QA Investigation Results

Pennsylvania Department of Health
AZURA VASCULAR CARE SOUTH PHILADELPHIA
Health Inspection Results
AZURA VASCULAR CARE SOUTH PHILADELPHIA
Health Inspection Results For:


There are  13 surveys for this facility. Please select a date to view the survey results.

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Initial Comments:

This report is the result of a State licensure survey conducted on February 26, 2021, and completed on March 25, 2021, at Azura Vascular Care South Philadelphia. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.


















Plan of Correction:




51.31 LICENSURE
Exceptions - Principle

Name - Component - 00
51.31. Principle

The Department may grant exceptions to this part when the policy and objectives contained therein are
otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident. No exceptions or departures from this part will be granted if compliance with the requirement is provided for by statute.


Observations:

Based on review of facility documents, personnel files (PF), credential files (CF) and interview with staff (EMP), it was determined the facility failed to adhere to the Department of Health (the "Department") requirements for an "Exception Request" granted for the use of surgical skin preparations that contain combustible agents by not requiring the participation of all clinical staff in annual mandatory education in the use of surgical skin preparations that contain combustible agents.

Findings include:

A review on February 26, 2021, of the "Department" letter to the facility's Chief Executive Officer dated December 21, 2012, revealed "The Department of Health is in receipt of your request for an exception to 28 Pa. Code 569.35, relating to regulations for control of anesthetic explosion hazards. You have completed the process established by the Department for requesting an exception to this regulation and agreed to the following: ...The facility shall institute annual mandatory education provided to all staff, including the physician staff, involved in the use of surgical skin preparations that contain combustible agents. The content of the education provided and documentation of same will be reviewed by the Department during survey activity."

A review on February 26, 2021, of personnel files for PF1, PF2, PF3, PF4 and PF5, and credential files for CF2, CF3, CF4 and CF5 revealed there was no evidence of documentation of annual mandatory education for all staff in the use of surgical skin preparations that contain combustible agents.

A request was made by the survey team on February 26, 2021, at 3:15 PM to EMP3 for documentation of annual mandatory education in the use of surgical skin preparations that contain combustible agents provided to all staff for the period January 1, 2020, to February 26, 2021. The facility was unable to provide the documentation requested by the survey team.

An interview conducted on February 26, 2021, at 3:15 PM with EMP3 confirmed the facility had not provided annual mandatory education in the use of surgical skin preparations that contain combustible agents to all staff as required by the "Department" for the period January 1, 2020 to February 26, 2021.













Plan of Correction:

Corrective Action: The current deficiency will be corrected by providing 2021 annual education regarding surgical skin preparations with combustible agents to all clinical staff, physicians and Allied Health Practitioners (AHP's). This training was initiated on 2/26/21 and will be completed by 7/30/21. The success of this training will be reported to the Quality Committee and the Governing Body by the next scheduled meetings occurring on or before 7/31/21. At that time the Governing Body committee members will receive education regarding the requirement.
To prevent the reoccurrence of the event, this annual education requirement has been added to the Mandatory Annual Education roster/log for all clinical staff, physicians and AHP's as Required Annual Education. The review of this roster/log will become part of the Facility Administrator's annual Q1 audit which will be reported annually to the Governing Body during the annual meeting conducted in Q1 no later than 4/30 each year. All instances of non-compliance will be addressed by the Facility Administrator and Medical Director.

Monitoring Activities: The Facility Administrator will audit files for completeness annually during the first quarter and provide an annual report to the Quality Committee and the Governing Body at the annual Q1 meeting no later than 4/30 each year.

Responsible Party: Director of Nursing, Facility Administrator and Medical Director.

Corrective action will be completed by: 7/31/21






553.3 (8)(ii) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(ii) Applications for positions requiring a licensed person shall be hired only after obtaining verification of their licenses, records of education, and written references.



Observations:

Based on a review of facility policy, personnel files (PF) and interview with staff (EMP), it was determined that the facility failed to verify written references prior to hiring licensed personnel as required by the "Department" for two of two personnel files reviewed (PF2 and PF5).

Findings include:

A review of the facility's policy "Hiring" dated February 27, 2020, revealed "Introduction: FMCNA's (Fresenius Medial Care) hiring and employment reporting practices adhere to all applicable federal, state, and local regulations and guidelines... Reference Checks: Personal and/or professional references may be required."

Review on February 26, 2021, of PF2, a registered nurse hired on May 2, 2018, revealed no evidence of documentation that written references were verified prior to hiring.

Review on February 26, 2021, of PF5, a registered nurse hired on March 8, 2019, revealed no evidence of documentation that written references were verified prior to hiring.

An interview conducted on February 26, 2021, at 3:15 PM with EMP3 confirmed that the facility could not provide documentation that written references were verified for EMP2 and EMP5 prior to hiring. EMP1 stated "We do not have verified written references for these employees. An outside agency obtained verbal references by phone." EMP1 confirmed the facility was not in compliance with the "Department" for ambulatory surgical facilities.























Plan of Correction:

Corrective Action: The identified deficiency will be corrected by providing education and changing the hiring process. Education will be provided to the Governing Body by the next scheduled meeting occurring on or before 7/31/21. Education will be provided regarding "Hiring Policy 101A" which states that the hiring process adheres to all regulations including state regulations. This education will also be electronically provided to the HR Business Partner/HR Resource Manager in Human Resources who coordinates reference checks for new employees. A sign-in sheet will be kept for the education provided.
The identified files were employees hired a considerable time ago. The file of the only new licensed employee since this survey, who began employment in May 2021, will be audited and if written references are absent, they will be obtained by 6/30/21.
To prevent this event from recurring, the Facility Administrator will not allow new licensed employees to begin work without the required written references.

Monitoring Activities: The Facility Administrator will audit this for each new hire of a licensed individual prior to beginning work to insure compliance prior to starting employment. This will be reported to the Quality Committee and Governing Body at each quarterly meeting.

Responsible Party: Facility Administrator

Complete Date: 8/31/21








553.12 (a) LICENSURE
Patient's Bill of Rights - Implementation

Name - Component - 00
553.12 PATIENT'S BILL OF RIGHTS -
IMPLEMENTATION

(a) The ASF governing body shall establish a patient's bill of rights not less in substance and coverage than the minimal patient's bill of rights provided by subsection (b).


Observations:

Based on review of facility documents and interviews with staff (EMP), it was determined the facility failed to establish a Patient Rights and Responsibilities document not less in substance and coverage than the minimal Patient's Bill of Rights provided by subsection (b) of the Pennsylvania State Regulations as required by the Department of Health (the "Department") for an ambulatory surgical center (ASC).

Findings include:

A review on February 26, 2021, of facility document "Pennsylvania Patient Bill of Rights," undated, revealed it did not include "(b)(10) A patient or, if the patient is unable to give informed consent, a responsible person, has the right to be advised when a practitioner is considering the patient as a part of a medical care research program or donor program, and the patient, or responsible person, shall give informed consent prior to actual participation in the program. A patient, or responsible person, may refuse to continue in a program to which he has previously given informed consent." Futher review revealed the document did not include "(b)(11) A patient has the right to refuse drugs or procedures, to the extent permitted by statute, and a practitioner shall inform the patient of the medical consequences of the patient's refusal of drugs or procedures."

An interview conducted on February 26, 2021, at 11:44 AM with EMP3, confirmed the facility document "Pennsylvania Patient Bill of Rights," not dated, was the current Patient Rights document provided to patients by the ASC. EMP3 further confirmed the document did not contain all of the required elements as specified by the "Department" for an ASC.



















Plan of Correction:

Corrective Action: The findings were immediately corrected on 2/26/21 by creating a new Patient Rights and Responsibilities document, which covered all elements of the requirement. The Quality Committee and Governing Body were educated on 4/14/21 and the revision was approved by the Governing Body on that date. The outdated document was removed and the revised document has been posted. The revised document is also provided to patients at the time of registration.
Facility staff will be educated by 7/30/21 during staff meetings and documentation sign-in sheets will be maintained. This corrective action plan will be reviewed with the Governing Body at their next meeting to be held prior to 7/31/21. To prevent recurrences, the Facility Administrator will review state guidelines annually, at a minimum, prior to reporting to the Governing Body during the annual meeting.

Monitoring Activities: Annually, the Governing Body will review Patient Rights beginning the 1st quarter of each year during the annual meeting.

Responsible Party: Facility Administrator

Complete Date: Done. 7/30/21.






555.1 Principle LICENSURE
CHAPTER 555 - MEDICAL STAFF

Name - Component - 00
555.1 Principle

There shall be an organized medical staff which is accountable to the governing body and which has responsibility for the quality of medical care provided to patients and for the ethical conduct and professional practice of its members and other practitioners who have been granted clinical privileges in the ASF.


Observations:

Based on a review of facility Bylaws, credential files (CF), and interview with staff (EMP), it was determined the facility failed to ensure an organized medical staff specific to Azura Vascular Care South Philadelphia for completion of the reappointment process for credentialing of the facility's medical staff for four of four credential files reviewed (CF1, CF2, CF3 and CF5).

Findings include:

A review of the facility document "Medical Staff Bylaws American Access Care of SP ASC, LLC Philadelphia, Pennsylvania," dated April 2017 revealed "The Medical Staff is responsible for the quality of medical care in the Facility and for the ethical conduct and professional practice of its members and other practitioners who have been granted clinical privileges at the Facility. The Medical Staff accepts and assumes these responsibilities. The Medical Staff is self-governed, organized in conformity with these bylaws and accountable to the ultimate authority of the Company's Governing Body. These Medical Staff Bylaws are prepared for compliance with appropriate licensing laws and accreditation standards."

A review on February 26, 2021, of CF1, a physician, revealed a Delineation of Privileges form signed by the applicant on January 22, 2020, for the reappointment period of April 20, 2020, to April 20, 2022. Further review revealed the form was titled with both Azura Surgery Center of South Philadelphia and Azura Vascular Care of South Philadelphia. The Delineation of Privileges form was not specific to Azura Vascular Care of South Philadelphia, nor was there delineation of privileges specific to the Azura Vascular Care of South Philadelphia for CF1.

A review on February 26, 2021, of CF2, a physician, revealed a Delineation of Privileges form signed by the applicant on February 12, 2020, for the reappointment period of April 20, 2020, to April 20, 2022. Further review revealed the form was titled with both Azura Surgery Center of South Philadelphia and Azura Vascular Care of South Philadelphia. The Delineation of Privileges form was not specific to Azura Vascular Care of South Philadelphia, nor was there delineation of privileges specific to the Azura Vascular Care of South Philadelphia for CF2.

A review on February 26, 2021, of CF3, a physician, revealed a Delineation of Privileges form signed by the applicant on January 20, 2020, for the reappointment period of April 20, 2020, to April 20, 2022. Further review revealed the form was titled with both Azura Surgery Center of South Philadelphia and Azura Vascular Care of South Philadelphia. The Delineation of Privileges form was not specific to Azura Vascular Care of South Philadelphia, nor was there delineation of privileges specific to the Azura Vascular Care of South Philadelphia for CF3.

A review on February 26, 2021, of CF5, a certified registered nurse anesthetist, revealed a Delineation of Privileges form signed by the applicant on September 16, 2020, for the reappointment period of September 21, 2020, to September 21, 2022. Further review revealed the form was titled with both Azura Surgery Center of South Philadelphia and Azura Vascular Care of South Philadelphia. The Delineation of Privileges form was not specific to Azura Vascular Care of South Philadelphia, nor was there delineation of privileges specific to the Azura Vascular Care of South Philadelphia for CF5.

An interview conducted on February 26, 2021, at 1:30 PM with EMP3, confirmed the Delineation of Privileges forms signed by CF1, CF2, CF3 and CF5 was not specific to Azura Vascular Care of South Philadelphia and the delineation of privileges was not specific to Azura Vascular Care of South Philadelphia.

Cross Reference:
555.2: Medical Staff Membership


















Plan of Correction:

Corrective Action: The findings will be corrected by providing education and revising documentation requirements. The education was provided to the Governing Body on 4/14/21 regarding the need for the medical staff to be specific to Azura Vascular Care South Philadelphia only, which cannot include shared privilege forms. The Delineation of Privileges form was revised to be specific to Azura Vascular Care South Philadelphia. The Governing Body was educated and approved the new, specific Delineation of Privilege form on 4/14/21. To ensure the issue does not recur, the new form was put into use immediately with the new appointments during the Medical Staff meeting on 4/28/21 and Governing Board meeting on 4/29/21. The new documentation will be used with all re-appointments when re-credentialing occurs.

Monitoring Activities: The Medical Executive Committee and the Governing Body will ensure that all approvals include the revised document. The Facility Administrator will audit every file at the time of appointment or reappointment and report findings to the Governing Body. All instances of non-compliance will be addressed by the Facility Administrator.

Responsible Party: Facility Administrator

Complete Date: 6/1/21





555.2 LICENSURE
Medical staff membership

Name - Component - 00
555.2 Medical Staff Membership

A member of the medical staff shall be qualified for membership and the exercise of clinical privileges granted to him. The governing body of the ASF, after considering the recommendations of the medical staff, may grant clinical privileges to qualified, licensed practitioners in accordance with their training, experience and demonstrated competence and judgement. Members of the medicals staff and others granted clinical privileges shall currently hold licenses to practice in this Commonwealth.


Observations:

Based on review of facility Bylaws, documents, credential files (CF) and interview with staff (EMP), it was determined the facility failed to comply with granting privileges to Allied Health Professionals (Certified Registered Nurse Anesthetists) in accordance with the facility's established process for the appointment and reappointment for two of two credential files reviewed (CF4 and CF5).

Findings include:

A review of facility document "Medical Staff Bylaws, American Access Care of SP ASC, LLC Philadelphia, Pennsylvania" dated April 2017 revealed "2.4 Medical Executive Committee... (b) Responsibilities and Duties: (iii) reviewing, investigating and making recommendations to the Governing Body on all matters relating to credentialing, appointments, reappointments, Clinical Privileges and corrective actions. When Allied Health Professionals provide, or recommended to provide, services in the Facility, the MEC shall make recommendations to the Governing Body on their qualifications to provide those services and on the degree of supervision required... Article V Allied Health Professionals... 5.2 (a) Applications by Allied Health Professionals are processed as for individuals applying for Medical Staff Membership."

A review of facility document "Governing Body Meeting Minutes - Ad-HOC American Access Care of South Philadelphia d/b/a Azura Vascular Center of South Philadelphia" dated September 9, 2020, revealed "Credentialing. (CF4) is now the full time CRNA (Certified Registered Nurse Anesthetist) in this location."

A review of facility document "Governing Body Meeting Minutes - Ad-HOC American Access Care of South Philadelphia d/b/a Azura Vascular Center of South Philadelphia" dated September 21, 2020, revealed "Courtesy Approval. ...[XXXX] name redacted and (CF5) are approved for courtesy privileges effective today."

A review of facility document "Medical Executive Committee Meeting Minutes - Q 3" dated October 29, 2020, revealed CF5, who had been approved for reappointment in the ad-HOC Governing Body meeting on September 21, 2020, was not included in the list of CRNAs reappointed to the facility.

A review on February 26, 2021, of CF4, a certified registered nurse anesthetist (CRNA), revealed the Governing Body approved CF4's reappointment for the period of September 9, 2020, through September 9, 2022, on September 9, 2020. Further review revealed there was no evidence of approval by the Medical Executive Committee prior to the Governing Body approval as required by the facility's Medical Staff Bylaws.

A review on February 26, 2021, of CF5, a certified registered nurse anesthetist (CRNA), revealed the Governing Body approved CF5's reappointment for the period of September 21, 2020, through September 21, 2022, on September 21, 2020. Further review revealed there was no evidence of approval for reappointment by the Medical Executive Committee.

An interview conducted on February 26, 2021, at 1:45 PM with EMP3 confirmed the Medical Executive Committee had not approved CF4 and CF5's reappointment before the Governing Body's approval as required by the Medical Staff Bylaws.

Cross Reference:
555.1: Principle-Chapter 555 Medical Staff















Plan of Correction:

Corrective Action: The findings will be corrected by revising the credentialing process to adhere to the bylaws defined process and require the Medical Executive Committee to make recommendations regarding credentialing to the Governing Body. A review of the bylaws was conducted and demonstrated compliance with state and CMS regulations. On 4/28/21 and 4/29/21, the Medical Executive Committee and Governing Body members were provided education regarding the Medical Staff Bylaws process for recommendation of appointments and reappointments by the Medical Staff to the Governing Body. The Governing Body will only review candidates presented by the Medical Executive Committee. This new process was implemented immediately. During the Med Exec Committee meeting on 4/28/21, the committee made credentialing recommendations to be considered by the Governing Board. On 4/29/21, the Governing Body reviewed those recommendations. Compliance with the bylaws was demonstrated by the end of April 2021. All individual names of credentialing candidates will be delineated in each of the respective meeting minutes.

Monitoring Activities: The Facility Administrator is responsible for all credentialing documents and will audit this process to insure compliance with the bylaws going forward, reporting variances to the Governing Board during every quarterly meeting.

Responsible Party: Medical Director and Facility Administrator

Complete Date: 4/29/21




555.22 (c)(1-5) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Pre-operative Care

(c) Written instruction for preoperative procedures, which have been approved by the medical
staff, shall be given to the patient or responsible person, and shall include:
(1) Applicable restrictions upon food and drink before surgery
(2) Special preparations to be made by the patient
(3) The required proximity of the patient to the ASF for a specific time following surgery if applicable.
(4) An understanding that the patient may require admission to the hospital in the event of medical need.
(5) The requirement that, upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether such patients require a responsible person to escort them home.


Observations:

Based on a review of facility policy, medical records (MR) and staff interview (EMP), it was determined the facility failed to provide preoperative written instructions for one of one medical records reviewed (MR1).

Findings include:

A review of facility policy "Universal Protocol- Pennsylvania," dated February 7, 2021, revealed "Procedure. 2. Preoperative instructions will be provided to the patient or responsible person and shall include: a. Applicable restrictions on food and drink before surgery b. Special preparations to be made by the patient c. An understanding that the patient may require admission to the hospital in the event of medical need, d. Upon discharge, a responsible person is to be available to escort the patient home."

A review on February 26, 2021, of MR1, admitted on May 22, 2020, for a fistulagram procedure, revealed no evidence of documentation that the patient was provided with preoperative instructions prior to procedure.

An interview conducted on February 26, 2021, at 9:20 AM with EMP1 confirmed there was no documentation that the patient was provided with preoperative instructions prior to the procedure. EMP1 stated "New patients will not have (a preoperative instruction) form. Patients may be in the middle of a dialysis treatment and have a clot and need to come in immediately. They do not receive preoperative instructions."





















Plan of Correction:

Corrective Action: The finding was corrected by reviewing the Universal Protocol Policy PC 200 with the Patient Service Coordinators who schedule patients. They were re-educated to the policy that all patients must have pre-op instructions provided. This must include same day scheduled cases and add-on cases. All pre-operative education is documented in the patient record as a Telephone Call. On 4/29/21, this education was provided to the Patient Service Coordinators which is documented in a sign-in sheet.
To prevent recurrence, this finding will be added to the Quarterly Medical Record Review Checklist and compliance reported to both the Quality Committee and Governing Board. These committees will be educated on this policy and expectation by the next scheduled meetings on or before 7/31/21.

Monitoring Activities: This element will be added to the quarterly medical record review checklist. Two (2) percent of patient records or a minimum of 10 records, whichever is greater, are monitored quarterly. Results will be reported to the Quality Committee and Governing Body. This will be reported for six (6) months through January 2022.

Responsible Party: Facility Administrator

Complete Date: 8/31/21




555.22 (e) LICENSURE
Surgical Services - Preoperative

Name - Component - 00
555.22 Pre-operative Care

(e) Prior to the administration of anesthesia, it is the responsibility of the primary operating surgeon and the person administrating anesthesia to properly identify the patient and the procedure to be performed and to document this identification in the patient's medical record. This procedure shall be in written policies designating the mechanism to be used to identify each surgical patient.

Observations:

Based on a review of the facility's policy, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure that a physician performed and documented the identification of the patient prior to the administration of anesthesia for seven of 10 medical records reviewed (MR4, MR5, MR6, MR7, MR8, MR9 and MR10).

Findings include:

A review of facility policy "Universal Protocol- Pennsylvania," dated February 7, 2021, revealed "Procedure. 6. Pre-procedure area. a. The Nurse completes the pre-procedure verification/site marking checklist. I. Patient identity is verified by asking them to state their name and DOB (date of birth)... Time Out 1. The "time out" must be conducted in the location where the procedure will be done, after the patient is prepped and draped an just before starting the procedure... 5. The following is the minimum information to be reviewed during the Time Out. a. Re-verify the patient's identity using two identifiers... Document where indicated in the medical record."

A review on March 1, 2021, of MR4, admitted on December 4, 2020, for a thrombectomy and angioplasty procedure under monitored anesthesia care, revealed there was no evidence of documentation that a physician identified the patient prior to the administration of anesthesia.

A review on March 1, 2021, of MR5, admitted on July 17, 2020, for a thrombectomy, angioplasty and stent placement procedure under monitored anesthesia care, revealed there was no evidence of documentation that a physician identified the patient prior to the administration of anesthesia.

A review on March 1, 2021, of MR6, admitted on July 17, 2020, for an angioplasty and stent placement procedure under monitored anesthesia care, revealed there was no evidence of documentation that a physician identified the patient prior to the administration of anesthesia.

A review on March 1, 2021, of MR7, admitted on August 14, 2020, for an angiogram procedure under monitored anesthesia care, revealed there was no evidence of documentation that a physician identified the patient prior to the administration of anesthesia.

A review on March 1, 2021, of MR8, admitted on August 28, 2020, for an angiogram procedure under monitored anesthesia care, revealed there was no evidence of documentation that a physician identified the patient prior to the administration of anesthesia.

A review on March 1, 2021, of MR9, admitted on September 11, 2020, for a thrombectomy procedure under monitored anesthesia care, revealed there was no evidence of documentation that a physician identified the patient prior to the administration of anesthesia.

A review on March 1, 2021, of MR10, admitted on October 9, 2020, for a fistulagram procedure under monitored anesthesia care, revealed there was no evidence of documentation that a physician identified the patient prior to the administration of anesthesia.

An interview conducted on March 1, 2021, at 10:50 AM with EMP4 confirmed that MR4, MR5, MR6, MR7, MR8, MR9 and MR10 did not contain evidence that a physician identified the patient prior to the administration of anesthesia. EMP4 stated "The (registered nurse) documents 'patient identity, site side and procedure have been confirmed.'"



















Plan of Correction:

Corrective Action: These findings will be corrected, and proper patient identification guaranteed by making changes to required documentation in the Electronic Medical Record (EMR) and by educating the medical staff. The EMR will be modified to include a section for patient identification in the operating physician's history and physical screen. The draft proposal was created on 4/29/21 and was available in the EMR on 6/1/21. Operating physicians will be educated regarding this addition in person and signatures will be obtained during the educational session. The education will include the requirement that the physician identify the patient prior to the procedure and use the new enhancement in the EMR to document this activity.
To ensure improvement is sustained, this will be monitored during the Quarterly Medical Record Review and results reported to the Quality Committee, Medical Executive Committee and the Governing Board. Two (2) percent of patient records or a minimum of 10 records, whichever is greater, are monitored quarterly. These committees will receive final education on this change by their next scheduled meeting on or before 7/31/21.


Monitoring Activities: This element will be added to the quarterly medical record review checklist. 2% of patient records or a minimum of 10 records are monitored quarterly. Results will be reported to the Quality Committee and Governing Body. This will be reported for six (6) months through January 2022, unless compliance is less than 100%. Compliance less than 100% will warrant ongoing reporting. All instances of non-compliance will be addressed by the Facility Administrator.

Responsible Party: Medical Director and Facility Administrator

Complete Date: 8/31/21






555.33 (c)(1-3) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.3 Anesthesia policies and procedures

(c) Policies and procedures shall be developed or anesthesia services and shall include the following:
(1) Education, training and supervision of personnel.
(2) Responsibilities of non physician anesthetists.
(3) Responsibilities of supervising physicians or dentists.

Observations:

Based on review of facility's Medical Staff Bylaws, credential files (CF), and interview with staff (EMP), it was determined the facility failed to provide for the direct supervion and direction of the certified registered nurse anesthetists (CRNAs) by a physician on the Medical Staff who is present in the Ambulatory Surgery Facility (ASF) for three of three credential files reviewed (CF1, CF2 and CF3).

Findings include:

A review of the facility's Medical Staff Bylaws, dated April 2017 revealed "Article V Allied Health Professionals...Allied Health Professionals shall be identified as individuals other than physicians who are granted privileges to practice in the Facility and are directly involved in patient care. Such persons ... must be under the direct supervision and direction of a physician on the Medical Staff, to the extent required by applicable law... These individuals may include... certified registered nurse anesthetists ("CRNAs")..."

A review on February 26, 2021, of CF1, a physician, revealed no documentation of privileges requested or approved for the direct supervision and direction of CRNAs.

A review on February 26, 2021, of CF2, a physician, revealed no documentation of privileges requested or approved for the direct supervision and direction of CRNAs.

A review on February 26, 2021, of CF3, a physician, revealed no documentation of privileges requested or approved for the direct supervision and direction of CRNAs.

An interview conducted on February 26, 2021, at 1:30 PM with EMP3 confirmed CF1, CF2, and CF3 provided direct supervision and direction of CRNAs during procedures. EMP3 further confirmed CF1, CF2, and CF3 did not include privileges requested or approved for the direct supervision and direction of CRNAs.














Plan of Correction:

Corrective Action: To correct these findings, a bylaws review and policy review were conducted. Bylaws comply with state regulations. Policy PC 195 Moderate Sedation requires non-physician sedation professionals to be directly supervised by a non-anesthesiologist sedation practitioner or an anesthesiologist. This policy satisfactorily complies with the requirement. To ensure compliance in practice, the operating physicians were educated and assumed responsibility to supervise Certified Registered Nurse Anesthetists (CRNA's) during each case. Physician Delineation of Privilege forms were amended to include Supervision of CRNA's and the CRNA Supervision Acknowledgement was obtained. This acknowledgement demonstrates that the operating physicians understand that there is no anesthesiologist present in the facility and that he/she must maintain supervision of the CRNA during each case. The amended Delineation of Privileges forms and Supervision of CRNA Acknowledgement forms were signed by the appropriate physicians. The documents were reviewed and approved at the 4/14/21 Medical Staff and Governing Body Meetings. To prevent recurrence, this privilege will be reviewed during each re-credentialing event.

Monitoring Activities: The Facility Administrator will audit all credentialing files as they are presented and report findings to the during the quarterly Governing Body meetings. The Governing Body will ensure that all operating physicians complete appropriate documents during the credentialing and re-credentialing processes.

Responsible Party: Medical Director and Facility Administrator

Complete Date: Complete by 8/31/21.




555.33 (d)(8)(i-v) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(8) Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by an anesthetist, the operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the postoperative check shall include at least the following:
(i) level of activity
(ii) respirations
(iii) blood pressure
(iv) level of consciousness
(v) oxygen saturation by pulse oximetry.

Observations:

Based on review of facility policies and procedures, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure patients were evaluated for proper anesthesia recovery as per the facility's policy in six of six medical records reviewed (MR5, MR6, MR7, MR8, MR9 and MR10).

Findings include:

A review on March 1, 2021, of facility policy "Patient Discharge," dated February 7, 2021, revealed "Policy... Patients are discharged in accordance with the regulatory requirements governing discharge, as well as this policy... 3. Each patient is evaluated by a physician, or an anesthetist for proper recovery before discharge... Anesthesia Recovery Evaluation: An evaluation of the patient's recovery from sedation or anesthesia, to determine whether the patient is recovering appropriately, must be completed, and documented before the patient is discharged."

A review on March 1, 2021, of MR5, admitted on July 17, 2020, revealed the patient received monitored anesthesia care for a thrombectomy, angioplasty and stent placement procedure. Further review revealed there was no evidence of documentation that a physician or anesthetist evaluated the patient for level of activity, respirations, and level of consciousness prior to discharge.

A review on March 1, 2021, of MR6, admitted on July 17, 2020, revealed the patient received monitored anesthesia care for an angioplasty and stent placement procedure. Further review revealed there was no evidence of documentation that a physician or anesthetist evaluated the patient for level of activity, respirations, and level of consciousness prior to discharge.

A review on March 1, 2021, of MR7, admitted on August 14, 2020, revealed the patient received monitored anesthesia care for an angiogram procedure. Further review revealed there was no evidence of documentation that a physician or anesthetist evaluated the patient for level of activity, respirations, and level of consciousness prior to discharge.

A review on March 1, 2021, of MR8, admitted on August 28, 2020, revealed the patient received monitored anesthesia care for an angiogram procedure. Further review revealed there was no evidence of documentation that a physician or anesthetist evaluated the patient for level of activity, respirations, and level of consciousness prior to discharge.

A review on March 1, 2021, of MR9, admitted on September 11, 2020, revealed the patient received monitored anesthesia care for a thrombectomy procedure. Further review revealed there was no evidence of documentation that a physician or anesthetist evaluated the patient for level of activity, respirations, and level of consciousness prior to discharge.

A review on March 1, 2021, of MR10, admitted on October 9, 2020, revealed the patient received monitored anesthesia care for a fistulagram procedure. Further review revealed there was no evidence of documentation that a physician or anesthetist evaluated the patient for level of activity, respirations, and level of consciousness prior to discharge.

An interview conducted on March 1, 2021, at 10:50 AM with EMP4 confirmed that MR5, MR6, MR7, MR8, MR9 and MR10 did not contain evidence of documentation that a physician or anesthetist evaluated the patient for level of activity, respirations, and level of consciousness prior to discharge.

















Plan of Correction:

Corrective Action: To correct the findings, a policy review was completed. Facility policy PC 107 Patient Discharge includes the required five (5) elements of an evaluation by a physician or anesthetist for proper recovery and minimally acceptable discharge criteria. This policy will be revised to ensure the evaluation is based on information gathered from a hands-on examination. The Policy PC 107 will be revised to include, "...an evaluation of a patient's condition and discharge prognosis based on information gathered from a physical, hands-on exam in accordance with company and local/state policies and standards". The policy will be revised by 8/31/21.
The Physicians and anesthesia staff will be provided education regarding the required discharge criteria to be included in the evaluation for discharge. The education will also include that if the assessment is completed by the anesthetist, that the physician will cosign the assessment and is ultimately responsible. This education will be conducted in person by 8/31/21 and sign in sheets will be maintained.

Compliance with this documentation will be monitored through the Quarterly Medical Record Review and reported to Quality Committee, Medical Executive Committee and Governing Body. Two (2) percent of patient records or a minimum of 10 records, whichever is greater, are monitored quarterly.

Monitoring Activities: This element will continue to be monitored through the quarterly medical record review checklist. 2% of patient records are monitored quarterly, or a minimum of 10 records. Results will be reported to the Quality Committee, Medical Executive Committee and Governing Body. This will be reported for six (6) months through January 2022 The Facility Administrator will address issues of non-compliance.

Responsible Party: Medical Director and Facility Administrator

Complete Date: 8/31/21






567.1 Principle LICENSURE
CHAPTER 567 - ENVIRONMENTAL SERVICES

Name - Component - 00
567.1 Principle

The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.


Observations:

Based on review of facility policies and procedures, observation, and interview with staff (EMP), it was determined the facility failed to provide a safe and sanitary environment in various areas of the Operating Room (OR) Suite.

Findings include:

A review of facility policy "Environmental Cleaning" dated February 6, 2021, revealed "Purpose: To maintain a clean and safe environment for patients, staff, and visitors. Policy: The patient care environment throughout the facility will be maintained in a state of cleanliness that meets professional standards in order to protect patients and healthcare personnel from potentially infectious microorganisms... Personnel responsible for cleaning the environment and equipment will receive education and training on proper environmental cleaning and disinfection methods, agent use and selection, and safety precautions... Terminal cleaning of each operating and procedure room will be completed daily... Spot wash all walls. Clean and disinfect all horizontal surfaces... Clean and disinfect procedure table including castors..."

An observational tour conducted on February 26, 2021, at 10:26 AM - 10:55 AM with EMP2 and EMP4 revealed the following:

Observation of OR 1 revealed high dust on the wall-mounted erasable marker board.

Observation in Pre/Post operative area Bay 1 and Bay 4 revealed dust on the protective molding on the wall behind the patient gurney.

An interview conducted on February 26, 2021, at 11:00 AM with EMP2 and EMP4 confirmed the presence of high dust on the marker board in OR1 as well as on the protective molding on the wall in Pre/Post operative area Bay 1 and Bay 4.

_________________
An observational tour on February 26, 2021, at 12:00 PM with EMP6 in OR 2 revealed reddish material resembling rust on the front and back of the base of the OR table and tarnish and reddish material resembling rust on the metal "mayo" stands used during patient procedures.

An interview conducted on February 26, 2021, at 12:18 PM with EMP1 confirmed the presence of rust on the front and back of the base of the OR table and tarnish and rust on the metal "mayo" stands used during patient procedures.









Plan of Correction:

Corrective Action: The immediate findings regarding dust were corrected by Monday 3/1/21 with staff assigned to complete high dusting. To prevent recurrence, on 3/19/21 the Facility Administrator met with the Environmental Services (EVS) contractor to provide education, review items of concern and raise performance expectations. This is documented in meeting minutes. The findings regarding the operating room table and mayo stand were satisfactorily repaired by 3/15/21. To prevent recurrence of the same issue, the operating room table was replaced on 5/15/21.
To audit this performance, a full EVS/Housekeeping Inspection will be completed weekly by the Facility Administrator for one month then monthly, and the results will be reviewed by the Infection Control Officer, reported to the Quality Committee, Medical Executive Committee and the Governing Board quarterly.

Monitoring Activities: A full EVS/Housekeeping Inspection will be completed and documented weekly for one month then monthly by the Facility Administrator who will address all issues of non-compliance. Issues will be reviewed with and corrected by the contracted provider and presented during each quarterly Quality Committee meeting and Governing Board meeting.

Responsible Party: Facility Administrator.

Complete Date: 8/31/21.






Initial Comments:

This report is the result of a full State Licensure survey conducted on February 26, 2021, at Azura Vascular Care South Philadelphia. It was determined the facility was not in compliance with the requirements of 35 P.S. 448.809 (b).
















Plan of Correction:




35 P. S. 448.809b LICENSURE
Photo Id Reg

Name - Component - 00
(1) The photo identification tag shall include a recent photograph of the employee, the employee's FIRST name, the employee's title and the name of the health care facility or employment agency.

(2) The title of the employee shall be as large as possible in block type and shall occupy a one-half inch tall strip as close as practicable to the bottom edge of the badge.

(3) Titles shall be as follows:
(i) A Medical Doctor shall have the title " Physician. "
(ii) A Doctor of Osteopathy shall have the title " Physician. "
(iii) A Registered Nurse shall have the title " Registered Nurse. "
(iv) A Licensed Practical Nurse shall have the title " Licensed Practical Nurse. "
(v) Abbreviated titles may be used when the title indicates licensure or certification by a Commonwealth agency.

(4)A notation, marker or indicator included on an identification badge that differentiates employees with the same first name is considered acceptable in lieu of displaying an employee's last name.



Observations:

Based on observation, and interview with staff (EMP), it was determined that the facility failed to conform to all applicable State laws.

Azura Vascular Care South Philadelphia was not in compliance with the following State law: Health Care Facilities Act PHOTO IDENTIFICATION TAG REGULATIONS. Act of Nov. 23, 2010, P.L.099, No.110.

"HEALTH CARE FACILITIES ACT 110 Clarification Notice: PHOTO IDENTIFICATION REGULATION" revealed "In the notice published at 45 Pa. B. 2427 (May 16, 2015), the department of health (Department) provided notice relating to the provisions of section 809.2 of the Health Care Facilities Act (35 P.S. 448.809 b), enacted by the act of November 23, 2010, (P.L. 1099, No 110), that would become effective June 1, 2015. This notice clarifies the notice published on May 15, 2015. In the previous notice, the Deparment listed four titles that must be used for applicable employees under Act 110: 1. A Medical Doctor shall have the title "Physician" 2. A Doctor of Osteopathy shall have the title "Physician" 3. A Registered Nurse shall have the title "Registered Nurse" 4. A Licensed Practical Nurse"..The Department wishes to clarify that abbreviated titles may not be used for the four titles listed above, as those titles are set in statue.

Section 54.2 Requirements
(b) As of June 1, 2015, an employee who delivers direct care in a health care facility and an employee of a physician practice group owned and operated by a health care provider shall wear a photo identification badge that meets the requirements of .54,3,

. 54.3 Contents of photo identification badge
(a) The photo identification badge shall include all of the following: (1) A recent photograph of the employee, updated as provided for in subsection (c). (2) The employee's full name. (3) The employee's title as required by 54.4. (4) The name of the employee's health care facility or employment agency.

54.4. Title
(a) The photo identification badge shall contain the title of the employee. (b) The title shall be the complete designation contained on the professional license, certification or registration of the employee. (c) If the employee does not possess a professional license, certificate or registration, the title shall be the designation which most accurately describes the employee's job function. (d) The title shall not be abbreviated. (e) The title of the employee or physician shall be in block type and shall occupy a one-half inch tall strip as close a practicable to the bottom edge of the badge. (f) This section shall take effect on June 1, 2015.

Based on observation, review of facility policy, and interview with staff (EMP), it was determined the facility failed to ensure staff was provided with appropriate identification badges to wear as required by law.

Findings include:

An observation on February 26, 2021, at approximately 12:00 PM of EMP5, a physician, revealed EMP5's photo identification badge contained the title "Medical Director" in the bottom margin of the identification badge, and did not contain the complete designation contained on the professional license as required.

An observation on February 26, 2021, at approximately 12:00 PM of EMP2, a registered nurse, revealed EMP2's photo identification badge contained the title "Director of Nursing" in the bottom margin of the identification badge, and did not contain the complete designation contained on the professional license as required.

An observation on February 26, 2021, at approximately 12:00 PM of EMP7, a registered nurse, revealed EMP7's photo identification badge did not contain the employee's full name.

An interview conducted on February 26, 2021, at 12:18 PM, with EMP1 and EMP3 confirmed the identification badges of EMP5 and EMP2 did not contain the required employee title contained on the professional license and that EMP7's identification badge did not contain the employee's full name.







Plan of Correction:

Corrective Action: The findings will be corrected with the purchase of compliant tags and monitoring by the Facility Administrator and Director of Nursing. On 4/29/21, a new tag specifying "Registered Nurse" instead of R.N., was ordered. The Medical Director's tag was corrected on 4/29/21 by replacing Medical Director with Physician. By 7/15/21, the Facility Administrator will conduct a complete audit of every employee and physician name tag to ensure compliance with the requirements of the HealthCare Facilities Act No. 110 which was fully reviewed. Any non-compliant tags will be corrected by 8/31/21. The process for name tag requires the Facility Administrator approval which will insure only compliant tags will be approved and used. The results of the audit will be reported to the Quality Committee and the Governing Board. The follow-up actions will be audited by the Facility Administrator and reported to the Governing Body at the 3rd quarter Governing Body meeting to be conducted no later than 10/31/21.

Monitoring Activities: The Facility Administrator and Director of Nursing will monitor employee and physician compliance for appropriate identification tags.

Responsible Party: The Facility Administrator will be responsible to ensure that all employees and physicians will maintain appropriate identification tags.


Complete Date: 8/31/21