HospitalInspections.org

Based on observation, interview, documentation for 16 of 16 surgeries or medical procedures in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), review of policies and procedures, and review of other documents it was determined that the hospital failed to fully develop and implement policies, procedures, and systems to ensure that it promoted for each patient the right to complete and timely informed consent and the right to the provision of safe and appropriate care.

These failures resulted in an adverse patient event, which for Patient 10 resulted in the provision of airway ventilation during surgery and anesthesia with a broken manual jet ventilator that contributed to the patient's death.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings include:

Refer to Tag A131, CFR 482.13(b)(2), Patient Rights: Informed Consent.
Refer to Tag A144, CFR 482.13(c)(2), Patient Rights: Care in Safe Setting.
Refer to Tag A700, CFR 482.41, Condition of Participation, Physical Environment.
Refer to Tag A1000, CFR 482.52, Condition of Participation, Anesthesia Services.

Based on interview, documentation for 16 of 16 surgeries or medical procedures in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to ensure that clear, complete, and timely informed consent was conducted and documented prior to all surgeries and procedures that required informed consent

Findings include:

Refer to Tag A466, CFR 482.24(c)(4)(v), Medical Record Services: Informed Consent.

Based on observation, interview, review of 4 of 4 medical records of patients who had anesthesia administered by a jet ventilator (Patients 1, 2, 4, and 10), review of PM records, review of policies and procedures, and review of other documents it was determined that the hospital failed to fully develop and implement policies, procedures, and systems to ensure that airway ventilation during surgery and anesthesia was conducted with devices that were maintained in safe and proper working condition.

This failure in the case of Patient 10 resulted in the provision of airway ventilation during surgery and anesthesia with a broken manual jet ventilator.

Policies and procedures for the use and operation of manual jet ventilators had not been developed, and there were inconsistencies throughout the investigation regarding manual jet ventilator use and operation in the following areas:
* Criteria and indications for use;
* Staff training and privileges to use;
* Proper set-up prior to procedures;
* Quality checks and inspections prior to procedures;
* Numbers of anesthesia providers required to be present;
* Documentation of use during procedures;
* Storage;
* Cleaning and disinfection; and
* Preventive maintenance.

Prior to the date of the incident involving Patient 10, manual jet ventilators were not incorporated into the hospital's medical equipment/device inventory and PM system. There was no systems to account for and track the types, numbers, and locations of those devices in the hospital; to account for where they were received from; to account for when they were put into service; to initially inspect those devices prior to putting them into service; to document repair work requested and done on those devices.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings include:

1. Equipment and devices referenced in this report:
* A manufacturer's document from Anesthesia Associates, Inc. described its manual jet ventilator as "A ventilating system for rigid-wall bronchoscopy, laryngeal microsurgery, and emergency use. Consisting of 5' high pressure tubing with O2 DISS fitting, flow control valve, thumb control valve, pressure gauge, and 20" clear plastic tubing with Luer lock fitting for attachment of adapters and tubes below."
* A document identified as from "aagbi" (Association of Anaesthetists of Great Britain and Ireland) was provided that described a Hunsaker as "The Hunsaker Mon-Jet catheter was designed specifically for microlaryngeal procedures...The ventilator is attached to the central lumen, with gas exiting through an aperture at the tip of the catheter."
* A Monsoon jet ventilator is a machine manufactured by Acutronic Medical Systems AG. The Acutronic website describes the Monsoon as "A universal ventilator for all procedures in laryngology, airway, thoracic and heart surgery...high-frequency jet ventilation application..."

2. The medical record of Patient 10 reflected he/she was an "Elective" admission on 01/29/2016 for "Direct Laryngoscopy, Bronchoscopy, CO2 laser..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 01/29/2016 at 1330.

On 01/29/2016 at 1149 the anesthesiologist recorded in the anesthesia Preprocedure Note that the patient "overdoses in Oct 2015 and required intubation. Self extubated [him/herself] while in ICU. Subsequently developed dyspnea - ENT dx subglottic stenosis...Current smoker...Asthma...Audible intermittent stridor with long inhalation and exhalation but pt does not seem to be in distress...Anesthesia Plan...Discussed: general anesthesia, endotracheal tube methods, postop pain [management]." At the end of the note under the "Author's name", the anesthesiologist recorded "Will discuss airway [management] with surgeon. Will be ready with TIVA and special Ett for laser treatment. Limit FIO2. PARQ discussed including risk of airway fire plus see above...[Discussed with] CRNA." It was not clear what specific entry or entries "see above" referred to. There was no documentation in the evaluation to reflect that the anesthesiologist discussed the airway management with the surgeon, and the evaluation did not identify the planned or possible use of jet ventilation using oxygen or air, either by using an automated machine or a manual device.

On 01/29/2016 at 1325 the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and Site verified. I have reviewed the patient's history, allergies, and physical exam. I agree with the ASA status and anesthetic plan." However, there was no documentation to indicate whether the plan had been fully established as reflected in the paragraph above.

The "Anesthesia Record" dated 01/29/2016 reflected the anesthesia start time was 1330 and the anesthesia end time was 1550. The form reflected that the CRNA was the primary anesthesia provider and that an anesthesiologist presented to the room after the patient began experiencing complications. However, the sequence of events, the time that the anesthesiologist entered the case, and the time a second CRNA entered the case, as well as the role of the second CRNA, was not clear.

The "Anesthesia Record" contained a handwritten entry in the "Induction" section of the form that was "Jet [Ventilation or Ventilator]." Another handwritten entry in the "Remarks" section of the form reflected "Jet ventilation intermittent with limited success. [Anesthesiologist] here assistg (sic) ...contine (sic) jet vent with aire [and] laser vocal cord excision." The anesthesia provider's documentation did not reflect whether the jet ventilation was provided using an automated machine or a manual device.

The "Machine #" on the "Anesthesia Record" was blank, and there was no documentation of the "case check" required by the policy and procedures.

The "Anesthesia Record" included a space for the type of anesthesia used. A checkmark was recorded in the "GA" box. The "TIVA" box was not marked. However, an anesthesiologist's progress note recorded on 01/29/2016 at 1548 reflected that TIVA was used.

On 01/29/2016 at 1527, prior to discharge from the OR at 1535, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed...a subglottiscope was used to visualize the oropharynx, hypopharynx, and larynx with the findings as noted. This was suspended. A Hunsaker jet ventilator was used to provide jet ventilation. Initially this was given at fairly prolonged pressure...The airway was noted to be markedly enlarged. An endotracheal tube was then placed with some difficulty. The patient was noted to have ST elevations...an EKG was obtained which continued to show ST elevations. A chest Xray showed bilateral pneumothoraces...placed bilateral chest tubes. The patient will be sent to ICU." The surgeon's documentation did not reflect whether the jet ventilation was provided using an automated machine or a manual device.

The note concluded with the following contradictory statement: "The patient was turned over to the Anesthesiology service and allowed to awaken and be taken to the recovery unit to recover in good condition."

On 01/29/2016 at 1548 an anesthesiologist's note reflected "[Pt] underwent laser treatment of scar tissue and tracheal dilation - under TIVA jet ventilation...During jet ventilation with air only (used to limit airway fire) pt became hypotensive...with drop in sp02...and [tachycardic]...and ST elevation...BP and sp02 improved with ventilation and hemodynamic support...Surgeon notified of EKG changes. Procedure quickly concluded."

On 01/29/2016 at 1631 an anesthesiologist's note reflected "Pt developed [bilateral] pneumothoraces and ST elevation during jet ventilation for laser treatment of subglottic stenosis."

On 01/30/2016 at 1806 an anesthesiologist's note reflected "POD #1 s/p TIVA jet ventilation for treatment of subglottic stenosis..."

On 01/31/2016 at 1124 an anesthesiologist's note reflected "POD #2 s/p tracheal dilation complicated by respiratory complication of pneumothoraces after jet-ventilation."

On 02/01/2016 at 1055 an anesthesiologist's note reflected "POD #3 s/p treatment of subglottic stenosis under jet ventilation, complicated by [bilateral] pneumothorax, MI and brain injury..."

3. A "Surgery/Procedure Event" form with an "Entered Date: 01-29-2016" included the following information in relation to Patient 10:
* "Specific Event Type - Complications of Surgery/Procedure"
* "Severity Level (Reported) - F. Harm - Temporary, Hospitalization Needed"
* "Injury Incurred? - Yes"
* "Equipment Involved/Malfunctioned? - Yes"
* "Brief Factual Description - Patient in the OR for EENT procedure i.e. related to subglottic stenosis using ICO2 laser. Attempted insertion of 5.0 laser tube insertion was not able to bypass the stenosis. [Surgeon] requested jet ventialtion (sic). Using air for jet ventilation did not function properly to deliver appropriate inspiratory pressures This resulted in bilateral pneumothoraces in the patient."
* The name of the patient affected was identified as Patient 10.
* "Event Date - 01-29-2016
* "Equipment/Device(s) Involved - Equipment ID #/Asset # - Jet ventilation Hose"
* "Equipment/Device type - Anesthesia"
* "Equipment Serial # - none"
* "Removed from Service? - Yes"
* "Other Equipment Notes - equipment noted to be malfunctioning intraop."
* "Resolutions and outcomes of the event - Severity Level (Actual) - G. Harm - Permanent"
* "Contributing Factors (Actual)...Monitoring Inadequate...Handoffs & continuity issues...Internal-Communication among practitioners or department...Equipment/device/product: Contamination of drug, product or device used...Communication Issue...Lack of or inadequate training"
* "Outcome Actions Taken...Debrief...Equipment Removed...Equipment Repaired/Replaced...Policy/Procedure Changes (Recommended)...Process Modified/Improved...Referred Issue to Leadership...Root Cause Analysis...Staff Educated or Trained"

4. During interview with the CTM on 03/31/2016 beginning at 1345 he/she stated that manual jet ventilators had no manufacturer's recommendation for periodic maintenance or calibration and that prior to the incident the manual jet ventilators were not identified as "essential inventory." The CTM stated that manual jet ventilator devices were added to the CT inventory of medical equipment/devices "this week", referring to the week of this onsite investigation. He/she stated that those devices will now be subject to PM inspections as a result of the incident and a request from the anesthesiology group.

During the interview the CTM stated that the manual jet ventilators in the hospital at the time of incident had been removed from service. He/she indicated the model and style of the device used in the incident was not used anymore. He/she stated that an extensive search had been conducted in all locations where the devices might be. However, he/she indicated that he/she didn't know how many manual jet ventilators had been removed from service nor where those devices were now located. He/she stated that the anesthesia department removed them.

The CTM stated that six new manual jet ventilators of a different model and style, from the one used for Patient 10, were added to the CT inventory "this week", although he/she didn't know the location(s) in the hospital where those were placed.

The CTM further stated that "now every medical device is being added" to the CT inventory.

5. During further interview on 03/31/2016 at 1725 the CTM confirmed that he/she was "not sure" of the number of manual jet ventilators available for use in the hospital prior to the incident. He/she also stated that any repair work that might have been done on any of the manual jet ventilators previously would not have been documented. He/she stated that there was no mechanism to document work done on any device that was not on the CT inventory of medical equipment/devices.

6. During interview with the DSS on 03/31/2016 at 1730 he/she stated that the manual jet ventilator used during the surgical procedure on 01/29/2016 had been immediately "sequestered" after the procedure and "handed off" to a person in risk management. He/she stated that staff tried to gather all the manual jet ventilators in the hospital and they were "99% confident" that all were found. He/she acknowledged that there was no list of the devices to compare what was found and staff did find some in places that were not expected. The DSS stated that he/she remembers finding eight devices initially, and then 11 devices in total were located.

The DSS stated that they considered eliminating the use of manual jet ventilators all together at the hospital. However, it was determined there was a need for emergency uses and so they decided to limit those devices to emergency airway carts in the ICU, ED, L&D, and anesthesia carts.

The DSS stated that 10 manual jet ventilators were collected from throughout the hospital and that only one was designed for manual jet ventilation with medical air as designated by the yellow-colored indicators on the device and that the others were designed for manual jet ventilation with oxygen as designated by the green-colored indicators on those devices. He/she explained that medical air is indicated for ventilation during procedures using lasers and that is why the "yellow" manual jet ventilator was used for Patient 10 during the 01/29/2016 procedure.

He/she stated that the "yellow one" came in a "tray" from another site, from the Kaiser Interstate Clinic ASC. The DSS explained that "trays" have "expensive instrumentation" in them so "it doesn't make sense" to have them duplicated at all sites. "Trays" are "borrowed" from other sites and transported to the site where the surgeon is working using "couriers" and "cabs." He/she confirmed that the transport occurs without staff in attendance and only the courier or cab driver is in control of the instruments, equipment or device.

7. During interview with QM staff including the Director of AR&L on 04/01/2016 beginning at 1135 it was confirmed there was a lack of awareness of where the manual jet ventilator used in the incident had come from and that there was a possibility that prior to use at KWMC it had been at another Kaiser hospital, KSMC. One QM staff member remarked, "We don't know [where it came from]."

In regards to the 6 "new" manual jet ventilators put into service at KWMC the QM staff indicated that they had been placed in emergency airway carts in ED, ICU, OR, and MPU; in L&D storage; and in OR "back-up" storage, which was inconsistent with where the DSS had indicated they were placed during the 03/31/2016 interview.

8. During observations in the RT department on 04/01/2016 at 1230 with RT and QM staff present, two manual jet ventilators were observed and were described as "new" devices. A CT inventory label with a unique number was observed on each device. Interview with RT staff present reflected that the device with the CT number "52977" was "going to ICU", and the device with the CT number "52979" was "going to ED."

9. During observations of the emergency airway cart in ICU on 04/01/2016 at 1255 no manual jet ventilators were observed. The ICU Nurse Manager present at that time stated that the manual jet ventilator had been removed from the ICU cart and a replacement had not been provided.

10. During interview with the Director of AR&L on 04/01/2016 beginning at 1600 he/she stated that "no one knows" where the manual jet ventilator with the yellow-colored tubing came from.

Further, additional reports were provided at that time regarding to number of manual jet ventilators removed from service after the 01/29/2016 incident. The Director of AR&L stated that reports from surgical services staff varied and reflected that eight total or 10 total or 11 total or 13 total manual jet ventilators had been removed from service.

11. On 04/01/2016 at 1600 the Director of AR&L provided an email dated and timed earlier that day on 04/1/2016 at 0915. The email from KWMC CT was to the manufacturer of the "new" manual jet ventilators the facility had put into service after the incident involving Patient 10 and included "Is there any required or recommended maintenance and, if so, are there any instructions?" The response from the manufacturer on 04/01/2016 at 1015 included "I have attached our Performance Check for our Manual Jet Ventilator." The attachment was not on manufacturer's letterhead or any form template and reflected "The user of this device should verify proper operation by checking the regulator after each use or approximately every six months, whichever occurs the soonest." There was no indication that anyone had confirmed that the verification of proper operation should occur before each use or after each use.

12. During interview with the hospital CMO, an anesthesiologist, on 04/01/2016 at 1625 he/she stated that he/she was unaware of any concerns expressed at KWMC related to jet ventilators, "manual or otherwise," prior to the 01/29/2016 incident. He/she indicated that anesthesia staff requested manual jet ventilators be replaced after the 01/29/2016 incident involving Patient 10.

The CMO stated the use of manual jet ventilation was "core training" for anesthesia staff including CRNAs and physicians. In regards to quality checks and device inspection prior to each use of the manual jet ventilator the CMO stated that it was "preferred." He/she stated that it was his/her practice "but it's not required."

13. During interview with the DSS and the Director of AR&L on 04/01/2016 at approximately 1635 they confirmed there were no written policies and procedures for borrowing or sharing of instruments, equipment, and devices between KWMC and other hospital and non-hospital facilities

14. During interview with the CMO and the Director of AR&L on 04/01/2016 at approximately 1635 they confirmed there were no written policies and procedures for use and operation of manual jet ventilators in the hospital.

15. On 04/04/2016 at 0900 the "sequestered" manual jet ventilator used in the 01/29/2016 incident was observed.

The ventilator was comprised of the following:
* Pieces of yellow-colored and clear tubing.
* Metal pieces connecting tubing to a manual lever regulator and a manual gauge with a needle for measuring medical air between "0" and "60" "psi".
* Metal pieces and a yellow plastic piece where the tubing would be connected to the medical air source.

Other observations were made at that time:
* There was no glass or clear, hard plastic cover in place on the gauge dial face.
* There were no KWMC or CT inventory numbers or labels on the device.
* There was no manufacturer's serial number on the device.
* On the metal piece where the manual lever was located a handwritten entry was recorded in black ink directly onto the metal that read "L+D 2."

A Post-it Note affixed to a large plastic bag was observed with the device. The undated and unauthenticated hand-written note read "Plastic on meter broken. Investigating Pt. harm".

An orange-colored and white "Broken Do Not Use" tag was observed with the device. On one side of the tag handwritten entries reflected the "Date" as "2/29", the "Dept/Contact" as "Surgical Services", the "Item" as "[The word oxygen crossed out] Air Jet Ventilator (Air)"; and "Critical" as "Yes." The other side of the tag contained several spaces. A handwritten entry recorded under the "Describe damage/problem: (How, When, What)" space on the tag read "Gage (sic) did not measure pressure. Glass obviously broken." The following remaining spaces on the tag were blank: Instrument Set; Assembled by; Procedure Name; Scrub; OR Nurse; Surgeon; and Service.

16. During interview with staff including the CMO, the Director of AR&L, and the RT Manager on 04/04/2016 beginning at 1415 the subject of staff training on the "new" manual jet ventilators was discussed and the following information provided:
* A training was planned to be provided to RT staff on 04/06/2016.
* A training for anesthesia staff was planned to occur at the same time as training on the automated Monsoon jet ventilator, which was planned to be received and put into service. There was no date identified for that training.
* A training for OR staff had been scheduled for 04/06/2016 but had to be rescheduled.

The CMO stated that "a lot" of physicians were concerned about not having the manual jet ventilator "modality" available for emergency use so it was decided to put them into service prior to the training.

However, the RT Manager stated that he/she had asked that the "new" manual jet ventilators be locked up because "We haven't had the inservice yet."

17. On 04/04/2016 at 1430 the Director of AR&L provided two documents that were not on KWMC letterhead or policy and procedure templates, contained no dates, and the author(s) were not identified.

The only verbiage that identified the "Regional Sterile Processing Loan & Borrow Guidelines" document as related to KWMC was "Use [Kaiser Permanente] courier system..." That document reflected:
"Send
* Inpatient - Using white board tracking
*ASC's - OR lead tracking
* Courier - Use KP courier system as much as possible
* Dust cover with Cardinal Bagging system. Oversized items will use a large trash bag.
* All trays sterilized in another facility shall be reprocessed on site for use.
Return
* Send back sets reconciled and unsterile."

The other document was titled "Loan & Borrow Workflow." That document consisted of a workflow diagram with eight boxes that contained verbiage related to preparation and transport of items borrowed and used between facilities. However, the specific facilities were not identified.

18. During interview on 04/05/2016 at 0945 the CMO stated that it could not be confirmed that the manual jet ventilator designed for medical air used in the 01/29/2015 incident was the only medical air manual jet ventilator used at KWMC since the hospital opened. (KWMC opened in August 2013.)

19. During interview on 04/05/2016 beginning at 1355 the CRNA who administered anesthesia during the surgical procedure on 01/29/2016 indicated the following:
* He/she believed that the medical air manual jet ventilator used on 01/29/2016 was the only medical air manual jet ventilator available in the hospital.
* In preparation for the procedure the manual jet ventilator was brought to the OR room by an anesthesia tech who set it up for the procedure.
* There was no manual jet ventilator for oxygen use set up in the OR room.
* He/she did a visual inspection but did not "fire" the device, and that there was "nothing out of the ordinary revealed on cursory inspection."
* He/she was not aware of any policies and procedures for use and operation of the manual jet ventilators and stated that "doesn't mean they don't exist."
* He/she was not familiar with the particular model of manual jet ventilator used on 01/29/2016.
* He/she had never used a manual jet ventilator for either medical air or oxygen at KWMC since coming to work at KWMC in August 2013.
* He/she had never worked on a laser surgery case before.

20. During interview on 04/05/2016 beginning at 1445 the Anesthesiologist who responded to requests for assistance during the surgical procedure on 01/29/2016 indicated the following:
* He/she arrived in the OR after the procedure had started and the surgeon was conducting the procedure.
* The CRNA was performing manual jet ventilation and reported that he/she had a hard time ventilating the patient.
* He/she took over the manual jet ventilation, noted changes to the patient's vital signs and EKG, "had to resuscitate", and told the surgeon that they needed to "intubate" the patient.
* During the procedure he/she had no indication there was a problem with the manual jet ventilator.
* He/she later learned that the manual jet ventilator gauge was not showing the medical air pressure.
* Prior to a procedure he/she "normally" squeezes the lever to see what pressure he/she is getting.
He/she would "check that" if conducting a procedure "by myself."
* He/she believed he/she had a case at KSMC where he/she used the same manual jet ventilator as used at KWMC during the 01/29/2016 procedure, but he/she wasn't sure.
* The number of anesthesia providers required depends on the patient's situation.
* He/she didn't know if there were policies and procedures for use and operation of the manual jet ventilators.
* He/she indicated it is part of the general skills of anesthesia providers but didn't know if there were specific privileges.

21. On 04/05/2016 at 1515 QM staff, including the Director of AR&L, provided a document that contained the following statements:
* "We do not know for certain, but it is presumed that the jet ventilator in question came to [KWMC] via [Kaiser Interstate Clinic] when [KWMC] first opened in August 2013."
* "Since there is no identifying numbers on this type of jet ventilator, we are not able to verify if this particular jet ventilator had been used in prior procedures."

During interview at that time the Director of AR&L stated that it wasn't clear what all the criteria were for use of a manual jet ventilator as they are intended for emergency use.

22. An email titled "CRNA Privilege Form" dated 04/05/2016 at 1530 was reviewed. It was from the Credentials Manager and reflected "Basically the CRNAs can have core privileges for adult or pediatric patients, that's about it, there are no delineated procedures."

Attached to that was a document titled "Privilege Request Form Anesthesiology - CRNA." The most recent date on the three page form was 07/23/2015. The form reflected: "Core privileges in CRNA - Anesthesiology Patients 7 years of age and older...Privileges include the administration of all types of general, regional, and local analgesia and anesthesia for elective and emergency procedures. Privileges will be exercised under the medical supervision of an Anesthesiologist." There were no specific procedures, methods, or types of machines or equipment specified.

23. During interview on 04/05/2016 beginning at 1545 the surgeon who conducted the surgical procedure on 01/29/2016 indicated the following:
*The procedure was started out with an ETT for ventilation and was switched to medical air manual jet ventilation because the ETT was not fitting.
* He/she believed the manual jet ventilator was in the room at the beginning of the procedure.
* He/she "assumed" that the same manual jet ventilator had been used in other cases.
* He/she "doubted" that the same manual jet ventilator had been used at KSMC.
* He/she didn't know if there were policies and procedures for use and operation of the manual jet ventilators.
* "Usually" there is one CRNA and one anesthesiologist, or two anesthesia providers, present when manual jet ventilation is used. On 01/29/2016 there was one CRNA prior to the anesthesiologist presenting.
* He/she was unaware there was a problem with the manual jet ventilator until after the procedure and understands there was a "broken dial."

24. On 04/05/2016 at 1615 QM staff confirmed that four patients in the last 12 months had surgical procedures during which jet ventilation was performed. In addition to Patient 10, those were Patients 1, 2, and 4.

25. The medical record of Patient 1 reflected he/she was an "Elective" admission on 04/22/2015 for "micro direct laryngoscopy with CO2 laser..."

On 04/22/2015 at 1341 the anesthesiologist, the anesthesia provider for the case, recorded in the anesthesia Preprocedure Note under the "Airway Exam" section that the patient had a "Potential difficult airway." Under the "Anesthesia Plan" the anesthesiologist recorded "[Discussed with surgeon.] May use jet ventilator." The documentation did not reflect whether the jet ventilation, using oxygen or air, was to be provided using an automated machine or a manual device.

The "Surgery Report" reflected that the patient was in the OR on 04/22/2015 at 1425. The Anesthesia Record dated 04/22/2015 reflected the anesthesia start time was 1425, the anesthesia end time was 1630, and GA was used. The "Machine No" space was marked with a "-" The form contained a handwritten entry in the "Gas" section that was "Jet Vent started with Air." Another handwritten entry in the "Induction" section of the form was "Jet Vent -." A third handwritten entry in the "Remarks" section was "1532 Jet ventil (sic) [with] air only prior to laser." The documentation did not clearly reflect whether oxygen was used during jet ventilation and whether the jet ventilation was provided using an automated machine or a manual device.

26. The medical record of Patient 2 reflected he/she was an "Elective" admission on 06/22/2015 for "Direct Laryngoscopy, Bronchoscopy...Possible Use of CO2 laser."

On 06/22/2015 at 0652 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan...Ask [acronym not clear] if Laser is to be utilized or if Jet ventilation is required..." The evaluation did not reflect that the anesthesiologist asked the questions and confirmed a plan to include jet ventilation. There was no indication as to whether jet ventilation if used, was to be provided using air or oxygen, using an automated machine or a manual device.

The "Surgery Report" reflected that the patient was in the OR on 06/22/2015 at 0725. The "Anesthesia Record" reflected that anesthesia was started on 06/22/2015 at "72C (sic)," the anesthesia end time was 1848, and GA was used. The "Machine No" space was blank. The record contained a handwritten entry in the "Gas" section that was "x Jet." A second handwritten entry in the "Monitoring/Equip" section was "Jet." Another handwritten entry in the "Induction" section of the form was "Jet Vent." The documentation did not reflect whether air or oxygen was used and whether the jet ventilation was provided using an automated machine or a manual device.

On 06/22/2015 at 0749, approximately 24 minutes after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified..I agree with the ASA status and anesthetic plan." However, there was no documentation to indicate that the plan had been fully established in advance of the procedure as reflected in the paragraph above.

27. The medical record of Patient 4 reflected he/she was an "Elective" admission on 09/23/2015 for "Microlaryngoscopy and Bronchoscopy with CO2 laser..."

The "Surgery Report" reflected that the patient was in the OR on 09/23/2015 at 1157. The "Anesthesia Record" reflected that anesthesia was started on 09/23/2015 at 1157, the anesthesia end time was 1319, and GA was used. The "Machine #" space was blank. The record contained a handwritten entry in the "Induction" section of the form that was "Jet [Ventilation or Ventilator]." Another handwritten entry in the "Remarks" section of the form referred to the use of a "Jet ventilation tube." The documentation did not reflect whether air or oxygen was used and whether the jet ventilation was provided using an automated machine or a manual device.

However, on 09/23/2015 at 1059 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, endotracheal tube methods, postop pain [management]" There was no indication to reflect the planned or possible use of jet ventilation, either by using an automated machine or a manual device.

Based on interview, documentation for 16 of 16 surgeries or medical procedures in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to ensure that clear, complete, and timely informed consent was conducted and documented prior to all surgeries and procedures that required informed consent:
* It was not clear that all surgical and anesthesia related aspects of the informed consent process were completed prior to the patient's completion and signature on the informed consent forms.
* It was not clear who reviewed the informed consent form with the patient and obtained the patient's signature.
* The date and time of the patient's signature on informed consent forms was not always recorded or legible to clearly reflect that the patient's documented consent was prior to the procedure.
* The surgical procedures described on informed consent forms were not always accurate or clear. In one case the procedure had been altered.
* Time entries confirm that sedative and narcotic medications were administered to patients prior to their review of, and signature on, the informed consent forms, and no evaluation of the patient's ability to consent in those case was documented.
* Documentation on pre-operative checklists reflected that patient informed consent forms were complete and on the chart before the time the patient actually signed the form.
* The name of the practitioner who was to perform the procedure was not always recorded on the form.
* Entries in handwriting that appeared to be other than that of the patient's signature were not authenticated, dated, and timed.
* Specific risks of the surgery and anesthesia were identified for some patients on the informed consent form, but not others.

Findings include:

1. Policies and procedures were reviewed:

* The policy and procedure titled "Informed Consent" dated as revised December 2015 reflected that
"Informed consent is a process, not a form...Informed consent must be obtained for procedures that are 'complex'...which include, but are not limited to the following...Major or minor surgery...All procedures in which anesthesia is used...A written consent form will be signed by the patient/patient's legal representative that authorizes the treatment/procedure...The written consent form is completed after the clinician has discussed, obtained, and documented the informed consent but prior to beginning the treatment/procedure/surgery or operation...The clinician/surgeon will obtain the informed consent for treatment procedures, surgeries or operations and sedation identified as requiring informed consent...The taking of a sedative before a medical procedure does not necessarily make a patient incapable of giving informed consent. It is up to the clinician to determine if the patient is able to provide consent...For elective surgeries/operations, special diagnostic or therapeutic procedures involving anesthesia, the informed consent for anesthesia will be obtained by the anesthesia provider...The nursing staff will verify that the clinician/surgeon obtained informed consent and that the clinician/surgeon has documented that the informed consent has been obtained...The nursing staff will verify that the form "Documentation of Informed Consent Process" has been completed and signed by the patient or patient's legal representative...When a person other than the patient signs the consent form, the relationship of the person to the patient must be noted next to the signature."

* The policy and procedure titled "Pre-Induction Procedure", dated as revised June 2013, stipulated: "Prior to induction of anesthesia and the commencement of surgery...the responsible anesthesia care provider shall verify the following information in the patient's medical record...The informed consent, in writing and signed by the patient or his legal guardian, for the contemplated surgical procedures..."

2. The "Documentation of Informed Consent Process" form reviewed in patient records contained the following language: "I authorize [electronically printed practitioner name] and/or his/her assistants of choice and personnel assigned by the hospital or ambulatory surgery center to perform the following procedure: [electronically printed procedure name] and/or to do any other procedures that he/she believes are medically necessary to treat unexpected findings or complications that may occur during the procedure. The clinician above has explained to me the procedure, as well as the anticipated benefits and alternatives relating to the above procedure. The clinician has answered all of my questions about the procedure, benefits, and alternatives to my satisfaction. I have been informed of and understand the significant risks. The risks include but are not limited to, [space for electronically printed risks]. I authorize the use of anesthesia or sedation as medically necessary. Blood or Blood Products: I consent to receive blood or blood products as deemed necessary and appropriate by the clinician if a transfusion is required during or after the procedure __Yes __No I have been notified of the manner in which care will be provided to me if complications occur that required services beyond what this facility is able to provide. I authorize the examination and disposal of any removed body parts or tissues in accordance with customary practice, with the following exceptions (list any exceptions below): ____ Allergies: [space electronically printed patient allergies] I understand that under certain circumstances, Kaiser Permanente may be required by law to disclose or report certain information about me. I understand that I may withdraw this consent at any time prior to the procedure. I also understand that no warranty or guarantee has been made as to the result or cure. [spaces for patient or representative signature and name, date, time]."

3. During interview with the CMO on 04/12/2016 at 1130 he/she stated that the consent for procedures, anesthesia, and blood are combined on one form. The CMO indicated that if anesthesia was not related to a surgical case there would be a separate consent and that wasn't common. He/she stated that the anesthesiologist reviews the patient's chart, goes to the bedside to talk to the patient, does the H&P and PARQ, and writes the orders. When a CRNA is assigned to be the anesthesia provider, that CRNA reviews the anesthesiologist's documentation and confers with the anesthesiologist either in person or on the phone regarding that review. The CRNA then goes to the patient's bedside to talk to the patient and then documents an "attestation" that they have done the review.

During interview with the Director of AR&L on 04/20/2016 at 1310 he/she stated that the physician sometimes obtains the patient's signature on the informed consent form. The Director stated that if the RN checks the form and finds it is not signed she informs the physician, or sometimes if the patient verifies they spoke with the physician the RN may obtain the patient's signature on the informed consent form.

4. The medical record of Patient 10 reflected he/she was an "Elective" admission on 01/29/2016 for "Direct Laryngoscopy, Bronchoscopy, CO2 laser..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 01/29/2016 at 1330.

On 01/29/2016 at 1319, the MAR reflected that the patient was administered 1 mg. of IV Versed, a pre-operative sedative.

On 01/29/2016 at 1321, after the patient received IV Versed, the patient signed the "Documentation of Informed Consent Process" form.

There was no documentation to reflect an assessment that the patient's ability to provide informed consent had not been affected by the administration of IV Versed.

On 01/29/2016 at 1149 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, endotracheal tube methods, postop pain [management]." At the end of the note under the "Author's name", the anesthesiologist recorded "Will discuss airway [management] with surgeon. Will be ready with TIVA and special Ett for laser treatment. Limit FIO2. PARQ discussed including risk of airway fire plus see above." It was not clear what specific entry or entries "see above" referred to. There was no indication to reflect the planned or possible use of jet ventilation, either by using an automated machine or a manual device, and there was no indication that the use of jet ventilation, particularly if provided using a manual device, was discussed with the patient.

On 01/29/2016 at 1527, prior to discharge from the OR at 1535, and after the patient suffered complications during the procedure, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

* In addition, the record of Patient 10 reflected that on 02/02/2016 at 1315 a "Documentation of Informed Consent Process" for "The Placement of Peripherally Inserted Central Catheter" was signed. The name of the practitioner the consent was authorized for was printed on the form as "Vascular Access Registered Nurse."

* In the record of Patient 10 on 02/05/2016 a "Documentation of Informed Consent Process" for "Arterial line placement" was illegibly signed by an unidentified person. The space for the time that the consent was provided was blank. The name of the practitioner the consent was authorized for was printed on the form as "Dr. [name] or associates."

5. The medical record of Patient 1 reflected he/she was an "Elective" admission on 04/22/2015 for "micro direct laryngoscopy with CO2 laser..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 04/22/2015 at 1425.

On 04/22/2015 at 1126 an RN documented on the surgery "Preop Checks" record that yes, "Consents Complete...Consents on Chart." That was prior to the time the patient signed the consent form as described below.

On 04/22/2015 at 1200 noon the patient signed the "Documentation of Informed Consent Process" form. That was after the time the RN documented the consent was complete and on the chart.

On 04/22/2015 at 1341 the anesthesiologist recorded in the anesthesia Preprocedure Note under the "Airway Exam" section that the patient had a "Potential difficult airway." Under the "Anesthesia Plan the anesthesiologist recorded "[Discussed with surgeon.] May use jet ventilator." The documentation did not reflect whether the jet ventilation was to be provided using an automated machine or a manual device, and there was no indication that the use of jet ventilation, particularly if provided using a manual device, was discussed with the patient.

On 04/22/2015 at 1607, while the patient was still in the OR and prior to discharge to PACU at 1623, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

6. The medical record of Patient 2 reflected he/she was an "Elective" admission on 06/22/2015 for "Direct Laryngoscopy, Bronchoscopy...Possible Use of CO2 laser." The "Surgery Report" reflected that the patient was in the OR at 0725 and the "Anesthesia Record" reflected that anesthesia was started on 06/22/2015 at "72C (sic)." .

On 06/22/2015 at 0614 the patient signed the "Documentation of Informed Consent Process" form.

On 06/22/2015 at 0652 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Ask Sx if Laser is to be utilized or if Jet ventilation is required..." The documentation did not reflect that the anesthesiologist asked the question and confirmed a plan to include jet ventilation. There was no indication as to whether jet ventilation if used, was to be provided using an automated machine or a manual device, and there was no indication that the use of jet ventilation, particularly if provided using a manual device, was discussed with the patient.

On 06/22/2015 at 0836, while the patient was still in the OR and prior to discharge to PACU at 0841, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

7. The medical record of Patient 4 reflected he/she was an "Elective" admission on 09/23/2015 for "Microlaryngoscopy and Bronchoscopy with CO2 laser..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 09/23/2015 at 1157.

On 09/23/2015 at 1058 an RN documented on the surgery "Preop Checks" record that yes, "Consents Complete...Consents on Chart." That was prior to the time the patient signed the consent form as described below.

On 09/23/2015 at 1112 the patient signed the "Documentation of Informed Consent Process" form. That was after the time the RN documented the consent was complete and on the chart.

The Anesthesia Record dated 09/23/2015 contained a handwritten entry in the "Induction" section of the form that was "Jet [Ventilation or Ventilator]." Another handwritten entry in the "Remarks" section of the form referred to the use of a "Jet ventilation tube." The documentation did not reflect whether air or oxygen was used and whether the jet ventilation was provided using an automated machine or a manual device.

However, on 09/23/2015 at 1059 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, endotracheal tube methods, postop pain [management]" There was no indication to reflect the planned or possible use of jet ventilation, either by using an automated machine or a manual device, and there was no indication that the use of jet ventilation, particularly if provided using a manual device, was discussed with the patient.

On 09/23/2015 at 1302, while the patient was still in the OR and prior to discharge to PACU at 1313, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

8. The medical record of Patient 13 reflected he/she was an "Elective" admission on 04/01/2016 for "Suspension Microlaryngoscopy with CO2 Laser and Operating Microscope with biopsy...Operation on oral cavity...in the floor of the mouth*." The "Surgery Report" and the "Anesthesia Record" reflected that on the patient was in the OR and anesthesia was started on 04/01/2016 at 0906.

A H&P signed by the surgeon on 03/09/2016 at 1228, 23 days prior to admission, reflected that a PARQ was held with the patient.

On 04/01/2016 at 0730 the patient signed the "Documentation of Informed Consent Process" form. The procedure recorded on the form was "Suspension Microlaryngoscopy with CO2 Laser and Operating Microscope with biopsy...Operation on oral cavity...in the floor of the mouth*." There was no explanation for the "*", the asterisk symbol recorded at the end of the procedure. During the electronic review of the record, staff present did not know what the asterisk referred to.

On 04/01/2016 at 0830 an H&P Update note recorded by the surgeon contained no documentation related to PARQ or consent.

9. a. The medical record of Patient 3 reflected he/she was admitted on 09/19/2015 with onset of swelling and pain in the right knee. The patient was found to have an infection and underwent surgery on the right knee on 09/20/2015. The "Surgery Report" reflected that on 09/20/2015 the patient was in the OR at 1107 and the "Anesthesia Record" reflected that anesthesia was started at 1106.

On 09/19/2015 the patient signed the "Documentation of Informed Consent Process" form for a "Right knee incision, drainage, and debridement with polyethylene liner exchange." The space for the time of the patient's consent was blank.

b. The medical record of Patient 3 reflected that on 09/22/2015 at 1615 a PA documented that the "...plan is ERCP tomorrow." The MPU documentation reflected that the patient was in the MPU room on 09/23/2015 at 1343 and the "Anesthesia Record" reflected anesthesia was started at 1343.

On 09/23/2015 at 1226 the MAR reflected that the patient was administered 10 mg. of oral oxycodone, a narcotic medication.

On 09/23/2015 at 1242 RN documentation on the "Pre Procedure Verification" reflected "Accurate consent signed and available - No...Relevant documentation in chart? - No" There was no other preprocedure verification documented in the record.

On 09/23/2015 at 1257 the MAR reflected that the patient was administered 2 mg. of IV morphine, a narcotic medication.

On 09/23/2015 at 1342 the anesthesiologist recorded "Patient claims, 'I'm very confused'...Anesthesia Plan...discussed in person...procedure confirmed, consents reviewed, site verified...Discussed: general anesthesia...Risks, benefits, alternatives and related procedures for anesthesia discussed with patient. Questions invited and answered..."

On 09/23/2015 at 1343 the Anesthesia Record reflected that the anesthesia start time was 1343, one minute after anesthesiologist signed off on the evaluation and prior to the time recorded as the time the patient signed the consent form in the paragraph below.

On 09/23/2015 at 1345, after the anesthesia start time, the patient signed the "Documentation of Informed Consent Process" form for a second procedure. Although the procedure ordered to be performed was an "Endoscopic RetroGrade Cholangiopancreatography," also referred to as "ERCP," the consent form used was for a "Colonoscopy," a completely different procedure than an ERCP. An unidentified person had altered the consent form by crossing out the word "Colonoscopy"and had written next to it "ERCP." That handwritten alteration was not accurate, and was not authenticated or dated or timed. In addition, the date and time recorded next to the patient's signature was not in the same handwriting as the signature, and that entry was not authenticated and dated and timed by the author.

The pre-anesthesia evaluation documented by the anesthesiologist reflected that although the patient was "confused" the "informed consent process" continued and the patient's signature was obtained on the consent form at a time recorded as after anesthesia start. There was no documentation of an assessment around the patient's ability to provide consent, including whether the patient's abilities had been affected by the administration of the narcotic medications oxycodone and morphine.

On 09/23/2015 at 1541 the physician who conducted the ERCP documented "The procedure, indications, potential risks...and alternatives to the procedure were discussed with the patient prior to the planned procedure....Written informed consent was obtained." However, an accurate and appropriate written consent was not obtained as reflected in these findings.

10. The medical record of Patient 5 reflected he/she was an "Elective" admission on 12/07/2015 for "Bilateral hip replacements..." The "Surgery Report" reflected the patient was in the OR on 12/07/2015 at 0727 and the "Anesthesia Record" reflected that anesthesia was started on 12/07/2015 at 0714.

On 12/07/2015 at 0545 the patient signed the "Documentation of Informed Consent Process" form.

On 12/07/2015 at 1144, after the anesthesia end time, a note recorded by the CRNA reflected that "Actual anesthetic administered: MAC and Spinal."

However, on 12/07/2015 at 0711 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, regional anesthesia. Anesthesia Type Chosen Single shot spinal." There was no indication to reflect the planned or possible use of MAC or that it was discussed with the patient.

11. The medical record of Patient 6 reflected he/she presented to the ED on 12/14/2015 at 1454 and was transferred to the OR for "incision and drainage of peri-rectal abscess" on 12/14/2015 at 1945. The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 12/14/2015 at 2021.

On 12/14/2015 at 1948 an RN documented on the surgery "Preop Checks" record that yes "Consents Complete...Consents on Chart" .

The "Documentation of Informed Consent Process" form reflected a patient signature on the form. However, the signature "Date/Time" space on the form was blank.

There was no documentation on the form or elsewhere in the record to reflect who reviewed the form with the patient and obtained the patient's signature. There was no evidence to reflect when the patient reviewed and signed the form, before or after the surgery and administration of anesthesia.

12. The medical record of Patient 7 reflected he/she was an "Elective" admission on 12/28/2015 for "Left... knee replacement..." The "Surgery Report" and the "Anesthesia Record" reflected that on 12/28/2015 the patient was in the OR at 0731 and that anesthesia was started at 0710.

The "Documentation of Informed Consent Process" form reflected the patient signed the form on 12/28/2015 at 0545.

On 12/28/2015 at 0919 the CRNA recorded that "Actual anesthetic administered: MAC and Spinal."

However, on 12/28/2015 at 0706 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan...Discussed: general anesthesia, central neuraxial blocks. Anesthesia Type Chosen Single shot spinal." There was no indication to reflect the planned or possible use of MAC or that it was discussed with the patient.

On 12/28/2015 at 1326, after the surgery completion time earlier that day at 0947, the surgeon's Operative Report reflected that a "Preoperative PARQ discussion was held...provided written informed consent for the procedure."

13. The medical record of Patient 8 reflected he/she was an "Elective" admission on 01/25/2016 for "Suspension Microlaryngoscopy and Biopsy." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 01/25/2016 at 0904.

A H&P signed by the surgeon on 01/08/2016 at 0940, 17 days prior to admission, reflected that "Procedures, alternatives, risks discussed, and questions answered - Yes. Consent obtained - No."

On 01/25/2016 at 0718 an RN documented on the surgery "Preop Checks" record that yes, "Consents Complete...Consents on Chart" .

On 01/25/2016 at 0730 the patient signed the "Documentation of Informed Consent Process" form. That was after the time the RN documented the consent was complete and on the chart.

On 01/25/2016 at 0853 an H&P interval update note recorded by the surgeon contained no documentation related to PARQ or consent.

14. The medical record of Patient 9 reflected he/she was an "Elective" admission on 01/27/2016 for "Microlaryngoscopy with excision of laryngeal papillomas." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 01/27/2016 at 1127.

The H&P signed by the surgeon on 01/11/2016 at 1743, 16 days prior to admission, reflected that "An extensive PARQ....session was held...A consent was signed and witnessed..." However, there was no evidence in the record of the written consent signed by the patient on 01/11/2016.

However, the "Documentation of Informed Consent Process" form reflected the patient signed the form on 01/27/2016 at 0850.

15. The medical record of Patient 11 reflected he/she was an "Elective" admission on 02/04/2016 for surgery including "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 02/04/2016 at 1420.

On 02/04/206 at 1254 an RN documented on the surgery "Preop Checks" record that yes "Consents Complete...Consents on Chart." That was prior to the time the patient signed the consent form as described below.

On 02/04/2016 at 1310 the patient signed the "Documentation of Informed Consent Process" form. That was after the time the RN documented the consent was complete and on the chart.

On 02/04/2016 at 1411 the H&P signed by the surgeon contained no documentation of the informed consent process and that the risks of the procedure or anesthesia were addressed with the patient.

16. The medical record of Patient 12 reflected he/she was an "Elective" admission on 02/15/2016 for "Suspension Microlaryngoscopy..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 02/15/2016 at 0728.

On 02/15/2016 the patient signed the "Documentation of Informed Consent Process" form. The handwriting of the "Date/Time" was different than that of the signature and it was not clear whether the entry was 6:30 a.m. or 6:30 p.m.

On 02/15/2016 at 0837, after the patient had been discharged to the PACU at 0835, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

17. Specific risks of the surgery and anesthesia were electronically documented on the "Documentation of Informed Consent Process" forms for Patients 1, 2, 3 (for one procedure), 4, 7, 8, 9, 10, 11, 12, and 13. Only the form for Patient 11, which identified the most extensive risks, included "death" and "pneumothorax." There were no specific risks identified for Patient 3 for one procedure, and Patients 5 and 6.

Based on observation, interview, review of 4 of 4 medical records of patients who had anesthesia administered by a jet ventilator (Patients 1, 2, 4, and 10), review of PM records, review of policies and procedures, and review of other documents it was determined that the hospital failed to develop and implement policies, procedures, and systems to ensure that airway ventilation during surgery and anesthesia was conducted with devices that were maintained in safe and proper working condition

This failure in the case of Patient 10 resulted in the provision of airway ventilation during surgery and anesthesia with a broken manual jet ventilator.

Policies and procedures for the use, operation, and maintenance of manual jet ventilators had not been developed. Prior to the incident involving Patient 10 on 01/29/2016, manual jet ventilators not incorporated into the hospital's medical equipment/device inventory and PM system. There was no systems to account for and track the types, numbers, and locations of those devices in the hospital; to account for where they were received from; to account for when they were put into service; to initially inspect those devices prior to putting them into service; to document repair work requested and done on those devices.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting

Findings include:

Refer to Tag A724, CFR 482.41(c)(2), Physical Environment: Facilities, Supplies, Equipment Maintenance.
Refer to Tag A115, CFR 482.13, Condition of Participation, Patient Rights.
Refer to Tag A1000, CFR 482.52, Condition of Participation, Anesthesia Services.

Based on observation, interview, review of 4 of 4 medical records of patients who had anesthesia administered by a jet ventilator (Patients 1, 2, 4, and 10), review of PM records, review of policies and procedures, and review of other documents it was determined that the hospital failed to develop and implement policies, procedures, and systems to ensure that airway ventilation during surgery and anesthesia was conducted with devices that were maintained in safe and proper working condition

This failure in the case of Patient 10 resulted in the provision of airway ventilation during surgery and anesthesia with a broken manual jet ventilator.

Policies and procedures for the use, operation, and maintenance of manual jet ventilators had not been developed. Prior to the incident, manual jet ventilators not incorporated into the hospital's medical equipment/device inventory and PM system. There was no systems to account for and track the types, numbers, and locations of those devices in the hospital; to account for where they were received from; to account for when they were put into service; to initially inspect those devices prior to putting them into service; to document repair work requested and done on those devices.

Findings include:

Refer to Tag A144, CFR 482.13(c)(2), Patient's Rights: Care in Safe Setting.
Refer to Tag A951, CFR 482.51(b), Surgical Services: Operating Room Policies.

Based on observation, interview, documentation for 9 of 14 surgical procedures in 9 of 13 medical records reviewed (Patients 1, 2, 4, 8, 9, 10, 11, 12 and 13), and review of policies and procedures and other documents it was determined that the hospital failed to ensure the provision of safe and appropriate surgical care as surgical instruments and devices were borrowed from other hospital and non-hospital facilities and there were no policies and procedures for that practice.

Findings include:

1. Refer to Tag A144, CFR 482.13(c)(2), Patient Rights: Care in Safe Setting.

2. During interview with the DSS on 03/31/2016 at 1730 he/she stated that a manual jet ventilator used during a surgical procedure on 01/29/2016 at KWMC came to KWMC in a surgical "tray" from another site, the Kaiser Interstate Clinic ASC. The DSS explained that surgical "trays" have "expensive instrumentation" in them so "it doesn't make sense" to have them duplicated at all sites. "Trays" are "borrowed" from other sites and transported to the site where the surgeon is working using "couriers" and "cabs." He/she confirmed that the transport occurs without staff in attendance and only the courier or cab driver is in control of the instruments, equipment or device.

3. During interview with the DSS and the Director of AR&L on 04/01/2016 at approximately 1635 they confirmed there were no written policies and procedures for borrowing or sharing of instruments, equipment, and devices between KWMC and other hospital and non-hospital facilities

4. On 04/04/2016 at 1430 the Director of AR&L provided two documents that were not on KWMC letterhead or policy and procedure templates, contained no dates, and the author(s) were not identified.

The "Regional Sterile Processing Loan & Borrow Guidelines" document reflected:
"Send
* Inpatient - Using white board tracking
*ASC's - OR lead tracking
* Courier - Use [Kaiser Permanente] courier system as much as possible
* Dust cover with Cardinal Bagging system. Oversized items will use a large trash bag.
* All trays sterilizied in another facility shall be reprocessed on site for use.
Return
* Send back sets reconciled and unsterile."

The other document was titled "Loan & Borrow Workflow." That document consisted of a workflow diagram with eight boxes that contained verbiage related to preparation and transport of items borrowed and used between facilities. However, the specific facilities were not identified.

5. The review of medical records reflected at least eight cases where the surgical instruments and devices were identified as KPNW versus KWMC, consistent with the interview and document findings above.

6. The medical record of Patient 10 reflected he/she underwent a "Direct Laryngoscopy, Bronchoscopy, CO2 laser..." surgery on 01/29/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"
* "Holder Laryngoscope ENT KPNW"
* "Tray Scopes Steiner ENT WMC"

7. The medical record of Patient 1 reflected he/she underwent a "micro direct laryngoscopy with CO2 laser..." surgery on 04/22/2015. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Holder Laryngoscope ENT KPNW"
* "Tray Scopes Steiner ENT WMC"
* "Tray Laryngoscopy Micro KPNW"

8. The medical record of Patient 2 reflected he/she underwent a "Direct Laryngoscopy, Bronchoscopy...Possible Use of CO2 laser" surgery on 06/22/2015. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"

9. The medical record of Patient 4 reflected he/she underwent a "Microlaryngoscopy and Bronchoscopy with CO2 laser..." surgery on 09/23/2015. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"
* "Holder Laryngoscope ENT KPNW"

10. The medical record of Patient 13 reflected he/she underwent a "Suspension Microlaryngoscopy with CO2 Laser and Operating Microscope with biopsy...Operation on oral cavity...in the floor of the mouth*" surgery on 04/01/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Holder Laryngoscope ENT KPNW"
* "Tray Scopes Steiner ENT WMC"
* "Tray Light Carriers Laryngoscope ENT KPNW"
* "Tray Laryngoscopy Micro KPNW"

11. The medical record of Patient 8 reflected he/she underwent a "Suspension Microlaryngoscopy and Biopsy" on 01/25/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"

12. The medical record of Patient 9 reflected he/she underwent a "Microlaryngoscopy with excision of laryngeal papillomas" on 01/27/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"

13. The medical record of Patient 11 reflected he/she underwent a "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy" surgery on 02/04/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"
* "Tray T&A ENT KPNW"
* "Laryngoscope Hollinger Anterior WMC"

14. The medical record of Patient 12 reflected he/she underwent a "Suspension Microlaryngoscopy..." surgery on 02/15/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"

Based on interview, documentation for 16 of 16 surgeries or medical procedures in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to ensure that clear, complete, and timely informed consent was conducted and documented prior to all surgeries and procedures that required informed consent

Findings include:

Refer to Tag A466, CFR 482.24(c)(4)(v), Medical Record Services: Informed Consent.

Based on observation, interview, documentation for 14 of 14 surgical procedures that required anesthesia in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures that ensured the provision of safe and appropriate anesthesia services.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings include:

Refer to Tag A1002, CFR 485.52(b), Anesthesia Services: Delivery of Anesthesia Services.
Refer to Tag A1003, CFR 482.52(b)(1), Anesthesia Services: Pre-Anesthesia Evaluation.
Refer to Tag A1004, CFR 482.52(b)(2), Anesthesia Services: Intraoperative Anesthesia Record.
Refer to Tag A1005, CFR 482.52(b)(3), Anesthesia Services: Post-Anesthesia Evaluation.
Refer to Tag A115, CFR 482.13, Condition of Participation, Patient Rights.

Based on observation, interview, documentation for 14 of 14 surgical procedures that required anesthesia in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures that ensured the provision of safe and appropriate anesthesia services.

Findings include:

Refer to Tag A1003, CFR 482.52(b)(1), Anesthesia Services: Pre-Anesthesia Evaluation.
Refer to Tag A1004, CFR 482.52(b)(2), Anesthesia Services: Intraoperative Anesthesia Record.
Refer to Tag A1005, CFR 482.52(b)(3), Anesthesia Services: Post-Anesthesia Evaluation.
Refer to Tag A115, CFR 482.13, Condition of Participation, Patient Rights.

Based on interview, documentation for 10 of 14 surgical procedures that required anesthesia in 9 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 10, and 11), and review of policies and procedures it was determined that the hospital failed to ensure that accurate and complete pre-anesthesia evaluations were completed and documented prior to all surgeries or procedures requiring anesthesia services. Pre-anesthesia plans were not clear or complete, or were not completed by the anesthesia provider prior to the the delivery of the first dose of medication given for the purpose of inducing anesthesia.

Findings include:

1. Policies and Procedures were reviewed:

* The policy and procedure titled "Pre-Anesthesia Evaluation", dated as revised June 2013, stipulated: "The preanesthesia evaluation will be documented in the patient's electronic medical record in all areas where that is available. Alternatively, a written record will be prepared. Such documentation will include: The date and time of the interview...any extraordinary circumstances...Potential anesthesia problems...The anesthesia plan which has been discussed with the patient and significant other(s) and/or the parent and/or guardian, including...The type and route of anesthetic to be administered...Special needs for...intraoperative monitoring..."

* The policy and procedure titled "Pre-Induction Procedure", dated as revised June 2013, stipulated: "Prior to the induction of anesthesia, the responsible anesthesia care provider shall verify that...A complete machine checkout has been performed...There is documentation on the anesthetic record that the machine checkout has been performed...Presence of apparatus for airway maintenance...Prior to induction of anesthesia and the commencement of surgery...the responsible anesthesia care provider shall verify the following information in the patient's medical record...The informed consent, in writing and signed by the patient or his legal guardian, for the contemplated surgical procedures..."

* The policy and procedure titled "Medical Record Documentation", dated as revised June 2013, stipulated: "Immediately prior to the induction of anesthesia and the commencement of surgery, the responsible anesthesia care provider shall verify and document: Patient reassessment immediately prior to induction...The patient's identity and the site of the body to be operated on..."

2. During interview with the CMO on 04/12/2016 at 1130 he/she stated that prior to a procedure the anesthesiologist reviews the patient's chart, goes to the bedside to talk to the patient, does the H&P and PARQ, and writes the orders. When a CRNA is assigned to be the anesthesia provider, that CRNA reviews the anesthesiologist's documentation and confers with the anesthesiologist either in person or on the phone regarding that review. The CRNA then goes to the patient's bedside to talk to the patient and then documents an "attestation" that they have done the review.

3. Refer to Tag A144, CFR 482.13(c)(2), Care in Safe Setting, that reflects the lack of clear, complete, and timely pre-anesthesia evaluations for Patients 10, 1, 2, and 4.

4. a. The medical record of Patient 3 reflected he/she was admitted on 09/19/2015 with onset of swelling and pain in the right knee. The patient was found to have an infection and underwent surgery on the right knee on 09/20/2015. The "Surgery Report" reflected that on 09/20/2015 the patient was in the OR at 1107 and the "Anesthesia Record" reflected that anesthesia was started at 1106.

On 09/20/2015 at 1107, after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified..I agree with the ASA status and anesthetic plan."

b. The medical record of Patient 3 reflected that on 09/22/2015 at 1615 a PA documented that the "...plan is ERCP tomorrow." The "Case Tracking Events" on the procedure report reflected that on 09/23/2015 the patient was in the MPU at 1340 and the "Anesthesia Record" reflected that anesthesia was started at 1343.

On 09/23/2015 at 1226 the MAR reflected that the patient was administered 10 mg. of oral oxycodone.
On 09/23/2015 at 1257 the MAR reflected that the patient was administered 2 mg. of IV morphine.

On 09/23/2015 at 1342, one minute prior to the anesthesia start time of 1343, the anesthesiologist recorded "Patient claims, 'I'm very confused'...Anesthesia Plan...discussed in person...procedure confirmed, consents reviewed, site verified...Discussed: general anesthesia...Risks, benefits, alternatives and related procedures for anesthesia discussed with patient. Questions invited and answered..." Although the patient had received narcotic medications within 46 and 77 minutes prior to the evaluation, and the patient had expressed being confused, there was no documentation to reflect that the anesthesiologist had evaluated the patient's ability to discuss the anesthesia plan, and to provide consent.

On 09/23/2015 at 1435, 52 minutes after the anesthesia start time of 1343, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note" and documented "Patient verified, Procedure confirmed, Consents reviewed and Site verified...I agree with the ASA status and anesthetic plan."

There was no documentation to reflect that the anesthesiologist had evaluated the patient's ability to discuss the anesthesia plan, and to provide consent.

5. The medical record of Patient 5 reflected he/she was an "Elective" admission on 12/07/2015 for "Bilateral hip replacements..." The "Surgery Report" reflected the patient was in the OR on 12/07/2015 at 0727 and the "Anesthesia Record" reflected that anesthesia was started on 12/07/2015 at 0714.

On 12/07/2015 at 0711 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, regional anesthesia. Anesthesia Type Chosen Single shot spinal."

On 12/07/2015 at 0818, 64 minutes after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified...I agree with the ASA status and anesthetic plan." However, the CRNA also recorded "Patient Chart reviewed and plan discussed prior to surgery. Attestation documented after procedure start."

On 12/07/2015 at 1144 the a note recorded by the CRNA reflected that "Actual anesthetic administered: MAC and Spinal." The pre-anesthesia evaluation did not address the planned or possible use of MAC.

6. The medical record of Patient 6 reflected he/she presented to the ED on 12/14/2015 at 1454 and was transferred to the OR for "incision and drainage of peri-rectal abscess" on 12/14/2015 at 1945. The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 12/14/2015 at 2021.

On 12/14/2015 at 2043, 22 minutes after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified...I agree with the ASA status and anesthetic plan."

7. The medical record of Patient 7 reflected he/she was an "Elective" admission on 12/28/2015 for "Left... knee replacement..." The "Surgery Report" reflected that on 12/28/2015 the patient was in the OR at 0731 and the "Anesthesia Record" reflected that anesthesia was started on 12/28/2015 at 0710.

On 12/28/2015 at 0706 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan...Discussed: general anesthesia, central neuraxial blocks Anesthesia Type Chosen Single shot spinal."

On 12/07/2015 at 0708 the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified..I agree with the ASA status and anesthetic plan."

On 12/28/2015 at 0919 a note recorded by the CRNA reflected that "Actual anesthetic administered: MAC and Spinal." The pre-anesthesia evaluation did not address the planned or possible use of MAC.

8. The medical record of Patient 11 reflected he/she was an "Elective" admission on 02/04/2016 for surgery including "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 02/04/2016 at 1420.

On 02/04/2016 at 1444, 24 minutes after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, and Consents reviewed...I agree with the ASA status and anesthetic plan."

Based on interview, documentation for 14 of 14 surgical procedures that required anesthesia in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to ensure that the intraoperative anesthesia record was complete and accurate:
* Documentation of the management of complications during anesthesia was not clear and complete;
* Documentation of the anesthesia and ventilation equipment used was incomplete and inconsistent;
* Documentation of equipment checks prior to anesthesia was not evident; and
* Documentation of the type of anesthesia was incomplete.

Findings include:

1. Policies and procedures were reviewed:

* The policy and procedure titled "Pre-Induction Procedure", dated as revised June 2013, stipulated: "Prior to the induction of anesthesia, the responsible anesthesia care provider shall verify that...A complete machine checkout has been performed...There is documentation on the anesthetic record that the machine checkout has been performed...Presence of apparatus for airway maintenance..."

* The policy and procedure titled "Medical Record Documentation", dated as revised June 2013, stipulated: "The anesthesia care provider shall document the results of the equipment and supplies 'case check' before induction of anesthesia. This documentation will occur in the Record of Anesthesia. (See Pre-Induction Procedure.)"

* The policy and procedure titled "Patient Care Safety Guidelines" dated as revised January 2016, stipulated: "Preanesthesia Apparatus Check...The function of the anesthesia machine shall be tested prior to its first use during any work day...Completion of the machine checkout is documented on the anesthetic record...General anesthesia is to be administered only by using an anesthesia machine with appropriate safety devices...Surgical or anesthesia procedures are performed only when the necessary equipment, personnel, and organizations are available. Anesthesia Machine Checklist and Testing Procedure To be performed daily. Items marked with an * should be performed before each case...*Ventilator and alarm..."

The policy and procedure contained no provisions for a preanesthesia check of any other apparatus that may be used by the anesthesia provider to provide aspects of anesthesia care, including ventilation by a manually operated device such as a manual jet ventilator.

* The policy and procedure titled "Intra-Operative Monitoring", dated as revised June 2013, stipulated:
"During all anesthetic procedures, the patient's ventilation shall be continually evaluated...The adequacy of ventilation of all patients receiving general anesthesia shall be ensured through the monitoring of the carbon dioxide (CO2) content and/or volume of expired gas...When ventilation is controlled by a mechanical ventilator, a low pressure disconnect alarm shall be in continuous use. This device must give an audible signal when the alarm threshold is exceeded...During regional anesthesia and monitored anesthesia care, the adequacy of ventilation shall be evaluated, at least by continual observation of qualitative clinical signs such as chest excursion and auscultation of breath sounds, and pulse oximeter."

The policy and procedure contained no provisions for ventilation provided by a manually operated device such as a manual jet ventilator.

* The policy and procedure titled "Anesthesia During Laser Procedures", dated as revised June 2013, contained no provisions for ventilation with air only, or ventilation provided by a manually operated device such as a manual jet ventilator.

2. Refer to Tag A144, CFR 482.13(c)(2), Patient Rights: Care in Safe Setting, that reflects the lack of clear and complete documentation on the Anesthesia Records for Patients 10, 1, 2, and 4. In addition, documentation to reflect the "case check" described in the policies and procedures above was not evident in those records.

3. The medical record of Patient 13 reflected he/she was an "Elective" admission on 04/01/2016 for "Suspension Microlaryngoscopy with CO2 Laser and Operating Microscope with biopsy...Operation on oral cavity...in the floor of the mouth*." The "Surgery Report" reflected that the patient was in the OR on 04/01/2016 at 0906.

The "Anesthesia Record" reflected that anesthesia was started on 04/01/2016 at 0906, the anesthesia end time was 1106, and GA was used. The "Machine #" was blank and there was no documentation of the "case check."

4. a. The medical record of Patient 3 reflected he/she was admitted on 09/19/2015 with onset of swelling and pain in the right knee. The patient was found to have an infection and underwent surgery on the right knee on 09/20/2015. The "Surgery Report" reflected that on 09/20/2015 the patient was in the OR at 1107.

The "Anesthesia Record" reflected that anesthesia was started on 09/20/2015 at 1106, the anesthesia end time was 1348, and GA was used. The "Machine No" was recorded as "-" and there was no documentation of the "case check.

b. The medical record of Patient 3 reflected that on 09/22/2015 at 1615 a PA documented that the "...plan is ERCP tomorrow." The MPU documentation reflected that the patient was in the MPU room on 09/23/2015 at 1343.

The "Anesthesia Record" reflected anesthesia was started at 1343, the anesthesia end time was 1455, and GA was used. The "Machine #" was recorded as "3" and there was no documentation of the "case check."

5. The medical record of Patient 5 reflected he/she was an "Elective" admission on 12/07/2015 for "Bilateral hip replacements..." The "Surgery Report" reflected the patient was in the OR on 12/07/2015 at 0727.

The"Anesthesia Record" reflected that anesthesia was started on 12/07/2015 at 0714, the anesthesia end time was 1218, and that MAC and Regional Anesthesia were provided. The "Machine #" was recorded as "8" and there was no documentation of the "case check."

6. The medical record of Patient 6 reflected he/she presented to the ED on 12/14/2015 at 1454 and was transferred to the OR for "incision and drainage of peri-rectal abscess" on 12/14/2015 at 1945. The "Surgery Report" reflected that the patient was in the OR on 12/14/2015 at 2021.

The "Anesthesia Record" reflected that anesthesia was started on 12/14/2015 at 2021, the anesthesia end time was 2139, and GA was used. The "Machine #" was recorded as "51961" and there was no documentation of the "case check."

7. The medical record of Patient 7 reflected he/she was an "Elective" admission on 12/28/2015 for "Left... knee replacement..." The "Surgery Report" reflected that on 12/28/2015 the patient was in the OR at 0731.

The "Anesthesia Record" reflected that anesthesia was started on 12/28/2015 at 0710, the anesthesia end time was 0955, and Regional Anesthesia was used. However, in a note on 12/28/2015 at 0919 the CRNA recorded that "Actual anesthetic administered: MAC and Spinal." The "Machine #" was recorded as "4" and there was no documentation of the "case check."

8. The medical record of Patient 8 reflected he/she was an "Elective" admission on 01/25/2016 for "Suspension Microlaryngoscopy and Biopsy." The "Surgery Report" reflected that the patient was in the OR on 01/25/2016 at 0904.

The "Anesthesia Record" reflected that anesthesia was started on 01/25/2016 at 0904, the anesthesia end time was 0956, and GA was used. The "Machine #" was blank and there was no documentation of the "case check."

9. The medical record of Patient 9 reflected he/she was an "Elective" admission on 01/27/2016 for "Microlaryngoscopy with excision of laryngeal papillomas." The "Surgery Report" reflected that the patient was in the OR on 01/27/2016 at 1127.

The "Anesthesia Record" reflected that anesthesia was started on 01/27/2016 at 1127, the anesthesia end time was 1238, and GA was used. The "Machine #" was recorded as "52907" and there was no documentation of the "case check."

10. The medical record of Patient 11 reflected he/she was an "Elective" admission on 02/04/2016 for surgery including "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy." The "Surgery Report" reflected that the patient was in the OR 02/04/2016 at 1420.

The "Anesthesia Record" reflected that anesthesia was started on 02/04/2016 at 1420, the anesthesia end time was 1655, and GA was used. The "Machine #" was blank and there was no documentation of the "case check."

11. The medical record of Patient 12 reflected he/she was an "Elective" admission on 02/15/2016 for "Suspension Microlaryngoscopy..." The "Surgery Report" reflected that on the patient was in the OR on 02/15/2016 at 0728.

The "Anesthesia Record" reflected that anesthesia was started on 02/15/2016 at 0728, the anesthesia end time was 0844, and GA was provided. The "Machine #" was recorded as "911" and there was no documentation of the "case check."

Based on interview, documentation for 2 of 14 surgical procedures that required anesthesia in 2 of 13 medical records reviewed (Patients 6 and 11), and review of policies and procedures it was determined that the hospital failed to ensure that a post-anesthesia evaluation was completed and documented no later than 48 hours after a surgery or procedure that required anesthesia services.

Findings include:

1. The policy and procedure titled "Post-Anesthesia Evaluation and Care", dated as revised June 2013, stipulated: "Post-anesthesia visits...after the patient's complete recovery from anesthesia, shall be documented, including date and time, in the patient's electronic record...Post-anesthesia visits are routinely done within 24 hours by an anesthesia provider, but must be provided within 48 hours."

2. The medical record of Patient 6 reflected he/she presented to the ED on 12/14/2015 at 1454 and was transferred to the OR for "incision and drainage of peri-rectal abscess" on 12/14/2015 at 1945. The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 12/14/2015 at 2021.

The "Case Tracking Events" section of the "Surgery Report" reflected the patient was transferred out of the OR on 12/14/2015 at 2131 and the "Anesthesia Record" reflected that the anesthesia end time on 12/14/2015 was 2139. There was no evidence of an "Anesthesia Post-procedure Evaluation" in the record performed after the patient's recovery from anesthesia.

That was confirmed during interview with staff present at the time of the electronic record review on 4/12/2016 at 1500.

3. The medical record of Patient 11 reflected he/she was an "Elective" admission on 02/04/2016 for surgery including "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 02/04/2016 at 1420.

The "Case Tracking Events" section of the "Surgery Report" reflected the patient was transferred out of the OR on 02/04/2016 at 1643, and the "Anesthesia Record" reflected that the anesthesia end time on 02/04/2016 was 1655. There was no evidence of an "Anesthesia Post-procedure Evaluation" in the record performed after the patient's recovery from anesthesia.

That was confirmed during interview with staff present at the time of the electronic record review on 4/12/2016 at 1535.

Based on observation, interview, documentation for 16 of 16 surgeries or medical procedures in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), review of policies and procedures, and review of other documents it was determined that the hospital failed to fully develop and implement policies, procedures, and systems to ensure that it promoted for each patient the right to complete and timely informed consent and the right to the provision of safe and appropriate care.

These failures resulted in an adverse patient event, which for Patient 10 resulted in the provision of airway ventilation during surgery and anesthesia with a broken manual jet ventilator that contributed to the patient's death.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings include:

Refer to Tag A131, CFR 482.13(b)(2), Patient Rights: Informed Consent.
Refer to Tag A144, CFR 482.13(c)(2), Patient Rights: Care in Safe Setting.
Refer to Tag A700, CFR 482.41, Condition of Participation, Physical Environment.
Refer to Tag A1000, CFR 482.52, Condition of Participation, Anesthesia Services.

Based on interview, documentation for 16 of 16 surgeries or medical procedures in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to ensure that clear, complete, and timely informed consent was conducted and documented prior to all surgeries and procedures that required informed consent

Findings include:

Refer to Tag A466, CFR 482.24(c)(4)(v), Medical Record Services: Informed Consent.

Based on observation, interview, review of 4 of 4 medical records of patients who had anesthesia administered by a jet ventilator (Patients 1, 2, 4, and 10), review of PM records, review of policies and procedures, and review of other documents it was determined that the hospital failed to fully develop and implement policies, procedures, and systems to ensure that airway ventilation during surgery and anesthesia was conducted with devices that were maintained in safe and proper working condition.

This failure in the case of Patient 10 resulted in the provision of airway ventilation during surgery and anesthesia with a broken manual jet ventilator.

Policies and procedures for the use and operation of manual jet ventilators had not been developed, and there were inconsistencies throughout the investigation regarding manual jet ventilator use and operation in the following areas:
* Criteria and indications for use;
* Staff training and privileges to use;
* Proper set-up prior to procedures;
* Quality checks and inspections prior to procedures;
* Numbers of anesthesia providers required to be present;
* Documentation of use during procedures;
* Storage;
* Cleaning and disinfection; and
* Preventive maintenance.

Prior to the date of the incident involving Patient 10, manual jet ventilators were not incorporated into the hospital's medical equipment/device inventory and PM system. There was no systems to account for and track the types, numbers, and locations of those devices in the hospital; to account for where they were received from; to account for when they were put into service; to initially inspect those devices prior to putting them into service; to document repair work requested and done on those devices.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings include:

1. Equipment and devices referenced in this report:
* A manufacturer's document from Anesthesia Associates, Inc. described its manual jet ventilator as "A ventilating system for rigid-wall bronchoscopy, laryngeal microsurgery, and emergency use. Consisting of 5' high pressure tubing with O2 DISS fitting, flow control valve, thumb control valve, pressure gauge, and 20" clear plastic tubing with Luer lock fitting for attachment of adapters and tubes below."
* A document identified as from "aagbi" (Association of Anaesthetists of Great Britain and Ireland) was provided that described a Hunsaker as "The Hunsaker Mon-Jet catheter was designed specifically for microlaryngeal procedures...The ventilator is attached to the central lumen, with gas exiting through an aperture at the tip of the catheter."
* A Monsoon jet ventilator is a machine manufactured by Acutronic Medical Systems AG. The Acutronic website describes the Monsoon as "A universal ventilator for all procedures in laryngology, airway, thoracic and heart surgery...high-frequency jet ventilation application..."

2. The medical record of Patient 10 reflected he/she was an "Elective" admission on 01/29/2016 for "Direct Laryngoscopy, Bronchoscopy, CO2 laser..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 01/29/2016 at 1330.

On 01/29/2016 at 1149 the anesthesiologist recorded in the anesthesia Preprocedure Note that the patient "overdoses in Oct 2015 and required intubation. Self extubated [him/herself] while in ICU. Subsequently developed dyspnea - ENT dx subglottic stenosis...Current smoker...Asthma...Audible intermittent stridor with long inhalation and exhalation but pt does not seem to be in distress...Anesthesia Plan...Discussed: general anesthesia, endotracheal tube methods, postop pain [management]." At the end of the note under the "Author's name", the anesthesiologist recorded "Will discuss airway [management] with surgeon. Will be ready with TIVA and special Ett for laser treatment. Limit FIO2. PARQ discussed including risk of airway fire plus see above...[Discussed with] CRNA." It was not clear what specific entry or entries "see above" referred to. There was no documentation in the evaluation to reflect that the anesthesiologist discussed the airway management with the surgeon, and the evaluation did not identify the planned or possible use of jet ventilation using oxygen or air, either by using an automated machine or a manual device.

On 01/29/2016 at 1325 the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and Site verified. I have reviewed the patient's history, allergies, and physical exam. I agree with the ASA status and anesthetic plan." However, there was no documentation to indicate whether the plan had been fully established as reflected in the paragraph above.

The "Anesthesia Record" dated 01/29/2016 reflected the anesthesia start time was 1330 and the anesthesia end time was 1550. The form reflected that the CRNA was the primary anesthesia provider and that an anesthesiologist presented to the room after the patient began experiencing complications. However, the sequence of events, the time that the anesthesiologist entered the case, and the time a second CRNA entered the case, as well as the role of the second CRNA, was not clear.

The "Anesthesia Record" contained a handwritten entry in the "Induction" section of the form that was "Jet [Ventilation or Ventilator]." Another handwritten entry in the "Remarks" section of the form reflected "Jet ventilation intermittent with limited success. [Anesthesiologist] here assistg (sic) ...contine (sic) jet vent with aire [and] laser vocal cord excision." The anesthesia provider's documentation did not reflect whether the jet ventilation was provided using an automated machine or a manual device.

The "Machine #" on the "Anesthesia Record" was blank, and there was no documentation of the "case check" required by the policy and procedures.

The "Anesthesia Record" included a space for the type of anesthesia used. A checkmark was recorded in the "GA" box. The "TIVA" box was not marked. However, an anesthesiologist's progress note recorded on 01/29/2016 at 1548 reflected that TIVA was used.

On 01/29/2016 at 1527, prior to discharge from the OR at 1535, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed...a subglottiscope was used to visualize the oropharynx, hypopharynx, and larynx with the findings as noted. This was suspended. A Hunsaker jet ventilator was used to provide jet ventilation. Initially this was given at fairly prolonged pressure...The airway was noted to be markedly enlarged. An endotracheal tube was then placed with some difficulty. The patient was noted to have ST elevations...an EKG was obtained which continued to show ST elevations. A chest Xray showed bilateral pneumothoraces...placed bilateral chest tubes. The patient will be sent to ICU." The surgeon's documentation did not reflect whether the jet ventilation was provided using an automated machine or a manual device.

The note concluded with the following contradictory statement: "The patient was turned over to the Anesthesiology service and allowed to awaken and be taken to the recovery unit to recover in good condition."

On 01/29/2016 at 1548 an anesthesiologist's note reflected "[Pt] underwent laser treatment of scar tissue and tracheal dilation - under TIVA jet ventilation...During jet ventilation with air only (used to limit airway fire) pt became hypotensive...with drop in sp02...and [tachycardic]...and ST elevation...BP and sp02 improved with ventilation and hemodynamic support...Surgeon notified of EKG changes. Procedure quickly concluded."

On 01/29/2016 at 1631 an anesthesiologist's note reflected "Pt developed [bilateral] pneumothoraces and ST elevation during jet ventilation for laser treatment of subglottic stenosis."

On 01/30/2016 at 1806 an anesthesiologist's note reflected "POD #1 s/p TIVA jet ventilation for treatment of subglottic stenosis..."

On 01/31/2016 at 1124 an anesthesiologist's note reflected "POD #2 s/p tracheal dilation complicated by respiratory complication of pneumothoraces after jet-ventilation."

On 02/01/2016 at 1055 an anesthesiologist's note reflected "POD #3 s/p treatment of subglottic stenosis under jet ventilation, complicated by [bilateral] pneumothorax, MI and brain injury..."

3. A "Surgery/Procedure Event" form with an "Entered Date: 01-29-2016" included the following information in relation to Patient 10:
* "Specific Event Type - Complications of Surgery/Procedure"
* "Severity Level (Reported) - F. Harm - Temporary, Hospitalization Needed"
* "Injury Incurred? - Yes"
* "Equipment Involved/Malfunctioned? - Yes"
* "Brief Factual Description - Patient in the OR for EENT procedure i.e. related to subglottic stenosis using ICO2 laser. Attempted insertion of 5.0 laser tube insertion was not able to bypass the stenosis. [Surgeon] requested jet ventialtion (sic). Using air for jet ventilation did not function properly to deliver appropriate inspiratory pressures This resulted in bilateral pneumothoraces in the patient."
* The name of the patient affected was identified as Patient 10.
* "Event Date - 01-29-2016
* "Equipment/Device(s) Involved - Equipment ID #/Asset # - Jet ventilation Hose"
* "Equipment/Device type - Anesthesia"
* "Equipment Serial # - none"
* "Removed from Service? - Yes"
* "Other Equipment Notes - equipment noted to be malfunctioning intraop."
* "Resolutions and outcomes of the event - Severity Level (Actual) - G. Harm - Permanent"
* "Contributing Factors (Actual)...Monitoring Inadequate...Handoffs & continuity issues...Internal-Communication among practitioners or department...Equipment/device/product: Contamination of drug, product or device used...Communication Issue...Lack of or inadequate training"
* "Outcome Actions Taken...Debrief...Equipment Removed...Equipment Repaired/Replaced...Policy/Procedure Changes (Recommended)...Process Modified/Improved...Referred Issue to Leadership...Root Cause Analysis...Staff Educated or Trained"

4. During interview with the CTM on 03/31/2016 beginning at 1345 he/she stated that manual jet ventilators had no manufacturer's recommendation for periodic maintenance or calibration and that prior to the incident the manual jet ventilators were not identified as "essential inventory." The CTM stated that manual jet ventilator devices were added to the CT inventory of medical equipment/devices "this week", referring to the week of this onsite investigation. He/she stated that those devices will now be subject to PM inspections as a result of the incident and a request from the anesthesiology group.

During the interview the CTM stated that the manual jet ventilators in the hospital at the time of incident had been removed from service. He/she indicated the model and style of the device used in the incident was not used anymore. He/she stated that an extensive search had been conducted in all locations where the devices might be. However, he/she indicated that he/she didn't know how many manual jet ventilators had been removed from service nor where those devices were now located. He/she stated that the anesthesia department removed them.

The CTM stated that six new manual jet ventilators of a different model and style, from the one used for Patient 10, were added to the CT inventory "this week", although he/she didn't know the location(s) in the hospital where those were placed.

The CTM further stated that "now every medical device is being added" to the CT inventory.

5. During further interview on 03/31/2016 at 1725 the CTM confirmed that he/she was "not sure" of the number of manual jet ventilators available for use in the hospital prior to the incident. He/she also stated that any repair work that might have been done on any of the manual jet ventilators previously would not have been documented. He/she stated that there was no mechanism to document work done on any device that was not on the CT inventory of medical equipment/devices.

6. During interview with the DSS on 03/31/2016 at 1730 he/she stated that the manual jet ventilator used during the surgical procedure on 01/29/2016 had been immediately "sequestered" after the procedure and "handed off" to a person in risk management. He/she stated that staff tried to gather all the manual jet ventilators in the hospital and they were "99% confident" that all were found. He/she acknowledged that there was no list of the devices to compare what was found and staff did find some in places that were not expected. The DSS stated that he/she remembers finding eight devices initially, and then 11 devices in total were located.

The DSS stated that they considered eliminating the use of manual jet ventilators all together at the hospital. However, it was determined there was a need for emergency uses and so they decided to limit those devices to emergency airway carts in the ICU, ED, L&D, and anesthesia carts.

The DSS stated that 10 manual jet ventilators were collected from throughout the hospital and that only one was designed for manual jet ventilation with medical air as designated by the yellow-colored indicators on the device and that the others were designed for manual jet ventilation with oxygen as designated by the green-colored indicators on those devices. He/she explained that medical air is indicated for ventilation during procedures using lasers and that is why the "yellow" manual jet ventilator was used for Patient 10 during the 01/29/2016 procedure.

He/she stated that the "yellow one" came in a "tray" from another site, from the Kaiser Interstate Clinic ASC. The DSS explained that "trays" have "expensive instrumentation" in them so "it doesn't make sense" to have them duplicated at all sites. "Trays" are "borrowed" from other sites and transported to the site where the surgeon is working using "couriers" and "cabs." He/she confirmed that the transport occurs without staff in attendance and only the courier or cab driver is in control of the instruments, equipment or device.

7. During interview with QM staff including the Director of AR&L on 04/01/2016 beginning at 1135 it was confirmed there was a lack of awareness of where the manual jet ventilator used in the incident had come from and that there was a possibility that prior to use at KWMC it had been at another Kaiser hospital, KSMC. One QM staff member remarked, "We don't know [where it came from]."

In regards to the 6 "new" manual jet ventilators put into service at KWMC the QM staff indicated that they had been placed in emergency airway carts in ED, ICU, OR, and MPU; in L&D storage; and in OR "back-up" storage, which was inconsistent with where the DSS had indicated they were placed during the 03/31/2016 interview.

8. During observations in the RT department on 04/01/2016 at 1230 with RT and QM staff present, two manual jet ventilators were observed and were described as "new" devices. A CT inventory label with a unique number was observed on each device. Interview with RT staff present reflected that the device with the CT number "52977" was "going to ICU", and the device with the CT number "52979" was "going to ED."

9. During observations of the emergency airway cart in ICU on 04/01/2016 at 1255 no manual jet ventilators were observed. The ICU Nurse Manager present at that time stated that the manual jet ventilator had been removed from the ICU cart and a replacement had not been provided.

10. During interview with the Director of AR&L on 04/01/2016 beginning at 1600 he/she stated that "no one knows" where the manual jet ventilator with the yellow-colored tubing came from.

Further, additional reports were provided at that time regarding to number of manual jet ventilators removed from service after the 01/29/2016 incident. The Director of AR&L stated that reports from surgical services staff varied and reflected that eight total or 10 total or 11 total or 13 total manual jet ventilators had been removed from service.

11. On 04/01/2016 at 1600 the Director of AR&L provided an email dated and timed earlier that day on 04/1/2016 at 0915. The email from KWMC CT was to the manufacturer of the "new" manual jet ventilators the facility had put into service after the incident involving Patient 10 and included "Is there any required or recommended maintenance and, if so, are there any instructions?" The response from the manufacturer on 04/01/2016 at 1015 included "I have attached our Performance Check for our Manual Jet Ventilator." The attachment was not on manufacturer's letterhead or any form template and reflected "The user of this device should verify proper operation by checking the regulator after each use or approximately every six months, whichever occurs the soonest." There was no indication that anyone had confirmed that the verification of proper operation should occur before each use or after each use.

12. During interview with the hospital CMO, an anesthesiologist, on 04/01/2016 at 1625 he/she stated that he/she was unaware of any concerns expressed at KWMC related to jet ventilators, "manual or otherwise," prior to the 01/29/2016 incident. He/she indicated that anesthesia staff requested manual jet ventilators be replaced after the 01/29/2016 incident involving Patient 10.

The CMO stated the use of manual jet ventilation was "core training" for anesthesia staff including CRNAs and physicians. In regards to quality checks and device inspection prior to each use of the manual jet ventilator the CMO stated that it was "preferred." He/she stated that it was his/her practice "but it's not required."

13. During interview with the DSS and the Director of AR&L on 04/01/2016 at approximately 1635 they confirmed there were no written policies and procedures for borrowing or sharing of instruments, equipment, and devices between KWMC and other hospital and non-hospital facilities

14. During interview with the CMO and the Director of AR&L on 04/01/2016 at approximately 1635 they confirmed there were no written policies and procedures for use and operation of manual jet ventilators in the hospital.

15. On 04/04/2016 at 0900 the "sequestered" manual jet ventilator used in the 01/29/2016 incident was observed.

The ventilator was comprised of the following:
* Pieces of yellow-colored and clear tubing.
* Metal pieces connecting tubing to a manual lever regulator and a manual gauge with a needle for measuring medical air between "0" and "60" "psi".
* Metal pieces and a yellow plastic piece where the tubing would be connected to the medical air source.

Other observations were made at that time:
* There was no glass or clear, hard plastic cover in place on the gauge dial face.
* There were no KWMC or CT inventory numbers or labels on the device.
* There was no manufacturer's serial number on the device.
* On the metal piece where the manual lever was located a handwritten entry was recorded in black ink directly onto the metal that read "L+D 2."

A Post-it Note affixed to a large plastic bag was observed with the device. The undated and unauthenticated hand-written note read "Plastic on meter broken. Investigating Pt. harm".

An orange-colored and white "Broken Do Not Use" tag was observed with the device. On one side of the tag handwritten entries reflected the "Date" as "2/29", the "Dept/Contact" as "Surgical Services", the "Item" as "[The word oxygen crossed out] Air Jet Ventilator (Air)"; and "Critical" as "Yes." The other side of the tag contained several spaces. A handwritten entry recorded under the "Describe damage/problem: (How, When, What)" space on the tag read "Gage (sic) did not measure pressure. Glass obviously broken." The following remaining spaces on the tag were blank: Instrument Set; Assembled by; Procedure Name; Scrub; OR Nurse; Surgeon; and Service.

16. During interview with staff including the CMO, the Director of AR&L, and the RT Manager on 04/04/2016 beginning at 1415 the subject of staff training on the "new" manual jet ventilators was discussed and the following information provided:
* A training was planned to be provided to RT staff on 04/06/2016.
* A training for anesthesia staff was planned to occur at the same time as training on the automated Monsoon jet ventilator, which was planned to be received and put into service. There was no date identified for that training.
* A training for OR staff had been scheduled for 04/06/2016 but had to be rescheduled.

The CMO stated that "a lot" of physicians were concerned about not having the manual jet ventilator "modality" available for emergency use so it was decided to put them into service prior to the training.

However, the RT Manager stated that he/she had asked that the "new" manual jet ventilators be locked up because "We haven't had the inservice yet."

17. On 04/04/2016 at 1430 the Director of AR&L provided two documents that were not on KWMC letterhead or policy and procedure templates, contained no dates, and the author(s) were not identified.

The only verbiage that identified the "Regional Sterile Processing Loan & Borrow Guidelines" document as related to KWMC was "Use [Kaiser Permanente] courier system..." That document reflected:
"Send
* Inpatient - Using white board tracking
*ASC's - OR lead tracking
* Courier - Use KP courier system as much as possible
* Dust cover with Cardinal Bagging system. Oversized items will use a large trash bag.
* All trays sterilized in another facility shall be reprocessed on site for use.
Return
* Send back sets reconciled and unsterile."

The other document was titled "Loan & Borrow Workflow." That document consisted of a workflow diagram with eight boxes that contained verbiage related to preparation and transport of items borrowed and used between facilities. However, the specific facilities were not identified.

18. During interview on 04/05/2016 at 0945 the CMO stated that it could not be confirmed that the manual jet ventilator designed for medical air used in the 01/29/2015 incident was the only medical air manual jet ventilator used at KWMC since the hospital opened. (KWMC opened in August 2013.)

19. During interview on 04/05/2016 beginning at 1355 the CRNA who administered anesthesia during the surgical procedure on 01/29/2016 indicated the following:
* He/she believed that the medical air manual jet ventilator used on 01/29/2016 was the only medical air manual jet ventilator available in the hospital.
* In preparation for the procedure the manual jet ventilator was brought to the OR room by an anesthesia tech who set it up for the procedure.
* There was no manual jet ventilator for oxygen use set up in the OR room.
* He/she did a visual inspection but did not "fire" the device, and that there was "nothing out of the ordinary revealed on cursory inspection."
* He/she was not aware of any policies and procedures for use and operation of the manual jet ventilators and stated that "doesn't mean they don't exist."
* He/she was not familiar with the particular model of manual jet ventilator used on 01/29/2016.
* He/she had never used a manual jet ventilator for either medical air or oxygen at KWMC since coming to work at KWMC in August 2013.
* He/she had never worked on a laser surgery case before.

20. During interview on 04/05/2016 beginning at 1445 the Anesthesiologist who responded to requests for assistance during the surgical procedure on 01/29/2016 indicated the following:
* He/she arrived in the OR after the procedure had started and the surgeon was conducting the procedure.
* The CRNA was performing manual jet ventilation and reported that he/she had a hard time ventilating the patient.
* He/she took over the manual jet ventilation, noted changes to the patient's vital signs and EKG, "had to resuscitate", and told the surgeon that they needed to "intubate" the patient.
* During the procedure he/she had no indication there was a problem with the manual jet ventilator.
* He/she later learned that the manual jet ventilator gauge was not showing the medical air pressure.
* Prior to a procedure he/she "normally" squeezes the lever to see what pressure he/she is getting.
He/she would "check that" if conducting a procedure "by myself."
* He/she believed he/she had a case at KSMC where he/she used the same manual jet ventilator as used at KWMC during the 01/29/2016 procedure, but he/she wasn't sure.
* The number of anesthesia providers required depends on the patient's situation.
* He/she didn't know if there were policies and procedures for use and operation of the manual jet ventilators.
* He/she indicated it is part of the general skills of anesthesia providers but didn't know if there were specific privileges.

21. On 04/05/2016 at 1515 QM staff, including the Director of AR&L, provided a document that contained the following statements:
* "We do not know for certain, but it is presumed that the jet ventilator in question came to [KWMC] via [Kaiser Interstate Clinic] when [KWMC] first opened in August 2013."
* "Since there is no identifying numbers on this type of jet ventilator, we are not able to verify if this particular jet ventilator had been used in prior procedures."

During interview at that time the Director of AR&L stated that it wasn't clear what all the criteria were for use of a manual jet ventilator as they are intended for emergency use.

22. An email titled "CRNA Privilege Form" dated 04/05/2016 at 1530 was reviewed. It was from the Credentials Manager and reflected "Basically the CRNAs can have core privileges for adult or pediatric patients, that's about it, there are no delineated procedures."

Attached to that was a document titled "Privilege Request Form Anesthesiology - CRNA." The most recent date on the three page form was 07/23/2015. The form reflected: "Core privileges in CRNA - Anesthesiology Patients 7 years of age and older...Privileges include the administration of all types of general, regional, and local analgesia and anesthesia for elective and emergency procedures. Privileges will be exercised under the medical supervision of an Anesthesiologist." There were no specific procedures, methods, or types of machines or equipment specified.

23. During interview on 04/05/2016 beginning at 1545 the surgeon who conducted the surgical procedure on 01/29/2016 indicated the following:
*The procedure was started out with an ETT for ventilation and was switched to medical air manual jet ventilation because the ETT was not fitting.
* He/she believed the manual jet ventilator was in the room at the beginning of the procedure.
* He/she "assumed" that the same manual jet ventilator had been used in other cases.
* He/she "doubted" that the same manual jet ventilator had been used at KSMC.
* He/she didn't know if there were policies and procedures for use and operation of the manual jet ventilators.
* "Usually" there is one CRNA and one anesthesiologist, or two anesthesia providers, present when manual jet ventilation is used. On 01/29/2016 there was one CRNA prior to the anesthesiologist presenting.
* He/she was unaware there was a problem with the manual jet ventilator until after the procedure and understands there was a "broken dial."

24. On 04/05/2016 at 1615 QM staff confirmed that four patients in the last 12 months had surgical procedures during which jet ventilation was performed. In addition to Patient 10, those were Patients 1, 2, and 4.

25. The medical record of Patient 1 reflected he/she was an "Elective" admission on 04/22/2015 for "micro direct laryngoscopy with CO2 laser..."

On 04/22/2015 at 1341 the anesthesiologist, the anesthesia provider for the case, recorded in the anesthesia Preprocedure Note under the "Airway Exam" section that the patient had a "Potential difficult airway." Under the "Anesthesia Plan" the anesthesiologist recorded "[Discussed with surgeon.] May use jet ventilator." The documentation did not reflect whether the jet ventilation, using oxygen or air, was to be provided using an automated machine or a manual device.

The "Surgery Report" reflected that the patient was in the OR on 04/22/2015 at 1425. The Anesthesia Record dated 04/22/2015 reflected the anesthesia start time was 1425, the anesthesia end time was 1630, and GA was used. The "Machine No" space was marked with a "-" The form contained a handwritten entry in the "Gas" section that was "Jet Vent started with Air." Another handwritten entry in the "Induction" section of the form was "Jet Vent -." A third handwritten entry in the "Remarks" section was "1532 Jet ventil (sic) [with] air only prior to laser." The documentation did not clearly reflect whether oxygen was used during jet ventilation and whether the jet ventilation was provided using an automated machine or a manual device.

26. The medical record of Patient 2 reflected he/she was an "Elective" admission on 06/22/2015 for "Direct Laryngoscopy, Bronchoscopy...Possible Use of CO2 laser."

On 06/22/2015 at 0652 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan...Ask [acronym not clear] if Laser is to be utilized or if Jet ventilation is required..." The evaluation did not reflect that the anesthesiologist asked the questions and confirmed a plan to include jet ventilation. There was no indication as to whether jet ventilation if used, was to be provided using air or oxygen, using an automated machine or a manual device.

The "Surgery Report" reflected that the patient was in the OR on 06/22/2015 at 0725. The "Anesthesia Record" reflected that anesthesia was started on 06/22/2015 at "72C (sic)," the anesthesia end time was 1848, and GA was used. The "Machine No" space was blank. The record contained a handwritten entry in the "Gas" section that was "x Jet." A second handwritten entry in the "Monitoring/Equip" section was "Jet." Another handwritten entry in the "Induction" section of the form was "Jet Vent." The documentation did not reflect whether air or oxygen was used and whether the jet ventilation was provided using an automated machine or a manual device.

On 06/22/2015 at 0749, approximately 24 minutes after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified..I agree with the ASA status and anesthetic plan." However, there was no documentation to indicate that the plan had been fully established in advance of the procedure as reflected in the paragraph above.

27. The medical record of Patient 4 reflected he/she was an "Elective" admission on 09/23/2015 for "Microlaryngoscopy and Bronchoscopy with CO2 laser..."

The "Surgery Report" reflected that the patient was in the OR on 09/23/2015 at 1157. The "Anesthesia Record" reflected that anesthesia was started on 09/23/2015 at 1157, the anesthesia end time was 1319, and GA was used. The "Machine #" space was blank. The record contained a handwritten entry in the "Induction" section of the form that was "Jet [Ventilation or Ventilator]." Another handwritten entry in the "Remarks" section of the form referred to the use of a "Jet ventilation tube." The documentation did not reflect whether air or oxygen was used and whether the jet ventilation was provided using an automated machine or a manual device.

However, on 09/23/2015 at 1059 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, endotracheal tube methods, postop pain [management]" There was no indication to reflect the planned or possible use of jet ventilation, either by using an automated machine or a manual device.

Based on interview, documentation for 16 of 16 surgeries or medical procedures in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to ensure that clear, complete, and timely informed consent was conducted and documented prior to all surgeries and procedures that required informed consent:
* It was not clear that all surgical and anesthesia related aspects of the informed consent process were completed prior to the patient's completion and signature on the informed consent forms.
* It was not clear who reviewed the informed consent form with the patient and obtained the patient's signature.
* The date and time of the patient's signature on informed consent forms was not always recorded or legible to clearly reflect that the patient's documented consent was prior to the procedure.
* The surgical procedures described on informed consent forms were not always accurate or clear. In one case the procedure had been altered.
* Time entries confirm that sedative and narcotic medications were administered to patients prior to their review of, and signature on, the informed consent forms, and no evaluation of the patient's ability to consent in those case was documented.
* Documentation on pre-operative checklists reflected that patient informed consent forms were complete and on the chart before the time the patient actually signed the form.
* The name of the practitioner who was to perform the procedure was not always recorded on the form.
* Entries in handwriting that appeared to be other than that of the patient's signature were not authenticated, dated, and timed.
* Specific risks of the surgery and anesthesia were identified for some patients on the informed consent form, but not others.

Findings include:

1. Policies and procedures were reviewed:

* The policy and procedure titled "Informed Consent" dated as revised December 2015 reflected that
"Informed consent is a process, not a form...Informed consent must be obtained for procedures that are 'complex'...which include, but are not limited to the following...Major or minor surgery...All procedures in which anesthesia is used...A written consent form will be signed by the patient/patient's legal representative that authorizes the treatment/procedure...The written consent form is completed after the clinician has discussed, obtained, and documented the informed consent but prior to beginning the treatment/procedure/surgery or operation...The clinician/surgeon will obtain the informed consent for treatment procedures, surgeries or operations and sedation identified as requiring informed consent...The taking of a sedative before a medical procedure does not necessarily make a patient incapable of giving informed consent. It is up to the clinician to determine if the patient is able to provide consent...For elective surgeries/operations, special diagnostic or therapeutic procedures involving anesthesia, the informed consent for anesthesia will be obtained by the anesthesia provider...The nursing staff will verify that the clinician/surgeon obtained informed consent and that the clinician/surgeon has documented that the informed consent has been obtained...The nursing staff will verify that the form "Documentation of Informed Consent Process" has been completed and signed by the patient or patient's legal representative...When a person other than the patient signs the consent form, the relationship of the person to the patient must be noted next to the signature."

* The policy and procedure titled "Pre-Induction Procedure", dated as revised June 2013, stipulated: "Prior to induction of anesthesia and the commencement of surgery...the responsible anesthesia care provider shall verify the following information in the patient's medical record...The informed consent, in writing and signed by the patient or his legal guardian, for the contemplated surgical procedures..."

2. The "Documentation of Informed Consent Process" form reviewed in patient records contained the following language: "I authorize [electronically printed practitioner name] and/or his/her assistants of choice and personnel assigned by the hospital or ambulatory surgery center to perform the following procedure: [electronically printed procedure name] and/or to do any other procedures that he/she believes are medically necessary to treat unexpected findings or complications that may occur during the procedure. The clinician above has explained to me the procedure, as well as the anticipated benefits and alternatives relating to the above procedure. The clinician has answered all of my questions about the procedure, benefits, and alternatives to my satisfaction. I have been informed of and understand the significant risks. The risks include but are not limited to, [space for electronically printed risks]. I authorize the use of anesthesia or sedation as medically necessary. Blood or Blood Products: I consent to receive blood or blood products as deemed necessary and appropriate by the clinician if a transfusion is required during or after the procedure __Yes __No I have been notified of the manner in which care will be provided to me if complications occur that required services beyond what this facility is able to provide. I authorize the examination and disposal of any removed body parts or tissues in accordance with customary practice, with the following exceptions (list any exceptions below): ____ Allergies: [space electronically printed patient allergies] I understand that under certain circumstances, Kaiser Permanente may be required by law to disclose or report certain information about me. I understand that I may withdraw this consent at any time prior to the procedure. I also understand that no warranty or guarantee has been made as to the result or cure. [spaces for patient or representative signature and name, date, time]."

3. During interview with the CMO on 04/12/2016 at 1130 he/she stated that the consent for procedures, anesthesia, and blood are combined on one form. The CMO indicated that if anesthesia was not related to a surgical case there would be a separate consent and that wasn't common. He/she stated that the anesthesiologist reviews the patient's chart, goes to the bedside to talk to the patient, does the H&P and PARQ, and writes the orders. When a CRNA is assigned to be the anesthesia provider, that CRNA reviews the anesthesiologist's documentation and confers with the anesthesiologist either in person or on the phone regarding that review. The CRNA then goes to the patient's bedside to talk to the patient and then documents an "attestation" that they have done the review.

During interview with the Director of AR&L on 04/20/2016 at 1310 he/she stated that the physician sometimes obtains the patient's signature on the informed consent form. The Director stated that if the RN checks the form and finds it is not signed she informs the physician, or sometimes if the patient verifies they spoke with the physician the RN may obtain the patient's signature on the informed consent form.

4. The medical record of Patient 10 reflected he/she was an "Elective" admission on 01/29/2016 for "Direct Laryngoscopy, Bronchoscopy, CO2 laser..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 01/29/2016 at 1330.

On 01/29/2016 at 1319, the MAR reflected that the patient was administered 1 mg. of IV Versed, a pre-operative sedative.

On 01/29/2016 at 1321, after the patient received IV Versed, the patient signed the "Documentation of Informed Consent Process" form.

There was no documentation to reflect an assessment that the patient's ability to provide informed consent had not been affected by the administration of IV Versed.

On 01/29/2016 at 1149 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, endotracheal tube methods, postop pain [management]." At the end of the note under the "Author's name", the anesthesiologist recorded "Will discuss airway [management] with surgeon. Will be ready with TIVA and special Ett for laser treatment. Limit FIO2. PARQ discussed including risk of airway fire plus see above." It was not clear what specific entry or entries "see above" referred to. There was no indication to reflect the planned or possible use of jet ventilation, either by using an automated machine or a manual device, and there was no indication that the use of jet ventilation, particularly if provided using a manual device, was discussed with the patient.

On 01/29/2016 at 1527, prior to discharge from the OR at 1535, and after the patient suffered complications during the procedure, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

* In addition, the record of Patient 10 reflected that on 02/02/2016 at 1315 a "Documentation of Informed Consent Process" for "The Placement of Peripherally Inserted Central Catheter" was signed. The name of the practitioner the consent was authorized for was printed on the form as "Vascular Access Registered Nurse."

* In the record of Patient 10 on 02/05/2016 a "Documentation of Informed Consent Process" for "Arterial line placement" was illegibly signed by an unidentified person. The space for the time that the consent was provided was blank. The name of the practitioner the consent was authorized for was printed on the form as "Dr. [name] or associates."

5. The medical record of Patient 1 reflected he/she was an "Elective" admission on 04/22/2015 for "micro direct laryngoscopy with CO2 laser..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 04/22/2015 at 1425.

On 04/22/2015 at 1126 an RN documented on the surgery "Preop Checks" record that yes, "Consents Complete...Consents on Chart." That was prior to the time the patient signed the consent form as described below.

On 04/22/2015 at 1200 noon the patient signed the "Documentation of Informed Consent Process" form. That was after the time the RN documented the consent was complete and on the chart.

On 04/22/2015 at 1341 the anesthesiologist recorded in the anesthesia Preprocedure Note under the "Airway Exam" section that the patient had a "Potential difficult airway." Under the "Anesthesia Plan the anesthesiologist recorded "[Discussed with surgeon.] May use jet ventilator." The documentation did not reflect whether the jet ventilation was to be provided using an automated machine or a manual device, and there was no indication that the use of jet ventilation, particularly if provided using a manual device, was discussed with the patient.

On 04/22/2015 at 1607, while the patient was still in the OR and prior to discharge to PACU at 1623, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

6. The medical record of Patient 2 reflected he/she was an "Elective" admission on 06/22/2015 for "Direct Laryngoscopy, Bronchoscopy...Possible Use of CO2 laser." The "Surgery Report" reflected that the patient was in the OR at 0725 and the "Anesthesia Record" reflected that anesthesia was started on 06/22/2015 at "72C (sic)." .

On 06/22/2015 at 0614 the patient signed the "Documentation of Informed Consent Process" form.

On 06/22/2015 at 0652 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Ask Sx if Laser is to be utilized or if Jet ventilation is required..." The documentation did not reflect that the anesthesiologist asked the question and confirmed a plan to include jet ventilation. There was no indication as to whether jet ventilation if used, was to be provided using an automated machine or a manual device, and there was no indication that the use of jet ventilation, particularly if provided using a manual device, was discussed with the patient.

On 06/22/2015 at 0836, while the patient was still in the OR and prior to discharge to PACU at 0841, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

7. The medical record of Patient 4 reflected he/she was an "Elective" admission on 09/23/2015 for "Microlaryngoscopy and Bronchoscopy with CO2 laser..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 09/23/2015 at 1157.

On 09/23/2015 at 1058 an RN documented on the surgery "Preop Checks" record that yes, "Consents Complete...Consents on Chart." That was prior to the time the patient signed the consent form as described below.

On 09/23/2015 at 1112 the patient signed the "Documentation of Informed Consent Process" form. That was after the time the RN documented the consent was complete and on the chart.

The Anesthesia Record dated 09/23/2015 contained a handwritten entry in the "Induction" section of the form that was "Jet [Ventilation or Ventilator]." Another handwritten entry in the "Remarks" section of the form referred to the use of a "Jet ventilation tube." The documentation did not reflect whether air or oxygen was used and whether the jet ventilation was provided using an automated machine or a manual device.

However, on 09/23/2015 at 1059 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, endotracheal tube methods, postop pain [management]" There was no indication to reflect the planned or possible use of jet ventilation, either by using an automated machine or a manual device, and there was no indication that the use of jet ventilation, particularly if provided using a manual device, was discussed with the patient.

On 09/23/2015 at 1302, while the patient was still in the OR and prior to discharge to PACU at 1313, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

8. The medical record of Patient 13 reflected he/she was an "Elective" admission on 04/01/2016 for "Suspension Microlaryngoscopy with CO2 Laser and Operating Microscope with biopsy...Operation on oral cavity...in the floor of the mouth*." The "Surgery Report" and the "Anesthesia Record" reflected that on the patient was in the OR and anesthesia was started on 04/01/2016 at 0906.

A H&P signed by the surgeon on 03/09/2016 at 1228, 23 days prior to admission, reflected that a PARQ was held with the patient.

On 04/01/2016 at 0730 the patient signed the "Documentation of Informed Consent Process" form. The procedure recorded on the form was "Suspension Microlaryngoscopy with CO2 Laser and Operating Microscope with biopsy...Operation on oral cavity...in the floor of the mouth*." There was no explanation for the "*", the asterisk symbol recorded at the end of the procedure. During the electronic review of the record, staff present did not know what the asterisk referred to.

On 04/01/2016 at 0830 an H&P Update note recorded by the surgeon contained no documentation related to PARQ or consent.

9. a. The medical record of Patient 3 reflected he/she was admitted on 09/19/2015 with onset of swelling and pain in the right knee. The patient was found to have an infection and underwent surgery on the right knee on 09/20/2015. The "Surgery Report" reflected that on 09/20/2015 the patient was in the OR at 1107 and the "Anesthesia Record" reflected that anesthesia was started at 1106.

On 09/19/2015 the patient signed the "Documentation of Informed Consent Process" form for a "Right knee incision, drainage, and debridement with polyethylene liner exchange." The space for the time of the patient's consent was blank.

b. The medical record of Patient 3 reflected that on 09/22/2015 at 1615 a PA documented that the "...plan is ERCP tomorrow." The MPU documentation reflected that the patient was in the MPU room on 09/23/2015 at 1343 and the "Anesthesia Record" reflected anesthesia was started at 1343.

On 09/23/2015 at 1226 the MAR reflected that the patient was administered 10 mg. of oral oxycodone, a narcotic medication.

On 09/23/2015 at 1242 RN documentation on the "Pre Procedure Verification" reflected "Accurate consent signed and available - No...Relevant documentation in chart? - No" There was no other preprocedure verification documented in the record.

On 09/23/2015 at 1257 the MAR reflected that the patient was administered 2 mg. of IV morphine, a narcotic medication.

On 09/23/2015 at 1342 the anesthesiologist recorded "Patient claims, 'I'm very confused'...Anesthesia Plan...discussed in person...procedure confirmed, consents reviewed, site verified...Discussed: general anesthesia...Risks, benefits, alternatives and related procedures for anesthesia discussed with patient. Questions invited and answered..."

On 09/23/2015 at 1343 the Anesthesia Record reflected that the anesthesia start time was 1343, one minute after anesthesiologist signed off on the evaluation and prior to the time recorded as the time the patient signed the consent form in the paragraph below.

On 09/23/2015 at 1345, after the anesthesia start time, the patient signed the "Documentation of Informed Consent Process" form for a second procedure. Although the procedure ordered to be performed was an "Endoscopic RetroGrade Cholangiopancreatography," also referred to as "ERCP," the consent form used was for a "Colonoscopy," a completely different procedure than an ERCP. An unidentified person had altered the consent form by crossing out the word "Colonoscopy"and had written next to it "ERCP." That handwritten alteration was not accurate, and was not authenticated or dated or timed. In addition, the date and time recorded next to the patient's signature was not in the same handwriting as the signature, and that entry was not authenticated and dated and timed by the author.

The pre-anesthesia evaluation documented by the anesthesiologist reflected that although the patient was "confused" the "informed consent process" continued and the patient's signature was obtained on the consent form at a time recorded as after anesthesia start. There was no documentation of an assessment around the patient's ability to provide consent, including whether the patient's abilities had been affected by the administration of the narcotic medications oxycodone and morphine.

On 09/23/2015 at 1541 the physician who conducted the ERCP documented "The procedure, indications, potential risks...and alternatives to the procedure were discussed with the patient prior to the planned procedure....Written informed consent was obtained." However, an accurate and appropriate written consent was not obtained as reflected in these findings.

10. The medical record of Patient 5 reflected he/she was an "Elective" admission on 12/07/2015 for "Bilateral hip replacements..." The "Surgery Report" reflected the patient was in the OR on 12/07/2015 at 0727 and the "Anesthesia Record" reflected that anesthesia was started on 12/07/2015 at 0714.

On 12/07/2015 at 0545 the patient signed the "Documentation of Informed Consent Process" form.

On 12/07/2015 at 1144, after the anesthesia end time, a note recorded by the CRNA reflected that "Actual anesthetic administered: MAC and Spinal."

However, on 12/07/2015 at 0711 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, regional anesthesia. Anesthesia Type Chosen Single shot spinal." There was no indication to reflect the planned or possible use of MAC or that it was discussed with the patient.

11. The medical record of Patient 6 reflected he/she presented to the ED on 12/14/2015 at 1454 and was transferred to the OR for "incision and drainage of peri-rectal abscess" on 12/14/2015 at 1945. The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 12/14/2015 at 2021.

On 12/14/2015 at 1948 an RN documented on the surgery "Preop Checks" record that yes "Consents Complete...Consents on Chart" .

The "Documentation of Informed Consent Process" form reflected a patient signature on the form. However, the signature "Date/Time" space on the form was blank.

There was no documentation on the form or elsewhere in the record to reflect who reviewed the form with the patient and obtained the patient's signature. There was no evidence to reflect when the patient reviewed and signed the form, before or after the surgery and administration of anesthesia.

12. The medical record of Patient 7 reflected he/she was an "Elective" admission on 12/28/2015 for "Left... knee replacement..." The "Surgery Report" and the "Anesthesia Record" reflected that on 12/28/2015 the patient was in the OR at 0731 and that anesthesia was started at 0710.

The "Documentation of Informed Consent Process" form reflected the patient signed the form on 12/28/2015 at 0545.

On 12/28/2015 at 0919 the CRNA recorded that "Actual anesthetic administered: MAC and Spinal."

However, on 12/28/2015 at 0706 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan...Discussed: general anesthesia, central neuraxial blocks. Anesthesia Type Chosen Single shot spinal." There was no indication to reflect the planned or possible use of MAC or that it was discussed with the patient.

On 12/28/2015 at 1326, after the surgery completion time earlier that day at 0947, the surgeon's Operative Report reflected that a "Preoperative PARQ discussion was held...provided written informed consent for the procedure."

13. The medical record of Patient 8 reflected he/she was an "Elective" admission on 01/25/2016 for "Suspension Microlaryngoscopy and Biopsy." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 01/25/2016 at 0904.

A H&P signed by the surgeon on 01/08/2016 at 0940, 17 days prior to admission, reflected that "Procedures, alternatives, risks discussed, and questions answered - Yes. Consent obtained - No."

On 01/25/2016 at 0718 an RN documented on the surgery "Preop Checks" record that yes, "Consents Complete...Consents on Chart" .

On 01/25/2016 at 0730 the patient signed the "Documentation of Informed Consent Process" form. That was after the time the RN documented the consent was complete and on the chart.

On 01/25/2016 at 0853 an H&P interval update note recorded by the surgeon contained no documentation related to PARQ or consent.

14. The medical record of Patient 9 reflected he/she was an "Elective" admission on 01/27/2016 for "Microlaryngoscopy with excision of laryngeal papillomas." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 01/27/2016 at 1127.

The H&P signed by the surgeon on 01/11/2016 at 1743, 16 days prior to admission, reflected that "An extensive PARQ....session was held...A consent was signed and witnessed..." However, there was no evidence in the record of the written consent signed by the patient on 01/11/2016.

However, the "Documentation of Informed Consent Process" form reflected the patient signed the form on 01/27/2016 at 0850.

15. The medical record of Patient 11 reflected he/she was an "Elective" admission on 02/04/2016 for surgery including "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 02/04/2016 at 1420.

On 02/04/206 at 1254 an RN documented on the surgery "Preop Checks" record that yes "Consents Complete...Consents on Chart." That was prior to the time the patient signed the consent form as described below.

On 02/04/2016 at 1310 the patient signed the "Documentation of Informed Consent Process" form. That was after the time the RN documented the consent was complete and on the chart.

On 02/04/2016 at 1411 the H&P signed by the surgeon contained no documentation of the informed consent process and that the risks of the procedure or anesthesia were addressed with the patient.

16. The medical record of Patient 12 reflected he/she was an "Elective" admission on 02/15/2016 for "Suspension Microlaryngoscopy..." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 02/15/2016 at 0728.

On 02/15/2016 the patient signed the "Documentation of Informed Consent Process" form. The handwriting of the "Date/Time" was different than that of the signature and it was not clear whether the entry was 6:30 a.m. or 6:30 p.m.

On 02/15/2016 at 0837, after the patient had been discharged to the PACU at 0835, the surgeon's Operative Report reflected that "Procedure, alternatives, risks were explained and questions answered. Consent was signed."

17. Specific risks of the surgery and anesthesia were electronically documented on the "Documentation of Informed Consent Process" forms for Patients 1, 2, 3 (for one procedure), 4, 7, 8, 9, 10, 11, 12, and 13. Only the form for Patient 11, which identified the most extensive risks, included "death" and "pneumothorax." There were no specific risks identified for Patient 3 for one procedure, and Patients 5 and 6.

Based on observation, interview, review of 4 of 4 medical records of patients who had anesthesia administered by a jet ventilator (Patients 1, 2, 4, and 10), review of PM records, review of policies and procedures, and review of other documents it was determined that the hospital failed to develop and implement policies, procedures, and systems to ensure that airway ventilation during surgery and anesthesia was conducted with devices that were maintained in safe and proper working condition

This failure in the case of Patient 10 resulted in the provision of airway ventilation during surgery and anesthesia with a broken manual jet ventilator.

Policies and procedures for the use, operation, and maintenance of manual jet ventilators had not been developed. Prior to the incident involving Patient 10 on 01/29/2016, manual jet ventilators not incorporated into the hospital's medical equipment/device inventory and PM system. There was no systems to account for and track the types, numbers, and locations of those devices in the hospital; to account for where they were received from; to account for when they were put into service; to initially inspect those devices prior to putting them into service; to document repair work requested and done on those devices.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting

Findings include:

Refer to Tag A724, CFR 482.41(c)(2), Physical Environment: Facilities, Supplies, Equipment Maintenance.
Refer to Tag A115, CFR 482.13, Condition of Participation, Patient Rights.
Refer to Tag A1000, CFR 482.52, Condition of Participation, Anesthesia Services.

Based on observation, interview, review of 4 of 4 medical records of patients who had anesthesia administered by a jet ventilator (Patients 1, 2, 4, and 10), review of PM records, review of policies and procedures, and review of other documents it was determined that the hospital failed to develop and implement policies, procedures, and systems to ensure that airway ventilation during surgery and anesthesia was conducted with devices that were maintained in safe and proper working condition

This failure in the case of Patient 10 resulted in the provision of airway ventilation during surgery and anesthesia with a broken manual jet ventilator.

Policies and procedures for the use, operation, and maintenance of manual jet ventilators had not been developed. Prior to the incident, manual jet ventilators not incorporated into the hospital's medical equipment/device inventory and PM system. There was no systems to account for and track the types, numbers, and locations of those devices in the hospital; to account for where they were received from; to account for when they were put into service; to initially inspect those devices prior to putting them into service; to document repair work requested and done on those devices.

Findings include:

Refer to Tag A144, CFR 482.13(c)(2), Patient's Rights: Care in Safe Setting.
Refer to Tag A951, CFR 482.51(b), Surgical Services: Operating Room Policies.

Based on observation, interview, documentation for 9 of 14 surgical procedures in 9 of 13 medical records reviewed (Patients 1, 2, 4, 8, 9, 10, 11, 12 and 13), and review of policies and procedures and other documents it was determined that the hospital failed to ensure the provision of safe and appropriate surgical care as surgical instruments and devices were borrowed from other hospital and non-hospital facilities and there were no policies and procedures for that practice.

Findings include:

1. Refer to Tag A144, CFR 482.13(c)(2), Patient Rights: Care in Safe Setting.

2. During interview with the DSS on 03/31/2016 at 1730 he/she stated that a manual jet ventilator used during a surgical procedure on 01/29/2016 at KWMC came to KWMC in a surgical "tray" from another site, the Kaiser Interstate Clinic ASC. The DSS explained that surgical "trays" have "expensive instrumentation" in them so "it doesn't make sense" to have them duplicated at all sites. "Trays" are "borrowed" from other sites and transported to the site where the surgeon is working using "couriers" and "cabs." He/she confirmed that the transport occurs without staff in attendance and only the courier or cab driver is in control of the instruments, equipment or device.

3. During interview with the DSS and the Director of AR&L on 04/01/2016 at approximately 1635 they confirmed there were no written policies and procedures for borrowing or sharing of instruments, equipment, and devices between KWMC and other hospital and non-hospital facilities

4. On 04/04/2016 at 1430 the Director of AR&L provided two documents that were not on KWMC letterhead or policy and procedure templates, contained no dates, and the author(s) were not identified.

The "Regional Sterile Processing Loan & Borrow Guidelines" document reflected:
"Send
* Inpatient - Using white board tracking
*ASC's - OR lead tracking
* Courier - Use [Kaiser Permanente] courier system as much as possible
* Dust cover with Cardinal Bagging system. Oversized items will use a large trash bag.
* All trays sterilizied in another facility shall be reprocessed on site for use.
Return
* Send back sets reconciled and unsterile."

The other document was titled "Loan & Borrow Workflow." That document consisted of a workflow diagram with eight boxes that contained verbiage related to preparation and transport of items borrowed and used between facilities. However, the specific facilities were not identified.

5. The review of medical records reflected at least eight cases where the surgical instruments and devices were identified as KPNW versus KWMC, consistent with the interview and document findings above.

6. The medical record of Patient 10 reflected he/she underwent a "Direct Laryngoscopy, Bronchoscopy, CO2 laser..." surgery on 01/29/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"
* "Holder Laryngoscope ENT KPNW"
* "Tray Scopes Steiner ENT WMC"

7. The medical record of Patient 1 reflected he/she underwent a "micro direct laryngoscopy with CO2 laser..." surgery on 04/22/2015. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Holder Laryngoscope ENT KPNW"
* "Tray Scopes Steiner ENT WMC"
* "Tray Laryngoscopy Micro KPNW"

8. The medical record of Patient 2 reflected he/she underwent a "Direct Laryngoscopy, Bronchoscopy...Possible Use of CO2 laser" surgery on 06/22/2015. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"

9. The medical record of Patient 4 reflected he/she underwent a "Microlaryngoscopy and Bronchoscopy with CO2 laser..." surgery on 09/23/2015. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"
* "Holder Laryngoscope ENT KPNW"

10. The medical record of Patient 13 reflected he/she underwent a "Suspension Microlaryngoscopy with CO2 Laser and Operating Microscope with biopsy...Operation on oral cavity...in the floor of the mouth*" surgery on 04/01/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Holder Laryngoscope ENT KPNW"
* "Tray Scopes Steiner ENT WMC"
* "Tray Light Carriers Laryngoscope ENT KPNW"
* "Tray Laryngoscopy Micro KPNW"

11. The medical record of Patient 8 reflected he/she underwent a "Suspension Microlaryngoscopy and Biopsy" on 01/25/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"

12. The medical record of Patient 9 reflected he/she underwent a "Microlaryngoscopy with excision of laryngeal papillomas" on 01/27/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"

13. The medical record of Patient 11 reflected he/she underwent a "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy" surgery on 02/04/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"
* "Tray T&A ENT KPNW"
* "Laryngoscope Hollinger Anterior WMC"

14. The medical record of Patient 12 reflected he/she underwent a "Suspension Microlaryngoscopy..." surgery on 02/15/2016. The "Surgery Report" contained a list of instruments used during the surgery that included:
* "Tray Laryngoscopy Micro KPNW"

Based on interview, documentation for 16 of 16 surgeries or medical procedures in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to ensure that clear, complete, and timely informed consent was conducted and documented prior to all surgeries and procedures that required informed consent

Findings include:

Refer to Tag A466, CFR 482.24(c)(4)(v), Medical Record Services: Informed Consent.

Based on observation, interview, documentation for 14 of 14 surgical procedures that required anesthesia in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures that ensured the provision of safe and appropriate anesthesia services.

These failures substantially limit the capacity of the hospital to furnish care in a safe setting.

Findings include:

Refer to Tag A1002, CFR 485.52(b), Anesthesia Services: Delivery of Anesthesia Services.
Refer to Tag A1003, CFR 482.52(b)(1), Anesthesia Services: Pre-Anesthesia Evaluation.
Refer to Tag A1004, CFR 482.52(b)(2), Anesthesia Services: Intraoperative Anesthesia Record.
Refer to Tag A1005, CFR 482.52(b)(3), Anesthesia Services: Post-Anesthesia Evaluation.
Refer to Tag A115, CFR 482.13, Condition of Participation, Patient Rights.

Based on observation, interview, documentation for 14 of 14 surgical procedures that required anesthesia in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures that ensured the provision of safe and appropriate anesthesia services.

Findings include:

Refer to Tag A1003, CFR 482.52(b)(1), Anesthesia Services: Pre-Anesthesia Evaluation.
Refer to Tag A1004, CFR 482.52(b)(2), Anesthesia Services: Intraoperative Anesthesia Record.
Refer to Tag A1005, CFR 482.52(b)(3), Anesthesia Services: Post-Anesthesia Evaluation.
Refer to Tag A115, CFR 482.13, Condition of Participation, Patient Rights.

Based on interview, documentation for 10 of 14 surgical procedures that required anesthesia in 9 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 10, and 11), and review of policies and procedures it was determined that the hospital failed to ensure that accurate and complete pre-anesthesia evaluations were completed and documented prior to all surgeries or procedures requiring anesthesia services. Pre-anesthesia plans were not clear or complete, or were not completed by the anesthesia provider prior to the the delivery of the first dose of medication given for the purpose of inducing anesthesia.

Findings include:

1. Policies and Procedures were reviewed:

* The policy and procedure titled "Pre-Anesthesia Evaluation", dated as revised June 2013, stipulated: "The preanesthesia evaluation will be documented in the patient's electronic medical record in all areas where that is available. Alternatively, a written record will be prepared. Such documentation will include: The date and time of the interview...any extraordinary circumstances...Potential anesthesia problems...The anesthesia plan which has been discussed with the patient and significant other(s) and/or the parent and/or guardian, including...The type and route of anesthetic to be administered...Special needs for...intraoperative monitoring..."

* The policy and procedure titled "Pre-Induction Procedure", dated as revised June 2013, stipulated: "Prior to the induction of anesthesia, the responsible anesthesia care provider shall verify that...A complete machine checkout has been performed...There is documentation on the anesthetic record that the machine checkout has been performed...Presence of apparatus for airway maintenance...Prior to induction of anesthesia and the commencement of surgery...the responsible anesthesia care provider shall verify the following information in the patient's medical record...The informed consent, in writing and signed by the patient or his legal guardian, for the contemplated surgical procedures..."

* The policy and procedure titled "Medical Record Documentation", dated as revised June 2013, stipulated: "Immediately prior to the induction of anesthesia and the commencement of surgery, the responsible anesthesia care provider shall verify and document: Patient reassessment immediately prior to induction...The patient's identity and the site of the body to be operated on..."

2. During interview with the CMO on 04/12/2016 at 1130 he/she stated that prior to a procedure the anesthesiologist reviews the patient's chart, goes to the bedside to talk to the patient, does the H&P and PARQ, and writes the orders. When a CRNA is assigned to be the anesthesia provider, that CRNA reviews the anesthesiologist's documentation and confers with the anesthesiologist either in person or on the phone regarding that review. The CRNA then goes to the patient's bedside to talk to the patient and then documents an "attestation" that they have done the review.

3. Refer to Tag A144, CFR 482.13(c)(2), Care in Safe Setting, that reflects the lack of clear, complete, and timely pre-anesthesia evaluations for Patients 10, 1, 2, and 4.

4. a. The medical record of Patient 3 reflected he/she was admitted on 09/19/2015 with onset of swelling and pain in the right knee. The patient was found to have an infection and underwent surgery on the right knee on 09/20/2015. The "Surgery Report" reflected that on 09/20/2015 the patient was in the OR at 1107 and the "Anesthesia Record" reflected that anesthesia was started at 1106.

On 09/20/2015 at 1107, after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified..I agree with the ASA status and anesthetic plan."

b. The medical record of Patient 3 reflected that on 09/22/2015 at 1615 a PA documented that the "...plan is ERCP tomorrow." The "Case Tracking Events" on the procedure report reflected that on 09/23/2015 the patient was in the MPU at 1340 and the "Anesthesia Record" reflected that anesthesia was started at 1343.

On 09/23/2015 at 1226 the MAR reflected that the patient was administered 10 mg. of oral oxycodone.
On 09/23/2015 at 1257 the MAR reflected that the patient was administered 2 mg. of IV morphine.

On 09/23/2015 at 1342, one minute prior to the anesthesia start time of 1343, the anesthesiologist recorded "Patient claims, 'I'm very confused'...Anesthesia Plan...discussed in person...procedure confirmed, consents reviewed, site verified...Discussed: general anesthesia...Risks, benefits, alternatives and related procedures for anesthesia discussed with patient. Questions invited and answered..." Although the patient had received narcotic medications within 46 and 77 minutes prior to the evaluation, and the patient had expressed being confused, there was no documentation to reflect that the anesthesiologist had evaluated the patient's ability to discuss the anesthesia plan, and to provide consent.

On 09/23/2015 at 1435, 52 minutes after the anesthesia start time of 1343, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note" and documented "Patient verified, Procedure confirmed, Consents reviewed and Site verified...I agree with the ASA status and anesthetic plan."

There was no documentation to reflect that the anesthesiologist had evaluated the patient's ability to discuss the anesthesia plan, and to provide consent.

5. The medical record of Patient 5 reflected he/she was an "Elective" admission on 12/07/2015 for "Bilateral hip replacements..." The "Surgery Report" reflected the patient was in the OR on 12/07/2015 at 0727 and the "Anesthesia Record" reflected that anesthesia was started on 12/07/2015 at 0714.

On 12/07/2015 at 0711 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan," "Discussed: general anesthesia, regional anesthesia. Anesthesia Type Chosen Single shot spinal."

On 12/07/2015 at 0818, 64 minutes after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified...I agree with the ASA status and anesthetic plan." However, the CRNA also recorded "Patient Chart reviewed and plan discussed prior to surgery. Attestation documented after procedure start."

On 12/07/2015 at 1144 the a note recorded by the CRNA reflected that "Actual anesthetic administered: MAC and Spinal." The pre-anesthesia evaluation did not address the planned or possible use of MAC.

6. The medical record of Patient 6 reflected he/she presented to the ED on 12/14/2015 at 1454 and was transferred to the OR for "incision and drainage of peri-rectal abscess" on 12/14/2015 at 1945. The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 12/14/2015 at 2021.

On 12/14/2015 at 2043, 22 minutes after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified...I agree with the ASA status and anesthetic plan."

7. The medical record of Patient 7 reflected he/she was an "Elective" admission on 12/28/2015 for "Left... knee replacement..." The "Surgery Report" reflected that on 12/28/2015 the patient was in the OR at 0731 and the "Anesthesia Record" reflected that anesthesia was started on 12/28/2015 at 0710.

On 12/28/2015 at 0706 the anesthesiologist recorded in the anesthesia Preprocedure Note "Anesthesia Plan...Discussed: general anesthesia, central neuraxial blocks Anesthesia Type Chosen Single shot spinal."

On 12/07/2015 at 0708 the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, Consents reviewed and SITE verified..I agree with the ASA status and anesthetic plan."

On 12/28/2015 at 0919 a note recorded by the CRNA reflected that "Actual anesthetic administered: MAC and Spinal." The pre-anesthesia evaluation did not address the planned or possible use of MAC.

8. The medical record of Patient 11 reflected he/she was an "Elective" admission on 02/04/2016 for surgery including "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 02/04/2016 at 1420.

On 02/04/2016 at 1444, 24 minutes after the anesthesia start time, the CRNA anesthesia provider for the case completed the anesthesia "Preprocedure Note." The CRNA recorded "Patient verified, Procedure confirmed, and Consents reviewed...I agree with the ASA status and anesthetic plan."

Based on interview, documentation for 14 of 14 surgical procedures that required anesthesia in 13 of 13 medical records reviewed (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13), and review of policies and procedures it was determined that the hospital failed to ensure that the intraoperative anesthesia record was complete and accurate:
* Documentation of the management of complications during anesthesia was not clear and complete;
* Documentation of the anesthesia and ventilation equipment used was incomplete and inconsistent;
* Documentation of equipment checks prior to anesthesia was not evident; and
* Documentation of the type of anesthesia was incomplete.

Findings include:

1. Policies and procedures were reviewed:

* The policy and procedure titled "Pre-Induction Procedure", dated as revised June 2013, stipulated: "Prior to the induction of anesthesia, the responsible anesthesia care provider shall verify that...A complete machine checkout has been performed...There is documentation on the anesthetic record that the machine checkout has been performed...Presence of apparatus for airway maintenance..."

* The policy and procedure titled "Medical Record Documentation", dated as revised June 2013, stipulated: "The anesthesia care provider shall document the results of the equipment and supplies 'case check' before induction of anesthesia. This documentation will occur in the Record of Anesthesia. (See Pre-Induction Procedure.)"

* The policy and procedure titled "Patient Care Safety Guidelines" dated as revised January 2016, stipulated: "Preanesthesia Apparatus Check...The function of the anesthesia machine shall be tested prior to its first use during any work day...Completion of the machine checkout is documented on the anesthetic record...General anesthesia is to be administered only by using an anesthesia machine with appropriate safety devices...Surgical or anesthesia procedures are performed only when the necessary equipment, personnel, and organizations are available. Anesthesia Machine Checklist and Testing Procedure To be performed daily. Items marked with an * should be performed before each case...*Ventilator and alarm..."

The policy and procedure contained no provisions for a preanesthesia check of any other apparatus that may be used by the anesthesia provider to provide aspects of anesthesia care, including ventilation by a manually operated device such as a manual jet ventilator.

* The policy and procedure titled "Intra-Operative Monitoring", dated as revised June 2013, stipulated:
"During all anesthetic procedures, the patient's ventilation shall be continually evaluated...The adequacy of ventilation of all patients receiving general anesthesia shall be ensured through the monitoring of the carbon dioxide (CO2) content and/or volume of expired gas...When ventilation is controlled by a mechanical ventilator, a low pressure disconnect alarm shall be in continuous use. This device must give an audible signal when the alarm threshold is exceeded...During regional anesthesia and monitored anesthesia care, the adequacy of ventilation shall be evaluated, at least by continual observation of qualitative clinical signs such as chest excursion and auscultation of breath sounds, and pulse oximeter."

The policy and procedure contained no provisions for ventilation provided by a manually operated device such as a manual jet ventilator.

* The policy and procedure titled "Anesthesia During Laser Procedures", dated as revised June 2013, contained no provisions for ventilation with air only, or ventilation provided by a manually operated device such as a manual jet ventilator.

2. Refer to Tag A144, CFR 482.13(c)(2), Patient Rights: Care in Safe Setting, that reflects the lack of clear and complete documentation on the Anesthesia Records for Patients 10, 1, 2, and 4. In addition, documentation to reflect the "case check" described in the policies and procedures above was not evident in those records.

3. The medical record of Patient 13 reflected he/she was an "Elective" admission on 04/01/2016 for "Suspension Microlaryngoscopy with CO2 Laser and Operating Microscope with biopsy...Operation on oral cavity...in the floor of the mouth*." The "Surgery Report" reflected that the patient was in the OR on 04/01/2016 at 0906.

The "Anesthesia Record" reflected that anesthesia was started on 04/01/2016 at 0906, the anesthesia end time was 1106, and GA was used. The "Machine #" was blank and there was no documentation of the "case check."

4. a. The medical record of Patient 3 reflected he/she was admitted on 09/19/2015 with onset of swelling and pain in the right knee. The patient was found to have an infection and underwent surgery on the right knee on 09/20/2015. The "Surgery Report" reflected that on 09/20/2015 the patient was in the OR at 1107.

The "Anesthesia Record" reflected that anesthesia was started on 09/20/2015 at 1106, the anesthesia end time was 1348, and GA was used. The "Machine No" was recorded as "-" and there was no documentation of the "case check.

b. The medical record of Patient 3 reflected that on 09/22/2015 at 1615 a PA documented that the "...plan is ERCP tomorrow." The MPU documentation reflected that the patient was in the MPU room on 09/23/2015 at 1343.

The "Anesthesia Record" reflected anesthesia was started at 1343, the anesthesia end time was 1455, and GA was used. The "Machine #" was recorded as "3" and there was no documentation of the "case check."

5. The medical record of Patient 5 reflected he/she was an "Elective" admission on 12/07/2015 for "Bilateral hip replacements..." The "Surgery Report" reflected the patient was in the OR on 12/07/2015 at 0727.

The"Anesthesia Record" reflected that anesthesia was started on 12/07/2015 at 0714, the anesthesia end time was 1218, and that MAC and Regional Anesthesia were provided. The "Machine #" was recorded as "8" and there was no documentation of the "case check."

6. The medical record of Patient 6 reflected he/she presented to the ED on 12/14/2015 at 1454 and was transferred to the OR for "incision and drainage of peri-rectal abscess" on 12/14/2015 at 1945. The "Surgery Report" reflected that the patient was in the OR on 12/14/2015 at 2021.

The "Anesthesia Record" reflected that anesthesia was started on 12/14/2015 at 2021, the anesthesia end time was 2139, and GA was used. The "Machine #" was recorded as "51961" and there was no documentation of the "case check."

7. The medical record of Patient 7 reflected he/she was an "Elective" admission on 12/28/2015 for "Left... knee replacement..." The "Surgery Report" reflected that on 12/28/2015 the patient was in the OR at 0731.

The "Anesthesia Record" reflected that anesthesia was started on 12/28/2015 at 0710, the anesthesia end time was 0955, and Regional Anesthesia was used. However, in a note on 12/28/2015 at 0919 the CRNA recorded that "Actual anesthetic administered: MAC and Spinal." The "Machine #" was recorded as "4" and there was no documentation of the "case check."

8. The medical record of Patient 8 reflected he/she was an "Elective" admission on 01/25/2016 for "Suspension Microlaryngoscopy and Biopsy." The "Surgery Report" reflected that the patient was in the OR on 01/25/2016 at 0904.

The "Anesthesia Record" reflected that anesthesia was started on 01/25/2016 at 0904, the anesthesia end time was 0956, and GA was used. The "Machine #" was blank and there was no documentation of the "case check."

9. The medical record of Patient 9 reflected he/she was an "Elective" admission on 01/27/2016 for "Microlaryngoscopy with excision of laryngeal papillomas." The "Surgery Report" reflected that the patient was in the OR on 01/27/2016 at 1127.

The "Anesthesia Record" reflected that anesthesia was started on 01/27/2016 at 1127, the anesthesia end time was 1238, and GA was used. The "Machine #" was recorded as "52907" and there was no documentation of the "case check."

10. The medical record of Patient 11 reflected he/she was an "Elective" admission on 02/04/2016 for surgery including "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy." The "Surgery Report" reflected that the patient was in the OR 02/04/2016 at 1420.

The "Anesthesia Record" reflected that anesthesia was started on 02/04/2016 at 1420, the anesthesia end time was 1655, and GA was used. The "Machine #" was blank and there was no documentation of the "case check."

11. The medical record of Patient 12 reflected he/she was an "Elective" admission on 02/15/2016 for "Suspension Microlaryngoscopy..." The "Surgery Report" reflected that on the patient was in the OR on 02/15/2016 at 0728.

The "Anesthesia Record" reflected that anesthesia was started on 02/15/2016 at 0728, the anesthesia end time was 0844, and GA was provided. The "Machine #" was recorded as "911" and there was no documentation of the "case check."

Based on interview, documentation for 2 of 14 surgical procedures that required anesthesia in 2 of 13 medical records reviewed (Patients 6 and 11), and review of policies and procedures it was determined that the hospital failed to ensure that a post-anesthesia evaluation was completed and documented no later than 48 hours after a surgery or procedure that required anesthesia services.

Findings include:

1. The policy and procedure titled "Post-Anesthesia Evaluation and Care", dated as revised June 2013, stipulated: "Post-anesthesia visits...after the patient's complete recovery from anesthesia, shall be documented, including date and time, in the patient's electronic record...Post-anesthesia visits are routinely done within 24 hours by an anesthesia provider, but must be provided within 48 hours."

2. The medical record of Patient 6 reflected he/she presented to the ED on 12/14/2015 at 1454 and was transferred to the OR for "incision and drainage of peri-rectal abscess" on 12/14/2015 at 1945. The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 12/14/2015 at 2021.

The "Case Tracking Events" section of the "Surgery Report" reflected the patient was transferred out of the OR on 12/14/2015 at 2131 and the "Anesthesia Record" reflected that the anesthesia end time on 12/14/2015 was 2139. There was no evidence of an "Anesthesia Post-procedure Evaluation" in the record performed after the patient's recovery from anesthesia.

That was confirmed during interview with staff present at the time of the electronic record review on 4/12/2016 at 1500.

3. The medical record of Patient 11 reflected he/she was an "Elective" admission on 02/04/2016 for surgery including "Esophagoscopy...Laryngoscopy with Biopsy...Dental extractions...Possible Nasopharyngoscopy with biopsy." The "Surgery Report" and the "Anesthesia Record" reflected that the patient was in the OR and anesthesia was started on 02/04/2016 at 1420.

The "Case Tracking Events" section of the "Surgery Report" reflected the patient was transferred out of the OR on 02/04/2016 at 1643, and the "Anesthesia Record" reflected that the anesthesia end time on 02/04/2016 was 1655. There was no evidence of an "Anesthesia Post-procedure Evaluation" in the record performed after the patient's recovery from anesthesia.

That was confirmed during interview with staff present at the time of the electronic record review on 4/12/2016 at 1535.