QA Investigation Results

Pennsylvania Department of Health
EINSTEIN ENDOSCOPY CENTER - BLUE BELL
Health Inspection Results
EINSTEIN ENDOSCOPY CENTER - BLUE BELL
Health Inspection Results For:


There are  4 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 October 5, 2020, and completed on December 9, 2020, at Einstein Endoscopy Center - Blue Bell. 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:




551.21 (e)(1-3) LICENSURE
Criteria for ambulatory surgery

Name - Component - 00
551.21 Criteria for ambulatory surgery

(e) In obtaining informed consent, the practitioner performing the surgery shall be responsible for disclosure of:
(1) The risks, benefits and alternatives associated with the anesthesia which will be administered.
(2) The risks, benefits and alternatives associated with the procedure which will be performed.
(3) The comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital.

Observations:

Based on review of facility policies, medical record review (MR) and interview with staff (EMP) it was determined the facility failed to develop a process to ensure patients were informed of the comparative risks, benefits, and alternatives associated with performing a procedure in an Ambulatory Surgery Facility (ASF) instead of a hospital for two of two medical records reviewed (MR5 and MR10).

Findings include:

A review on December 10, 2020, of facility policy "Albert Einstein Healthcare Network Policy and Procedure... Informed Consent" dated March 28, 2019, revealed "K. Consent at Einstein Endoscopy Center - Blue Bell (EECBB)... 1) (a) ...the Responsible Practioner performing a procedure at the EECBB, which is a location with a separate ambulatory surgery facility license, is responsible for explaining to the adult patient that he/she has elected to have the procedure performed at the EECBB instead of a hospital, as well as the following... iii. The comparative risks, benefits and alternatives associated with performing the procedure at the EECBB, instead of a hospital. b) The Responsible Practitioner must also explain to the patient that in the event he/she requires medical care beyond the capabilities of the EECBB, he/she will be transported to a hospital."

A review on October 27, 2020, of MR10 revealed the patient was admitted to the ASF on August 10, 2020, for an upper endoscopy procedure. The signed consent form did not contain an explanation that the patient had elected to have the procedure at the EECBB instead of a hospital; disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in an Ambulatory Surgery Facility instead of a hospital; or an explanation that in the event he/she requires medical care beyond the capabilities of the EECBB, he/she will be transported to a hospital. Further review revealed "2. As has been explained to me, this facility is a teaching hospital."

A review on October 27, 2020, of MR5 revealed the patient was admitted to the ASF on August 11, 2020, for a colonoscopy and polyp removal procedure. The signed consent form did not contain an explanation that the patient had elected to have the procedure at the EECBB instead of a hospital; disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in an Ambulatory Surgery Facility instead of a hospital; or an explanation that in the event he/she requires medical care beyond the capabilities of the EECBB, he/she will be transported to a hospital. Further review revealed "2. As has been explained to me, this facility is a teaching hospital."

A telephone interview conducted on December 9, 2020, at 1:45 PM with EMP1 confirmed the facility had adopted the hospital consent form used by the Healthcare Network and did not include an explanation that the patient had elected to have the procedure at the EECBB instead of a hospital or a disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in an Ambulatory Surgery Facility instead of a hospital. EMP1 stated "We will need to ensure the patient knows they are receiving care in an ambulatory surgery facility."



Cross Reference 553.3(6) Governing Body Responsibilities.















Plan of Correction:

Procedure specific consent forms for Einstein Endoscopy Center Blue Bell were developed and approved for use on 01/13/2021. These consent forms inform the patient of the comparative risks, benefits and alternatives associated with having the procedure performed in an outpatient/ambulatory surgery facility instead of a hospital. All Nursing staff were educated on the consent forms by the Clinical Director on 01/26/2021. All providers were educated on the consent forms by the Medical Director via email on 01/27/2021. Read receipt will be tracked and maintained in the file. Education about the consent forms was posted at each provider's workstation. The forms will be used for all patients beginning 02/01/2021.

10% of charts will be audited per month, to ensure the correct consent forms are being used, until 100% compliance is achieved for three consecutive months. Charts will be selected by reviewing every other chart for a maximum of two charts per day until 10% of charts are achieved for the month.

The Einstein Endoscopy Center Blue Bell Board Quality Committee and the Einstein Endoscopy Center Blue Bell Board of Trustees will receive monthly updates regarding compliance with the above noted Plan of Correction.

The site Administrator or designee has overall responsibility for this Plan of Correction.

Completion Date:
04/30/2021



553.3 (6) LICENSURE
Governing Body Responsibilities

Name - Component - 00
Governing Body responsibilities include:
(6) Adopting policies or procedures necessary for the orderly conduct of the ASF.


Observations:

Based on review of the facility's Bylaws, policies, medical records (MR), and interview with staff (EMP), it was determined the Governing Body failed to ensure the facility followed their informed consent policy to verify patient information and failed to ensure the facility's informed consent form was in accordance with the license granted by the "Department" as an ambulatory surgical facility (ASF) by including the administration of blood products on the ASF consent form in two of two medical records reviewed (MR5 and MR10).

Findings include:

A review on December 11, 2020, of the facility's Bylaws dated October 24, 2018, revealed Article III. Section 3: Responsibilities and Powers of the Board of Trustees. Subject to the member Reserved powers, and in compliance with all applicable laws and regulations, the responsibilities and powers of the Board of Trustees shall include, without limitation: ...e. Developing and approving policies and programs with respect to personnel and labor relations, patient care, patient safety, quality care, nursing, research, physical facilities and professional graduate medical education... r. Serving as the governing body of the EECBB assuming full legal authority and responsibility for the conduct of the EECBB, responsible for establishing and overseeing the administration and operations of the EECBB, and conducting business related to the EECBB separate from the business of the hospital."

A review on December 10, 2020, of facility policy "Albert Einstein Healthcare Network Policy and Procedure... Informed Consent" dated March 28, 2019, revealed "II. Scope. This Policy applies to... Einstein Endoscopy Center - Blue Bell... H. Attending Surgeon's Verification. 1) If the procedure is performed in the operating room, and after the patient is placed on the operating room table, it is the attending surgeon's responsibility, under Pennsylvania law, to verify the patient's name, operative site including side and to document and complete the section on the patient's Consent Form (Appendix A) for such verification with signature, date and time."

1). A review on October 27, 2020, of MR5 revealed the patient was admitted to the ASF on August 11, 2020, for a colonoscopy and polyp removal procedure. The signed consent form did not contain the time of verification, the patient's name and operative site in the "Attending Surgeon's Verification" section of the consent form.

A review on October 27, 2020, of MR10 revealed the patient was admitted to the ASF on August 10, 2020, for an upper endoscopy procedure. The signed consent form did not contain the operative site in the "Attending Surgeon's Verification" section of the consent form.

A telephone interview conducted on December 9, 2020, at 1:46 PM with EMP1 confirmed the "Attending Surgeon's Verification" section on the consent form for MR5 and MR10 was not completed by the attending surgeon. MR5's and MR10's consent form should have been completed. EMP1 stated "They should enter the procedure they are doing in the verification section."

_____________________________
A review on October 27, 2020, of facility document "Consent for operation and rendering other medical services," not dated, revealed "5. I understand that if it is necessary for me to receive a blood transfusion during this procedure or immediate post-op period, the blood will be supplied by sources available to the hospital... I hereby consent to blood transfusion(s) and/or blood products(s)."

2). A review on October 27, 2020, of MR5 revealed the patient was admitted to the ASF on August 11, 2020, for a colonoscopy and polyp removal procedure. MR5's signed consent form included consent to receive a blood transfusion during the procedure or immediate post-op period.

A review on October 27, 2020, of MR10 revealed the patient was admitted to the ASF on August 10, 2020, for an upper endoscopy procedure. MR10's signed consent form included consent to receive a blood transfusion during the procedure or immediate post-op period.

A telephone interview conducted on December 9, 2020, at 1:46 PM with EMP1 confirmed the administration of blood products during the procedure or in the immediate postoperative period at the ASF was not in accordance with the license granted by the "Department" for an ASF. EMP1 further stated "Blood transfusion would not be applicable at the ambulatory surgery facility."

A telephone interview conducted on December 9, 2020, at 3:18 PM with EMP1 confirmed the facility adopted the "Consent for operation and rendering other medical services" form used by the Einstein Healthcare Network hospitals for the ASF.




Cross Reference:
551.21(e): Criteria For Ambulatory Surgery















Plan of Correction:

Procedure specific consent forms for Einstein Endoscopy Center Blue Bell were developed and approved for use on 01/13/2021. All Nursing staff were educated on the procedure specific consent forms by the Clinical Director on 01/26/2021. All providers were educated on the consent forms by the Medical Director via email on 01/27/2021 and education about the consent forms was posted at each provider's workstation. The procedure specific consent forms for Einstein Endoscopy Center Blue Bell will be used for all patients beginning 02/01/2021.

Ten charts per month will be audited, to ensure the correct consent forms are being used, for three months or until 100% compliance is achieved. Charts will be selected by reviewing every other chart for a maximum of two charts per day until ten charts are achieved for the month.

The Einstein Endoscopy Center Blue Bell Board Quality Committee and the Einstein Endoscopy Center Blue Bell Board of Trustees will receive monthly updates regarding compliance with the above noted Plan of Correction.

The site Administrator or designee has overall responsibility for this Plan of Correction.

Completion Date:
04/30/2021



553.25 (1-6) LICENSURE
Discharge Criteria

Name - Component - 00
553.25 Discharge Criteria

A patient may only be discharged from an ASF if the following physical status criteria are met:
(1) Vital signs. Blood pressure, heart rate, temperature and respiratory rate are within the normal range for the patient's age or at preoperative levels for that patient.
(2) Activity. The patient has regained preoperative mobility without assistance or syncope, or function at his usual level considering limitations imposed by the surgical procedure.
(3) Mental status. The patient is awake, alert or functions at his preoperative mental status.
(4) Pain. The patient's pain can be effectively controlled with medication.
(5) Bleeding. Bleeding is controlled and consistent with that expected from the surgical procedure.
(6) Nausea/vomiting. Minimal nausea or vomiting is controlled and consistent with that expected from the surgical procedure.

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 discharge criteria as per the facility's policy prior to discharge for one of ten medical records reviewed (MR10).

Findings include:

A review on October 5, 2020, of the facility's policy "Post-Operative Recovery of the GI Patient" last revised June 24, 2020, revealed "The post-operative GI (Gastro-intestinal) patient will be monitored until the patient meets discharge criteria. Parameters to be monitored include: Consciousness level, Hemodynamic parameters, Oxygenation, Pain level... A patient will be deemed suitable for discharge when discharge criteria are met."

A review on October 27, 2020, of MR10, admitted on August 10, 2020, for an upper endoscopy procedure, revealed no evidence of documentation that the patient had met the required discharge criteria for vital signs, activity, mental status, pain, bleeding and nausea/vomiting prior to discharge.

A telephone interview conducted on October 27, 2020, at 12:20 PM with EMP2 confirmed MR10 did not contain the required discharge criteria for vital signs, activity, mental status, pain, bleeding and nausea/vomiting. EMP2 stated "I cannot find the nurse's post surgical assessment form in the medical record." The facility was unable to provide the nurse's post surgical assessment form documenting required discharge criteria as requested by the survey team.



Cross Reference:
555.24 Post Operative Care
555.33 Anesthesia Policies and Procedures
















Plan of Correction:

Nurses will conduct and document a post-surgical assessment prior to the patient being discharged. The Clinical Director educated nursing staff at a staff meeting on 01/26/2021 regarding this process. A checklist has been posted in the Nurse's Station and workflow cards have been mounted on all Workstations on Wheels.

10% of charts will be audited per month until 100% compliance is achieved for three consecutive months. Charts will be selected by reviewing every other chart for a maximum of two charts per day until 10% of charts are achieved for the month.

The Einstein Endoscopy Center Blue Bell Board Quality Committee and the Einstein Endoscopy Center Blue Bell Board of Trustees will receive monthly updates regarding compliance with the above noted Plan of Correction.

The Clinical Director or designee has overall responsibility for this Plan of Correction.

Completion Date:
04/30/2021



555.24 (g) LICENSURE
Surgical Services - Postoperative

Name - Component - 00
555.24 Post Operative Care

(g) Patients shall be discharged only upon the written signed order of a practitioner.


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 patient's were discharged based upon a practitioner's written discharge order for one of one medical record reviewed (MR10).
Findings include:
A review on October 5, 2020, of the facility's policy "Patient Discharge" last revised July 1, 2018, revealed "Policy. Patients are discharged upon the order of a physician or physician extender."
A review on October 27, 2020, of MR10, admitted on August 10, 2020, for an upper endoscopy procedure, revealed no order for discharge was in the medical record.

A telephone interview conducted on October 27, 2020, at 12:23 PM with EMP2 confirmed MR10 did not contain an order for discharge. EMP2 stated "I am not able to find an order for discharge." The facility was unable to provide an order for the patient's discharge as requested by the survey team.


Cross Reference:
553.25 Discharge Criteria
555.33 Anesthesia Policies and Procedures
















Plan of Correction:

Gastroenterology (GI) practitioners will enter a written order for discharge in the electronic medical record. The Medical Director has educated the GI practitioners by email on 01/27/2021. Read receipt will be tracked and maintained in the file.

10% of charts will be audited per month until 100% compliance is achieved for three consecutive months. Charts will be selected by viewing every other chart for a maximum of two charts per day until 10% of charts are achieved for the month.

The Einstein Endoscopy Center Blue Bell Board Quality Committee and the Einstein Endoscopy Center Blue Bell Board of Trustees will receive monthly updates regarding compliance with the above noted Plan of Correction.

The site Administrator, or designee, and the site Medical Director have overall responsibility for this Plan of Correction.

Completion Date:
04/30/2021



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 one of ten medical records reviewed (MR5).

Findings include:

A review on October 5, 2020, of the facility's policy "PACU Level II Discharge Criteria" last revised July 1, 2018, revealed "II. Policy. Patients post procedure will be discharged to the appropriate destination after meeting the following criteria. All patients receiving monitored anesthesia care must be evaluated and discharged by an anesthesiologist.

A review on October 5, 2020, of MR5, admitted on August 11, 2020, revealed the patient received monitored anesthesia care for a colonoscopy and polyp removal procedure. Further review revealed no documented evidence that MR5 was evaluated by an anesthesiologist prior to discharge.

An interview conducted on October 5, 2020, at 2:30 PM with EMP2 confirmed there was no documented evidence that an anesthesiologist evaluated MR5 prior to discharge for the monitored anesthesia care received during the surgical procedure performed at the ambulatory surgical facility (ASF).



Cross Reference:
555.24 Post Operative Care
553.25 Discharge Criteria.
















Plan of Correction:

Anesthesiologists will evaluate each patient prior to discharge to ensure that all discharge criteria have been met. The Medical Director educated the anesthesiologists of the need to evaluate the patient for proper anesthesia recovery prior to discharge via email on 01/27/2021. Read receipt will be tracked and maintained in the file. This requirement was also reinforced at the 01/28/2021 faculty meeting.

10% of charts will be audited per month until 100% compliance is achieved for three consecutive months. Charts will be selected by viewing every other chart for a maximum of two charts per day until 10% of charts are achieved for the month.

The Einstein Endoscopy Center Blue Bell Board Quality Committee and the Einstein Endoscopy Center Blue Bell Board of Trustees will receive monthly updates regarding compliance with the above noted Plan of Correction.

The site Medical Director has overall responsibility for this Plan of Correction.

Completion Date:
04/30/2021