The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST JOHNS REGIONAL MEDICAL CENTER 1600 N ROSE AVE OXNARD, CA 93030 Aug. 25, 2016
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview and document review, the hospital's governing body was not effective at ensuring that the Quality Assurance and Performance Improvement (QAPI) program was performing its required functions. There was evidence that the surgical services were not being properly monitored for safe and adequate patient care, resulting in substantial risk to patients and staff throughout the hospital.

Findings:

1. The hospital's governing body did not ensure that all services were adequately monitored by Quality Staff (Refer to tag A-0263 an A0083)

2. The governing body failed to ensure that the provision of surgical services was done in a way to assure the achievement and maintenance of high standards of medical practice and patient care. (Refer to tag A-0940 and 0951)

These findings together resulted in the condition for Governing Body being NOT MET
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on interview and record review the governing body was not effective at ensuring oversight on contracted services.

Findings:

A review of the written agreement between the hospital and the perfusionist services (PS)signed 2/12/15 on 1/13/16 at 3 p.m., revealed the following: the perfusionist was to prepare and maintain all necessary equipment for the procedure, set up the heart-lung machine, regulate blood flow, and provide a complete and accurate medical record. Also, according to the written agreement the PS was to provide quarterly quality monitoring reports to the hospital. There was no end date on the contract. Interview with the quality staff manager and the operating room manager on 4/5/16 at 3:20 p.m., revealed that quarterly reports were not provided according to the PS contract, but that the operating room manager prepared an annual quality report. Further interview revealed there was no documentation that the medical executive committee reviewed the PS contracted service as required by facility policy as stated by the quality manager. There was no documentation that the PS contract was renewed by the facility board when reviewed on 8/19/15; and there was no end date on the contract. There was no documentation provided that all recommendations made to prevent reoccurrence in the malfunction of the machine, or to prevent user error were discussed with the PS staff. On 1/20/16 and 5/17/16 an inservice attendance form containing two perfusionist signatures was provided, but no lesson plan was available.

During an interview with administrative staff on 8/22/16 at 8:45 a.m., the VP of quality shared that after the perfusion incident, the hospital leadership also reviewed other, similar, contracted services. This included a dialysis contracted service. According to the VP of Medical Quality there will be more oversight of such services such as checklists indicating what information has been obtained on a contracted employee.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
Based on observation, interview and record review the facility failed to ensure that 2 of 31 sampled patients (Patient N103 and N203) had a plan of care or an update of the plan of care as to the need for restraints. This failure had the potential to decrease continuity and assurance that care plan goals were met.

Findings:

Hospital policy and procedure entitled, "Restraints," dated 3/92, last revised 11/14, page 7 of 9 indicated in part, "J. Documentation...... 9. Modification of plan of care to include the use and discontinuation of restraints."

During an observation on 8/22/16, at 11:15 a.m., accompanied with LN3, Patient N103 was seen laying on his back, in bed wearing a diaper. There were no sheets covering the patient. A soft restraint was noted on his right wrist which was attached to the bed rail. The patient did not give eye contact and had no verbal response to questions asked.

During a concurrent record review and interview with LN3 on 8/22/16 starting at 12:15, LN3 was asked if she could locate the restraint use in the patients plan of care, LN3 acknowledged she could not locate any restraints in the patients plan of care. LN3 shared the plan of care should include the use of a restraint but it was not noted.

Review of the clinical record for N203 on 8/22/16, at 11:04 a.m, revealed conditions including Methicillin-resistant Staphylococcus aureus (MRSA) (a bacteria responsible for several difficult-to-treat infections in humans) in blood and urine, acute kidney injury, anxiety and urinary tract infection. The physician ordered restraints started on 8/15/16 and renewed the order on 8/17, 8/19, 8/20 and 8/22/16.

During an observation on 8/22/16, at 11:00 a.m, Patient N 203 was seen in the isolation room, calling the nurse in a high toned voice with bilateral soft restraints on both wrists.

During an interview and concurrent record review with licensed nurse (LN4) on 8/22/16, at 11:08 a.m, LN4 shared there was no care plan regarding the use of restraints or the fact that restraints were initiated/updated on 8/15, 8/17, 8/19, 8/20 and 8/22/16.

The policy and procedure titled "Restraints" dated 1/2014 indicated an order must be obtained prior to the use of restraints, initiate the plan of care and review at least daily and update the plan of care per patient problem, goals and intervention change.
VIOLATION: QAPI Tag No: A0263
Based on observation, interview and document review, the hospital's Quality Department failed to adequately monitor all services provided. A number of improper practices in the operating rooms were not addressed by the hospital's quality department. The Quality staff were unware of issues regarding the sterilization of surgical instruments, performance of surgical counts, and the improper use of personal protective equipment during surgery. They were not aware that the operating room floors were being cleaned with a not EPA-registered product. Endoscopes were improperly stored. Water bottles used in the Gastrointestinal (GI) lab to irrigate endoscopes during procedures were not changed between patients.

These deficient practices resulted in the possibility of an increased risk of transmission of infectious agents between patients and staff.

Findings:

1.The hospital's governing body did not ensure that all services were adequately monitored by Quality Staff (Refer to tag A-0286 and A-0083)

2. The hospital failed to ensure that processes of care and operations were measured, analyzed, and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practice. (Refer to tag A-286 and A-309)

3. The facility failed to show measurable improvement and establish clear safety measures. (Refer to tag A-0286).
4. The hospital's quality staff failed to monitor the provision of surgical services were provided in a way to assure the achievement and maintenance of high standards of medical practice in accordance with acceptable standards of practice. (Refer to tag A-0940)


These findings together result in the condition for Quality Assurance and Performance Improvement being NOT MET.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on observation, interview and record review the facility failed to provide evidence to show measurable improvement and establish clear safety measures as evident by the three index cases:
1. The hospital failed to fully implement and monitor their root cause analysis (RCA) following a surgical event which involved the retention of a piece of a towel clamp in 1 patient. The facility did not put an action plan in place following their RCA in order to prevent any future retained foreign object's such as retained broken surgical equipment when performing surgeries.
2. The hospital failed to identify opportunity for improvement and implement actions to track performance and ensure improvements are in place and sustained when they failed to collect accurate data related to the death of Patient N 500, thus not ensuring changes were implemented to avoid a similar event. Patient N 500 was undergoing open heart surgery when a malfunction in the bypass machine (heart lung machine) and/or end user error by the perfusionist caused the blood to remain inside the pump rather than the patient for 20 minutes resulting in the death of Patient N 500. According to the facility's quality staff, they were not privileged to the results of the "forensic investigation". Without quality staff being aware of the reasons for the failure they were unable to ensure steps were taken to prevent further mishaps of the same nature from occurring.
3. The hospital failed to identify/report a miscount in the operating room, resulting in the retained pacemaker pin in one patient (N 402).
Findings:
1. During an interview with Adm 1, on 8/23/16 at 4:50 p.m., Adm 1 explained that after the RCA, a policy and procedure addressing the inspection of surgical instruments and/or tagging damaged instruments in the surgical services was created to prevent future RFO events.
During another interview with Adm 1, on 8/24/16 at 9:55 a.m., she acknowledged and confirmed the mentioned policy had not been created. She was not able to provide such a policy. Adm 1 stated "Ok, the policy is not there, it would be my action plan to create or make sure the policy is created to address the instrument inspection".
During an interview with Adm 3 on 8/24/16 at 10:02 a.m., she explained that during the RFO adverse event, there was no process in place in the operating room (OR) as to what to do if an instrument was damaged (broken towel clamp tip). The OR staff did whatever they thought was the correct thing to do. It was up to the OR staff "diligence" to do what was needed for a damaged instrument.
The VP of Quality presented the manufacturer's recommendations for the towel clamps used in surgery in the hospital. The Backhaus towel clamp description from the manufacturer indicated in addition to its use to clamp towels it can also be used for "holding or reducing small bone fractures".
2. During an interview on 12/21/15 at 1:13 p.m., quality staff 1 revealed that an inspection of the failed machine was done, but that the quality staff did not have access to the report. Quality staff referred to the investigation as a "Forensic report" which was "client attorney privilege only"

During an interview on 2/2/16 at 11:30 a.m. quality staff 1 revealed she was not certain if all recommendations from the forensic report would be followed. At one point, according to quality staff the report had indicated the "RPM's" on the bypass machine may need to be "slowed down", but "only if the manufacturer agreed", the reason for the suggestion was not shared with the quality staff. According to the Quality staff the perfusionist involved (P1) with the case was not allowed to operate the pumps in the facility any longer and only manufacturers parts for the machine would be used.

During an interview with the medical office staff and a concurrent review of perfusionist's (P1) personnel file on 3/28/16 at 12:00 p.m., the file revealed that P1 currently had all the privileges granted by the facility including operating a heart-lung machine. There was no documentation of the restriction of his practice.

During an interview and concurrent observation on 4/5/16 at 1:00 p.m., with quality staff 2 present, P3 demonstrated how a heart-lung machine operated and showed how the pump head would be replaced. He also indicated that when there is no flow he would use the hand crank first to get the blood back into the patient before performing any changes on the bypas machine. A review of manufacturer's instructions for the machine with P3 revealed that their same brand of pump head should be used "exclusively" with the machine. P3 indicated that the pump head P1 used (not the brand recommended) had been routinely used by their company, but since Patient N500's death only the recommended brand is used. Review of the operating room storage area with quality staff 2 revealed that the off brand pump heads were stored and available for use; there was no documentation to support the changes made in the use of pump heads. When questioned, P3 said the off brand pump heads can be used on the other machine.

A review of the written agreement between the hospital and the perfusionist services (PS)signed 2/12/15 on 1/13/16 at 3 p.m., revealed the following: the perfusionist was to prepare and maintain all necessary equipment for the procedure, set up the heart-lung machine, regulate blood flow, and provide a complete and accurate medical record. Also, according to the written agreement the PS was to provide quarterly quality monitoring reports to the hospital. There was no end date on the contract. Interview with quality staff manager and the operating room manager on 4/5/16 at 3:20 p.m. revealed that quarterly reports were not provided according to the PS contract, but that the operating room manager prepared a yearly quality report. Further interview revealed there was no documentation that medical executive committee reviewed PS contracted service as required by facility policy as stated by the quality manager. There was no documentation that the PS contract was renewed by the facility board when reviewed on 8/19/15; and there was no end date on the contract. There was no documentation provided that all recommendations made to prevent reoccurrence in the malfunction of the machine, or to prevent user error were discussed with the PS staff. On 1/20/16 and 5/17/16 an inservice attendance form containing two perfusionist signatures was provided, but no lesson plan was available.

An interview with quality staff and the medical director on 5/17/16 revealed that they do not know the exact cause of the heart lung machine malfunction.

During an interview with the VP of quality on 8/24/16 at 2:00 p.m., he stated that some of the staff in the OR at the time of the perfusion incident were not available during the initial five days of the RCA when most of the interviews were done. He stated that it was a "gap" in the investigation that these individuals were not interviewed later when they were available. He also stated that the new policy on instrument counts and examination of surgical instruments in the OR was still being developed.

3. During an emergency record review dated 7/6/15, Patient N 402 returned to the hospital's emergency room , complaining of abdominal pain for the past 15 days. A CT scan was done and according to the CT report there was a "7 cm (2.75 inches) long metallic wire within the upper abdominal wall subcutaneous tissues...probably represents a remnant epicardial pacing lead...correlation with clinical findings and the surgical history recommended..." According to the ED Physician note dated 7/6/15 at 3:09 a.m., when the object was removed in the emergency room under local anesthesia, it "appeared to be a surgical straight suture needle." The pathology report dated 7/6/15 indicated "...Specimen is a silver needle-like object 7 cm in length, approximately 1 mm in diameter..."
During an interview on 7/28/15 at 12:00 p.m., with the surgeon, regarding Patient N 402's retained needle following heart surgery on 12/19/14, the surgeon stated "One of the pacer wire needles broke off, the needle got lost inside the patient's abdominal tissue, I attempted to retrieve the needle, but I couldn't retrieve it." The surgeon shared continuing to attempt to retrieve the needle would have caused more damage to the patient. According to the surgeon "I forgot about the needle completely, I didn't remember anything about the pacer-wire needle until recently when Quality contacted me to let me know there was a needle inside the patient. At that time, I remembered the incident again."
During an interview and concurrent record review for Patient N402 on 7/28/15 at 1:50 p.m., LN 7 reported during the procedure the surgical count was documented as being "correct" for all three counts as the surgical staff were counting the lost needle inside Patient N402 as a part of the count. According to LN 7, the count was considered correct because they knew where the needle was, inside the patient.
During an interview on 7/28/15 at 2:25 p.m., the scrub tech (SCT 1) stated, "When we counted I mentioned there was a needle inside the patient. Everyone knew one needle was still inside the patient. We started counting by saying, "One needle in the patient" that was needle number 1, then we continued counting the rest of the needles on the table.
The quality department was not aware of a RFO in Patient N401, even though the surgical team was, until the patient returned almost 8 months later due to pain from a migrating needle.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on observation, interview and document review, the hospital's governing body failed to ensure that the Quality Department was adequately monitoring all services provided. A number of improper practices in the operating rooms were not addressed by the hospital's quality department. The Quality staff were unware of issues regarding the improper use of personal protective equipment during surgery. They were not aware that the operating room floors were being cleaned with a not EPA-registered product. Endoscopes were improperly stored.

These deficient practices resulted in the possibility of an increased risk of transmission of infectious agents between patients and staff.

Findings:

The Ambulatory Surgery Center was inspected on August 24, 2016 at 9:00 AM. An observation was made of housekeeping staff cleaning the floor of one of the OR's with a mop. OR cleaning personnel were questioned regarding the contact time for the product she was using. She stated there was no contact time and that she only had to wet the floor once. She produced a jug labeled "Prominence Heavy Duty Floor Cleaner." Inspection of the label indicated that this was a general floor cleaner. No indications for use in hospitals or operating rooms were stated. There was no evidence of EPA registration. The hospital policy on the sanitation of surgical suites entitled "Between Case Surgery Suite Cleaning" (ES. 2.16, last review 2/5/24), indicated "Using General Purpose Cleaner, work in a counter clockwise direction..." The policy also indicated the same product can be used for objects and surfaces in the ORs. The hospital follows the guidelines of the American Organization of peri-Operative Nurses "Guidelines for Environmental Cleaning, January 2016" inidcated that "a multidisciplinary team should evaluate the following factors during selection of a cleaning detergent or disinfectant chemical....EPA registration and rating as hospital grade."

Closed medical records of surgical patients were reviewed on 8/24/16 at 3:05 PM. Patient MC 8 received general anesthesia for a complex abdominal surgery in the Ambulatory Surgery OR on 6/16/16. No post-anesthesia assessment could be found in the medical record. The Clinical Informatics Nurse was present and unable to find the assessment. She agreed that the post anesthesia assessment is required. The Vice President of Medical Quality was interviewed on 8/24/16 at 4:00 PM. He stated that a post anesthesia note should be present when anesthesia is used and that hospital leadership had addressed this issue about a year ago.

Patient MC 9 had surgery at the Ambulatory Surgery Center on 7/11/16. She was sent home after recovering from sedation, however there was no discharge order in the record. The Clinical Informatics Nurse was present and unable to find the order.
VIOLATION: NURSING CARE PLAN Tag No: A0396
The facility failed to implement a plan of care for two patients (N100 and N300) as it related to pressure ulcers.

Findings:

A review of the record of Patient N100, revealed the patient was admitted with a diagnoses to include "Sacral decubitus ulcers" (a skin ulcer compromised by pressure over a bony prominence). Further review of the care plan did not indicate the patient had a plan of care for the decubitus ulcer.

During a concurrent record review and interview with Adm 4 staff, on 8/23/16, starting at 9:20 a.m., Adm.4 confirmed the lack of a care plan for the decubitus ulcer stating "...should have been care planned."




During a record review and concurrent interview on 8/24/16 at 11:00 a.m., the director of medical/surgical unit (DMS) acknowledged that on 8/22/16 the post anesthesia care unit (recovery area from surgery) nurse documented Patient N300 had a stage II pressure ulcer (localized injury to the skin and/or underlying tissue, usually over a body prominence as a result of pressure, or pressure in combination with shear). The DMS was unable to provide any documentation mentioning the pressure ulcer until 8/23/16 at 7 p.m. when an order for a wound nurse was entered into the computer. The DMS reported there was no care plan in place to address prevention of skin breakdown on a patient who had orthopedic surgery and had limited mobility. The DMS reported a care plan should have been initiated for skin integrity on admission to the unit.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on record review and interview, the facility failed to ensure:

1. Documentation of post pain medication administration intensity level for six of 31 sampled patients (N201, N203, N100, N101, N102 and N300)

2. The facility failed to assure physicians order were present when patient N 304 was placed on oxygen.

These deficient practices placed patient's at risk for uncontrolled pain and medication errors.

Findings:

The facility policy and procedure titled "Pain Management", dated 6/2014, indicated, reassess and document patient pain status within 30 to 60 minutes after pain intervention.

1. Review of the clinical record for Patient N201 on 8/22/16 at 11:30 a.m, revealed conditions including post surgery of gangrenous foot, left leg amputation and pressure ulcer on the left hip. A physician order dated 8/9/16, revealed an order for morphine (narcotic pain medication) one to three milligram (mg), intravenous push, every 4 hours as needed for pain scale.

Review of the medication administration record (MAR) summary on 8/22/16, at 11:32 a.m, revealed on 8/9/16, Patient N201 received morphine 3 mg at 9:05 p.m for pain intensity of "8".

During an interview with the licensed nurse (LN4) on 8/22/16 at 11:34 a.m, the LN was unable to locate any notation to indicate Patient N201's pain was re-evaluated following the morphine administration.

2. The clinical record for Patient N203 was reviewed on 8/24/16 at 9:10 a.m.. according to the MAR Patient N203 received Norco (a narcotic pain medication) 5/325 mg two tablets on 8/19/16 at 9:26 a.m and 5:52 p.m.

During an interview with the licensed nurse (LN3) on 8/24/16 at 9:15 a.m, LN3 confirmed, there was no post pain medication assessment documented.










3. During a concurrent record review and interview with ADM4 on 8/23/16, at 9:20 a.m., Patient N100's record revealed Patient N100 had received Norco (pain medication) 1 tablet on 8/21/16, at 4:24 P.M., for pain level intensity of "8". The order written by the physician indicated to "assess response after 30 minutes." ADM 4 acknowledged after a review of the record there was no post pain medication assessment.

4. During a concurrent record review amd interview with LN3 on 8/22/16 at 11 a.m., Patient N101's record revealed Patient N101 had received the following pain medications:
On 8/3/16 at 8:30 Patient N101 received the pain medication Norco for a pain level of 10. The pain was reassessed at 9:03 a.m., and was still a "10" however no further pain medication or physician notification was documented. On 8/4/16, at 2:15 a.m., Patient N101 received Norco for a pain level of 7. On 8/4/16, at 4:10 a.m., the pain level was reassessed at "7" there was no documentation of pain medication or physician notification. On 8/7/16, at 1:27 p.m., Patient N101 received Norco for a pain level of "5". On 8/7/16, at 1:57 p.m., Patient N101 was reassessed at a pain level of "5" there was documentation of further medications for pain at this time and no calls to the medical doctor related to Patient N101's continued pain. LN3 after reviewing the record acknowledged there was documentation to indicate the patients pain was controlled.

5. During a record review and concurrent interview with LN3 on 8/22/16, 11:45 a.m., Patient N102's record revealed an order for pain medication (Norco) was administered on 8/14/16 at 4:39 p.m., for a pain level of 5. The order indicated the patient was to be reassessed after 30 minutes. According to the documentation Patient N102's pain level was not re-assessed until 6:19 p.m. LN3 stated, "That's a long time."









6. During a record review For Patient N300 (had surgery on 8/22/16) and a concurrent interview on 8/24/16 at 10:30 a.m., the director of the medical/surgical unit reported Patient N300's record indicated on 8/22/16 at 6:05 p.m, Patient N300's pain level was a 10 (highest level) and the patient was medicated with morphine (a narcotic). The DON verified no pain scale was done again for Patient N300 until 10 p.m. The DMS stated, "The patient's pain level should have been checked within 30 minutes to an hour afer the pain medication was given."

7. During an observation, interview and concurrent record review on 8/23/16 at 9:45 a.m., Patient N304 was observed with oxygen (02) at 1.5 liters/minute via a nasal cannula (tubes going into lower part of nose to deliver oxygen). Patient N304 complained of irritation at the nostril area stating, "It's all dry and itchy." Patient N304's record revealed the last five documented oxygen saturations (amount oxygen saturated in the blood) were 98%. The director of nurses was unable to locate an order for oxygen in Patient N304's record and stated, "I don't know why he has 02, probably just left from surgery."

According to "Fundamentals of Nursing", second edition by Wilkinson and Treas; Unit 4, page 888, " Providing Oxygen Therapy...because oxygen is a medication, it requires a medical prescription for dosage (concentration) and route."
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interviews, medical record and document review, there was evidence that the surgical services provided provided by the hospital were not in standing with nationally recognized standards of practice.

Findings:

The facility failed to ensure the heart lung machine was operated in accordance with manufacturer's instructions (Refer to A286).

The facility failed to follow the Association of peri-Operative Registered Nurses (AORN) guidelines to prevent the retention of foreign objects during surgery.(Refer to 0951)

The facility failed to ensure a time out was completed when one patient entered the operating room.(Refer to 0951).

There was not clear and consistent demonstration of the adequate use of PPE and hand washing in the Surgical area. Crash carts were not checked routinely in the OR, staff were unclear as to the correct contact time for different disinfecting agents. The facility failed to store gastrointestinal (GI) scopes per AORN recommendations. The facility failed to change water bottles used during GI procedures between cases. The facility failed to ensure that the policy and practice for the cleaning of the floors of the ORs in the Ambulatory Surgery Center were consistent with high standards of medical practice and patient care.(Refer to A951).

The facility failed to assure an updated history and physical (Refer to A- 0952)

There was not consistent evidence of a post anesthesia evaluation or anesthesia discharge orders prior to the patient leaving the post anesthesia care unit. Patient discharge documentation and post operative reports were not completed timely and pain was not controlled in the post operative phase of recovery. (Refer to A 0957 and A0959)

The cumulative effect of these systemic problems resulted in the hospitals failure to deliver safe care to all patients requiring surgical services and together resulted in the condition for surgical services being NOT MET.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to follow hospital policies and implement the Association of peri-Operative Registered Nurses (AORN) standards to achieve and maintain standards of medical practice and patient care for patients in the peri operative area as evidence by:

Findings:

1) According to the 2016, Association of PeriOperative Registered Nurses (AORN), Guideline for Prevention of Retained Surgical Items, accurately accounting for items used during a surgical procedure is a primary responsibility of the scrub person. The scrub person should actively participate in safety measures to prevent retained surgical items RSIs. The scrub person should: Verify the integrity and completeness of items when they are returned from the surgical site. Surgeons...should actively participate in safety measures to prevent RSIs.

During an interview with Adm 1, on 8/22/16 at 4:10 p.m., she explained that for the bunionectomy (surgically removal of a foot bunion) surgery performed for Patient N400, MD 1 had acknowledged that the retained foreign object (RFO) was "The tip of a towel clamp". During another interview with Adm 1, on 8/23/16 at 4:50 p.m., she indicated MD 1 had stated "I didn't notice it at the time of the surgery. Retrospectively, I can see the retained object; it may have been a towel clamp tip". MD 1 was asked to review the fluoroscopy imaging (series of x-rays). During the viewing of the fluoroscopy imaging MD 1 acknowledged seeing the "towel clamp tip". MD 1 was not interviewed during the investigation as Adm 1 reported MD 1 had declined to be interviewed.
During an interview with surgical staff (SS1), he acknowledged that during MD1's bunionecomy surgeries MD1 uses a towel clamp to hold the bone in place while cutting or drilling the bone. SS1 displayed two towel clamps (Listed in MD1's hand and foot tray) and indicated that he could see how the tip of the towel clip/clamp could have been broken off. Furthermore SS1 explained he didn't inspect every instrument used during the surgery. If a towel clamp tip was broken, he would throw away the clamp in the trash. The clamp is not a repairable instrument and could not be used again. According to SS1, the towel clamp is not an instrument that is counted at the end of the surgery, therefore it was ok to throw away.
During an interview with Adm 3 on 8/24/16 at 10:02 a.m., she explained there isn't a formal process, check list or competency indicating the scrub OR staff need to inspect each instrument after the instrument is being given back to the OR staff by the surgeons.
During an interview with Adm 2 on 8/24/16 at 9:25 a.m., he explained the towel clamp is a very common clamp, that if is missing from MD1's tray; the clamp would be easily replaced when the tray came down to processing for the instruments to get processed. According to Adm 2, it was possible the clamp would not ever be documented as missing.
During a review of MD1's "Operative Report", dated 4/1/15, the report indicated "There is a broken piece of metal over the dorsal aspect of the distal first metatarsal. This felt to be consistent with a broken tip from a bone reduction clamp and was not recognized at the time of the original surgery as being in place".
2) During an emergency record review dated 7/6/15, Patient N402 returned to the hospital's emergency room , complaining of abdominal pain for the past 15 days. A CT scan was done and according to the CT report there was a "7 cm (2.75 inches) long metallic wire within the upper abdominal wall subcutaneous tissues...probably represents a remnant epicardial pacing lead ...correlation with clinical findings and the surgical history recommended..." According to the ED Physician note dated 7/6/15 at 3:09 a.m., when the object was removed in the emergency room under local anesthesia, it "appeared to be a surgical straight suture needle." The pathology report dated 7/6/15 indicated "...Specimen is a silver needle-like object 7 cm in length, approximately 1 mm in diameter..."
The surgeon who performed surgery on Patient N 402 on 12/19/14 was interviewed on 7/28/15 at 12:00 p.m. The surgeon stated "One of the pacer wire needles broke off, the needle got lost inside the patient's abdominal tissue, I attempted to retrieve the needle, but I couldn't retrieve it." The surgeon shared continuing attempts to retrieve the needle would have caused more damage to the patient. According to the surgeon he said he "forgot about the needle completely, I didn't remember anything about the pacer-wire needle until recently when Quality contacted me to let me know there was a needle inside the patient. At that time, I remembered the incident again."
During an interview and concurrent record review for Patient N402 on 7/28/15 at 1:50 p.m., LN 7 reported the count was considered correct because they knew where the needle was. LN 7 stated, "I asked the scrub tech, where's the needle? The scrub tech pointed to the patient. We both knew where the needle was (in the patient), that's why we counted the needle (inside the patient) as number one". LN 7 reported during the procedure the surgical count was documented as being "correct" for all three counts. The surgical staff was counting the lost needle inside Patient N402 as a part of the official OR count.
During an interview on 7/28/15 at 2:25 p.m., scrub tech (SCT 1) stated, "When we counted I mentioned there was a needle inside the patient. Everyone knew one needle was still inside the patient. We started counting by saying, "One needle in the patient" that was needle number 1, then we continued counting the rest of the needles on the table.
The facility policy entitled "...Needles/Sharps/Misc. Small Items/Instruments", dated 4/14, indicated the purpose is to 1) Account for sponges, sharps, miscellaneous small items and instruments used in operative/invasive procedures. 2) To safeguard the surgical patient from retained foreign bodies and 3) to define surgical materials to be counted...the documentation required...Sponges, sharps, and miscellaneous items will be counted before the closure of a cavity within a cavity, before wound closure begins, at skin closure or the end of procedure ...The surgeon will account for all parts of sharps broken during the surgical procedure ...Items will be counted before procedure is concluded ensuring only the device intended for implant was left in the patient".
According to the Association of Peri-Operative Registered Nurses (2014) standards and best practices for prevention of retained surgical items (RSI), "The final count should not be considered complete until ALL of the sharps, broken parts, sponges, equipment....used in the surgical procedure are returned to the scrub person."
3) During an observation, interview, and record review on 8/22/16 at 9:30 a.m., the operating room (OR) assistant manager (ORAM) acknowledged the staff had not signed the daily check list log since 8/18/16 on the adult crash cart, labeled "14", and the pediatric crash cart, labeled "3" in the supply area. The ORAM reported there were cases on 8/19/16 and 8/20/16.

The facility policy and procedure titled, "Crash Cart Policy" dated 12/14, indicated, "Daily check of the equipment and crash cart is performed every 24 hours and be kept on Daily Checklist Binder."

4) During an observation, interview, and record review on 8/22/16 at 9:40 a.m., the instrument tech (IT) entered the supply area with a used mask hanging around the neck.
The IT stated, "I just left a room." The IT acknowledged masks are to me discarded when not in use.

The facility policy and procedure titled, "Surgical/Procedural Attire and Hospital Provided Scrubs," dated 12/14, indicated "Masks are discarded after each procedure. It is either "on" or "off" and is not worn hanging about the neck or perched on the forehead."

5) During an observation, interview, and record review on 8/22/16 at 10:28 a.m., the ORAM confirmed the circulating nurse's (LN 11) hair was not completely covered and cover hat was worn behind the ears with small hoop earrings present. The ORAM acknowledged the nurse should not be wearing dangling earrings.

The facility policy and procedure titled, "Surgical/Procedural Attire and Hospital Provided Scrubs," dated 12/14, indicated, "Jewelry including earrings, necklaces, watches, and bracelets that cannot be contained or confined within the surgical attire will not be worn."

6) During an observation, interview, and record review on 8/22/16 at 12: 15 p.m., the ORAM confirmed nurses (LN6, LN7, LN8, and LN9) in the room for the surgical procedure for Patient N303 had disposable bouffant hair covering on their head behind their ears with hair hanging outside and earrings present.

The facility policy and procedure titled, "Surgical/Procedural Attire and Hospital Provided Scrubs," dated 12/14, indicated "Shedding from hair has been shown to affect surgical wound infection. Head and facial hair, including side burns and necklines are to be covered with hospital approved disposable bouffant or hood-style covers.
According to the AORN standards published online January 2016, "Guidelines for PeriOperative Practice", indicated, "Guideline for Surgical Attire Recommendation III: Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair."
7) During an observation, interview, and record review on 8/22/16 at 12:15 p.m., the ORAM confirmed LN 9 was wearing a short sleeve top while assisting with the care of Patient N303 in the OR. The ORAM concurred this was not appropriate OR attire.
The facility policy and procedure titled, "Surgical/Procedural Attire and Hospital Provided Scrubs," dated 12/14, indicated "Bare arms are to be covered in semi-restricted/restricted areas by non-scrubbed personnel to prevent bacterial shedding from bare arms."
8) During an observation, interview, and record review on 8/22/16 at 10:58 a.m., the anesthesia tech (AT) and orderly were cleaning OR 5, while cleaning the operating room, they reported the time needed for Oxivir Tb wipes (used to disinfectant surfaces) to stay wet (dwell time) was "three to five minutes." The AT reported, "I was on vacation when we started using them and never got inserviced." The AORM reported Oxivir Tb wipes are being used because they did not contain alcohol which was drying the OR table mattresses. Neither staff member was able to verbalize the manufacturer's instruction dwell times required.
According to the data sheet for Oxivir Tb Wipes, dated 2012, indicated, "Effective: Bactericidal (kills bacteria) and virucidal (kills viruses) in one minute, kills HBV (hepatitis B virus (a virus that causes a serious liver infection), HCV (hepatitis C virus (a virus that attacks the liver causing inflammation), HIV-1 (AIDS virus) in one minute, Tuberculocidal (kills [DIAGNOSES REDACTED] bacilli - a potentially serious infectious diseases that mainly affects the lungs) in five minutes and kills fungi (fungus) in ten minutes."
9) During an observation, interview, and record review on 8/23/16 at 9:25 a.m., endoscopy tech (ET 1) reported the orange colored containers for the Sani Wipes (cleaning wipes used to disinfect surface areas in the OR's) were to be used if a patient had [DIAGNOSES REDACTED] (clostridium difficile, a spore forming bacterium that causes infectious diarrhea). ET1 was unable to explain correct contact times for disinfecting surfaces when using the orange top Sani-Cloth Bleach Germicidal Disposable Wipe.
According to the data sheet for Sani-Cloth Bleach Germicidal Disposable Wipe, dated 2013, indicated, "Effective against 50 microorganisms in 4 minutes including the following..."
10) During an observation, interview, and record review on 8/22/16 at 12:30 p.m., the AORM acknowledged the circulating nurse (LN9) for patient N303, put on sterile gloves, prepped the surgical area, removed the sterile gloves, obtained supplies from across the room, and put on nonsterile gloves without performing hand hygiene between each process.
11) During an observation and record review on 8/23/16 at 9:30 a.m., the circulating nurse (LN 10) for patient N307 was observed picking up a blood pressure cable that had fallen to the floor and attaching it to the patient N307, touched her face, used the computer key board, and assisted with patient care and transporting patient N307 out of the room without ever removing gloves and performing hand hygiene.
The facility policy and procedure titled, "Hand Hygiene," dated 12/14, indicated "All personnel shall cleanse hands:...After removal of gloves... Decontaminate hands before having direct contact with patients... Decontaminate hands...after contact with a patient's intact skin...after removing gloves...after contact with inanimate sources that are likely to be contaminated with micro organisms."
12) During an observation, interview, and record review on 8/22/16 at 12:20 p.m., the AORM confirmed there was no patient /procedure/site verification (time out) done when patient N303 entered the OR and prior to anesthesia starting. The AORM reported there are four "time outs" done on patients in the OR, the first is done in the holding area, the second is done on entering the OR, the third is after the patient has been prepped and draped prior to procedure, and the fourth is done at the end of the case.
The facility policy and procedure titled, "Surgical/Invasive Patient/Procedure/Site Verification," dated 12/14, indicated "Operating/Procedure Room Procedure Verification. At the time the patient is transferred from the Holding Unit to the Operating Room, the following verifications are to occur: Verify the patient identity using the patient's name and date of birth. Confirm the procedure and site. This information is to confirmed with patient in addition to appropriate source document."
13) During observation, interview, and record review on 8/23/16 at 9:20 a.m., the infection control nurse (ICN) confirmed the scopes were stored touching each other and there was no ventilation in the storage cabinet.
According to the AORN standards published online January 2016, "Guidelines for PeriOperative Practice", indicate, "Guideline for Processing Flexible Endoscopes . . . Recommendation IX: Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage. Flexible endoscopes should be stored in a drying cabinet. If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes."
14) During observation, interview, and record review on 8/23/16 at 9 a.m., the endoscopy tech (ET 1) reported the water bottles used during the case are not changed until the end of the day. The ET 1 reported if the water runs out, we refill it with more water.
The facility policy and procedure titled, "Disinfection of Endoscopy Equipment and Sterilization," dated 3/12, indicated "All equipment used during the procedure will be washed in Enzyme solution, then rinsed with tap water."
15) During an observation and interview on 8/23/16 at 9:30 a.m., the endoscopy technician (ET 2) reported the prewashing was done with an enzymatic cleaner. The ET 2 stated "I fill the sink with water to about here (pointing to a spot in the sink) and push the button three times to get the cleaner (EmPower Enzymatic Detergent) in the sink The ET 2 reported he was not sure how much water or cleaner went in the sink. ET 2 reported there use to be a piece of tape marking where to fill the water but it disappeared "a while ago." The ICN and ET 2 acknowledged this was not an acceptable way to mix the solution to pre clean the scopes.
According to "EmPower Enzymatic Detergent" instruction, undated, indicates "...Dilute EmPower Enzymatic Detergent 1 fluid ounce (1 pump) per gallon of water."
16) During observation of an upper endoscopy procedure with biopsy and record review on 8/23/16 at 8:45 a.m., it was noted the ET 1 and the circulating nurse (LN 10) were not wearing PPE goggles or mask while standing at the head of the bed during the procedure.
The facility policy and procedure titled, "Surgical/Procedural Attire and Hospital Provided Scrubs," dated 12/14, indicated "Protective eyewear, mask or face shield must be worn when splashing or spraying is likely."
17) The Ambulatory Surgery Center was inspected on August 24, 2016 at 9:00 AM. An observation was made of housekeeping staff cleaning the floor of one of the OR's with a mop. OR cleaning personnel MD 1 was questioned regarding the contact time for the product she was using. She stated there was no contact time and that she only had to wet the floor once. She produced a jug labeled "Prominence Heavy Duty Floor Cleaner." Inspection of the label indicated that this was a general floor cleaner. No indications for use in hospitals or operating rooms were stated. There was no evidence of EPA registration.
The hospital policy on the sanitation of surgical suites entitled "Between Case Surgery Suite Cleaning (ES.2.16, last review 2/5/24), indicated "Using General Purpose Cleaner, work in a counter clockwise direction ..." The policy also states the same product can be used for objects and surfaces in the ORs. The hospital follows the guidelines of the American Organization of peri-Operative Nurses (AORN) "Guidelines for Environmental Cleaning, January 2016" which indicates "a multidisciplinary team should evaluate the following factors during selection of a cleaning detergent or disinfectant chemical....EPA registration and rating as hospital grade."
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
Based on record review and interview, the facility failed to assure an updated history and physical (H&P) on two of eight patients (N302 and N304) was completed prior to the surgical procedure.

These failures had the potential that surgery was performed in the presence of an unrecognized medical problem which could result in harm to patients.

Finding:

Patient N 302's record was reviewed with the AORM on 8/22/16 at 10:30 a.m. The AORM confirmed the H&P Update stamped on the surgeon's note dated August 9, 2016 was not completed. The AORM reported there must be an H&P completed within 30 days of the surgery and an update to the H&P in the medical record prior to surgery unless it is an emergency surgery.

Patient N304's record was reviewed with the AORM on 8/24/16, 10:45 a.m. The AORM confirmed the H&P dictated on 8/19/16 and dated 8/22/16 had not been updated. The AORM reported there must be an H&P completed within 30 days of the surgery and an update to the H&P in the medical record prior to surgery unless it is an emergency surgery.

During an interview on 8/24/16 at 3:00 p.m., the Medical Director confirmed the H&P's for patients N302 and N304 were not updated as required by the Medical Staff Bylaws.

The facility's Rules and Regulations of the Medical Staff, dated 2/2015, indicated "Surgical and invasive procedures: An H&P shall be performed and recorded within the 24 hours before the performance of an inpatient or outpatient surgical or invasive procedure. The H&P, including all updates and assessments, must be included in the medical record prior to surgery."
VIOLATION: POST-OPERATIVE CARE Tag No: A0957
Based on interview and record review, the facility failed to provide adequate post-operative care for seven out of 17 patients.

These failures have the potential to compromise patient care.

Findings:

Closed medical records of surgical patients were reviewed on 8/24/16 at 3:05 PM. Patient MC 8 received general anesthesia for a complex abdominal surgery in the Ambulatory Surgery OR on 6/16/16. No post-anesthesia assessment could be found in the medical record. The Clinical Informatics Nurse was present and unable to find the assessment. She agreed that the post anesthesia assessment is required. The Vice President of Medical Quality was interviewed on 8/24/16 at 4:00 PM. He stated that a post anesthesia note should be present when anesthesia is used and that hospital leadership had addressed this issue about a year ago.

During record reviews for Patients N301, N302, N303, and N304 and concurrent interview on 8/25/16 at 9:30 a.m., the assistant operating room manager (AORM) confirmed there were no discharge orders from PACU in any of these records. The AORM reported the PACU nurse should call the anesthesiologist for discharge orders if none are written. The AORM was unable to provide documentation the anesthesiologist was contacted for discharge orders.

Patient MC 9 had surgery at the Ambulatory Surgery Center on 7/11/16. She was sent home after recovering from sedation, however there was no discharge order in the record. The Clinical Informatics Nurse was present and unable to find the order.

The facility policy and procedure titled, Discharge/Transfer from PACU, dated 12/14, indicates, "...The RN will notify the Anesthesiologist when the patient meets discharge criteria."

During a record review for N303 and concurrent interview on 4/22/16 at 4:30 p.m., the AORM no PACU notes in the computer and N303 had been transferred same day surgery unit at 2:03 p.m. and sent home at 2:50 p.m. The AORM reported the only paper documentation in the PACU on N303 was the charge sheet which had the initial vital signs. The AORN reported this was not an acceptable practice and the PACU patients charting should be completed on discharge from PACU.

During a record review for Patient N300 and concurrent interview on 8/22/16 at 4:10 p.m., the AORM reported the patient was in PACU from 1:34 p.m. to 3:30 p.m. The PACU record indicated Patient N300 received Dilaudid (a strong narcotic) 0.5 milligrams intravenous (IV) at 1:54 p.m. for a pain level of 10 on a pain scale of 1-10. At 2 p.m. the patient was medicated for a pain level of 10/10, at 2:24 p.m. the patient was medicated for a pain level of 8/10, and again at 2:35 for a pain level of 7/10. The AORM reported there were no further pain assessment done for Patient N300 while in PACU. The AORM was unable to provide any documentation that any other pain relieving measures were tried or the doctor was called for the patients continued pain. The AORM reported the record indicates Patient N300 arrived to the floor with experiencing a pain of eight out of 10. The AORM reported on admission the patient stated four would be an acceptable pain level.

During an interview on 4/24/16 at 10:10 a.m., Patient N300, reported he arrived to the floor from surgery in "horrible pain" and it took quiet awhile to get it controlled.

The facility policy and procedure entitled, "Pain," dated 6/14 indicates, "...8. Pain will be considered the 5th vital sign and will be monitored and reported when a full set of vital signs is taken. 9. If pain intensity is rated at 5 or greater and /or unacceptable to the patient (based on patient comfort goal), pain relieving interventions will be implemented as appropriate, with reassessment and follow-up."
VIOLATION: OPERATIVE REPORT Tag No: A0959
Based on record review and interview, the facility failed to assure an operative report for one Patient (N306) was dictated in a timely manner and completed accurately.

This failure has the potential of other health care providers being unaware of the patient care provided and could potentially affect the continuity of the patients care and jeopardize patient outcome.

Findings:

During a record review for Patient N306 and concurrent interview on 8/24/16 at 9:05 a.m., the director of critical care (DCC) acknowledged there were two operative (OP) reports in Patient N306's chart dictated on 8/22/16:

1. Left carotid endarterectomy (surgery on the large artery in neck leading to the brain)performed on 8/20/16.
2. Coronary artery bypass (surgery on the arteries of the heart) performed on 8/21/16.

The DCC confirmed:
Patient N306 never had an endarterectomy surgery.
Patient N306 had emergency coronary bypass surgery on 8/19/16 not 8/21/16.

During a record review and concurrent interview on 8/24/16 at 3:30 p.m., the medical director reported this was not an acceptable practice.

During a record review and concurrent interview on 8/25/16 to 10:15 a.m., the assistant operating room manager reported the endarterectomy surgery op report was actually for the surgery performed on 8/22/16 on a different patient.

The facility's "Rules and Regulations for the Medical Staff," dated 2/15, indicated, "Operative/Procedure reports shall be dictated or written in the medical record immediately after surgery."