QA Investigation Results

Pennsylvania Department of Health
BRYN MAWR MEDICAL SPECIALIST ENDOSCOPY ASSOCIATES LTD.
Health Inspection Results
BRYN MAWR MEDICAL SPECIALIST ENDOSCOPY ASSOCIATES LTD.
Health Inspection Results For:


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Initial Comments:

This report is the result of a State licensure survey conducted on April 10, 2019, and June 10, 2019, at Bryn Mawr Medical Specialist Endoscopy Associates. 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:




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 review of facility documents, personnel files (PF) and interview with staff (EMP), it was determined that the facility failed to obtain written references for two of two personnel files reviewed (PF1 and PF2).

Findings include:

A request was made to EMP1 on June 10, 2019, at 1:40PM, for a Hiring Policy regarding verification of written references for licensed personnel . The facility was unable to provide a policy.

Review on June 10, 2019, of PF1, a licensed registered nurse, with a hire date of January 28, 2019, revealed no documented evidence that written references were verified prior to employment.

Review on June 10, 2019, of PF2, a licensed registered nurse with a hire date of March 25, 2019, revealed no documented evidence that written references were verified prior to employment.

An interview conducted on June 10, 2019, with EMP1 at 2:40PM, confirmed no evidence of documentation that written references were verified prior to employment for PF1 and PF2. Further interview confirmed the facility did not have a Hiring policy regarding the verification of written reference.






Plan of Correction:

Admin Policy #82 (Verification of Facility Employees' Credentials), initiated November, 2010, which states "the center will verify... prior to employment... written reference letters," was reviewed and compared to state regulations to ensure compliance. An audit was conducted by the ASC Director of all employee files which found two files (the aforementioned) were not in compliance with the center's policy requiring written reference letters prior to employment. All other files contained proof of verification of references.
A new employee candidate reference check form has been developed by the ASC Director to ensure any future candidate is screened appropriately, according to the center's policy. The employee candidate reference check form will be submitted to the governing body for review and approval. Once approved, this form will be reviewed and signed by the ASC Director prior to the start date of each new employee, and will be retained as part of the employees file.
Moving forward, the ASC Director will review all new hires and all licensed staff on a yearly basis and submit audit report to the QAPI and Governing Body committees. The ASC Director is responsible for this plan of corrections and will have it completed by September, 2019.



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 Bylaws, credential files (CF), and interview with staff (EMP), it was determined the facility failed to ensure that each credential file contained documentation of a written record of privileges that were requested and either granted or denied for two of two credential files reviewed (CF1 and CF2).

Findings include:

Review of facility policy "Medical Staff Bylaws" dated January 24, 2012, revealed "Section B. Section 1. The Governing Body is the final authority regarding the management of the Center. ...The Credentialing Committee is established to oversee the credentialing and recredentialing process developed by the facility...Credentials review shall be performed by the Credentialing Committee."

Review on June 10, 2019, of CF1, credential time frame of July 21, 2017, through July 31, 2019, revealed the facility form for requesting and granting of privileges failed to provide evidence of documentation that the privileges requested were granted or denied.

Review on June 10, 2019, of CF2, credential time frame of July 21, 2017, through July 31, 2019, revealed the form for requesting and granting of privileges failed to provide evidence of documentation that the privileges requested were granted or denied.

An interview conducted on June 10, 2019, at approximately 12:30 PM with EMP1 confirmed the form for requesting and granting of privileges failed to provide evidence of documentation that the privileges requested were granted or denied.








Plan of Correction:

The Medical Staff bylaws were reviewed and compared to the state regulations to ensure compliance. In order to carry out the policies stated in the by laws, "the committee shall recommend privileges for specific procedures to be granted," the ASC Director will revise the Procedural Privilege List form to include a column labeled "privileges granted or privileges denied." The updated form will be submitted for review and approval to the Medical Executive Committee and the Governing Body.
The Medical Director or designee will educate 100% of the Medical Staff on the revised procedural privilege list form by July 15, 2019. An audit of credentialing files was performed by the ASC Director and found to be in compliance with facility policy. Each new medical staff candidate applying for credentialing/recredentialing will be audited prior to credentialing committee finalizing the credentialing process. An audit listing will be maintained as evidence of audit activity for each medical staff member.
The ASC Director and the Medical Director are responsible for this plan of corrections and will have it completed by August 1, 2019



555.22 (a)(1-2) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Pre-operative Care

(a) Pertinent medical histories and physical examinations, and supplemental information regarding drug sensitivities documented day of surgery or one of the following:
(1) If medical evaluation, examination and referral are made from a private practitioner's office, hospital or clinic, pertinent records thereof shall be available and made part of the clinical record at the time the patient is registered and admitted tot he ASF. This information is considered valid no more than 30 days prior to the date of surgery.
(2) A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record.



Observations:

Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that Bryn Mawr Medical Specialists Endoscopy failed to ensure that patients received a physical examination completed by a physician for three of three medical records reviewed (MR1, MR2 and MR3).

Findings include:

Review of the facility's "Medical Staff By-Laws Rules and Regulations" dated January k24, 2012, revealed "The Medical Staff member is responsible for the completion of a medical record for each of his/ her patients. This record shall include, at a minimum:...a medical history and physical exam performed or reviewed within 30 days of admission."

A review on June 10, 2019, of MR1, admitted on May 21, 2019, revealed no evidence of documentation of a Medical History and Physical Examination completed by a physician.

A review on June 10, 2019, of MR2, admitted on May 7, 2019, revealed no evidence of documentation of a Medical History and Physical Examination completed by a physician.

A review on June 10, 2019, of MR3, admitted on May 1, 2017, revealed no evidence of documentation of a Medical History and Physical Examination completed by a physician.

An interview conducted on June 10, 2019, at 2:55 PM with EMP1 confirmed MR1, MR2, and MR3 did not contain evidence of documentation that a Medical History and Physical Examination had been completed by a physician for these patients. Further review revealed the Medical History and Physical Examination was completed and signed by the Registered Nurse.






Plan of Correction:

The ASC Director has reviewed the Clinical Policy#87 (Evaluation of Patient's Pre-Op Health Status) and will revise the policy to ensure compliance with state regulations. The policy will state that the Physician will complete a Medical History and Physical form immediately prior to any procedure or review and sign and date a medical history and physical form that has been completed within 30 days of admission. The ASC Director and Medical Director approved the revised Medical History and Physical form on 6/25/2019. This will be submitted to the next Governing Board Meeting for review and approval. The Medical Director or designee will educate 100% of the Medical Staff on the revised Medical History and Physical form by 7/1/2019. All forms will be kept as part of the patients' medical record and audited daily to ensure 100% compliance is sustained for 3 months.
The ASC Director and Medical Director are responsible for ensuring medical records are complete. Any non-compliance by Medical Staff members with the new Medical History and Physical Form will be reported to the Medical Director for individual counseling. Results of auditing activities and any additional action taken will be submitted to the quarterly QAPI Committee meetings for review and recommendations.
The ASC Director and Medical Director are responsible for this plan of corrections and will have it completed by September 30, 2019.



555.31 (a) LICENSURE
ANESTHESIA SERVICES - Principle

Name - Component - 00
Anesthesia Services

555.31 Principle
(a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per ASF licence.

Observations:
Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to limit anesthesia techniques to those that are appropriate to the assigned "B" classification on the facility license for three of three medical records reviewed (MR1, MR2 and MR3).

Findings include:

State regulation "551.3 Definitions ... (ii) Class B ... facility with a distinct part used solely for ambulatory surgical treatments involving administration of sedation analgesia or dissociative drugs where in reflexes may be obtunded."

Review on April 10, 2019, of current facility license revealed the facility was licensed as a Class "B" Ambulatory Surgical Center.

Review of MR1, a colonoscopy procedure, revealed an "Anesthesia Consent Form" dated May 21, 2019, "A. Statement of Consent": 5. Regardless of the choice of anesthesia discussed, conditions during the anesthesia and/or operative procedure may require converting to a general anesthetic (pending me asleep)." Further review revealed the form did not specify the type of anesthesia the patient was consenting to receive for the surgical procedure.

Review of MR2, a colonoscopy procedure revealed an "Anesthesia Consent Form" dated May 7, 2019, "A. Statement of Consent": 5. Regardless of the choice of anesthesia discussed, conditions during the anesthesia and/or operative procedure may require converting to a general anesthetic (pending me asleep)." Further review revealed the form did not specify the type of anesthesia the patient was consenting to receive for the surgical procedure.


Review of MR3, a colonoscopy procedure revealed an "Anesthesia Consent Form" dated May 1, 2019, "A. Statement of Consent": 5. Regardless of the choice of anesthesia discussed, conditions during the anesthesia and/or operative procedure may require converting to a general anesthetic (pending me asleep)." Further review revealed the form did not specify the type of anesthesia the patient was consenting to receive for the surgical procedure.


An interview conducted on June 10, 2019, at 1:05 PM with EMP1 confirmed the above findings. Further interview with EMP1 confirmed the Anesthesia Consent Forms for MR1, MR2 and MR3 did not specify the type of anesthesia the patients were consenting to receive for the surgical procedures based on the "B" Classification of the facility.











Plan of Correction:

The ASC director has reviewed the Administrative Policy# 15 (Informed Consent) and compared it to the state regulations to ensure compliance. Upon review, it was determined the Anesthesia consent form did not address the type of anesthesia used.
The ASC Director will revise the Anesthesia consent form so that it is in compliance with the terms set as a Class B ambulatory surgical center. The Anesthesia consent form will be updated to include the type of anesthesia the patient will receive (MAC anesthesia) with a description of what MAC anesthesia includes and the responsibility of both the physician and the anesthesia provider during procedures requiring anesthesia. This correction will take place immediately after review and approval by the Governing Body. Anesthesia staff and physicians will be notified of the revised form. Documentation evidence of the medical staff notification of this revision to the form will be maintained for review.
An Audit will be conducted for 3 consecutive months following the start of the new consent form to ensure proper consent is given to the patient upon admission. Results of the audit will be submitted to the Patient Safety and Governing Body committees.
The ASC director is responsible for this plan of corrections and will have it implemented by July 1, 2019 with the conclusion of the audit reported to committees by September 30, 2019.



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 observation tour and interview with staff (EMP), it was determined the facility failed to maintain a functional and sanitary environment for the provision of surgical services.

Findings include:

1. Observation on April 10, 2019, at 11:24 AM with EMP1 revealed a wall hung dispenser unit with 700 ml of a hand sanitizing liquid agent dated October 2016. Further observation revealed an additonal dispenser unit with a hand sanitizing liquid agent dated November 2018. In addition, the soiled utility room contained a wall hung soap dispenser with a hand sanitizing agent, expiration date of January 2019.

2. Observation on April 10, 2019, at 11:30 AM with EMP1 of the Clean Supply Room revealed liter bags of intravenous fluids. Further review revealed storage instruction of the intravenous fluids "Storage: Room temperature (25 degrees (Celsius), Avoid excessive heat"). The facility was unable to provide documentation of temperature monitoring for the Clean Supply Room.

3. Observation on April 10, 2019, at 12:05 PM with EMP1 of the Decontamination Room revealed High Level Disinfectant Storage 1.32 gallon. Further review revealed manufacturer's instructions on the gallon size container " Maintain temp below 75 degrees (F), avoid contact with combustible materials. The facility was unable to provide documentation of temperature monitoring for the Decontamination Room.

4. Observation on April 10, 2019, at 12:10 PM with EMP1 of the Decontamination Room revealed a partially used box of Rapicide ( Fahrenheit) strips -100 count strips without an expiration date.

An interview conducted on April 10, 2019, at 1:11 PM with EMP1 and EMP3 confirmed the above findings. EMP1 stated "We are in the process of developing many new systems to identify these issues when we complete environmental rounds in the facility."



























Plan of Correction:

The ASC Director, along with the Infection Prevention Officer have reviewed the Administrative Policy #55 (Housekeeping Services) and compared to state regulations to ensure compliance. Actions taken to ensure the center is following policies is as follows:
1) All soap dispensers have been checked and any outdated supplies have been removed and replaced.
2 and 3) Temperature is being monitored daily in any area where items are stored which require regulation of temperature or relative humidity.
4) Any opened packaging of multi-use supplies were inspected and removed if expiration date was not written on packaging upon opening. All new packaging is clearly marked with date opened and date of expiration.
The following systems have been put in place to ensure these incidents to not reoccur:
1) A monthly task list has been generated, assigning staff the task of checking all soap dispensers and hand sanitizers in the ASC for expiration dates. Staff have been educated on the new process during the monthly staff meeting and documented in the minutes.
2 and 3) Temperature and Relative Humidity logs have been created for areas containing stored supplies requiring regulation of temperature or relative humidity. Staff are assigned this task according to their daily work assignment area. Clinical Policy # 70 (Temperature and Humidity Control) has been updated to include the new designated areas to be monitored. This new policy and practice is now in effect as of April 23, 2019.
4) Clinical Policy #43 (Reprocessing of Gastrointestinal Endoscopes) has been updated to include the following guidelines: " The Rapicide PA Test Strips bottle will be signed and dated with date opened and date they will expire per manufacturers instructions for use (4 months from date opened)."
1) The Infection Prevention Officer, under direction from the ASC Director, is responsible for ensuring all products used in the ASC are within recommended use date. Monthly inspections by the Infection Prevention Officer will take place to ensure staff are complying with this new assignment. Results of monitoring activities and any additional action taken will be submitted at the quarterly Infection Control Committee meetings for review and recommendations. The new policy will be submitted to the Governing Body for review and approval.
2 and 3) The ASC Director is responsible for ensuring areas in the ASC are monitored for correct temperature and relative humidity. Staff are to report any discrepancies to the ASC Director and the matter will be corrected upon notification. Records will be kept and available upon inspection.
4) The Infection Prevention Officer is responsible for ensuring staff are properly trained in the Reprocessing of Gastrointestinal Endoscopes as well as proper cleaning and storage of equipment and supplies. Monitoring will be done by the Infection Prevention Officer to ensure staff are following policies and properly labeling multi-use supplies for easy identification of use dates, in accordance with the updated clinical policy. Any discrepancies will be immediately corrected and reported at the quarterly Infection Control Committee and Patient Safety committee meetings.
The ASC Director is responsible for this plan of corrections and will be completed by July, 2019.