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206 EAST BROWN STREET

EAST STROUDSBURG, PA 18301

MEDICAL STAFF BYLAWS

Tag No.: A0353

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure a qualified practitioner ordered Sevoflurane, a general anesthetic for one of one medical record reviewed (MR1).

Findings:

Review on October 5, 2020, of the facility document, "Lehigh Valley Hospital - Pocono Medical Staff Bylaws," last revised September 20, 2019, revealed "... Rules And Regulations A. Orders All orders for medication or treatment shall be in the E M R [electronic medical record]. Verbal orders for medication or treatment are acceptable under urgent circumstances when it is impractical for such orders to be given in writing by the responsible practitioner. Oral orders shall be taken only by the following personnel: a practitioner, a professional nurse, a licensed practical nurse, a pharmacist (who may take oral orders pertaining to drugs only), a physical therapist (who may take oral orders pertaining to physical therapy regimens only), a respiratory therapist (who may take oral orders pertaining to a respiratory therapy regimens only), and a paramedic providing emergency paramedic services. All oral orders shall be transcribed in the proper place in the patient's medical record. Transcribed orders shall include the date and time of the order and shall be signed by the transcriber, with the name of the practitioner also indicated. The practitioner shall authenticate the transcribed order within seven (7) days (or prior to the patient discharge, whichever is earlier) and date and time them. If the practitioner is not the attending physician, he must be authorized by the attending physician and must be knowledgeable about the patient's condition. Orders shall be entered only by Practitioners acting within the scope of their respective licenses and as credentialed according to the Medical Staff Bylaws. All orders shall be entered in the proper manner in the medical record of the patient and shall include the date, time and the signature of the person giving the order. ..."

Review on October 5, 2020, of MR1 revealed nursing documentation MR1 was under a general anesthetic, Sevoflurane, from approximately 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. MR1 did not contain documentation of a physician order for the administration of Sevoflurane.

Interview on October 5, 2020, with EMP2 and EMP3, at approximately 10:50 AM, confirmed MR1 was under a general anesthetic, Sevoflurane, from approximately 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. EMP2 and EMP3 confirmed MR1 did not contain documentation of a physician order for the administration of Sevoflurane.

MEDICAL STAFF PRIVILEGING

Tag No.: A0355

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure providers practiced within their delineated privileges for two of six credential files reviewed (CF2 and CF3).

Findings:

Review on October 5, 2020, of the facility document, "Lehigh Valley Hospital - Pocono Medical Staff Bylaws," last revised September 20, 2019, revealed " ... Article II - Purposes And Responsibilities ... Section B - Responsibilities 1. Membership on the Medical Staff implies a responsibility and obligation consistent with full cooperative participation in all required and necessary activities for the assessment and improvement of the effectiveness and efficiency of medical care provided in the Hospital, including but not limited to: ... 2. Each member of the Medical Staff shall: a) Provide his patients with the best possible quality of care consistent with the circumstance of each case; b) Abide by these Bylaws Rules and Regulations, Department Rules and Regulations and Hospital Policies; ... Article X - Clinical Privileges Section A - Delineation Of Clinical Privileges 1. Medical Staff membership and Medical Staff appointment entitles a practitioner to exercise only those clinical privileges specifically granted to him/her by the Board of Directors upon the report and recommendation of the appropriate Department Chief(s), Credentials Committee and Medical Executive Committee. The privileges delineated will be based upon the criteria developed by the appropriate Department(s) and the Medical Executive Committee. Clinical privileges are granted only by the Board of Directors. Each practitioner's clinical privileges shall be specified in the Notice of Appointment/Reappointment directed to the practitioner by the President pursuant to Article IX. 2. Each initial application for Medical Staff appointment and each application for reappointment for the appropriate Medical Staff categories must contain a request for specific privileges desired by the applicant. All determinations as to the delineation of clinical privileges shall be based upon evidence of current licensure, the applicant's education, training and experience, demonstrated current competence and current health status, and such other information as may be deemed pertinent including consideration of professional performance, judgment, skills, and knowledge as reflected in peer recommendations, termination of privileges at other hospitals, challenges to licensure or registration, the status of his continuing education, timely, complete, accurate, clear and legible entries in medical records, participation in hospital and medical staff affairs and performance improvement activities, working relationships with medical colleagues and others in the Hospital, and other reasonable indications of continuing qualifications, and shall include an appraisal and recommendation to the Credentials Committee by the appropriate Department Chief(s) with respect to each individual privilege requested. ..."

Review on October 5, 2020, of MR1 revealed a nurse's note dated and timed September 26, 2020, at 6:29 PM. There was nursing documentation MR1 was experiencing difficulty breathing due to asthma and required manual assistance breathing from respiratory staff. There was nursing documentation CF2 reached out to anesthesia to put the patient under general anesthesia.

Continued review of MR1 revealed a nurse's note dated and timed September 26, 2020, at 6:57 PM. There was nursing documentation anesthesia staff were at MR1's beside and showed CF2 and the primary nurse how to administer and work the anesthesia machine. There was nursing documentation the primary nurse refused to administer anesthesia and CF2 was made aware.

Continued review of MR1 revealed a nurse's note dated and timed September 26, 2020, at 7:31 PM. There was nursing documentation anesthesia staff refused to stay with the patient and administer the anesthesia. There was nursing documentation CF2 and the nursing supervisor were made aware. There was nursing documentation CF2 stated they were using the general anesthesia as a bronchodilator and they would take full coverage for administering anesthesia. There was nursing documentation CF3 would cover for CF2 once CF3 left for the evening.

Continued review of MR1 revealed a physician progress note dated and timed September 26, 2020, at 7:32 PM. CF2 documented MR1 was started on Sevoflurane with air and oxygen mixture through an anesthesia machine to achieve better bronchodilation. CF2 documented the ventilator part will be monitored by the respiratory therapist and CF3 under their supervision.

Interview on October 6, 2020, with EMP6, at approximately 9:55 AM, revealed EMP6 was the primary nurse for MR1 on September 26, 2020. EMP6 revealed MR1 was experiencing respiratory failure. EMP6 revealed CF2 called anesthesia to administer Sevoflurane (a general anesthetic, inhalation agent) in order to bronchodilate MR1. EMP6 revealed CF5 and CF6 came to the Intensive Care Unit (ICU) with an anesthesia machine and showed EMP6 and CF2 how to administer Sevoflurane and use the anesthesia machine. EMP6 revealed they did not feel qualified to administer general anesthesia and explained that to CF5 and CF6. EMP6 revealed CF5 and CF6 refused to stay with MR1 while they received the Sevoflurane and left the ICU.

Interview on October 6, 2020, with EMP7, at approximately 10:09 AM, revealed EMP7 was the ICU Charge Nurse on September 26, 2020. EMP7 revealed she recalled CF5 and CF6 came to the unit around 7:00 PM with an anesthesia machine to administer Sevoflurane. EMP7 stated she had never seen that done before and called the nursing supervisor to ask who was responsible for administering the general anesthetic and monitoring the patient. EMP7 explained after CF5 and CF6 set up the anesthesia machine they left the ICU.

Interview on October 6, 2020, with CF5, at approximately 12:30 PM, confirmed CF5 and CF6 set up the anesthesia machine and administered Sevoflurane to MR1 on September 26, 2020, in the ICU. CF5 confirmed CF5 and CF6 left the ICU after setting up the anesthesia machine. CF5 confirmed CF5 and CF6 did not stay and monitor the patient while receiving Sevoflurane. CF5 revealed the Sevoflurane was being administered under CF2.

Review on October 5, 2020, of CF2 and CF3, revealed these providers did not have privileges to administer general anesthesia via an anesthesia machine.

Interview on October 5, 2020, with EMP8, at approximately 11:00 AM, confirmed CF2 and CF3 did not have privileges to administer general anesthesia via an anesthesia machine.

Interview on October 6, 2020, with OTH6, at approximately 1:30 PM, confirmed CF2 and CF3 did not have privileges to administer general anesthesia via an anesthesia machine. OTH6 confirmed CF2 and CF3 practiced outside of their privileges by taking responsibility for the administration of Sevoflurane in the ICU. OTH6 confirmed anesthesia staff should monitor and administer Sevoflurane via an anesthesia machine in any area of the hospital.

ANESTHESIA SERVICES

Tag No.: A1000

Based on the systemic non-compliance and the effect on patient outcome, the facility failed to substantially comply with this condition.

482.52(a) Tag A-1001
Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure a qualified practitioner administered a general anesthetic for one of one medical record reviewed (MR1).

482.52(b) Tag A-1002
Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to develop a procedure for the administration of general anesthesia in the Intensive Care Unit for one of one medical record reviewed (MR1).

482. 52(b)(1) Tag A-1003
Based on review of facility documents, medical records (MR), and staff interview (EMP) it was determined the facility failed to ensure patient safety while administering a general anesthetic by not completing a preanesthesia evaluation and not checking the anesthesia machine prior to using a general anesthetic for one of one medical record reviewed (MR1).

482.52(b)(2) Tag A-1004
Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure a qualified practitioner monitored a patient receiving a general anesthetic for one of one medical record reviewed (MR1).

482.52(b)(3) Tag A-1005
Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to evaluate the patient status for discharge from anesthesia care for one of one medical record reviewed (MR1).

A discussion took place with the survey team and the facility's administrative staff (OTH6, EMP1, EMP4, and EMP5) regarding the survey teams concerns related to Anesthesia Services on October 6, 2020, at approximately 1:00 PM.

ORGANIZATION OF ANESTHESIA SERVICES

Tag No.: A1001

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure a qualified practitioner administered a general anesthetic for one of one medical record reviewed (MR1).

Findings:

Review on October 5, 2020, of the facility's policy, "Standard Of Anesthesia Care," last reviewed July 3, 2014, revealed "Purpose The Director of the Department of Anesthesiology will develop, implement and evaluate standards of Anesthesia care provided by the Medical Center in order to establish guidelines for the development of patient care throughout the patient's experience while receiving anesthesia. Scope Guidelines 1. Procedure/Responsibility/Action a. Principles i. Standard I 1. Anesthesia Services will be available to meet the needs of patients receiving diagnostic, therapeutic, invasive, or surgical procedures, this includes the OR, OB, MRI, IR, Cath Lab, EP Lab, SPU/Endo. ii. Standard II 1. Licensed practitioners (i.e. Anesthesiologists, certified registered nurse anesthetists) will provide anesthesia care to patients. 2. Anesthesia care throughout the Medical Center will be provided by only those personnel with granted clinical privileges under the policies and procedures established and approved by the Chief of the Department of Anesthesiology and Medical Staff by-laws. ... iv. Standard IV 1. Anesthesia care will only be provided when the appropriate and/or necessary equipment, personnel and support organizations are available. ... ii. Anesthetic Monitoring 1. Standard I a. Only qualified anesthesia personnel will be in attendance throughout the conduct of all general anesthetics, regional anesthetics, and monitored anesthesia care; b. Qualified anesthesia personnel will remain in the room throughout the patient's procedure. i. In the event of an emergency requiring the temporary absence of the anesthesia staff member primarily responsible for the anesthetic, the best judgment of the anesthesiologist will be exercised in comparing the emergency patient's condition with that of the anesthetized patient's condition and will accept responsibility for determining the selection of the person left responsible for the anesthetic during the temporary absence. Back-up personnel should be immediately called first. 2. Standard II a. The patient's oxygenation, ventilation, and circulation will be continuously monitored and evaluated throughout the duration of administration of anesthesia. Ability to monitor temperature should be continuously available. ... iii Post Anesthesia Care 1. Standard I a. All patients who have received general anesthesia, regional anesthesia, or monitored anesthesia care will receive appropriate post anesthesia care. ... b. Qualified anesthesia personnel will evaluate the patient's post-procedure status upon admission and discharge from post anesthesia care unit. c. Qualified anesthesia personnel with clinical privileges will discharge the patient from post anesthesia care unit. ... "

Review on October 5, 2020, of the facility's, "Lehigh Valley Hospital - Pocono Medical Staff Bylaws," last revised September 20, 2019, revealed "... Article X - Clinical Privileges Section A - Delineation Of Clinical Privileges 1. Medical Staff membership and Medical Staff appointment entitles a practitioner to exercise only those clinical privileges specifically granted to him/her by the Board of Directors upon the report and recommendation of the appropriate Department Chief(s), Credentials Committee and Medical Executive Committee. The privileges delineated will be based upon the criteria developed by the appropriate Departments(s) and the Medical Executive Committee. Clinical privileges are granted only by the Board of Directors. Each practitioner's clinical privileges shall be specified in the Notice of Appointment/Reappointment directed to the practitioner by the President pursuant to Article IX. 2. Each initial application for Medical Staff appointment and each application for reappointment for the appropriate Medical Staff categories must contain a request for specific privileges desired by the applicant. All determinations as to the delineation of clinical privileges shall be based upon evidence of current licensure, the applicant's education, training and experience, demonstrated current competence and current health status, and such other information as may be deemed pertinent including consideration of professional performance, judgement, skills, and knowledge as reflected in peer recommendations, termination of privileges at other hospitals, challenges to licensure or registration, the status of his continuing education, timely, complete, accurate, clear and legible entries in medical records, participation in hospital and medical staff affairs and performance improvement activities, working relationships with medical colleagues and others in the Hospital, and other reasonable indications of continuing qualifications, and shall include an appraisal and recommendation to the Credentials Committee by the appropriate Department Chief(s) with respect to each individual privilege requested. ..."

Review on October 5, 2020, of MR1 revealed a nurse's note dated and timed, September 26, 2020, 6:57 PM. There was nursing documentation anesthesia was at MR1's bedside and showed CF2 and PF1 how to administer and work the anesthesia machine. There was nursing documentation PF1 stated nursing should not be administering anesthesia and would call anesthesia for replacement gas.

Interview on October 5, 2020, with EMP2 and EMP3, at approximately 10:30 AM, confirmed MR1 contained a nurse's note anesthesia showed PF1 and CF2 how to administer and work the anesthesia machine.

Interview on October 6, 2020, with PF1, at approximately 9:55 AM, revealed PF1 was the primary nurse for MR1 on September 26, 2020. PF1 revealed MR1 was experiencing respiratory failure secondary to Status Asthmaticus. PF1 revealed CF2 called anesthesia to administer Sevoflurane (a general anesthetic, inhalation agent) in order to bronchodilate MR1. PF1 revealed OTH3 and OTH4 came to the Intensive Care Unit (ICU) with an anesthesia machine and showed PF1 and CF2 how to administer Sevoflurane and use the anesthesia machine. PF1 revealed they did not feel qualified to administer general anesthesia and explained that to OTH3 and OTH4. PF1 revealed OTH3 and OTH4 refused to stay with MR1 while MR1 received the Sevoflurane and left the ICU.

Review on October 5, 2020, of MR1 revealed a nurse's note dated and timed, September 26, 2020 at 7:31 PM. There was documentation PF1 called OTH4 and requested anesthesia staff remain at MR1's bedside during the administration of anesthesia. There was documentation OTH4 refused PF1's request. There was nursing documentation CF2 would take anesthesia administration coverage until they left for the night and then CF3 would take anesthesia administration coverage.

Continued review of MR1 revealed a physician progress note dated and timed, September 26, 2020 at 7:32 PM. There was physician documentation MR1 was started on Sevoflurane with air and oxygen mixture though an anesthesia machine to achieve better bronchodilation. CF2 documented the ventilator part would be monitored by the respiratory therapist and CF3 under his supervision. CF2 documented the Sevoflurane would be refilled by anesthesia staff as needed. There was no documentation from anesthesia staff regarding the administration of the Sevoflurane.

Interview on October 5, 2020, with EMP2 and EMP3, at approximately 11:05 AM, confirmed there was physician documentation MR1 was started on Sevoflurane via anesthesia machine and was monitored by the respiratory therapist and CF3. EMP2 and EMP3 confirmed there was no documentation from anesthesia staff regarding the administration of Sevoflurane.

Interview on October 6, 2020, with OTH3, at approximately 12:30 PM, confirmed OTH3 and OTH4 set up the anesthesia machine and administered Sevoflurane to MR1 on September 26, 2020, in the ICU. OTH3 confirmed OTH3 and OTH4 left the ICU after setting up the anesthesia machine. OTH3 confirmed OTH3 and OTH4 did not stay and monitor the patient while receiving Sevoflurane. OTH3 confirmed there was no anesthesia documentation in MR1. OTH3 confirmed they stay with and monitor patients in the operating room while receiving Sevoflurane. OTH3 confirmed they had specialized training and education to administer anesthesia.

Review on October 5, 2020, of the facility's Job Description, "Registered Nurse Critical Care Unit," last revised February 5, 2019, revealed no duties or training for the administration of general anesthesia or the use of an anesthesia machine.

Review on October 6, 2020, of PF1's personnel file, revealed PF1 was a Registered Nurse for the Intensive Care Unit (ICU).

Review on October 5, 2020, of the ICU Assignment Sheet, dated September 26, 2020, revealed PF1, PF2, and PF3 provided nursing care for MR1.

Review on October 6, 2020, of PF1, PF2, and PF3, revealed these staff had no training or qualifications to administer general anesthesia via an anesthesia machine.

Interview on October 6, 2020, with EMP4, at approximately 2:30 PM, confirmed PF1, PF2, and PF3 did not have qualifications or training to administer general anesthesia via an anesthesia machine.

Review on October 5, 2020, of CF2 and CF3, revealed these providers did not have privileges to administer general anesthesia via an anesthesia machine.

Interview on October 5, 2020, with EMP8, at approximately 11:00 AM, confirmed CF2 and CF3 did not have privileges to administer general anesthesia via an anesthesia machine.

Interview on October 6, 2020, with OTH6, at approximately 1:30 PM, confirmed CF2 and CF3 did not have privileges to administer general anesthesia via an anesthesia machine. OTH6 confirmed CF2 and CF3 practiced outside of their privileges by taking responsibility for the administration of Sevoflurane in the ICU. OTH6 confirmed anesthesia staff should monitor and administer Sevoflurane via an anesthesia machine in any area of the hospital.

DELIVERY OF ANESTHESIA SERVICES

Tag No.: A1002

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to develop a procedure for the administration of general anesthesia in the Intensive Care Unit for one of one medical record reviewed (MR1).

Findings:

A request was made for the facility policy and procedure for the administration of general anesthesia via anesthesia machine outside of the operating room (OR) on October 5, 2020.

Review on October 5, 2020, of the facility's Anesthesia Department's Policies and Procedures, revealed there was no Policy/Procedure for the administration of general anesthesia outside of the OR.

Interview on October 5, 2020, with OTH2, at approximately 11:55 AM, revealed the administration of general anesthesia outside of the OR was an infrequent practice, and the facility did not have a policy and procedure for the administration of general anesthesia via an anesthesia machine outside of the OR.

Review on October 5, 2020, of the facility contract, "Amended And Restated Professional Services Agreement," last revised October 1, 2018, revealed "This Professional Services Agreement (the "Agreement"), effective as of October 1, 2018 (the "Effective Date"), by and between Pocono Medical Center d/b/a Lehigh Valley Hospital - Pocono, a Pennsylvania not-for-profit corporation with its principal place of business at 206 East Brown Street, East Stroudsburg, Pennsylvania 18301 (the "Hospital" ), and [name]with its principal offices at [address]. Recitals ... Whereas, Hospital desires to continue to use [name] as an exclusive provider of Anesthesia Services at the Hospital as of the Effective Date, and [name] desires to render such services on an exclusive basis at the Hospital, each recognizing that exclusivity will: A. Promote consistency of service, quality control and safety of patients; B. Promote effective selection, maintenance and utilization of the Hospital's equipment; C. Facilitate administration, supervision and training of Department personnel; and D. Promote efficient and economical operation of the Department. Now, Therefore, It Is mutually Agreed As Follows: I Definitions. ... B. "Anesthesia Services" means the delivery of anesthesia to patients by Provided Practitioners in the following Hospital locations and/or through the following modalities: ... vii. ICU airway management ... C. "CRNA" means certified registered nurse anesthetist. ... L. "Hospital Policies" means the Bylaws, Policies, Rules and Regulations of the Hospital and its Medical Staff and the policy manuals of the Hospital administration, as adopted or approved by the Board of Trustees or the administration of the Hospital, as the same may be amended from time to time. ... P. "Privileges" means, with respect to Provided Practitioners, Medical Staff membership and/or clinical privileges to perform Anesthesia Services at Hospital. Q. "Provided Practitioner" means a physician or CRNA who is now, or who at any time during the Term becomes, employed or engaged by [name] and who: (i) is licensed to practice medicine or as a nurse anesthetist, in accordance with the laws of the Commonwealth of Pennsylvania: (ii) is licensed by the Drug Enforcement Administration to prescribe controlled substances; (iii) has privileges in good standing on the active Medical Staff of the Hospital and such Privileges have not been revoked or suspended; (iv) in the case of a physician, is Board Certified in his or her medical specialty or is Board Eligible in his or her medical specialty and achieves board certification in accordance with the Medical Staff Bylaws of the Hospital; ... (vii) complies with Hospital Policies; and (viii) is and remains satisfactory to the Hospital in performance of his or her duties. ... 4. Independent Contractor ... C. Nothing in this Agreement is intended, nor shall be construed, to created an employer/employee relationship, a joint venture relationship, or landlord/tenant relationship between the Hospital and [name], nor allow the Hospital to exercise any control or direction over the manner or method by which the Provided Practitioners perform Anesthesia Services. Notwithstanding the foregoing, the delivery of patient care services by Provided Practitioners shall comply with all Hospital Policies for patient care and shall be monitored on a regular basis by the Hospital's performance improvement personnel. ... 6. Administrative And Clinical Responsibilities. A. The Director shall fulfill the following administrative responsibilities: 1. Be responsible for clinical oversight of the Provided Practitioners in the Department. 2. Be responsible for the overall administrative and teaching functions of the Department, including such educational functions within the Hospital as may be reasonably requested by the Hospital. 3. Direct the Department to have each Provided Practitioner within the Department achieve compliance with Hospital Policies, including the requirements of the American Society of Anesthesiologists, the standards of professional ethics, Medicare Conditions of Participation for Hospital, the Commonwealth of Pennsylvania Department of Health, TJC [The Joint Commission] and all other applicable state and federal rules and regulations. ... 6. Work with the Hospital in consultation with the Network Chair to establish, implement and enforce Department policies, procedures, rules and regulations and methods of operation, and participate in committees and other Staff and administrative functions within the Hospital. 7. Advise the Hospital in consultation with the Network Chair with respect to specific clinical and administrative issues in the Department. 9. Work with the Hospital and the Network Chair to monitor and evaluate procedures and as the Director deems necessary to promote the consistency, quality and appropriateness of services provided by Provided Practitioners in the Department; and participate in the Hospital's overall quality improvement, utilization management and malpractice prevention programs in accordance with Hospital Policies, including submission to the Network Chair of periodic reports regarding the quality assurance and utilization review programs in the Department. ... 11. Cooperate with the Hospital in the planning, investigation, selection and installation of devices, machinery, equipment and systems to be used in assigned areas. 12. Resolve, in a timely fashion after notice by the Hospital to the Director, complaints from patients, employees of the Hospital and other physicians with Privileges with respect to the Department and problems relating to the quality of Anesthesia Services rendered in the Department. ... 7. Records And Data. A. [name] shall cause the Director and each Provided Practitioner to generate and maintain medical records on a timely basis and in form and content consistent with Hospital Policies. ... 9. Compliance With Laws And Hospital Policies. A. Each Party shall at all times conduct itself in compliance with (i) all applicable federal, state and local laws, rules and regulations, including without limitation those relating to equal employment opportunity; (ii) Hospital Policies; and (iii) applicable regulatory and accreditation requirements or standards. B. Each Party shall maintain such standards and meet such requirements for (i) accreditation of the Hospital by TJC or other applicable accreditation agency; (ii) continuance of the Hospital's license or operating certificate; (iii) continuance of the Hospital's participation in Medicare and Medicaid; (iv) retention of the Hospital's Tax Exemption; and (v) approval, accreditation and certification by applicable review or certifying boards and/or agencies in connection with such postgraduate training programs as are or may be adopted by the Hospital. ... 14. Hospital Obligation. The Parties agree and acknowledge that the Hospital remains responsible for ensuring that any service provided at the hospital (whether pursuant to the Agreement or otherwise) complies with all pertinent provisions of federal, state and local statues, rules and regulations, and that the Hospital thereby retains ultimate and overall review and oversight of all services provided at the Hospital, including the Anesthesia Services performed pursuant to this Agreement, in furtherance of patient care and safety. ..."

Review on October 5, 2020, of MR1 revealed a nurse's note dated and timed, September 26, 2020, 6:57 PM. There was nursing documentation, anesthesia was at MR1's bedside showing OTH1 and EMP6 how to administer and work the anesthesia machine. There was nursing documentation EMP6 stated nursing should not be administered anesthesia and would call anesthesia for replacement gas.

Interview on October 6, 2020, with OTH3, at approximately 12:30 PM, confirmed OTH3 and OTH4 set up the anesthesia machine and administered Sevoflurane to MR1 on September 26, 2020, in the ICU. OTH3 confirmed OTH3 and OTH4 left the ICU after setting up the anesthesia machine. OTH3 confirmed OTH3 and OTH4 did not stay and monitor the patient while receiving Sevoflurane. OTH3 confirmed there was no anesthesia documentation in MR1. OTH3 confirmed they stay with and monitor patients in the operating room while receiving Sevoflurane. OTH3 confirmed they had specialized training and education to administer anesthesia.

PRE-ANESTHESIA EVALUATION

Tag No.: A1003

Based on review of facility documents, medical records (MR), and staff interview (EMP) it was determined the facility failed to ensure patient safety while administering a general anesthetic by not completing a preanesthesia evaluation and not checking the anesthesia machine prior to using a general anesthetic for one of one medical record reviewed (MR1).

Findings:

Review on October 5, 2020, of the facility policy, "Patient Peri-Anesthesia Safety," last reviewed July 3,2014, revealed "Purpose To identify areas of patient care to ensure safety while receiving anesthesia for invasive, therapeutic, diagnostic and surgical procedures. Scope Guidelines 1. Procedure/Responsibility/Action a. Anesthesia care will be provided by Anesthesiologists and Certified Registered Nurse Anesthetists. i. Each patient's medical condition will be the responsibility of a qualified physician member of the Medical Staff; ii. Except in extreme emergencies the pre-anesthesia evaluation will be completed prior to the patient's transfer to the procedure area; ... vi. Anesthesia will be defined as the use of any medication administered intravenously, intramuscularly, or by inhalation that would affect the patient's protective reflexes during diagnostic, invasive, therapeutic, or surgical procedures. vii. Anesthesia will be administered only when the appropriate equipment, supplies, personnel and support organizations are in readiness. ... c. Perianesthesia i. The patient's condition will be reviewed immediately prior to the induction of anesthesia, including a review of the medical record to include as applicable: 1. Current history and physical; 2. Laboratory results; 3. X-Ray film diagnosis; 4. Time and dosage of pre-anesthesia medication; 5. EKG results; 6. Any changes in condition as compared with previous notations. ii. Prior to administering anesthesia, the practitioner administering anesthesia will check and document the readiness, availability, cleanliness, and working condition of alarm system of all equipment to be used. Peri-anesthesia documentation will include: 1. Dosage, route, drugs, and agents utilized; 2. Type and amounts of all fluids administered, including blood and blood products; 3. Continuous evidence of monitoring; 4. Description of technique(s) used; 5. Record of any usual occurrence(s) during anesthesia; 6. Status of patient at conclusion of procedure. ... "

Review on October 5, 2020, of MR1 revealed nursing documentation MR1 was under Sevoflurane, a general anesthetic, from 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. There was no documentation MR1 was evaluated by anesthesia staff. There was no documentation the anesthesia machine alarms were checked prior to the administration of a general anesthetic. MR1 contained no documentation from anesthesia staff.

Interview on October 5, 2020, with EMP2 and EMP3, at approximately 10:45 AM, confirmed MR1 was under Sevoflurane, a general anesthetic from 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. EMP2 and EMP3 confirmed there was no documentation MR1 was evaluated by anesthesia staff. There was no documentation the anesthesia machine alarms were checked prior to the administration of a general anesthetic. MR1 contained no documentation from anesthesia staff.

Interview on October 6, 2020, with OTH3, at approximately 12:35 PM, confirmed they did not document the evaluation of MR1 or the anesthesia machine check prior to the administration of a general anesthetic in MR1. OTH3 confirmed they did not document in MR1 or remain with the patient throughout the administration of a general anesthetic.

Interview on October 6, 2020, with OTH6, at approximately 2:35 PM, confirmed anesthesia staff were responsible for evaluating MR1, checking anesthesia machine alarms prior to administration of a general anesthetic, and documenting in MR1. OTH6 confirmed the administration of a general anesthetic without anesthesia staff present was an unacceptable practice.

INTRAOPERATIVE ANESTHESIA RECORD

Tag No.: A1004

Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure a qualified practitioner monitored a patient receiving a general anesthetic for one of one medical record reviewed (MR1).

Findings:

Review on October 5, 2020, of the facility policy, "Patient Peri-Anesthesia Safety," last reviewed July 3,2014, revealed "Purpose To identify areas of patient care to ensure safety while receiving anesthesia for invasive, therapeutic, diagnostic and surgical procedures. Scope Guidelines 1. Procedure/Responsibility/Action ... Peri-anesthesia documentation will include: 1. Dosage, route, drugs, and agents utilized; 2. Type and amounts of all fluids administered, including blood and blood products; 3. Continuous evidence of monitoring; 4. Description of technique(s) used; 5. Record of any usual occurrence(s) during anesthesia; ..."

Review on October 5, 2020, of MR1 revealed nursing documentation MR1 was under Sevoflurane, a general anesthetic, from 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. There was no anesthesia documentation regarding the dosage, route, drugs, and agents utilized. There was no anesthesia documentation regarding the type and amounts of fluids administered, including blood and blood products. There was no anesthesia documentation regarding evidence of continuous monitoring. There was no anesthesia documentation regarding the description of techniques used.

Interview on October 5, 2020, with EMP2 and EMP3, at approximately 10:40 AM, confirmed MR1 was under Sevoflurane, a general anesthetic, from 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. EMP2 and EMP3 confirmed there was no anesthesia documentation regarding the dosage, route, drugs, and agents utilized. EMP2 and EMP3 confirmed there was no anesthesia documentation regarding the type and amounts of fluids administered, including blood and blood products. EMP2 and EMP3 confirmed there was no anesthesia documentation regarding evidence of continuous monitoring. EMP2 and EMP3 confirmed there was no anesthesia documentation regarding the description of techniques used.

Interview on October 6, 2020, with OTH3, at approximately 12:40 PM, MR1 was under Sevoflurane, a general anesthetic, from approximately 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. OTH3 confirmed they did not document the dosage, route, drugs, and agents utilized. OTH3 confirmed they did not document the type and amounts of fluids administered, including blood and blood products. OTH3 confirmed they did not document or continuously monitor the patient. OTH3 confirmed they did not document the description of techniques used.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to evaluate the patient status for discharge from anesthesia care for one of one medical record reviewed (MR1).

Findings:

Review on October 5, 2020, of the facility policy, "Patient Peri-Anesthesia Safety," last reviewed July 3, 2014, revealed "Purpose To identify areas of patient care to ensure safety while receiving anesthesia for invasive, therapeutic, diagnostic and surgical procedures. Scope Guidelines 1. Procedure/Responsibility/Action ... d. PostAnesthesia [sic] ... ii. Post anesthesia documentation will include, but not be limited to: 1. Comparison of patient evaluation from admission to discharge; 2. A time based record of vital signs and level of consciousness; 3. All drugs administered and their dosages; 4. Type and amounts of intravenous fluids administered, including blood and blood products; 5. Any unusual events including post anesthesia and post procedural complications; 6. Post anesthesia visits; a. To be performed within 24 hours of procedure on patient's [sic] admitted to the hospital and to include evaluations for post anesthetic complications. ..."

Review on October 5, 2020, of MR1 revealed MR1 was under a general anesthetic Sevoflurane from approximately, 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. There was no documentation MR1's post anesthesia status was evaluated by anesthesia staff at the conclusion of the administration of Sevoflurane.

Interview on October 5, 2020, with EMP2 and EMP3, at approximately 10:45 AM, confirmed MR1 was under a general anesthetic Sevoflurane from approximately, 6:57 PM on September 26, 2020, to 1:32 AM on September 27, 2020. EMP2 and EMP3 confirmed was no documentation MR1's post anesthesia status was evaluated by anesthesia staff at the conclusion of the administration of Sevoflurane.