HospitalInspections.org

Based on observations, review of documentation, and interviews with staff, the governing body failed to ensure that the medical staff rules and regulations were implemented and enforced for 1 of 1 patient observed in the operating room, as an anesthesiologist was observed recapping a needle during a procedure.

Findings were:

Patient #100 was observed during a surgical procedure on 7/17/2013 in Operating Room #3 on the Women and Infant Specialty Health (WISH) unit. At 10:02 am during the procedure, the supervising anesthesiologist, Staff # 134, was observed injecting a portion of medication into the IV bag port, then recapping the needled syringe using both hands.

Facility policy entitled DISPOSAL OF USED NEEDLES AND SHARPS, last revised and approved in October 2012, states under the section PROCEDURE, that " To prevent needle stick injuries, needles should not be recapped ..... If necessary, a one handed scoop method will be utilized. "

The Medical Staff Rules and Regulations, last approved 4/22/13, state in Section 1:1 that "All physician members are expected to participate in providing a safe care environment ...and to adhere to all hospital policies and procedures, including but not limited to, following safe practices such as ...universal protocol in the Operating Room .... "

An in-person interview was conducted with Staff #133, the associate unit manager of the WISH unit, at 11:35 am on 7/17/13. Staff #133 indicated that the anesthesiologist recapping a needle using both hands violated facility policy and procedure.

Based on review of documentation and interviews with facility staff, the facility failed to obtain written informed consent using a consent form fully translated in the patient's preferred language in 3 of 10 patient records reviewed of patients involved in research studies. This was in violation of facility policy and potentially could have resulted in the patients not being fully informed regarding participation in the research study.

The findings were:

The facility policy entitled "Human Research Subject Protection and Research Consent" Policy # Admin 13-01 with a review date 5/13 was reviewed on 6/18/13 and reflected in part "Informed Consent: 3. The information that is given to the subject or representative shall be in a language understandable to the subject or representative."

The medical records of the following patients were reviewed on 6/18/13.

1. The medical record of patient # 45 Patient Information page reflected in part "In what language do you prefer to discuss your health care? 4/17/13 1315 Spanish." The record of patient # 45 also contained a form entitled "Consentimento para Participar en una Investigacion" signed by patient # 45 on 5/17/13 which was in Spanish with the exception of "Title of Research: A Phase I/II Study of Bavituximab and Sorafenib in Patients with Advanced Hepatocellular Carcinoma."

2. The medical record of patient # 26 Patient Information page reflected in part "In what language do you prefer to discuss your health care? 1/22/13 0600 Spanish." The record of patient # 26 also contained a form entitled "Autorizacion para Utilizar y Revelar Informacion sobre el Estado de Salud para Fines de Investigacion" signed by patient # 26 on 11/20/12 which was in Spanish with the exception of "An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Ramucirumab (IMC 1121B) Drug Product or IMC 18F1 in Combination With Capecitabine or Capecitabine Monotherapy, in Unresectable, Locally Advanced or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy."

3. The medical record of patient # 58 reflected in part "In what language do you prefer to discuss your health care? 1/24/13 0753 Spanish." The record of patient # 58 also contained a form entitled "Consentimento para Participar en una Investigacion" signed by patient # 58 on 1/18/13 which was in Spanish with the exception of "OVA1 Post Marketing Surveillance Study PS110001."

The above findings were confirmed in an in-person interview held in a Pharmacy Department office with staff # 96 on 6/18/13 at 9:30 am.

Based on a review of documentation and interviews it was determined that the facility failed to ensure that opportunities for improvement and change were identified for incorporation into the overall hospital wide QAPI program and specifically into the Radiology Performance Improvement program.
Findings were:
The facility failed to incorporate into the Radiology department QAPI program, data regarding stat CT and X-ray wait times for patients who had Radiology tests ordered. Review of the medical records of 3 of 3 ICU (intensive care unit) patients, patients#4, #46, and #47 revealed that these patients had STAT (as soon as possible) physician orders for radiological studies that were not performed according to the physician orders. Patient #46 had an order for a chest X-ray, STAT, written at 14:33 on 6/17/13. This order was not fulfilled until 9 hours later, 6/18/13 at 4 am. Patient #47 had an order for a CT scan of the chest written 6/18/13 at 16:45; this STAT order was fulfilled 9 hours later, on 6/19/13 at 02:00. Patient #4 had an order for a STAT CT scan of the chest written 6/17/13 at 21:39; this order was fulfilled 24 hours later, on 6/18/13 at 21:42.
In an interview conducted on 6/20/2013 at approximately 8:30 am with the Director of Radiology it was revealed that his interpretation of a "stat" order was defined as soon as possible or within one hour. The Director also acknowledged in the same interview that the Radiology department does not have a policy regarding "Stat" orders. It was further acknowledged that the Radiology department QAPI binder did not contain quality indicators pertaining to Stat inpatient radiology order turnaround time.
In an interview with the Chief Medical Officer on 6/20/2013 at approximately 11:45 the survey team was told that there was no institution wide definition of the word STAT.
According to an interview with the Vice President of HIM (Health Information Management) the surveyors were told there was not a hospital wide approved abbreviation list and instead Parkland Hospital used a book entitled: "Medical Abbreviations: 32,000 Conveniences at the Expense of Communication and Safety" 15th edition. On page 309 of this book the abbreviation STAT is defined as "immediately (or as defined by the institution)."
Record review of a document titled "Quality Assessment and Performance Improvement Program" dated 3/27/13 stated "Purpose: The Quality Assessment and Performance Improvement (QAPI) Program promotes the mission of Parkland Health and Hospital System by maintaining and implementing an ongoing enterprise-wide, data-driven program designed to increase patient safety and continually improve the quality of care provided with the organization. As part of its QAPI Program, Parkland will conduct performance improvement projects. The QAPI Program uses a quantitative prioritization matrix to select and recommend performance improvement activities that a) focus on high-risk, high volume, or problem prone areas; and c) affect heat outcomes, patient safety and quality of care ..."

Based on observations, interviews, and records review, the facility's Infection Control Officer did not ensure implementation of infection control practices in 2 of 5 areas during a tour on 07/17/13 and 07/18/13, citing:

(A) During a tour of the Dietary Department on 7/18/2013, beginning at 8:20 AM, the Infection Preventionist failed to identify areas where infection and cross-contamination could occur.

(B) 1 of 1 anesthesia technician (Personnel #137) did not perform appropriate hand hygiene after taking off her soiled gloves, and did not appropriately sanitize the anesthesia cart in the Labor and Delivery West (L&D) operating room (OR) #3.


Findings included:

(A) The facility's Infection Preventionist led a tour of the Dietary Department on 7/18/2013 beginning at 8:20 AM. In interview, the preventionist related that it currently takes about one hour to do the daily inspection of the dietary department including the food preparation area, freezers, refrigerators, loading docks, serving line, dishwashers, and pan cleaning area.

In the walk-in meat freezer, the infection preventionist failed to identify two boxes of frozen cod where the frozen product was unsealed and directly exposed to the freezer air. The dietary manager disposed of the product after the survey staff indicated this exposure.

In the food preparation room, a cart of white vegetables was parked next to a sink. On the bottom shelf of the cart were several stalks of celery, some of which were exposed outside of the plastic cling wrap, exposed to the room air. The exposed celery was immediately next to a bucket of disinfection fluid in a red square bucket. The survey staff found it necessary to point this out to the infection preventionist as it had not been observed by any of the staff present. When the bucket was moved, or if the cart came in contact with the bucket, the fluid contents could easily has spilled unto the food products.

In an area used for food preparation, a container of cleaned serving instruments was wrapped in plastic cling wrap ready and available for immediate use. The ladles within this wrapped container were stored inappropriately with the bowl side up. This also was unobserved by the infection preventionist until indicated by the survey staff.

In a storage area numerous muffin pans were stored on an upper shelf, some stacked together and wrapped with cling wrap. These pans were alleged to be clean and ready for use. On direct examination, three of the tins had food particles stuck to them, then stacked on top of other tins, thus increasing the potential for cross contamination of all the tins stored and ready for use. This was pointed out to the infection preventionist, who had not noticed this issue previously.

Also in the food preparation area, there was a stack of cookie trays found . Some of the trays were obviously new, some were the older-type with rolled edges. When one of the sheets with the rolled edges was held on its side, a clear liquid-waterlike poured from the side. The same happened with subsequent cookie sheets with the rolled sides. This has the potential for the growth of pseudomonas. The infection preventionist was not aware of this issue until it was indicated by the survey staff.

(B) On 07/17/13 at approximately 11:12 AM, Personnel #137 was cleaning OR #3 which was previously used by Patient #100. Personnel #137 was observed obtaining a disposable sanitizing cloth and disinfecting the base portion of the anesthesia cart. Then, using the same disposable sanitizing cloth, Personnel #137 sanitized the top portion of the anesthesia cart. At 11:19 AM, Personnel #137 took off her soiled gloves after sanitizing two (2) arm boards. Personnel #137 then proceeded to obtain two (2) pieces of clean blue cloths and wrapped these cloths around the two (2) arm boards. Personnel #137 did not perform hand hygiene after taking off her soiled gloves.

On 07/17/13 at approximately 11:35 AM, Personnel #133 was informed of the above findings. She confirmed the above findings. Personnel #133 stated the anesthesia technician should have disinfected the equipment from "clean to dirty" according to policy and procedure.

Policy: "L & D 18-05 Cleaning of Delivery Rooms/Operating Rooms" revised 03/2013 required "5. Used approved disinfectant to clean equipment, start with the cleanest items and work to the dirtiest."

Policy: Infection Prevention "Admin 7-21 Surgical Attire in Semi-Restricted and Restricted Areas" revised 05/2013 required VII Additional Protective Barriers...1...Perform hand hygiene after gloves are removed."