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Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation: CFR 482.12 Governing Body was met by failing to ensure:

1. The policy and procedure was implemented during a surgical procedure, when there was no documented evidence a complete count (the process of accounting of all the surgical items), and a visual inspection of the integrity of the surgical items was performed. (Refer to A-0063)

2. Multiple charts under the surgical count section, the word "Other" identified the specific item being used during surgery for 14 of 46 sampled patients. (Refer to A-0063)

3. Sanitary conditions were maintained when clean and "ready-to-use" medical devices (three medical equipment tower units) were stored together with dirty trash containers and a laundry receptacle. (Refer to A-0063)

4. Temperatures in the sterile processing departments (the area in the facility where they clean, store, and sterilize the surgical instruments) were in appropriate ranges. (Refer to A-0063)

5. Surgical instruments were properly sterilized that were located inside a major and minor tray (where sterilized surgical instruments are stored). (Refer to A-0063)

6. One of three sterilizers (used to sterilize surgical instruments) did not contain a dry white stain at the bottom of the chamber. (Refer to A-0063)

7. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed daily in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments). (Refer to A-0063)

8. The facility followed manufacturer's recommendations on how to clean the cabinet dryer (used to dry various types of medical equipment). (Refer to A-0063)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Governing Body.

Based on observations, interviews, and record reviews, the Governing Body failed to ensure the delivery of surgical services were provided in accordance with standard of practice when:

1. For one (1) of 46 sampled patients (Patient 6), Facility 1 failed to ensure its policy and procedure was implemented during a surgical procedure, there was no documented evidence a complete count (the process of accounting of all the surgical items), and a visual inspection of the integrity of the surgical items was performed.

This failure resulted in retention of a foreign object (RFO, an unintended retention of surgical items during a surgical procedure), of the cartridge to the tacker (an "articulating reloadable fixation device" used to tack the mesh in place), which created adverse effects in the overall health and safety of Patient 6.

2. Multiple charts from Facility 1 and Facility 2 under the surgical count section, the word "Other" did not identify the specific item used during surgery for 14 of 46 sampled patients (Patients 1, 2, 7, 10, 21, 22, 23, 24, 25, 26, 27, 28, 29, 36). This failure created a potential for an RFO incident to occur. (Refer to findings #2, 5 and 11)

3. Facility 1 failed to ensure sanitary conditions were maintained when clean and "ready-to-use" medical devices (three medical equipment tower units) were stored together with dirty trash containers and a laundry receptacle. This failure created the potential for dirty equipment to be used on a surgical patient.

4. Temperatures in the sterile processing departments at Facility 1 and Facility 2 (the area where they clean, store, and sterilize the surgical instruments) were out of range. This failure created the potential for the spread of infection for surgical patients.

5. (Refer to #2 above)

6. At Facility 1, surgical instruments were not properly sterilized (to destroy any microorganisms used by using high temperature with steam, dry heat, or boiling liquid) that were located inside a major tray (where sterilized surgical instruments are stored). This failure created the potential for cross-contamination among surgical patients.

7. At Facility 1, one of three sterilizers (used to sterilize surgical instruments) contained a dry white stain at the bottom of the chamber. This failure created the potential for the spread of infection for surgical patients.

8. No documented evidence that terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed on January 19, 2018 and January 24, 2018 in the sterile processing department at Facility 1 (the area in the facility where they clean and sterilize the surgical instruments). This failure had the potential for the spread of infection for surgical patients.

9. At Facility 1 and Facility 2, manufacturer's recommendations were not followed on how to clean the cabinet dryer (used to dry various types of medical equipment). This failure had the potential for the spread of infection.

10. Facility 1 failed to remove a damaged instrument from a minor surgical tray. This failure created the potential for the device to carry infection.

11. (Refer to #2 above)

Findings:

1. On August 25, 2017, the California Department of Health (CDPH) received an entity self-reported incident (ERI)report of an RFO incident regarding the "cartridge" (the cartridge, which contained staples, was attached to a tacker and was reloadable. The tacker, a reloadable articulating fixation device, was used to tack the mesh {a sheet used to support the organs or tissues during the surgical procedure}), involving Patient 6.

A review of the "OPERATIVE NOTE" dated December 2, 2016, revealed Patient 6 underwent left inguinal hernia (a protrusion of abdominal cavity contents through a weak spot in the inguinal wall) repair laparoscopic (an operation performed in the abdomen or pelvis through small incisions with the aid of a camera) with prosthesis (artificial devise) or graft (surgical procedure to move tissue from one site to another) procedure, by Surgeon 1. The note further revealed, "...DETAILS OF OPERATION: ... The sponge, needle and instrument counts (the accountancy of the items) were correct at the end of the case."

A review of the "Counts" sheet during Patient 6's surgery dated December 2, 2016, revealed the counts of the sponge, needles/sharps, "Other," were documented as "correct" during the initial, closing, and the final counts.

A review of the "DISCHARGE SUMMARY," dated December 2, 2016, revealed Patient 6 was discharged to home on December 2, 2016 (the same day of the surgical procedure). The discharge summary further revealed, "...HOSPITAL COURSE: ... Pt (patient) tolerated the procedure well and went to recovery in stable condition."

A review of the history and physical (H & P) documented by the Chief of General Surgery (CGS), dated August 10, 2017, revealed, Patient 6 underwent a laparoscopic left inguinal hernia repair on December 2, 2016. Since the surgery on December 2, 2016, Patient 6 had some discomfort when having bowel movements or when urinating. Patient 6 recently had some urgency and hematuria (presence of blood in the urine). Patient 6 was evaluated by his primary care physician and was given antibiotics and the symptoms resolved. Patient 6 underwent a Computerized Tomography scan (CT scan, a diagnostic procedure) of the abdomen to rule out kidney stones. The CT scan result revealed, "7 mm (millimeter, a unit of measurement) tubular structure in the low pelvis as detailed above. The etiology is uncertain although the structure has an appearance similar to a (name of the manufacturer) stent (a metal or plastic tube inserted into the lumen of a vessel)..."

A review of Surgeon 1's documentation titled "Assessment/Plan," dated August 10, 2017, revealed, "... s/p laparoscopic left inguinal hernia repair in December now with a foreign body in his pelvis. According to the radiologist it does not appear to be intraluminal (the space in the middle)... I have discussed possibility of retained foreign body from surgery although low likelihood as I don't put anything inside the patient except instruments that are always in my trocar and hand at the same time or the mesh. I can see the mesh in place in the left inguinal region and there is no recurrence of his hernia. The patient denies ingestion or placement of any foreign body so it is truly unclear what this is..."

A review of the "OPERATIVE NOTE," dated August 23, 2017, revealed, "... DETAILS... A foreign body was observed in the lower abdomen and the grasper (a surgical instrument) was used to isolate the foreign body... The foreign body was pulled through the right lateral port site along with the port itself..."

A review of the "OR Post-Op" (operating room postoperative-after surgery) note by the CGS dated August 23, 2017, revealed, "Informed pt (patient) and family, that the retained foreign body was the tip (cartridge) of tacker used in lap (laparoscopic) inguinal surgery..."

A review of the Surgical Pathology report dated August 24, 2017, revealed, "... GROSS DESCRIPTION...'foreign body' is a 7.9 cm (centimeter-a unit of measurement) in length x 0.5 cm in diameter hollow silver, metallic bar inscribed with '(name of the manufacturer) 10 Tacks'..."

An interview with Surgeon 1 was conducted on January 31, 2018 at 11:01 AM. Surgeon 1 stated she was not aware of the RFO incident on December 2, 2016, until Patient 6 sent an email on August 9, 2017 (approximately eight months after the surgery), indicating Patient 6's discomfort upon urination with presence of bleeding. Surgeon 1 stated during the surgical procedure on December 2, 2016, no one expressed knowledge of the RFO incident. If she would have known about it, Surgeon 1 stated she would have removed the RFO and would have reported it. Surgeon 1 stated, "We didn't see it happen." Surgeon 1 stated that sometime in December 2016, there was a poll was taken by the surgeons regarding the tacker. The surgeons had indicated that they did not like using this tacker because it was long, was difficult to use, and it flexed too much.

The Surgeon 1 confirmed when the tacker was pulled out of the patient, Surgeon 1 handed the tacker to the Operating Room (OR) Scrub Nurse (ORSN). The Surgeon 1 confirmed a visual inspection of the tacker was not conducted when the tacker was pulled out of Patient 6; "No, usually I am looking at the screen and I pass the instrument to the Scrub tech (nurse)."

When asked if the cartridge should have been accounted for, Surgeon 1 stated the Scrub Nurse and the Circulating Nurse would tell the Surgeon 1 if the count was "OK." Surgeon 1 stated the Scrub nurse was responsible to check if the instrument was intact.

An interview with the Operating Room Scrub Nurse (ORSN), in the presence of the Director of Risk Management and Patient Safety (DRMPS), and a concurrent review of Patient 6's clinical record, were conducted on February 1, 2018 at 2:30 PM.

The ORSN stated the tacker, was a single-use device that came in two parts; the tacker and the reloadable cartridge that contained ten staples in each cartridge. The tacker used during Patient 6's surgery came with four cartridges. The ORSN stated she had to "put it (the tacker and the cartridge) together" by loading the tacker with the cartridge, before handing it to Surgeon 1. The ORSN stated she could not remember how many times she had to reload the tacker with the cartridge.

During the initial count, the ORSN stated she and the OR Circulating Nurse (ORCN) noted there were four cartridges. During the final count, the tacker and the cartridge were counted as "one," and the count was noted to be correct. The ORSN stated, "How it got overlooked, I can't tell you." The ORSN stated, "I probably counted (the tacker and the cartridge) as one (unit) because I did not disengage the 4th cartridge." The ORSN stated the 4th cartridge was the one that "came off the field." The ORCN stated, "More than likely we overlooked the count" because the tacker was counted as one unit, "thinking" the 4th cartridge was still attached to it.

When asked to provide documented evidence to show the tacker and the cartridges were included during the count, the ORSN stated the final count of the tacker was noted under the section "Other (items other than the sponges, needles, instruments, and sharps)" on the count sheet.

During a concurrent review of the "Count" sheet, it revealed the count for the "Other" was correct. The ORSN confirmed the count sheet did not specify the instruments counted under the section "Other" and that there was no documented evidence to show the accounting of the tacker and the cartridges. During the surgical procedure, the ORSN stated, they would document the surgical items, other than the sharps, sponges, needles, and instruments on a whiteboard (a "wipeable" board on the wall, inside the OR). The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORSN and the DRMPS stated the computer software would not allow the staff to enter any "free text" under the section "Other."

The ORSN confirmed that during the surgical procedure, it was not brought to anyone's attention that the cartridge came off of the tacker or that the tacker was missing the cartridge. The ORSN stated this particular tacker was purchased because it "angulates" and stated they did not know that the cartridge could "come off easily."

An interview with the Chief of General Surgery (CGS), in the presence of the DRMPS, and a concurrent record review, were conducted on February 2, 2018 at 9:50 AM. The CGS confirmed the cartridge of the tacker "came loose" during the surgery on December 2, 2016. When asked what the process was to ensure the surgical items were accounted for and the integrity of the instruments were inspected, the CGS stated the "disposable instruments (i.e tacker)" were not part of the surgical instrument count. The CGS stated all the surgical items brought in during the surgical procedure should have been accounted for.

An interview with the ORCN, in the presence of the DRMPS, and a concurrent record review, were conducted on February 2, 2018 at 10:30 AM.

The ORCN confirmed the tacker and the cartridges were not part of the surgical count per the facility's policy and procedure, at the time the RFO incident on December 2016 happened. The ORCN stated, the tacker was "one long instrument." The ORCN stated she could not remember how many cartridges were used during Patient 6's surgical procedure on December 2, 2016. The ORCN confirmed she was "not familiar with this particular tacker." The ORCN stated she was more familiar with the "old" product (a single-use, non-reloadable tacker that did not have to use a cartridge), that had been used in the past. The ORCN stated, "I didn't even realize we had changed the whole instrument (from the non-reloadable tacker to this reloadable tacker)." The ORCN confirmed she did not notice the change of the product and did not realize it was not the same product she has been familiar with.

The ORCN added, "I don't scrub much, I'm not familiar with the stuff on the (surgical) field," noting that she used to work at the Obstetrics and Gynecology (OBGYN, pertains top the delivery of babies and the treatment of the diseases of the reproductive organs) department.

The ORCN stated the tacker and the cartridges were never part of the count at the time the RFO incident happened. If it were, it would have been documented under the section "Other" on the count sheet. During the surgical procedure, the ORCN stated, they would document the surgical items, other than the sharps, sponges and instruments, on a whiteboard but not on the "count" sheet. The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORCN confirmed they had never specified what items were accounted for and documented under "Other." The DRMPS stated the computer software would not allow them to specify which instruments were counted and documented under the section "Other." The DRMPS confirmed, "We have realized the problem."

The ORCN confirmed that during the surgical procedure, it was not brought to anyone's attention that the cartridge came off or that the tacker was missing the cartridge.

During a review of the facility's Quality Assurance and Performance Improvement Program (QAPI) on February 5, 2018 at 9:10 AM, the QAPI committee members confirmed they were not aware of the RFO incident during Patient 6's surgical procedure on December 2, 2016, until the Patient 6 presented with complaints in August 2017 (approximately eight months after the RFO incident). In the case of Patient 6, the Assistant Hospital Administrator Perioperative Services (AHAPS) confirmed the facility's policy and procedure indicating that all surgical items should have been evaluated for integrity, was not followed.

A review of the facility's policy and procedure titled, "Counts, Sponge, Sharps, and Instruments (Prevention of Retained Surgical Items), revision date: September 2016, set forth, "POLICY STATEMENT(S):... 2. Counts of sponges; sharps; miscellaneous items; and instruments are performed to account for all items used on the surgical field and to lessen the potential for injury to the patient as a result of a retained surgical item... 5. All items introduced to the field will be visually inspected before, during, and after a procedure by the scrub person and accounted for in their entirety. Particular attention must be given to instruments and devices with multiple parts anytime an item is modified from its "original state" including but not limited to penrose drain, umbilical tape, and vessel loops will be inspected by the surgical team members. Items will be measured before use, after removal and documented on the white board...11. If at any time, a count discrepancy is noted, it is the responsibility of the scrub person and circulating nurse to inform the team immediately...PROVISIONS/PROCEDURES FOR INSTRUMENTS: 1. The scrub person will perform an instrument inventory of all instruments prior to and at the end of all procedures, utilizing instrument count sheets. 2. Instrument count sheets will list type and amount of each instrument. 3. Instrument count sheets will be passed off to the circulating nurse by scrub person. 4. The scrub person and the circulating nurse will verify that the instrument count sheets are accurate. This verification will be noted by the circulator on each count sheet by documenting the initials of the scrub person and circulating nurse. 5. Individual pieces of assembled instruments (suction tips, wing nuts, blades, sheaths) will be accounted for separately...7. Added instruments will be recorded on the instrument count sheet and/or white board to ensure they are counted with the rest of the instruments... Documentation...1. In the patient's electronic medical record under the intra-operative section: A. All surgical counts and cavity checks will be documented in the patient's intra-operative record by the circulating nurse..."

2a. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 1's clinical record were conducted on February 1, 2018 at 9:35 AM.

A review of Patient 1's clinical record revealed, Patient 1 was admitted on January 27, 2018.

The operative report dated January 30, 2018, revealed Patient 1 underwent surgical procedures that included aortocoronary bypass (a surgical procedure pertaining to the heart and the arteries) of coronary arteries. The report revealed that the surgical counts under the section "Other," during the initial count (prior to skin incision), and the cavity closing, the closing, the final (at the end), revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under the section "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles, and instruments.

b. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 2's clinical record were conducted on February 1, 2018 at 10:20 AM.

A review of Patient 2's clinical record revealed, Patient 2 was admitted on January 30, 2018.

The operative report dated January 30, 2018, revealed Patient 2 underwent surgical procedures that included ventral hernia (pertains to the abdominal wall) repair. The note revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under "Other."

When asked what items were accounted for under "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges and instruments.

c. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 7's clinical record were conducted on February 1, 2018 at 3:35 PM.

A review of Patient 7's clinical record revealed, Patient 7 was admitted on December 12, 2017.

The operative report dated December 12, 2017, revealed Patient 7 underwent surgical procedure appendectomy (pertains to the removal of the appendix, the lower end of the large intestine). The note revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under the section "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles and instruments.

d. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 10's clinical record were conducted on February 2, 2018 at 11 AM.

A review of Patient 10's clinical record revealed, Patient 10 was admitted on January 29, 2018.

The operative report dated January 29, 2018, revealed Patient 10 underwent surgical procedures that included hemi laminotomy (a surgical procedure to relieve the pressure of the spine).

The report revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles and instruments.

An interview with the Operating Room Scrub Nurse (ORSN), in the presence of the Director of Risk Management and Patient Safety (DRMPS), was conducted on February 1, 2018 at 2:30 PM.

During the surgical procedure, the ORSN stated, they would document the surgical items, other than the sharps, sponges, needles, and instruments on a whiteboard (a "wipeable" board on the wall, inside the OR). The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORSN and the DRMPS stated the computer software would not allow the staff to enter any "free text" under the section "Other."

An interview with the Operating Room Circulating Nurse (ORCN), in the presence of the DRMPS, was conducted on February 2, 2018 at 10:30 AM.

During the surgical procedure, the ORCN stated, they would document the surgical items, other than the sharps, sponges and instruments, on a whiteboard but not on the "count" sheet. The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORCN confirmed they had never specified what items were accounted for and documented under "Other." The DRMPS stated the computer software would not allow them to specify which instruments were counted and documented under the section "Other." The DRMPS confirmed, "We have realized the problem."

3. A tour of the operating room (OR) department was conducted with the Perioperative Services Nurse Manager (PSNM 1), the Assistant Clinical Director Perioperative Services (ACDPS), the Charge Nurse, the Director of Nursing of Perioperative Services (DNPS), the Manager of Sterile Processing (MSP), on January 30, 2018 at 2:45 PM.

During an inspection of the storage area near the Operating Room 8, the following were noted to be stored on one side of the room:

1. (Name of manufacturer) "GI (gastrointestinal) Tower," was used for gastrointestinal process.

2. (Name of manufacturer) "Tower 4," was used for "laparoscopic process" (surgical procedures for visualization/examination of organs).

3. (Name of manufacturer) "Tower 5," was used for "laparoscopic process."

Immediately to the side of "Tower 5," was a blue receptacle containing bags of "laundry." On the other side of the room, there were five "biohazard" gray bins and one trash bag container.

The three tower units, the blue receptacle containing bags of "laundry," the five "biohazard" gray bins, and the one trash bag container, were not labeled whether they were clean or dirty.

The PSNM 1 stated the three tower units stored in this room were clean and were "ready" for use. When asked what the process was to ensure the tower units were clean and ready to be used in the OR rooms, the PSNM 1 stated the staff should clean the tower units before taking them inside the OR rooms. When asked how he would track to ensure it was being done, the PSNM 1 stated, "I do not have a method of tracking."

The MSP stated the practice was, "normally" the tower units would have a plastic bag over them to indicate that they were clean.


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4. During a tour of the main hospital facility 2 sterile processing department storage area (where sterilized surgical instruments were stored) on January 30, 2018 at 3:03 PM, the temperature was 75.5 degrees Fahrenheit. (Normal temperature may be as high as 75 degrees Fahrenheit).

During a concurrent interview with the Chief Engineer (CE 1), the CE 1 confirmed that the temperature of 75.5 degrees Fahrenheit was out of range.

During a tour of the facility 2 sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 30, 2018 at 3:05 PM, the temperature of the area was 74.7 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 74.7 degrees Fahrenheit was out of range.

During a tour of the facility 2 sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 30, 2018 at 3:06 PM, the temperature was 75.8 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit).

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 75.8 degrees Fahrenheit was out of range.

During a tour of the facility 2 ambulatory surgery center (same day surgery) sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 30, 2018 at 3:35 PM, the temperature was 77.5 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 77.5 degrees Fahrenheit was out of range.

During a tour of the facility 2 ambulatory surgery center (same day surgery) sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 30, 2018 at 3:45 PM, the temperature was 76.3 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit).

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 76.3 degrees Fahrenheit was out of range.

During a tour of the facility 1 sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 31, 2018 at 10:42 AM, the temperature was 73.0 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit).

During a concurrent interview with the Plant Engineer II (PE II), the PE II confirmed that the temperature of 73.0 degrees Fahrenheit was out of range.

During a review of the facility 1 Sterile Processing Department Decontamination temperature log dated January 31, 2018 at 7:34 AM, indicated the temperature was 70 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit).

During an interview with the Sterile Processing Department Technician (SPDT 2) on January 31, 2018 at 10:57 AM, the SPDT 2 stated that the decontamination temperature on January 31, 2018 at 7:34 AM, was 70 Fahrenheit and that the normal temperature ranges in the decontamination room area is 68 degrees Fahrenheit to 70 degrees Fahrenheit.

During a tour of the facility 1 sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 31, 2018 at 11:10 AM, the temperature was 74.0 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the PE II, the PE II confirmed that the temperature of 74.0 degrees Fahrenheit was out of range.

According to the CDC "Healthcare Infection Control Practices Advisory Committee Guideline for Disinfection and Sterilization in Healthcare Facilities", "...the sterile storage area should have controlled temperatures and may be as high as 75 degrees Fahrenheit and the relative humidity should be 30% to 60% in all work area except sterile storage, where the relative humidity should not exceed 70%."

A review of the facility's current policy and procedure titled, "Temperature and Relative Humidity Management" dated September 2017, included the following: "When controlling the climate and environmental quality in the medical center buildings using heating, ventilation and air conditioning (HVAC) systems, it is important to not only control the room temperature, but also the relative humidity in a range that is comfortable and supports infection control prevention practices and safety. Pursuant to the Association of perioperative Registered Nurses (AORN) and Association for the Advancement of Medical Instrumentation (AAMI) recommend practices, sterile packages shall be stored under environmentally controlled conditions, consistent with the manufacturer's recommendations. Clean preparation, packing, sterile storage, and sterile processing (temperature ranges are (68 degrees Fahrenheit to 73 degrees Fahrenheit) and humidity ranges are 10-60 percent). Sterile Processing Decontamination (temperature ranges are 60 degrees Fahrenheit to 65 degrees Fahrenheit)..."

During an interview with the Assistant Hospital Administrator Perioperative Services (AHAPS) on February 5, 2018 at 8:15 AM, stated that the word "Other" in the surgical count section is associated with miscellaneous items for example: a vessel loop (used to occlude and retract vessels, veins, nerves, and tendons during a surgical procedure), any type of drains (intention is to decompress, or drain either fluid, or air from the area of surgery), and K-wires (are sterilized, sharpened, and stainless steel pins used to hold bone fragments or to provide an anchor for skeletal traction).

5a. During a review of Patient 21's clinical record revealed Patient 21 presented to the facility on February 1, 2018 at 12:14 PM, with admission diagnosis of cancer metastatic to brain (brain cancer).

Review of Patient 21's clinical record revealed Patient 21 had a left frontotemporal craniectomy (part of the skull is removed) for debulking (surgical removal part of a tumor) frontemporal mass adenocarcinoma (malignant tumor) on February 1, 2018. The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery.

b. During a review of Patient 22's clinical record revealed Patient 22 presented to the facility on February 1, 2018 at 6:34 AM, with admission diagnosis of umbilical hernia (occurs when the stomach muscles do not join completely and the intestine bulges thru this weak spot).

During a review of Patient 22's clinical record revealed Patient 22 had a umbilical hernia repair with prosthesis (a composite mesh placed in the underlay position with no primary closure of the defect) on February 1, 2018. The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery.

c. During a review of Patient 23's clinical record revealed Patient 23 presented to the facility on February 1, 2018 at 12:34 PM, with admission diagnosis of chronic kidney disease stage 5 (kidneys have lost nearly all their ability to do their job effectively and no longer able to remove waste, fluids from the body, and toxins build up in the blood).

During a review of Patient 23's clinical record revealed Patient 23 had a dialysis access peritoneal dialysis catheter insertion laparoscopic (an alternate form of dialysis for patients in end-stage renal disease). The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery.

d. During a review of Patient 24's clinical record revealed Patient 24 presented to the facility on February 1, 2018 at 9:14 AM, with admission diagnosis of left inguinal hernia (a protrusion of abdominal cavity contents through the inguinal canal).

During a review of Patient 24's clinical record revealed Patient 24 had a inguinal hernia repair (closes a weakness in the abdominal wall that is near the inguinal canal) on February 1, 2018. The surgical count section indicated the word "Other" and did not identify the specific items that were used durin

Based on interview and record review, the facility failed to implement its policy and procedure when there was no documented evidence a notice of the conditions of admission was provided to one of 46 sampled patients (Patient 5), before providing care and treatment.

This failure had the potential to result in Patient 5 not being informed of the patient rights before proceeding with the care and treatment, affecting the patient's overall health and safety.

Findings:

An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 6's clinical record were conducted on February 1, 2018 at 1:32 PM.

A review of the Patient 6's clinical record revealed Patient 6 was admitted on December 14, 2017, and presented with complaints of abdominal pain associated with nausea and vomiting.

The operative report dated December 14, 2017, revealed Patient 6 underwent right inguinal hernia (a condition wherein the tissue protrudes through a weak spot in the abdominal muscles) repair and diagnostic laparoscopy (a procedure performed in the abdomen or pelvis through a small incision with the use of a camera).

Patient 6 was discharged from the facility on December 17, 2017.

During a concurrent interview, the DRMPS confirmed there was no documented evidence of an acknowledgment of an agreement to the facility's conditions of admission by Patient 6.

A review of the facility's policy and procedure titled, "Conditions of Admissions," review date: January 2017, set forth, "...POLICY STATEMENT(S):1. The relationship between a hospital and a patient is contractual. In order that the scope of such relationship be clearly stated and understood by the patient or patient's legal representative, it is mandatory that an agreement be properly executed at the earliest possible time. 2. At the earliest possible opportunity at each confinement, the written consent of the patient or patient's legal representative must be obtained and properly witnessed. PROVISIONS/PROCEDURE: 1. The basic agreement is considered the "Hospital Conditions of Admissions" (COA) form. The Admitting Department will be responsible for obtaining a signed COA upon admission or at the earliest opportunity following admission..."

A review of the form titled, "HOSPITAL CONDITION OF ADMISSION (INPATIENT/OUTPATIENT SERVICES)," revealed, "Please read and sign the following agreement so that we may proceed with the care and treatment ordered by your physician...1. CONSENT TO MEDICAL CARE... 2. EDUCATIONAL CONSENT... 3. PERSONAL VALUABLES... 4. FINANCIAL AGREEMENT... 5. ASSIGNMENT OF BENEFITS... 6. AUTHORIZED REPRESENTATIVE... 7. DISCHARGE AGREEMENT... 8. FACILITY DIRECTORY... 9. ADVANCE DIRECTIVE... 10. ACKNOWLEDGMENT OF RECEIPT..."

The facility failed to ensure the Condition of Participation: CFR 482.21 Quality Assessment Performance Improvement (QAPI) was met by failing to ensure:

1. Policy and procedures were implemented during a surgical procedure, there was no documented evidence a complete count (the process of accounting of all the surgical items), and a visual inspection of the integrity of the surgical items were performed. (Refer to A-0286)

2. Multiple charts under the surgical count section, the word "Other" identified the specific item being used during surgery. (Refer to A-0286)

3. Sanitary conditions were maintained when clean and "ready-to-use" medical devices were stored together with dirty trash containers and a laundry receptacle. (Refer to A-0286)

4. Temperatures in the sterile processing departments (the area in the facility where they clean, store, and sterilize the surgical instruments) were within appropriate ranges. (Refer to A-0286)

5. Surgical instruments were properly sterilized that were located inside a major and minor tray (where sterilized surgical instruments are stored). (Refer to A-0286)

6. One of three sterilizers (used to sterilize surgical instruments) did not contain a dry white stain at the bottom of the chamber. (Refer to A-0286)

7. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed daily in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments). (Refer to A-0286)

8. Manufacturer's recommendations were followed on how to clean the cabinet dryer (used to dry various types of medical equipment). (Refer to A-0286)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: QAPI.

Based on observation, interview, and record review, the Quality Assurance Improvement Program (QAPI), failed to ensure:

1. For Patient 6, Facility 1 failed to ensure its policy and procedure was implemented during a surgical procedure, there was no documented evidence a complete count (the process of accounting of all the surgical items), and a visual inspection of the integrity of the surgical items were performed.

This failure resulted in retention of a foreign object (RFO, an unintended retention of surgical items during a surgical procedure), of the cartridge to the tacker (an "articulating reloadable fixation device" used to tack the mesh in place), which created adverse effects in the overall health and safety of Patient 6.

2. Charts from Facility 1 and Facility 2 under the surgical count section, the word "Other" did not identify the specific item used during surgery for 14 of 46 sampled patients (Patients 1, 2, 7, 10, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 36). This failure created a potential for an RFO incident to occur. (refer to findings #2, 5 and 11)

3. Facility 1 failed to ensure sanitary conditions were maintained when clean and "ready-to-use" medical devices (three medical equipment tower units) were stored together with dirty trash containers and a laundry receptacle. This failure created the potential for dirty equipment to be used on a surgical patient.

4. Temperatures in the sterile processing departments at Facility 1 and Facility 2 (the area where they clean, store, and sterilize the surgical instruments) were out of range. This failure created the potential for the spread of infection for surgical patients.

5. (Refer to #2 above)

6. At Facility 1, surgical instruments were not properly sterilized (to destroy any microorganisms used by using high temperature with steam, dry heat, or boiling liquid) that were located inside a major tray (where sterilized surgical instruments are stored). This failure created the potential for cross-contamination among surgical patients.

7. At Facility 1, one of three sterilizers (used to sterilize surgical instruments) contained a dry white stain at the bottom of the chamber. This failure created the potential for the spread of infection for surgical patients.

8. No documented evidence that terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed on January 19, 2018 and January 24, 2018 in the sterile processing department at Facility 1 (the area in the facility where they clean and sterilize the surgical instruments). This failure had the potential for the spread of infection for surgical patients.

9. At Facility 1 and Facility 2, manufacturer's recommendations were not followed on how to clean the cabinet dryer (used to dry various types of medical equipment). This failure had the potential for the spread of infection.

10. Facility 1 failed to remove a damaged instrument from a minor surgical tray. This failure created the potential for the device to carry infection.

11. (Refer to #2 above)

Findings:

1. On August 25, 2017, the California Department of Public Health (CDPH) received an entity self-reported incident (ERI) report of an RFO incident regarding the "cartridge" (the cartridge, which contained staples, was attached to a tacker and was reloadable. The tacker, a reloadable articulating fixation device, was used to tack the mesh {a sheet used to support the organs or tissues during the surgical procedure}), involving Patient 6.

A review of the "OPERATIVE NOTE" dated December 2, 2016, revealed Patient 6 underwent left inguinal hernia (a protrusion of abdominal cavity contents through a weak spot in the inguinal wall) repair laparoscopic (a surgical technique) with prosthesis or graft procedure, by Surgeon 1. The note further revealed, "...DETAILS OF OPERATION: ... The sponge, needle and instrument counts (the accountancy of the items) were correct at the end of the case."

A review of the "Counts" sheet during Patient 6's surgery dated December 2, 2016, revealed the counts of the sponge, needles/sharps, "Other," were documented as "correct" during the initial, closing, and the final counts.

A review of the "DISCHARGE SUMMARY," dated December 2, 2016, revealed Patient 6 was discharged to home on December 2, 2016 (the same day of the surgical procedure). The discharge summary further revealed, "...HOSPITAL COURSE:... Pt (patient) tolerated the procedure well and went to recovery in stable condition."

A review of the history and physical (H & P) documented by the Chief of General Surgery (CGS), dated August 10, 2017, revealed, Patient 6 underwent a laparoscopic left inguinal hernia repair on December 2, 2016. Since the surgery on December 2, 2016, Patient 6 had some discomfort when having bowel movements or when urinating. Patient 6 recently had some urgency and hematuria (presence of blood in the urine). Patient 6 was evaluated by his primary care physician and was given antibiotics and the symptoms resolved. Patient 6 underwent a Computerized Tomography scan (CT scan, a diagnostic procedure) of the abdomen to rule out kidney stones. The CT scan result revealed, "7 mm (millimeter, a unit of measurement) tubular structure in the low pelvis as detailed above. The etiology is uncertain although the structure has an appearance similar to a (name of the manufacturer) stent (a metal or plastic tube inserted into the lumen of a vessel)..."

A review of Surgeon 1's documentation titled, "Assessment/Plan," dated August 10, 2017, revealed, "... s/p laparoscopic left inguinal hernia repair in December now with a foreign body in his pelvis. According to the radiologist it does not appear to be intraluminal (the space in the middle)... I have discussed possibility of retained foreign body from surgery although low likelihood as I don't put anything inside the patient except instruments that are always in my trocar and hand at the same time or the mesh. I can see the mesh in place in the left inguinal region and there is no recurrence of his hernia. The patient denies ingestion or placement of any foreign body so it is truly unclear what this is..."

A review of the "OPERATIVE NOTE," dated August 23, 2017, revealed, "... DETAILS... A foreign body was observed in the lower abdomen and the grasper (a surgical instrument) was used to isolate the foreign body... The foreign body was pulled through the right lateral port site along with the port itself..."

A review of the "OR Post-Op" (operating room postoperative-after surgery) note by the CGS dated August 23, 2017, revealed, "Informed pt (patient) and family, that the retained foreign body was the tip (cartridge) of tacker used in lap (laparoscopic) inguinal surgery..."

A review of the Surgical Pathology report dated August 24, 2017, revealed, "...GROSS DESCRIPTION...'foreign body' is a 7.9 cm (centimeter-a unit of measurement) in length x 0.5 cm in diameter hollow silver, metallic bar inscribed with '(name of the manufacturer) 10 Tacks'..."

An interview with Surgeon 1 was conducted on January 31, 2018 at 11:01 AM. Surgeon 1 stated she was not aware of the RFO incident on December 2, 2016, until Patient 6 sent an email on August 9, 2017 (approximately eight months after the surgery), indicating Patient 6's discomfort upon urination with presence of bleeding. Surgeon 1 stated during the surgical procedure on December 2, 2016, no one expressed knowledge of the RFO incident. If she would have known about it, Surgeon 1 stated she would have removed the RFO and would have reported it. Surgeon 1 stated, "We didn't see it happen." Surgeon 1 stated that sometime in December 2016, there was a poll was taken by the surgeons regarding the tacker. The surgeons had indicated that they did not like using this tacker because it was long, was difficult to use, and it flexed too much.

The Surgeon 1 confirmed when the tacker was pulled out of the patient, the Surgeon 1 handed the tacker to the Operating Room (OR) Scrub Nurse (ORSN). The Surgeon 1 confirmed a visual inspection of the tacker was not conducted when the tacker was pulled out of Patient 6; "No, usually I am looking at the screen and I pass the instrument to the Scrub tech (nurse)."

When asked if the cartridge should have been accounted for, the Surgeon 1 stated the Scrub Nurse and the Circulating Nurse would tell the Surgeon 1 if the count was "OK." The Surgeon 1 stated the Scrub nurse was responsible to check if the instrument was intact.

An interview with the Operating Room Scrub Nurse (ORSN), in the presence of the Director of Risk Management and Patient Safety (DRMPS), and a concurrent review of Patient 6's clinical record, were conducted on February 1, 2018 at 2:30 PM.

The ORSN stated the tacker, was a single-use device that came in two parts; the tacker and the reloadable cartridge that contained ten staples in each cartridge. The tacker used during Patient 6's surgery came with four cartridges. The ORSN stated she had to "put it (the tacker and the cartridge) together" by loading the tacker with the cartridge, before handing it to Surgeon 1. The ORSN stated she could not remember how many times she had to reload the tacker with the cartridge.

During the initial count, the ORSN stated she and the OR Circulating Nurse (ORCN) noted there were four cartridges. During the final count, the tacker and the cartridge were counted as "one," and the count was noted to be correct. The ORSN stated, "How it got overlooked, I can't tell you." The ORSN stated, "I probably counted (the tacker and the cartridge) as one (unit) because I did not disengage the 4th cartridge." The ORSN stated the 4th cartridge was the one that "came off the field." The ORCN stated, "More than likely we overlooked the count" because the tacker was counted as one unit, "thinking" the 4th cartridge was still attached to it.

When asked to provide documented evidence to show the tacker and the cartridges were included during the count, the ORSN stated the final count of the tacker was noted under the section "Other (items other than the sponges, needles, instruments, and sharps)" on the count sheet.

During a concurrent review of the "Count" sheet, it revealed the count for the "Other" was correct. The ORSN confirmed the count sheet did not specify the instruments counted under the section "Other" and that there was no documented evidence to show the accounting of the tacker and the cartridges. During the surgical procedure, the ORSN stated, they would document the surgical items, other than the sharps, sponges, needles, and instruments on a whiteboard (a "wipeable" board on the wall, inside the OR). The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORSN and the DRMPS stated the computer software would not allow the staff to enter any "free text" under the section "Other."

The ORSN confirmed that during the surgical procedure, it was not brought to anyone's attention that the cartridge came off of the tacker or that the tacker was missing the cartridge. The ORSN stated this particular tacker was purchased because it "angulates" and stated they did not know that the cartridge could "come off easily."

An interview with the Chief of General Surgery (CGS), the presence of the DRMPS, and a concurrent record review, were conducted on February 2, 2018 at 9:50 AM. The CGS confirmed the cartridge of the tacker "came loose" during the surgery on December 2, 2016. When asked what the process was to ensure the surgical items were accounted for and the integrity of the instruments were inspected, the CGS stated the "disposable instruments (i.e tacker)" were not part of the surgical instrument count. The CGS stated all the surgical items brought in during the surgical procedure should have been accounted for.

An interview with the ORCN, in the presence of the DRMPS, and a concurrent record review, were conducted on February 2, 2018 at 10:30 AM.

The ORCN confirmed the tacker and the cartridges were not part of the surgical count per the facility's policy and procedure, at the time the RFO incident on December 2016 happened. The ORCN stated, the tacker was "one long instrument." The ORCN stated she could not remember how many cartridges were used during Patient 6's surgical procedure on December 2, 2016. The ORCN confirmed she was "not familiar with this particular tacker." The ORCN stated she was more familiar with the "old" product (a single-use, non-reloadable tacker that did not have to use a cartridge), that had been used in the past. The ORCN stated, "I didn't even realize we had changed the whole instrument (from the non-reloadable tacker to this reloadable tacker)." The ORCN confirmed she did not notice the change of the product and did not realize it was not the same product she has been familiar with.

The ORCN added, "I don't scrub much, I'm not familiar with the stuff on the (surgical) field," noting that she used to work at the Obstetrics and Gynecology (OBGYN, pertains to the delivery of babies and the treatment of the diseases of the reproductive organs) department.

The ORCN stated the tacker and the cartridges were never part of the count at the time the RFO incident happened. If it were, it would have been documented under the section "Other" on the count sheet. During the surgical procedure, the ORCN stated, they would document the surgical items, other than the sharps, sponges and instruments, on a whiteboard but not on the "count" sheet. The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORCN confirmed they had never specified what items were accounted for and documented under "Other." The DRMPS stated the computer software would not allow them to specify which instruments were counted and documented under the section "Other." The DRMPS confirmed, "We have realized the problem."

The ORCN confirmed that during the surgical procedure, it was not brought to anyone's attention that the cartridge came off or that the tacker was missing the cartridge.

During a review of the facility's Quality Assurance and Performance Improvement Program (QAPI) on February 5, 2018 at 9:10 AM, the QAPI committee members confirmed they were not aware of the RFO incident during Patient 6's surgical procedure on December 2, 2016, until the Patient 6 presented with complaints in August 2017 (approximately eight months after the RFO incident). In the case of Patient 6, the Assistant Hospital Administrator Perioperative Services (AHAPS) confirmed the facility's policy and procedure indicating that all surgical items should have been evaluated for integrity, was not followed.

A review of the facility's policy and procedure titled, "Counts, Sponge, Sharps, and Instruments (Prevention of Retained Surgical Items), revision date: September 2016, set forth, "POLICY STATEMENT(S):... 2. Counts of sponges; sharps; miscellaneous items; and instruments are performed to account for all items used on the surgical field and to lessen the potential for injury to the patient as a result of a retained surgical item... 5. All items introduced to the field will be visually inspected before, during, and after a procedure by the scrub person and accounted for in their entirety. Particular attention must be given to instruments and devices with multiple parts anytime an item is modified from its "original state" including but not limited to penrose drain, umbilical tape, and vessel loops will be inspected by the surgical team members. Items will be measured before use, after removal and documented on the white board...11. If at any time, a count discrepancy is noted, it is the responsibility of the scrub person and circulating nurse to inform the team immediately...PROVISIONS/PROCEDURES FOR INSTRUMENTS: 1. The scrub person will perform an instrument inventory of all instruments prior to and at the end of all procedures, utilizing instrument count sheets. 2. Instrument count sheets will list type and amount of each instrument. 3. Instrument count sheets will be passed off to the circulating nurse by scrub person. 4. The scrub person and the circulating nurse will verify that the instrument count sheets are accurate. This verification will be noted by the circulator on each count sheet by documenting the initials of the scrub person and circulating nurse. 5. Individual pieces of assembled instruments (suction tips, wing nuts, blades, sheaths) will be accounted for separately...7. Added instruments will be recorded on the instrument count sheet and/or white board to ensure they are counted with the rest of the instruments... Documentation...1. In the patient's electronic medical record under the intra-operative section: A. All surgical counts and cavity checks will be documented in the patient's intra-operative record by the circulating nurse..."

2a. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 1's clinical record were conducted on February 1, 2018 at 9:35 AM.

A review of Patient 1's clinical record revealed, Patient 1 was admitted on January 27, 2018.

The operative report dated January 30, 2018, revealed Patient 1 underwent surgical procedures that included aortocoronary bypass (a surgical procedure pertaining to the heart and the arteries) of coronary arteries. The note revealed that the surgical counts under the section "Other," during the initial count (prior to skin incision), and the cavity closing, the closing, the final (at the end), revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under this section "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles, and instruments.

b. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 2's clinical record were conducted on February 1, 2018 at 10:20 AM.

A review of Patient 2's clinical record revealed, Patient 2 was admitted on January 30, 2018.

The operative report dated January 30, 2018, revealed Patient 2 underwent surgical procedures that included ventral hernia (pertains to the abdominal wall) repair. The note revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under "Other."

When asked what items were accounted for under "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges and instruments.

c. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 7's clinical record were conducted on February 1, 2018 at 3:35 PM.

A review of Patient 7's clinical record revealed, Patient 7 was admitted on December 12, 2017.

The operative report dated December 12, 2017, revealed Patient 7 underwent surgical procedure appendectomy (pertains to the removal of the appendix, the lower end of the large intestine). The note revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under the section "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles and instruments.

d. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 10's clinical record were conducted on February 2, 2018 at 11 AM.

A review of Patient 10's clinical record revealed, Patient 10 was admitted on January 29, 2018.

The operative report dated January 29, 2018, revealed Patient 10 underwent surgical procedures that included hemi laminotomy (a surgical procedure to relieve the pressure of the spine).

The note revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles and instruments.

An interview with the Operating Room Scrub Nurse (ORSN), in the presence of the Director of Risk Management and Patient Safety (DRMPS), was conducted on February 1, 2018 at 2:30 PM.

During the surgical procedure, the ORSN stated, they would document the surgical items, other than the sharps, sponges, needles, and instruments on a whiteboard (a "wipeable" board on the wall, inside the OR). The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORSN and the DRMPS stated the computer software would not allow the staff to enter any "free text" under the section "Other."

An interview with the Operating Room Circulating Nurse (ORCN), in the presence of the DRMPS, was conducted on February 2, 2018 at 10:30 AM.

During the surgical procedure, the ORCN stated, they would document the surgical items, other than the sharps, sponges and instruments, on a whiteboard but not on the "count" sheet. The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORCN confirmed they had never specified what items were accounted for and documented under "Other." The DRMPS stated the computer software would not allow them to specify which instruments were counted and documented under the section "Other." The DRMPS confirmed, "We have realized the problem."

During a review of the facility's Quality Assurance and Performance Improvement Program (QAPI) on February 5, 2018 at 9:10 AM, the Assistant Hospital Administrator Perioperative Services (AHAPS) confirmed under "Other," the staff would not document each surgical items that were accounted for as per the "standards." The AHAPS stated they followed the accrediting organization's guidelines.

A review of the accrediting organization guidelines provided and highlighted by the facility, titled, "(Name of the Accrediting Organization) Sentinel Event Alert," Issue 51, dated October 17, 2013, revealed, "...URFOs (unintended retention of foreign objects) refer to any item or foreign object related to any operative or invasive procedure that is left inside a patient. Objects most commonly left behind after a procedure are:... Small miscellaneous items, including unretrieved device components or fragments (such as broken parts of instruments), stapler components, parts of laparoscopic trocars, guidewires, catheters, and pieces of drains..."

3. A tour of the operating room (OR) department was conducted with the Perioperative Services Nurse Manager (PSNM 1), the Assistant Clinical Director Perioperative Services (ACDPS), the Charge Nurse, the Director of Nursing of Perioperative Services (DNPS), and the Manager of Sterile Processing (MSP), on January 30, 2018 at 2:45 PM.

During an inspection of the storage area near the Operating Room 8, the following were noted to be stored on one side of the room:

1. (Name of manufacturer) "GI (gastrointestinal) Tower," was used for gastrointestinal process.

2. (Name of manufacturer) "Tower 4," was used for "laparoscopic process" (surgical procedures for visualization/examination of organs).

3. (Name of manufacturer) "Tower 5," was used for "laparoscopic process."

Immediately to the side of "Tower 5," was a blue receptacle containing bags of "laundry." On the other side of the room, there were five "biohazard" gray bins and one trash bag container.

The three tower units, the blue receptacle containing bags of "laundry," the five "biohazard" gray bins, and the one trash bag container, were not labeled whether they were clean or dirty.

The PSNM 1 stated the three tower units stored in this room were clean and were "ready" for use. When asked what the process was to ensure the tower units were clean and ready to be used in the OR rooms, the PSNM 1 stated the staff should clean the tower units before taking them inside the OR rooms. When asked how he would track to ensure it was being done, the PSNM 1 stated, "I do not have a method of tracking."

The MSP stated the practice was, "normally" the tower units would have a plastic bag over them to indicate that they were clean.


34959

4. During a tour of the main hospital facility 2 sterile processing department storage area (where sterilized surgical instruments were stored) on January 30, 2018 at 3:03 PM, the temperature was 75.5 degrees Fahrenheit. (Normal temperature may be as high as 75 degrees Fahrenheit).

During a concurrent interview with the Chief Engineer (CE 1), the CE 1 confirmed that the temperature of 75.5 degrees Fahrenheit was out of range.

During a tour of the facility 2 sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 30, 2018 at 3:05 PM, the temperature of the area was 74.7 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 74.7 degrees Fahrenheit was out of range.

During a tour of the facility 2 sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 30, 2018 at 3:06 PM, the temperature was 75.8 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit)

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 75.8 degrees Fahrenheit was out of range.

During a tour of the facility 2 ambulatory surgery center (same day surgery) sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 30, 2018 at 3:35 PM, the temperature was 77.5 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 77.5 degrees Fahrenheit was out of range.

During a tour of the facility 2 ambulatory surgery center (same day surgery) sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 30, 2018 at 3:45 PM, the temperature was 76.3 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit)

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 76.3 degrees Fahrenheit was out of range.

During a tour of the facility 1 sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 31, 2018 at 10:42 AM, the temperature was 73.0 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit)

During a concurrent interview with the Plant Engineer II (PE II), the PE II confirmed that the temperature of 73.0 degrees Fahrenheit was out of range.

During a review of the facility 1 Sterile Processing Department Decontamination temperature log dated January 31, 2018 at 7:34 AM, indicated the temperature was 70 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit)

During an interview with the Sterile Processing Department Technician (SPDT 2) on January 31, 2018 at 10:57 AM, the SPDT 2 stated that the decontamination temperature on January 31, 2018 at 7:34 AM, was 70 Fahrenheit and that the normal temperature ranges in the decontamination room area is 68 degrees Fahrenheit to 70 degrees Fahrenheit.

During a tour of the facility 1 sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 31, 2018 at 11:10 AM, the temperature was 74.0 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the PE II, the PE II confirmed that the temperature of 74.0 degrees Fahrenheit was out of range.

According to the CDC "Healthcare Infection Control Practices Advisory Committee Guideline for Disinfection and Sterilization in Healthcare Facilities", "...the sterile storage area should have controlled temperatures and may be as high as 75 degrees Fahrenheit and the relative humidity should be 30% to 60% in all work area except sterile storage, where the relative humidity should not exceed 70%."

A review of the facility's current policy and procedure titled, "Temperature and Relative Humidity Management" dated September 2017, included the following: "When controlling the climate and environmental quality in the medical center buildings using heating, ventilation and air conditioning (HVAC) systems, it is important to not only control the room temperature, but also the relative humidity in a range that is comfortable and supports infection control prevention practices and safety. Pursuant to the Association of perioperative Registered Nurses (AORN) and Association for the Advancement of Medical Instrumentation (AAMI) recommend practices, sterile packages shall be stored under environmentally controlled conditions, consistent with the manufacturer's recommendations. Clean preparation, packing, sterile storage, and sterile processing (temperature ranges are (68 degrees Fahrenheit to 73 degrees Fahrenheit) and humidity ranges are 10-60 percent). Sterile Processing Decontamination (temperature ranges are 60 degrees Fahrenheit to 65 degrees Fahrenheit)..."

5a. During a review of Patient 21's clinical record revealed Patient 21 presented to the facility on February 1, 2018 at 12:14 PM, with admission diagnosis of cancer metastatic to brain (brain cancer).

During review of Patient 21's clinical record revealed Patient 21 had a left frontotemporal craniectomy (part of the skull is removed) for debulking (surgical removal part of a tumor) frontemporal mass adenocarcinoma (malignant tumor) on February 1, 2018. The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery.

b. During a review of Patient 22's clinical record revealed Patient 22 presented to the facility on February 1, 2018 at 6:34 AM, with admission diagnosis of umbilical hernia (occurs when the stomach muscles do not join completely and the intestine bulges thru this weak spot).

During a review of Patient 22's clinical record revealed Patient 22 had a umbilical hernia repair with prosthesis (a composite mesh placed in the underlay position with no primary closure of the defect) on February 1, 2018. The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery.

c. During a review of Patient 23's clinical record revealed Patient 23 presented to the facility on February 1, 2018 at 12:34 PM, with admission diagnosis of chronic kidney disease stage 5 (kidneys have lost nearly all their ability to do their job effectively and no longer able to remove waste, fluids from the body, and toxins build up in the blood).

During a review of Patient 23's clinical record revealed Patient 23 had a dialysis access peritoneal dialysis catheter insertion laparoscopic (an alternate form of dialysis for patients in end-stage renal disease). The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery

d. During a review of Patient 24's clinical record revealed Patient 24 presented to the facility on February 1, 2018 at 9:14 AM, with admission diagnosis of left inguinal hernia (a protrusion of abdominal cavity contents through the inguinal canal).

During a review of Patient 24's clinical record revealed Patient 24 had a inguinal hernia repair

Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation: CFR 482.51 Surgical Services was met by failing to ensure:

1. Policy and procedures were implemented during a surgical procedure, there was no documented evidence a complete count (the process of accounting of all the surgical items), and a visual inspection of the integrity of the surgical items were performed. (Refer to A-0951)

2. Multiple charts under the surgical count section, the word "Other" did not identify the specific item being used during surgery. (Refer to A-0951)

3. Sanitary conditions were maintained when clean and "ready-to-use" medical devices were stored together with dirty trash containers and a laundry receptacle. (Refer to A-0951)

4. Temperatures in the sterile processing departments (the area in the facility where they clean, store, and sterilize the surgical instruments) were in appropriate ranges. (Refer to A-00951)

5. Surgical instruments were properly sterilized that were located inside a major and minor tray (where sterilized surgical instruments are stored). (Refer to A-0951)

6. One of three sterilizers (used to sterilize surgical instruments) did not contain a dry white stain at the bottom of the chamber. (Refer to A-0951)

7. Terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed daily in the sterile processing department (the area in the facility where they clean and sterilize the surgical instruments). (Refer to A-0951)

8. The facility followed manufacturer's recommendations on how to clean the cabinet dryer (used to dry various types of medical equipment). (Refer to A-0951)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Surgical Services.

Based on observation, interview, and record review, the hospital failed to ensure the delivery of surgical services were provided in accordance with standard of practice when:

1. For one of 46 sampled patients (Patient 6), Facility 1 failed to ensure its policy and procedure was implemented during a surgical procedure, when there was no documented evidence a complete count (the process of accounting of all the surgical items), and a visual inspection of the integrity of the surgical items were performed.

This failure resulted in retention of a foreign object (RFO, an unintended retention of surgical items during a surgical procedure), of the cartridge to the tacker (an "articulating reloadable fixation device" used to tack the mesh in place), which created adverse effects in the overall health and safety of Patient 6.

2. Multiple charts from Facility 1 and Facility 2 under the surgical count section, the word "Other" did not identify the specific item used during surgery for 14 of 46 sampled patients (Patients 1, 2, 7, 10, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 36). This failure created a potential for an RFO incident to occur. (Refer to findings #2, 5 and 11)

3. Facility 1 failed to ensure sanitary conditions were maintained when clean and "ready-to-use" medical devices (three medical equipment tower units) were stored together with dirty trash containers and a laundry receptacle. This failure created the potential for dirty equipment to be used on a surgical patient.

4. Temperatures in the sterile processing departments at Facility 1 and Facility 2 (the area where they clean, store, and sterilize the surgical instruments) were out of range. This failure created the potential for the spread of infection for surgical patients.

5. (Refer to #2 above)

6. At Facility 1, surgical instruments were not properly sterilized (to destroy any microorganisms used by using high temperature with steam, dry heat, or boiling liquid) that were located inside a major tray (where sterilized surgical instruments are stored). This failure created the potential for cross-contamination among surgical patients.

7. At Facility 1, one of three sterilizers (used to sterilize surgical instruments) contained a dry white stain at the bottom of the chamber. This failure created the potential for the spread of infection for surgical patients.

8. No documented evidence that terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) was performed on January 19, 2018 and January 24, 2018 in the sterile processing department at Facility 1 (the area in the facility where they clean and sterilize the surgical instruments). This failure had the potential for the spread of infection for surgical patients.

9. At Facility 1 and Facility 2, manufacturer's recommendations were not followed on how to clean the cabinet dryer (used to dry various types of medical equipment). This failure had the potential for the spread of infection.

10. Facility 1 failed to remove a damaged instrument from a minor surgical tray. This failure created the potential for the device to carry infection.

11. (Refer to #2 above)

Findings:

1. On August 25, 2017, the California Department of Health (CDPH) received an entity self-reported incident (ERI)report of an RFO incident regarding the "cartridge" (the cartridge, which contained staples, was attached to a tacker and was reloadable. The tacker, a reloadable articulating fixation device, was used to tack the mesh {a sheet used to support the organs or tissues during the surgical procedure}), involving Patient 6.

A review of the "OPERATIVE NOTE" dated December 2, 2016, revealed Patient 6 underwent Left Inguinal Hernia (a protrusion of abdominal cavity contents through a weak spot in the inguinal wall) Repair Laparoscopic (a surgical technique) with prosthesis or graft procedure, by Surgeon 1. The note further revealed, "...DETAILS OF OPERATION: ... The sponge, needle and instrument counts (the accountancy of the items) were correct at the end of the case."

A review of the "Counts" sheet during Patient 6's surgery dated December 2, 2016, revealed the counts of the sponge, needles/sharps, "Other," were documented as "correct" during the initial, closing, and the final counts.

A review of the "DISCHARGE SUMMARY," dated December 2, 2016, revealed Patient 6 was discharged to home on December 2, 2016 (the same day of the surgical procedure). The discharge summary further revealed, "...HOSPITAL COURSE:... Pt (patient) tolerated the procedure well and went to recovery in stable condition."

A review of the history and physical (H & P) documented by the Chief of General Surgery (CGS), dated August 10, 2017, revealed, Patient 6 underwent a laparoscopic left inguinal hernia repair on December 2, 2016. Since the surgery on December 2, 2016, Patient 6 had some discomfort when having bowel movements or when urinating. Patient 6 recently had some urgency and hematuria (presence of blood in the urine). Patient 6 was evaluated by his primary care physician and was given antibiotics and the symptoms were resolved. Patient 6 underwent a Computerized Tomography scan (CT scan, a diagnostic procedure) of the abdomen to rule out kidney stones. The CT scan result revealed, "7 mm (millimeter, a unit of measurement) tubular structure in the low pelvis as detailed above. The etiology is uncertain although the structure has an appearance similar to a (name of the manufacturer) stent (a metal or plastic tube inserted into the lumen of a vessel)..."

A review of Surgeon 1's documentation titled "Assessment/Plan," dated August 10, 2017, revealed, "... s/p laparoscopic left inguinal hernia repair in December now with a foreign body in his pelvis. According to the radiologist it does not appear to be intraluminal (the space in the middle)... I have discussed possibility of retained foreign body from surgery although low likelihood as I don't put anything inside the patient except instruments that are always in my trocar and hand at the same time or the mesh. I can see the mesh in place in the left inguinal region and there is no recurrence of his hernia. The patient denies ingestion or placement of any foreign body so it is truly unclear what this is..."

A review of the "OPERATIVE NOTE," dated August 23, 2017, revealed, "... DETAILS... A foreign body was observed in the lower abdomen and the grasper (a surgical instrument) was used to isolate the foreign body... The foreign body was pulled through the right lateral port site along with the port itself..."

A review of the "OR Post-Op" (operating room postoperative-after surgery) note by the CGS dated August 23, 2017, revealed, "Informed pt (patient) and family, that the retained foreign body was the tip (cartridge) of tacker used in lap (laparoscopic) inguinal surgery..."

A review of the Surgical Pathology report dated August 24, 2017, revealed, "...GROSS DESCRIPTION...'foreign body' is a 7.9 cm (centimeter-a unit of measurement) in length x 0.5 cm in diameter hollow silver, metallic bar inscribed with '(name of the manufacturer) 10 Tacks'..."

An interview with Surgeon 1 was conducted on January 31, 2018 at 11:01 AM. Surgeon 1 stated she was not aware of the RFO incident on December 2, 2016, until Patient 6 sent an email on August 9, 2017 (approximately eight months after the surgery), indicating Patient 6's discomfort upon urination with presence of bleeding. Surgeon 1 stated during the surgical procedure on December 2, 2016, no one expressed knowledge of the RFO incident. If she would have known about it, Surgeon 1 stated she would have removed the RFO and would have reported it. Surgeon 1 stated, "We didn't see it happen." Surgeon 1 stated that sometime in December 2016, there was a poll was taken by the surgeons regarding the tacker. The surgeons had indicated that they did not like using this tacker because it was long, was difficult to use, and it flexed too much.

The Surgeon 1 confirmed when the tacker was pulled out of the patient, Surgeon 1 handed the tacker to the Operating Room (OR) Scrub Nurse (ORSN). The Surgeon 1 confirmed a visual inspection of the tacker was not conducted when the tacker was pulled out of Patient 6; "No, usually I am looking at the screen and I pass the instrument to the Scrub tech (nurse)."

When asked if the cartridge should have been accounted for, the Surgeon 1 stated the Scrub Nurse and the Circulating Nurse would tell the Surgeon 1 if the count was "OK." The Surgeon 1 stated the Scrub nurse was responsible to check if the instrument was intact.

An interview with the Operating Room Scrub Nurse (ORSN), in the presence of the Director of Risk Management and Patient Safety (DRMPS), and a concurrent review of Patient 6's clinical record, were conducted on February 1, 2018 at 2:30 PM.

The ORSN stated the tacker was a single-use device that came in two parts; the tacker and the reloadable cartridge that contained ten staples in each cartridge. The tacker used during Patient 6's surgery came with four cartridges. The ORSN stated she had to "put it (the tacker and the cartridge) together" by loading the tacker with the cartridge, before handing it to Surgeon 1. The ORSN stated she could not remember how many times she had to reload the tacker with the cartridge.

During the initial count, the ORSN stated she and the OR Circulating Nurse (ORCN) noted there were four cartridges. During the final count, the tacker and the cartridge were counted as "one," and the count was noted to be correct. The ORSN stated, "How it got overlooked, I can't tell you." The ORSN stated, "I probably counted (the tacker and the cartridge) as one (unit) because I did not disengage the 4th cartridge." The ORSN stated the 4th cartridge was the one that "came off the field." The ORCN stated, "More than likely we overlooked the count" because the tacker was counted as one unit, "thinking" the 4th cartridge was still attached to it.

When asked to provide documented evidence to show the tacker and the cartridges were included during the count, the ORSN stated the final count of the tacker was noted under the section, "Other (items other than the sponges, needles, instruments, and sharps)" on the count sheet.

During a concurrent review of the "Count" sheet, it revealed the count for the "Other" was correct. The ORSN confirmed the count sheet did not specify the instruments counted under the section "Other" and that there was no documented evidence to show the accounting of the tacker and the cartridges. During the surgical procedure, the ORSN stated, they would document the surgical items, other than the sharps, sponges, needles, and instruments on a whiteboard (a "wipeable" board on the wall, inside the OR). The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORSN and the DRMPS stated the computer software would not allow the staff to enter any "free text" under the section "Other."

The ORSN confirmed that during the surgical procedure, it was not brought to anyone's attention that the cartridge came off of the tacker or that the tacker was missing the cartridge. The ORSN stated this particular tacker was purchased because it "angulates" and stated they did not know that the cartridge could "come off easily."

An interview with the Chief of General Surgery (CGS), the presence of the DRMPS, and a concurrent record review, were conducted on February 2, 2018 at 9:50 AM. The CGS confirmed the cartridge of the tacker "came loose" during the surgery on December 2, 2016. When asked what the process was to ensure the surgical items were accounted for and the integrity of the instruments were inspected, the CGS stated the "disposable instruments (i.e tacker)" were not part of the surgical instrument count. The CGS stated all the surgical items brought in during the surgical procedure should have been accounted for.

An interview with the ORCN, in the presence of the DRMPS, and a concurrent record review were conducted on February 2, 2018 at 10:30 AM.

The ORCN confirmed the tacker and the cartridges were not part of the surgical count per the facility's policy and procedure, at the time the RFO incident on December 2016 happened. The ORCN stated, the tacker was "one long instrument." The ORCN stated she could not remember how many cartridges were used during Patient 6's surgical procedure on December 2, 2016. The ORCN confirmed she was "not familiar with this particular tacker." The ORCN stated she was more familiar with the "old" product (a single-use, non-reloadable tacker that did not have to use a cartridge), that had been used in the past. The ORCN stated, "I didn't even realize we had changed the whole instrument (from the non-reloadable tacker to this reloadable tacker)." The ORCN confirmed she did not notice the change of the product and did not realize it was not the same product she has been familiar with.

The ORCN added, "I don't scrub much, I'm not familiar with the stuff on the (surgical) field," noting that she used to work at the Obstetrics and Gynecology (OBGYN, pertains to the delivery of babies and the treatment of disease of the reproductive organs) department.

The ORCN stated the tacker and the cartridges were never part of the count at the time the RFO incident happened. If it were, it would have been documented under the section "Other" on the count sheet. During the surgical procedure, the ORCN stated, they would document the surgical items, other than the sharps, sponges and instruments, on a whiteboard but not on the "count" sheet. The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORCN confirmed they had never specified what items were accounted for and documented under "Other." The DRMPS stated the computer software would not allow them to specify which instruments were counted and documented under the section "Other." The DRMPS confirmed, "We have realized the problem."

The ORCN confirmed that during the surgical procedure, it was not brought to anyone's attention that the cartridge came off or that the tacker was missing the cartridge.

During a review of the facility's Quality Assurance and Performance Improvement Program (QAPI) on February 5, 2018 at 9:10 AM, the QAPI committee members confirmed they were not aware of the RFO incident during Patient 6's surgical procedure on December 2, 2016, until the Patient 6 presented with complaints in August 2017 (approximately eight months after the RFO incident). In the case of Patient 6, the Assistant Hospital Administrator Perioperative Services (AHAPS) confirmed the facility's policy and procedure indicating that all surgical items should have been evaluated for integrity, was not followed.

A review of the facility's policy and procedure titled, "Counts, Sponge, Sharps, and Instruments (Prevention of Retained Surgical Items), revision date: September 2016, set forth, "POLICY STATEMENT(S):... 2. Counts of sponges; sharps; miscellaneous items; and instruments are performed to account for all items used on the surgical field and to lessen the potential for injury to the patient as a result of a retained surgical item... 5. All items introduced to the field will be visually inspected before, during, and after a procedure by the scrub person and accounted for in their entirety. Particular attention must be given to instruments and devices with multiple parts anytime an item is modified from its "original state" including but not limited to penrose drain, umbilical tape, and vessel loops will be inspected by the surgical team members. Items will be measured before use, after removal and documented on the white board...11. If at any time, a count discrepancy is noted, it is the responsibility of the scrub person and circulating nurse to inform the team immediately...PROVISIONS/PROCEDURES FOR INSTRUMENTS: 1. The scrub person will perform an instrument inventory of all instruments prior to and at the end of all procedures, utilizing instrument count sheets. 2. Instrument count sheets will list type and amount of each instrument. 3. Instrument count sheets will be passed off to the circulating nurse by scrub person. 4. The scrub person and the circulating nurse will verify that the instrument count sheets are accurate. This verification will be noted by the circulator on each count sheet by documenting the initials of the scrub person and circulating nurse. 5. Individual pieces of assembled instruments (suction tips, wing nuts, blades, sheaths) will be accounted for separately...7. Added instruments will be recorded on the instrument count sheet and/or white board to ensure they are counted with the rest of the instruments... Documentation...1. In the patient's electronic medical record under the intra-operative section: A. All surgical counts and cavity checks will be documented in the patient's intra-operative record by the circulating nurse..."

2a. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 1's clinical record were conducted on February 1, 2018 at 9:35 AM.

A review of Patient 1's clinical record revealed, Patient 1 was admitted on January 27, 2018.

The operative report dated January 30, 2018, revealed Patient 1 underwent surgical procedures that included aortocoronary bypass (a surgical procedure pertaining to the heart and the arteries) of coronary arteries. The note revealed that the surgical counts under the section "Other," during the initial count (prior to skin incision), and the cavity closing, the closing, the final (at the end), revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under this section "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles, and instruments.

b. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 2's clinical record were conducted on February 1, 2018 at 10:20 AM.

A review of Patient 2's clinical record revealed, Patient 2 was admitted on January 30, 2018.

The operative report dated January 30, 2018, revealed Patient 2 underwent surgical procedures that included ventral hernia (pertains to the abdominal wall) repair. The note revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges and instruments.

c. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 7's clinical record were conducted on February 1, 2018 at 3:35 PM.

A review of Patient 7's clinical record revealed, Patient 7 was admitted on December 12, 2017.

The operative report dated December 12, 2017, revealed Patient 7 underwent surgical procedure appendectomy (pertains to the removal of the appendix, the lower end of the large intestine). The note revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under the section "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles and instruments.

d. An interview with the Director of Risk Management and Patient Safety (DRMPS) and a concurrent review of Patient 10's clinical record were conducted on February 2, 2018 at 11 AM.

A review of Patient 10's clinical record revealed, Patient 10 was admitted on January 29, 2018.

The operative report dated January 29, 2018, revealed Patient 10 underwent surgical procedures that included hemi laminotomy (a surgical procedure to relieve the pressure of the spine).

The note revealed that the surgical counts under the section "Other," during the initial count, the closing, and the final, revealed, the surgical counts were correct.

There was no documented evidence of what surgical items were accounted for under the section "Other."

When asked what items were accounted for under "Other," the DRMPS stated, it would be the surgical items, other than the sharps, sponges, needles and instruments.

An interview with the Operating Room Scrub Nurse (ORSN), in the presence of the Director of Risk Management and Patient Safety (DRMPS), was conducted on February 1, 2018 at 2:30 PM.

During the surgical procedure, the ORSN stated, they would document the surgical items, other than the sharps, sponges, needles, and instruments on a whiteboard (a "wipeable" board on the wall, inside the OR). The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORSN and the DRMPS stated the computer software would not allow the staff to enter any "free text" under the section "Other."

An interview with the Operating Room Circulating Nurse (ORCN), in the presence of the DRMPS, was conducted on February 2, 2018 at 10:30 AM.

During the surgical procedure, the ORCN stated, they would document the surgical items, other than the sharps, sponges and instruments, on a whiteboard but not on the "count" sheet. The result of the count (whether correct or not) would then be documented under the section "Other" on the "count" sheet. The count under the section "Other" would not document the specific items counted. The ORCN confirmed they had never specified what items were accounted for and documented under "Other." The DRMPS stated the computer software would not allow them to specify which instruments were counted and documented under the section "Other." The DRMPS confirmed, "We have realized the problem."

During a review of the facility's Quality Assurance and Performance Improvement Program (QAPI) on February 5, 2018 at 9:10 AM, the Assistant Hospital Administrator Perioperative Services (AHAPS) confirmed under "Other," the staff would not document each surgical items that were accounted for as per the "standards." The AHAPS stated they followed the accrediting organization's guidelines.

A review of the accrediting organization guidelines provided and highlighted by the facility, titled, "(Name of the Accrediting Organization) Sentinel Event Alert," Issue 51, dated October 17, 2013, revealed, "...URFOs (unintended retention of foreign objects) refer to any item or foreign object related to any operative or invasive procedure that is left inside a patient. Objects most commonly left behind after a procedure are:... Small miscellaneous items, including unretrieved device components or fragments (such as broken parts of instruments), stapler components, parts of laparoscopic trocars, guidewires, catheters, and pieces of drains..."

3. A tour of the operating room (OR) department was conducted with the Perioperative Services Nurse Manager (PSNM 1), the Assistant Clinical Director Perioperative Services (ACDPS), the Charge Nurse, the Director of Nursing of Perioperative Services (DNPS), the Manager of Sterile Processing (MSP), on January 30, 2018 at 2:45 PM.

During an inspection of the storage area near the Operating Room 8, the following was observed to be stored on one side of the room:

1. (Name of manufacturer) "GI (gastrointestinal) Tower," was used for gastrointestinal process.

2. (Name of manufacturer) "Tower 4," was used for "laparoscopic process" (surgical procedures for visualization/examination of organs).

3. (Name of manufacturer) "Tower 5," was used for "laparoscopic process."

Immediately to the side of "Tower 5," was a blue receptacle containing bags of "laundry." On the other side of the room, there were five "biohazard" gray bins and one trash bag container.

The three tower units, the blue receptacle containing bags of "laundry," the five "biohazard" gray bins, and the one trash bag container, were not labeled whether they were clean or dirty.

The PSNM 1 stated the three tower units stored in this room were clean and were "ready" for use. When asked what the process was to ensure the tower units were clean and ready to be used in the OR rooms, the PSNM 1 stated the staff should clean the tower units before taking them inside the OR rooms. When asked how he would track to ensure it was being done, the PSNM 1 stated, "I do not have a method of tracking."

The MSP stated the practice was, "normally" the tower units would have a plastic bag over them to indicate that they were clean.


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4. During a tour of the main hospital facility 2 sterile processing department storage area (where sterilized surgical instruments were stored) on January 30, 2018 at 3:03 PM, the temperature was 75.5 degrees Fahrenheit. (Normal temperature may be as high as 75 degrees Fahrenheit).

During a concurrent interview with the Chief Engineer (CE 1), the CE 1 confirmed that the temperature of 75.5 degrees Fahrenheit was out of range.

During a tour of the facility 2 sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 30, 2018 at 3:05 PM, the temperature of the area was 74.7 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 74.7 degrees Fahrenheit was out of range.

During a tour of the facility 2 sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 30, 2018 at 3:06 PM, the temperature was 75.8 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit)

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 75.8 degrees Fahrenheit was out of range.

During a tour of the facility 2 ambulatory surgery center (same day surgery) sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 30, 2018 at 3:35 PM, the temperature was 77.5 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 77.5 degrees Fahrenheit was out of range.

During a tour of the facility 2 ambulatory surgery center (same day surgery) sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 30, 2018 at 3:45 PM, the temperature was 76.3 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit)

During a concurrent interview with the CE 1, the CE 1 confirmed that the temperature of 76.3 degrees Fahrenheit was out of range.

During a tour of the facility 1 sterile processing department decontamination room (a room where the surgical instruments are cleaned of gross soil and are inspected for damage) on January 31, 2018 at 10:42 AM, the temperature was 73.0 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit)

During a concurrent interview with the Plant Engineer II (PE II), the PE II confirmed that the temperature of 73.0 degrees Fahrenheit was out of range.

During a review of the facility 1 Sterile Processing Department Decontamination temperature log dated January 31, 2018 at 7:34 AM, indicated the temperature was 70 degrees Fahrenheit. (Normal temperature are 60 degrees Fahrenheit to 65 degrees Fahrenheit)

During an interview with the Sterile Processing Department Technician (SPDT 2) on January 31, 2018 at 10:57 AM, the SPDT 2 stated that the decontamination temperature on January 31, 2018 at 7:34 AM, was 70 Fahrenheit and that the normal temperature ranges in the decontamination room area is 68 degrees Fahrenheit to 70 degrees Fahrenheit.

During a tour of the facility 1 sterile processing department preparing and packing area (where they pack and place the surgical instruments in the trays) on January 31, 2018 at 11:10 AM, the temperature was 74.0 degrees Fahrenheit. (Normal temperature are 68 degrees Fahrenheit to 73 degrees Fahrenheit).

During a concurrent interview with the PE II, the PE II confirmed that the temperature of 74.0 degrees Fahrenheit was out of range.

According to the CDC "Healthcare Infection Control Practices Advisory Committee Guideline for Disinfection and Sterilization in Healthcare Facilities", "...the sterile storage area should have controlled temperatures and may be as high as 75 degrees Fahrenheit and the relative humidity should be 30% to 60% in all work area except sterile storage, where the relative humidity should not exceed 70%."

A review of the facility's current policy and procedure titled, "Temperature and Relative Humidity Management" dated September 2017, included the following: "When controlling the climate and environmental quality in the medical center buildings using heating, ventilation and air conditioning (HVAC) systems, it is important to not only control the room temperature, but also the relative humidity in a range that is comfortable and supports infection control prevention practices and safety. Pursuant to the Association of perioperative Registered Nurses (AORN) and Association for the Advancement of Medical Instrumentation (AAMI) recommend practices, sterile packages shall be stored under environmentally controlled conditions, consistent with the manufacturer's recommendations. Clean preparation, packing, sterile storage, and sterile processing (temperature ranges are (68 degrees Fahrenheit to 73 degrees Fahrenheit) and humidity ranges are 10-60 percent). Sterile Processing Decontamination (temperature ranges are 60 degrees Fahrenheit to 65 degrees Fahrenheit)..."

5a. During a review of Patient 21's clinical record revealed Patient 21 presented to the facility on February 1, 2018 at 12:14 PM, with admission diagnosis of cancer metastatic to brain (brain cancer).

During a review of Patient 21's clinical record revealed Patient 21 had a left frontotemporal craniectomy (part of the skull is removed) for debulking (surgical removal part of a tumor) frontemporal mass adenocarcinoma (malignant tumor) on February 1, 2018. The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery.

b. During a review of Patient 22's clinical record revealed Patient 22 presented to the facility on February 1, 2018 at 6:34 AM, with admission diagnosis of umbilical hernia (occurs when the stomach muscles do not join completely and the intestine bulges thru this weak spot).

During a review of Patient 22's clinical record revealed Patient 22 had a umbilical hernia repair with prosthesis (a composite mesh placed in the underlay position with no primary closure of the defect) on February 1, 2018. The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery.

c. During a review of Patient 23's clinical record revealed Patient 23 presented to the facility on February 1, 2018 at 12:34 PM, with admission diagnosis of chronic kidney disease stage 5 (kidneys have lost nearly all their ability to do their job effectively and no longer able to remove waste, fluids from the body, and toxins build up in the blood).

During a review of Patient 23's clinical record revealed Patient 23 had a dialysis access peritoneal dialysis catheter insertion laparoscopic (an alternate form of dialysis for patients in end-stage renal disease). The surgical count section indicated the word "Other" and did not identify the specific items that were used during surgery

d. During a review of Patient 24's clinical record revealed Patient 24 presented to the facility on February 1, 2018 at 9:14 AM, with admission diagnosis of left inguinal hernia (a protrusion of abdominal cavity contents through the inguinal canal).