HospitalInspections.org

Based on interview, review of medical records for 4 of 4 patients who underwent surgery and anesthesia (Patients 1, 2, 3, and 4), review of the medical record of 1 of 1 patient who was scheduled for surgery and anesthesia (Patient 5), and review of policies and procedures it was determined that the CAH failed to provide for an organizational structure governing its total operation that ensured the provision of appropriate and safe surgical services and anesthesia services.

The failures identified during the survey reflect the CAH's limited capacity to provide safe and appropriate care and services, and represent a Condition-level deficiency of CFR 485.627, Condition of Participation: Organizational Structure.

Findings include:

Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services.

Based on interview, review of medical records for 4 of 4 patients who underwent surgery and anesthesia (Patients 1, 2, 3, and 4), review of the medical record of 1 of 1 patient who was scheduled for surgery and anesthesia (Patient 5), and review of policies and procedures it was determined that the CAH failed to fully develop and enforce policies and procedures that ensured the provision of appropriate and safe surgical services and anesthesia services.

Patient 2 who expired during anesthesia and surgery was not properly assessed prior to anesthesia. The CRNA documented and signed the pre-anesthesia evaluation prior to the patient's arrival to the hospital; the CRNA had not physically examined the patient; the CRNA had not assessed the patient's vital signs or ASA status which was potentially impacted by the patient's documented history of alcohol intake; the CRNA had not evaluated the patient's non-compliance with NPO instructions up to the time of arrival at the hospital nor physician's orders for NPO for eight hours prior to surgery written after the patient's arrival. The CRNA documented prior to the patient's arrival to the hospital that the anesthesia plan and risks were discussed with Patient 2; the CRNA did not provide appropriate informed consent and sign the informed consent form as required; and anesthesia was started less than two hours after Patient 2's last fluid intake.

The following failures were identified for Patients 1 through 5:
* Pre-anesthesia evaluations were conducted prior to patient's arrival at the hospital for Patients 1, 2, and 5.
* Pre-anesthesia evaluations were incomplete or unclear for Patients 1, 2, 3, and 4.
* Anesthesia informed consents were not valid and not signed by the CRNA for Patients 1, 2, 3, and 4.
* Anesthesia was started less than two hours after fluids were consumed for Patients 2 and 3.
* The H&P update was not documented and in the EHR prior to surgery for Patient 3.
* The policies and procedures regarding surgical informed consent processes were not clear and surgical informed consents were not signed by the physician who performed the procedure for Patients 1, 2, 3, and 4.
* Patient safety surgical "timeouts" were not timely or clear for Patients 1, 2, 3, and 4.
* There was no documentation by surgical RNs that the physicians or anesthetists were notified of abnormal vital signs or non-compliant NPO status for Patients 1, 2, and 3.
* The surgical RNs documented that the H&P update was complete and on the record before the H&P update was documented and signed by the physicians for Patient 2 and 3.

The failures identified during the survey reflect the CAH's limited capacity to provide safe and appropriate care and services, and represent a Condition-level deficiency of CFR 485.639, Condition of Participation: Surgical Services.

Findings include:

1. Refer to the deficiency cited at Tag C322, CFR 485.639(b), Standard: Anesthetic Risk and Evaluations. Those findings reflect the following failures for Patient 2 and other patients:
* Pre-anesthesia evaluations were documented prior to patients' arrivals at the hospital for Patients 1, 2, and 5.
* Pre-anesthesia evaluations were incomplete or unclear for Patients 1, 2, 3, and 4.
* Anesthesia informed consents were not valid and not signed by the anesthetist for Patients 1, 2, 3, and 4.
* Anesthesia was started less than two hours after fluid intake for Patient 2 and 3.

2. Policies and procedures and protocol documents reviewed:

a. "Samaritan North Lincoln Hospital Medical Staff Bylaws," including Rules and Regulations, adopted 08/31/2017, included the following requirements:
* Section 10.2.3, "Patient Assessment...The admitting practitioner will be responsible for documenting a medical history, physical examination and clinical decision-making report (H&P) that contain salient elements adequate to convey all necessary clinical information to provide safe and efficiency (sic) medical care, conform to community standards and to all applicable requirements of regulatory bodies. A copy of the H&P...Must be available before any surgical procedure requiring sedation or anesthesia services...May have been dictated up to 30 days prior to surgery as long as it is accompanied by additional documentation verifying that the information remains current."
* Section 10.2.6, "Outpatient Ambulatory Surgery: A history and physical examination report (H&P) is completed prior to...the ambulatory surgery procedure...If a complete H&P has been performed within thirty (30) days of the procedure (e.g. office H&P or prenatal record), a legible copy of the report may be used in the patient's Hospital medical record, provided any changes in the patient's clinical status are recorded in the medical record at the time of the procedure. An updated assessment must be recorded in the progress notes or in an opening statement in the procedure record if the H&P was completed prior to admission...The H&P for ambulatory surgery outpatient procedures will include all elements required for appropriate patient care and regulatory requirements.."
* Section 10.2.15, "Informed Consent...obtained from the patient or the patient's legal representative prior to the performance of any invasive procedure. As part of the informed consent process, the Medical Staff member documents that a conference was held with the patient or the patient's representative to discuss the procedure, alternatives, and risks of the planned medical treatment or invasive procedure. This 'PAR' conference should be documented in the progress notes, history and physical examination report, or procedure report."
* Section 10.4.6, "Clinical Documentation Monitoring Process...H&Ps shall be completed...before an outpatient procedure is performed. The History & Physical must be on the record prior to surgery."

b. The policy and procedure titled "Consent for Care or Treatment," revised 02/27/2018 to include language related to Oregon Elective Permanent Sterilization consent, and previously revised 09/25/2017, included the following:
* "Samaritan Health Services personnel will verify that the physician or licensed independent practitioner (LIP) has obtained an informed consent from patients or their legal representatives prior to any procedure or treatment including surgery...A written signed consent form is required unless an extreme lift (sic) threatening emergency exists...Employees may witness the patient's signature. The witness is documenting that he/she observed the signature and that the patient's designee did so on his/her own free will..."
* "It is the responsibility, which cannot be delegated, of the treating physician or LIP to obtain informed consent from the patient (or authorized representative) by a direct personal exchange of information with the person."
* "The physician or LIP must obtain the patient's informed consent before the procedure is administered, at a time that the patient is not sedated, and when the patient judgment is not otherwise impaired."
* "Consent Process...Prior to procedures requiring informed consent, the physician or LIP is to explain to the patient or authorized representative in general terms the procedure or treatment to be undertaken; alternative procedures or methods of treatment, if any; and risks, if any, associated with the procedure or treatment. The physician or LIP must ask the patient or designee if he/she wants a more detailed explanation and, if so, provide that in substantial detail. Prior to procedures requiring a signed consent form, as specified in this policy, clinical staff is to ensure that a signed consent form is present. If not present, staff, the physician or the LIP is to elicit and witness the patient or their representative's signature on an informed consent form."

This policy and procedure did not clearly specify the physician's or LIP's responsibility related to signing the informed consent form where it says that "A written signed consent form is required...Employees may witness...It is the responsibility, which cannot be delegated, of the treating physician or LIP to obtain informed consent..." The responsibility is additionally unclear where the Medical Staff Bylaws Rules and Regulations at Section 10.2.15 reflect that, "Informed Consent...As part of the informed consent process, the Medical Staff member documents that a conference was held with the patient or the patient's representative to discuss the procedure, alternatives, and risks of the planned medical treatment or invasive procedure." According to this requirement the PAR conference is only part of informed consent.

c. The policy and procedure titled "Procedural Site Verification (Universal Protocol) - System," revised 04/28/2016, included the following:
* "Pre-procedure Verification - Prior to any invasive procedure, staff must complete the following verification process: Prior to administration of anesthesia or sedation...Compare the patient's identification with the consent form, H&P, physician orders...to ensure they concur with the planned procedure...Document on the designated pre-operative checklist (surgical safety pause/time out). Site Marking...Prior to the patient entering the procedure room or operating room, the Provider performing the procedure, with the patient's participation, must mark the procedural site with their initials..."
* "Time Out or Final Pause - Immediately prior to the procedure and in the procedure location, performs the following time out: Prior to any incision, puncture, or insertion, and after the patient is draped, all members of the procedure team actively participate in a "HARD STOP." All activity will cease and the following will be verified..."
* "Time Out or Final Pause prior to patient leaving the OR - performs the following time out: Following the procedure, all members of the procedure team actively participate: Name of correct procedure recorded...Counts correct...Any equipment problems to be addressed...Potential Recovery concerns reviewed?"

d. The policy and procedure titled "Documentation," revised 05/12/2017, included the following:
* "Accurate, detailed communication shows the extent and quality of the care...the outcomes of that care...Thorough, accurate documentation decreases the potential for miscommunication and errors...If you need to add a late entry...label it as a 'late entry'...Then record the date and time of the entry as well as the date and time when the entry should have been made...Specifically state in the body of your note the time that events occurred and the action taken because most computer systems record the date and time that you make any entry...Document information as soon as possible to ensure the accuracy of the information and to reflect ongoing care. Delayed documentation increases the potential for omissions, error, and inaccuracy from memory lapse. Document only care, treatments, and medications that you've actually provided or administered; never chart in advance. Describe observations and behaviors of the patient...Never tamper with documentation or any part of the clinical record; tampering includes adding to a clinical note at a later date without indicating that it's a late entry, inserting inaccurate information in the record, purposefully omitting information, rewriting or altering the documentation, destroying clinical record notes or other documentation, or adding to someone else's notes without indicating your identity and the date. If information...doesn't apply to your patient, write "N/A" (not applicable) rather than leaving the space blank. This notation shows that you read the questions and that it doesn't apply, rather than that you forgot to gather the data. It also prevents someone else from adding the information later."

3. The surgical log reflected that Patient 2 underwent a "Hysteroscopy D&C with Myosure" under "general LMA" anesthesia on 12/28/2017. The closed medical record of the patient in the complaint, Patient 2, was reviewed electronically with the hospital CWS.

a. Patient 2's pre-procedure clinical record was reviewed:
* On 12/08/2017 at 1143, a "Preoperative History and Physical" was filed and electronically signed by Physician 13 on the date of Patient 2's clinic visit prior to the date of outpatient surgery.
* On 12/20/2017 at 0836, a "Preoperative History and Physical" was filed and electronically signed by Physician 13. Although the H&P was dated on 12/20/2017 there was no documentation to reflect that the physician saw or examined Patient 2 on that date.
* Those two H&Ps included the following identical evaluation, assessment, and plan language:
- "Patient presents with Follow-up Postmenopausal Bleeding."
- "[Patient 2] presents for Follow-up Postmenopausal Bleeding. No LMP recorded. Patient is postmenopausal."
- "I first saw [Patient 2] 2/9/17 for fibroids...Although no further bleeding episodes, it is concerning and thus warrants more thorough eval."
- "Current Outpatient Prescriptions...Calcium-Vitamin D-Vitamin K...conjugated estrogens...ibuprofen...No current facility-administered medications for this visit."
- "No Known Allergies."
- "The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, past family history, past medical history, past social history, past surgical history and problem list."
- "Physical Exam: Vital Signs: weight is 135 lb 11.2 oz (61.6 kg). [His/her] blood pressure is 108/68. General: Alert, oriented, no acute distress, nontoxic. Head: Normocephalic and atraumatic. C (sic) Abdomen: Soft, nontender, non-distended, bowel sounds normal; no masses, no guarding, no organomegaly. Pelvic: Normal appearing vulva, labia majora, labia minora, clitoris and introitus. Urethra: Normal by palpation without discharge. Urethral Meatus: Normal size and location, no lesions or discharge. Spec exam easily accommodated. Normal vag vault, normal cervix, no lesions, or abnormal discharge. (sic) Bimanual exam reveals a bladder without mass or tenderness, a mildly enlarged 10 week size midposition uterus, mobile, firm nodularities note, fibroids do not fill posterior culdesac, non tender, adnexa not palpable Psych: Normal mood and affect, appropriate interaction and eye contact."
- "Assessment and Plan...Visit Diagnoses Thickened endometrium - Primary, Intramural, submucous, and subserous leiomyoma of uterus."
- "Reviewed the prior ultrasounds and the concern given a change in the endometrial stripe. Given two prior EMBs with inconclusive and atrophic findings, my recommendation at this point is to move forward with hysteroscopy dilation and curettage. PARQ held today for this procedure - reviewed risks of the procedure including but not limited to anesthesia, infection, bleeding, perforation. Discussed my suspicion for malignancy is low, but need to be able to rule it out with this procedure. Pt agrees to proceed."

b. Patient 2's hospital outpatient surgery record for 12/28/2017 was reviewed:
* The outpatient surgical record reflected the following timeline of events on 12/28/2017:
- 1124 In facility
- 1152 In Pre-Procedure
- 1204 Anesthesia Ready
- 1239 Pre-Procedure Complete
- 1309 In Room
- 1310 Anesthesia Start
- 1328 Procedure Start
- 1600 Procedure Finish
- 1602 Anesthesia Finish
- 1641 Out of Room

* Information recorded in the historical "Patient History" section of the EHR included: "Patient History...Alcohol Use as of 12/28/2017" was recorded as "Alcohol Use Yes - Comments gin and tonic several times a week - Source Provider." There was no documentation this information was evaluated as part of the H&Ps for Patient 2 documented by Physician 13 on 12/08/2017 and 12/20/2017.

* The first documentation by staff for Patient 2 was recorded prior to the patient's arrival on 12/28/2017 at 1027. CRNA 12 filed and electronically signed an "Anesthesia Evaluation" for Patient 2 on 12/28/2017 at 1027. The evaluation reflected:
- "Patient summary reviewed. Nursing notes reviewed, Patient allergies reviewed and NPO status verified. No history of anesthetic complications.
- Airway Mallampati: I - TM distance: [less than] 3 FB - Neck ROM: full
- Dental - normal exam
- Pulmonary - negative ROS and normal exam
- Cardiovascular - negative ROS and normal exam
- Neuro/Psych - negative ROS
- GI/Hepatic/Renal (+) GERD
- Endo/Other - negative ROS
- Abdominal - normal exam Abdomen: soft
- Anesthesia Plan ASA 1 general LMA Intravenous induction Anesthetic plan and risks discussed with patient."

This documentation was filed and signed by the CRNA approximately one hour prior to the patient's arrival. The evaluation reflected information that could only be obtained from a physical or visual examination, however, the patient did not arrive to the hospital until 1124, after the evaluation had been documented. In addition, there was no documentation of patient vital signs, NPO status, or nursing notes recorded at that time as the patient had not arrived at the hospital. There was no documentation to reflect that the CRNA had evaluated all aspects of the patient's history, labs, ECGs or other diagnostic studies to ensure there were no contraindications for anesthesia. Although there is no documentation that the CRNA addressed the alcohol use documented in the patient's history he/she determined that the patient was "ASA 1" which is defined by ASA as "Healthy, non-smoking, no or minimal alcohol use." Anesthetic plan and risks could not have been discussed with the patient as the patient had not arrived to the hospital. There was no documentation to reflect that the CRNA had physically evaluated the patient or communicated with the patient within 48 hours prior to 12/28/2017.

* 12/28/2017 at 1124, Patient 2 arrived at the hospital, was admitted to Outpatient Surgery, and electronically signed the hospital's general "Conditions of Admission" consent document. This was not specific consent for surgery or anesthesia.

* 12/28/2017 at 1156, RN 10 recorded a "Pre-Procedure Care Plan...Potential for Fluid Volume Deficit Related to NPO Status" under which was written: - "Has the patient been NPO? No will notify anesthesia." There was no documentation to reflect that anesthesia had been notified or the surgeon was notified.

* 12/28/2017 at 1204, fields at the end of the "Intra-op Record" reflected "Weight: 61.6 kg (135 lb 11.2 oz) (12/08/17) NPO Status: Not recorded."

* 12/28/2017 at 1204, CRNA 12 recorded "Ready for Procedure."

* 12/28/2017 at 1205, Surgical consent was signed and dated "12/28/17" by Patient 2. The "Time" recorded as "1205" was in a different handwriting than that of the patient. The "Signature of Witness/Provider" was signed by RN 10. The consent was not signed by the physician.

* Physicians orders reflected:
- 12/28/2017 1206, "Diet NPO...Effective Now"
- 12/28/2017 1206, "Diet instructions to nursing...Once...Other comments: NPO 8 hrs prior to surgery."

* Pre-procedure nursing assessment entries recorded by RN 10:
- 12/28/2017 at 1206, "Date of last liquid: 12/28/2017; Time of last liquid: 1130; Date of last solid: 12/27/2017; Time of last solid: 1030." There was no documentation to reflect the surgeon or anesthesia was notified that the patient had consumed fluids less than two hours before the assessment and subsequently less than two hours before anesthesia start.
- 12/28/2017 at 1212, Pulse 74; Resp 18; BP 126/75; Temp 36.8 (98.2); Actual current weight 60.8 kg (134 lb).
- 12/28/2017 at 1214, Respiratory, Cardiac, and Gastrointestinal all "WDL."

* 12/28/2017 at 1214, "Preop Checklist Before Induction of Anesthesia" entries recorded by RN 10:
- "H&P completed Yes; Interval H&P completed Yes." However, the interval H&P note was not recorded until after that entry at 1225.
- "NPO No; Date of Last Oral Intake 12/28/2017; Time of Last Oral Intake 1130 4 ounces of water, up until 1030 this AM freely drinking water and a few sips of black coffee." There was no documentation to reflect the surgeon or anesthesia was notified.

* 12/28/2017 at 1225, Physician 13 filed and electronically signed an "Interval H&P Note." The note reflected "The current H&P was reviewed. The patient was re-examined. Re-evaluation of the patient confirms the necessity for the scheduled procedure. No change in the patient's condition since the H&P was completed less than 30 days ago."

* 12/28/2017 at 1240, Anesthesia Consent was signed by Patient 2. The "Date" recorded as "12/28/17" and "Time" recorded as "1240" were in a different handwriting than that of the patient. The "Signature of Witness" was signed by RN 10. The consent was not signed by the CRNA as required by the "Anesthesia Care of the Peri-Operative Patient" policy and procedure. This document did not clearly reflect a valid informed consent as the anesthesia evaluation, and therefore identification of patient specific risks, was conducted prior to the patient's arrival and was incomplete.

* 12/28/2017 at 1310, Anesthesia was started less than two hours after the patient had last consumed liquids at 1130, inconsistent with policies and procedures and physician orders.

* 12/28/2017 at 1316, "Preop Checklist Before Induction of Anesthesia" entries recorded by RN 5 after the anesthesia start time of 1310: - "NPO No; Date of Last Oral Intake 12/28/2017; Time of Last Oral Intake 1130." There was no documentation to reflect the surgeon or anesthesia was notified that the patient had consumed fluids less than two hours before anesthesia start.

* "Timeout" documentation on the surgical record by RNs 5 and 6 reflected the following on 12/28/2017:
- 1317 "Preoperative" timeout type field. This timeout was documented after anesthesia had started at 1310.
- 1318 All remaining fields of the preoperative timeout were also documented after anesthesia start including: "Correct Patient, Correct Procedure, H&P Note Complete, Allergies Reviewed..."

- 1322 "Before Leaving Surgery Room" timeout type field. This timeout was documented as conducted prior to the beginning of the procedure that started at 1328.
- 1322 "Equipment Problems Addressed - No."
- 1322 "Recovery Issues Reviewed - Yes."
- 1322 "Correct Procedure Documented - Yes."
- 1322 "Wound Classification Confirmed - Class 2 - Clean/contaminated."
- 1322 "Opportunities for Improvement Reviewed - Yes." There was no documentation to reflect what post-surgery opportunities for improvement were identified as the surgery did not start until 1328.

- 1326 "Pre-incision" timeout type field.
- 1326 All remaining field of the pre-incision timeout were documented including: "Anesthesia Concerns Reviewed - Yes; Surgical Team Concerns Reviewed - Yes; Reviewed Equipment Problems - No..." There was no documentation to reflect what anesthesia concerns were at this time after anesthesia had already been started at 1310; what surgical team concerns were; and what equipment problems were not reviewed.

The "timeouts" were not conducted and documented timely in accordance with the surgical timeline, were contradictory to the "timeout" process to ensure patient safety, and rendered the medical record unclear and inaccurate.

* Post-Mortem RN documentation:
- 12/28/2017 at 1700, "Is this a medical examiner's case: Y; Medical Examiner notified: Y."
- 12/28/2017 at 1800, "Physician request Autopsy: Y...Is this a medical examiner's case: N per conversations with ME."

* 12/28/2017 at 1939, Physician 13 filed and electronically signed a "Procedure Note." The noted reflected "The patient was then taken to the operating room where [he/she] was placed supine on an operating table. SCDs were placed and inflated. [He/she] was then administered a general anesthetic. A timeout was taken to confirm the patient's identity and plan procedure. [His/her] legs were placed in lithotomy stirrups. The vagina was prepped and draped in the usual sterile fashion. Bimanual exam was performed with the above findings. A weighted speculum was placed in the posterior vagina and right angle retractor was placed in the anterior vagina and a single toothed tenaculum was placed on the anterior lip of the cervix. With inferior traction there was minimal descensus of the cervix. A sound was then passed with the uterus sounding to 8 cm. The cervix was then gently dilated using blunt dilators. Once the cervix was adequately dilated, the hysteroscope was introduced and the endometrial cavity was visualized using NS as a distention media. There was no evidence of perforation. There was a large fleshy vascular appearing polyp extending from the posterior cavity down to the level of the cervical os. The camera was able to be passed around the polyp and both tubal ostia were visualized. The hysteroscope was removed and the myosure brought to the field. It did not pass easily and therefore the cervix was then further dilated allowing for entrance of the myosure device. Once inserted into the cavity it was felt to have created the beginning of a false passage into the myometrium on the left side, but perforation was not seen. The myosure was removed, the hysteroscope reinserted for better visualization. Polyp was again identified and cavity integrity noted. The left wall of the uterine cavity was inspected closely and found to be completely intact with minor tunneling into the myometrium. My partner was called in to confirm my assessment and was in concurrence that it was ok to proceed. The hysteroscope was removed in anticipation of continuing with the myosure polypectomy and anesthesia noted cardiac arrhythmia. The procedure was immediately aborted, instruments removed completely and code team called. Please see further nursing and IMS documentation for details of the code. Specimens were not obtained."

* 12/29/2017 at 1919, Physician 16 filed and electronically signed a "Medical Consultation" note. The note reflected "Reason for consult: Cardiac arrest. This patient, about 10 minutes into hysteroscope procedure under anesthesia, without warning abruptly developed a 5-6 beat run of wide complex rhythm followed by asystole. {He/she] had just received IV Zofran in anticipation of post op nausea when the event occurred. Code was called and when I arrived surgery had been aborted, patient was pulpless (sic) and without organized electrical activity on monitor, an LMA was in place and [he/she] was being bagged by anesthesia. Closed chest compressions were started immediately. Shortly thereafter LMA was removed and ET tube placed by anesthesia using video laryngoscope. Bloody fluid could be seen in the larynx with that instrument before the tube was passed. Copious amounts of bright red, bloody, slightly frothy fluid fluid (sic) begin pouring immediately from the ET tube. CVP catheter was placed successfully in the left subclavian vein...An NG tube was eventually placed as well. Interrupting chest compressions briefly, a portable CXR was obtained showing diffuse pulmonary edema and satisfactory placement of ET tube and CVP cannula. Several minutes later, again interrupting chest compression, a quick look ultrasound done by echo tech demonstrated no pericardial effusion. [His/her] abdomen did not appear distended, remained soft and there was no significant bleeding from the vagina." The note continues with descriptions of the resuscitative efforts during which Patient 2 eventually "...developed a sustained regular rhythm...This condition lasted long enough to request transport to Salem ICU where the intensivist would accept [him/her] for admission...respiratory acidosis continued to worsen in the face of even more profuse bloody fluid from ET tube, which by this time had darkened considerable...Coincident with failing ventilatory efforts [his/her] pulse again slowed. Another round of chest compressions and sympathomimetics were given resulting in return of organized rhythm with BP measurable by the A line. But hemodynamics were insufficient to sustain the patient and the code was terminated at 4 pm. Word received from the lab just before code's end was that all blood samples received in the lab were badly hemolyzed. For that reason some requested test could not be done including coagulation tests. HGB 4.1 and HCT 11.4 (reported on hematology section of lab at 1601) was actually done on fluid pouring from ET tube."

* 12/31/2017 at 1225, Physician 13 filed and electronically signed a "Death Summary" that reflected "Patient 2 was pronounced dead at 1600 on 12/28/2017." The summary reflected "Cause of Death: unexplained cardiopulmonary arrest. Other diagnosis contributing to but not direct cause of death: none. Active problems: Endometrial thickening on ultra sound, endometrial polyp, postmenopausal bleeding, fibroid uterus...Pt was admitted for scheduled elective hysteroscopy, dilation and curettage after having increased thickening of the endometrium noted on outpatient ultrasound with negative findings on in (sic) office biopsies...Hysteroscopy with cervical dilation, procedure was performed without complications but was aborted prior to polypectomy being performed due to cardiac arrest...Approximately 15 minutes intraoperatively anesthesia announced cardiac arrhythmia and the procedure was immediately aborted and chest compressions initiated as [he/she] was asystolic. Code 99 was paged overhead. Please see documentation in patients chart for further details about the code. Pt was noted to have significant amount of sanguinous exudate coming from [his/her] ET tube. Resuscitative efforts proceeded for a total of over 90 minutes, with return of cardiac activity at one point for sustainable amount of time to secure transport to Salem ICU. Patient then decompensated again and was unable to be further resuscitated...Autopsy was discussed with [family]. Patient had indicated organ donation on their driver's license. Body released to the funeral home."

* Findings in this record were confirmed during interview with the CWS at the time of the review on 03/20/2018 beginning at 1015.

4. Patient 1 - The surgical log reflected that Patient 1 underwent a "Hysteroscopy D&C Polypectomy" under "general LMA" anesthesia on 12/28/2017. The closed medical record of Patient 1 was reviewed electronically with the hospital CWS.

* Review of the anesthesia and surgical services documentation revealed that the timeline of events was unclear and contradictory to hospital policies and procedures:
- 0834 CRNA documented the pre-anesthesia evaluation prior to the patient's arrival.
- 0916 Patient arrived at hospital.
- 0949 RN recorded first documentation of NPO status that reflected patient had consumed fluids at 0630 on 12/28/2017.
- 0950 RN recorded first vital signs taken. The patient's BP was flagged as elevated at 147/82. There was no documentation to reflect that the RN had informed the physician or anesthetist.
- 0955 Anesthesia consent signed.
- 1007 Anesthesia started.
- 1024 Surgery started.
- 1047 "Pre-operative timeout" conducted after anesthesia and surgery start.
- 1048 "Pre-incision timeout" conducted after surgery start.
- 1052 Surgery stopped.
- 1059 Patient left the operating room.
- 1100 Patient in recovery room.
- 1104 "Before leaving surgical room timeout" conducted after patient left the operating room and was in recovery.
- 12/29/2017 at 0937 Surgical consent signed.

* "12-29-17" at 0937, Surgical consent was signed and dated "12-29-17" by Patient 1, the day after the surgery. The "Signature of Witness/Provider" was signed by an RN. The consent was not signed by the physician.

* The "timeouts" were not conducted and documented timely in accordance with the surgical timeline, were contradictory to the "timeout" process to ensure patient safety, and rendered the medical record unclear and inaccurate.

* Findings in this record were confirmed during interview with the CWS at the time of the review on 03/21/2018 beginning at 0930.

5. Patient 3 - The surgical log reflected that Patient 3 underwent a "Hysteroscopy D&C BX Endometrial Ablation" under "general LMA" anesthesia on 01/04/2018. The closed medical record of Patient 3 was reviewed electronically with the hospital CWS.

* Review of the anesthesia and surgical services documentation revealed that the timeline of events was unclear and contradictory to hospital policies and procedures:
- 0654 Patient arrived at hospital.
- 0725 Surgical consent signed.
- 0739 CRNA documented the pre-anesthesia evaluation.
- 0745 Anesthesia consent signed.
- 0746 RN recorded first vital signs taken. The patien

Based on interview, review of medical records for 4 of 4 patients who underwent surgery and anesthesia (Patients 1, 2, 3, and 4), review of the medical record of 1 of 1 patient who was scheduled for surgery and anesthesia (Patient 5), and review of policies and procedures it was determined that the CAH failed to fully develop and enforce policies and procedures that ensured the provision of appropriate and safe anesthesia services.

Patient 2 who expired during anesthesia and surgery was not properly assessed prior to anesthesia. The CRNA documented and signed the pre-anesthesia evaluation prior to the patient's arrival to the hospital; the CRNA had not physically examined the patient; the CRNA had not assessed the patient's vital signs or ASA status which was potentially impacted by the patient's documented history of alcohol intake; the CRNA had not evaluated the patient's non-compliance with NPO instructions up to the time of arrival at the hospital nor physician's orders for NPO for eight hours prior to surgery written after the patient's arrival. The CRNA documented prior to the patient's arrival to the hospital that the anesthesia plan and risks were discussed with Patient 2; the CRNA did not provide appropriate informed consent and sign the informed consent form as required; and anesthesia was started less than two hours after Patient 2's last fluid intake.

The following failures were identified for Patients 1 through 5:
* Pre-anesthesia evaluations were conducted prior to patient's arrival at the hospital for Patients 1, 2, and 5.
* Pre-anesthesia evaluations were incomplete or unclear for Patients 1, 2, 3, and 4.
* Anesthesia informed consents were not valid and not signed by the CRNA for Patients 1, 2, 3, and 4.
* Anesthesia was started less than two hours after fluids were consumed for Patients 2 and 3.

Findings include:

1. Policies and procedures and protocol documents reviewed:

a. The "Samaritan North Lincoln Hospital Medical Staff Bylaws," including Rules and Regulations, adopted 08/31/2017, included the following requirements:
* Section 10.2.9, "The anesthesiologist/CRNA documents pre-anesthesia evaluations within 48 hours prior to surgery and post-anesthesia evaluations no later than 48 hours after surgery. The pre-anesthesia assessment for patients undergoing anesthesia will include: a determination that the patient is a candidate for anesthesia, the anesthesia risk, the type of anesthesia planned."

b. The document titled "Admission of Patient to Surgical Services - WI," revised 04/26/2016, included the following:
* "Patients having inpatient or outpatient surgery or a procedure in the Surgical Services Department will be assessed and prepared following a plan of care designed to meet the physical, psycho-spiritual, sociocultural, and environmental needs of the patient/family/significant other...Day of Surgery/Procedure: Assessment and management criteria include, but are not limited to: Review and/or complete preadmission assessment and management criteria, as appropriate. Relevant preoperative status including electrocardiogram, vital signs (including temperature), oxygen saturation, radiology findings, laboratory prep (sic) and anesthesia."

c. The policy and procedure titled "General anesthesia patient care, OR," revised 11/17/2017, included the following:
* "Review the patient's medical record for allergies, medical history, and information related to previous surgical procedures and anesthesia...Conduct a preprocedure verification to make sure that all relevant documentation, related information, and equipment is available and correctly identified to the patient's identifiers. Verify that laboratory and imaging studies have been completed as ordered and that results are in the patient's medical records...Confirm the patient's nothing-by-mouth status before the procedure. Minimum fasting recommendations include 2 hours for clear liquids...Conduct a preoperative assessment of the patient if not already done. Before transporting the patient to the OR suite, ask about medical conditions, including any personal or family history of allergies or any problems related to anesthetics that could cause adverse reactions with general anesthesia."

d. The policy and procedure titled "Anesthesia Care of the Peri-Operative Patient," revised 11/28/2016, included the following:
* Pre-Operative: The anesthetist will perform a pre-operative examination of each patient prior to ordering pre-operative medication. Except in extreme cases, the evaluation will be completed prior to the patient being transferred to the operating room suite. The evaluation will include: A review of the patient's chart and an interview with the patient for pertinent information relative to the anticipated procedure, and the type of anesthesia to be used: The patient's previous and present drug history; Other anesthesia experiences and other pertinent medical or family history that will affect the choice of anesthesia; The patient's physical status assessment (i.e., standards listed by the American Society of Anesthesiologists); Results of diagnostic studies and the discussion with the patient and family regarding anesthesia options and risks will be documented on the Pre-Anesthesia Evaluation. The CRNA will give the patient and/or family an Informed Consent for Anesthesia to sign; the CRNA will sign as well. The entry on the Pre-Anesthesia Record will designate the type of anesthesia that is anticipated."

* During telephone interview with the COO, VPPC, DQR and SDM on 04/11/2018 at 1540 it was confirmed that the current informed consent form does not have a place for the anesthetist's signature, and although the CRNA's name is at the top of the form as the anesthesia provider, the CRNAs have not signed the informed consent forms as required in the policy and procedure.

2. The surgical log reflected that Patient 2 underwent a "Hysteroscopy D&C with Myosure" under "general LMA" anesthesia on 12/28/2017. The closed medical record of the patient in the complaint, Patient 2, was reviewed electronically with the hospital CWS.

* The record reflected the following timeline of events on 12/28/2017:
- 1124 In facility
- 1152 In Pre-Procedure
- 1204 Anesthesia Ready
- 1239 Pre-Procedure Complete
- 1309 In Room
- 1310 Anesthesia Start
- 1328 Procedure Start
- 1600 Procedure Finish
- 1602 Anesthesia Finish
- 1641 Out of Room

* Patient history documentation in the record at the time of the patient's encounter reflected that "Alcohol Use as of 12/28/2017" was recorded as "Alcohol Use Yes - Comments gin and tonic several times a week - Source Provider."

* 12/28/2017 at 1027, prior to the patient's arrival, CRNA 12 filed and electronically signed an "Anesthesia Evaluation" for Patient 2. The evaluation reflected:
- "Patient summary reviewed. Nursing notes reviewed, Patient allergies reviewed and NPO status verified. No history of anesthetic complications.
- Airway Mallampati: I - TM distance: [less than] 3 FB - Neck ROM: full
- Dental - normal exam
- Pulmonary - negative ROS and normal exam
- Cardiovascular - negative ROS and normal exam
- Neuro/Psych - negative ROS
- GI/Hepatic/Renal (+) GERD
- Endo/Other - negative ROS
- Abdominal - normal exam Abdomen: soft
- Anesthesia Plan ASA 1 general LMA Intravenous induction Anesthetic plan and risks discussed with patient."

This documentation was filed and signed by the CRNA approximately one hour prior to the patient's arrival. The evaluation reflected information that could only be obtained from a physical or visual examination, however, the patient had not arrived to the hospital. In addition, there was no documentation of patient vital signs, NPO status, or nursing notes recorded at that time as the patient had not arrived at the hospital. There was no documentation to reflect that the CRNA had evaluated all aspects of the patient's history, labs, ECGs or other diagnostic studies to ensure there were no contraindications for anesthesia. Although there is no documentation that the CRNA addressed the alcohol use documented in the patient's history he/she determined that the patient was "ASA 1" which is defined by ASA as "Healthy, non-smoking, no or minimal alcohol use." Anesthetic plan and risks could not have been discussed with the patient as the patient had not arrived to the hospital. There was no documentation to reflect that the CRNA had physically evaluated the patient or communicated with the patient within 48 hours prior to 12/28/2017.

* 12/28/2017 at 1124, Patient 2 arrived at the hospital and was admitted to Outpatient Surgery.

* 12/28/2017 at 1156, RN 10 recorded a "Pre-Procedure Care Plan...Potential for Fluid Volume Deficit Related to NPO Status" under which was written:
- "Has the patient been NPO? No will notify anesthesia." There was no documentation to reflect that anesthesia had been notified or the surgeon was notified.

* 12/28/2017 at 1204, fields at the end of the "Intra-op Record" reflected "Weight: 61.6 kg (135 lb 11.2 oz) (12/08/17) NPO Status: Not recorded."

* 12/28/2017 at 1204, CRNA 12 recorded "Ready for Procedure."

* Physicians orders reflected:
- 12/28/2017 1206, "Diet NPO...Effective Now"
- 12/28/2017 1206, "Diet instructions to nursing...Once...Other comments: NPO 8 hrs prior to surgery."

* Pre-procedure nursing assessment entries recorded by RN 10:
- 12/28/2017 at 1206, "Date of last liquid: 12/28/2017; Time of last liquid: 1130; Date of last solid: 12/27/2017; Time of last solid: 1030." There was no documentation to reflect the surgeon or anesthesia was notified that the patient had consumed fluids less than two hours before the assessment and subsequently less than two hours before anesthesia start.
- 12/28/2017 at 1212, Pulse 74; Resp 18; BP 126/75; Temp 36.8 (98.2); Actual current weight 60.8 kg (134 lb).
- 12/28/2017 at 1214, Respiratory, Cardiac, and Gastrointestinal all "WDL."

* 12/28/2017 at 1214, "Preop Checklist Before Induction of Anesthesia" entries recorded by RN 10:
- "H&P completed Yes; Interval H&P completed Yes." However, the interval note was not recorded until after that entry at 1225.
- "NPO No; Date of Last Oral Intake 12/28/2017; Time of Last Oral Intake 1130 4 ounces of water, up until 1030 this AM freely drinking water and a few sips of black coffee." There was no documentation to reflect the surgeon or CRNA was notified.

* 12/28/2017 at 1240, Anesthesia Consent was signed by Patient 2. The "Date" recorded as "12/28/17" and "Time" recorded as "1240" were in a different handwriting than that of the patient. The "Signature of Witness" was signed by RN 10. The consent was not signed by the CRNA as required by the "Anesthesia Care of the Peri-Operative Patient" policy and procedure. This document did not clearly reflect a valid informed consent as the anesthesia evaluation, and therefore identification of patient specific risks, was conducted prior to the patient's arrival and was incomplete.

* 12/28/2017 at 1310, Anesthesia was started less than two hours after the patient had last consumed liquids at 1120, inconsistent with policies and procedures and physician orders.

* 12/28/2017 at 1316, "Preop Checklist Before Induction of Anesthesia" entries recorded by RN 5 after the anesthesia start time of 1310:
- "NPO No; Date of Last Oral Intake 12/28/2017; Time of Last Oral Intake 1130." There was no documentation to reflect the surgeon or CRNA was notified that the patient had consumed fluids less than two hours before anesthesia start.

* 12/28/2017 at 1317 the "Preoperative" timeout was documented. This was after anesthesia had been started at 1310.

* Entries in the record reflected that the patient experienced cardiac arrhythmia after the surgical procedure had started, resuscitative efforts were initiated, however the patient expired at 1600. The "Death Summary" filed and electronically signed by Physician 13 on 12/31/2017 at 1225 reflected "Patient 2 was pronounced dead at 1600 on 12/28/2017." The summary reflected "Cause of Death: unexplained cardiopulmonary arrest. Other diagnosis contributing to but not direct cause of death: none. Active problems: Endometrial thickening on ultra sound, endometrial polyp, postmenopausal bleeding, fibroid uterus...Pt was admitted for scheduled elective hysteroscopy, dilation and curettage after having increased thickening of the endometrium noted on outpatient ultrasound with negative findings on in (sic) office biopsies...Hysteroscopy with cervical dilation, procedure was performed without complications but was aborted prior to polypectomy being performed due to cardiac arrest...Approximately 15 minutes intraoperatively anesthesia announced cardiac arrhythmia and the procedure was immediately aborted and chest compressions initiated as [he/she] was asystolic. Code 99 was paged overhead. Please see documentation in patients chart for further details about the code. Pt was noted to have significant amount of sanguinous exudate coming from [his/her] ET tube. Resuscitative efforts proceeded for a total of over 90 minutes, with return of cardiac activity at one point for sustainable amount of time to secure transport to Salem ICU. Patient then decompensated again and was unable to be further resuscitated...Autopsy was discussed with [family]. Patient had indicated organ donation on their driver's license. Body released to the funeral home."

* Findings in this record were confirmed during interview with the CWS at the time of the review on 03/20/2018 beginning at 1015.

3. The surgical log reflected that Patient 1 underwent a "Hysteroscopy D&C Polypectomy" under "general LMA" anesthesia on 12/28/2017. The closed medical record of Patient 1 was reviewed electronically with the hospital CWS.

* Review of the documentation revealed that the timeline of anesthesia events was unclear and contradictory to hospital policies and procedures:
- 0834 CRNA documented the pre-anesthesia evaluation prior to the patient's arrival.
- 0916 Patient arrived at hospital.
- 0949 RN recorded first documentation of NPO status that reflected patient had consumed fluids at 0630 on 12/28/2017.
- 0950 RN recorded first vital signs taken. The patient's BP was flagged as elevated at 147/82. There was no documentation to reflect that the RN had informed the physician or anesthetist.
- 0955 Anesthesia consent signed.
- 1007 Anesthesia started.
- 1024 Surgery started.
- 1047 "Pre-operative timeout" conducted after anesthesia and surgery start.
- 1048 "Pre-incision timeout" conducted after surgery start.
- 1052 Surgery stopped.
- 1059 Patient left the operating room.
- 1100 Patient in recovery room.
- 1104 "Before leaving surgical room timeout" conducted after patient left the operating room and was in recovery.

* On 12/28/2017 at 0834, CRNA 12 filed and electronically signed an "Anesthesia Evaluation" for Patient 1. The evaluation reflected:
- "Patient summary reviewed. Nursing notes reviewed, Patient allergies reviewed and NPO status verified. No history of anesthetic complications.
- Airway Mallampati: I TM distance: [less than] 3 FB Neck ROM: full
- Dental - normal exam
- Pulmonary - normal exam (+) asthma, sleep apnea,
- Cardiovascular - normal exam (+) hypertension
- Neuro/Psych Pre-anesthetic state: awake.
- GI/Hepatic/Renal (+) chronic renal disease,
- Endo/Other (+) diabetes mellitus type 2 well controlled,
- Abdominal (+) obese, Abdomen: soft
- Anesthesia Plan ASA 3 general LMA intravenous induction Anesthetic plan and risks discussed with patient."

This documentation was filed and signed by the CRNA approximately one hour and 15 minutes prior to the patient's arrival. The evaluation reflected information that could only be obtained from a physical or visual examination and the patient had not arrived to the hospital. In addition, there was no documentation of patient vital signs, NPO status, or nursing notes recorded at that time as the patient had not arrived at the hospital. Anesthetic plan and risks could not have been discussed with the patient as the patient had not arrived to the hospital. There was no documentation to reflect that the CRNA had physically evaluated the patient or communicated with the patient within 48 hours prior to 12/28/2017. The patient's BP was flagged as elevated, however, that potential problem was not assessed.

* In addition, an Anesthesia Consent was signed by Patient 1, the "Date" recorded as "12/28/17" and "Time" recorded as "0955." The "Signature of Witness" was signed by an RN. The consent was not signed by the CRNA as required by the "Anesthesia Care of the Peri-Operative Patient" policy and procedure. This document did not clearly reflect a valid informed consent as the anesthesia evaluation, and therefore identification of patient specific risks, was conducted prior to the patient's arrival and was incomplete.

* Findings in this record were confirmed during interview with the CWS at the time of the review on 03/21/2018 beginning at 0930.

4. The surgical log reflected that Patient 3 underwent a "Hysteroscopy D&C BX Endometrial Ablation" under "general LMA" anesthesia on 01/04/2018. The closed medical record of Patient 3 was reviewed electronically with the hospital CWS.

* Review of the documentation revealed that the timeline of anesthesia events was unclear and contradictory to hospital policies and procedures.
- 0654 Patient arrived at hospital.
- 0725 Surgical consent signed.
- 0739 CRNA documented the pre-anesthesia evaluation.
- 0745 Anesthesia consent signed.
- 0746 RN recorded first vital signs taken. The patient's BP was flagged as elevated at 146/89. There was no documentation to reflect that the RN had informed the physician or anesthetist.
- 0752 RN recorded first documentation of NPO status that reflected patient had consumed fluids at 0630 on 01/04/2018, less than two hours prior to the assessment and subsequently less than two hours prior to anesthesia start. There was no documentation to reflect that the RN had informed the physician or anesthetist.
- 0811 Anesthesia started.
- 0824 "Pre-operative timeout" conducted after anesthesia start, and reflected that "H&P Note Complete" even though it was not completed until 0851.
- 0828 Surgery started.
- 0833 "Before leaving surgical room timeout" conducted before the surgery was completed.
- 0848 Surgery stopped.
- 0851 H&P update completed and signed after the surgery was concluded.
- 0855 Patient left the operating room.
- 0855 Patient in recovery room.

* On 01/04/2018 at 0739 CRNA 12 filed and electronically signed an "Anesthesia Evaluation" for Patient 3. The evaluation reflected:
- "Patient summary reviewed. Nursing notes reviewed, Patient allergies reviewed and NPO status verified. No history of anesthetic complications.
- Airway Mallampati: I TM distance: [less than] 3 FB Neck ROM: full
- Dental - normal exam
- Pulmonary - normal exam (+) asthma,
- Cardiovascular - normal exam (+) hypertension,
- Neuro/Psych Pre-anesthetic state: awake.
- GI/Hepatic/Renal - negative ROS
- Endo/Other - negative ROS
- Abdominal - normal exam Abdomen: soft
- Anesthesia Plan ASA 2 general LMA intravenous induction Anesthetic plan and risks discussed with patient."

There were no vital signs, NPO status, or nursing notes recorded at the time the pre-anesthesia evaluation was recorded. The patient's BP was flagged as elevated and the patient had not been NPO however, those potential problems were not assessed.

* 01/04/2018 at 0752 "Preop Checklist Before Induction of Anesthesia" entries were recorded by RN 17:
- "H&P completed Yes; Interval H&P completed Yes." However, the interval note was not recorded until 0851, after the surgery was concluded.
- "Date of Last Oral Intake 01/04/18; Time of Last Oral Intake 0630." There was no documentation to reflect the surgeon or anesthesia was notified that the patient had consumed liquids less than two hours prior to the assessment. In addition, this assessment was recorded after the pre-anesthesia evaluation recorded at 0739 in which the CRNA recorded the patient's NPO status was verified.

* In addition, an Anesthesia Consent was signed by Patient 3, the "Date" recorded as "1/4/18" and "Time" recorded as "0745." The "Signature of Witness" was signed by an RN. The consent was not signed by the CRNA as required by the "Anesthesia Care of the Peri-Operative Patient" policy and procedure. This document did not clearly reflect a valid informed consent as the anesthesia evaluation, and therefore identification of patient specific risks, was conducted prior to nursing assessment which included vital signs and NPO status information.

* 01/04/2018 at 0811, Anesthesia was started less than two hours after the patient had last consumed liquids at 0630, inconsistent with policies and procedures.

* Findings in this record were confirmed during interview with the CWS at the time of the review on 03/21/2018 beginning at 0930.

5. The surgical log reflected that Patient 4 underwent a "Hysteroscopy D&C, IUD removal" under "general LMA" anesthesia on 02/01/2018. The closed medical record of Patient 4 was reviewed electronically with the hospital CWS.

* Review of the documentation revealed that the timeline of anesthesia events was unclear and contradictory to hospital policies and procedures.
- 0648 Patient arrived at hospital..
- 0735 Anesthesia consent signed.
- 0756 CRNA documented the pre-anesthesia evaluation, after the consent was signed.
- 0816 Anesthesia started.
- 0839 Surgery started.
- 0840 "Pre-operative timeout" conducted after anesthesia and surgery start.
- 0842 "Pre-incision timeout" conducted after surgery start and at the time the surgery stopped.
- 0842 Surgery stopped.
- 0850 Patient left the operating room.
- 0852 Patient in recovery room.
- 0907 "Before leaving surgical room timeout" conducted after patient left the operating room and was in recovery.

* On 02/01/2018 at 0756 , CRNA 8 filed and electronically signed an "Anesthesia Evaluation" for Patient 4. The evaluation reflected:
- "Patient summary reviewed. Nursing notes reviewed, Patient allergies reviewed and NPO status verified. No history of anesthetic complications.
- Airway Mallampati: II TM distance: [less than] 3 FB - Neck ROM: full
- Dental - normal exam Comment: Retainer with 'flipper' one tooth otherwise normal exam
- Pulmonary - negative ROS and normal exam breath sounds clear to auscultation
- Cardiovascular - normal exam Exercise tolerance: good Rhythm: regular Rate: normal
- Neuro/Psych (+) headaches, Pre-anesthetic state: awake and calm.
- GI/Hepatic/Renal [no information recorded]
- Endo/Other - negative ROS
- Abdominal (+) obese
- Anesthesia Plan ASA 2 general LMA (Procedure, Alternatives, Risks discussed, Questions answered. Discussed case with surgeon. Ready to proceed.) Intravenous induction Anesthetic plan and risks discussed with patient."

This documentation was filed and signed by the CRNA after the patient's consent had been obtained for anesthesia. The documentation does not reflect that all risks recorded in the evaluation were identified, assessed and discussed with the patient by the CRNA prior to the patient's signature on the consent. Further the evaluation was not complete as the "GI/Hepatic/Renal" section was blank.

* In addition, the Anesthesia Consent was signed by Patient 4, the "Date" recorded as "2-1-18" and "Time" recorded as "0735." The "Signature of Witness" was signed by RN 6. The consent was not signed by the CRNA as required by the "Anesthesia Care of the Peri-Operative Patient" policy and procedure. This document did not clearly reflect a valid informed consent as the anesthesia evaluation, and therefore identification of patient specific risks, was conducted prior to nursing assessment which included vital signs and NPO status information.

* Findings in this record were confirmed during interview with the CWS at the time of the review on 03/21/2018 beginning at 0930.

6. The open medical record of Patient 5 scheduled for a similar surgery on 03/22/2018, two days after the entrance date of this survey, was reviewed. The surgery "Master Daily Schedule" for the week of the survey reflected that Patient 5 was scheduled to undergo a "Hysteroscopy Vaginal Bso A&P, Cystoscopy" on 03/22/2018. The open medical record of Patient 5 was reviewed electronically with CRNA 8 on 03/20/2018 at 1540, and on 03/21/2018 at 1000 with the CWS.

* On 03/20/2018 at 1543, CRNA 8 electronically initiated and filed an "Anesthesia Evaluation" for Patient 5. The evaluation reflected:
- "Patient summary reviewed. Nursing notes reviewed and Patient allergies reviewed.
- Airway
- Dental
- Pulmonary (+) asthma
- Cardiovascular ECG reviewed
- Neuro/Psych (+) neuromuscular disease, , (sic) (+) depression
- GI/Hepatic/Renal
- Endo/Other (+) arthritis,
- Abdominal (-) obese
- Anesthesia Plan ASA 2 general endotracheal Intravenous induction Anesthetic plan and risks discussed with patient."

This documentation was documented by the CRNA two days prior to the patient's arrival. The "patient summary" section of the EHR reflected "No preprocedure extracts available to display." There was no indication of the "nursing notes" the CRNA referred to. There was also no indication of the ECG referred to that included the date of the test and an assessment of the results. Anesthetic plan and risks could not have been discussed with the patient as the patient was not scheduled to arrive at the hospital for two days. There was no documentation to reflect that the CRNA had physically evaluated the patient or communicated with the patient to complete the evaluation to ensure the plan was appropriate and that all actual risks identified were discussed.

* Findings in this record were confirmed during interviews with CRNA 8 and the CWS at the times of the reviews.

7. During an interview with the DQR, RDR, RCRM and the COO on 03/21/2018 at 1400 they confirmed that the pre-anesthesia assessment for Patient 2 was "minimal" and that the documentation didn't reflect the patient was evaluated prior to surgery. They confirmed that pre-anesthesia assessments were being done before patients were seen by the CRNA, and stated that all CRNAs have been counseled about appropriate practice. The DQR stated that the practice should be that the majority of the assessment should be done after the patient's arrival, with the exception of historical data and information. The patient's vital signs must be taken, NPO status confirmed, and a physical exam conducted before the evaluation is documented. In regards to NPO status they stated that the anesthetist has the final call whether it's ok to proceed if a patient has not been NPO as instructed. If the patient has not been NPO for two hours prior to start the CRNA should document an assessment including all considerations and communications with the patient about the plan and the next steps.

Based on interview, review of medical records for 4 of 4 patients who underwent surgery and anesthesia (Patients 1, 2, 3, and 4), review of the medical record of 1 of 1 patient who was scheduled for surgery and anesthesia (Patient 5), and review of policies and procedures it was determined that the CAH failed to implement an effective quality assurance program that ensured the provision of appropriate and safe surgical services and anesthesia services.

The failures identified during the survey reflect the CAH's limited capacity to provide safe and appropriate care and services, and represent a Condition-level deficiency of CFR 485.641, Condition of Participation: Periodic Evaluation and Quality Assurance Review.

Findings include:

Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services.