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A. Based on review of Hospital policy, clinical records and staff interview, it was determined, that for 1 of 3 clinical records reviewed (Pt. #8) for patients in restraints, the Hospital failed to ensure restraint orders were signed by a Licensed Practitioner.

Findings include:

1. Hospital policy titled, "Sinai Health System Restraint and Seclusion Policy" was reviewed on 9/26/11 at 11:15 AM. The policy required, "B. Ordering Restraint 1. Only a Licensed Independent Practitioner (LIP) may order restraint."

2. On 9/26/11 at 10:20 AM, the clinical record of Pt. #8 was reviewed. Pt. #8 was a 34 year old male, admitted on 9/12/11, with diagnoses of Schizophrenic Affective Disorder, Paranoia, and Mild Mental Retardation. Two restraint orders dated 9/18/11 at 5:45 PM and 9/20/11 at 8:00 PM, lacked the signatures of the physicians who had ordered the restraints.

3. These findings were confirmed by the Psychiatric Unit Manager on 9/26/11 at 11:30 AM, during an interview.

A. Based on review of Hospital policy, clinical records, and staff interview, it was determined, that for 1 of 3 clinical records reviewed (Pt. #10), for a patient in restraints, the Hospital failed to ensure an incident report was completed when a patient injury was identified.

Findings include:

1. Hospital policy titled, "Confidential Occurrence / Investigation Reports was reviewed on 9/28/11 at 10:00 AM. The policy required, "The Occurrence Report System should be utilized by personnel and Medical Staff members to notify the Quality Improvement Department of unusual occurrences. The system Occurrence Report should be completed on line for the Quality Improvement Department within twenty-four (24) hours of the occurrence/ event or its discovery."

2. On 9/27/11 at 11:00 AM, the clinical record of Pt. #10 was reviewed. Pt. #10 was a 39 year old female, admitted on 1/11/11, with diagnoses of Bipolar Affective Disorder, Hypertension, Diabetes Mellitus, and Obesity. Nursing notes dated 1/16/11 at 12:51 PM, included, "The mental health staff performing her morning care reported to writer a dark purple oblong bruise located on her right side lateral to the right breast. Due to the state of psychosis the patient was unable to express the origin of the bruise..."

3. An unusual occurrence report regarding Pt.#10's bruise was requested for review. However, during an interview with the Chief Nursing Officer (CNO) on 9/28/11 at 2:30 PM, the CNO stated that an unusual occurrence report regarding the bruise was not completed because the bruise may have resulted from the patient's fall (on 1/15/11 at 12:55 AM) and may not have been visible immediately after the fall. These findings were confirmed by the CNO during the interview.

A. Based on clinical record review and staff interview, it was determined that in 1 of 3 (Pt #23) clinical records reviewed on the 6 North Unit, the Hospital failed to ensure adherence to the physician's order.

Findings include:

1. The clinical record of Pt #23 was reviewed on 9/27/11 at approximately 10:45 AM. Pt #1 was an 82 year old male admitted on 9/24/11 with diagnoses of Dehydration and Acute Renal Failure. The clinical record contained a physician's order dated 9/24/11 that required Pt #23 to be weighed daily. The clinical record lacked documentation of daily weights performed on 9/25 and 9/26/11.

2. The finding was verified by the Unit Director of the 6 North Unit during an interview on 9/27/11 at approximately 11:00 AM.

A. Based on review of Hospital policy, clinical records, and staff interview, it was determined that for 1 of 4 (Pt #2) clinical records reviewed of patients on the Mother Baby Unit (MBU), the Hospital failed to ensure medications were administered as ordered by the physician.

Findings include:

1. The Hospital policy entitled, "Hospital Policy and Procedure No. MSH-NUR-4.01 (C)" was reviewed on 9/26/11 at approximately 9:00 AM and required, "...Document administration on MAR by drawing a line through designated time and sign your initials. Place your initials and full signature with title at bottom of the page. If there is no preprinted time enter and draw a line through actual time given..."

2. The clinical record for Pt #2 was reviewed on 9/26/11 at approximately 10:00 AM. Pt #2 was a 3 day old baby born on 9/23/11. The clinical record contained a physician's order dated 9/23/11 that required, "...Phytonadione 1 mg (milligram) IM (intramuscular) before 1 hour of age...Erythromycin ophthalmic ointment 0.5% for eye prophylaxis administer x 1 OU (both eyes)...Hepatitis B vaccine (Engerix-B) 10 mcg (microgram)/ 0.5 mL (milliliter) IM- give in Delivery Room..." The clinical record contained a hand written Medication Administration Record (MAR) with the above ordered medications listed. However, the MAR lacked administration times and the nurse's signature to indicate that these medications were administered to Pt #2.

3. The above findings were confirmed with the Director of the MBU during an interview conducted on 9/26/11 at approximately 11:15 AM.

A. Based on a review of the Hospital Bylaws, Rules and Regulation, a letter of attestation, and staff interview, it was determined that the Hospital failed to ensure all records were completed within 30 days following discharge.

Findings include:

1. The Hospital's Medical Staff "Bylaws, Rules and Regulation" revised July 2009, and reviewed on 9/27/11, at approximately 10:00 AM included, "12. The medical record must be completed with in thirty (30) days after discharge of the patient."

2. A letter of attestation presented by the Director of Health Information Management (HIM), on 9/28/11, at approximately 11:00 AM, indicated that as of 9/28/11 there were 183 medical records incomplete 30 days after discharge.

3. The above finding was confirmed with the Director of HIM during an interview on 9/28/11, at approximately 11:00 AM.

A. Based on review of Hospital policy, observation, and staff interview, it was determined that the Hospital failed to ensure the proper storage and labeling of food products in the dietary department, which potentially affected all patients receiving dietary services as of 9/28/11.

Findings include:

1. The Hospital policy entitled, "Food Storage" was reviewed on 9/28/11 at approximately 10:00 AM, and required "...Storage:...Dry bulk foods...In metal or plastic containers with tight lids...Paper supplies...Away from food...Discard dented, bulging or leaking cans...Date products..."

2. During a tour of the dietary department conducted on 9/28/11 between approximately 10:30 AM and 11:45 AM, the following was observed:

-In the dry food storage area:
- One 30 pound box of golden raisins was open without a lid and was also not labeled with date product was opened.
- 1 bottle (1 gallon) of browning and seasoning sauce was open with no lid (opening was covered with plastic wrap).
- 1 bottle (1 gallon) of corn syrup was open and undated.
- 2 bottles (1 gallon) pancake syrup were open and undated.
- 5 bags of pasta, opened and undated.
- 1 can of food thickener, opened and undated.
- 1 box of brown rice opened, exposed to air, and undated.
- 6 foil bags of unknown content, unlabeled and undated.
- Various food items taken out of the original packaging, unlabeled and undated.

In the Walk-In Refrigerator for Dairy/Juice:
- 1 large bag of Pecorino-romano cheese, opened and undated
- 1 gallon of milk, opened and undated

In Walk-In Refrigerator for Fresh produce:
- left-over muffins dated 9/22/11

3. These findings were confirmed with the Dietary Director (E#19) on 9/28/11, at approximately 11:45 A.M.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Medicare Sample Validation Survey conducted on September 26 - 28, 2011, the surveyors find that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see A710.

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Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Medicare Sample Validation Survey conducted on September 26 - 28, 2011, the surveyors find that the facility does not comply with the applicable provisions of the 2000 Edition of the NFPA 101 Life Safety Code.
See the Life Safety Code deficiencies identified with K-Tags on the CMS Form 2567, dated September 28, 2011.

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A. Based on observation and staff interview, it was determined that in the Mother Baby Unit (MBU), the Hospital failed to ensure outdated blood culture bottles were not available for patient use. This potentially affected all of the patients in the MBU that had blood cultures drawn between the dates of 5/1/11-9/26/11.

Findings include:

1. During a tour of the Hospital's Mother Baby Unit (MBU) conducted on 9/26/11 between approximately 9:45 AM and 10:30 AM, the following outdated supplies were found in the clean utility room:
-7 aerobic blood culture tubes with expiration dates of 4/30/11;
-8 anaerobic blood culture tubes with expiration dates of 5/31/11.

2. The above findings were confirmed with the Director of MBU during an interview conducted on 9/26/11 at approximately 11:15 AM.


B. Based on review of the Biomedical Vision Statement, observation, staff interview, and Hospital policy review, it was determined that the Hospital failed to ensure proper maintenance of equipment. This potentially affected all patients on the Labor and Delivery (LDR), 4 patients on the 6 East Psychiatry Unit, all patients in Telemetry Unit, and all patients that used Operating Rooms #3 and #5 on varying dates from 9/26- 9/29/11.

Findings include:

This was found on the Labor and Delivery Unit:

1. The Biomedical Vision Statement was reviewed on 9/28/11 at 3:00 PM. The statement required (pg. 19) "13. BMETS [Bio-Medical Engineering Technical Service] will adhere to a prescribed preventive maintenance schedule of all equipment..."

2. During a tour of the Labor and Delivery Unit (LDR) conducted on 9/26/11 between approximately 10:30 AM and 11:15 AM, one 'Spot Vital Signs' machine in the equipment room was labeled with a sticker that included a biomed check due date of 8/11. The Hospital failed to provide documentation to evidence that the biomed check had been completed.

3. The above finding was confirmed with the Director of LDR during an interview conducted on 9/26/11 at approximately 11:15 AM.

This was found on the 6 East Psychiatric Unit:

4. On 9/26/2011 during an observational tour of the Psychiatric Unit, the following were noted:

- At approximately 9:45AM, 4 of 5 patient's bathrooms (K650 ,K653, K653, K657), lacked patient call lights that were in working order.

-At approximately 10:10 AM, 1 of 1 Occupational Therapy room contained a detached section of a radiator cover, on the floor.

5. The above findings were confirmed on 9/26/2011, at approximately 11:30 AM, with the Director of the Psychiatric Unit.

This was found on the 5th floor Telemetry Unit:

6. At approximately 1:00 PM, a fan found in Room 505, lacked a Biomed sticker to document that an inspection of the equipment had been performed.

7. The above finding was confirmed with the Director of Telemetry during an interview conducted on 9/26/11 at approximately 1:30 PM.



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This was found in the Operating Rooms:

8. On 9/27/2011, at approximately 10:30 AM, the Hospital policy titled, " Maintenance Program Perioperative Services" was reviewed. The policy included, "malfunction or suspected malfunction of any surgical equipment... broken/old furniture is to be reported to the OR Manager...is to be taken out of service immediately...until repaired..."

9. On 9/27/2011 at 7:00 AM, during an observational tour of OR#3, 1 of 2 armboards contained tears and residual tape, and 1 of 1 IV poles had residual tape and paper stickers attached.

10. On 9/27/11 an observational tour was conducted in OR#5 from 7:08 AM until approximately 8:00 AM. Three of 4 IV poles contained rust.

11. The above findings were discussed with the Interim OR Director during an interview on 9/27/11 at approximately 8:25 AM.

A. Based on Hospital policy review, observation and staff interview, it was determined that for 2 of 2 anesthesia staff observed (in OR #3 and #5), the Hospital failed to ensure staff cleaned the diaphragm of multidose vials with an antiseptic, in accordance with policy.

Findings include:

1. On 9/27/11 at approximately 9:45 AM, policy #SRH-RX-C-035 titled "Multi-dose vial" was reviewed. The policy included," Clean the access diaphragm of multidose vials with an antiseptic before entering into the vial."

2. During an observational tour of OR-3 on 9/27/11 at approximately 7:20 AM, the Anesthesiologist (E #11) was drawing medication from 3 multi dose vials. E#11 did not clean the diaphragm before inserting the needle into the vial.

3. On 9/27/11 at approximately 7:40 AM, in OR-5, the Certified Registered Nurse Anesthetist E#3 was withdrawing medication from 3 vials without first cleaning the diaphragm of the vials with an antiseptic.

4. The above findings were confirmed with the Interim Director of Surgery during an interview on 9/27/11, at approximately 8:15 AM.

A. Based on observation and staff interview, it was determined that the Hospital failed to ensure open sterile surgical packs were not left unattended. This potentially affected all patients that had surgery in Operating Rooms #4 & #5 on 9/27/11.

Findings include:

1. The AORN Perioperative Standard and Recommended Practices "Maintain a Sterile Field", reviewed on 9/27/11 at approximately 11:00 AM, required, "...A sterile field should be maintained and monitored constantly...."

2. A tour of OR #4 was conducted on 9/27/11 between approximately 7:05 AM and 7:45 AM. A sterile field was created by a scrub technician (E #6) at 7:15 AM. At 7:30 AM, E #6 was the only staff member in the room and left OR #4 for 4 minutes, thus leaving the sterile field unattended.

3. A tour of OR#5 on 09/27/11 at approximately 7:12 AM, surgical packs were opened in OR #5. All staff members exited OR#5 at approximately 7:16 AM leaving the open sterile surgical packs unattended. A scrub nurse (E # 1) returned to OR #5 less than a minute later.

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4. The above findings were discussed with the Interim Director of Surgery during an interview on 9/27/11 at approximately 8:15 AM.


B. Based on observation and staff interview, it was determined that for 2 of 4 staff members observed (E#3 and #4) in OR #5, the facility failed to ensure contaminated equipment was not used on a patient.

Findings include:

1. During an observation of OR #5 on 9/27/11 at approximately 7:08 AM, 2 electrodes and one pulse oximetry probe was dangling on the floor. The contaminated equipment was placed on Pt. #32 at approximately 7:40 AM.

2. During an observation of OR # 5 on 9/27/11 at approximately 7:30 AM, an unidentified staff member entered OR #5 and stepped on a bottom shelf containing clean supplies, thus potentially contaminating the clean supplies.

3. On 9/27/11 at approximately 7:50 AM, E#4 held the oral intubation tube for Pt. #32 without wearing protective gloves.

4. The above findings were discussed with the Interim Director of Surgery during an interview on 9/27/11 at approximately 8:15 AM.


C. Based on Hospital policy review, observation and staff interview, it was determined that for 8 of 12 staff ( E # 10, 4, 1, 5, 7, 8, 9, & 12), the Hospital failed to ensure staff adherence to the dress code policy.

Findings include:

1. The Hospital policy entitled, "Traffic Patterns Perioperative Services" was reviewed on 9/26/11 at approximately 1:00 PM, and required "...Semi Restricted Area...Inpatient and Outpatient holding room...Restricted Area...Operating Rooms...All persons entering the semi-restricted area an/or restricted area will change into scrub attire in the locker room before entering these areas..."

2. The Hospital policy entitled, "Surgical Attire Perioperative Services" was reviewed on 9/26/11 at approximately 1:00 PM, and required "...Wear scrub caps and hoods so as to cover all possible head and facial hair...The mask should fully cover both mouth and nose completely and be secured in a manner that prevents venting..."

3. On 9/27/11 observations were conducted in OR #5 from 7:08 AM until approximately 8:00 AM. The following was observed:

* At approximately 7:22 AM, E#10 entered OR#5 while tying the lower portion of the surgical mask.
* At approximately 7:30 AM, E#4 entered OR #5 while tying the lower portion of the surgical mask.
* At approximately 7:40 AM, E#1 entered OR #5 while tying the lower portion of the surgical mask.

4. A tour of OR #4 and Inpatient Holding area was conducted on 9/27/11 between approximately 7:05 AM and 8:10 AM. During the tour, the following was observed:

* At approximately 7:15 AM, E #5 entered OR #4 holding her unsecured mask over the mouth and nose.
* At approximately 7:35 AM, E #7 entered OR #4 with hair exposed from both sides of the head cover.
* At approximately 7:35 AM, E # 8 entered OR #4 with the bottom of the mask unsecured.
* At approximately 8:00 AM, E #9 entered the Inpatient Holding Area wearing street clothes.
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5. During an observational tour of OR#3, on 9/27/2011 at approximately 7:15 AM, E#12 was observed in the the OR wearing a skull cap with hair exposed below the skull cap.
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6. The above findings were confirmed with the Interim Director of Surgery during interview conducted on 9/27/11 at approximately 8:15 AM.


D. Based on observation and staff interview, it was determined that for 1 of 4 employees ( E#4) observed in OR #5, the Hospital failed to ensure staff change a contaminated surgical mask.

Findings include:

1. The "AORN 2011 Perioperative Standards and Recommended Practices" was reviewed on 9/27/11. The standards included, "The mask should be replaced and discarded whenever it becomes wet or soiled. The filtering capacity of a mask is compromised when it becomes wet..."

2. During a tour of OR #5 on 9/27/11 at approximately 7:48 AM, E #4 who was sitting near the anesthesia cart in OR#5 sneezed into the surgical mask. E#4 failed to change the surgical mask in accordance with Hospital practice.

3. On 9/27/11 at approximately 8:00 AM, the Nurse Manager for the OR was interviewed. The Manager stated that it is hospital practice to promptly change any surgical mask that was potentially contaminated per AORN standards.

4. The above finding was discussed with the Interim Director of Surgery during an interview on 9/27/11, at approximately 8:00 AM