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Based on observation and staff interview, it was determined the hospital failed to

a. ensure surgical instrument decontamination and sterile processing was performed in appropriate rooms with adequate space and provided in a manner to prevent breeches in infection control;

b. ensure mechanical equipment was installed in appropriate areas of the surgical department; and

c. failed to ensure all essential and patient care equipment was maintained in safe operating condition. See Tag C-0222.

Findings:

During observations of the surgical department, the following practices were noted:

1. A laparoscopic instrument processor was set up in the surgery restricted corridor, rather than in a clean surgical instrument processing area. All the electrical and plumbing fixtures were open and exposed to the surgical environment.

2. A large steam sterilizer was placed in the surgery restricted corridor. There was no enclosure for the mechanical side of the sterilizer. The electrical and plumbing fixtures were open and exposed to the surgical environment. The steam sterilizer was located directly across from a warming cabinet that held sterile IV fluids.

3. Sterile surgical instruments were stored in a corridor enclosed by two doors. This area was not ventilated and did not maintain temperature and humidity as required for the storage of sterile supplies. The area did not allow for adequate air circulation and was over-crowded with supplies and equipment. The surgery department did not have a sterile supply room.

4. Sterile supplies were stored in plastic cabinetry in the restricted corridor. The cabinetry was dirty, dusty and had multiple areas where old adhesive tape had been applied. The staff stated this cabinetry was never cleaned. Some cabinets were missing doors. Instead, linen (sheet-like) material similar to curtains, was hung over it as a means of protection from contamination.

5. A very large, free-standing blanket warmer was installed in a surgical procedure room. The staff stated there were problems with temperature and humidity in this procedure room.

6. Endoscopy equipment was cleaned in a small area originally designed as a janitor's closet. The room was not large enough to process this equipment without multiple opportunities for contamination and breeches in infection control.

The two sinks located in this room were too small and too shallow for scope processing. There was inadequate counter space. There was inadequate storage for general supplies and equipment available in the room.

There was no provision for the storage and disposal of personal protective equipment. This room had no space for the collection of trash and biohazardous waste. There was no separate staff hand-washing sink.

The automated endoscope cleaning unit was located directly adjacent to the contaminated sinks. It was not possible to maintain separate clean and dirty areas of the room.

There was indication this room did not get regular terminal cleaning and was not routinely deep-cleaned.

7. The surgical instrument decontamination room and the sterile processing room were located outside the surgery department. These two rooms were not connected in a manner so the staff could move from area to another without traveling through a public corridor.

Because of the location and design of these areas, it would be very difficult to maintain acceptable infection control practices. The rooms had not been designed to allow for staff to don or remove personal protective equipment before leaving or entering the rooms.

The staff stated the hospital did not have policies and procedures to direct staff on performance of activities in these areas.

8. The surgery department did not have clean and dirty equipment storage areas, did not have soiled and clean utility rooms and did not have an room designated to collect biohazardous waste. The surgery department did not have a dedicated medication storage room.

There was no storage for medical gases. There was no anesthesia workroom.

Based on document review, observation, and staff interview, the hospital did not ensure all essential and patient care equipment was maintained in safe operating condition.

Findings:
1. On the morning of March 18, 2014, surveyors toured the emergency department (ED).
Surveyors observed a Biphasic Zoll defibrillator/monitor/pacer in Room 3 that was not inspected or tested.
Surveyors observed Staff O testing a Zoll defibrillator/monitor/pacer in Room 3 which did not deliver the 20 joules (typically used for testing the device) of energy.
Staff O told surveyors that the Zoll defibrillator/monitor/pacer in Room 3 did not work properly and had to press the red buttons on the paddles multiple times before it would deliver the shock.
2. On the afternoon of March 19, 2014, surveyors toured the radiology department and mobile Magnetic Resonance Imaging (MRI) unit.
Surveyors observed a fire extinguisher unsecured on the floor near the entrance to the magnet.
Staff HH told surveyors that the fire pull does not work in the Mobile MRI unit and would call the radiology department to report a fire.
Staff HH informed surveyors, "There was a special fire extinguisher which contained water only and would use it to extinguish a small fire but did not have training to use the extinguisher."

Based on observation, infection control meeting minutes, infection control committee minutes, policy and procedure review and interview, the hospital failed:
a. to have an active surveillance program that includes specific measures for prevention, early detection, control, education and investigation of infections and communicable diseases.
b. to provide a safe environment consistent with nationally recognized infection control precautions.
c. to approve the disinfectants used in the hospital.
d. to monitor and evaluate aseptic practices in all hospital departments.

Findings:

1. On the morning of 03/18/2014, surveyors requested the infection control policies and procedures, the infection control plan and all surveillance and monitoring activities, and infection control meeting minutes.
2. No surveillance and monitoring activities were provided.
3. Surveyors reviewed the infection control meeting minutes. The meeting minutes contained no documentation of surveillance with investigation of infectious diseases.
4. On the morning of 03/18/2014, surveyors observed a room labeled as a biohazard/soiled room in the Emergency Department that contained a bedside commode that was tagged and labeled as clean.
5. On the morning of 03/18/2014, surveyors observed wheel chairs throughout the Emergency Department for patient use. Surveyors asked staff JJ how she would know if the wheelchairs were clean or dirty. Staff JJ stated "I guess you don't. "
6. On the morning of 03/18/2014, surveyors asked staff H if the Infection Control Practitioner (ICP) and infection control committee had reviewed and approved all the disinfectants used in the hospital. Staff H stated that "we adopted the disinfectants used at {facility name deleted}"
7. On the morning of 03/18/2014, surveyors observed an emergency airway cart in the Emergency Department. The second drawer of the cart contained emergency airway supplies. Surveyors asked staff JJ how she would know if the supplies were clean. Staff JJ stated "I guess you don't."
8. Review of infection control meeting minutes and infection control policies and procedures contained no evidence that the hospital's disinfectants had been reviewed and approved by the Infection Control Practitioner.
9. On the morning of 03/20/2014, surveyors asked staff H if the ICP made environmental rounds of all departments to monitor aseptic practices. Staff H stated, "I think she does."
10. On the morning of 03/20/2014, surveyors asked staff H for documentation of environmental rounds. No documentation of environmental rounds was provided.
11. Throughout the survey 03/18/2014 to 03/20/2014 the ICP was unavailable.

Based on hospital document review, policy and procedure review, and staff interview, the hospital did not ensure all policies were reviewed at least annually.
Findings:
1. On the morning of 03/18/14, surveyors requested hospital policies and procedures.
Administrative staff provided hospital wide policies which did not have documented evidence that any polices were reviewed annually.
2. On the afternoon of 03/18/14, the Director of Nursing (DON) told surveyors, "The facility adopted policies and procedures from [facility name deleted]."
On the morning of 03/19/14, the DON told surveyors, "Policies were being reviewed by department managers. If changes were needed, the manager of the department makes changes and it should go to medical executive committee. If no changes are needed, the policy is printed and put into the department manual and kept online."
3. The DON verified that there was no evidence that policies and procedures are being reviewed annually.

Based on observation, document review and staff interview, it was determined the hospital failed to:

a. provide outpatient surgical services in a manner consistent with inpatients;

b. maintain a current written scope of surgical services that was approved by the medical staff;

c. develop and approve a policy that addressed the required qualifications for the operating room (OR) supervisor;

d. provide post-operative care in accordance with acceptable standards of practice;

e. implement and enforce surgical attire policies and procedures according to recognized standards of practice;

f. ensure sterilized materials were packaged, handled, labeled and stored in a manner to ensure sterility; and

g. the hospital failed to ensure complete documentation of sterilization cycles.

Findings:

1. During a tour of the hospital's surgery and recovery areas, the staff stated that not all surgery outpatients went to the recovery room. The decision to go to the recovery room was based on the patient's surgical procedure and not based on the patient's condition or level of sedation.

2. The staff stated the hospital did not have a current written scope of surgical services (types of surgical procedures performed, population served, hours of operation, types of personnel available, etc.) that was approved by the medical staff.

3. The hospital did not have documentation of the required qualifications for the OR supervisor.

4. At the time of survey, and while recovering patients were present, the hospital's recovery room was not ready to provide emergency intervention if needed. For example, the suction and oxygen administration equipment was not set up with tubing, suction tips and masks. The room was cluttered and appeared disorganized. The room did not appear to be cleaned regularly.

The hospital did not have policies and procedures that specified transfer requirements to and from the recovery room and did not have policies and procedures to define a "step-down" period of recovery. In addition, there were no policies and procedures that detailed the requirements for patient assessment during the recovery period. Patients had no documentation of assessment related directly to their surgical procedure.

One geriatric patient who received general anesthesia and a reversal agent was discharged after only 33 minutes in recovery. The patient then went to the step-down unit with no direct RN observation and was discharged home 38 minutes later. A hospital policy documented patients who received a reversal agent should be monitored in recovery for a minimum of two hours.

During the survey, it was determined the hospital did not provided direct observation by an RN for those surgery patients who did not go to the recovery room. Those patients went to a patient room in the pre-op area without direct observation at all times. In addition, the rooms were not set up to provide emergency suction and oxygen. The rooms did not have EKG monitoring capability.

5. During the survey, OR staff were observed in surgical attire in various areas of the hospital. These staff were not required to change into clean scrubs when entering the OR department. At the time of interview, the staff stated they were allowed to wear scrubs from home to the hospital without any cover-up. Non- hospital staff arrived from outside the hospital and went in and out of the OR department in the same scrub attire. Staff were not required to wear a cover gown or coat. Personnel wore the same shoes uncovered, in and out of the OR. Some staff wore shoe covers in and out of the OR without changing them.

6. Sterilized materials were not packaged correctly. Items were double peel-packed. The internal packaging was folded and wrinkled. Peel packages were stored cramped in containers that subjected them to rips and tears.

Sets were not wrapped tightly to prevent air contamination.

Sterile supplies were stored with non-sterile supplies. Sterile supplies were stored in a corridor that was not designed,ventilated or temperature controlled as required for sterile supplies.

7. Sterilization records reviewed for the six month period prior to survey had the following missing documentation:

no year documented
no documentation of the sterilization parameters (time, temperature, pressure, duration, dry times, etc.)
no details of the contents of the load - only documented "knee", "ortho", or "hip."

Immediate use sterilization records did not document the sterilization parameters and did not document how the item was packaged (or not). The records did not document the reason for the shortened cycle.

Based on record review and staff interview, it was determined the hospital failed to ensure all patients were discharged in the company of a responsible adult.

Findings:

The clinical records for five surgical patients were reviewed. The records did not document when the patient was discharged, the patient's disposition or the person accompanying the patient at the time of discharge.

Hospital staff confirmed this finding.

Based on document review and staff interview, it was determined the hospital failed to implement an effective quality assessment and performance improvement (QAPI) program.

Findings:

A review of the hospital's QAPI meeting minutes and records of data collection documented the data was collected and calculated for compliance with defined thresholds. However, when the thresholds were met, month after month, and year to year, no new quality indicators were identified.

There was no documentation information related to incidents, unusual events, or complaints or grievances was analyzed, evaluated and responded to with corrective actions. For example, there were multiple incident reports related to laboratory services. There was no documentation this was identified as a quality indicator.

If corrective actions were taken, there was no documentation of the results of those actions.

There was no documentation all hospital services affecting patient health and safety were evaluated for quality. Contracted services were not a part of the QAPI program.

The findings were discussed with hospital leadership. No other information was provided.

Based on policy and procedure review, medical record review and review of the organ procurement development plan, it was determined the hospital failed to notify the Organ Procurement Organization of every death that occurred in the hospital.
This occurred in 1 of 2 death records reviewed. (#7 & 16)
Findings:
1. A Policy titled,"Death Policy", documented," ...will notify Life Share within 1 hour of death ..."
2. A hospital document titled, "Life Share Hospital Development Plan", documented,
" ... Life Share will educate staff and provide educational materials to remind staff to call within one hour of patient's death ..."
3. Review of the medical record for patient #16 contained no documentation that Life Share was notified of the patient's death