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27110


Based on observations and staff interviews, the Hospital Infection Control Officer failed to consistently enforce hospital policies that governed the control and prevention of infection. Specifically, implementation of policies for cleaning and storage of patient equipment.

Findings included:

Observations of the Operating Room (OR) Suite, and interviews with the Director of Perioperative Services at 9:20 A.M. and 10:30 A.M. on 12/19/2011, revealed two areas [the OR corridor and Post -Anesthesia Care Unit (PACU)] in which supplies and equipment were stored in a manner that created a risk for cross-contamination and patient safety, as follows:

A. Observation of the OR corridor revealed approximately nine pieces of large equipment (e.g., video towers - equipment used during endoscopic procedures, stored in the high traffic corridor. The stored equipment reduced the accessible width of the corridor from approximately nine feet to five feet, making it difficult for staff to safely navigate the corridor with patients on stretchers, and increased the risk of cross-contamination of the equipment from staff, patients and visitors utilizing the corridor. Interview with the Director of Perioperative Services revealed that the corridor was not the best place to store the equipment.

B. Observations in the PACU at approximately 10:30 A.M. revealed the following:

1). The negative pressure isolation room was cluttered with: three metal file cabinets that measured approximately three feet high, one foot wide and 2.5 feet deep; three patient walkers; one wheelchair, two recliner chairs; one over-riding table; one precautions cart; three boxes of printer paper; two linen hampers, and one poster that measured approximately three and one half feet by two feet. The precautions cart contained a machine used to monitor patients' blood pressure and pulse, and a device that monitored patients' blood oxygen levels. Both pieces of equipment were dirty with built-up layers of dust. The top of the cart was also dirty with built-up layers of dust and small particles of white paper. Additionally, the ceiling vent was dirty with built-up layers of dust. The floor was dirty with dust and debris.

2). Observation of the Phase 2 Recovery Area (where patients awaiting discharge were located), revealed the vinyl fabric on the backs of eight recliner chairs was ripped and had been repaired with duct tape. The arms of the chairs had holes that exposed the chair stuffing. Tape residue was also observed where the holes had been covered with tape and then the tape removed. The chairs could not be effectively disinfected due to the poor condition of the chairs, increasing the risk of cross-contamination.

Based on observations, staff interviews, and review of hospital policies, procedures, cleaning schedules, patient medical records and employee health records, the Infection Control Coordinator (ICO) developed a system for identifying, reporting, investigating, and controlling infections. However, the Hospital failed to ensure that staff consistently implemented hospital infection control protocols for 7 of 14 sampled patients (#3, #4, #5, #6, #8, #9, #13). Specifically, non-compliance with protocols and standards for sterilization and disinfection, medication administration, use of personal protective equipment, aseptic technique (a method used to prevent contamination), hand hygiene, waste management, ventilator associated pneumonia and device related prevention activities, and infection prevention in the environment of care. Findings included:

A. Observations in the Operating Room (OR) Suite between 9:20 A.M. and 12:45 P.M. on 12/19/11, revealed the following:

In the Pre-Operative Holding Area at 11:20 A.M. on 12/19/11, RN #5 punctured the patient's finger to obtain a blood specimen for testing on Patient #3. The RN failed to perform hand hygiene prior to donning a pair of clean gloves and obtaining the blood specimen, although required by Hospital policy.

B. Observations in the reprocessing area of the OR at 10:00 A.M. on 12/19/11, revealed a tray for disinfecting flexible endoscopes (i.e. ureteroscopes) stored directly on the floor. Interview with Certified Surgical Technician (CST) #2, during the observation, revealed that the tray should have been stored on the shelf and not on the floor. The CST removed the tray from the floor and placed it on a shelf. However, the CST did not disinfect the tray after it had been on the floor, increasing the risk of cross-contamination.

Additionally, observations also revealed an open container of sterilizer testing strips used to ensure the disinfection process. The container lacked the date it was opened and an expiration date. CST #2 said that the strips expired six months after they were opened. The CST also said that Hospital policy required the container to be labeled with the date it was opened and the date it expired, and since the container was not labeled, there was no way to determine if the strips were safe to use.

C. Observations in the sub-sterile room that serviced OR #8, at 10:30 A.M. on 12/19/2011, revealed two containers of sterilizer testing strips (#1, #2). Container #1 lacked the date the container was opened and an expiration date. Container #2, was labeled with the date the container was opened (7/19/11), and an expiration date (1/9/12). The container of strips that was dated (Container #2), in accordance with Hospital policy, was full. The container of strips that was not dated (Container #1), was almost empty. Interview with the Nurse Manager of Perioperative Services during the observation, revealed that staff had been using the strips from Container #1, the container that had not been labeled. Since the container was not dated, there was no way to determine if the unlabeled container of strips was outdated and would accurately reflect test results.

D. Observations in OR #2, between 11:30 A.M. and 12:10 P.M. on 12/19/11, during the surgical procedure for Patient #3, revealed the following:

1. At 11:45 A.M., Anesthesia Technician #1, entered the OR with a surgical mask that was not adequately secured. The Anesthesia Technician failed to tie the mask around his neck. During the observation, the Nurse Manager of Perioperative Services said that OR policy required masks to be securely tied around the necks and heads of OR staff, when in OR procedure rooms. The Anesthesia Tech failed to adhere to the OR policy.

2. At 11:50 A.M., RN #3 left OR #2 to obtain additional supplies. The RN did not perform hand hygiene prior to leaving or prior to re-entering the room. Interview with the Nurse Manager of Perioperative Services at approximately 12:30 P.M. on 12/19/11, revealed that Hospital policy required staff to perform hand hygiene when leaving and entering an OR.

3. At approximately 12:00 P.M., RN #3 handled blood soaked sponges with gloved hands, to perform a sponge count. After glove removal, the RN failed to perform hand hygiene. With contaminated hands, the RN delivered sterile gauze packing and dressing sponges to the sterile, surgical field, and touched the computer keyboard to document in the patient's electronic medical record, increasing the risk of cross-contamination.

E. Observations in the Post-Anesthesia Care Unit (PACU) at 12:10 P.M. on 12/19/11, revealed that a thermometer (used to take patients' temperatures) fell on the floor. Anesthesiologist #1 picked it up from the floor and placed it on patient #3's bed, without first disinfecting the thermometer. RN #4 used the thermometer that had fallen on the floor and was now contaminated, to take Patient #3's temperature. The RN failed to disinfect the thermometer prior to use and prior to returning the thermometer to the thermometer holder.

F. Observations of a spinal injection procedure for Patient #8, in the Pain Clinic from 2:00 P.M. to 2:30 P.M. on 12/19/11 revealed the following:

1. Upon entering the procedure room, multidose vials of the medications Lidocaine (a topical anesthetic) and Kenalog (an antibiotic) were observed on the bedside table. Observation revealed that Anesthesiologist #2 drew each medication into separate syringes at the bedside of Patient #8. Anesthesiologist #2 said that he had used medication from the vials for the previous patient and he would use medication from the same vial for other patients because they were multidose vials and he used a new needle and syringe with each patient. According to CDC (Center for Disease Control) Standards of Infection Control, injectable medications, in multidose vials, brought to a patient's bedside, must be used for only that patient.

Additionally, Anesthesiologist #2 failed to perform hand hygiene prior to donning the sterile gloves used to perform the spinal injection.

2. After cleansing the patient's back, RN #12 removed her gloves. However, the RN failed to perform hand hygiene after glove removal. The RN also failed to perform hand hygiene after helping Patient #8 put on both shoes and prior to handling the patient's chart.

3. Interview with Corporate Quality Consultant #1, at approximately 2:30 P.M. on 12/19/11, revealed that both Anesthesiologist #2 and RN #12 failed to adhere to the Hospital's infection control policies for hand hygiene and use of multidose medication vials, increasing the risk of cross-contamination.

G. Observations in the Central Processing Department (CPD) at 3:30 P.M. on 12/19/2011, revealed that the inside of the ultrasonic machine (used to remove debris from surgical instruments by sonic waves) was dirty with a gritty substance and the cover of the ultrasonic machine was stored directly on the floor next to the machine. During the observation, the CPD Supervisor said that the ultrasonic machine looked like it had not been cleaned the previous night and that the machine cover should have been stored on the machine, not the floor. The CPD Supervisor removed the cover from the floor and placed it on top of the ultrasonic machine, without first disinfecting the cover.

H. Observations of a colonoscopy (a procedure to examine portions of the intestines using a flexible tube passed through the anus) in the Endoscopy Suite for Patient #9, from 8:50 A.M. to 10:00 A.M. on 12/20/11, revealed the following:

1. Observations at 8:50 A.M., revealed that while disinfecting the video cart (used to set-up the colonoscopy equipment), Endoscopy Technician (ET) #1 removed the contaminated specimen holder, containing six containers of specimens from the previous patient, and placed it on top of a box of clean gloves. ET #1 failed to remove the box of gloves contaminated by the specimen holder from the disinfected video cart, until Surveyor intervention.

2. Observations at 9:05 A.M. revealed that Physician #1 failed to perform hand hygiene prior to donning clean gloves, to perform the patient's colonoscopy. After completing the procedure, Physician #1 removed the contaminated gloves and picked up the contaminated specimen holder from the video cart without first performing hand hygiene and donning a pair of gloves. The Physician then placed the contaminated specimen holder on the procedure room desk. Physician #1, then handled and labeled each specimen container, without wearing gloves. After labeling the specimens, the physician failed to perform hand hygiene.

I. Observations of the insertion of a central venous catheter (CVC) and an indwelling urinary catheter, for Patient #13 [a patient diagnosed with Methicillin Resistant Staphylococcus Aureus (MRSA)], in OR #7, between 8:45 A.M. and 10:30 A.M. on 12/21/11, revealed the following:

1. At 8:45 A.M., RN #15 donned sterile gloves in order to verify the safe function of the urinary catheter balloon. The RN failed to perform hand hygiene prior to donning sterile gloves, although required by the Hospital's Infection Control Policy.

2. The RN dropped the patient safety strap on the floor and failed to disinfect the strap prior to placing it back on the OR table. Interview with the Director of Perioperative Services during the observation, revealed Hospital policy required the strap to be disinfected if contaminated, e.g., in contact with the floor.

3. RN #15 left and re-entered OR #7, on two occasions. Both times the RN failed to perform hand hygiene upon exiting and re-entering the OR. Prior to inserting the patient's indwelling urinary catheter, the RN donned sterile gloves without first performing hand hygiene. Additionally, the RN failed to perform hand hygiene after glove removal.
Interview with the Director of Perioperative Services during the observation, revealed Hospital policy required hand hygiene to be performed prior to donning and after removal of gloves.

4. Observation of the insertion of a CVC at 9:55 A.M., revealed that Anesthesiologist #1 failed to use a sterile drape that covered the full body and head of the patient, as required by CDC, Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011. The Anesthesiologist only applied the sterile drape from Patient #13's waist to, and covering, the patient's head.

J. After several requests for the schedules of routine preventative maintenance of the CPD sterilizers, and the Endoscopy high level disinfection machines, on 12/19, 12/20, and 12/21/11, the Hospital was unable to provide documentation of the maintenance.


27110


K. The hospital failed to structure their respiratory protection program to comply with the Occupational Safety and Health Administration (OSHA) general industry standard for respiratory protection for healthcare workers.
Findings include:

Review of the written hospital policy entitled "TB Exposure Plan," revealed that the requirements for the Respiratory Protection Team did not meet the OSHA standard, i.e., annual fit testing (a procedure to ensure correct fit of an employee's respirator/mask). Instead of an annual fit test for all members of the respiratory protection team as required by OSHA, the hospital performed an annual respirator evaluation questionnaire. According to interview with the Employee Health Nurse, new employees were fit tested upon hire and annually would answer questions related to any facial changes (i.e. weight gain or facial surgery). Review of employee health records on 12/19/11 indicated 6 of 6 nursing personnel had not received annual fit testing as required by OSHA.

L. The Hospital failed to ensure that a high level disinfection (HLD) process (a cleaning process that should destroy all microorganisms, except for bacterial spores) was used to reprocess semi-critical items (items that contact mucous membranes or non-intact skin) in the Ultrasound Department.
Findings include:

Interview with the Director of Ultrasound on 12/21/11 at 3:20 P.M. and review of the hospital policy entitled "Transvaginal Sonographic Probe Cleaning and Disinfection" indicated the vaginal probe was cleaned with bleach. Bleach solution is not a Federal Drug Administration (FDA) approved high level disinfectant. According to the Director of Ultrasound, he was aware that the probe required HLD, however, he had not identified a space in the department to accommodate HLD processing.

M. The hospital failed to consistently comply with Infection Prevention standards for the prevention of Ventilator Associated Pneumonia (VAP).
Findings include:

To prevent aspiration of secretions or tube feedings, a patient undergoing mechanical ventilation is to be positioned in the semi-recumbent position (head of bed [HOB] at 30-45 degree elevation). The degree of elevation is to be measured, documented and validated regularly. Observations and interviews with Registered Nurse (RN #8) in the Intensive Care Unit (ICU) on 12/20/11 between 9:20 A.M. and 11:00 A.M., revealed the Patient #6 was positioned at less than a 30 degree elevation.

According to RN #8 Patient #6 was in an older bed that lacked an HOB measurement device and therefore the HOB measurement was estimated. However, the ICU Nurse Manager was able to identify the measurement device on the bed, and it indicated a position below 30 degrees.

N. The hospital failed to minimize the risk of cross contamination during fingerstick blood sugar (FSBS) testing procedures.
Findings include:

1. Observation on the A 3 medical/surgical unit on 12/19/11 between 11:30 A.M. and 12 Noon, revealed four glucometer cases each containing two liquid "controls" (performance tests that are conducted on the glucometer [device to monitor blood sugar] to ensure that it is functioning properly.) According to the manufacturer's directions for use, the controls expire three months after opening. However, 6 of the 8 opened controls were not dated, therefore, the effectiveness of the control solution could not be assured.

2. Observation of Nurse Technician (NT #1) on the A 3 unit at 11:35 A.M., revealed NT #1 brought the glucometer case into the patient's room (containing the meter, test strips, finger lancets, alcohol swabs, gauze, and band-aids.) The case was placed on the patient's overbed table. After direct contact with the patient, NT #1 reached back into glucometer case to retrieve additional clean supplies to complete the procedure, increasing the risk of cross- contamination between patients. The case was returned to the storage area for future use.

O. The hospital failed to monitor the airborne infection isolation room (AIIR) according to an acceptable standard of safety.
Findings include:

Observation in the Intensive Care Unit (ICU) on 12/20/11 between 9:20 A.M. and 11:00 A.M., revealed an AIIR room. Observation in the AIIR room, the ante-room and interview with the ICU Nurse Manager revealed a visual air pressure monitor was not in place to indicate the negative pressure status of the room. According to the Nurse Manager, prior to the admission of a patient requiring an AIIR, the room was checked by the facilities department personnel, using a smoke tube, to ensure the room was in negative pressure. However, ongoing monitoring was not provided to ensure negative pressure was maintained while the room was occupied by a patient requiring airborne isolation.

P. The hospital failed to consistently comply with Infection Prevention standards for the prevention of device-related infections (i.e. central lines, indwelling urinary catheters) by documenting the indications for use, and an ongoing review for the necessity of these devices.
Findings include:

1. Review of Patient #6's record, on 12/20/11, indicated the patient had a central line in place. A central line is a tube that is placed into a large vein of a patient, usually in the neck, chest, arm or groin. A central line provides direct access to administer fluids, medication, withdraw blood, and monitor the patient's condition. However, according to the CDC, Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011, of an estimated 248,000 bloodstream infections that occur in U.S. hospitals each year, a large proportion of these are associated with the presence of a central line. Therefore, prompt removal of the central line is an important approach to the prevention of central line associated bloodstream infection (CLABSI). According to review of the record of Patient
#6, there was no indication of ongoing review to determine the continued necessity of the central line.

2. Review of the medical records of Patient #4 and #5 on 12/20/11 indicated both patients had an indwelling urinary catheter device in place. According to the CDC Guideline for the Prevention of Catheter-Associated Urinary Tract infections 2009, to identify and remove catheters that are no longer needed (e.g., daily review of their continued need) has demonstrated effectiveness in reducing infections. According to review of the patients' records there was no indication of ongoing review for the continued necessity of the indwelling urinary catheters.

Q. According to 105 CMR 480.100 (B) and 480.100 (C)(1), all areas for on-site storage of containers of medical or biological waste, shall be in a room or area used exclusively for waste storage and be designed to prevent unauthorized access.
Findings include:

Based on observation and staff interview, the Hospital failed to ensure the Biohazard Waste Storage Room was used exclusively for waste storage.

Observation in the Biohazard Waste Storage Room and interview with the Director of Facilities, revealed biohazard waste was stored in an area that was not used exclusively for waste storage. The room was used as a soiled laundry storage area.


R. The hospital failed to provide education to the Health Care Worker (HCW) in accordance with the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen standard.
Findings include:

According to provision 1910.1030(g)(2)(ii)(A) and 1910.1030(g)(2)(ii)(B), HCW's receive training "at the time of initial assignment to tasks where occupational exposure may take place; and at least annually thereafter". Review of employee files on 12/20/2011 indicated nine of nine employee files lacked evidence that they had completed Bloodborne Pathogen training in 2011.

S. The hospital failed to consistently meet the standard of care for transport of soiled equipment.

1) Observations in the Operating Room (OR) on 12/20/2011 at 7:40 AM included a Transesophageal Echocardiography (TEE) procedure in OR Room 6. (The TEE probe is a long flexible instrument with an ultrasound sensor located at the tip. The probe is passed through the patient's mouth, down the back of the throat, and into the esophagus and stomach. This allows viewing of the patient's heart and valves through ultrasound images.) According to the Echocardiogram Technician (ET #1), the TEE probe is stored in a clean storage closet in the Ambulatory Care area. On observation, it was noted that the TEE probe was placed in a container lined with a clear plastic bag. At the completion of the procedure, the soiled TEE probe was returned to the container and covered with the same clear plastic bag. The probe was then returned to the decontamination room in the Ambulatory Care area. According to ET #1, the process described was the routine procedure for transporting soiled scopes.

2) According to the Occupational Safety and Health Administration (OSHA) regulations,1910.1030(g)(1)(A), warning labels shall be affixed to containers used to store, transport or ship blood or other potentially infectious materials. The soiled TEE probe was not transported in a manner that would comply with OSHA requirements, nor was a visual warning label affixed to the container (i.e., biohazard label or red bag), to reduce the risk of exposure to employees or patients to equipment that has not been disinfected.