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A. Based on review of Hospital policies, observational tour, and staff interview, it was determined that for 3 of 8 patients (Pts.#32, 33 and 34) on suicide precautions at the St. Elizabeth Campus, the Hospital failed to ensure staff removed sharp objects and prevent potential patient injuries. This has the potential of affecting 14 patients.

Findings include:

1. On 2/7/12 at approximately 10:00 AM, Hospital policy, titled, "Suicide Precaution" #1408.75 revised January 2012, was reviewed. The policy required, "Suicide precautions will be initiated and potentially dangerous items will be reviewed (i.e. sharp objects...)".

2. On 2/7/12 at approximately 12:30 PM, Facility policy titled,"Valuables and Belongings of Patient" included, "Items put in contraband closet are those considered to be dangerous to self or others. This includes sharp objects."

This was identified at the St. Elizabeth campus.

3. On 2/7/12 at approximately 9:00 AM an observational tour was conducted on the boys closed psychiatric unit (9S) from 9:00 AM until approximately 11:00 AM.

4. The clinical record for Pt. #32 in room 920-1 was reviewed on 2/7/12 at approximately 9:30 AM. Pt. #32, a 14 year old male, was admitted on 2/3/12 with diagnoses of Major Depression and Suicidal Ideation. Admission orders, dated 2/3/12 included suicide precautions. Room 920 contained 4 sharpened pencils (contraband items) during the observational tour on 2/7/12.

5. The clinical record for Pt. #33 was reviewed on 2/7/12 at approximately 10:00 AM. Pt. #33, a 14 year old male, was admitted on 1/31/12 with diagnoses of Major Depression and Suicidal Ideation. Admission orders dated, 1/31/12, included suicide precautions. Pt. #33 was also in Room 920, which contained 4 sharpened pencils (contraband items).

6. The clinical record for Pt. #34 was reviewed on 2/7/12 at approximately 10:30 AM. Pt. #34, a 13 year old male, was admitted on 1/28/12 with diagnoses of Depression/Suicidal Ideation. Room 923 contained 2 sharpened pencils (contraband items).

7. On 2/7/12 at approximately 9:40 AM, the Program Therapist (E#11) was interviewed. E#11 stated that patients may have pencils to journal as long as they are not "cutters" or may cause self harm.

8. On 2/7/12 at 11:00 AM, these findings were confirmed by the St. Elizabeth campus Director of Nursing, during an interview.

A. Based on review of Hospital policy, documentation from the Medical Records Department, delinquent records statistics, medical executive committee meeting minutes, medical records committee meeting minutes and staff interview, it was determined that for 12 of 12 months (January - December 2011) the Hospital failed to ensure delinquent medical records data was used to identify changes for improvement (decrease amount of delinquent records).

Findings include:

1. The Hospital policy titled, "Health Information Committee", revised 5/11, was reviewed on 2/7/12 at 3:15 PM. The policy included, "Delinquent medical record - a record that is missing any one of the required completion requirements and has reached an age of greater than thirty days".

2. Documentation presented by the Director of Health Information Management on 2/7/12 at approximately 12:00 PM indicated that as of survey date 2/7/12, there were 208 medical records at the Saint Elizabeth campus and 3598 medical records at the Saint Mary campus that were delinquent greater than 30 days post discharge.

3. The Delinquent Record statistics for 2011 were reviewed on 2/7/12 at approximately 2:00 PM. The statistics which included the number of delinquent records at the St. Mary campus ranged from 3567 to 4113 (> 47% of medical records) for calendar year 2011.

4. The Medical Executive Committee meeting minutes for 2011 were reviewed on 2/7/12 at approximately 2:30 PM. The minutes for 1/11, 5/11, 6/11, 9/11 and 12/11 included, "Previously distributed and reviewed delinquent record count was accepted as informational."

5. The Medical Records Committee meeting minutes for 2011 were reviewed on 2/7/12 at 3:30 PM. The minutes from 1/11, 3/11, 4/11, 5/11, 7/11, 8/11 and 11/11 included, "The following items were accepted as informational: ... Delinquent record count." There was no documention that the committee identified or took action to address the delinquent records.

6. The Director of Health Information Management was interviewed on 2/7/12 at approximately 1:30 PM. She indicated that "the number of delinquent records has been consistently about 48% for the last year." The number of delinquent records is reported to the Medical Records committee and then to the Medical Executive committee. The process of suspending physicians that do not complete their records promptly has been in place. However, there has been no additional formal plan put in place to decrease the number of delinquent records. The Director stated that, "the statistics report is not provided to the quality committee".

7. The Director of Health Information Management confirmed the above findings on 2/7/12 at approximately 3:30 PM, during an interview.

A. Based on review of the Hospital's Medical Staff Rules and Regulations, letters of attestation from the Medical Record Department, and staff interview, it was determined that for 2 of 2 (St. Mary's & St. Elizabeth) Medical Records departments, the Hospital failed to ensure completion of medical records within 30 days post discharge.

Findings include:

1. The Hospital's Medical Staff Rules and Regulations, amended 6/2/11, reviewed on 2/7/12 at approximately 9:45 AM included, "...Physicians are responsible for completing the medical records of their patients within the thirty (30) days after discharge."

2. A letter of attestation presented by the Director of Health Information Management on 2/7/12 at approximately 12:00 PM indicated that as of survey date 2/7/12, there were 208 delinquent medical records at Saint Elizabeth and 3598 delinquent medical records at Saint Mary, greater than 30 days post discharge.

3. The above findings were confirmed with the Director of Health Information Management during an interview on 2/7/12 at approximately 1:30 PM.

surveyors:15168 & 27125

A. Based on review of Hospital policy, observational tour, and staff interview, it was determined that for 1 of 3 suture carts (pod #2) in the Emergency Department (ED) at the St. Mary campus, the Hospital failed to ensure open multiple dose vials were dated to ensure usage within 28 days as required by policy. This has the potential of affecting 27 ED patients.

Findings include:

1. The Hospital policy, entitled "Expiration Dating Policy for Multi-Dose Injectable" (revised 1/2010), was reviewed on 2/8/12 at approximately 12:00 PM and required, "...multi-dose injections will not be used beyond 28 days from opening or day of initial use..."

2. An observational tour of the St. Mary ED was conducted on 2/8/12 between approximately 1:15 PM and 1:55 PM. The suture cart (Pod #2) included the following multi-dose medication vials that were open and undated. Therefore it could not be determined how long each vial had been opened.

- 5 vials (4 - 50 ml and 1- 20 ml) of 1 % Lidocaine
- 1 vial of Lidocaine/Epinephrine 20 ml
- 2 vials of Sensorcaine 30 ml

3. The above findings were confirmed with the ED Manager during an interview on 2/8/12 at approximately 2:00 PM.

A. Based on review of Hospital policy, observation and staff interview, it was determined that for 1 of 2 Dietary departments (St Elizabeth Campus) the Hospital failed to ensure all food products were properly labeled and not outdated.

Findings include:

1. Hospital policy entitled, "Food Receiving and Storage - Food and Non Food Products - includes Alcoholic Beverages, Flammables (Cover, Label/Date)," with revision date December 2009, was reviewed on 2/7/12 at approximately 3:40 PM. The policy required, "...Storage of Cooked and/or Ready to Eat Foods (Covering/labeling/dating):..7. General Storage Guidelines for Food and Nutrition Services:..i. Dry food which is being stored in dry storage/kitchen/other - such as flour, rice, etc - use date that it is opened."

2. An observational tour was conducted in the Hospital's dietary department on 2/7/12 between 12:00 PM and 1:15 PM. During the tour the following items were found to be unlabeled with the date opened or beyond the one year time frame:

This was found at the St Elizabeth Campus:

- 18 ounce containers of Red Pepper (2) without date opened,
- Cajun salt opened 1/8/09,
- Sesame Seeds opened 11/28/08,
- Chili Pepper without date opened,
- Curry Powder opened 11/16/10,
- Tarragon Leaves opened 10/7/10,
- Garlic Salt opened 7/29/10,
- 2 Pepper Corn opened 10/23/08 and 11/28/08,
- 2 Thyme Leaves opened 8/20/09 and 9/3/09,
- Cinnamon Sticks without date opened;
- 28 ounce containers - Sliced Almonds, Onion Powder, Garlic powder, Parsley Flakes, Italian Seasoning, and Cumin.

3. The findings were verified by the Interim Director of Dietary during an interview on 2/7/12 at approximately 1:15 PM. During the interview, the Director stated that the length of time an item can be opened before it must be discarded is one year.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Medicare Full Survey due to a Complaint conducted on February 6-9, 2012, 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.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Medicare Full Survey due to a Complaint conducted on February 6 -9 2012, 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 February 9, 2012.

A. Based on review of Hospital policy, observation, and staff interview, it was determined that for 2 of 2 expired suture types (polypropylene and prolene) and size, the Hospital failed to ensure outdated sterile supplies were not available for patient use. This has the potential for affecting all surgical patients.

Findings include:

1. The Hospital policy titled "Cleaning Routine -Specific to OR Personnel" (revised 7/10) was reviewed on 2/8/12 at approximately 1:45 PM. The policy required, "Inventory Supply Coordinator will check all dates of sterile supplies monthly on an ongoing basis...Sterile supplies with dates nearing expiration will be brought to the attention of the Nurse Manager and service line staff to be used quickly... Supplies with a date close to expiration may also be returned ...to the vendor for exchange or refund."

2. During a tour of the Surgical Department's Central Core area on 2/8/12 between 7:10 and 7:45 AM, the following expired sutures were found:

- 1 box of 5-0 Polypropylene suture expired 1/12/12
- 1 box of 5-0 Prolene suture, expired 7/11

3. The Director of Surgical Services was interviewed on 1/8/12 at approximately 7:45 AM and 1:45 PM. The Director stated that expired surgical supplies such as sutures should be taken out of the supply area and not available for patient use. The findings were confirmed by the Director during the interview.

A. Based on a review of surgery schedule for 2/7/12, suspension report dated 2/7/12, Medical Staff Bylaws Rules and Regulation, Hospital policy and staff interview, it was determined that for 1 of 11 (E# 1) physicians scheduled to perform a procedure in the St. Mary campus Operating Rooms, the Hospital failed to ensure physicians on suspension were not allowed to schedule/conduct surgical procedures.

Findings include:

1. The St. Mary surgery schedule for 2/7/12 was reviewed on 2/7/12 at approximately 11:00 AM. The report included 3 Lumbar Epidural Steroid Injections (Pt. #25 at 9:30 AM, Pt. #26 at 10:00 AM, and Pt. #27 at 10:30 AM) by E #1.

2. The "Suspension Report" presented by the Health Information Management Director on 2/7/12 at 12:00 PM, was reviewed on 2/7/12 at approximately 12:30 PM. The Report included E #1 who was placed on suspension on 1/11/12.

3. The Hospital's Medical Staff Rules and Regulation (revised 8/25/11), reviewed on 2/7/12, at approximately 1:00 PM required, "Physicians are responsible for completing the medical records of their patients within the thirty (30) days after discharge. Once the records remain incomplete for greater than 30 days, the physician is notified of being suspended... A physician who fails to complete medical records in the manner and time required by the Health Information Committee (HIC) Policy, shall have their consulting, admitting and all clinical privileges automatically suspended until such medical records are completed."

4. The Hospital policy titled, "Health Information Committee" (revised 9/10), reviewed on 2/7/12 at 1:50 PM required, "Suspension of Clinical Privileges ...11.1 Physicians who have not dictated or electronically created their operative/invasive reports ...are not allowed to schedule or perform procedures. A list of physicians who have not dictated their reports ...is compiled and incorporated to the daily update of the suspension list. 12. Once a physician is placed on the suspension list, he/she must complete all delinquent records before having clinical privileges reinstated."

5. The Director of the Surgical services was interviewed on 2/7/12 at approximately 2:15 PM. The Director indicated that Pts. #25, and 26 were added to the St. Mary surgery schedule on 1/30/12 and Pt. #27 on 2/1/12, while E #1 was on the suspension list. The above findings were confirmed by the Director of Surgical Services during the interview.

A. Based on review of Hospital policy, Flash Sterilization logs, and staff interview, it was determined that for 2 of 2 days (2/2/12 and 2/6/12) when outpatient eye surgery was scheduled at the St Elizabeth campus, the Hospital failed to ensure adequate surgical instruments were available to prevent the need for flash sterilization. This has the potential for affecting 9 cataract surgery patients for 2/2/12 and 2/6/12.

Findings include:

1. Hospital policy entitled, "Flash Sterilization," effective date July 2007 was reviewed on 2/7/12 at approximately 10:15 AM. The policy required, "Purpose: This protocol describes the use of flash sterilization for emergent conditions..."

These findings were identified at the Saint Elizabeth Campus:

2. The Flash Sterilization Logs for the month of 2/2012 were reviewed on 2/7/12 at approximately 10:00 AM. On 2/2/12, the log documented that two (2) flash sterilization loads (a cataract tray and physician specific eye instrument tray) were processed and on 2/6/12 four (4) flash sterilization loads (2 eye instrument trays and 2 cataract trays) were processed.

3. On 2/7/12 at approximately 10:10 AM the Surgical Team Leader was interviewed . The Team Leader stated that the Hospital performs flash sterilization on the eye trays because the Hospital only has four (4) eye trays.

4. The findings were verified by the Manager of Surgical Services during an interview on 2/8/12 at approximately 10:30 AM.

B. Based on review of Hospital policy, observation, and staff interview it was determined that in 3 of 4 (St Elizabeth (Room 5) and St Mary Campus (Room 4 & 7)) Hospital surgical suites, the Hospital failed to ensure adherence to dress code. This has the potential of affecting 19 surgical patients at both campuses.

Findings include:

1. Hospital policy entitled, "Uniform - Surgery," with revision date August 2010, reviewed on 2/6/12 at approximately 10:50 AM required, "Process:..2. Scrub Caps and Hoods: Disposable. 2.1 Wear scrub caps so as to cover all possible head and facial hair including sideburns, beards and neckline.:

This was observed at the St Elizabeth Campus:

2. On 2/8/12 between approximately 8:00 AM and 9:00 AM, a tour was conducted in OR suite 5.

- At approximately 8:45 AM, the surgeon (E #12) entered the surgical suite, wearing a cap with approximately 3 inches of exposed hair at the back of his cap.

3. The findings were verified by the Manager of the Surgical Department during an interview on 2/8/12 at approximately 9:15 AM.

This was observed at Saint Mary's Hospital:

4. An observational tour of surgical suites #4 & 7 was conducted on 2/8/12 between approximately 8:00 AM and 9:45 AM. The following was found:

- At approximately 8:15 AM, E#2 (CRNA) was observed in the restricted area (center core) entering OR#4 without wearing a surgical mask.

- At approximately 8:20 AM, E#3 (surgical assistant) was observed entering OR room #4 with approximately 2 inches of exposed hair below the surgical skull cap.

- At approximately 8:50 AM, E#4 (surgeon) was observed entering OR room #4 with approximately 1 inch of exposed hair below the surgical skull cap.

- At 8:25 AM, E #6 (Circulating RN) entered OR #7 with approximately 1 inch of exposed hair below the surgical cap.

- At 8:30 AM, E #5 (Surgical Assistant) entered OR #7 with approximately 2 inches of exposed hair to the back of the head, below the surgical skull cap.

- At 8:50 AM, E #8 (Anesthesiologist) entered OR #7 with approximately 2 inches of hair to the back of the head, not covered by the surgical cap; and E #8's surgical mask was hanging around his neck not covering his face.

5. The findings were verified by the Director of Surgical Services during an interview on 2/8/12 at approximately 9:00 AM.

surveyors: 15168, 27125, & 30195


30195


C. Based on review of Association of Operating Room Nurses (AORN) 2011 Perioperative Standards and Recommended Practices, observation, and staff interview, it was determined that for 2 of 4 (OR #4 and OR #7) operating rooms observed, the Hospital failed to ensure that open sterile instruments were not left unattended. This has the potential of affecting the 2 patients scheduled for the rooms.

Findings include:

1. The AORN 2011 Perioperative Standards and Recommended Practices, chapter entitled, "Maintaining a Sterile Field" were reviewed on 2/8/12 at approximately 9:30 AM, and required, "...A sterile field should be maintained and monitored constantly...An open sterile field requires continuous visual observation..."

The following were observed in the St Mary Campus Surgical Suite:

2. An observational tour of the surgical department was conducted on 2/8/12 between approximately 8:00 AM and 9:45 AM.

- On 2 occasions (8:30 AM and 8:35 AM), in OR #4, when sterile packs open, the room was left unattended for approximately 45 seconds each time, .

- At 8:53 AM, in OR #7, the room was left unattended for approximately 3 minutes, with sterile packs open.

3. An interview was conducted with the Director of Surgical Services on 2/8/12 at 9:00 AM. The Director stated that the Department follows the AORN standards of practice. The above findings were confirmed with the Director of Surgical Services during an interview on 2/8/12 at approximately 9:00 AM.

A. Based on review of Hospital policy, crash cart log, OR schedule and staff interview, it was determined that for 1 of 2 crash carts (Center Core) in the surgical area of the St. Mary campus, the Hospital failed to ensure the crash cart and defibrillator were checked daily, as required by policy. This has the potential of affecting 11 surgical patients.

Findings include:

1. The Hospital policy titled, "Crash Carts/Defibrillators" effective April 2004, was reviewed on 2/8/12 at approximately 2:45 PM. The policy included, " 1. Crash cart is to be checked on each shift...1.2 Checking of crash cart and defibrillator checks log... 5.1 Defibrillator/ monitor to be checked every shift..."

2. On 2/8/12 at approximately 8:10 AM, the crash cart and defibrillator logs for the surgical department were reviewed. The log for the crash cart in the Center Core lacked documentation on 12/14/11 and 12/21/11 that the crash cart and defibrillator were checked.

3. The surgery schedules for 12/14/11 and 12/21/11 were reviewed on 2/8/12 at approximately 8:30 AM indicated that the department was in operation on both dates.

4. The above findings were confirmed with the Director of Surgical Services on 2/8/12 at approximately 8:30 AM during an interview.