QA Investigation Results

Pennsylvania Department of Health
ENDOSCOPY CENTER OF THE PENNSYLVANIA HOSPITAL, THE
Health Inspection Results
ENDOSCOPY CENTER OF THE PENNSYLVANIA HOSPITAL, THE
Health Inspection Results For:


There are  23 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 full Medicare recertification survey conducted on October 24, 2018, and completed on October 25, 2018, at the Endoscopy Center Of The Pennsylvania Hospital. It was determined that the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions of Participation for Ambulatory Surgical Centers.









Plan of Correction:




416.45(a) STANDARD
MEMBERSHIP AND CLINICAL PRIVILEGES

Name - Component - 00
Members of the medical staff must be legally and professionally qualified for the positions to which they are appointed and for the performance of privileges granted. The ASC grants privileges in accordance with recommendations from qualified medical personnel.


Observations:
Based on a review of facility documents, credential files (CF) and interviews with staff it was determined that the Governing Body failed to ensure that anesthesia privileges approved for physicians of the Endoscopy Center are congruent with the type of anesthesia approved for the facility by the Department of Health (Department) as documented on the facility's license for three of three credential files reviewed (CF2, CF3, CF4).

Findings include:

A review of the facility"s annual license issued by the Department effective November 30, 2017, revealed: Registration Status: Class B; Type of Anesthesia: Moderate Sedation; Physical Status: PS3 with an approved exception dated June 3, 2013.

A review on October 25, 2018, of CF2, "Endoscopy Center of Pennsylvania Hospital Provider Privileges" revealed "This delineation is in effect from July 1, 2018, to March 31, 2019. Specialities: Anesthesiology. Further review revealed the privileges were approved and signed on March 16, 2017, by EMP7. There was no evidence of documentation that the approved anesthesiology privilege was specific to moderate sedation.

A review on October 25, 2018, of CF3, "Endoscopy Center of Pennsylvania Hospital Provider Privileges" revealed "This delineation is in effect from August 20, 2018, to July 31, 2020. Specialities: Anesthesiology. Further review revealed the privileges were approved and signed on June 28, 2018, by EMP6. There was no evidence of documentation that the approved anesthesiology privilege was specific to moderate sedation.

A review on October 25, 2018, of CF4, "Endoscopy Center of Pennsylvania Hospital Provider Privileges" revealed "This delineation is in effect from March 2017, to February 28, 2019. Specialities: Anesthesiology. Further review revealed the privileges were approved and signed on January 23, 2017, by EMP6. There was no evidence of documentation that the approved anesthesiology privilege was specific to moderate sedation.

An interview conducted on October 25, 2018, at 1:30 PM with EMP1 and EMP2 confirmed CF2, CF3 and CF4 was approved for anesthesiology privileges which included moderate sedation and general anesthesia at the Endoscopy Center of the Pennsylvania Hospital.











Plan of Correction:

Q0121
The Administrative Director and the Medical Director of the Endoscopy Center of Pennsylvania Hospital are responsible for the following corrective actions.
The Manager of the Corporate Office of Medical Affairs ("OMA") notified the Chairman of the Department of Anesthesia on October 24, 2018 that the privileges currently approved for Anesthesia providers privileged at the Endoscopy Center of Pennsylvania Hospital were not an accurate reflection of the authorized procedures for the Endoscopy Center by the Department of Health (DOH) ASF licensure.
The administrative director and the Medical Director of the Endoscopy Center of Pennsylvania Hospital are responsible for the following corrective actions:
1. The Corporate Office of Medical Affairs ("OMA") reviewed all current Anesthesia provider privileges. At that time edits and deletions were completed on each practitioner's privilege listing document. This was to assure an accurate list that reflects only the anesthesia procedures authorized by the DAAC ASF licensure. All privileges that were listed and found to not be an authorized procedure at the ASF licensed Endoscopy Center of Pennsylvania Hospital were removed.
2. The edited and now accurate privilege lists for all Anesthesiologists practicing at the Endoscopy center were submitted and approved by the organization's Medical Staff Credentialing Committee on November 7, 2018. The Medical Staff Executive Committee approved all the anesthesiologist applications from the Credentialing Committee on November 12, 2018 and the Board of Managers Executive Committee approved all the Endoscopy Center Anesthesiologists revised privledge lists November 12, 2018.
3. The Corporate Director of OMA re-educated the Manager of OMA regarding the necessity of assuring accuracy of privileging lists by reviewing with Administration/clinical staff during onboarding and at the time of re-privileging cycles. All provider applications for privileges are to be reviewed by both the Department Chairman and OMA Manager to verify that the privileges reflect only procedures authorized by licensure to be performed at the Endoscopy Center.
4. The Chief Medical Officer issued an educational bulletin 2/6/2019 to the Chairmen of the Anesthesia department and to all current members of the Credentials Committee. The education addressed the importance that privileging reviews, reports and recommendations for re-appointment are accurate from the department before the Credentials Committee approves and advances to the Board of Managers for final approval. Acknowledgment of having received and understanding the education will be tracked using an electronic "Read/Received receipt"
5. The OMA personnel will perform and document a new process to review of privileges with responsible department chairman/clinical leadership to assure facility procedures approved matches the medical staff privileges list for the Endoscopy Center.
6. The Endoscopy Center Nurse Manager will check the online resource to check that all provider privilege lists are accurate for medical staff at the Endoscopy. The once a month auditing activity will be performed till three months of sustained compliance achieved. The Endoscopy Center Nurse Manager will review all medical staff newly privileged for the Endoscopy Center to verify that the provider has the accurate approved privileges prior to clinical practice at the Endoscopy Center. The re-credential/re-privledge cycle occurs bi-annually for all medical staff so at each renewal period the online listing will be checked for accuracy of privileges approved and posted for staff reference.



416.47(b) STANDARD
FORM AND CONTENT OF RECORD

Name - Component - 00
The ASC must maintain a medical record for each patient. Every record must be accurate, legible, and promptly completed. Medical records must include at least the following:

(1) Patient identification.
(2) Significant medical history and results of physical examination.
(3) Pre-operative diagnostic studies (entered before surgery), if performed.
(4) Findings and techniques of the operation, including a pathologist's report on all tissues removed during surgery, except those exempted by the governing body.
(5) Any allergies and abnormal drug reactions.
(6) Entries related to anesthesia administration.
(7) Documentation of properly executed informed patient consent.
(8) Discharge diagnosis.

Observations:

Based on review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to ensure that the medical record was accurate and complete for eight of eight medical records reviewed (MR1 through MR8).

Findings include:

Review of facility policy #805 "Purpose and Content of the Medical Records" last reviewed 2/07 revealed "...Guidelines: 1. A complete, concise medical record will be maintained on each patient in a consistent manner."

1. A review on October 25, 2018, of MR1 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on March 22, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR2 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on October 8, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR3 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on August 15, 2018, which contained the incorrect name of the physician performing the procedure in the" Agreement" section of the patient consent form.

A review on October 25, 2018, of MR4 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on August 15, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR5 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on October 9, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR6 revealed EMP12 obtained a signed patient consent form for performing a Upper Gastrointestinal Endoscopy procedure on October 9, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR8 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on October 9, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

An interview conducted on October 25, 2018, at 12:00PM with EMP1 and EMP2 confirmed that MR1 through MR6 and MR8 contained the incorrect name of the physician performing the procedure in the "Agreement" section of the consent forms.

2. A review on October 25, 2018, of MR7 revealed EMP13 obtained a signed patient consent form for performing a Colonoscopy procedure on October 24, 2018, "Agreement: The information on this form was explained to me by _______________. I understand the information and I have had the opportunity to ask any questions that I might have regarding a colonoscopy, the reasons the procedure is being performed, the associated potential risks and complications, and the possible alternative forms of evaluation and treatment. I agree to undergo the procedure to be performed by _____________... . " Further review of the signed consent form revealed the "Agreement" section of the consent form was not completed.

An interview conducted on October 25, 2018, at 12:10 PM with EMP1 and EMP2 confirmed that the "Agreement "section of the signed consent form obtained by EMP13 for MR7 was incomplete. EMP2 stated "I have no explanation to offer as to why this was not completed."













Plan of Correction:

Standard Form and Content of Record

POC: The Endoscopy Center of Pennsylvania Hospital ("Endoscopy Center") will require procedural consents forms to be accurate and complete through the initiation of a new process called the "Red Sign" STOP process (POLICY PEC2). Beginning 2/1/2019, the following steps have been initiated for each patient:
- Upon patient arrival to the preoperative patient bay, a red stop sign is physically posted indicating "STOP, the patient is not ready to proceed back to the procedure room".
- After traditional preoperative care is completed, the RN performs a final check to verify that consent documentation is complete. In particular, the "Agreement section" of the procedural consent form will be double checked. Any documentation issues are brought to the appropriate practitioner's attention and are rectified prior to the patient proceeding to the procedure room.
- A final chart verification is performed by the RN. Once the documentation requirements are met, including a complete consent form, the red sign is removed by the RN, indicating that the patient is ready to proceed to the procedure room. Only the preoperative RN is permitted to remove the stop sign and allow transition to the next phase of care.

Staff Education related to this new process has been completed as of January 31,2019 by the Endoscopy Center Director of Nursing. Evidence of the education will be provided by a sign-in sheet.

The Medical Director will issue an educational bulletin on 2/7/2019 to all physician providers practicing at the center. The education will address the deficiency and details related to the new "Red Sign" STOP process described above. Acknowledgment of having received and understanding the education will be tracked using an electronic "Read/Received receipt" The bulletin and "Read/Received receipt" log will be available for review on the unit and will demonstrate 100% compliance by February 14, 2019.

A policy (POLICY PEC2) was developed to describe this modification in practice. It was reviewed and approved at the January 15, 2019 Endoscopy Center CEQI Quarterly Meeting and will be presented for approval at the next scheduled Pennsylvania Hospital Board of Managers ASF/Coordinating Committee meeting.

20 chart audits / month will be performed by the Endoscopy Center Director of Nursing or designee to verify that the "Agreement section" of the patient consent form is complete. Any charts identified as noncompliant will be investigated and reviewed with the responsible practitioner. Chart audits will continue until 100% compliance is sustained for 2 quarters. Chart audits will begin in February 2019. Audit findings will be presented at the Endoscopy Center Clinical Effectiveness and Quality Improvement Committee (CEQI) meetings for 2 quarters of sustained compliance and thereafter as needed as part of the quality assurance and performance improvement activities.

The Endoscopy Center's Administrative Director and Medical Director will be responsible for ensuring action items are complete as stated above.




416.51(a) STANDARD
SANITARY ENVIRONMENT

Name - Component - 00
The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.



Observations:

Based on a review of facility policy, observation and interview with staff (EMP), it was determined that the facility failed to maintain sanitary standards of practice for injectable medication administration during a surgical procedure.

A review of facility policy "Surgical Attire" last reviewed on April 2015 revealed "... . 8. Protective Barriers. A. Protective barriers are available to reduce risk of exposure. These include: sterile and non-sterile gloves are to be worn dependent upon task to be performed and are changed when soiled and between patient contact..."

1. Observation on October 24, 2018, of a surgical procedure for MR1 in Procedure Room One at 1:27 PM revealed EMP5 administered a liquid medication (Propofol) used for sedation through a syringe into the intravenous catheter of MR1 without donning gloves prior to the injection. Additonal observation at 1:30 PM revealed EMP5 administering additional sedation (Propofol) medication through a syringe into the patient's intravenous catheter without donning gloves prior to the injection.

An interview conducted on October 24, 2018, at 2:05 PM with EMP2 confirmed that EMP5 did not follow the facility's policy when administering the sedation medication (Propofol) through a syringe into the intravenous catheter of MR1 in Procedure Room One without donning gloves prior to the injection.

______________


Based on review of facility policy, observation and interviews with staff (EMP), it was determined that the facility failed to prohibit the use of artificial fingernails and/or extenders for personnel when having direct contact with patients.

Findings include:

Review of facility policy "Surgical Attire" last reviewed April 2015 revealed " 5. Hands. A. Fingernails must be kept short, clean and healthy. Artificial nails may not be worn. Artificial nails harbor organisms and prevent effective hand washing. Nail polish may not be worn.

2. Observation on October 24, 2018, at 1:27PM in Procedure Room One during a surgical procedure for MR1 revealed EMP5 with artificial nails and/or extenders, with black nail polish and a clear stone design on the nail of the fourth finger of the left and right hand.

An interview conducted on October 24, 2018, at 2:05 PM with EMP2 confirmed that EMP5 was not in compliance with the facility's policy regarding the use of artificial nails and nail polish. EMP2 stated "I will need to speak with her about the failure to follow the facility's policy."

________________________

Based on review of facility policy, documents and interviews with staff (EMP), it was determined that the facility failed to provide and maintain documentation of end of the day daily cleaning for Procedure Rooms One, Two and Three (Procedure Rooms One through, Three).

A review of facility document "Resolution Approving Governance Organizational Structure of the Endoscopy Center of Pennsylvania Hospital Licensed as an Ambulatory Surgical Facility (ASF)." last reviewed May 21, 2013 revealed "b) The governing body of PAH, the Board of managers, will be the governing body of the ... and the Endoscopy Center. The Chair of the Board of Managers will appoint a standing Board Committee, to be renamed as the Tuttleman/ASF Coordinating Committee. This Board Committee will have oversight for the day to day operations of the Endoscopy Center... . With respect to the Endoscopy Center, the Tuttleman/ASF Coordinating Committee provides oversight to the following and reports annually to the Board: i)...ii)Endoscopy Center clinical, operations and administrative services; iii) Endoscopy Center patient safety, quality and infection control activities;...vi) Review and approval of amended policies and procedures and adoption of additonal policies and procedures for the operation of the Endoscopy Center. 2) Free Standing medical Ambulatory Surgical center. The Endoscopy Center will be a free-standing Ambulatory Surgical Center pursuant to CMS regulations and will have its own Medicare provider number."

A review of facility policy "Infection Prevention Plan-FY18" last revised November 2017, revealed "A. The Infection Prevention Plan covers the care, treatment and services for all Pennsylvania Hospital and all off-campus licensed facilities and ambulatory surgical facilities including but not limited to the...and Endoscopy Center."

A request was made for evidence of documentation for end of day cleaning for Procedure Rooms One, Two and Three during an interview on October 24, 2018, at 2:55 PM with EMP1, EMP2 and EMP3. The facility was unable to produce documentation that Procedure Rooms One, Two and Three had been cleaned for this re-licensure survey period.

An interview conducted on October 24, 2018, at 3:05 PM with EMP1, EMP2 and EMP3 confirmed the facility did not have documentation that Procedure Rooms One, Two and Three were cleaned daily at the end of the day. EMP2 stated "We do not have documentation that the contractor we hired to complete the end of day cleaning in Procedure Rooms One, Two and Three is completing the cleaning. We do not have documentation that we audit the contractor's cleaning services for the Procedure Rooms. The facility was unable to provide a cleaning policy for the Procedure Rooms. In addition, the facility was unable to provide a policy for end of day cleaning for Procedure Rooms One, Two and Three.

























































Plan of Correction:

The Endoscopy Center of Pennsylvania Hospital ("Endoscopy Center") will maintain sanitary standards of practice for injectable medication administration during procedures and enforce policies concerning appropriate surgical attire of anesthesia providers involved in direct patient contact.

This will be achieved via the following actions:

The Endoscopy Center will provide all anesthesia providers who practice at the Endoscopy Center education concerning sanitary standards of practice for injectable medication administration and proper surgical attire during a procedure. This education will be provided via internal email communication. The education will consist of a power point presentation which includes the surgical attire policy (SS-12) and education concerning sanitary standards of practice for injectable medication administration. Education will focus on the requirement of donning gloves prior to administering medication(s) via a syringe through an intravenous line. Policy SS-12 mandates that fingernails of any "healthcare personnel who have direct patient contact must be kept short, clean and healthy. Artificial nails may not be worn. Artificial nails harbor organisms and prevent effective hand washing. Nail polish may not be worn."

Acknowledgment of having received the education will be tracked using an electronic "Read/Received receipt" The power point education and "Read/Received receipt" log will be available for review on the unit and will demonstrate 100% compliance by January 31, 2019.

Compliance related to the surgical attire policy and the requirement to wear gloves during administration of Injectable medication(s) via an intravenous line will be monitored via observations/audits conducted by the Endoscopy Center Director of Nursing or designee. Beginning in January 2019, the Director of Nursing or designee will complete 20 observations/month. Any deficiencies noted will be reviewed with the responsible practitioner at the time of the occurrence. Observations (20 / month) will continue until 100% compliance is sustained for 2 quarters. Findings will be presented at the Endoscopy Center Quarterly Clinical Effectiveness and Quality Improvement Committee (CEQI) meetings for 2 quarters of sustained compliance and thereafter as needed as part of the quality assurance and performance improvement activities.


The Endoscopy Center's Administrative Director will be responsible for ensuring action items are complete as stated above.



Initial Comments:
This report is the result of a full State Licensure survey conducted on October 24 2018, and completed on October 25, 2018, at the Endoscopy Center Of The Pennsylvania Hospital. 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:




555.3 (d)(1) LICENSURE
Requirements

Name - Component - 00
555.3 Requirements for membership and privileges.

(d) Granting of clinical privileges shall follow established policies and procedures in the bylaws or similar rules and regulations the procedures shall provide the following.
(1) Written record of the application, which includes the scope of
privileges sought and granted. The delineation "clinical privileges" shall address the administration of anesthesia.


Observations:
Based on a review of facility documents, credential files (CF) and interviews with staff it was determined that the Governing Body failed to ensure that anesthesia privileges approved for physicians of the Endoscopy Center are congruent with the type of anesthesia approved for the facility by the Department of Health (Department) as documented on the facility's license for three of three credential files reviewed (CF2, CF3, CF4).

Findings include:

A review of the facility"s annual license issued by the Department effective November 30, 2017, revealed: Registration Status: Class B; Type of Anesthesia: Moderate Sedation; Physical Status: PS3 with an approved exception dated June 3, 2013.

A review on October 25, 2018, of CF2, "Endoscopy Center of Pennsylvania Hospital Provider Privileges" revealed "This delineation is in effect from July 1, 2018, to March 31, 2019. Specialities: Anesthesiology. Further review revealed the privileges were approved and signed on March 16, 2017, by EMP7. There was no evidence of documentation that the approved anesthesiology privilege was specific to moderate sedation.

A review on October 25, 2018, of CF3, "Endoscopy Center of Pennsylvania Hospital Provider Privileges" revealed "This delineation is in effect from August 20, 2018, to July 31, 2020. Specialities: Anesthesiology. Further review revealed the privileges were approved and signed on June 28, 2018, by EMP6. There was no evidence of documentation that the approved anesthesiology privilege was specific to moderate sedation.

A review on October 25, 2018, of CF4, "Endoscopy Center of Pennsylvania Hospital Provider Privileges" revealed "This delineation is in effect from March 2017, to February 28, 2019. Specialities: Anesthesiology. Further review revealed the privileges were approved and signed on January 23, 2017, by EMP6. There was no evidence of documentation that the approved anesthesiology privilege was specific to moderate sedation.

An interview conducted on October 25, 2018, at 1:30 PM with EMP1 and EMP2 confirmed CF2, CF3 and CF4 was approved for anesthesiology privileges which included moderate sedation and general anesthesia at the Endoscopy Center of the Pennsylvania Hospital.









Plan of Correction:

The Administrative Director and the Medical Director of the Endoscopy Center of Pennsylvania Hospital are responsible for the following corrective actions.
The Manager of the Corporate Office of Medical Affairs ("OMA") notified the Chairman of the Department of Anesthesia on October 24, 2018 that the privileges currently approved for Anesthesia providers privileged at the Endoscopy Center of Pennsylvania Hospital were not an accurate reflection of the authorized procedures for the Endoscopy Center by the Department of Health (DOH) ASF licensure.
The administrative director and the Medical Director of the Endoscopy Center of Pennsylvania Hospital are responsible for the following corrective actions:
1. The Corporate Office of Medical Affairs ("OMA") reviewed all current Anesthesia provider privileges. At that time edits and deletions were completed on each practitioner's privilege listing document. This was to assure an accurate list that reflects only the anesthesia procedures authorized by the DAAC ASF licensure. All privileges that were listed and found to not be an authorized procedure at the ASF licensed Endoscopy Center of Pennsylvania Hospital were removed.
2. The edited and now accurate privilege lists for all Anesthesiologists practicing at the Endoscopy center were submitted and approved by the organization's Medical Staff Credentialing Committee on November 7, 2018. The Medical Staff Executive Committee approved all the anesthesiologist applications from the Credentialing Committee on November 12, 2018 and the Board of Managers Executive Committee approved all the Endoscopy Center Anesthesiologists revised privledge lists November 12, 2018.
3. The Corporate Director of OMA re-educated the Manager of OMA regarding the necessity of assuring accuracy of privileging lists by reviewing with Administration/clinical staff during onboarding and at the time of re-privileging cycles. All provider applications for privileges are to be reviewed by both the Department Chairman and OMA Manager to verify that the privileges reflect only procedures authorized by licensure to be performed at the Endoscopy Center.
4. The Chief Medical Officer issued an educational bulletin 2/6/2019 to the Chairmen of the Anesthesia department and to all current members of the Credentials Committee. The education addressed the importance that privileging reviews, reports and recommendations for re-appointment are accurate from the department before the Credentials Committee approves and advances to the Board of Managers for final approval. Acknowledgment of having received and understanding the education will be tracked using an electronic "Read/Received receipt"
5. The OMA personnel will perform and document a new process to review of privileges with responsible department chairman/clinical leadership to assure facility procedures approved matches the medical staff privileges list for the Endoscopy Center.
6. The Endoscopy Center Nurse Manager will check the online resource to check that all provider privilege lists are accurate for medical staff at the Endoscopy. The once a month auditing activity will be performed till three months of sustained compliance achieved. The Endoscopy Center Nurse Manager will review all medical staff newly privileged for the Endoscopy Center to verify that the provider has the accurate approved privileges prior to clinical practice at the Endoscopy Center. The re-credential/re-privledge cycle occurs bi-annually for all medical staff so at each renewal period the online listing will be checked for accuracy of privileges approved and posted for staff reference.




563.1 LICENSURE
CHAPTER 563 - MEDICAL RECORDS - Principle

Name - Component - 00
563.1 Principle

The ASF shall maintain complete, comprehensive and accurate medical
records for every patient to ensure adequate patient care.


Observations:

Based on review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to ensure that the medical record was accurate and complete for eight of eight medical records reviewed (MR1 through MR8).

Findings include:

Review of facility policy #805 "Purpose and Content of the Medical Records" last reviewed 2/07 revealed "...Guidelines: 1. A complete, concise medical record will be maintained on each patient in a consistent manner."

1. A review on October 25, 2018, of MR1 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on March 22, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR2 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on October 8, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR3 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on August 15, 2018, which contained the incorrect name of the physician performing the procedure in the" Agreement" section of the patient consent form.

A review on October 25, 2018, of MR4 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on August 15, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR5 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on October 9, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR6 revealed EMP12 obtained a signed patient consent form for performing a Upper Gastrointestinal Endoscopy procedure on October 9, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

A review on October 25, 2018, of MR8 revealed EMP12 obtained a signed patient consent form for performing a Colonoscopy procedure on October 9, 2018, which contained the incorrect name of the physician performing the procedure in the "Agreement" section of the patient consent form.

An interview conducted on October 25, 2018, at 12:00PM with EMP1 and EMP2 confirmed that MR1 through MR6 and MR8 contained the incorrect name of the physician performing the procedure in the "Agreement" section of the consent forms.

2. A review on October 25, 2018, of MR7 revealed EMP13 obtained a signed patient consent form for performing a Colonoscopy procedure on October 24, 2018, "Agreement: The information on this form was explained to me by _______________. I understand the information and I have had the opportunity to ask any questions that I might have regarding a colonoscopy, the reasons the procedure is being performed, the associated potential risks and complications, and the possible alternative forms of evaluation and treatment. I agree to undergo the procedure to be performed by _____________... . " Further review of the signed consent form revealed the "Agreement" section of the consent form was not completed.

An interview conducted on October 25, 2018, at 12:10 PM with EMP1 and EMP2 confirmed that the "Agreement "section of the signed consent form obtained by EMP13 for MR7 was incomplete. EMP2 stated "I have no explanation to offer as to why this was not completed."












Plan of Correction:

POC: The Endoscopy Center of Pennsylvania Hospital ("Endoscopy Center") will require procedural consents forms to be accurate and complete through the initiation of a new process called the "Red Sign" STOP process (POLICY PEC2). Beginning 2/1/2019, the following steps have been initiated for each patient:
- Upon patient arrival to the preoperative patient bay, a red stop sign is physically posted indicating "STOP, the patient is not ready to proceed back to the procedure room".
- After traditional preoperative care is completed, the RN performs a final check to verify that consent documentation is complete. In particular, the "Agreement section" of the procedural consent form will be double checked. Any documentation issues are brought to the appropriate practitioner's attention and are rectified prior to the patient proceeding to the procedure room.
- A final chart verification is performed by the RN. Once the documentation requirements are met, including a complete consent form, the red sign is removed by the RN, indicating that the patient is ready to proceed to the procedure room. Only the preoperative RN is permitted to remove the stop sign and allow transition to the next phase of care.

Staff Education related to this new process has been completed as of January 31,2019 by the Endoscopy Center Director of Nursing. Evidence of the education will be provided by a sign-in sheet.

The Medical Director will issue an educational bulletin on 2/7/2019 to all physician providers practicing at the center. The education will address the deficiency and details related to the new "Red Sign" STOP process described above. Acknowledgment of having received and understanding the education will be tracked using an electronic "Read/Received receipt" The bulletin and "Read/Received receipt" log will be available for review on the unit and will demonstrate 100% compliance by February 14, 2019.

A policy (POLICY PEC2) was developed to describe this modification in practice. It was reviewed and approved at the January 15, 2019 Endoscopy Center CEQI Quarterly Meeting and will be presented for approval at the next scheduled Pennsylvania Hospital Board of Managers ASF/Coordinating Committee meeting.

20 chart audits / month will be performed by the Endoscopy Center Director of Nursing or designee to verify that the "Agreement section" of the patient consent form is complete. Any charts identified as noncompliant will be investigated and reviewed with the responsible practitioner. Chart audits will continue until 100% compliance is sustained for 2 quarters. Chart audits will begin in February 2019. Audit findings will be presented at the Endoscopy Center Clinical Effectiveness and Quality Improvement Committee (CEQI) meetings for 2 quarters of sustained compliance and thereafter as needed as part of the quality assurance and performance improvement activities.

The Endoscopy Center's Administrative Director and Medical Director will be responsible for ensuring action items are complete as stated above.




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 a review of facility policy, observation and interview with staff (EMP), it was determined that the facility failed to maintain sanitary standards of practice for injectable medication administration during a surgical procedure.

A review of facility policy "Surgical Attire" last reviewed on April 2015 revealed "... . 8. Protective Barriers. A. Protective barriers are available to reduce risk of exposure. These include: sterile and non-sterile gloves are to be worn dependent upon task to be performed and are changed when soiled and between patient contact..."

1. Observation on October 24, 2018, of a surgical procedure for MR1 in Procedure Room One at 1:27 PM revealed EMP5 administered a liquid medication (Propofol) used for sedation through a syringe into the intravenous catheter of MR1 without donning gloves prior to the injection. Additonal observation at 1:30 PM revealed EMP5 administering additional sedation (Propofol) medication through a syringe into the patient's intravenous catheter without donning gloves prior to the injection.

An interview conducted on October 24, 2018, at 2:05 PM with EMP2 confirmed that EMP5 did not follow the facility's policy when administering the sedation medication (Propofol) through a syringe into the intravenous catheter of MR1 in Procedure Room One without donning gloves prior to the injection.

______________


Based on review of facility policy, observation and interviews with staff (EMP), it was determined that the facility failed to prohibit the use of artificial fingernails and/or extenders for personnel when having direct contact with patients.

Findings include:

Review of facility policy "Surgical Attire" last reviewed April 2015 revealed " 5. Hands. A. Fingernails must be kept short, clean and healthy. Artificial nails may not be worn. Artificial nails harbor organisms and prevent effective hand washing. Nail polish may not be worn.

2. Observation on October 24, 2018, at 1:27PM in Procedure Room One during a surgical procedure for MR1 revealed EMP5 with artificial nails and/or extenders, with black nail polish and a clear stone design on the nail of the fourth finger of the left and right hand.

An interview conducted on October 24, 2018, at 2:05 PM with EMP2 confirmed that EMP5 was not in compliance with the facility's policy regarding the use of artificial nails and nail polish. EMP2 stated "I will need to speak with her about the failure to follow the facility's policy."

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Based on review of facility policy, documents and interviews with staff (EMP), it was determined that the facility failed to provide and maintain documentation of end of the day daily cleaning for Procedure Rooms One, Two and Three (Procedure Rooms One through, Three).

A review of facility document "Resolution Approving Governance Organizational Structure of the Endoscopy Center of Pennsylvania Hospital Licensed as an Ambulatory Surgical Facility (ASF)." last reviewed May 21, 2013 revealed "b) The governing body of PAH, the Board of managers, will be the governing body of the ... and the Endoscopy Center. The Chair of the Board of Managers will appoint a standing Board Committee, to be renamed as the Tuttleman/ASF Coordinating Committee. This Board Committee will have oversight for the day to day operations of the Endoscopy Center... . With respect to the Endoscopy Center, the Tuttleman/ASF Coordinating Committee provides oversight to the following and reports annually to the Board: i)...ii)Endoscopy Center clinical, operations and administrative services; iii) Endoscopy Center patient safety, quality and infection control activities;...vi) Review and approval of amended policies and procedures and adoption of additonal policies and procedures for the operation of the Endoscopy Center. 2) Free Standing medical Ambulatory Surgical center. The Endoscopy Center will be a free-standing Ambulatory Surgical Center pursuant to CMS regulations and will have its own Medicare provider number."

A review of facility policy "Infection Prevention Plan-FY18" last revised November 2017, revealed "A. The Infection Prevention Plan covers the care, treatment and services for all Pennsylvania Hospital and all off-campus licensed facilities and ambulatory surgical facilities including but not limited to the...and Endoscopy Center."

A request was made for evidence of documentation for end of day cleaning for Procedure Rooms One, Two and Three during an interview on October 24, 2018, at 2:55 PM with EMP1, EMP2 and EMP3. The facility was unable to produce documentation that Procedure Rooms One, Two and Three had been cleaned for this re-licensure survey period.

An interview conducted on October 24, 2018, at 3:05 PM with EMP1, EMP2 and EMP3 confirmed the facility did not have documentation that Procedure Rooms One, Two and Three were cleaned daily at the end of the day. EMP2 stated "We do not have documentation that the contractor we hired to complete the end of day cleaning in Procedure Rooms One, Two and Three is completing the cleaning. We do not have documentation that we audit the contractor's cleaning services for the Procedure Rooms. The facility was unable to provide a cleaning policy for the Procedure Rooms. In addition, the facility was unable to provide a policy for end of day cleaning for Procedure Rooms One, Two and Three.






















Plan of Correction:

The Endoscopy Center of Pennsylvania Hospital ("Endoscopy Center") will maintain sanitary standards of practice for injectable medication administration during procedures and enforce policies concerning appropriate surgical attire of anesthesia providers involved in direct patient contact.

This will be achieved via the following actions:

The Endoscopy Center will provide all anesthesia providers who practice at the Endoscopy Center education concerning sanitary standards of practice for injectable medication administration and proper surgical attire during a procedure. This education will be provided via internal email communication. The education will consist of a power point presentation which includes the surgical attire policy (SS-12) and education concerning sanitary standards of practice for injectable medication administration. Education will focus on the requirement of donning gloves prior to administering medication(s) via a syringe through an intravenous line. Policy SS-12 mandates that fingernails of any "healthcare personnel who have direct patient contact must be kept short, clean and healthy. Artificial nails may not be worn. Artificial nails harbor organisms and prevent effective hand washing. Nail polish may not be worn."

Acknowledgment of having received the education will be tracked using an electronic "Read/Received receipt" The power point education and "Read/Received receipt" log will be available for review on the unit and will demonstrate 100% compliance by January 31, 2019.

Compliance related to the surgical attire policy and the requirement to wear gloves during administration of Injectable medication(s) via an intravenous line will be monitored via observations/audits conducted by the Endoscopy Center Director of Nursing or designee. Beginning in January 2019, the Director of Nursing or designee will complete 20 observations/month. Any deficiencies noted will be reviewed with the responsible practitioner at the time of the occurrence. Observations (20 / month) will continue until 100% compliance is sustained for 2 quarters. Findings will be presented at the Endoscopy Center Quarterly Clinical Effectiveness and Quality Improvement Committee (CEQI) meetings for 2 quarters of sustained compliance and thereafter as needed as part of the quality assurance and performance improvement activities.


The Endoscopy Center's Administrative Director will be responsible for ensuring action items are complete as stated above.



Initial Comments:
This report is the result of a full State Licensure survey conducted on October 24, 2018,and completed on October 25 , 2018, at the Endoscopy Center Of The Pennsylvania Hospital. 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 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.



Observations:

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

The Endoscopy Center of Pennsylvania Hospital was not in compliance with the following State law related to Act 110 of November 23, 2010, and subsequent provisions effective June 1, 2015, Health Care Facilities Act PHOTO IDENTIFICATION TAG REGULATIONS.

"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.

This is not met as evidenced by:

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

Findings include:

Review of the facility's policy "Photo Identification Badges" This policy also applies to: (i) those practices and sites that are off campus facilities or departments of Pennsylvania Hospital (PAH) and operating under its license;(ii) all ambulatory surgical facilities (ASF) owned and operated by PAH including e.g.... and Endoscopy Center of PAH; The Director of Security is responsible for assuring that no Photo Identification Badges are issued
without proper authorization as prescribed in this policy. The Director of Security is also responsible for assuring that identification badges are completed correctly and bear all required information."

A review of facility document "Resolution Approving Governance Organizational Structure of the Endoscopy Center of Pennsylvania Hospital Licensed as an Ambulatory Surgical Facility (ASF)." last reviewed May 21, 2013 revealed "b) The governing body of PAH, the Board of managers, will be the governing body of the ... and the Endoscopy Center. The Chair of the Board of Managers will appoint a standing Board Committee, to be renamed as the Tuttleman/ASF Coordinating Committee. This Board Committee will have oversight for the day to day operations of the Endoscopy Center... . With respect to the Endoscopy Center, the Tuttleman/ASF Coordinating Committee provides oversight to the following and reports annually to the Board: i)...ii) Endoscopy Center clinical, operations and administrative services; iii) Endoscopy Center patient safety, quality and infection control activities;...vi) Review and approval of amended policies and procedures and adoption of additonal policies and procedures for the operation of the Endoscopy Center. 2) Free Standing medical Ambulatory Surgical center. The Endoscopy Center will be a free-standing Ambulatory Surgical Center pursuant to CMS regulations and will have its own Medicare provider number."

1. Observation on October 25, 2018, of EMP2, EMP8, EMP9, EMP10 and EMP11 badges revealed the badges did not contain the name of the facility. Further observation revealed the badges contained the name Pennsylvania Hospital and did not contain the name of the facility "Endoscopy Center of the Pennsylvania Hospital".

An interview conducted on October 25, 2018, at 2:50 PM with EMP1 and EMP2 revealed the badges of EMP2, EMP8, EMP9, EMP10 and EMP11 did not contain the name of the facility (Endoscopy Center of the Pennsylvania Hospital). EMP1 confirmed that the employee's identification badges were not compliant with ACT 110.
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2. Observation on October 25, 2018, of EMP2's badge, a registered nurse revealed the badge did not contain the title "Registered Nurse" but contained an abbreviated title of "RN".

Observation on October 25, 2018, of EMP10's badge, a certified registered nurse anesthetist revealed an abbreviated title, "CRNA".

Observation of EMP11's badge, a lead gastrointestinal technician revealed an abbreviated title "Lead GI Tech".

An interview conducted on October 25, 2018, at 2:55 PM with EMP1 and EMP2 confirmed that the badges of EMP2, EMP10 and EMP11 used abbreviated titles.
EMP1 confirmed that EMP2, EMP8, EMP9, EMP10 and EMP11 were employees of the Endoscopy Center that provided direct patient care. EMP1 confirmed that the employee's identification badges were not compliant with ACT 110.













Plan of Correction:

Effective January 10, 2019, the Endoscopy Center of Pennsylvania Hospital ("Endoscopy Center") has provided Endoscopy Center staff with updated photo identification badges that meet the requirements of Act 110 and the associated PA. Department of Health regulations. Abbreviated staff titles have been removed from the badges and the "Endoscopy Center of Pennsylvania Hospital" is now clearly visible on the badges. The badges also identify the four titles of "Physician", "Registered Nurse", "Endoscopy Technician", "Medical Assistant" or "Nurse Anesthetist".

In collaboration with Human Resources and the Director of Security, an updated template was created in the photo identification badge creation software. This template is specific to the Endoscopy Center and is inclusive of the elements referenced above.

The Endoscopy Center's unit- based Clinical Effectiveness Quality Improvement Committee (CEQI) meets quarterly. The next meeting is scheduled for January 15, 2019. Acknowledgment by the committee that the badges have been updated and distributed will be documented at this meeting and be reflected in the meeting minutes.


The Endoscopy Center's Administrative Director will be responsible for ensuring action items are complete as stated above.