. Mobile Communications device is defined as any cell phone... Recording Devices- As a general rule, recording devices and camera-equipped devices (including mobile communications devices) and their uses are restricted in accordance with state and federal regulatory guidelines concerning unauthorized surveillance. Employees shall not use the picture taking functionality of mobile communication devices in the workplace...Unauthorized use of cameras at any University-owned facility...without the express written consent of the department manager is not allowed... In compliance with the privacy regulations contained in the Health Insurance Portability & Accountability Act (HIPAA), visual and recording devices shall not be used in patient care areas..."

Reference #2: Facility policy titled "Photographing/Taping/Interviewing of Patients" revised 11/04 states, "All requests to Photograph/film/tape or interview patients for purposes not directly related to patient care must be consented to in writing by the patient, if an adult and competent..."

1. A review of the ED log dated 11/25/09 through 11/26/09 revealed the following:

a. A 36 year old male (Medical Record #13) presented to the ED via Emergency Medical Services (EMS), with injuries resulting after being struck by a vehicle as a pedestrian.

b. The ED log also indicated that there were no other patients admitted during the time frame from 11/25/09 through 11/26/09 that were struck by a vehicle as a pedestrian.

2. A review of Medical Record #13 revealed the following:

a. A 36 year old male presented to the ED on 11/26/09 @ 4:30 AM via EMS after being struck by a vehicle as a pedestrian.

b. The "Emergency Physician Record Multiple Trauma" dated 11/26/09 stated, "36 y.o. M [male] alert oriented...breast implants BLC [bilateral chest]. Trauma at bedside."

c. Documented on the "Trauma Team Physical Exam/Injuries" form: "36 y.o. ...Transgender received awake and alert ... Clothing Cut ...Breasts silicone injections..."

3. A review of an investigative report written by Staff #12 dated 12/1/09 signed by Staff #12 on 12/2/09 revealed the following:

a. "I arrived in the ED at 8:30 am on December 1, 2009. I was immediately informed there was an incident in the ED during the early morning hours 4-5 am. A Nurse... (Staff #8) had pictures on a cell phone that could have been a picture of a he-she patient from the trauma area on November 25, 2009..."

b. Interview with Staff #13 stated the following: "During the interviews with B___during the day he/she stated, "...the picture on the cell phone was the patient treated in Trauma on Wednesday, November 25, 2009. The patient was a she-he with breast and a penis. (Staff #13) stated the picture was a text with (Staff #7) name in a box. The picture looked like it was taken in a hospital. The person was on a stretcher with a code cart next to the side rails, the person had a c-collar with straps over the chest attached to a penis."

c. Interview with Staff #14 stated the following: "Staff #14 was shown a partially clothed picture... Ms. B___ said to me this stuff has to stop. Pictures on facebook, comments about patients and other staff; it is out of control..."

d. Interview with Staff #15 stated the following: "In response to your request for a statement involving a sexually graphic photograph shown in the ED...Around 05:30 on 12/1/2009 at the nurses station in the Pediatric ED, (Staff #8) showed me a picture on her cell phone of a person from the waist down with genitals exposed. She explained that it was not a man but a female wearing an external prosthetic device..."

e. Interview with Staff #8 stated the following:"(Staff #8) received the text while on break..Staff #8 described the picture as a body of a person with a c collar, strap to a big penis..."

4. A review of a written statement from Staff #7 dated 12/1/09 revealed the following: "had received from an unknown source text picture of a person undressed from waist down ... I send it to my closest friend at work... (Staff #8)"

5. A review of an interoffice memorandum dated 12/2/09 from Staff #12 to the CEO states, "I am requesting a compliance investigative review of the cell phone incident in the ED on December 1, 2009. After interviewing several staff members I am concerned regarding violations of privacy, confidentiality, pornography via telephone devices in the work place and sexual diversity issues...My concern is this may not be an isolated case but more widespread than first thought..."

6. A review of a memorandum dated 12/2/09 Staff #28 to Staff #29 stating, "After interviewing several staff members I am concerned regarding violations of privacy, confidentiality, pornography via telephone devices in the work place...My concern is this may not be an isolated case but more widespread than first thought...."

7. There was no evidence that the facility enforced the policy and procedure to limit the use of personal cellular phones in patient care areas to protect the privacy of patients as indicated in the facility policy referenced in #1 above.

8. There was no evidence that the facility implemented the policy for the unauthorized use of cameras at any University owned facility, without written consent of the department manager as per the facility referenced in #1 above.


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C. Based on observation and review of facility policy, it was determined that the facility failed to provide all patients the right to the confidentiality of their medical records.

Findings include:

Reference #1: Facility Policy and Procedure Subject: 'Corporate Compliance and Privacy', Titled: 'Standards for Privacy of Individually Identifiable Health Information', states "... V. Policy ... All [-----] employees, students, and individuals working on behalf of [-----] in any capacity (including board members, medical staff, business associates, independent contractors, and volunteers) will conduct themselves and their activities in a manner so as to protect the confidentiality of patients' individually identifiable health information as required by state and federal law and in conformance with University policies. A. Requirements: 1. ...c. ...iii. Implementing appropriate and reasonable administrative, technical, and physical safeguards to protect the privacy of PHI (Protected Health Information) from unauthorized use or disclosure;"

1. On 7/1/10 at 11:00 AM the Mid-Track of the ED was toured in the presence of Staff
#12. The following observations were made that indicated that the facility did not implement appropriate and reasonable safeguards to protect the privacy of PHI from unauthorized use or disclosure, as per policy:

a. The unlocked yellow isolation cart outside the GYN Exam Room #6 contained a 'PATIENT OBSERVATION RECORD' form that contained Patient #35's name, account number, medical record number, physicians's name, date of service, date of birth, name of insurance, and the address of his/her insurance provider.

b. The ENT (eye, nose, throat) Procedure Room #9 had a 'CONSULTATION EXAMINATION AND RECOMMENDATIONS' form for Patient #34 on the left side table next to the examination chair. The form had Patient #34's name, account number, medical record number, date of birth, and indicated the patient was self pay.

A. Based on interviews and document review, it was determined that the facility failed to implement a security system that is rigidly enforced to control access to and egress from the facility.

Findings Include:

Reference #1: The "Public Safety Manual - University Hospital Security Operations Manual" contained written "Post Instructions, University Hospital," which stated:

i. "Fixed Post UH-1&2, Main Entrance/Central Lobby:"
-"Visitors must have a visitors Pass before being allowed to enter hospital,"
-"The officer on duty shall check identification cards of all employees entering the area. All employees shall be advised to wear identification cards in plain view while in the building. Verification from department supervisors shall be required for employees not having identification cards prior to the employee entering the building. Employees without identification cards shall be required to sign in and will be issued a temporary identification card."

ii. "Foot Patrol/Relief - UH-3:"
- Public Safety officers will ensure that the Visitor Pass Policy is not violated and that only authorized persons, displaying proper passes are allowed within University Hospital. This includes patients, visitors, temporary employees (Contractors), etc."
- Any persons found without passes: Officer shall: identify that person, determine the reason for their visit and why they do not have a pass. The officer may then either issue a temporary pass, or escort them to the appropriate area (information Desk for patient visitors, etc.)"

iii. "Roving Post UH-6, Psychiatric Emergency Service(Crisis) & The New Fast Track (Unit #6):"
- "The officer on duty shall check identification cards of all employees and the passes of all visitors. All employees shall required to wear identification cards in plain view."

Reference 2: The "Patient Observation" policy and procedure states that the patient care giver is "to remain within arms reach of the patient at all times, including off unit procedures."

Reference 3: The "Security Management Program" policy and procedure states that

a. "All staff and employees are encouraged to report any situations of suspicious nature to Public Safety."

b. "Issuance of Keys for access to interior doors ...is strictly enforced."

Reference 4: The"Patient Elopement" policy and procedure states that the nurse is responsible to notify the Department of Public Safety immediately to begin a search of the public areas.

1. On 6/29/10 at 3:00 PM, Staff #1 confirmed that the Public Safety Security Officers and University Police Officers do not check all visitors, staff, and employees for identification as stated in the "Post Instructions, University Hospital" documents, Reference 1.

a. Staff #1 confirmed that Public Safety has Post instructions, not facility policy and procedures, to check all visitors, staff, and employees for identification.

b. Staff #1 stated that the Public Safety Department has placed security cameras at entrances which are not monitored by Public Safety Staff. These cameras are used to record all activity at the facility entrances and the tape recordings are viewed only, if and when, a problem occurs.

c. On 6/29/10 at 3:00 PM, Staff #1 confirmed that the visitors, staff, and employees continue to not have proper identification.

i. On 6/29/10 at 1:30 PM, behind the nurses desk in the ED, an individual with no identification visible, was observed with two students. The students stated that the individual was new and on his way to get an ID, but they wanted to show him the ED first. This individual did not have a visitor pass and there was no evidence provided to show that the Public Safety officers checked this individuals identification first.

ii. On 6/29/10 at 1:40 PM, near the nurses desk in the ED, two individuals with no identification visible were observed. One identified herself as a patient access representative and the other as a nurse. These employees did not have employee Identification on them and did not have a visitor pass issued by public safety. There was no evidence that the Public Safety officer checked these individuals for identification.

2. On 6/29/10 at 3:00 PM, Staff #1 confirmed that an individual posing as a Nuclear Medicine Technician, gained access to the hospital on 10/3/09, and removed Patient #1 from the hospital. The individual posing as a Nuclear Medicine Technician was later identified to be the patient's daughter, who had restricted visiting rights.

a. On 6/29/10 at 3:00 PM, Staff #1 confirmed that Medical Record #7 contained a "Restricted Visitors" form, dated and signed by the physician on 9/28/09. The "Restricted Visitors" form states "As per request of attending physician, do not allow daughter...to visit patient in 207, at any time until discharge, she is hindrance to patient care."

b. On 6/29/10 at 3:00 PM, Staff #1 confirmed that Medical Record #1 contained ongoing orders, dated from 9/27/09 to 10/2/09, for "one to one" coverage to provide for "patient safety due to unpredictable behavior and elopement precautions."

c. On 6/29/10 at 3:00 PM, Staff #1 confirmed that on 10/3/09 at 7:00 AM, the nurse received a call from an unknown individual stating that the "Nuclear Medicine Technician" would be coming up to transport Patient #7 for Nuclear Medicine testing.

i. On 6/29/10 at 3:00 PM, Staff #1 confirmed that the nurse on duty failed to review the medical record to confirm that nuclear medicine orders were written, and to confirm the identity of the individual posing as a Nuclear Medicine Technician, as she did not have an ID/Swipe card.

ii. On 6/29/10 at 3:00 PM, Staff #1 confirmed that the facility patient care giver failed "to remain within arms reach of the patient at all times, including off unit procedures," as written in the facility "Patient Observation" policy and procedure, Reference 2.

iii. On 6/29/10 at 3:00 PM, Staff #1 confirmed that the patient caregiver failed to assess as suspicious, and report to security, that the individual posing as a Nuclear Medicine Technician lacked an employee ID/swipe card for the transport elevators. The patient caregiver utilized her own ID/swipe card to access the transport elevators, and failed to report the suspicious behavior to Public Safety as written in the "Security Management Program" policy and procedure, Reference 3.

iv. On 6/29/10 at 3:00 PM, Staff #1 confirmed that upon arrival to the Nuclear Medicine hallway, the patient caregiver noticed that the medical record was missing. The patient caregiver requested that the individual posing as a Nuclear Medicine Technician return to the floor to get the chart since the patient was on a one to one. The individual posing as a Nuclear Medicine Technician replied that the patient was in her care and that the patient caregiver should go to get the chart. The patient caregiver left the patient at 7:20 AM and did not remain within arms reach of the patient, as indicated in the facility "Patient Observation" policy and procedure, Reference 2.

v. On 6/29/10 at 3:00 PM, Staff #1 confirmed that Public Safety Officers observed on the front entrance facility camera monitor tapes, recorded 10/3/09 at approximately 7:30 AM, were two women matching the descriptions of the person posing as a Nuclear Medicine Technician and the patient getting into a taxi cab. The patient was removed from the building by the person posing as a nuclear medicine technician, and located in NYC Time Square the next day.

vi. On 6/29/10 at 3:00 PM, Staff #1 confirmed that on 10/3/09, at 7:25 AM, the patient caregiver returned to the Nuclear Medicine hallway and discovered that Patient #7 was not there. The patient caregiver returned to the patient unit and notified the nurse. The patient caregiver and nurse then continued to search for Patient #7 throughout the facility. The patient care flow sheet narrative dated 10/3/09, had written, that two women were seen leaving the hospital by security "about 30 minutes ago." Public Safety was notified regarding the missing patient approximately 35-40 minutes after the patient was determined to be missing. The nurse did not notify Public Safety immediately as required per facility "Patient Elopement" policy and procedure, Reference 4.

d. On 6/29/10 at 3:00 PM, Staff #1 confirmed that they were not able to determine where and how the individual posing as a Nuclear Medicine Technician gained access to the facility.

3. The above findings were confirmed by Staff #1 on 7/1/10 at 2:15 PM.


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B. Based on observations and staff interviews, it was determined that the facility failed to staff the ED to ensure a safe environment.

Findings include:

1. A tour of the 6 bed psychiatric crisis area in the ED was conducted on 6/29/10 at approximately 2:30 PM and the following was observed:

a. There was one adult patient (Patient #10) located in Room #4 in 4-point restraints for assaultive and hostile behavior.

b. There was a 14 year old male (Patient #9) located in Room #2, in 4-point restraints for aggressive behavior toward police and staff.

c. There was one registered nurse and one security guard present for this 6 bed unit with a census of 6. The psychiatric crisis area was not staffed to ensure a safe environment for all patients.

d. Staff #10 stated during interview, that the unit was staffed with an additional technician at 7:00 AM but that the technician was reassigned to the Main ED at 8:30 AM and had not been replaced.

e. A review of the staff assignment sheet dated 6/29/10 for the AM to PM shift, indicated that one registered nurse and one technician were scheduled for the 6 bed unit.

f. An interview with Staff #11 confirmed that the employee was reassigned to the main ED at 8:30 AM.

g. There was no evidence of any other staff present in the patient care area. There was no evidence that the Psychiatric Crisis area was staffed to ensure a safe setting for all patients and staff.

h. There was no pediatric code cart in the Psychiatric Crisis area where a pediatric patient was present and in 4-point restraints.

i. There was no evidence that the Psychiatric Crisis area was properly equipped to provide a safe environment for all patients.

2. A tour of the main ED was conducted on 6/29/10 at approximately 2:00 PM and the following findings were observed.

a. The trauma area could be accessed from the hallway leading to the main ED and the door to the trama area was not secured.

b. Upon entering one of the unsecured trauma rooms, there were 12 unsecured syringes on a tray table and three boxes of unsecured scalpels.

c. In Room #3 the hand sanitizer dispenser located on the wall, was broken, suspended upside down from the wall, and empty.

d. In "Triage Room II," there was no hand washing sink or any portable hand sanitizers.

e. A bench in the patient blood lab area was cracked and worn excessively.

f. A stretcher in the blood lab area did not have a protective cover on it and the exposed mattress was cracked in several places.

g. Room #2, #7, #8, #10, #11, #14, #15 and #18 were observed with patients present. The call bells for each of these patients were unreachable and tangled behind the patient stretchers.

h. The assignment board for the registered nurses did not clearly designate who was responsible for what patient beds.

i. Patient #8 was present in the Main ED "Asthma area," and reported to the surveyor that he was escorted to the Main ED "Asthma area" by Staff #9. Upon questioning Staff #6 and Staff #7, it was verified that no Registered Nurse was aware of the patient being present in the Asthma area since his arrival to the Main ED.


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C. Based on observation, it was determined that the facility failed to provide a safe environment of care in the ED.

Findings include:

Reference #1: Facility Policy and Procedure titled 'Patient Care Services:: Critical Care::Visiting; Patient Centered Flexible Visiting Policy- Issue #600-100-2001' states "...Policy: ... A patient may receive two (2) visitors at any given time..."

Reference #2: Facility Policy Issue NO: 707-800-103, SUBJECT: Multi-Dose Vial Policy, states "... POLICY: All multi-dose medication vials will be labeled with a twenty eight (28) day beyond use date immediately upon opening the multi-dose medication vial. ...Multi-dose-vial (MDV) shall be discarded once they reach their beyond use date. Any opened multi-dose-vial not properly labeled shall be appropriately removed/discarded."

Reference #3: Facility Policy and Procedure Manual Department: Physical Plant- Environmental Services, policy Subject: 'Maintenance and Cleaning of Patient Transport Equipment' states "Policy: 1. The Transport Services Department will designate staff to inspect transport equipment for cleanliness, operational safety and needed repairs on a daily basis. 2. Transport Services is responsible for communicating to Physical Plant the location of Transport equipment in need of repairs and cleaning. 3. Physical Plant will clean stretchers and wheelchairs at least twice a week or when needed, i.e., blood stains, debris, etc. ... Procedures for Repairs: ... 2. The Transport Supervisor or designee will assign staff to inspect equipment daily for cleanliness, operational safety and needed repairs. 3. Equipment found to present a safety hazard or in need of repair will be removed from service by the dispatcher..."

1. On 7/1/10 at 11:00 AM, the ED and Mid-Track area was toured in the presence of Staff
#12. The following observations were made that indicated patients were receiving care in an unsafe setting:

a. There was a large hole [estimated 9"] in the wall of the alcove between Triage Room #1 and Triage Room #2.

b. A sign posted on the ED entrance states "One visitor at the bedside for a short visit." Two patients were observed on stretchers along the left side wall upon entry to the ED. Each patient had three visitors. Staff #12 confirmed that the facility's practice for the ED is to allow only one visitor to each patient in the ED, as indicated on the sign. The facility did not follow their posted visiting rules by allowing more than one visitor at the patients' bedside. The facility did not implement their visitor policy in Reference #1 by allowing more than two visitors' at the patients' bedside.

c. In the Mid-Track area within the ED, a Stretcher in Bay #2 had brown rust staining and dust/debris on the upper right lateral side [would be patients' right side]. A stretcher in Bay
#3 had a blood stained glucose monitoring strip on the small storage space below the mattress area, a spot of blood on its lower right side rail, and tears in its mattress. The mattress tears do not allow for the mattress to be a cleanable surface. The stretcher also had broken wheels that did not allow for it to roll/ transport. This was confirmed by Staff #12.

i. Per Staff #12, the patient stretchers are steam cleaned by environmental services, but could not verify when the stretcher in Bay #3 was last steam cleaned. Staff #12 confirmed there was no identifier on the stretcher to be used for tracking purposes for a cleaning rotation. Staff #12 also confirmed that the stretcher should have been removed by transport for repair of its broken wheels.

ii. Staff #18 and #19 stated in interview on 7/1/10 at 2:00 PM, that the Transport Department lets environmental services know when the patient transport equipment needs to be cleaned/repaired, and that there is also a environmental services supervisor on the floor that does rounds to check the stretchers.

iii. The facility did not implement its policy and procedure, in Reference #3, for cleaning transport equipment and removing equipment in need of repairs.

d. The unlocked ENT (eye, nose, throat) Procedure Room #9 had a table on the left side of the room next to the examination chair. The table had the following on top of it:

i. Three opened 30 milliliter (ml) multi-dose bottles of Lidocaine Hydrochloride 1% with epinephrine 1:100,000 injection.

ii. A Multi-dose bottle of 2% Lidocaine Hydrochloride 20 milligrams/ml.

iii. The 'Beyond-Use Date' stickers attached to each of the above bottles that indicates the date of expiration were blank. Without indication as to when the bottles were opened, or the beyond use date, it could not be determined if the bottles of medication were within their 28 day expiration as per policy in Reference #2.

iv. A 500 ml opened bottle of 0.9% Sodium Chloride Irrigation that contained the manufacturer's printed instructions on its label that stated "...No antimicrobial agent has been added. ...Discard unused portion". The bottle was available for repeated use.

v. Two 20 gauge (g) angio catheters [intravenous needles].

vi. Three 18 g angio catheters.

vii. A used fluorescein test strip.

e. The following items were found on the shelves within a double door silver cabinet, to the right of the table in Procedure Room #9:

i. Two 500 ml open bottles of 0.9% Sodium Chloride Irrigation.

ii. Two 500 ml open bottles of Sterile Water for Irrigation that contained the manufacturer's printed instructions on its label that stated "...No antimicrobial agent has been added. ...Discard unused portion". The bottles were available for repeated use.

iii. An opened suture set with gauze and scissors. Per Staff #12, the suture set was used/soiled.

iv. A cardboard box for 4 X 4 gauze that did not contain gauze, but stored a 22g angio catheter, a 25g angio catheter, a 5 ml and a 10 ml syringe, eight opened bottles of Lidocaine Hydrochloride 1% with epinephrine 1:100,000 injection.

f. The eye exanimation chair in the ENT Procedure Room #9 had tape adhered to the right shoulder area of the chair, and the mechanical portion had dust and dried fluid splashes on its surface.

g. The double doors that lead from the Mid Track area of the ED to the Pediatric area of the ED were unlocked.

h. In Pediatric Bay #8, the basket mounted on the wall above the stretcher was observed to have spackle that was not painted. The unpainted surface/spackle is not a cleanable surface.

i. The stretcher in Pediatric Bay #8 had a blood splash on its right lateral side [patient side] that leaked down through the whole of the metal and onto the interior metal surface.

j. The nurses' station counter top, where the specimens are placed for pick up, had two areas of cardboard sticking to its surface, and several areas of paper tape applied to its surface.

k. The Pediatric Waiting Room had a play station/table that contained a basin in which a potato chip, dried sticky liquid, and splashes of a clear pink colored liquid were found.

l. The double doors leading to the long corridor behind the main ED from the Pediatric ED, were propped opened. There was a red sticker applied to the right door that states "Fire Barrier Door."

m. Upon leaving the Pediatric ED and walking the long corridor behind the Main ED to re-enter the Main ED, a patient's visitor from the Main ED was observed walking in the long corridor that can lead to Fast Track, Mid-Track, and the Pediatric ED.

n. In the Main ED's medication room, a large hole approximately three inches in diameter, was observed in the wall behind the door.

o. The Main ED's medication refrigerator contained a opened multi-dose bottle of Novolin R Insulin that did not have a beyond use date indicated on the 'Beyond-Use Date' sticker applied to its surface.

Based on a review of 2 of 3 (#9 and #10) medical records patients that were restrained, it was determined that the facility failed to ensure that all physicians's orders for restraints are time limited in accordance with the following limits; 2 hours for 9 to 17 years of age and 4 hours for adults, 18 years and older.

Findings include:

1. A review of Medical Record #9 revealed that a 14 year old male patient arrived in the ED at 12:49 PM on 6/29/10 for a psychiatric evaluation for aggressive and assaultive behavior.

a. A physician order was reviewed and indicated that the Patient was placed in "Four Point Leather" restraints on 6/29/10 at 12:50 PM for "Emergency Behavior Management (Agitated, Combative)" behavior.

b. There was no evidence that the physician's order for restraints was time limited for 2 hours, in accordance with the patients age of 14 years old.

2. A review of Medical Record #10 revealed that a 24 year old male arrived in the ED on 6/27/10 at 11:58 AM for assaultive and aggressive behavior at home.

a. The patient was placed in "Four Point Leather" restraints on the following dates and times: 6/27/10 at 11:30 PM, 6/28/10 at 4:00 AM and 6/28/10 at 15:00.

b. There was no evidence in all three physician's orders for restraints of the time limit of 4 hours in accordance with the patient's age of 24 years old.

Based on a review of 3 of 3 medical records (#9, #10 and #12) of patients that were restrained, it was determined that the facility failed to ensure that least restrictive measures were attempted and were unsuccessful prior to the use of restraints.

Findings include:

1. A review of Medical Record #9 revealed that a 14 year old male patient arrived in the ED at 12:49 PM on 6/29/10 for a psychiatric evaluation for aggressive and assaultive behavior.

a. A physician order was reviewed and indicated that the patient was placed in "Four Point Leather" restraints on 6/29/10 at 12:50 PM for "Emergency Behavior Management (Agitated, Combative)" behavior.

b. A review of a physician's order dated 6/29/10 at 14:05 indicated that the patient was given "Haloperidol 0.5 mg po now."

c. There is no evidence in Medical Record #9 of any least restrictive measures that were attempted prior to the use of 4-point restraints that were applied at 12:49 PM.

2. A review of Medical Record #10 revealed that a 24 year old male patient was brought to the ED for a psychiatric evaluation due to assaultive and aggressive behavior at home.

a. The Medical Record indicated that on 6/27/10 at 11:30 PM and on 6/29/10 at 10:30 AM, the patient was placed in 4-point leather restraints for assaultive behavior.

b. There was no evidence in Medical Record #10 of any least restrictive measures that were attempted prior to the use of the 4-point restraints that were applied on 6/27/10 at 11:30 PM and 6/29/10 at 10:30 AM.

3. A review of Medical Record #12 revealed that a 28 year old male patient was given a PRN medication of Prolixin 5 mg PO, Ativan 2 mg IM, and Benadryl 50 mg IM for assaultive and intrusive behavior on 6/29/10 at 4:45 PM.

a. The patient was placed in "Four Point Restraints" on 6/24/10 at 4:45 PM for "Emergency Behavior Management (Agitated, Combative)" behavior.

b. At 8:30 PM on 6/29/10, review of a physician's order indicated that the "Four Point Restraints" were continued because the "Patient refused contract for safety, agitated, verbally threatening to repeat his behavior..."

c. There was no evidence in Medical Record #12, that least restrictive measures were attempted and were unsuccessful, prior to continuing the use of 4-point leather restraints.

Based on observations, staffing patterns, and staff interviews, it was determined that the facility failed to meet the emergency needs of patients and their families in accordance with acceptable standards of practice.

Findings include:

1. The facility failed to provide the required organization and direction. (Cross refer 1101).

2. The facility failed to implement ED policies and procedures that govern the medical care provided for emergency services. (Cross refer 1104).

Based on observations made during a tour and staff interview, it was determined that the facility failed to provide organization and direction of emergency services to patients in the ED.

Finding include;

1. A tour of the ED was conducted on 6/29/10 at approximately 12:30 PM and the following observations were made:

a. The ED waiting room had approximately 40 patients waiting for services.

b. The triage area was staffed with one RN. The triage area prevented complete visualization of all of the patients the waiting room.

c. Staff #6 stated that there was a second triage nurse on duty but was completing mandatory education. There was no evidence of a replacement in his/her absence.

d. The 6 bed psychiatric crisis area was staffed with one RN and one security guard. The census was six. Two of the six patients were in restraints.

e. There were 4 patients in stretchers in the Main ED hallways without call bells.

f. A patient on a stretcher was being examined by a physician without privacy curtains.

2. The ED staff were questioned, at the time of the observations, as to who was in charge. ED staff reported that Staff #12 was on lunch break and no one had a clear understanding of who was in charge of the unit.

3. There was no evidence based on the above observations that the ED was effectively directed and organized, to provide emergency services to patients.

A. Based on interviews, observations, and review of the ED's policies and procedures, it was determined that the facility failed to ensure that all ED policies are established and implemented.

Findings include:

Reference 1: The Emergency Department Staffing policy #(23)30-25-25:07 states that: "The Emergency Department Assistant Nurse Manager under the guidance of the Director of Patient Care Services for Emergency will coordinate nursing coverage for 24 hours based upon patient volume and acuity... 3. Each area will be staffed according to patient caseload and acuity so nursing assignments can be changed as required. Area to be staffed include: Triage, Critical Care/Trauma, Pediatrics, Psychiatry, Fast Track, Main Adult ER -C-370. 4. Triage will be staffed based upon patient volume with three Registered Nurses during heavy patient flow hours. 5. The critical care trauma area will have Registered Nurses assigned based upon patient volume and acuity. Adequate staff will be assigned to maintain a primary care nursing coverage. The covering manager or designee will coordinate all patient care activities and assign ancillary staff as required to assist the primary nurse. 6. The main receiving area (Room C370) for adult patients will be staffed by emergency medicine physicians, RN's and support staff. The covering manager or designee will coordinate all staff activities (RN, NA, Medical Technician, WC) in this area. The covering manager or designee will reassign staff as required by patient flow and acuity..."

1. On 6/29/10 at 2:35 PM, Staff #1 was asked to provide for review, specific ED patient privacy policies including protecting the patients identity in the ED waiting area.

a. On 6/30/10 at 2:00 PM, Staff #1 confirmed that the ED does not have established patient privacy policies and procedures to protect the patients identity in the ED waiting area.

2. On 6/29/10 at 2:35 PM, Staff #1 was asked to provide for review, specific ED staffing policies and procedures.

a. On 6/30/10 at 2:45 PM, Staff #1 provided for review, the ED staffing policy as stated in Reference 1. This policy did not specify the required staff per patient ratio. The policy states that the staffing is based on volume. The volume, heavy flow hours, and adequate staff, is not defined.

i. The policy in Reference 1 states that the "Triage will be staffed based upon patient volume with three Registered Nurses during heavy patient flow hours...." The patient volume is not defined. The heavy flow hours are not defined.

ii. The policy in Reference 1 states that "The critical care trauma area will have Registered Nurses assigned based upon patient volume and acuity. Adequate staff will be assigned..." The number of Registered Nurses needed per patient is not defined.

iii. The policy in Reference 1 states that "The main receiving area (Room C370) for adult patients will be staffed by emergency medicine physicians, RN's and support staff..." The number of emergency medicine physicians, RN's and support staff needed per patient, is not defined.

iv. The policy in Reference 1 states that "Each area will be staffed according to patient caseload and acuity so nursing assignments can be changed as required. Areas to be staffed include: Triage, Critical Care/Trauma, Pediatrics, Psychiatry, Fast Track, Main Adult ER-C-370." The required number and type of staff per patient ratio is not defined for the Triage, Critical Care/Trauma, Pediatrics, Psychiatry, Fast Track, Main Adult ER-C-370 areas.

3. The above findings were confirmed by Staff #1 on 7/1/10 at 2:15 PM


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B. Based on observations and a review of the ED's policies and procedures, it was determined that the facility failed to ensure that all ED policies are implemented.

Findings include:

Reference 1: The Emergency Department Staffing policy #(23)30-25-25:07 states that: "The Emergency Department Assistant Nurse Manager under the guidance of the Director of Patient Care Services for Emergency will coordinate nursing coverage for 24 hours based upon patient volume and acuity... 3. Each area will be staffed according to patient caseload and acuity so nursing assignments can be changed as required. Area to be staffed include: Triage, Critical Care/Trauma, Pediatrics, Psychiatry, Fast Track, Main Adult ER -C-370. 4. Triage will be staffed based upon patient volume with three Registered Nurses during heavy patient flow hours....6. The main receiving area (Room C370) for adult patients will be staffed by emergency medicine physicians, RN's and support staff. The covering manager or designee will coordinate all staff activities (RN, NA, Medical Technician, WC) in this area. The covering manager or designee will reassign staff as required by patient flow and acuity..."

Reference #2: The Emergency Department policy #(23)30-25-30:03 titled "Triage" states that: "Patients arriving to the Emergency Department with any known complaint or medical condition shall be assessed by a registered professional nurse (R.N.) or qualified medical personnel ( M. D.)...The acuity assessment will be reflected on the EPIC electric medical record and tracking system...All triage documentation will be entered into EPIC by triage/ intake nurse during the triage process..."

1. During the tour of the ED 6 bed Psychiatric Crisis Unit on 6/29/10 at approximately 2:30 PM, it was noted that two staff were present on the unit, (one RN and one security guard). The census was 6 patients, 2 of which were in 4- point restraints. One of the six patients (#9), was placed in 4-point restraints at 12:50 PM. The second patient (#10), was placed in 4-point restraints at 1:30 PM.

a. Staff #10 reported, upon questioning on 6/29/10 at approximately 2:35 PM, that a third staff member (a technician) was assigned to the Psychiatric Crisis Unit for the 7AM to 3PM shift but was reassigned to the Main ED area at approximately 9:00 AM.

b. A review of the "Emergency Department Daily Assignment Log" dated 6/29/10 confirmed that a third staff member (a technician) was assigned to the "Psych" area for the 7AM to 3PM shift.

c. There was no evidence on the "Emergency Department Daily Assignment Log" dated 6/29/10 that a staff member had been reassigned from the Psychiatric Crisis Unit to the Main ED at 9:00 AM.

d. There was no evidence that a staff member was reassigned to the Psychiatric Crisis Unit to meet the acuity needs of the unit, once the patients were placed in restraints.

e. There was no evidence that the covering manager or designee coordinated all staff activities (RN, NA, Medical technician, WC) in this area and reassigned staff as required by patient flow and acuity as stated in Reference #1.

2. During the tour of the Main ED area on 6/29/10 at 1:30 PM, it was noted that Patient #8 was located in the designated area of the ED called the "Asthma Area."

a. Patient #8 approached the surveyor at 1:30 PM and stated that he/she had been escorted from the waiting room to the designated "Asthma Area" at 12 noon by a "Greeter" and no medical personnel had assessed him/her.

b. Upon questioning the ED nursing staff about who was assigned this patient, no one was aware that he/she had arrived to the Main ED area and what the patient's medical needs were.

c. A review of Medical Record #8 failed to provide evidence that Patient #8 was triaged prior to being escorted from the waiting area to the Main ED.

d. There was no evidence that the facility implemented the Triage policy as stated in Reference #2.