The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

UMASS MEMORIAL MEDICAL CENTER INC 55 LAKE AVENUE NORTH WORCESTER, MA 01655 Nov. 30, 2011
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, staff interviews, and review of hospital policies, procedures, cleaning schedules, 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 2 of 9 sampled patients (#4, #5), and 5 non-sampled Patients (NS #1, NS #2, NS #3, NS #4, NS #5). Specifically, non-compliance with protocols and standards for medication administration, use of personal protective equipment, aseptic technique (a method used to prevent contamination), hand hygiene, and infection prevention in the environment of care. Findings included:

1. Observations and staff interviews in the medication preparation area of the Surgical Admissions Care Unit (SACU), from approximately 9:30 A.M. to 9:50 A.M. on 11/28/11, revealed that when Registered Nurse (RN) #8 removed a vial of the medication Insulin (lowers patients' blood sugar) from the automated medication dispensing machine, a label on the insulin that read, "Use by 11/13/11." Interviews with RN #8, the Director of Perioperative Nursing, and Quality/Risk Nurse #1, indicated that Pharmacy staff place outdate labels on insulin vials, and the label indicated the insulin had outdated on 11/13/11, 15 days prior to survey. The Director of Perioperative Nursing said that it was hospital policy for Pharmacy personnel to inspect all automated medication dispensing machines in the hospital on a monthly basis and remove any outdated medications.

Interview with Pharmacist #1 and review of the Pharmacy Department's "Set-up Parameters Report" from 9:50 A.M. to 10:05 A.M. on 11/28/11, revealed that the date on the insulin label indicated the insulin was outdated. Pharmacist #1 said that labels identifying outdates were placed on all medication vials when they were placed in the automated medication dispensing machine. Those dates were then entered into the "date function" of the machine. A weekly report, to identify outdated medications, was then generated. Pharmacist #1 said that the insulin was missed by the Pharmacy staff.

Continued review of the "Set-up Parameters Report" with Pharmacist #1, indicated that the insulin was refilled on 11/15/11, with an 'outdate' label attached. The Pharmacist said that an incorrect date of 11/13/11 was placed on the insulin vial and that the insulin should have been labeled with a 12/15/11 outdate. Further review of the report with the Pharmacist also indicated that on three occasions: (1)10:20 A.M. on 11/15/11; (2) 10:46 A.M. on 11/15/11; and (3) 10:41 A.M. on 11/25/11, the vial of insulin, with the incorrect outdate label attached, was removed by three different nurses and insulin was administered to three different patients (NS #2, NS #3, NS #4). Continued interview with Pharmacist #1, indicated that because an incorrect date was placed on the insulin vial the events were considered medication errors, although the insulin was not actually outdated.

According to the Hospital medication administration policy, entitled "2030 Medication Administration" the clinical staff administering medication must do the following: "Verify that the medication has not expired." The three SACU nurses failed to follow hospital policy.

Review of Hospital Policy 2203, Automated Dispensing Machines (ADM) indicated "Pharmacy technicians will inventory and remove outdates from stock." Additionally, the Pharmacy Department Policy #2.1.2, Unit Inspections, required the Pharmacy Department to conduct inspections of all areas where medications were dispensed, every 30 days, return expired drugs to the Pharmacy, and properly label drugs with expiration dates. The Pharmacy Department failed to ensure compliance with this policy.

2. For Patient NS #1, observations in Operating Room (OR) #5, from 10:35 A.M. to 10:50 A.M. on 11/28/11, revealed that RN #13 performed a surgical skin preparation (prep) and a shave prep for a heel and lower leg procedure. However, the RN failed to adhere to the OR infection control policies entitled "Types of Patient Skin Preparation in the Operating Room," effective April 2011, and Infection Control Policy/Procedure, effective July 19, 2011.

a). Review of the OR policy "Types of Patient Skin Preparation in the Operating Room," at approximately 1:30 P.M. on 11/30/11, indicated the following: "The person prepping exposes the area to be prepped and dons sterile gloves. The first stroke is made over the intended incision site. Complete the prep with vertical and horizontal strokes working toward the outer edges. Do not repeat (go back over) a stroke once it has been made."

b). RN #13 prepped the patient's foot to mid-calf, using up, down and sideways strokes. The RN prepped over previously prepped areas of the foot and lower leg. Additionally, the RN prepped the patient's toes, toenails, and between the toes and then prepped the patient's foot, leg and back to the foot.

c). According to interview with Quality/Risk Nurse #1 at 11:00 A.M. on 11/28/11, RN #13 did not adhere to the OR's surgical prep policy.

d). Prior to performing the surgical skin prep the RN shaved the hair off the patient's lower leg in OR #5, while the patient was on the OR table. Review of the hospital's "OR Infection Control Policy/Procedure" at approximately 11:30 A.M. on 11/30/11, revealed the following: "Hair removal should be done in the Surgical Admissions or the pre-op holding area, whenever possible, to avoid the presence of hair on the operative field."

Addendum C of the OR Infection Control Policy, entitled "Skin Preparation/Hair Removal" indicated that hair removal should take place away from the sterile field, preferably in an area outside of the room where the procedure is to be performed." RN #13 failed to follow the OR's infection control policies.

3. Observations in the Post-Anesthesia Care Unit [(PACU), the area where patients have intravenous (IV) lines inserted prior to heart surgery], from 10:05 A.M. to 10:30 A.M. on 11/29/11, revealed the following:

a). Review of the Hospital's hand hygiene policy entitled "5009 Hand Hygiene" at approximately 10:00 A.M. on 11/30/11, indicated that staff were required to perform hand hygiene before donning sterile gloves and after glove removal.

b). In preparation for the insertion of an IV (a sterile tubing placed in a patient's vein to administer fluids and/or medication) and an arterial line (a sterile thin tubing placed in a patient's artery to monitor a patient's pressures and to draw blood), Anesthesia Resident #1 donned clean gloves and then touched a contaminated bedside table, and moved the table to the other side of the patient's stretcher.

c). The Anesthesia Resident then accessed the clean Anesthesia Supply Cart and obtained a glass ampule of the medication Lidocaine 1% (a local anesthetic), and a syringe, without first removing the contaminated gloves and performing hand hygiene. According to the Hospital hand hygiene policy (5009 Hand Hygiene), the gloves were considered contaminated and hand hygiene was required prior to accessing the clean Anesthesia Supply Cart because the Anesthesia Resident "touched inanimate objects (the patient's furniture) in the immediate vicinity of the patient."

d). The Anesthesia Resident then changed gloves and donned another pair of clean gloves without first performing hand hygiene, as required by hospital policy. The Anesthesia Resident then drew the Lidocaine into the syringe and administered it to Patient #4.

Additionally, the Anesthesia Resident failed to use a filter needle to draw the medication from the glass ampule into the syringe. According to documentation provided by Quality/Risk Nurse #1, at approximately 10:00 A.M. on 11/30/11, hospital policy required staff to use a filter needle to draw medication from a glass ampule, to filter out any potential glass splinters.

The Anesthesia Resident failed to follow Hospital policies for hand hygiene and medication administration.

4. Observations in the OR from 1:45 P.M. to 2:30 P.M. on 11/29/11, revealed the following:

a). Both Physician Assistant (PA) #1 and RN #10, failed to perform hand hygiene prior to donning sterile gloves and sterile gowns, in order to perform a surgical skin prep for Patient #4 who was scheduled for heart surgery, thereby increasing the risk of cross-contamination.

b). RN #10 failed to perform hand hygiene prior to donning sterile gloves, in order to insert a urinary catheter for Patient #4. After insertion of the urinary catheter, the RN failed to perform hand hygiene after glove removal and prior to accessing the clean glove box, increasing the risk of cross-contamination.

c). After positioning Patient #4 for surgery, RN #10 again failed to perform hand hygiene after glove removal and prior to accessing the clean glove box.

PA #1 and RN #10, failed to adhere to the Hospital policy for hand hygiene.

5. Observation in Procedure Room #3, of the Endoscopy Unit from 11:00 A.M. to 11:30 A.M. on 11/29/11, revealed the following:
a). RN #11, dropped three electrocardiogram electrodes (self-adhesive pads) on the floor. The RN then placed two of the leads back in their box and placed the third lead on the patient's chest. The RN then dropped a piece of paper on the floor, picked it up and threw it in the waste basket. The RN then proceeded to don clean gloves and draw up medications for patient sedation, Versed and Fentanyl, into two separate syringes and administered the medications intravenously (into the patient's vein). RN #11 failed to perform hand hygiene after removing items from the floor and before accessing the clean glove box and donning clean gloves, as required by Hospital policy.
b). During the colonoscopy procedure for Patient #5, Endoscopy Technician (Endo Tech) #1 removed his gloves and touched the computer keyboard to access patient data. The Endo Tech failed to perform hand hygiene after glove removal and prior to touching the computer keyboard. Additionally, the Endo Tech then failed to perform hand hygiene prior to accessing the clean glove box and donning a second pair of gloves.

Endoscopy Technician #1, failed to follow the Hospital's Hand Hygiene Policy which required staff to perform hand hygiene after glove removal, after contact with mucous membranes, and after contact with medical equipment (i.e., the colonoscope used for Patient #5).

6. For Patient NS #5, observations in the Surgical Admissions Care Unit (SACU) discharge area, from 3:05 P.M. to 3:20 P.M. on 11/28/11, revealed that RN #9, failed to adhere to the Hospital's Hand Hygiene Policy as follows:

a). RN #9 failed to perform hand hygiene before accessing the clean glove box and donning a pair of gloves to move the bed sheets and assess the dressing of Patient NS #5.

b). After the RN assessed the dressing and placed the bed sheets back over the patient, the RN did not perform hand hygiene after removing the gloves. Interview with RN #9 revealed that the patient's incision was oozing blood and the surgical dressing needed to be re-inforced (additional sponges added to the existing dressing).

c). The RN then obtained additional sponges, removed the bed sheets covering the dressing, donned clean gloves, reinforced the dressing, covered the patient with the bed sheets, removed the gloves, and performed hand hygiene. Although the RN performed hand hygiene after glove removal, the RN failed to perform hand hygiene prior to donning the gloves, although required by Hospital policy.





7. Observations and interview in the Ultrasound Department with the Ultrasound Technician on 11-30-2011 at 9 A.M., and in the OR with Anesthesia Technician #2, on 11/29/11 at approximately 2:45 P.M., indicated that that 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 these departments.

The following step was not performed in accordance with manufacturer's instructions. Findings include:

The manufacturer's guidelines for use required a specific solution temperature (20? Centigrade, 68? Fahrenheit) to ensure the effectiveness of the chemical.

a. Observations of the OPA station in the Ultrasound (US) Procedure Room of the Imaging Department, (used to reprocess vaginal probes), on 11/30/2011 at 9 A.M., and in the OR [used to reprocess transesophageal endoscopes (TEE)] on 11/29/11 at approximately 2:45 P.M., revealed there were no thermometers available for monitoring the temperature of the solution. According to interviews with the US Technician and Anesthesia Tech #2, at the time of the observations, the temperature of the product was not monitored to ensure the minimum temperature was achieved, as required by the manufacturer's directions for use.

b. Also, the vaginal probes were rinsed in a container in the handwashing sink, instead of in a clinical service sink, as required.

8. Observations on the East and West 6 Units (Medical -Surgical) on 11/28/11, and 11/29/2011, revealed the hospital failed to ensure that Personal Protective Equipment (PPE) was consistently used in accordance with hospital policy and standards of care, as follows:

a. Observation on 6 West on 11/28/11 at 11:45 A.M. revealed a Registered Nurse (RN #2), failed to wear PPE (gloves) while performing point-of-care testing on a patient's blood sample.

b. Observation and interview with RN #1, on 6 East on 11/28/11 at 12 Noon, revealed that RN #1 was caring for a patient in an Airborne Infection Isolation Room. According to RN #1, she was medically cleared and fit tested (a procedure to check that the mask size and mask model fits the wearer's face and that there is minimal air leakage between the face and the mask), according to the hospital policy and the OSHA respiratory protection regulation. However, review of the employee health record of RN #1 revealed that she had not been fit tested since 9/7/09, instead of the required annual fit test.

c. Observations on 6 West on 11/28/11 between 2 P.M. and 2:45 P.M. revealed a Physician (MD #1) and a Nurse Practitioner (NP #1) in two different contact precaution rooms failed to don personal protective equipment (PPE), in accordance with Hospital policy. Precaution room signs, revealed gloves were to be worn when entering patient contact precaution rooms.

9. Observations in the East and West 6 Units (Medical -Surgical) on 11/30/2011, revealed non-critical items, used to monitor vital signs, were stored in two alcoves. According to the nursing staff, these vital sign machines were cleaned in between each patient use. Observation of the machines on 11-30-2011 in the late morning, revealed 5 of 7 vital sign machines had a sticky substance that was visibly soiled. According to the Nurse Manager on 6 East, it was probably old tape.

10. Interview with the Hospital Epidemiologist and the Manager of Infection Prevention on November 28, 2011 and review of the Infection Control Program and the Isolation Precautions policy indicated that the hospital did not comply with the CDC Guidelines (2006 Management of Multi-Drug Resistant Organisms In Healthcare Settings, and 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings) or the Final Recommendations of the Expert Panel (Prevention and Control of Healthcare-Associated Infections In Massachusetts), "In addition to Standard Precautions, use Transmission-Based Precautions for patients with documented or suspected infection or colonization with highly transmissible or epidemiologically-important pathogens for which additional precautions are needed to prevent transmission."
According to the hospital policy only those patients suspected or diagnosed with active infections and whose secretions could not be contained, were placed on Contact Precautions(measures used to prevent the spread of pathogens to include: patient placement, gloving and gowning, care of patient-care equipment and instruments/devices, hand hygiene, and environmental measures). Therefore, patients colonized with Multi-Drug Resistant Organisms were not placed on Contact Precautions.