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Based on a review of facility policies and procedures; facility documents and logs; medical records, and staff interviews, it was determined that nursing staff:
1. Failed to document in the patient's medical record for two (P#1 and P#2) of four sampled patients when: a) P#1's bone flap collection, label verification and storage information was not documented in the medical record during an operative procedure on 7/30/22 b) The serial number of P#2's allograft was not documented in the medical record c) Ten individual bags containing patients removed bone flaps were observed to not include all required identification information during a tour on 8/28/24.
2. Failed to ensure that products introduced into the sterile field for patient use were not expired when one (P#3) of four sampled patients was administered an injectable implant with of expiration date of 6/20/20 during an operative procedure on 7/3/24.

Findings Included:

Cross-refer to A-0411 as it related to the facility's failure to ensure that nursing staff verified the expiration date of products prior to patient administration.

Cross-refer to A-0450 as it related to the failure of nursing services to document required information in medical records and on collected specimens.

Based on review of policy and procedures, facility documents and interviews with staff it was determined that nursing staff failed to ensure injectable implants provided to the surgeon for administration to the patient were not expired when it was determined that one (P#3) of four sampled patients was administered an injectable implant with an expiration date of 6/20/20 during an operative procedure on 7/3/24.

Findings included:

A review of the facility's policy 'Inventory Management,' no number, last reviewed 7/18/22, revealed that the policy's purpose is to ensure that critical supplies are available for patient care.

Procedures were listed as follows:
1. Perpetual Inventory-The Materials management department maintained an official inventory set up for the storage and distribution of selected items. The criteria used to determine which items will be included in the inventory are based on the length of time it takes to obtain a product, the frequency in which the item is used by various departments, and how critical it is to patients' well-being. Perpetual inventory is conducted on a scheduled cycle and should only be accessed by Materials Management.
2. Just-in-time par-level management: Upon the issue of any items from the Storeroom, Materials Management staff will ensure the product is in date, and the packaging is sealed, thereby not breaking the sterile barrier of the product. Any products found to be expired or damaged will be discarded. Material management relied upon Vendors to ship products in date and undamaged condition.

When conducting Cycle Counts in Centralized Storerooms, expiration dates and the packing of products will be inspected to prevent the issue of expired and damaged items. If a product is issued to Nursing/Ancillary areas, it becomes the responsibility of that area to routinely check expiration dates before use. In the even expired product is found expired or damaged, the supply will be discarded, and Materials Management is notified of for replacement. Every effort will be made by Materials Management staff when counting and replenishing supply carts to ensure product is in date.

A review of the purchase Orders placed for Prolaryn Plus from 8/18 through 5/24 revealed that the facility purchased 62 boxes of Prolaryn Plus, part number 8044K0K5. The dates placed and batch/lot numbers are recorded on the purchase orders, along with expiration dates for ones purchased after 2/19/21 . A review of the Purchase Orders for the Prolaryn Plus 1 CC injectable implant revealed that the item's part number is 8044K0K5. A further review showed that Lot number #100111385 was used on P#3 and came from the purchase order placed on 9/25/18.


A review of the facility incident log for 4/1/24 through 8/22/24 revealed an incident report was made on 7/3/24 regarding P#3. The report revealed that a relief circulating RN noted that the injectable implant used in the procedure had an expiration date of 6/20/20. It was also determined that the circulating RN present in the case failed to chart the implant reference number in the medical record. The relieving circulating RN notified the surgeon and the charge nurse.

An interview was conducted in the facility's conference room on 8/28/24 at 10:25 a.m. with the Operating Room and Endoscopy Education Coordinator, RN JJ, who has been in the position since April. RN JJ explained that supplies were treated like medications when they are pulled to place on the surgical field. They check that it is the right product, the right patient, the right procedure, and quality inspection, including checking the expiration date and lot numbers. She learned that the expired product, ProLaryn Pro, was used on P#3 and cannot understand how that occurred if the nurse followed standard procedures. She stated that incident raised questions that are being followed up on by the facility. She further explained that the only time in her practice that an expired product or medication would be used is in a life-or-death situation.

A phone interview was conducted on 8/28/24 at 1:00 p.m. with Material Management (MM) NN, who explained that she has a team of 12. She explained that each staff member was assigned to particular area to check inventory in the OR. The ProLaryn Plus Implant Injectable was stocked near the ENT Operating Rooms and taken from the shelves as needed by the OR staff. This item was routinely stocked on the ENT cart. Materials Management staff checked the cart daily for routinely stocked items, rotates stock, and labels any product near its expiration date. In the case of ProLaryn, she was unsure of how inventory that had expired remained on the ENT cart. When MM NN learned of the expired goods being used in the OR on P#3, the cart was checked, and no additional expired ProLaryn was found on the cart. Since the incident, Material management has started a spreadsheet to track all products and their expiration dates.

A phone interview was conducted on 8/28/24 at 4:00 p.m. with Purchasing Manager (PM) QQ. His department is responsible for ordering the ProLaryn. It was ordered as needed. He was unaware that the expired ProLaryn was used in the operating room on P#3. A review of purchase orders for ProLaryn Plus from 2018 to present revealed that orders place prior to 1/28/21 included the batch number only. Purchase orders from 1/28/21 to 7/10/24 include the batch, manufacturing date, and expiration date. On 7/10/24, the facility ordered six. PM RR explained that expired products not on consignment, like ProLaryn, are discarded by the facility once they expire.

A telephone interview was conducted on 8/30/24 at 2:00 p.m. with the Medical Doctor (MD) LL, who performed the surgery on P#3. MD LL remembered P#3 and was made aware of the expiration date on the ProLaryn Plus Injectable after he had already used the injectable in surgery. He said he expected the circulating RN to check the medication for expiration and the integrity of the box or supplies. In general, he does not routinely ask operating room staff to read out the expiration dates to himself or the surgical technician except on certain medications. He explained that he plans to make this a part of his general practice and procedure. He stated that the patient was doing well and that there were no complications from the procedure. He recalled that he informed the patient after being made aware of the incident but could not remember if he had put anything in the operative notes. He thought that the Lot number was recorded in the operative report.

A telephone interview was conducted on 8/30/24 at 2:30 p.m. with relieving Circulating Registered Nurse (RN) CC for P#3. She has been an RN for five years and has worked as a circulating RN or scrub RN at the facility. She explained that when getting any item requested by the MD, she routinely checks the item for the expiration date and box integrity. Prior to opening the box, she repeated the expiration date with the Surgical Tech so the MD will also hear it. The first circulating nurse in the case with P#3 (RN RR) failed to complete the paperwork for the implants and had only provided a reference number. RN CC completed the paperwork. RN CC had to go back into EPIC and complete the charting on the product. At that point it was realized that the ProLaryn Plus RN RR had been pulled and given to MD LL and had an expiration date of 6/20/20. RN CC informed MD LL and the Charge Registered Nurse (RN) DD. RN DD told her to complete an incident report, which she did. RN CC shared a photograph of the label for the ProLaryn Pro, Lot #100111385, with an expiration date of 6/20/20.

A phone interview was conducted on 9/4/24 at 11:00 a.m. with RN RR who was the circulating RN in P#3's case. She recalled the incident with P#3 regarding the expired ProLaryn Plus. She learned about the incident after she had left for the day. She stated that the product was new to her and that there was a cart outside the OR for this product. She recalled that the surgeon requesting the product and explained that she generally read back the product, lot, and expiration date to the Scrub Technician (ST) but could not recall if she did this in the case of P#3. She stated that the normal process when getting an implant for the surgeon was to verbalize the request and then confirm the product with the scrub tech by reading out the product name, lot number, and expiration date. She explained that she did not enter the information into the record prior to turning the case over to the incoming circulating nurse as it was shift change. She remembered that RN CC had caught the expiration date after the product had already been administered to P#3 and that RN CC had written the incident report and reported it to MD LL and Charge RN DD.

Based on a review of facility policies and procedures, facility logbooks, medical records, observations and staff interviews, it was determined that nursing services failed:
1. To document in the patient's medical record per facility policy for two (P#1 and P#2) of four sampled patient records when:
a. P#1's bone flap collection, label verification, and storage information was not documented in the record.
b. The serial number of P#2's allograft (tissue, organ, or cells transplanted from a donor to a patient) was not documented in the electronic medical record. These failures could result in the inability of the facility to trace donors in the event of an unexpected event or outcome.
2. To document required information on 10 of twenty bags containing removed bone flaps observed in the freezer on 8/28/24.

Findings Included:

A review of the facility's policy titled "Cranial Bone Flap Banking," effective 2/4/20, revealed that the purpose of the policy was to assure proper storage and handling of cranial bone flap for re-implantation.

PROCEDURE:
1. When the flap is obtained, the nurse will confirm with a second person the accuracy of the label and enter a note in the patient record that the bone flap has been stored according to hospital policy. At the time of the reimplantation, the nurse will confirm with a second person that the identifying information matches the patient's and enter a note stating that the patient's autologous bone flap was reimplanted according to hospital policy.
2. Overall authority, accountability, and responsibility of the tissue autograft handling belong to the Department of Nursing, Operating Room, in conjunction with the Tissue Bank.

A review of the facility's "Culture and tissue handling, OR" no policy number, last reviewed on 8/7/23, revealed that specimens obtained during a surgical procedure in the operating room must be properly collected, identified, transported, and stored to ensure accurate disease diagnosis and appropriate treatment.

Implementation:
Circulating nurse
o Using the read-back method, ask the surgeon to confirm patient and specimen identification, including the specimen type, the source and location the specimen will be taken from, required tests, special handling needs, and the date and time.
o Complete all labels and laboratory request forms with at least two patient identifiers, the specimen type, the source and location the specimen was taken from, the date and time of the collection, the surgeon's name, the type of preservative, and required tests.
o Label the specimen containers.

Complications associated with culture and tissue handling in the OR may include:
o Loss, mislabeling, or misidentification of a specimen
o Need for a second procedure

Documentation includes patient identifiers, history, diagnosis, culture preferences, type of specimen, required tests, date and time of collection, type of specimen, required tests, date and time of collection, information pertinent to the specimen or source, name of the surgeon, contact information, name of the nurse performing the preparation, and documentation of the specimen for transport.
A review of the facility's "Cranial Bone Flap Autograph Tracking Sheet Logbook" dated 9/30/22 through 8/23/24 revealed that P#1's bone flap records did not have a documented tissue expiration date or witness signature.

A review of the Complaint Log dated 4/1/24 through 8/22/24 revealed that on 8/22/24, an incident reported regarding P#2. The report revealed that on 8/21/24, the circulating RN removed two frozen tissue allografts out of the designated freezer and failed to complete the Human Requisition Form (HRF). The surgeon, surgery date, patient location, and serial number were missing from the HRF. In addition, the Circulating RN failed to document the implantation in the electronic medical record and failed to document the serial number for both allographs.

A tour of the facility OR was conducted on 8/28/24 at 4:00 p.m. with RN JJ. The tour revealed a locked InVita cabinet where the GRAFIX is stored. The InVita Cabinet is kept locked and requires a nurse to have the authority to access these grafts.

A review of P#1's medical record revealed that P#1 was a 60-year-old male who was admitted to the facility's Emergency Department on 9/30/22 at 6:07 a.m. with a chief complaint of fall-related head injury.
A review of "Progress Notes" dated 9/30/22 at 1:43 p.m., revealed that P#1 was taken to the operating room to undergo a right-sided decompressive hemicraniotomy (resection of an extensive bone flap) to allow room for brain swelling. Continued review of the progress note revealed that a 12 by (x) 15-centimeter (cm) craniotomy (a surgical procedure to remove a portion of the skull) was created. A drain was placed, and the skin was closed. P#1 was transferred post-operatively back to the ICU on 9/30/22 at 3:58 p.m.

Further review of P#1's medical record failed to reveal documentation related to the collection, hand-off, and storage of P#1's bone flap.

A review of "Clinical Notes" dated 11/11/22 at 12:40 p.m. revealed that a provider rounded on P#1 and noted that P#1 was in good spirits and was going to the operating room today for a Cranioplasty (a surgical procedure that repairs or reshapes the skull to correct defects).

A review of the "Case Request" dated 11/11/22 revealed that a request to cancel P#1's scheduled 11/11/22 cranioplasty procedure was made. Further review revealed that the case was canceled for the noted reason "Other - the bone flap for the cranium was missing a sticker, and the doctor could not put an unidentified flap in the patient."

Review of "Clinical Notes" dated 11/11/22 at 8:31 p.m. Medical Doctor (MD) UU noted, "Although we were informed yesterday by OR staff that P#1's bone flap was located and ready for replacement, it could not be found today when preparing for surgery. We inspected the freezer where bone flaps are stored and could not find a bone flap with P#1's patient identification. There were several bone flaps with incomplete or missing patient identification, but we could not be certain which, if any, of these belonged to P#1. As a result, we were unfortunately forced to cancel the surgery. The circumstances of the cancellation were discussed in detail with the patient, his spouse (who was present), and other family over the phone. They were understandably upset by the situation, and we encouraged them to reach out to patient advocacy. We additionally made the OR front desk aware of the situation and discussed it with neurosurgery leadership. I advised the patient and his family that he may eat and that we will plan on proceeding with cranioplasty in several weeks once a synthetic three-dimensional (3D) printed implant can be generated based on his latest CT scan. All questions were answered to their satisfaction, and we advised them that we would continue to be available for any other questions or concerns. Neurosurgeon (NS) AA has been notified".

A continued medical record review revealed that the 3D-printed synthetic cranioplasty was arranged with the vendor and would be available for implant on 11/23/22.

A review of the "Op Note" dated 11/23/22 at 9:28 a.m. revealed that P#1 was brought to the operating room at 7:25 a.m. for a cranioplasty. A review of "Case 131994 (CRANIOPLASTY)" dated 11/23/24 revealed that a Stryker customized permanent implant, model number 7850030, and Plate 2 Hole 16-millimeter (mm) bar, model number 5305216, was implanted into P#1's right frontal lobe.

The patient was awakened from anesthesia and extubated. He was then taken to the recovery room in stable condition. P#1 and his family received and acknowledged understanding of the provided discharge instructions. On 11/30/22 at 1:39 p.m., P#1 was discharged to an acute care skilled nursing facility in stable condition with a final diagnosis of multi-compartmental intracranial hemorrhage and cerebral edema.

A review of P#2 revealed that she was admitted on 8/19/24 for a diabetic foot infection and a left leg incision and drainage. P#2 was taken to the operating room on 8/21/24 for incision and drainage and the application of a biological graft to the right heel ulcer. Two GRAFIX 5x5 frozen implants were placed on the right foot, and no complications were noted. P#2 was discharged on 8/22/24 at 1:46 p.m. to home.

During a tour of the facility on 8/28/24 beginning at 4:00 p.m. accompanied by RN JJ, twenty individual bags of removed patient bone flaps were observed in the bone flap freezer. Upon further observation the following identification information was not included on the individual bags:
Missing patient name of label of one individual bag.
Missing patient admission date on four individual bags.
Missing collection date on four individual bags.
Missing expiration date on six individual bags.
Incorrect expiration date on one individual bag. Expiration date should be five years from collection date.
Missing physician name on six individual bags.
Missing label on two individual bags.

During an interview on 8/27/24 at 3:30 p.m. with Neurosurgeon (NS) AA in a hallway, he stated that he was the surgeon who cared for P#1 in 2022. He said that he went to the OR, checked the bone flap freezer, and located three bone flap bags that did not have labels, as the labels were lying at the bottom of the freezer. NS AA canceled P#1's cranioplasty because he could not say with 100 percent (%) certainty which bone flap belonged to P#1. He met with P#1 and his family and explained what happened. He said they were upset about the situation, but he assured them he could get an expedited synthetic flap made. P#1 and his family agreed to the synthetic flap, and P#1 underwent a cranioplasty a week later. NS AA added that he also treated P#1's infection 14 months later. He said that P#1's infection was not related to the surgery or the implant, as it occurred 14 months later. Typically, implant infections occur within 90 days of the surgical procedure. He said that this bone flap storage situation has not reoccurred since the incident in 2022 and that changes were made to how the bone flaps were labeled and stored.

During an interview on 8/27/24 at 3:45 p.m. with Registered Nurse (RN) BB in a supply room, RN BB stated that she does not document the bone flap verification in the patient's medical record. Still, she can rely on her text messages if she needs to review confirmation. She added that documentation and labeling of the bone flap is the responsibility of the RN. RN BB said that she reviews the bone flap logbook weekly to ensure compliance, but there are times when the RN has not fully completed the forms. She added that if the second witness's signature is missing, she will try to hunt down the surgeon or the surgical tech on the case and ask them if they recall the patient and the bone flap. She will ask the staff members to add their witness signatures to the form if they can remember the patient. RN BB said that it could be days or weeks later that she could obtain any missing information from the form.

During an interview on 8/27/24 at 4:11 p.m. with RN KK in a supply room, RN KK stated that she is an RN who primarily circulates on neurosurgery cases. RN KK said she is unfamiliar with the bone flap process and relies on the OR bone flap instruction book to label and store the bone flap properly. RN KK said she is unsure whether she should document anything about the bone flap in the patient's medical record.

During an interview on 8/27/24 at 4:30 p.m. in a supply room, RN GG stated that he has been an OR nurse for the facility since 2021. RN GG explained that he did not know the process for bone flap storage and documentation. He explained that he does not usually circulate on craniotomy cases and is unaware if he has ever had training on bone flaps.

During an interview on 8/28/24 at 10:00 a.m. in a conference room, RN FF stated that she had been an OR Nurse for five years and primarily circulates in neurology, spine, craniotomy, and orthopedic surgical cases. RN FF said that when she circulates on craniotomy cases, she relies on the procedure book to verify how she collects, packages, labels, and stores the patient's bone flaps. RN FF could not recall whether she charts information about the bone flap in the patient's medical record. She said she would never forget a step in the craniotomy process because she has the procedure book, which gives step-by-step instructions. When this surveyor presented RN FF with P#1's incomplete bone flap form and asked her to explain why the bone flap expiration date and witness signature were missing, RN FF said that she was unsure why she did not complete the required documentation.

An interview was conducted in the facility's conference room on 8/28/24 at 10:25 a.m. with the Operating Room and Endoscopy Education Coordinator, RN JJ., who has been in the position since April. She explained that she expected the circulating nurse handling 'bone flaps' to follow policy and that if they were unfamiliar with the process, a procedure book by the freezer would walk them through it.

RN JJ explained that only nurses with badge access can remove an allograph from the InVita cabinet. The Circulating RN completes the "human Requisition Form" before removing any allograft from the cabinet. The form is then placed in a folder on the side of the cabinet and picked up daily by the Blood Bank. If the form is incomplete, the person picking up the forms must try to identify the person who removed the allographs from the cabinet to get the form completed. An incident form is completed whenever information was missing from a form. The human allograph should be documented in EPIC along with the serial number. When these things are not completed, EPIC will not properly interface with the Tissue Tracking System, known as the UDI Tracker. RN JJ explained that she has provided in-services to the OR staff and that the Impact Log Form attached to each GRAFIX allograph is the serial number highlighted in yellow. A note also tells the RN not to chart anything in the LOT number section in EPIC. The RN must chart the serial number located on the implant log form. She further explained that there are guides in EPIC that have been created to help the OR staff chart human tissue correctly. Security can identify who went into the cabinet.

RN JJ explained that she only recently became aware of the issue with P#2 when the "GRAFIX allografts" were retrieved without circulating nurses properly completing the paperwork, so a SAFE report was made. When a report was made, the nurse managers generally see it and if necessary, it was escalated to her. She explained that when an issue arises, the OR Nurses should report it to the shift nurse manager or the Unit Director. The shift Nurse Manager is generally responsible for 'closing the loop.'

A telephone interview was conducted on 8/28/24 at 2:00 p.m. with Operating Room Unit Director (ORD) II in she explained that she is new to the Director position. She expects the circulating RNs to follow the facility's policies and procedures when handling specimens and patient tissue. She added that nursing staff should know where to chart information on the patient's bone flap in the medical record and be accountable for knowing specimens are at all times during their surgical cases. ORD II explained that said she did not know where bone flap information should be charted in the medical record. ORD II explained that staff education is conducted quarterly.

During an interview on 8/29/24 at 10:51 a.m. with Pathology Director (PD) WW in the blood bank hallway, PD WW explained that bone is one of the few human tissues that does not degrade if the temperature is too warm or cold. The bone flap is not used for the cells but for support and structure.

Based on a review of policies and procedures, observation of the facility's freezer and inventory carts, and staff interviews it was determined that the facility failed to maintain equipment and inventory utilized by to ensure an acceptable level of safety and quality when it was determined that the freezer used to store removed bone grafts was not maintained at the recommended temperature of -40 degrees Celsius (C).

Findings:

Cross refer to A-0724 as it relates to the facility's failure to ensure that the bone graft freezer temperature was maintained within acceptable range.

Based on a review of the facility's policies; observations; facility reports and logs; and interviews with staff it was determined that the facility failed to ensure that the bone flap storage freezer was maintained at the recommended temperature of at least negative 40 (-40) degrees when it was determined that on 11/14/22 from 7:25 a.m. to 3:15 p.m. and on 4/25/24 from 11:00 a.m. to 4:05 p.m., the temperature was greater than the recommended temperature.

A review of the facility's policy "Bone Flap Banking" no policy number, last reviewed 9/19/23 revealed that the Purpose of the policy was to assure proper storage and handling of cranial bone flap for replantation.

Policy Statement: Cranial Bone Flap autographs will be recovered, processed, stored, and transplanted/re-implanted in a manner that minimizes microbial growth, reduces the risk of errors, and meets guidelines established by the American Association of Tissue Banks (AATB) and the FDA.

Procedure:
1) the selected package or container for storing the bone will provides an adequate barrier to microbial contamination, will be compatible with the desired type of preservation and storage conditions, and will be impervious to moisture.
2) Aerobic and anaerobic tissue cultures should d be ordered by the attending surgeon if desired (optional)
3) The selected package or container will be labeled according to AATB guidelines, including the following information:

a. Cranial bone flap
b. For autologous Use Only
c. Donor name, age, sex
d. Hospital medical record number
e. Hospital name and address
f. Name of surgeon
g. Date and time collected
h. Date and time of expiration
i. Disinfection steps/additives
j. C&S of bone flap sent ___Yes ___No
k. Pt. evaluated for infectious disease ___Yes ___No
l. Bone flap store in -40-degree (minimum) freezer

5) Autografts will be stored in a temperature-monitored -40-degree centigrade freezer that allows for storage of up to 5 years. (Freezer cannot be an under-the-counter product.)
6) Autografts will be released only to the donor for reimplantation and pending confirmation that all processing, labeling, and storage criteria have been reviewed and met.
7) When the flap is obtained, the nurse will confirm with a second person the accuracy of the label and enter a note in the patient record that the bone flap has been stored according to hospital policy. At the time of the reimplantation, the nurse will confirm with a second person that the identifying information matches the patient's and enter a note stating that the patient's autologous
bone flap was reimplanted according to hospital policy.
8) Temperature monitoring of the cranial bone flap freezer will be ongoing through a wireless connection with the Tissue Bank/Blood Bank.
9) When placing a bone flap in the freezer or removing a bone flap from the freezer, appropriate PPE must be worn. This consists of reusable insulated safety gloves appropriate for use with a -40-degree centigrade freezer. Gloves must be located adjacent to the freezer, easily accessible by staff
10) Overall authority, accountability and responsibility of the tissue autograft handling belongs to the Department of Nursing, Operating Room, in conjunction with the Tissue Bank.

A review of the facility policy "Reporting Medical Equipment Problems to GE Medical Engineering," no policy number, last reviewed 1/10/22. Purpose- to provide a mechanism for the facility's healthcare staff to make service requests (SRs) on applicable biomedical and imaging devices and track the status of service thereof.

Procedure: How to obtain service: for the universal submission of service requests (SEs), please call 1-866-366-7511. GE Healthcare call center dedicated to the facility, which is available 24 hours per day, seven days a week, and have your biomedical device asset/Control ID or your imaging device system ready.

Once you have obtained a Service Request (SR) number, complete a Yellow Maintenance Requested hangtag by indicating the date, department, reporter, phone number, description of the problem, and GE Case # /SR and attach it to the device.

How to report unusual occurrences/patient incidents/ SAFE events
1) Complete "how to obtain service"
2) Mark "yes" to the question "Was the device involved in a patient incident?" on the yellow Maintenance Requested hangtag.
3) Follow instructions on the reversed side of a Yellow Maintenance Requested hangtag including the recoding of applicable medical record Numbers, Contacting Risk Management, and Completion of an Incident Report in SAFE.

A review of the facility's policy titled 'CTCT TempTrak Equipment and Environmental Monitoring', last approved 2/22/24 revealed that the storage device was used for blood, blood components, tissue, derivatives and reagents are monitored. Sensors placed in or on the equipment take readings every five minutes. Different alarm profiles for each type of equipment allow customization of in-range readings. An alarm bell rings or light flashes when the reading is out-of-range for a specified period of time. Action by a technologist is required to clear the alarm. The action taken is recorded along with the date and name of the technologist clearing the alarm. The Temp Trak software provides historical data for all readings, alarms, and corrective action taken for any out-of-range readings. In place of recording manual temperature and humidity readings, a review of the previous day's readings is documented. Reports are available at any time to satisfy regulatory requirements.

On 8/28/24 beginning at 4:00 p.m. accompanied by RN JJ, a tour continued to the area where the Freezer stores the "bone flaps." It is a so-low freezer CH45-5, Serial number 1718368. The freezer top has a label that states, "Human tissue storage unit- Do not open without authorization." The temperature was -52 degrees Centigrade-Inspected-GE Healthcare Due date: 2/2026, GE Healthcare 601529045. On the right side of the freezer is a Bluetooth sensor that she explained goes to the blood bank, monitors the temperature 24/7, and records the temperature every five minutes.

A review of the TempTrack logs for 2022 through August 2024 revealed that the report shows a temperature every five minutes. The sensor number was recorded as 244222/2

The TempTrack sensor history report for November 2022 log revealed that on 11/14/22, at 7:20 a.m., a temperature of -40.9 degrees C was recorded. On 11/14/22, the freezer temperature remained above -40 degrees C for 97 readings from 7:20 a.m. until 3:25 p.m. The temperature ranged from -40.9 degrees C at 7:20 a.m. to +7.4 degrees C at 1:15 p.m.; at 3:25 p.m., the freezer temperature was -41.2 degrees C.

The TempTrack sensor history report for the April 2024 log revealed that on 4/23/24 at 11:00 a.m., it reported a temp of -37.9 degrees C, and the temperature remained above -40 degrees C for 63 readings from 11:00 a.m. until 4:10 p.m. The freezer readings ranged from -37.9 degrees C at 11:00 a.m. to +31.9 Centigrade at 2:10 p.m. until 4:10 pm when the freezer temperature was -41.2 degrees C.

A review of the "Bone Flap Freezer Temperature Out of Range Log" created on 12/5/22 revealed no entries on the log where flaps were removed from the freezer and taken to the blood bank.

A review of the lab chest freezer CH series, a so-low user manual, revealed that it was for indoor use, with a temperature range of 15 degrees centigrade to 32 degrees centigrade.

A review of the TempTrack Sensor Audit Report from the facility's blood bank revealed: Audit ID # 98010 on 11/14/22 at 1:45 a.m. freezer 1 door was recently opened. At this time, all sensors have been reviewed, and at this time, the sensors are all in range.
Audit ID # 98038 for 11/15/22 at 12:29 a.m. revealed that the auto flap freezer notified maintenance OR defrosting.
Audit ID # 114794 from 4/23/24 at 12:18 a.m. showed that the refrigerator door was recently opened. At this time, all sensors have been reviewed. At this time, all sensors are within an acceptable range.
Audit ID # 114830 from 4/24/24 at 12:21 a.m. revealed that the freezer door was recently opened. Skull freezer defrosting. At this time, all sensors have been reviewed. At this time, all sensors are within an acceptable range.

An interview was conducted in the facility's conference room on 8/28/24 at 10:25 a.m. with the Operating Room and Endoscopy Education Coordinator, RN JJ., who has been in the position since April and was interviewed in the facility's conference room. She explained that she expected the circulating nurse handling 'bone flaps' to follow policy and that if they were unfamiliar with the process, a procedure book by the freezer would walk them through it.
RN JJ explained that next to the Bone Flap Freezer is an instruction manual and a logbook to record any flaps in the freezer. A review of the instruction manual revealed that under "storing" flaps "may be frozen or cryopreserved stored at -40 degrees centigrade or colder for up to five (5) years."

During an interview on 8/29/24 at 10:42 a.m. with Biomedical Technician (BM) VV in the blood bank hallway, BM VV stated that he works for General Electric and is subcontracted by the facility to conduct maintenance checks and repairs on facility biomedical equipment. BM VV said annual checks are performed on all biomedical equipment, including the bone flap freezer in the facility OR. He explained that the blood bank monitors the bone flap freezer's temperature, and if there is an issue with the freezer, he will not know about it unless the OR staff creates a service ticket. He said that per the manufacturer's guidelines, the temperature range is -50 degrees Celsius (C), but it is up to the OR staff to set the temperature range based on what is being stored inside it. When this surveyor asked him to explain the provided maintenance records for the bone flap freezer, he said the records showed that scheduled annual maintenance checks were conducted.

An interview was conducted on 8/29/24 at 2:50 pm with the Nurse Manager for Orthopedics and Neurology, RN PP; she has been in the role since 2022, primarily Ortho's, pain, podiatry, loaners, contact representatives, assignments, and schedules. She recalled that she consulted with a sister hospital, and adopted the same equipment, documentation, and labels for the storage of bone flaps. There were no in-services done and they learned on their own in 2022. There were not too many issues, The blood bank keeps track of the temperature with Bluetooth monitoring. The blood bank calls the OR if it's out of range. The freezer defrosts several times a year.
On 11/11/22, bone flaps were transferred to the blood bank. A whole batch went to the blood bank at that particular time, recorded on the bottom of the individual patient log pages. Biomed came and replaced the battery in the alarm. She could not remember if it was because it was beeping, so she contacted the blood bank.

An interview was conducted on 8/29/24 at 10:30 a.m. with Blood Bank (BB) SS and discussed how the "flap freezer" temperature is monitored. She explained that the TempTrack is kept in the blood bank and monitored 24/7. The blue tooth sensor records a temperature every 5 minutes, and these results are then recorded electronically on a daily log. She explained that the OR sets the freezer temperature range. If the TempTrack senses a temperature above or below the set temperature, it will send an audible alarm to the blood bank. She believed the set temperature range was -40 degrees Celsius to -80 degrees C. If the blood bank staff hears an alarm, they called the OR to have someone check the freezer. If the alarm continued, the OR was called again. She explained that the OR staff is responsible for checking the freezer and issuing a maintenance request. She was unaware that the freezer TempTrack was out of range for any extended period. BB SS explained that there have been times when the OR staff has had to defrost the "flap" freezer, and when this occurs, they bring the flaps to the blood bank freezer for storage.

During an interview on 8/29/24 at 10:51 a.m. with Pathology Director (PD) WW in the blood bank hallway, PD WW explained that bone is one of the few human tissues that does not degrade if the temperature is too warm or cold. The bone flap is not used for the cells but for support and structure.