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Based on interview, review of 2 of 4 contracts reviewed (OAG and Waveform), review of documentation in 4 of 5 medical records of patients who received anesthesia services (Patients 1, 10, 11 and 12), and review of policies and procedures it was determined that the hospital failed to ensure the contractors of services furnished those services in a manner that permitted the hospital to comply with all applicable CMS requirements.

Findings include:

1. A written contract for anesthesia services between PPMC and the Oregon Anesthesiology Group, P.C. (OAG) was signed and dated by both parties on 05/01/2016.

A "Medical Director Performance Management Program - 2017 Bonus Incentive Compensation" form reflected that the PPMC OAG Anesthesia Medical Director's performance was evaluated on 06/23/2018. In addition, "Regional OB Anesthesia Medical Director Objectives" and "Regional Pediatric Anesthesia Medical Director Objectives" forms reflected that the performances of those "regional" Medical Directors were evaluated in 2018. However, there was no other documentation to reflect that the anesthesia services rendered in the hospital to inpatients and outpatients were evaluated since 05/01/2016 to determine whether they were provided in a manner to ensure the hospital complied with the CMS requirements.

* Refer to the findings identified under Tag A1002, CFR 482.52(b), Delivery of Anesthesia Services, that reflects a lack of clear and complete written policies and procedures for anesthesia services, including pre-anesthesia evaluations.

* Refer to the findings identified under Tag A1003, CFR 482.52(b)(1), Pre-Anesthesia Evaluation, that reflects those evaluations were not completed in a timely manner prior to the start of anesthesia.

2. A written contract for "Transportable Health Care Services" between PPMC and Wave Form Systems, Inc. was signed and dated by both parties in November 2016. Services provided under the contract were Holmium Laser System, Cyber TM Laser System and Cryocare Surgery Systems.

There was no documentation to reflect that the services provided under this contract had been evaluated since November 2016. During interview with the CEO and other executive staff at the time of the contract review on 01/25/2019 at 1140 they indicated there was no documentation of formal review of the contracted service.

Based on interview, review of grievance documentation for 4 of 10 patients selected from the grievance log (Patients 25, 27, 28 and 29) and review of policies and procedures, it was determined that the hospital failed to fully develop and enforce written policies and procedures to ensure that a written grievance notice was provided to patients/patients' representatives in response to their grievances and that it contained all the required elements. Written notices were not provided, or they contained unclear information and lacked the steps taken on behalf of the patient to investigate the grievance.

Findings include:

1. The policy and procedure titled "Patient Complaints and Grievances" dated as last revised "04/2018" included the following direction:
* "In the written response to the patient/patient's representative, the following elements will be included: A. Steps taken to investigate the grievance..."
* "A written response to the patient or patient's representative applies to all grievances."

2. The "Providence Feedback Administrator Form...Formal Grievance" form for a grievance submitted by Patient 25 on 11/19/2018 alleged a nurse "slapped" the patient's hand. The documentation reflected he/she received a written response to the grievance in a letter dated 05/31/2018, six (6) months prior to receipt of the grievance. The copy of the letter referred to the patient's grievance as related to an event on 11/27/2018, a date eight (8) days after the grievance was submitted. Further, the letter did not include the "steps taken to investigate the grievance" as required by the regulation and the hospital's policy and procedure. In relation to the investigation of the potential abuse the letter stated only "Since receiving your information, our team has completed an internal review..." There was no specific information about the steps of the investigation.

3. The "Providence Feedback Administrator Form...Formal Grievance" form for a grievance submitted by Patient 27 on 11/26/2018 included complaints about "rough handling" by staff. The documentation reflected he/she received a written response to the grievance in a letter dated 11/26/2018, the date the grievance was received. The copy of the letter reflected that the grievance had been received verbally on 11/21/2018. The letter did not include the "steps taken to investigate the grievance" as required by the regulation and the hospital's policy and procedure. In relation to the investigation of the "rough handling" the letter stated only "...we have investigated and discussed the concerns you raised regarding your experience in Critical Care..." There was no specific information about the steps of the investigation.

4. The "Providence Feedback Administrator Form...Formal Grievance" form for a grievance submitted by Patient 28 on 12/07/2018 reflected "Patient upset about treatment by RN." The allegations were described further in the grievance and included "...lack of privacy during [catheterization] procedure...procedure was painful and the RN just shoved the catheter in...put in restraints...phone taken away..." The documentation reflected the grievance was closed on 12/07/2018 and a written notice in response was not generated or sent to the patient.

5. The "Providence Feedback Administrator Form...Formal Grievance" form for a grievance submitted by Patient 29 on 12/13/2018 alleged "rough handling." The documentation reflected he/she received a written response to the grievance in a letter dated 12/26/2018. The copy of the letter did not include the "steps taken to investigate the grievance" as required by the regulation and the hospital's policy and procedure. In relation to the investigation of "rough handling" the letter stated only "Since receiving your information we have completed a review of the care provided in relation to your feedback and experience." There was no specific information about the steps of the investigation.

6. The findings for Patients 25, 27, 28 and 29 were confirmed during interview with the RM at the time of the review on 01/23/2019 beginning at 1210.

Based on observations, interviews, review of incident/event and medical record documentation for 1 of 3 patients (Patient 20) and review of policies and procedures it was determined that the hospital failed to fully develop and enforce written policies and procedures to ensure that all components of an effective abuse prevention program were evident, including clear and complete investigations of abuse or neglect, as defined by CMS, to ensure those incidents and events did not recur.

The CMS Interpretive Guideline for this requirement at CFR 482.13(c)(3) reflects "Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Findings include:

1. Review of the medical record of Patient 20 reflected that he/she presented to the ED on 11/02/2018 at 1158 by ambulance. The record reflected the following sequence of events in the ED:
* On 11/02/2018 at 1201 RN "ED Triage Notes" reflected "Per EMS - pt from Barbara West House, has chronic mental illness...increasingly agitated, disorganized, verbal aggression, increased delusions...Acuity...Emergent."
* "Cascadia Behavioral Healthcare Face Sheet" dated 12/20/2017 included the patient's demographic, mental health facility and contact information, provider and other information. The "Major Medical Concerns" section of the form reflected "[Patient] sometimes experiences constipation and impacted bowels. [Patient] has been known to ingest non-food items such as batteries and coins which can become lodged inside [him/her] and exacerbate bowel obstruction."
* On 11/02/2018 at 1238 an RN "Safety Assessment" note reflected "Belongings Searched...key, pants, socks, shirt, pt has calculator with [him/her]."
* On 11/02/2018 at 1244 an RN "Patient Belongings" note reflected "Jewelry - Ring; Secured on Unit...Clothing - Pant; Shirt; Secured on Unit...Other Valuables - Keys; Secured on Unit."
* On 11/02/2018 at 1312 QMHP "ED Notes," and on 11/02/2018 at 1430 an Adult Psychiatrist Consult note, identically reflected "Patient has history of ingesting non food objects such as batteries (this gives [patient] 'power'), paper, small loose items. [Patient] uses [his/her] calculator to 'talk to God' per care home but also needs to be observed as [he/she] will try to eat the keys from [his/her] calculator...history of self harm in form of swallowing non food items."
* On 11/02/2018 at 1354 a QMHP "Ready for BH" note reflected "risk for swallowing things and risk for adgitation (sic)...patietn (sic) uses a calculator to talk to God, some concern if not watched [he/she] will eat the keys."
* On 11/02/2018 at 1548 RN "ED Quick Notes" reflected "PT grabbed at Rn (sic) and took ativan shot away and threw it out of room..."
* The following day, on 11/03/2018 at 0747 RN "ED Quick Notes...Audit Information" reflected "per noc RN pt attempted to put ring in mouth and swallow it. states pt put ring on finger and hasn't attempted to swallow since. called for security for standby while I attempted to take ring from pt. pt refused to give me the ring and quickly put it in [his/her] mouth and swallowed it. MD notified"
* On 11/03/2018 at 0807 CNA "ED Quick Notes" reflected "While in x-ray pt became combative with sitter and the two techs (hitting, kicking, yelling, ripping off badge). The techs could not finish x-ray so pt was taken back to [his/her] ED room...personal possessions in reach; sitter at bedside..."
* On 11/03/2018 at 0858 RN "ED Quick Notes" reflected "attempted to give pt [his/her] medication. pt slapped medication and water our (sic) of hand. security at bedside..."
* On 11/03/2018 at 1133 a Gastroenterologist Consult reflected "The patient was seen putting a ring into [his/her] mouth and then later the ring was not seen on the patient. A CXR reveals that the ring is now in [his/her] esophagus. [Patient] has a history of ingesting foreign objects and has undergone an EGD for ingesting AA battery 5/20/14...and coins leading to a colonoscopy 1/19/17..."
* On 11/03/2018 at 1150 RN "ED Quick Notes...Audit Information" reflected "...took pt's bracelet off and placed it in [his/her] belongings..."
* On 11/03/2018 at 1245 "ED Provider Notes" reflected "At approximately 7:30 AM, the patient swallowed a ring...We were able to have the radiograph performed which shows an esophageal foreign body...Case was discussed with [gastroenterologist] who will take the patient to the endoscopy suite."
* On 11/03/2018 at 1256 an RN "Sedation Documentation" note reflected "Patient's ring retrieved during endoscopy, sent with Avery (sercurity (sic) officer)."
* On 11/03/2018 the "Patient Belongings" section of the EHR reflected "No documentation."
* On 11/04/2018 at 1135 a "Phlebotomy/Bedside Testing" note reflected "Verified By...Hospital ID Bracelet."
* On 11/04/2018 the "Patient Belongings" section of the EHR reflected "No documentation."
* On 11/05/2018 the "Patient Belongings" section of the EHR reflected "No documentation."
* On 11/05/2018 at 1211 "ED Notes" reflected that Patient 20 was transferred from the ED to a hospital with a psych bed not available at PPMC.

2. Review of incident documentation reflected an incident that involved Patient 20 was reported through the hospital reporting system on 11/03/2018 at 1133 for an incident that occurred on 11/03/2018 at 0732 in the ED. The documentation included the following:
* "Event Type - Behavior."
* "Event Category - Destructive Behavior."
* "Description...took over pt assignment in the morning. In report I was told by the night shift RN that pt has hx of pica and swallowing objects. per noc RN pt was playing with ring and putting it in [his/her] mouth during the night. states pt put ring on [his/her] finger and hadn't played with it since. noc rn states [he/she] did not take ring away from [Patient 20]. called security and attempted to take ring away from pt when. (sic) pt pulled off [his/her] ring and quickly placed it in [his/her] mouth and swallowed it."
* "Harm Level...Moderate Harm...Temporary Harm / Required Initial or Prolonged Hospitalization."
* "Was there a deviation from generally accepted performance standards...Yes; Did it reach the patient? - Yes."
* "Follow Up Notes...11/06/2018...Patient had to undergo an endoscopy procedure and required additional monitoring."
* "Actions Taken...11/06/2018...Follow up with RNs involved with this patient's care prior to...this incident happening. Coaching and counseling performed, as this ring should have been removed much earlier in the patient's stay. immediately take small objects away from pt's that have history of swallowing."
* "Failure Mode...Individual Failure Mode."

There was no documentation dated after 11/06/2018 and no other documentation of investigation or actions.

The incident documentation did not reflect a clear and complete investigation to identify contributing factors, evaluation of implementation or adequacy of procedures, causes, specific failures, specific actions to prevent recurrence, etc. For example:
* The documentation did not reflect an "Event Type" or "Event Category" that characterized the incident.
* There was no "Follow Up" investigation documentation to reflect what specific failures were identified and when those failures occurred for this patient with a clear history of swallowing objects. The only reference was under "Actions Taken" and was "ring should have been removed much earlier..."
* There was no documentation to reflect evaluation of the lack of clarity and completeness related to personal belongings documentation that reflected, for instance, that the ring was "secured on unit" versus the documentation that the patient was wearing a ring that he/she eventually swallowed.
* There was no evaluation of the personal belongings and behavior management policies and procedures to determine whether the directions were clear, complete and followed.
* There was no evaluation of the staff's failure to mitigate further risk to prevent the patient access to items that he/she could use to swallow or self-harm. Those items were: A "bracelet" that was not documented as removed for 4 hours after he/she swallowed the ring; A filled syringe that the patient grabbed from an RN; A badge that the patient ripped off a staff person; An ID Band on the patient; and a calculator with keys identified as a risk that remained in the patient's possession.
* There was no documentation to reflect the lack of documentation by the night shift RN who verbally reported to the oncoming day shift RN the patient's behaviors that included putting the ring in his/her mouth during that shift.
* Although the documentation reflected the incident was result of an "individual failure mode" the "actions taken" reflected that "RNs," more than one, were involved. Further, the medical record reflected a number of staff involved in the patient's care from entry to the ED, including the QMHP and physicians, had awareness of the history and failed to ensure the patient did not have access to items he/she could swallow.
* There was no documentation to reflect what specific "coaching and counseling" was performed and specifically for who.

3. a. The policy and procedure titled "Abuse Identification and Intervention" dated as last revised "09/2017" reflected the following:
* "Definitions" for "Abuse of Mentally Ill or Developmentally Disabled Persons" included "Neglect which includes...Failure to provide the care, supervision, or services necessary to maintain the physical and mental health of a person with a developmental disability that results in actual harm or creates a significant risk of physical harm or significant emotional harm...Such failure may occur whether due to passive or active neglect, or through negligent omission or negligent treatment..."
* "Process, Reporting and Documentation of Patient allegations of abuse or harassment involving Providence Health and Services staff...Manager of notified staff immediately contacts QM and/or Human Resources who will together begin the Patient Abuse Allegation Process Flow...Involved caregiver is taken out of direct contact with the patient. Caregiver will be placed on paid administrative leave at the discretion of the investigation team utilizing the Patient Abuse Allegation Process Flow...Begin investigation - coordinated by QM and HR."

The policy did not reflect the CMS definition of abuse, that included neglect, as reflected in the deficiency statement above. Nor did the policy include provisions to exclude neglect events from the delineated process.

b. The policy and procedure titled "Unusual Occurrence Reporting" dated as last reviewed "10/2018" reflected the following:
* "Objectives...To facilitate the identification of preventable adverse events, near misses and problem prone processes."
* "The [incident documentation] will be reviewed by the unit manager or department head (or designee) who is responsible to investigate the situation, take actions as indicated, follow-up with applicable staff, and document their findings on the [incident documentation] This individual also reviews the [incident documentation] for completeness and accuracy, and submits the completed record within 14 days."

The policy did not include procedures to ensure clear and complete investigations that identified causes and ensured clear and complete plans for corrective actions to prevent recurrence of adverse events that resulted from neglect as defined by hospital policy and this CMS regulation.

4. The medical record and incident documentation for Patient 20 was reviewed with the RDA, DoN, QR and HRBA on 01/24/2019 at 1000 and no additional information was provided.

Based on observation, interview and review of policies and procedures it was determined that the hospital failed to ensure that policies and procedures for safe food handling were fully developed and enforced. Food storage and kitchen cleaning practices were inconsistent and not effective.

Findings include:

1. The policy and procedure titled "Receiving and Food Storage" dated as last reviewed on "11/18" included the following direction:
* "All food is stored in a manner, which protects it from contamination and spoilage."
* "Food, whether raw or prepared, that has been removed from its original container, is stored in a clean, covered, labeled and dated container, except during periods of preparation or service."
* "Container covers are impervious and nonabsorbent...Such foods are dated with the date it was opened."
* "Bulk food such as cooking oil, syrup, salt, sugar or flour that is not being stored in the original product container, are stored in a labeled container identifying the food by common name and date. All scoops are stored outside of the food container/original bulk packaging."

2. During a tour of the kitchen with the PDM and other staff on 01/23/2019 beginning at 1135 observations were made that included, but were not limited to:

a. In the dry food storage room:
* Surfaces on metal shelving had rusted, degraded and corroded areas.
* Dried and sticky spills, and food and packaging debris were present on shelving surfaces.
* A large, clear plastic rigid container of "Quinoa," as handwritten on an attached label and that was not in its original manufacturer's packaging, had a "Prepared Date:" on the label handwritten as "3/13/18." The "Use By:" date and "[Employee]" spaces on the label were blank.
* A second large, clear plastic rigid container of "Quinoa," as handwritten on an attached label and that was not in its original manufacturer's packaging, had a "Prepared Date:" on the label handwritten as "9-28." The "Use By:" date and "Time" spaces on the label were blank.
* A large, clear plastic rigid container of an unidentified dry, loose oat or grain type food product, that was not in its original manufacturer's packaging, had no labeling. A food scoop was placed on top of the container. The top of the container, the shelving on which the container was located and the shelving below were covered with spills and particles of that food product.
* A clear plastic bag of white dried beans that had been opened was observed with no labeling.
* Cardboard boxes of black beans and lentils were observed to be open and the black beans and lentils inside the boxes were uncovered and unprotected.

b. In the walk-in freezers:
* Surfaces on the metal floors had areas covered with pieces of ice, pieces of food and packaging, and a build-up of dirt and debris.
* Food products stored in clear plastic bags had no labels and were open, leaving the food product unprotected. For example: Cookies, and food product described by staff at the time of the observation as "salmon scraps."
* Metal containers that contained food products and were loosely covered with pieces of plastic wrap, had labels attached that were not completely or clearly filled out. For example: A container of "Honey butter" as handwritten on the label had a "Prepared Date:" of "4/4" and in the "Use By:" date space the symbol for "none," a 0 with a line through it, was written.

c. In the refrigerator:
* A cart was observed with four trays of frozen meat patties, covered with ice, that were thawing as described by staff during the observation. The meat patties were uncovered and unprotected.

d. In the main kitchen area the large Hobart standing mixer was observed to have debris on it, and had rusted and degraded surfaces. A large garbage can on wheels was located immediately next to the mixer.

Based on interview, review of documentation in 4 of 5 medical records of patients who received anesthesia services (Patients 1, 10, 11 and 12), review of a contract for anesthesia services and review of policies and procedures it was determined that the hospital failed to develop and enforce clear and complete written policies and procedures for the provision of anesthesia services.

Findings include:

1. On 01/24/2019 at 0910 the DoQ provided page 79 of the "Policies and Procedures" of the "Professional Staff" and a document titled "V. Safe Surgery Checklist for: Non-Operating Room Settings." The DoQ stated that those were the hospital's policies and procedures for anesthesia services. At 1630 on that date the DoQ further confirmed that there were no other PPMC anesthesia services policies and procedures.
* Page 79 of the "Policies and Procedures" of the "Professional Staff" dated as revised 05/28/2018 contained the following section: "Anesthesia Record: The medical record of patients receiving anesthesia, with the exception of local only, shall include: A record of the pre-anesthesia patient visit; The anesthesia record; and A record of the post-anesthesia patient visit or evidence that the patient meets discharge criteria as set by the Anesthesia services. All parts of the anesthesia record must be signed by the appropriate Member."
* The undated "V. Safe Surgery Checklist for: Non-Operating Room Settings" document reflected in referenced to pre-anesthesia evaluations: "The RNs in the Pre-procedure area and the Procedure room lead the confirmation of the Briefing items on the Safe Surgery Checklist...All Checklist elements will be addressed before the start of the procedure. The following are suggested elements of a briefing checklist for all Procedural Areas. The circulating Nurse (or equivalent) will lead a confirmation of the following:...Pre-sedation or Pre-Anesthesia Note. (If Moderate Sedation or Anesthesia is planned)."

2. The policy and procedure titled "Universal Protocol for Invasive Procedures" was dated as last reviewed "12/2018" and reflected:
* "Safe Surgery Checklist for Operating Room Areas...Confirmation of Briefing elements may begin in the pre surgery areas. In the Operating Room, the Circulating RN will lead the confirmation of all remaining elements of the Briefing portion of the Safe Surgery Checklist. All Surgery Team members will cooperate fully with the Circulating RN, and all Checklist elements will be addressed prior to surgery start. The following are suggested elements of a briefing checklist for all Operating Room Settings: The circulating RN will lead confirmation of the following:..Pre-Anesthesia Note."

3. The policy and procedure titled "Deep Sedation - Procedure Related by Non-Anesthesiologist Physicians" was dated as last reviewed "10/2018" and reflected:
* "This policy is effective in all care/service areas whenever a non-anesthesiologist physician orders procedure-related deep sedation. This policy does not apply to anesthesiologists or CRNAs...Whenever deep sedation is administered, a physician privileged in deep sedation must be present, at the patient's bedside, during administration of sedation. A deep sedation credentialed registered nurse must be in attendance when deep sedation is administered."

Although the Anesthesia Services CoP at CFR 482.52 reflected that anesthesia services governed by the CoP included MAC, and that Deep Sedation is included in MAC, the policy and procedure reflected it did not apply to anesthesiologists or CRNAs and there was no other MAC or Deep Sedation policy and procedure provided.

4. During interview with the DCA on 01/25/2019 at 1520 he/she stated that PPMC anesthesia services, with the exception of nurse administered conscious sedation, were provided under a contract by the OAG. He/she confirmed that the anesthesia services policies and procedures consisted of those identified under findings 1 and 2 above.

5. The policy and procedure of the OAG titled "Medical Record Documentation" dated as last revised 01/16/2017 was provided. Although that policy and its attachment "Exhibit A ASA Statement on Documentation of Anesthesia Care" identified content of pre-anesthesia evaluations, intraoperative anesthesia care, and post-anesthesia evaluations it contained no timeframes or processes related to when and how those were to be completed and documented.

6. The contract between PPMC and the OAG for anesthesia services was signed and dated 05/01/2016 and included the following:
* Anesthesia services provided by OAG included General Anesthesia, Regional Anesthesia, MAC services, etc.
* An obligation for OAG to "Perform and document a valid pre-anesthesia evaluation and anesthetic plan on the day of surgery...on all patients prior to surgery."
* An obligation for OAG to "Perform postoperative evaluations on all in-patients after surgery."
* The contract also stated that "The following anesthesia services are not part of the exclusive arrangement: Anesthesia services provided to Kaiser Permanente patients/members."

The contract failed to specify pre-anesthesia and post-anesthesia evaluation timelines and processes, and intra-operative anesthesia processes to ensure the hospital's compliance with the Hospital CMS CoPs.

7. During interview with the DoQ, the DoN, the RDA and the DCA on 01/25/2019 at 1550 they confirmed that there were no PPMC or Regional Providence anesthesia services policies and procedures.

8. Refer to the findings identified under Tag A1003, CFR 482.52(b)(1), Pre-Anesthesia Evaluation, that reflects those evaluations were not completed in a timely manner prior to the start of anesthesia.

Based on interview, review of documentation in 4 of 5 medical records of patients who received anesthesia services (Patients 1, 10, 11 and 12) and review of policies and procedures it was determined that the hospital failed to develop and enforce clear and complete written policies and procedures to ensure appropriate pre-anesthesia evaluations were completed and documented within 48 hours prior to the delivery of the first dose of medication(s) for the purpose of inducing anesthesia:
* Physical exam, NPO status verification and other components of pre-anesthesia evaluations were documented prior to the patient's arrival to the hospital and prior to being seen and examined by the anesthesiologist.
* Pre-anesthesia evaluations were completed and documented after anesthesia start, anesthesia induction, first surgical incision and after completion of the surgery.

Findings include:

1. The medical record of Patient 1 reflected that he/she underwent a "Right S I Joint Infusion" under general anesthesia on 10/01/2018 as an outpatient. The record reflected the following in regards to the pre-anesthesia evaluation:
* On 09/29/2018 at 0802, two days prior to the outpatient surgery the "Preanesthesia Evaluation" was completed and signed by the anesthesiologist, including the "Physical Exam" section of the evaluation. Documentation on the evaluation included the following:
- "Medical history, anesthesia, medications, allergy, NPO status verified, histories reviewed. Labs reviewed."
- "Airway MP II, Neck: full ROM. Dental Grossly normal except where noted below.; CV Rhythm regular. Rate Normal. Pulm Clear to auscultation bilaterally. Neuro Grossly normal."
- "Anesthesia Plan - ASA 3 Type: General...Potential problems: None anticipated. Monitors: Standard ASA monitors. Consent statement: PARQ.
* On 10/01/2018 at 0759, two days later and after the start of anesthesia, the pre-anesthesia evaluation originally dated 09/29/2018 at 0802 was signed again as an "addendum" by the anesthesiologist. The documentation reflected that there were no changes made to the evaluation documented two days prior.
* The 10/01/2018 surgical "Case Tracking Events" and notes included the following timeline:
- 0718 Anesthesia Start.
- 0729 In Room.
- 0730 Induction.
- 0758 First Incision/Proc Start.
- 0759 Pre-anesthesia evaluation "addendum" dated and signed by anesthesiologist, after anesthesia induction and first surgical incision.
- 0846 Procedure Close.
- 0854 Out of Room.
- 0903 Anesthesia Stop.

There was no documentation to reflect that the anesthesiologist examined the outpatient in person on 09/29/2018 when he/she documented the pre-anesthesia evaluation in its entirety, 48 hours prior to surgery and anesthesia start on 10/01/2018. Further, the documentation reflected that the "addendum" was signed at 0759, after the anesthesia start at 0718, and after the first incision of the surgical procedure at 0758.

These findings were confirmed with the DoN and surgical services staff during the review on 01/24/2019 at 1445.

2. The medical record of Patient 10 reflected that he/she underwent a "Laryngoscopy...Emergent Intubation...Emergent Neck Exploration..." under general anesthesia on 01/18/2019. The record reflected the following in regards to the pre-anesthesia evaluation:
* The "Preanesthesia Evaluation" was dated and signed on 01/18/2019 at 1524.
* The 01/18/2019 surgical "Case Tracking Events" and "Anesthesia Events" notes included the following timeline:
- 1205 Anesthesia Start.
- 1210 In Room.
- 1216 Induction.
- 1229 First incision/Proc Start.
- 1445 Procedure Close/End.
- 1457 Out of Room.
- 1510 Anesthesia Stop.
- 1522 "Postanesthesia Evaluation" dated and signed by anesthesiologist.
- 1524 Pre-anesthesia evaluation dated and signed by anesthesiologist, after the surgery was completed and after the post-anesthesia evaluation.

During interview with the the DoN and surgical services staff at the time of the review on 01/25/2019 at 1205 they confirmed that the pre-anesthesia evaluation was completed and documented after the surgical procedure was completed for this emergency case.

3. The medical record of Patient 11 reflected that he/she underwent a "Open abdominoperineal resection...Cystoscopy..." under general anesthesia on 01/21/2019. The record reflected the following in regards to the pre-anesthesia evaluation:
* The "Preanesthesia Evaluation" was dated and signed on 01/21/2019 at 0823.
* The 01/21/2019 surgical "Case Tracking Events" and "Anesthesia Events" included the following timeline:
- 0735 Anesthesia Start.
- 0740 In Room.
- 0748 Induction.
- 0823 Pre-anesthesia evaluation dated and signed by anesthesiologist, after anesthesia start and induction.
- 0846 First incision/Proc Start.
- 1403 Procedure Close/End.
- 1406 Out of Room.
- 1410 Anesthesia Stop.

During interview with the DoN and a NM at the time of the review on 01/22/2019 at 1625 they confirmed they were unable to find documentation to reflect that the pre-anesthesia evaluation was completed and documented before the anesthesia start time.

4. The medical record of Patient 12 reflected that he/she underwent a "Left brachial artery exposure...Open repair of left femoral arteriotomy" under general anesthesia on 01/22/2019. The record reflected the following in regards to the pre-anesthesia evaluation:
* The "Preanesthesia Evaluation" was dated and signed on 01/22/2019 at 1359.
* The 01/22/2019 surgical "Case Tracking Events" and "Anesthesia Events" included the following timeline:
- 1132 Anesthesia Start.
- 1207 Induction.
- 1210 In Room.
- 1234 First incision/Proc Start.
- 1359 Pre-anesthesia evaluation dated and signed by anesthesiologist, after anesthesia induction and first surgical incision.
- 1627 Procedure Close/End.
- 1638 Out of Room.
- 1656 Anesthesia Stop.

These findings were confirmed at the time of the review with the DoN on 01/25/2019 at 1250.

5. During interview with CoS and the AMD on 01/24/2019 at 1540 they indicated that there was a case in which pre-anesthesia evaluation findings may have been entered the night before the surgery from someone else's physical exam information. They indicated that generally some history information from previous surgical procedures may be entered into the electronic pre-anesthesia evaluation form prior to seeing the patient and the note then "pended." They further stated that findings from a previous physical exam may also be entered in advance and if those findings are consistent with the physical exam when the patient is seen and examined the day of the procedure the documentation wouldn't be changed.

The CoS stated that he/she thought the hospital's policies were clear and appropriate.

6. During interview with the DCA on 01/25/2019 at 1520 he/she stated that pre-anesthesia evaluations are "supposed to be done before administering anesthetic" and further stated that the pre-anesthesia evaluation documentation should be complete before the patient enters the OR. The DCA indicated that the pre-anesthesia evaluation documentation in the EHR can start "anytime we start to review the chart, generally the day before" the procedure. He/she stated that the anesthetic plan can be documented "before hand" and indicated that the physical exam should be documented at the time the patient is seen and examined. The DCA stated that "the general expectation is you document a note when you actually do the exam." The DCA further stated that he/she was not aware that the practice of documenting the physical exam before the patient was seen was "widespread."

7. Refer to the findings identified under Tag A1002, CFR 482.52(b), Delivery of Anesthesia Services, that reflects a lack of clear and complete written policies and procedures for anesthesia services, including pre-anesthesia evaluations.