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Based on observation, interview and record review the hospital's infection control program failed to conduct adequate monitoring of expired surgical items in the surgical area, cleansing agents in other patient care related areas and infection control staff practices such Foley catheter use and care as evidenced by the following:

1. The lack of a system and policy and procedure to monitor the shelf life of sterilized surgical items and removal of expired items from the supply rooms within the surgical suites.

2. The use of an an expired enzymatic soap to initially wash the endoscopes processed in the gastrointestinal scope room. .

3. The lack of monitoring system to ensure at least 15 air exchanges per hour in the operating rooms and other areas in the surgical suite are maintained as recommended by AORN ( Association of Perioperative Registered Nurses, the nationally recognized organization for perioperative [all areas of the surgical suite] standards.)

4. Five surgical personnel did not observe the policy and procedure to completely cover the hair and jewelries with a surgical cap during the surgery of Patient 30.

5. In the central processing room where the TEE scopes were cleaned and disinfected, there were 20 expired soap sponges (the only supply left) to initially clean the scopes as part of the cleaning and disinfection process. (Trans-Esophageal Echocardiogram is a type of test in which an ultrasound on a thin tube is guided down the patient's throat into the esophagus or food tube and provides a close look at the heart without interference from the ribs or lungs.)

6. One of the central processing technicians walked into the semi-restricted area, where instruments were packaged and sterilized, without surgical attire. (Semi-restricted areas are the peripheral support areas of the surgical suite including the central processing area.)

7. The lack of a system, policy and procedure to monitor the shelf life and removal of expired items in the Definitive Observation Unit/Telemetry and Same Day Surgery.

8. The use of an expired abrasive cleaner found in the cart of an Environmental Services staff in the Emergency Department (ED).

9. The placement of a disinfected glucometer on a contaminated surface in the Definitive Observation Unit/Telemetry Unit (telemetry). The staff used a glucometer on Patient 21, suspected of having C-Diff (Clostridium Difficile is a spore forming organism that causes antibiotic-associated diarrhea and is highly contagious in a health-care setting. C-Diff is mainly spread to other patients by contact.).

10. In the telemetry unit, Patient 10's Foley catheter collection bag rested on the floor.

11. Patient 11 had a Foley order without an indication for use and physician's order and no documentation of an indication.

The cumulative effects of these systemic problems resulted in the inability of the hospital's infection control program to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases in accordance with the Condition of Participation for Infection Control.

Based on observations, interviews and record review the Infection Control Nurse failed to develop an active surveillance system to monitor and evaluate practices of asepsis (the exclusion of bacteria and other microorganisms, typically during surgery) in different areas of the surgery service, emergency room and other patient care units. This failure resulted in the storage and use of expired items in the surgical areas and emergency room, inadequate air exchanges in the operating rooms and inadequate disinfection of patient care equipment, care and indication for the use of a Foley catheter. The failure could potentially placed the patient population at risk for hospital acquired infections.
Findings:
1. During on observation on 6/9/15 at 11 a.m. in OR # 1 (an operating room), Surg Tech 1, a surgical technician, opened surgical supplies including a package of six 1/2 by 4 inches Steri-Strips (a paper thin adhesive used to secure a surgical wound) unto a surgical table. Inspection of the outer packaging of the Steri- Strips showed a symbol of an hour glass an expiration symbol established by the Federal Drug Administration) and expiration date of 10/24.
In an interview on 6/9/15 at the time of observation. Director 1, the Director of Surgical Services, instructed the staff to replace the supplies that came in contact with the expired Steri-Strips on the surgical table. Director 1 said the expired Steri-Strips came from the OR supply room and not from cabinets of OR 1. A cabinet inspected in OR 1 stored additional Steri-Strips: six 1/2 by 4 inches expired on 10/2014 and six 1/8 by 3 inches expired on 6/2010.
Director 1 said she would check the supply room immediately for expired Steri-Strips. At 11:20 a.m., Director 1 said she found and disposed a few outdated Steri-Strip packets in the supply room. Director 1 said, whoever pulled the supplies for the surgical case and Surg Tech 1 should have checked the expiration date of each package more closely.
At 12:15 p.m. to 12:40 p.m., during observations and interviews in the OR supply room, while accompanied by Director 1, the following packaged supplies were outdated:
a) a sterile drape expired 4/2015; a box of, 50, size eight latex surgical gloves, expired 2/2014;
b) three Alexis Wound Retractors (separates the edges of a wound and holds back tissues,) expired 12/2014;
c) five 4.8 mm Reloadable Staplers, three expired 3/2014 and two expired 5/2014;
d) twenty individually packaged, double 3-way stopcocks expired 5/2014; and,
e) one Epidural Catheterization Kit (to access epidural space just outside the membrane that surrounds the spinal cord in order to deliver medication or anesthetic agents) in the bottom compartment of the spinal cart expired 2/2015. The kit contents included 16 items: medications, a 3.5 inch epidural needle, a thirty inch catheter or threading assist device.
During concurrent interview, Director 1 said, no specific surgical staff had responsibility for checking the supply room for expired or nearly expired items. Director 1 said it's a "chore assignment" meaning it was listed on the OR assignment sheet. The registered nurse (RN) responsible for circulating during surgeries was also assigned to check supplies during her "free time." The next day, the assignment to check supplies may go to another person. Director 1 said she didn't have a policy and procedure for checking for expiration dates and for rotating supplies but the expectation was that there was a monthly check of all supplies with removal of expired items. Director 1 presented a bright green sticker, "Expiration Date" with a line for the date. She said whoever checks the room should place the sticker on items about to expire within a month.
By observation and as confirmed by Director 1, there were no stickers noted on any of the above listed expired items. There was no evidence of a process to rotate the supplies during storage. Director 1 said some supplies have no expiration dates and were checked for integrity of the package only " ...but if the company places an expiration date then we have to throw away any expired item. End of discussion. Some of the items which expired probably were not used in years but that's no excuse, they should've have been thrown away ...You will find expired items here [supply room] but the bottom line is prior to placing on the sterile field there should be a final check ... "

During an interview at 12:40 p.m., the surgical Material Coordinator said there was "no dedicated person to check supplies." Material Coordinator said that a contracted company comes in once a year to check supplies. "They should have discarded the 2014's when they checked." Director 1 said that the contract company checked which stocked items were low and didn't check for expiration dates. Director 1 said that the Material Coordinator and she would do a thorough check of the supply room, the carts, and the OR rooms on 6/9/15 and discard any expired items.

Director 1 said she advertised for a Perioperative Nurse Coordinator starting in 1/2015 but no qualified nurse applied yet. Director 1 said the Nurse Coordinator was the one who usually checked supplies for expiration dates. Director 1 said she brought the issue of lack of success in finding a qualified candidate for the Nurse Coordinator position to the Nursing Quality meeting but did not specifically discuss the issue of inability to check supplies consistently.

On 6/9/15 at 3:15 p.m., Director 1 said she had a discussion with the Administrator about training ancillary staff to check supplies. Director 1 "...realized that nurses can't do the supply check as an extra assignment and do a good job."

On 6/10/12, review of the job descriptions of the Material Coordinator and the Nurse Coordinator did not have any provision of a specific staff's responsibility to rotate and check supplies for expiration dates.

During an interview at 1:50 p.m. on 6/11/15, the Infection Control Nurse (ICN) said she did actual spot checks of supplies for expiration during Environment of Care Rounds. ICN said she relied on the information she received from Director 1 that supplies were checked monthly by surgical staff. The ICN didn't know there was no dedicated staff assigned to check supplies.

2. During an observation on 6/10 /15 at 12 p.m., in the gastro-intestinal scope room, Surg 2 brought in a colonoscope (a scope used during a colonoscopy to examine the colon ) from the operating room (OR) to clean and disinfect. Surg Tech 2 poured two ounces of Valsure Enzymatic Cleaner (soap) from a 3.87 liter container which had approximately one/third of the cleaner remaining) to the sink and and added two gallons of water. Surg Tech 2 used a sponge to scrub the colonoscope soaking in the enzymatic cleaner. Observers stood at a safe splash distance. Surg Tech 2 was asked to read off the expiration date on the container of the enzymatic soap. Surg Tech 2 read the expiration date as 11/2014 and said said most soaps didn't have an expiration date and was surprised the said container had one. Surg Tech 2 said he had used the same container of the Valsure Enzymatic Cleaner on other endoscopes.

During a phone interview at on 6/10 /15 at 2:10 p.m., the Valsure Company Representative said the enzymatic cleaner was used to break down the bio-burden (blood and other body fluids) on scopes. After the expiration date the enzymes lose their effectiveness in breaking down organic material (blood, mucous, and other body fluids.)

3. In an interview on n 6/10/15 at 11:15 a.m., during an interview, Director 1 said, she was not sure how many air exchanges per hour occurred in the five operating rooms. Director 1 said the Engineering Department performed the monitoring of air exchanges. On 6/12/15 at 9:30 a.m.., the Chief of Engineering said he was hired two months ago and had no record of air exchange monitoring in the five operating rooms. The Chief of Engineering said that was something on his agenda to work on--an automation system to monitor air exchanges. He presented a document showing that 15 air exchanges per hour was the standard for operating rooms. (Table 1 Ventilation Requirements for Ambulatory Surgical Centers) At 9:45 a.m., Engineer 2 said he performed spot checks of the air exchanges in the operating rooms. Engineer 2 said he used a hood method over the air vent and said that last month there were 12.5 exchanges per hour. Engineer 2 didn't document the results. At 11:45 a.m., during observations in OR rooms 4 and 5, Engineer 2 checked air exchanges using the hood method. The results showed that the rooms had 10.1 and 10.3 air exchanges per hour respectively. The other OR rooms were in use and the Chief Engineer said he would check the rooms later that evening.

On 6/12/15 at 10:35 a.m., ICN said she was always assured that Engineering monitored air exchanges and it was never an issue brought to the Infection Control Committee Meeting.

On 6/15/15, via e-mail, the Chief Engineer sent a document showing that the air exchanges in the five rooms ranged from 10.7 to 13.1.

(The air exchanges per hour in a restricted area [operating rooms and invasive procedural rooms] should be maintained at 20 total changes per hour, with a minimum of five air changes of outdoor air per hour. Studies show that the higher the air exchanges per hour the less microbial contamination in the OR. AORN 2015.)

4. On 6/9/15 at 11 a.m. to 12:15 p.m., during an observation of a surgical procedure on Patient 30 in OR 1, five personnel did not follow the policy and procedure to cover all head and facial hair. Two nurses, (RN's 3 and 4) and one surgical tech (Surgi Tech 1) had hand-made caps covered by a hospital supplied bouffant cap. The hand-made caps had crept up resulting in hair hanging below both caps in the back along the nape of the neck. A Physician Assistant (PA 1,) assisting the surgeon with the surgical procedure, had a few long wisps of hair hanging below the cap in the back and one 4-5 inch wisp hanging below the cap on the left side of face. PA 1 had stud earrings on not covered by the bouffant cap. Surg Tech 2, who relieved Surgical Tech 1, wore a skull cap, non-bouffant style, which tied in the back and was close-fitting to scalp, but left Surg Tech 2's sideburns and back hair-line uncovered.

On 6/10/15 at 11:15 a.m., during an interview, the Director 1 said all hair must be covered. There are special "hood cover" caps for sideburns. Director 1 said she can enforce the dress code for employees but not for non-employees (PA 1.) Director 1 said she would talk with the employees and PA 1 to reinforce the expectation that all hair and jewelry be covered in the OR rooms.

On 6/10/15, review of the policy and procedure, Surgical Attire, approved on 5/8/13 and "...based on AORN Standards..." showed the following instruction: "...All personnel should cover head and facial hair..."

5. On 6/10/15 at 10:30 a.m., during an interview, Director 1 said the Administrative Director of the Laboratory and Cardiology Departments (Director 2) was responsible for disinfection of TEE scopes in the central processing area. At 2:25 p.m., during an observation and concurrent interview, in a small room adjacent to the central processing department, there was a small plastic tub containing Cidex OPA, a disinfectant, on the sink countertop. Director 2 said that after using an enzymatic soap sponge to dissolve mucous and other body fluids, the TEE scope would be placed in the Cidex OPA for disinfecting. The sponges were on the shelf under the counter individually packaged. The entire supply of sponges (approximately 20 in a box) had an expiration date of 4/2014. Director 2 pulled the box of sponges from the shelf and said she would get rid of them. Director 2 said because TEE's weren't used often could be a reason the sponges expired. Director 2 said the technician who cleaned the TEE's should check supplies. Director 2 also said she would have to ensure that someone checked the supplies when delivered so that there weren't nearly expired sponges.

6. On 6/9/2015 at 9 a.m., accompanied by the ICN, during a tour and observation of sterile processing, Central Processing Technician (CPT) 1, while wearing non-hospital provided scrubs, crossed the semi-restricted storage area, opened the door and entered the semi-restricted sterile processing room without donning surgical attire. During a concurrent interview, the ICN said there should be red tape at the doorway entrance to the central processing area. (Semi-restricted areas are the peripheral support areas of the surgical suite which includes the sterilization central processing room. Restricted area refers to the operating rooms or other rooms where invasive procedures are performed. Personnel in semi-restricted and restricted areas should wear surgical attire and cover all head and facial hair. AORN 2015.)
On 6/9/2015 at 9:10 a.m., CPT 2 was observed wearing a surgical gown and stated that gowns were required while in the central supply area and that a gown and hair covering should be worn in the sterile processing room. CPT 2 pointed to a striped yellow line on the floor which marked the beginning of the semi-restricted storage area.
On 6/10/15 at 12:25 p.m., Director 1 said that CPT 1 definitely should have dressed in surgical attire in the central processing area; once the yellow-taped line was crossed. The staff should also wear a mask when processing surgical instruments. Director 1 said the CPT's should observe the same dress code ass if they were in the OR suite, despite the central processing area being a floor below the surgical area.
A review of the policy and procedure titled "Surgical Attire," approved 5/8/13, revealed that "...all individuals who enter the semi-restricted and restricted areas should wear... attire provided by the facility and intended for use within the perioperative setting...All personnel should cover head and facial hair when in the semi-restricted and restricted areas..."
7. On 6/11/15 at 1:50 p.m., during an observation of the Same Day Surgery supply cart while accompanied by the Charge Nurse (CN 3), there were six outdated secondary intravenous tubing sets: five had a use-by date of 2/2015 and one set had 4/2014. CN 3 said "We get to it [checking the supplies] as we have time. No specific person is assigned."
8. On 6/11/15 at 2:10 p.m., in the Definitive Observation Unit (a patient nursing care unit designated for continuous heart rhythm monitoring) the following expired items were observed in the supply cart: one Central Venous Catheterization Kit, expired 5/2015. (The kit contained 21 items including a catheter to thread into or near the heart, needles, medications and dressings); seven blood infusion tubing sets: one with a use-by date of 5/2013, and six with a use-by date of 5/2015; one Infusion System (for use with intravenous Nitroglycerin, a heart medication,) with a use-by date of 4/2015. CN 4 said she checked for expired materials only at the time of delivery of supplies.
9. On 6/10/15 at 2:40 p.m., during an observation and interview in the Emergency Department (ED) while accompanied by the Nurse Manager of the ED, Environmental Service Staff (EVS 1) worked the day shift, 7 a.m. to 3:30 p.m. EVS 1 presented the cleaning solutions on the cleaning cart that she had used during the day. A quart-sized bottle of Spartan Spar Crème abrasive cleaner had an expiration date of 11/26/14. EVS 1 did not know the cleaner had expired. At 2:50 p.m., the EVS Lead could not say who checked solutions for expiration dates.





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10. Review of the clinical record showed the hospital admitted Patient 10 on 6/13/15 through the Emergency Department (ED) to the telemetry unit with abdominal pain and found to have a stone in the right ureter (tube that connects the kidney and bladder). On 6/4/15, Patient 10 had a cystoscopy (to examine the urinary bladder and urethra (tube that carries urine from bladder to the outside of the body). During the procedure the physician placed a stent in the right ureter to filter sediments and prevent stone formation . The physician inserted a Foley catheter's sterile flexible to drain urine from the urinary bladder to a collection bag.
During an initial tour of the telemetry unit with the Clinical Nurse Leader (CNL), on 6/9/15 at 9:05 a.m., Patient 10 was in bed with his Foley catheter's drainage bag touching and resting on the floor. CNL said, it is the "hospital's requirement" that urine collection bags should have at least "a foot's" clearance from the floor.

During an interview on 6/11/15 at 2:30 p.m., the hospital's Infection Control Nurse (ICN) stated that if the urine collection bag rested on the floor there was the potential that "germs will crawl up" into the bag. In addition when the patient "fiddles" (taking the bag from where it was hanging) the outlet tube will touch the unclean floor and contaminate the system.

The hospital's policy and procedure entitled Catheter Associated Urinary Tract Infection (CAUTI) dated 09/2012, Procedure (3, b, ii) indicated, "Keep the collecting bag below the level of the bladder at all times. Do not rest the bag on the floor."

11. Review of the ER clinical records indicated the hospital admitted Patient 11 to the ED on 6/8/15 with severe sepsis due to aspiration pneumonia (lung infection) and a possible urinary tract infection. In the ED, RN 2 inserted a Foley catheter at 2:53 p.m. Further review of the emergency records did not show a physician's order and indication for the use of the Foley catheter..

The hospital form entitled, Sepsis management protocol and printed physician orders, number III, C had the following instruction: "Begin hourly urine collection (may insert Foley catheter with urimeter if patient unable to void)". The physician's order form was without the physician's signature. The Nursing Physical Assessment of Genito-urinary System did not indicate that the patient was "unable to void."

CNL stated, for patients with Foley catheters, the night shift nurses will place "24° Foley Alert" stickers in the physician's order. Stickers had small prompt boxes meant for physicians to check to continue/discontinue and "MUST indicate rationale" for the use of Foley catheters. Day shift nurses responsibility was to follow up with the physicians.

Review of the physician's order for Patient 11, the "24° Foley Alert" sticker dated 6/9/15, the box was not checked to continue or discontinue the Foley catheter. The "24° Foley Alert" sticker dated 6/10/15 was without a physician's signature. There was no evidence that the day shift nurses followed-up to alert Patient 11's physician to continue or discontinue the Foley catheter.

During an interview on 6/11/15 at 2:30 p.m., the ICN stated it's a "no, no, no" that tube ( Foley catheter) can be inserted in a patient's cavity without any indication and without a physician's order.


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12. On 6/9/15 at 11:36 a.m., as observed with Clinical Leader Nurse Educator (Nurse Educator) in the Defined Observation Unit (Telemetry Unit,) a Registered Nurse (RN1) holding a glucometer, said that she was going to do a finger stick blood sugar check on Patient 21. RN 1 said Patient 21 was in contact isolation with a rule out C. Difficile infection. C. Difficile is an infection easily transmitted by contact between patient and health care providers.

Surveyor and RN 1 took and wore gown and gloves from the supply table just outside Patient 21's room and entered the patient's room. In the room, RN 1 placed the glucometer (blood sugar check machine) on the patient's bed. RN 1 checked Patient 21's blood sugar and placed the glucometer on top of the supply table outside the patient's room. RN 1 took off her gloves and gowns, and sanitized her hands with the hand sanitizer. RN 1 sanitized the glucometer with bleach wipes, and put the glucometer back on top of the supply table without disinfecting the top of the supply table. When asked about the process, RN 1 said she should have sanitized the contaminated table first before putting the sanitized glucometer on it.

On 6/9/15 at 12:03 p.m., the Nurse Educator said that the glucometer was considered contaminated, even if there was no visible stool contamination, when the glucometer was placed on a patient's bed in a contact isolation room for C. Difficile.

In a staff interview on 6/10/15 at 8:40 a.m., ICN said that the glucometer was considered contaminated, when it was within the room of a patient on contact precautions. ICN said that the glucometer should have been sanitized immediately after it was used in the room before contact with any equipment outside the patient's room..

On 6/10/15 at 2:20 p.m., mutual review with the Nurse Educator, of the Bedside Capillary Blood Glucose Monitoring Policy and Procedure, revised on: 10/14, showed that a glucometer needed to be cleaned/disinfected after each patient use. The Nurse Educator said that contaminated items should be separated from clean items.