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Based on observation, document review, and interview it was determined that for 5 of 12 patients (Pts. #12, 13, 24, 25, and 26) on safety checks; 12 of 12 (Pt #11, 12, 13, 24, 26, 27, 28, 29, 30, 31, 32, and 33) patients requiring monitoring and for 1 of 2 patients (Pt #2) records reviewed for restraint usage, the hospital failed to provide and maintain a safe environment for patient care and promote patient rights.

The cumulative effects of these systemic practices resulted in the Hospital's failure to ensure patient safety was maintained. As a result, 42 CFR 482.13 Condition of Participation of Patient Rights, was not in compliance.

Findings include:

1. The Hospital failed to ensure patient safety checks were completed as required by policy. See deficiency cited at A144-A

2. The Hospital failed to ensure patient monitoring as per physicians' orders. See deficiency cited at A144-B

3. The Hospital failed to ensure restraints were not applied as a protocol. See deficiency cited at A169.

A. Based on document review, observation, and interview, it was determined for 5 of 12 patients (Pts. #12, 13, 24, 25, and 26) on the 4 west psychiatric unit, the Hospital failed to ensure patient safety checks were completed as required by policy.

Findings include:

1. Hospital policy entitled, "Observation Levels," (revised 11/19/12) required, "Policy...A. Three levels of staff monitoring are provided: 1, Standard Observation (assess and document at 15 minute intervals)...D, Assigned staff will complete the patient observations as rounds are made and document on the rounds form. Staff will observe the patient location, note patients' behavior...F. In addition to recording the whereabouts of patients at ordered intervals, the purpose of observations is to provide...J. Standard Observation: 1. The staff member will observe and check in with the patients' at least every 15 minutes and document the patient's location and status at each interval..."

2. On 8/13/15 at approximately 10:00 AM an observational tour of the 4 west unit was conducted. There was a total of 12 patients on the unit. The patients' precautions sheets for 8/13/15 were reviewed. The forms lacked the required checks every 15 minutes for the following patients:

Pt #12 - at 9:15 AM and 9:45 PM;
Pt #13 - at 9:15 AM, 9:30 AM, and 9:45 AM;
Pt #24 - at 9:15 AM and 9:45 AM;
Pt #25 - at 9:15 AM and 9:45 AM; and
Pt #26 - at 9:45 AM.

3. On 8/13/15 at approximately 10:15 AM the Nurse Manager of the 4 west Geri-Psych Unit was interviewed. The Manager stated the forms lacked the required checks every 15 minutes on all of the above patients.

B. Based on document review, observation, and interview, it was determined that for 12 of 12 (Pt #11, 12, 13, 24, 26, 27, 28, 29, 30, 31, 32, and 33) inpatients on the 4 west unit, the Hospital failed to ensure patient monitoring as per physicians' orders.

Findings include:

1. Hospital policy entitled, "Observation Levels," (revised 11/19/12) required, "Policy...A. Three levels of staff monitoring are provided: 1, Standard Observation (assess and document at 15 minute intervals)...F. In addition to recording the whereabouts of patients at ordered intervals, the purpose of observations is to provide a system of progressive intensity of patient observation, precaution and oversight based on patient acuity and type of symptoms, and overall needs..."

2. On 8/13/15 at approximately 10:00 AM an observational tour of the 4 west unit was conducted. There was a total of 12 patients on the unit.

3. The patients' precautions sheets for 8/13/15 were reviewed. The forms lacked documentation of the type of precautions, to indicate the patients were being monitored in accordance with physicians' orders. Examples include:

Pt #11 - admitted 8/10/15 with a physician's order for elopement and fall precautions;
Pt #12 - admitted 8/5/15 with a physician's order for suicide and assault precautions;
Pt #13 - admitted 8/10/15 with a physician's order for suicide, elopement and fall precautions;
Pt #24 - admitted 8/2/15 with a physician's order for fall and assault precautions;
Pt #26 - admitted 8/11/15 with a physician's order for elopement precautions;
Pt #27 - admitted 8/5/15 with a physician's order for elopement, fall and homicidal precautions;
Pt #28 - admitted 8/4/15 with a physician's order for homicidal precautions;
Pt #29 - admitted 7/30/15 with a physicians order for fall and assault precautions;
Pt #30 - admitted 8/13/15 with a physician's order for assault precautions;
Pt #31 - admitted 8/13/15 with a physician's order for fall, elopement and assault precautions;
Pt #32 - admitted 8/10/15 with a physician's order for fall and assault precautions; and
Pt #33 - admitted 8/11/15 with a physician's order for fall and assault precautions.

3. On 8/13/15 at approximately 2:00 PM the Director of Quality was interviewed. The Director of Quality stated the forms lacked documentation of the required types of precautions to be monitored.

Based on document review and interview, it was determined that for 1 of 2 patients (Pt #2) with usage of restraint devices while on a ventilator, the Hospital failed to ensure restraints were not applied per protocol.

Findings include:

1. Hospital policy entitled, "Use of Restraint Policy & Procedure," (revised 6/10) required, "Definitions: Restraint - A restraint is any manual, physical, or mechanical method of restricting an individual's freedom of movement, physical activity, or normal access to the body...Protective devices such as...or other appliances used to immobilize or limit the patient's movement are considered restraints...9. Restraints shall only be used upon written order of a physician...PRN/Standing orders are not acceptable and are not used to authorize the use of restraints..."

2. Hospital protocol entitled, "Ventilator Protocol," (revised 7/14) required, "...18. Apply mittens to prevent self extubation. Bilateral soft wrist restraints may be applied if necessary to prevent self-extubation. Call MD for order."

3. The clinical record of Pt #2 was reviewed on 8/11/15. Pt #2 was admitted on 7/24/15 with a diagnosis of Urosepsis. Clinical documentation included that on 8/9/15 Pt #2 was intubated and placed on a ventilator. At that time documentation indicated that Pt #2's hands were confined in mittens (as per protocol).

4. On 8/12/15 at approximately 9:15 AM the Director of Quality and ICU Charge Nurse were interviewed. Both stated they understand the protocol included the use of mittens but should not have.

Based on observation, interview and document review, it was determined that for 1 of 4 (Pt. #5) records reviewed, the Hospital failed to ensure patients were reassessed and fall precautions were implemented according to policy.

Findings include:

1. An observational tour of the Telemetry unit was conducted on 8/11/15 at approximately 10:00 AM. Patients who were on fall precautions were identified with a yellow fall risk sticker placed on the room numbers by the door and on the identification band. Pt. #5 in room 306-2 was not identified as a fall risk, with a yellow sticker on her identification band, or the fall risk sticker on the room door number or over head of bed.

2. Pt. #5 in room 306-2 was interviewed on 8/11/15 at approximately 10:15 AM. Pt. #5 stated she does not get up to walk or to use the bathroom, and needs assistance to get around.

3. The clinical record for Pt. #5 was reviewed on 8/12/15. Pt. #5 was a 62 year old female admitted to the Telemetry unit on 7/28/15 at 4:30 AM, with diagnoses of uncontrolled diabetes, respiratory distress, chronic obstructive pulmonary disease and asthma. The initial nursing assessment dated 7/28/15 indicated a Morse fall scale score (a score system to identify a patient risk for falls) of 55, indicating high risk for fall requiring implementation of fall prevention precautions. Pt. #5 was transferred on 7/28/15 (same day as admission to Tele) to the ICU unit. The record contained a fall re-assessment from ICU staff on 7/29/15 with a score of 22, indicating no risk. Pt. #5 was then transferred back to the Telemetry unit on 7/29/15. The record lacked a fall risk reassessment after the transfer back to the Telemetry unit as required. The clinical record indicated that patient activity including turning and bed to chair transfers required assistance of one or two staff.

4. The Hospital policy titled, "Fall Prevention and Management Policy" (Developed 8/08) required, "Registered Nurses are responsible for implementation and oversight of ...patient fall prevention care, as follows:...Reassessing patients for changing in fall risks when the patient is transferred...using the Morse Fall Scale (0-24 points: no risk; 25-50 Low risk-implement fall prevention and Management interventions; greater than 50 Implement Nursing Service Fall Prevention Standard. ...Fall prevention and management interventions: 14. Identify patient with a yellow tag on wrist band and over head of bed."

5. The "Nursing Service Fall Prevention Standard" (a part of the Fall prevention program) required, "Assess and document patient's fall risk upon admission ...or transfer in another unit...Place fall risk indicator (yellow tag) on patient's wristband and over head of bed."

6. The Manager and the Charge Nurse were interviewed on 8/11/15 at approximately 11:00 AM. The Manager stated that fall assessments are conducted on admission, on change of status or transfer to other unit. The Charge nurse stated Pt. #5 should have been reassessed for fall risk upon transfer back to the tele unit on 7/29/15 and that patient should have been identified and labeled as a fall risk due to the the patient needing 1-2 staff assistance when moving in and out of bed and for toileting needs.

Based on document review and interview it was determined that the Hospital failed to ensure medical records were completed within 30 days after the patient's discharge. This potentially affected all patients associated with the 852 delinquent records.

Findings include:

1. The policy entitled " Completion of Medical Records " ( Revised 2/10 " indicated " 5. Medical records must be completed, including signatures, within 30 days of discharge."

2. Medical Staff Rules and Regulations (Approved 11/5/13) indicated " 7. Completion of Medical Records ...d. If, for any reason, the medical record is not complete at time of discharge the attending physician will have a grace period, not exceeding thirty (30) days from the date of discharge, to complete the record. "

3. On 8/13/15 at 12:50 PM the Hospital presented an attestation letter dated 8/13/15 that indicated the Hospital has a total of 852 delinquent records past 30 days.

4. On 8/14/15 at approximately 2:30PM the Director of Quality was presented the amount of delinquent medical records and she stated "I know I know."

Based on observation, document review and interview, it was determined that for 3 of 6 (unit #2, 4, & 7) refrigerators and freezers, the Hospital failed to ensure the refrigerators and freezer were monitored as required by policy.

Findings include:

1. An observational tour of dietary/kitchen was conducted on 8/13/15 at approximately 11:00 AM. Three of 6 refrigerator/freezer monitor logs were missing temperature documentation.

2. Six refrigerator/freezer logs were reviewed for 7/29/15-8/13/15. The following lacked documentation of temperature monitoring:

-Unit #2 -8/12/15 evening shift.
-Unit #4 -8/12/15 day and evening shift.
-Unit #7- 7/31/15 day shift, 8/7/15 day shift, and 8/8/15 day shift.

3. The Hospital policy titled, "Equipment Temperature Monitoring Policy" (rev. 11/14) required, "...ensure that all refrigerators, freezers ...are maintained at the proper and safe temperature...The Engineering Department is responsible for monitoring and recording the temperatures of the walk in refrigerators and freezers. It is the responsibility of the Dietary Supervisor on duty to check all other units and record their temperature on the temperature check sheet."

4. The above findings were discussed with the Director of Dietary, during an interview on 8/13/15 at approximately 11:30 AM who stated that all refrigerators and freezers are monitored for temperature accuracy.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Full Survey Due to a Complaint conducted on August 11 - 12, 2015, 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 observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Full Survey Due to a Complaint conducted on August 11 - 12, 2015, 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 August 12, 2015.

A. Based on observation, document review and interview, it was determined that for 1 of 1 (E #1) employee observed performing a point of care test, the Hospital failed to ensure adherence to hand hygiene policy.

Findings include:

1. On 8/11/15 at approximately 10:30 AM a registered nurse (E #1) was observed performing a bedside glucose test. Prior to applying gloves for the procedure, E #1 failed to perform hand hygiene.

2. Hospital policy entitled, "Hand Hygiene," (revised 6/14) required, "Procedure...If hands are not visibly soiled, use an alcohol-based hand rub for decontaminating hands in all clinical situations. Examples: Before direct contact with a patient's intact skin...Before donning sterile gloves..."

3. The finding was discussed with the Charge Nurse during an interview on 8/11/15 at approximately 10:30 AM.


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B. Based on observation, document review and interview, it was determined that for 2 of 2 staff observed (E #2, and 3) in contact isolation precaution rooms, the Hospital failed to ensure staff adhered to isolation precautions as required.

Findings include:

1. An observational tour was conducted on the 3 East Telemetry unit on 8/11/15 at approximately 10:00 AM. Three (3) patients were identified on contact isolation precautions, and two were receiving care.

-E #2 a Registered Nurse was in Rm 314, with a contact isolation patient, wearing a gown and gloves while rendering care. E #2 gave the patient an injection and after the injection, lifted her gown and retrieved a medicine cup with wrapped medications from her pocket, wearing the same gloves (contaminated) used while injecting the patient, thus contaminating her clothing.

-E #3 a Nursing Aide was in room 315, with a contact isolation patient, wearing gloves and a gown that was not fastened, loose and hanging down in the chest area. E #3's chest and shoulder was exposed, thus potentially contaminating her clothing.

2. The Hospital policy titled, "Purpose: To prevent transmission of disease, including employee exposure to nosocomial infection and cross contamination. ...PPE: Hands are washed with an antiseptic hand washing agent immediately upon removal of gloves, after contact with contaminated items...."

3. The above findings were discussed with the Unit Manager during an interview on 8/11/15 at approximately 10:30 AM, who stated that E #2 should not carry the medicine cup in her pocket resulting in the contamination, and that the Nursing Aide should have fastened her cover gown and been fully covered.

C. Based on observation, interview and document review, it was determined that for 1 of 3 (E # 4) staff in the operating room (OR) A, the Hospital failed to ensure staff adhered to the surgical dress code policy.

Findings include:

1. OR-A was observed on 8/12/15 at between 8:40 AM and 9:30 AM. E #4 was wearing a scull cap that did not cover approximately 1 and 1/2 inches of his hair around the ears and the back of the head.

2. The OR Charge Nurse (E #6) interviewed on 8/12/15 at approximately 10:00 AM acknowledged that E #4 had exposed hair in the OR room.

The Hospital policy titled, " Wearing Apparel in the Operating Room" (rev 10/14) required, 1. All persons entering the operating room must be properly dressed 3. ...All hair must be covered...."

D. Based on observation, staff interview, and document review, it was determined that for 1 of 3 (E #5) staff observed, the Hospital failed to ensure aseptic technique was maintained when drawing medications from vials, as required by Hospital policy.

Findings include:

1. An observation of OR-A was conducted on 8/12/15 between 8:40 AM and 9:30 AM. E #5 was observed removing the lid to a vial for the scrub technician to draw out medication. E #5 failed to wipe clean the rubber top of the vial before holding the vial for the Scrub Tech to insert the needle and draw the medication.

2. The OR Charge Nurse (E #6), interviewed on 8/12/15 at approximately 10:00 AM indicated that the medication vial rubber top should be wiped after the plastic cap is removed before drawing the medication. E #6 stated the nurse did not wipe clean the last vial top like she did with the other vials, and should have.

3. The Hospital policy titled, "Medication Administration" (Developed 6/14) was reviewed on 8/12/15. The policy did not contain any requirement of cleansing the rubber lid of vial medication prior to inserting a needle to draw out medication.

4. The Director of Pharmacy interviewed on 8/12/15 at approximately 1:30 PM stated that there is no policy that requires cleansing/disinfecting the rubber lid of medications before drawing the medication, however, it is a standard practice to do so because the rubber lids are not sterile.



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E. Based on document review, observational tour, and interview, it was determined that for 1 for 1 Hydrotherapy area, the Hospital failed to ensure hydrotherapy patients were not contaminated during treatment, potentially affecting approximately 10 patient hydrotherapy treatments each month.

Findings include:

1. On 8/12/15 at 12:15 PM, Hospital policy titled, "Construction/Renovation Guidelines", reviewed 6/14, was reviewed by the surveyor. The policy required, "Purpose: Planning for facility renovation and construction projects as South Shore Hospital includes early consultation with Infection Control to ensure that... Dust and other microbial contamination is minimized during the work phases of construction/renovation projects... Hospital Infection Control (IC)... 3. Determine whether construction poses sufficient increased risk to require/recommend that patients be moved to an area of the hospital/facility where construction is not occurring..."

2. On 8/12/15 at 10:45 AM, an observational tour was conducted in the physical therapy area. There were 2 hydrotherapy tubs in the in the whirlpool room. There was also an approximately 2 foot by 2 foot hole in the wall with an unsecured and partially open plastic drape. Dust particles were observed flowing into the whirlpool room from the opening. The opening was approximately 8 feet from a hydrotherapy tub.

3. On 8/12/15 at 1050 AM, an interview was conducted with the physical therapy manager (E #7). E #7 stated the wall opening is where Internet wires were being run from the lower level and had been open for over 1 year. During a second interview with E #7 on 8/12/15 at 12:15 PM, E #7 stated there were approximately 10 hydrotherapy treatments per month in the whirlpool room.