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Based on observation, interviews, and record review, the facility failed to ensure safe temperatures of the blanket warmer on the third floor when the temperature was 136 degrees Fahrenheit.

This failure had the potential to cause burns to patients' skin.

Findings:

On 4/9/18 at 9:27 a.m., during an observation and concurrent interview in the "Equipment Storage" on the third floor, Registered Nurse (RN) 5 stated the blanket warmer temperature was 136 degrees Fahrenheit. RN 5 stated the housekeeping department is responsible for monitoring the temperatures of the warmer. When housekeeping was called by the Interim Director of Medical/Surgical Services (IDMS), housekeeping staff stated they do not check the temperatures. IDMS stated she was informed that a risk assessment was completed and it was concluded that checking the temperatures is no longer required. The process is for the staff to "touch or feel" the blankets.

On 4/9/18 at 9:30 a.m., during an interview, RN 5 stated staff removing blankets from the warmer are expected to check the temperatures on the blanket warmer. She stated the importance of checking the temperature is, " ...The blanket can be too hot, patients have fragile skin, it can cause a burn."

On 4/10/18 at 8:56 a.m., during an interview, Certified Nursing Assistant (CNA) 1 stated she utilizes the blanket warmer to provide warm blankets for her patients. When CNA 1 was asked about her process when obtaining a warm blanket, she stated, "Go in there [blanket warmer] and just get it out of there." CNA 1 stated she does not check the temperature of the blanket warmer and is unable to verbalize the expected ranges. CNA 1 stated an outcome of the blanket warmer being above the normal range is, " ...That [blanket] would burn the skin."

The facility policy and procedure titled, "Warming of Patient Blankets and Bathing Cloths" dated 4/16, indicated, "Policy Summary/Intent: To ensure safe warming of blankets ...D. Directions: Blankets ...2. Blanket warming ...are checked visually for appropriate temperature less than or equal to 130 degrees Fahrenheit ..."

Based on observation, staff interview, and document review, the facility failed to store food in accordance with professional standards for food service safety when:

1. A nourishment refrigerator located on the third floor North side had an internal temperature of 46 degrees Fahrenheit (F).

2. A nourishment refrigerator located on the second floor North side had an internal temperature of 47 degrees (F).

3. A nourishment refrigerator located on the second floor South side had an internal temperature of 50 degrees (F).

These failures had the potential cause foodborne illness for all patients.

Findings:

1. On 4/9/18, at 9:52 a.m., during a concurrent observation and interview, on the third floor North side, Registered Nurse (RN) 5 stated the internal temperature was 46 degrees (F). RN 5 stated, "It's [temperature] out of range." RN 5 stated the refrigerator contained turkey sandwiches, milk, margarine, and pudding. RN 5 stated an outcome of the internal temperature being out of range is a potential for food poisoning or bacterial growth.

On 4/9/18, at 9:54 a.m., during an interview, the Manager of Nutrition Services (MNS) stated the expected internal range of the refrigerator is 32-40 degrees (F). The MNS stated the importance of the refrigerator being within range is the food is time sensitive and it is a risk for foodborne illnesses.

The facility policy and procedure titled, "Corporate Standard Policy: Food Storage" indicated, "Policy Summary/Intent: To ensure the hospital stored food and nutrition products ...temperature...D. Refrigerated Storage...1. All refrigerated or readily perishable foods or beverages shall be maintained at temperatures of 41 degrees F or below..."

2. On 4/9/18, at 10: 55 a.m., during a concurrent observation and interview, on the second floor North side, RN 6 stated the internal temperature of the nutrition refrigerator was 47 degrees (F). RN 6 stated the refrigerator contained 7 turkey sandwiches, pudding, margarine, and milk. RN 6 stated the outcome of having above normal range temperatures could spoil food and "can cause illness."

The facility policy and procedure titled, "Corporate Standard Policy: Food Storage" indicated, "Policy Summary/Intent: To ensure the hospital stored food and nutrition products...temperature...D. Refrigerated Storage...1. All refrigerated or readily perishable foods or beverages shall be maintained at temperatures of 41 degrees F or below..."

3. On 4/9/18, at 11:12 a.m., during a concurrent observation and interview, on the second floor South side, Registered Nurse (RN) 7 stated the internal temperature of the refrigerator was 50 degrees (F). RN 7 stated the refrigerator "must be 32-41" degrees (F) and the refrigerator was not in range. RN 7 stated the importance of keeping the internal temperature of refrigerator within range, "...To not have foods too hot, and to keep temperature in range for food not to spoil, and to not give food with bacteria to patients."

On 4/9/18, at 11:15 a.m., during a concurrent observation and interview, the Nutrition Services Supervisor (NSS) stated spoiled foods can cause "foodborne illness." The NSS stated her expectation is for the refrigerator to be within range. The NSS used a thermometer to take temperatures of the items inside the refrigerator. The internal temperatures of foods were as follows: Chocolate pudding 46 degrees (F), Vanilla pudding 44 degrees (F), Milk 44 degrees (F). The NSS placed the pudding and milk into the trash receptacle.

The facility document titled, "Refrigerator Temperature Log" indicated, "Refrigerator temperature must be between 32-41 degrees (F)..."

The facility policy and procedure titled, "Corporate Standard Policy: Food Storage" indicated, "Policy Summary/Intent: To ensure the hospital stored food and nutrition products...temperature...D. Refrigerated Storage...1. All refrigerated or readily perishable foods or beverages shall be maintained at temperatures of 41 degrees F or below..."

Based on interview, clinical and administrative document review, the hospital failed to provide surgical services in accordance with hospital policy and procedures and nationally recognized guidelines when a surgical device was left in Patient 1 during a surgical procedure. (Refer to A-0951)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide patient care in a safe manner.

Based on interview, clinical and administrative document review, the hospital failed to follow the Operating Room (OR) policy and procedure for Sponge,Sharps,and Instrument Counts when a FISH Glassman Visceral Retainer (FISH) (a disposable, oblong, rubbery device measuring 23.52 centimeters [cm] x 16.5 cm x 0.4 cm, with a 50 cm looped string attached to a 5.2 cm x 0.2 cm ring [tail] used to retain and shield tissue and organs during closure of the abdominal incision) was left in the surgical site of Patient 1 following a procedure on 12/6/17.

This failure resulted in Patient 1 returning to the OR for a second surgery on 12/29/17 with the FISH identified as the retained foreign object. This caused Patient 1 to require subsequent hospitalization and caused preventable pain, injury and harm to Patient 1.

Findings:

A review of Patient 1's Electronic Medical Record (EMR) was conducted. The Operative Report indicated Patient 1 was admitted to Hospital A on 12/6/17, for a Laparoscopic Ventral Herniorrhaphy with mesh (a technique to fix a an abdominal hernia [a bulge through an opening in the muscles on the abdomen]) by using small incisions and placing laparoscopes (small telescopes inserted into the abdomen) to view the hernia and apply a mesh patch to reinforce the abdominal wall, possible open (through an incision in the abdominal wall). The report indicated Surgeon 1 examined the hernia via the laparoscopes and the hernia defect was very large and unsuitable for laparoscopic repair so the decision was made to perform an open incision to repair the hernia using mesh. Documentation by Surgeon 1 indicated Patient 1 had no complications in the OR and the surgical counts (all instruments, sponges and additional items are counted and verified by the scrub tech (an allied health professional working as a part of the team delivering surgical care assisting doctor with maintaining surgical field and providing equipment requested by doctor to use during surgery) and RN to prevent items being left inside the patient) prior to closure of the incision were correct. Patient 1 was discharged on 12/11/17 with staples closing the incision and three Jackson-Pratt Drains (a closed-suction medical device used as a post-operative drain for collecting bodily fluids from surgical sites) in the incision.

On 12/19/17 Patient 1 was seen by Surgeon 1 for a follow-up appointment. The staples and three drains were removed and Patient 1 was told to follow-up in a month with him at the clinic.

On 12/25/17 Patient 1 presented to Hospital A's Emergency Room with complaints of odor to the incisional site, drainage and possible opening of the incision. The incision was cleaned and Patient 1 was given an antibiotic, told to follow-up with Surgeon 1, and sent home.

On 12/27/17 Patient 1 presented to Hospital B's Emergency room with more drainage from the incision and pain. A Computed Tomography (CT) scan (cross-sectional, three-dimensional image of an internal body part) revealed a retained foreign object in Patient 1's abdomen.

On 12/29/17 Surgeon 1 opened the surgical incision and removed the retained foreign object, the FISH. A Wound Vac (therapeutic technique using a negative-pressure vacuum dressing to promote healing in acute wounds) was applied to Patient 1's incision and she was discharged on 1/4/18.

On 4/9/18 at 1:35 p.m., during an interview, the Risk Manager (RM) stated she was notified by OR staff about the discovery of the FISH in Patient 1 on 12/29/17 by phone call and written report. The RM stated after an internal investigation there were several contributing factors which lead to the FISH being missed during the first surgery. The RM stated the following factors were identified:

1. The surgical case was converted from a laparoscopic procedure to an open incisional surgery, increasing the length of time and complexity of the procedure.

2. Registered Nurse (RN) 1, was a new graduate who had just finished orientation to the OR and was inexperienced in the role of Circulating Nurse (makes preparations for the surgery, continually monitors the patient and staff during its course, works in the operating room outside the sterile field, and records the progress of the operation, accounts for the instruments, and items used during surgery).

3. RN 1 relieved Circulating RN 2 for a break and took over Patient 1's care midway through the surgery.

4. There was no documentation in the EMR of a surgical count being conducted between RN 1 and Scrub Technician (Scrub Tech) 1, during the break, which is in the hospital policy and procedure following a change in staff.

5. Surgeon 1 requested a FISH, and a FISH was opened and dropped by RN 1, who threw it in the kick bucket (bucket mounted on wheels to discard used sponges) used by Scrub Tech 1. RN 1 opened a second FISH and placed it on the sterile field. There was no documentation in the EMR of the dropped FISH or a second FISH being added to the surgical count by RN 1. When asked by Surgeon 1 if the count was correct before closing the abdominal incision, the FISH in the kick bucket was counted as the FISH used during the surgery and the count was confirmed correct by Scrub Tech 1 and RN 1.

On 4/10/18 at 1:45 p.m., during an interview, OR tech 1 stated he relieved the First Assist PA (FAPA-Physician 's Assistant trained to assist surgeon during surgical procedures) during Patient 1's first surgery on 12/6/17. OR tech 1 stated he took over, holding retractors (device used to hold the incision open) and helping Surgeon 1 with the suturing (stitches holding the edges of a wound or surgical incision together) by holding the suture material taunt, to prevent tangling. OR tech 1 stated he did not remember receiving report from the FAPA that a FISH was used during the surgery, seeing the ring or the tail from the FISH on the surgical drape outside Patient 1's incision, or hearing Surgeon 1 ask about the FISH. OR Tech 1 stated RN 1 was responsible to write on the White Board (a dry erase board used to keep track of any additional items used during surgery) any items added to the sterile field so Surgeon 1, the FAPA and/or the OR Tech 1 can track what is in the incision. OR Tech 1 stated he does not remember seeing a FISH written on the White Board.

On 4/10/18 at 2:07 p.m., during an interview, Scrub Tech 2 stated she was in the OR for Patient 1's second surgery on 12/29/17 for the removal of a retained foreign body. Scrub Tech 2 stated she asked Surgeon 1, "What are we looking for?", and he replied, "It's the FISH." Scrub Tech 2 stated she was holding a retractor after Surgeon 1 opened Patient 1's incision in the same place as the previous surgery and he put his hand in Patient 1's abdominal cavity. Scrub Tech 2 stated Surgeon 1 felt around and finally located the FISH in the upper right side inside Patient 1's abdomen. Scrub Tech 2 stated Surgeon 1 "wiggled" the fish and pulled it out intact.

On 4/10/18 at 2:28 p.m., during an interview, the FAPA stated she was assisting Surgeon 1 during Patient's 1's first surgery on 12/6/17. The FAPA stated she stayed 2 hours past her shift to assist Surgeon 1 through the hard part of the case and then she asked if she could leave. The FAPA stated, Surgeon 1 was getting ready to put in the mesh and all he needed was someone to retract and cut sutures. The FAPA stated, OR Tech 1 came in to relieve her. The FAPA stated all staff in the OR involved in any surgical case are responsible to know what is going on at all times, communication is very important for patient safety and she or Surgeon 1 would call out "FISH in" when inserting the device and "FISH out" when removing it. The FAPA stated she does not remember what she reported to OR Tech 1, and she did not remember the FISH being used while she was in the OR.

On 4/11/18 at 12:40 p.m., during an interview, the Director of Perioperative Services (DPOS) stated it was her expectation that all instruments, sponges and disposable devices get counted by the scrub tech and circulating nurse, and documented in the EMR and on the White Board as they are being used during the surgery by the circulating nurse. The DPOS stated staff is expected to follow hospital policy and procedure and the Association of periOperative Registered Nurses (AORN) guidelines for prevention of a retained foreign body. The DPOS stated it is also expected when staff provide relief in a room, a relief count of all the instruments, sponges and disposable devices is conducted and documented in the EMR. The DPOS stated there was not a relief count in the EMR for Patient 1, and there should have been. Also staff present in the room during the procedure did not remember if both FISH were written on the White Board and there should have been two, the first one dropped and contaminated and the second used for the procedure. The DPOS stated RN 1 was a new graduate from nursing school, had recently completed his 6 month orientation and was unfamiliar with the FISH. The DPOS stated all staff members are encouraged to speak up and ask for help when needed. The DPOS stated, "The Surgeon is the 'Captain' and everyone needs to work in their roles, but also together as a team; communication is important in the OR."

On 4/11/18 at 1 p.m., during an interview, RN 3 stated she was the circulating RN in the OR during Patient 1's second surgery on 12/29/17 for the removal of a retained foreign body. RN 3 stated, "I was shocked, I knew something was left inside her but didn't know it was a FISH." RN 3 stated she was away from the sterile field, but heard there was a problem with the string (tail) on the FISH. RN 3 stated she couldn't remember exactly what the problem was, but thinks the string was tangled.

On 4/11/18 at 1:55 p.m., during an interview, OR Tech 2 stated he was standing across the table assisting Surgeon 1 for Patient 1's second surgery on 12/29/17 for the removal of a retained foreign body. OR Tech 2 stated Surgeon 1 told him it was a FISH and we all asked, "How do you lose a FISH?" OR Tech 2 stated as the FISH was pulled out the string (tail) which was looped around the bowel had to be cut to completely remove the FISH.

A review of Surgeon 1's Operative Report dated 12/29/17 indicated, " ...We took down the omental [abdominal lining] adhesions [scar tissue] on the underside of mostly the upper portion of the incision in the left abdomen, but had to obtain enough of an opening in order for the operator's hand to fit through the opening. It was then I encounter what was felt to be a palpable [able to be touched or felt] foreign body. This was grasped and turned out to be the retained foreign body FISH Silastic bowel retractor which had been utilized at the patient's last surgery. This was grasped with Kochers [surgical instrument with locking teeth] and gently removed through the incision without any injury to the surrounding structures, associated bowel loop, omentum [abdominal lining]. The string and ring attached to the FISH had to be cut on the opposite side of the ring adjacent to the knot in order to avoid injury to viscera [intestines] and this was done which resulted in complete removal of the FISH retractor retaining ring and string ..."

On 4/11/18 at 2:05 p.m., during an interview, Surgeon 1 stated on 12/6/17 Patient 1 was the last case of the day and the biggest case. Surgeon 1 stated the procedure was set up as a laparoscopic hernia repair but became an open case due to the large hernia. Surgeon 1 stated, during the surgery the FISH is placed over the intestines to prevent suturing the mesh to the bowel, then the mesh is placed on top. Surgeon 1 stated, "I know I took my eyes off the surgical field a couple of times because I move around the table to do suturing of the fascia [A flat band of tissue below the skin that covers underlying tissues and separates different layers of tissue] starting from the top of the incision to midway and then the bottom of the incision to midway. I do this in my general surgery cases with big incisions." Surgeon 1 stated, "I know I asked for a count as I was closing and someone said correct, so I proceeded to close." Surgeon 1 stated, "I do not remember putting the FISH in, or pulling it out. If the FISH goes in, the FAPA or myself will call it going in, or coming out and I don't remember, I think the FAPA may have put it in." Surgeon 1 stated, "I realize as the surgeon I am responsible for what happens in the room, but I depend on my staff to keep track of the counts and disposable items, like the FISH. We all need to agree on the count before closing and verify it." Surgeon 1 stated he received a call from Hospital B and was told Patient 1 presented there on 12/27/17 with a wound infection which caused pain, odor and drainage from the incisional site. A CT scan showed a retained foreign body in Patient 1's abdomen. Surgeon 1 stated, "On 12/29/17, I opened [Patient 1] up and removed the FISH intact, the string and ring were also intact." Surgeon 1 stated Patient 1 was discharged home on 1/4/18 with a Wound Vac, and with orders to be followed by home health.

The hospital policy titled, "SPONGE, SHARPS, AND INSTRUMENT COUNTS" dated 7/25/17 indicated, "A. General Considerations 1. Sponge, needle and miscellaneous item counts must be performed in any circumstance where these items are opened for a procedure ...6. Sharps and miscellaneous items which have the potential for being retained in a surgical wound should be counted on all procedures ...13. The OR team may be more vulnerable to distraction in certain instances. Heightened awareness (situational awareness) will be emphasized in situations where the risk of retained items is greater due to the nature of the procedure, i.e., ...patient obesity, multiple surgical teams, shift changes, staff member inexperience. B. Frequency of Sponge and Sharps Counts 1. Sharps (including miscellaneous items) and sponge counts are performed at the following times: ... e. When either the scrub person or circulating nurse is relieved permanently, a count is taken by the relieving person ...D. Procedure for Sponge, Sharps and Instrument Counts ...3. All sponges, sharps and instruments added to the operative field during surgery ...are counted together and out loud and recorded immediately by the circulating nurse ...12. If a counted instrument is passed or dropped off the sterile field, the circulating nurse should retrieve the instrument, show it to the scrub person and isolate it from the field to be included in the final count. 13. The circulating nurse is responsible for: a. recording the count on the count worksheet or on the grease board. b. Recording the result of the final counts on the Intraoperative record. c. Informing the surgeon and team of the count results ..."

The AORN Guideline Essentials titled, "Retained Surgical Items, Guideline at a Glance" dated 2016 indicated, "RN Circulator ...Accurately accounting for items used during a surgical procedure is a primary responsibility of the RN circulator. The RN circulator plays a leading role in implementing measures to account for surgical items ...Scrub Person ...Accurately accounting for items used during a surgical procedure is a primary responsibility of the scrub person. Maintaining an organized sterile field facilitates accounting for all items during and after the procedure. Standardized sterile setups established by the health care organization's policy reduction variation may lessen the risk of error ...Timing of the Count ...Counts occur at specified times to ensure surgical items are accounted for before the next stage of the surgical procedure, such as before closing of a cavity within a cavity or the skin closure ..."

The AORN Guideline Essentials titled, "Retained Surgical Items, Key Takeaways" dated 2016 indicated, "All perioperative team members are responsible for the prevention of retained surgical items ...Distractions, noise and interruptions should be minimized during the surgical count ...A systems approach to performance improvement should be used for prevention of retained surgical items ..."

Based on interviews and record reviews, the facility failed to execute informed consents (process for getting permission before conducting a healthcare intervention on a person) for two of 30 Patients (Patient 3 and Patient 5) when:

1. Patient 5 had three informed consent forms that had missing items that included the date, time, and physician signature.

2. Patient 3 had an anesthesia form with the time missing.

This failure resulted in the potential to result in patients not properly informed of procedures and/or surgery.

Findings:

1. A record review of Patient 5's clinical document titled, "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures" dated 3/27/18 indicated no time of when Patient 5 signed the form. The "Physician Certification" section (section of the form where a physician signs to signify they have obtained informed consent) of the form had no date, time, signature of physician, or the physician's name printed.

A record review of Patient 5's clinical document titled, "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures" dated 3/30/18 indicated no time of when the physician signed the form.

A record review of Patient 5's clinical document titled, "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures" dated 4/2/18 indicated no date and time of when the physician signed the form.

On 4/10/18 at 1:10 p.m., during an interview, Registered Nurse (RN) 4 stated the surgeons are responsible for obtaining the informed consent. RN 4 stated prior to surgery, the surgeon will see the patient and answer last minute questions and sign the consent form, signifying they have talked to the patient. RN 4 stated she expects the informed consents to be complete, which includes the date, time, and required signatures.

On 4/10/18 at 1:23 p.m., during an interview, the Director of Peri-Operative Services (DPOS) stated her expectation is for the informed consent to be complete, which consists of the surgeon's signature, date, and time. She stated the importance of this is to allow proof prior to patients signing, an informed consent was obtained. The DPOS stated if there are missing items such as the date, time, or signature, the form is not complete. "The staff understands the importance of having the form complete- signature, date, and time." The DPOS stated it is imperative these items are present because, " ...you have to date and time things to be legal ...it's all a matter of timing and we follow process."

On 4/10/18 at 1:34 p.m., during an interview and concurrent record review, the Director of the Intensive Care Unit (DICU) validated Patient 5's informed consents had missing items that included the date, time, and signature of the physician. She stated her expectation is for the informed consents to be complete, which includes the date, time, and signature from the physician. The DICU stated if the forms are not complete, " ...I can't ensure the physician did his job in explaining the surgery."

The facility policy and procedure titled, "Informed Consent" dated 4/17, indicated, "Policy Summary/Intent: To outline the informed consent requirements prior to the performance of an operative and/or invasive procedure and diagnostic or therapeutic procedure ...Procedure: The following information must be written on the verification consent form ...7. Date and time consent is signed ..."

2. A record review of Patient 2's clinical document titled, "Informed Consent For Anesthesia" dated 4/9/18 indicated no time of when Patient 2 signed the form.

On 4/10/18 at 8:32 a.m., during an interview and concurrent record review, the Director of Labor and Delivery Services (DLDS) stated the consent form is not timed. She stated her expectation is for the form to be timed, dated, and signed.

The facility policy and procedure titled, "Informed Consent" dated 4/17, indicated, "Policy Summary/Intent: To outline the informed consent requirements prior to the performance of an operative and/or invasive procedure and diagnostic or therapeutic procedure ...Procedure: The following information must be written on the verification consent form ...7. Date and time consent is signed ..."