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.

TUCSON MEDICAL CENTER 5301 EAST GRANT ROAD TUCSON, AZ 85712 March 26, 2014
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on direct observation, review of facility policy/procedure, review of documents provided by the facility and interviews, it was determined that the Infection Control Officer:

1. failed to ensure that the disinfection of Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP) masks and air tubing, suitable for multiple patient use, be reprocessed according to hospital policy/procedure and manufacturers' guidelines in the outpatient Sleep Diagnostic Laboratory.

2. failed to ensure a sanitary environment was maintained in the hospital's main kitchen.

Findings include:

1.
Direct observation conducted on 3/18/14, revealed a utility room with a Pasteurizer which is utilized by the Sleep Diagnostic Laboratory to reprocess CPAP, BiPAP and humidifier equipment via high level disinfection. An unlabeled container of liquid detergent was on the counter for pre-washing the equipment. A toothbrush and manicure type brushes were located in a drawer in the utility room.

Review of the facility procedure titled (Name of Hospital) Neurophysiology/Sleep Lab revealed: "...Subject: Countertop pasteurizer for high-level disinfection of small loads...Purpose: The Mini-Pasteurmatic achieves high-level disinfection with simple, hot-water pasteurization. To ensure that all patients and employees are protected from the spread of bacteria and infections...Procedure: 1. The operator places the loaded baskets on the power hoist of the washer. A small amount of detergent is placed into the detergent dispenser...The operator turns the control dial to start the automatic 30-minute wash cycle...2. After the washing is completed...The baskets are then transferred to the pasteurizer and lowered into the tank of water thermostatically maintained at 167 (degrees) F...The timer is set to start the 30-minute pasteurizing cycle...Effective: 9/2004...REVIEWED: 9/2006...."

The Manager of the Sleep Lab provided a document identified as manufacturer guidelines for the pasteurizer. Review of this document revealed: "...Washer...The operator places the loaded baskets on the power hoist of the washer. A small amount of detergent (Pasteur Sol available from Olympic Medical) is placed into the detergent dispenser...5-Step Wash Cycle...Pasteurizer...After the washing is completed, the operator raises the power hoist, baskets and lid...The baskets are then transferred to the pasteurizer...."

Additional documents contained description of the Mini-Pasteurmatic: "...a table-top, nontoxic, high-level disinfection system...." Review of these documents revealed: "...The Mini-Pasteurmatic...Place the pre-washed parts in the perforated basket attached to the lid...Cycle Validation...Printout records time and temperature during the 30-minute pasteurization cycle...."

Employee # 2 confirmed during interview conducted on 3/18/14, that s/he manually washes the CPAP and BiPAP masks and tubing with dish detergent prior to placing then in the pasteurizer. S/he uses the toothbrush and other small brushes located in the utility room drawer. S/he also confirmed that s/he does not print a record of processing time and temperature.

The Manager of the Sleep Lab confirmed during interview conducted on 3/18/14, that the facility policy/procedure and other documents which contained instructions for pre-washing of equipment via a washer was not pertinent to the Mini-Pasteurmatic model used by the facility. He confirmed that staff manually pre-wash the equipment and that the facility does not have a written policy/procedure for manual pre-washing of equipment. The facility does not have manufacturer guidelines for the type of detergent or type of brushes to utilize during the pre-washing process or method of disinfection of brushes after use. He also confirmed that the facility does not print out validation of the time and temperature of each 30 minute pasteurization cycle.

Review of manufacturers' guidelines provided by the Director of Specialty Nursing Services on 3/20/14, for disinfection of "Nasal pillows systems" and Air tubing revealed: "...Validated disinfection and sterilization procedures...High level thermal disinfection...Thoroughly clean the separated mask components...with a soft bristle brush for one minute while soaking them in the detergent Alconox...Using a certified hot water disinfection system soak the disinfectable mask components using a temperature-time combination...Clean the air tubing with a soft bristle brush for one minute while soaking it in the detergent solution...ResMed has tested the following detergents according to the manufacturer's instructions: Alconox...Aniosyme...Neodisher MediZym...High level thermal...Immerse the air tubing in a water bath...Increase the water bath temperature to...167 (degrees) F for 30 minutes...."

The Director of Speciality Nursing Services confirmed, during interview conducted on 3/20/14, that she would require use of manufacturers' guidelines to ensure achievement of high-level disinfection for the items processed in the pasteurizer. She confirmed that neither the written procedure nor current practice utilized by employees of the Sleep Lab follow the manufacturer's guidelines. She confirmed that the Infection Control Specialist has not been aware of the pre-washing practice utilized or that the print out validation was not in use.




















2.
A tour of the hospital's main kitchen was conducted on 3/24/2014 with the Director of Dietary Services and the hospital's Associate Administrator of Clinical Practice. The following observations were made during that tour:

-The main kitchen included rooms in which large pipes were suspended from the ceiling. The pipes were identified by the hospital staff as part of a "cooling system." There were sections of the pipe that had areas of corrosion and deterioration. There were other sections of pipe that ran from the floor to the ceiling that had sections of exposed and frayed insulation. These were dry storage areas for food items including a large open box of potatoes.

-There was a significant visible buildup of dirt and debris underneath food storage racks, in the corners and around pipes.

-There were numerous areas throughout the kitchen of chipped and missing flooring tile, areas of the baseboards pulled away from the wall and chipped and/or peeling paint on the walls. Some of the walls had areas of spattering of liquid that had dried.

-Steam was observed coming out of the dishwasher during its use. The ceiling in the dishwashing room had numerous areas of water droplets hanging from the metal frames around the ceiling tiles including directly over areas of where clean food trays were stored. The metal frames were also observed to have numerous areas of orange/brown discoloration similar to rust. One of the tiles was observed to have spots of black/gray discoloration.

The Director of Food Services reported during an interview on 3/24/2014 that although there were no policies and procedures for routine cleaning and maintenance of the kitchen, she had developed and implemented cleaning schedules. She provided a sample of the cleaning schedules to the surveyor for review. The "Dishroom Responsibility Matrix" broke down each activity, the area/location, the responsible party, the frequency for cleaning, and a section for the employee to initial that the activity was completed. The sample of cleaning schedules provided for January, February and March 2014 revealed all of the areas assigned were not consistently cleaned according to the schedule. For example, according to the "matrix," for the week ending 3/25/2014, the following areas were to be cleaned daily: "Scrub floors w/deck brush, rinse w/hot water & mop . . . Clean out pulper by draining both bins, spray out residue & wipe w/rag . . . Wipe down outside of dishwasher . . . Wipe down outside of pulper." There were no staff initials that the activities were completed on 3/9, 3/10, or 3/11/2014.

Another cleaning schedule for the week of 3/16/2014 included a section for "Entree AM." The following activities were to be performed on a daily basis: "After lunch is served-drain water from steam table and replace with fresh water . . . Place temperature on high to increase water temperature . . . Wipe debris from surface areas . . . Remove debris from hot holding area under the steam wells . . . Wipe down plate warmers . . . Sweep/Mop Empty Trash . . . Clean 2 carts each shift." There were no staff initials documented that indicated those activities were completed by the assigned personnel on 3/18, 3/19, 3/20, 3/21, or 3/22/2014.

The Director of Food Services acknowledged the above. She was not able to explain why the assignments were not completed for multiple days at a time.

An interview was conducted on 3/25/2014 with the Director of Infection Control. She reported that infection control and safety rounds were conducted in the Kitchen on a yearly basis. She reported she had not been made aware of the above areas of concern in the kitchen prior to the survey.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review, and staff interview, it was determined the facility failed to ensure staff:

I. report a medication error.

II. complete the follow-up of 10 of 20 adverse events reviewed to prevent a re-occurrence.

Findings include:

The facility policy for the Event Reporting Process included: "Purpose: The event reporting process supports TMC's approach to patient safety and performance improvement and provides TMC the following: a. Data related to the nature and frequency of unusual occurrences, so that additional review, analysis, and steps to improve key processes may be taken to prevent recurrence....Any unusual occurrence involving a TMC patient, visitor, or volunteer, should be reported through an electronic quality alert report. Definitions: Patient Safety Event: Any event or circumstance that is not inkeeping with the routine, normal operations of TMC, or routine patient care which results in a loss or damage to property, or personal injury. Occurrences such as patient falls or improper administration of medications may be considered Patient Safety Events even if there is no permanent effect on the patient. Examples include but are not limited to, medication errors, adverse drug events, falls, errors involving treatment or procedures Patient Safety Events include any process variation that does not actually injure a patient but for which a recurrence carries a significant chance of a serious adverse outcome...Roles and Responsibility: Leadership Staff: Each director or manager will ensure the employees and supervisors have been instructed in the use of the Quality Alert System. In addition, each director or manager will complete and validate follow-up, with closure within thirty (30) business days of the reported event...Organizational leadership will support a culture of safety that views Patient Safety Events as potential 'systems' or 'process failures' rather than 'people failures'."

I.
Patient #9 was admitted to the facility on [DATE], for a Tonsillectomy and Adenoidectomy on 03/19/2014. Patient #9 was in the Pediatric Critical Care Unit (PCCU) due to Obstructive Sleep Apnea (OSA) and Hypertension. Review of Patient #9's Medical Administration Record (MAR) revealed the patient received Lortab Elixir for pain every 4 hours instead of every 6 hours as ordered by the physician. Patient #9 received Lortab Elixir 5 milliliters (ml) at 20:32 P.M. on 03/19/14, and then again at 00:18 A.M. on 09/20/14.

A phone interview conducted on 03/21/14, at 08:45 A.M., with the RN administering the medication, revealed she had realized the medication was given too soon when the patient's mother asked if the medication wasn't every 6 hours. The RN notified her Charge Nurse but did not fill out a medication error report or notify the physician. Patient #9 was on Bi-Pap for OSA and the RN monitored the patient's vitals without observing any decrease in oxygen saturation.

II.
Adverse Event (AE) Reports reviewed:
1. Intravenous Nitroglycerin was given in the Emergency Department (ED) on 03/03/14, and patient was allergic. The physician dc' d the medication at 1723 but the patient was sent to the 900 Unit with the medication still infusing at 1900. The patient had told the ED staff he was allergic. The report did not include the patient's allergic reaction to the medication or why it had been started at all with the patient being allergic. The Assistant ED Manager acknowledged the AE needed to be investigated with follow-up before it had been closed.

2. The anesthesiologist was administering Propofol in the Main Operating Room (OR) on 12/20/13, and saw that it was discolored. He discontinued the medication immediately and sent it to the pharmacy manager for analysis. The mother was informed and asked to monitor the patient. The report was closed without including the analysis of the Propofol or the mother's information after monitoring the child.

3. A patient left the adult medical telemetry unit Against Medical Advice (AMA) on 01/03/14. The AE revealed the Medical Social Worker and the RN attempted to resolve the patient's concerns but the patient left anyway. The closed report did not document what the concerns of the patient were or if the patient signed the AMA form. The Patient Safety Co-ordinator verified the staff could not learn to prevent a recurrence if the AE did not include the issues.

4. A patient on the Women's Care Unit was unresponsive after receiving Morphine PCA (Patient Controlled Analgesia) on 01/04/14. The Rapid Response Team was called and administered Narcan with positive results and the Morphine was decreased. The AE was still "open" after 30 days without the follow-up being completed.

5. The Main OR was opening an Advanced Laparoscopic tray on 06/04/13, and found the poole suction tip, which consists of two pieces screwed together during decontamination and sterilization. This prevented the inner portion of the suction from being properly sterilized. The tray was not used but returned to Central Sterile Processing (CSP). The AE was closed and follow-up revealed the Manager of CSP did not have proper documentation so he could not identify the staff member responsible to investigate the cause.

6. A patient on the Mother Baby Unit on 02/03/14, was sent home with another patient's prescriptions. The RN called the patient to have her tear them up in little pieces. The AE was closed without investigation for the cause or follow-up for prevention of a recurrence.

7. A patient in the Main OR had surgery for a Right hip displacement on 01/04/14, and had 2 new wounds on the Right buttocks after surgery. The AE was closed and sent to the Ortho OR manager since it had occurred in the 3rd floor OR. No AE was found by the Ortho OR Manager; no investigation or follow-up was done.

8. There was auto verification of a Warfarin order on 01/10/14. The cardiologist prescribed Warfarin 10mg daily and 5 mg daily. The patient confirmed he took 10 mg on M/W/Th/F/Su and 5 mg on T/Sa. The order was corrected prior to receiving the first dose and the patient did not receive the double dose. The Unit Manager was unsure how the auto verification occurs and included: "huge problem that prior warfarin orders were auto-verified without going through pharmacy verification." Follow-up included physician peer review but no information from the pharmacy on auto-verification.

9. Pharmacist verified an order for Warfarin before getting a recent INR on 11/11/13. A new Pharmacy policy directs getting an INR within 24 hours before verifying the order. The INR reached 8.58 (therapeutic range 2.0 - 3.0) on 11/15/13, while the patient was taking 10 mg daily. The AE report revealed the physician was sent to peer review. Follow-up did not include the pharmacy issue.

10. Pharmacist should have ordered a baseline INR before verifying warfarin on 01/22/14. The RN ordered the baseline INR as well as a Daily INR. The AE was closed on 03/14/2014, with a note: "follow-up completed with pharmacist involved. No harm to patient." No information was given for investigation, findings or the plan of action with the pharmacist.

The Patient Safety Co-ordinator verified in an interview conducted on 03/25/14, the Adverse Events had not been completed with investigations and follow-up before being closed.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on direct observation, review of hospital policy/procedure and interview, it was determined that the hospital failed to ensure:

1. The pediatric emergency "code" cart located in the hospital's outpatient "GI Lab" (Gastrointestinal Procedure Lab) be maintained with pediatric defibrillator pads required for intervention during a pediatric cardiac arrest.

2. Expired reagents were removed from current supply storage.

3. Glucometer controls were replaced when opened for 90 days.

Findings include:

1.
Direct observation of the GI Lab conducted on 3/20/14, revealed a Pediatric Broselow Cart and a Blue Metro Lifeline Adult Cart. A defibrillator was located on the Adult Cart with defibrillator pads enclosed in a pouch labeled "Adult". The Pediatric Cart also contained Adult defibrillator pads in the bottom drawer. Neither the Manager of the GI Lab nor the Director of the GI Lab were able to locate pediatric defibrillator pads for use in an emergency.

Review of hospital policy/procedure titled Defibrillators and Code Cart Monitoring and Maintenance of Supplies revealed: "...Purpose...to ensure that all resuscitation equipment is stocked as indicated by code cart contents list, is in working order, and in the proper place...Defibrillator...Cable is attached to multi-purpose defibrillator pads...."

The Manager of the GI Lab confirmed on 3/20/14, that small children and infants receive services in the GI Lab and receive general anesthesia during procedures performed in the lab. Both the Manager and the Director confirmed that pediatric defibrillator pads are required to be stocked in the pediatric emergency cart. They also confirmed that the pediatric cart did not contain a cart contents list.

2.
Observation of Respiratory Services conducted on 03/21/14, accompanied by the Director of Respiratory Services revealed 11 - 475 milliliter bottles of Chloridometer Acid Reagent in the supply shelving unit that had expired. 9 bottles had expired in August/2013, and 2 bottles had expired in September, 2012.

Manufacturer's specifications include: "The Digital Chloridometer is a coulometric titrator designed to determine chloride ion concentrations in clinical samples such as sweat, urine, serum and biological extracts... used in the diagnosis of [DIAGNOSES REDACTED]"

The Manager of Respiratory Services acknowledged the reagent bottles had expired and should have been removed from the supply racks.

3.
TMC Laboratory Procedure: Whole Glucose Using the Accu-Chek Inform II includes: "...Quality Control. Quality Control (QC) testing is performed as a primary means of ensuring on-going proper performance of the Accu-Chek Inform II System. Only certified operators are allowed to do quality control and patient testing...*Accu-Chek Inform II Control and linearity solutions expire on the date printed on the label or 3 months from opening, whichever comes first. Whenever an operator opens a vial of controls or linearity solutions, he/she must handwrite the expiration date and his/her initials on the vial...."

Observation during a tour of the Orthopedic Unit (4000) conducted on 03/19/2014, revealed 2 Accu-Chek glucometer's in each of the nursing stations; 4 glucometers. Control Level 1 (Low) and Control level 2 (High) solutions had all been opened on 11-26-13.

The Clinical Nurse Leader (CNL) for Unit 4000 verified the control solutions were only used for 3 months after opening. She acknowledged the 4 sets of controls should have been replaced in February.