QA Investigation Results

Pennsylvania Department of Health
PPSP SURGICAL LOCUST STREET HEALTH CENTER
Health Inspection Results
PPSP SURGICAL LOCUST STREET HEALTH CENTER
Health Inspection Results For:


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Initial Comments:

This report is the result of an Annual Registration survey conducted on October 24-25, 2017, at Ppsp Surgical Locust Street Health Center. It was determined the facility was in compliance with the requirements of the Pennsylvania Department of Health Regulations 28 Pa Code, Chapter 29, Subchapter D, Ambulatory Gynecological Surgery in Hospitals and Clinics.






Plan of Correction:




Initial Comments:
This report is the result of a full State Licensure survey conducted on October 24-25, 2017, at Ppsp Surgical Locust Street Health Center. 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 (1) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3
Governing Body responsibilities include:

(1) Conforming to all applicable Federal, State, and local laws.


Observations:

Ppsp Surgical Locust Street Health Center was not in compliance with the following State Law related to Act 13 of 2002, Medical Care Availability and Reduction of Error(MCARE) Act 40 PS. Patient Safety Committee.

"Section 310. Patient safety committee. (a) Composition.-- (2) An ambulatory surgical facility's ... patient safety committee ... shall meet at least monthly."

This is not met as evidenced by:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to have an ambulatory surgical facility specific Patient Safety Committee.

Findings include:

Review on October 24, 2017, of the facility's "Patient Safety Plan ... Planned Parenthood Southeastern Pennsylvania ... Address: 1144 Locust St. ... ", dated April 2015, revealed this plan included " ... Patient Safety Committee ... 4 Health Center Managers ... ".

Review on October 24, 2017, of the "Patient Safety Committee Meeting" minutes, dated January 2017, February 2017, May 2017, and August 2017, revealed there were committee members from other Planned Parenthood Southeastern Pennsylvania affiliates attending these meetings and information from these other affiliates were included in these meeting minutes. These minutes were not specific only to the Ppsp Surgical Locust Street Health Center.

Interview with EMP1 on October 24, 2017, at 2:00 PM, confirmed the patient safety committee meetings take place with other Planned Parenthood affiliates including Far Northeast, West Chester, and Norristown. EMP1 confirmed the meetings and minutes are not specific to the ambulatory surgery center.

















Plan of Correction:

The PPSP Surgical Locust Street Health Center (facility) is owned and operated by Planned Parenthood Southeastern Pennsylvania. Planned Parenthood Southeastern Pennsylvania (PPSP) is an independent not-for-profit corporation [501 (c)(3)] that operates health centers in Chester, Delaware, Montgomery, and Philadelphia counties, including the Surgical Locust Street Health Center. PPSP is governed by a Board of Directors.
Each PPSP facility has an individual Patient Safety Plan (identified by address), follows PPSP's patient safety policies and procedures, and attends the quarterly Patient Safety committee meeting.
The Patient Safety Committee includes all required members (per Act 13 of 2002, Section 310 Patient Safety Committee), and the facility (Surgical Locust Street) is represented by their patient safety officer, physician, nurse, center manager (ASF person-in-charge), and a resident of the community. The committee meetings include review of facility-specific items such as patient safety data, patient safety reports (serious events and action plans), updated policies and procedures, and results/findings/actions from regulatory agency (DOH, CLIA) site visits. The facility's Patient Safety Committee will continue to meet quarterly as directed by Act 13 of 2002, section 310 Patient Safety committee.
Changes were made, beginning with our 11/13/17 meeting, to the Patient Safety Committee meeting agenda and minutes to ensure PPSP Surgical Locust Street-specific activities and actions receive individual review and discussion. The Director of Clinical Services (Patient Safety officer) is responsible for maintaining the change to the meeting format. The facility's Patient Safety Committee minutes will reflect these changes and will be available for review.



553.3 (5)(i)(ii) LICENSURE
Governing Body Responsibilities

Name - Component - 00
Governing Body responsibilities include:
(5) Adopting bylaws or similar rules and regulations for the orderly development and management of the ASF, which:
(i) Describe the authority delegated to the person in charge and to the medical staff.
(ii) Require the governing body to review and approve the bylaws, or similar rules and regulations, of the medical staff.

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to adopt governing body bylaws that were applicable to the surgery center, that described the authority to the person in charge and to the medical staff, and that required the governing body to review and approve the bylaws of the medical staff.

Findings include:

Review on October 24, 2017, of "Planned Parenthood Southeastern Pennsylvania By-laws, no date, revealed these bylaws did not address the surgery center. Further review of these bylaws revealed they did not described the authority delegated to the person in charge and to the medical staff. These bylaws also did not require the governing body to review and approve the bylaws of the medical staff.

Interview with EMP1 on October 24, 2017, at 2:25 PM, confirmed the bylaws were not dated and they did not address the surgery center.









Plan of Correction:

The PPSP Surgical Locust Street Health Center (facility) is owned and operated by Planned Parenthood Southeastern Pennsylvania (PPSP). PPSP is governed by a Board of Directors (Board). PPSP has bylaws that apply to all of its health centers, and, to ensure orderly development and management specific to the ASF (Surgical Locust Street Health Center), the Board adopted the Abortion Policy Manual. The "Governing Body Responsibilities" policy (from the Abortion Policy Manual) specifically describes the authority delegated to the Center Manager (ASF person-in-charge) and the medical staff as well as the requirement that the Board adopts and approves policies at least annually necessary for the orderly conduct of the ASF. These policies are maintained onsite and available for review. By 12/21/17, the ASF-person-charge will receive training on the Abortion Services Manual policies to ensure familiarity with and understanding of PPSP rules and regulations that guide the orderly management of the ASF. By 1/15/18, the Medical Staff will receive training on the Abortion Services Manual policies to ensure familiarity with and understanding of PPSP rules and regulations that guide the orderly management of the ASF. The Director of Patient Services is responsible for ensuring this policy review and successful implementation of this plan of correction. Evidence of staff training will be available for review.


555.3 (f) LICENSURE
Requirements

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

(f) The governing body shall request and consider reports from the National Practitioner Data Bank on each practitioner who requests privileges.

Observations:

Based on a review of facility document, credential files (CF), and interview with staff (EMP), it was determined the facility failed to request and consider reports from the National Practitioner Data Bank for three of six credential files reviewed (CF4, CF5 and CF6).

Findings include:

Review on October 25, 2017, of facility document, "PPSP Credentialing requirements for contracted nurse anesthetists" dated October 25, 2017, (date of survey conducted) revealed no provision to request and consider reports from the National Practitioner Data Bank on each practitioner who requests privileges.

Review on October 24, 2017, of facility CF4 revealed the employee is a Certified Registered Nurse Anesthetist (CRNA). Further review revealed no documented evidence of a National Practitioner Data Bank report.

Review on October 24, 2017, of facility CF5 revealed the employee is a CRNA. Further review revealed no documented evidence of a National Practitioner Data Bank report.

Review on October 24, 2017, of facility CF6 revealed the employee is a CRNA. Further review revealed no documented evidence of a National Practitioner Data Bank report.

Interview on October 25, 2017, with EMP1 at approximately 11:50AM confirmed no documented evidence of a National Practitioner Data Bank report for CF4, CF5 and CF6.









Plan of Correction:

By December 30, 2017, PPSP's Human Resources Director will request and review reports from the National Practitioner Data Bank for all current CRNAs. Effective 1/1/18, documented evidence of the NPDB reports will be maintained in personnel files of all CRNAs and will be available for review. To ensure we fully document our ongoing compliance with this requirement, we updated our Standard Operating Procedure (SOP) on 12/15/17 titled, "Credentials and Training Requirements for Contract CRNAs." This SOP guides our CRNA hiring and training to include the requirement to obtain reports from the National Practitioner Data Bank for each CRNA practitioner at hire and annually. The Vice President for Human Resources and Organizational Development is responsible for ensuring immediate and ongoing compliance with this regulation, maintaining the documents which show evidence of compliance, and ensuring compliance by auditing annually.


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

Name - Component - 00
555.3 Anesthesia policies and procedures

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

Observations:

Based on review of facility documents, review of credential files (CF) and interview with staff (EMP), it was determined the facility failed to ensure policies and procedures were developed for the supervision of Certified Registered Nurse Anesthetists (CRNA) and failed to ensure privileges were approved for the supervision of CRNAs in two of two credential files reviewed (CF1, CF2).

Findings include:

Review on October 25, 2017, of the facility document "Anesthesia Policies," reviewed September 27, 2017, revealed no documentation that anesthesia policy and procedures addressing the supervision of the CRNA's clinical activities were developed and approved.

Review on October 25, 2017, of facility document "Job Description ... Physician-Surgical Provider ... " revealed no specific duties for supervision of the CRNA.

Review on October 24, 2017, of CF1, CF2 revealed no documentation that each of the physician-surgical providers were privileged for supervision of the CRNA.

Interview with EMP1 on October 25, 2017, at approximately 12:30 PM confirmed there were no policy and procedures addressing supervision of CRNA. EMP1 also confirmed the Job Description for the Physician-Surgical Provider did not contain specific duties for the supervision of the CRNA and the credential files for CF1 and CF2 did not contain specific privileges to supervise the CRNA.












Plan of Correction:

To ensure we fully document our ongoing compliance with this requirement, we have developed a new Anesthesia Services policy and updated our Governing Body Responsibilities policy, both within our Abortion Services Policy manual.

The Governing Body Responsibilities policy was updated to include the designation of a physician to function as the Director of Anesthesia Services. PPSP's Medical Director (physician) serves as the Director of Anesthesia Services and this designation is included in their job description. PPSP also has an Assistant Director of Anesthesia. These directors are responsible for oversight and direction of anesthesia services including establishing and updating policy and procedures, staff training, supervision and evaluation. Further, the Assistant Director of Anesthesia's responsibilities include ensuring compliance with PPSP's sedation policies and procedures, and with training requirements for contract CRNAs.

The Anesthesia Services policy details the policies and procedures for directing anesthesia services at the facility including the education, training, and supervision of personnel; the responsibilities of non-physician anesthetists (CRNAs) and evaluation of CRNA clinical activities; and the responsibilities of supervising physicians. The facility's Medical Director (Director of Anesthesia) and the Assistant Director of Anesthesia are responsible for establishing (and maintaining) these policies, which will reside in the facility's Abortion Policy Manual.

The Chief Operating Officer will present these new/updated policies to the Governing Body for review and approval at their next scheduled meeting on 12/14/17. The facility's Abortion Policy manual will be available on-site at the ASF for review, as will be the Governing Body's meeting minutes, to demonstrate evidence of compliance.

By 12/20/17, the ASF person-in-charge will receive training on Anesthesia services, including direction, oversight, policies and procedures. The Director of Patient Services is responsible for ensuring this policy review and successful implementation of this plan of correction. Evidence of staff training will be available for review.



557.4 (a)(1-4) LICENSURE
Quality Assurance & Improvement Committee

Name - Component - 00
557.4 Quality Assurance & Improvement Committee

(a) The committee shall consist of the following:
(1) A practitioner who is not an owner,
(2) A representative of administration,
(3) A registered nurse,
(4) Other health care personnel, as appropriate.


Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure the committee members included the Locust Street Center Manager or the Assistant Center Manager or other staff as assigned according to the Risk and Quality Management Plan.


Findings include:

Review on October 24, 2017 of facility document "Planned Parenthood Southeastern Pennsylvania Risk and Quality Management Fiscal Year 2017 Program Overview and Work Plan (July 1, 2016 - June 30, 2017) revealed " ... The FY17 [Fiscal Year 2017] Committee members include: ... A Center Manager or Assistant Center Manager ... Other staff as assigned based upon agenda items and/or program review".

Review on October 24, 2017 of facility's "Risk & Quality Management Meeting" minutes dated September 2016, December 2016, December 2016, February 2017, May 2017 and July 2017 revealed the Locust Street Center Manager, the Assistant Center Manager or other assigned facility staff did not attend any of these meetings.

Interview with EMP1 on October 25, 2017, at 12:30 PM confirmed the Locust Street Center Manager, the Assistant Center Manager or any other Locust Street facility staff did not attend the Risk & Quality Management Meetings.






Plan of Correction:

The facility currently has an integrated Risk & Quality Management (RQM) Program. The program includes an annual RQM Work Plan and a RQM Committee, which is lead by the agency Chief Operating Officer (COO). The committee's primary functions are to ensure systematic, ongoing, and effective monitoring and evaluation of the quality and appropriateness of patient care, and to pursue opportunities to improve patient care and resolve identified problems. The RQM Plan includes a list of Committee members. The current committee membership includes diverse representation from across the agency, including a practitioner for the facility who is not an owner (facility Medical Director), a representative of administration (COO) and a registered nurse (Director of Clinical Services).

To ensure we fully document our ongoing compliance with this requirement, the Chief Operating Officer (COO) will update the agency's Annual Risk & Quality Management Work Plan to include the specific list of required committee members including: 1) a practitioner who is not an owner, 2) a representative of administration, 3) a registered nurse, and 4) other health care personnel, as appropriate. Beginning with the next RQM Committee (meeting scheduled for 1/20/18), the COO will ensure the RQM committee membership includes the Surgical Locust Street Center Manager or Assistant Manager or other staff as assigned. Future meeting minutes will reflect the committee members as well as their representation, and these meeting minutes will serve as documented evidence of compliance. At the agency's next meeting of its Governing Body, on 2/22/18, the COO will present the updates to the RQM plan for review and approval.



559.2 (2) LICENSURE
Director of Nursing

Name - Component - 00
559.2 Director of Nursing

The director of nursing shall be currently licensed as a registered nurse in this Commonwealth
and be responsible and accountable to the person in charge of the ASF for:
(2) Development and maintenance of nursing service goals and objectives,
standards of nursing practice, nursing policy and procedure manuals and written job descriptions for each
level of personnel.


Observations:

Based on review of facility document and interview with staff it was determined the facility failed to ensure Nursing Policies and Procedures were established for the facility.
Findings include:
Review on October 25, 2017, of facility document, "Job Description - Position: Director of Clinical Services ..." revealed "Primary Function/Purpose: Provides clinical leadership and oversight of PPSP family planning and abortion services ... Ensures that all clinical policies, procedures and activities are conducted in accordance with internal and external requirements ... Lead implementation of changes to the Policy and Procedure Manual and disseminate to staff with required explanations and/or training ... Oversees training and evaluation of clinical staff ... Knowledge, Skills and Abilities: Clinical - Significant experience providing direct family planning patient care and developing and overseeing clinical policies and procedures. Clinician Management - Ability to develop and implement orientation and training of clinicians, and work one-on-one and with teams to ensure compliance with policies, procedures and productivity standards ..."
A request was made to EMP1 at 10:44AM on October 25, 2017, for a policy regarding Nursing Policies and Procedures. None was provided.
Interview on October 25, 2017, at 10:44AM with EMP1, confirmed there is no policy regarding Nursing Policies and Procedures.






Plan of Correction:

The Director of Clinical Services (DCS) at PPSP acts as the Director of Nursing at the ASF. Among other duties, the DCS is responsible for ensuring nursing policies and procedures are established at the facility. At this time, all relevant standards of nursing practice, including nursing care policies and procedures, are contained within PPSP's Medical Standards and Guidelines (MS&G). The current version of the PPSP MS&Gs was approved by the Medical Director on 11/16/2016. The MS&Gs are updated biennially and approved by the Medical Director prior to implementation. PPSP MS&Gs are next scheduled for update in November 2018 with implementation completed by 3/31/2019.

The DCS oversees the implementation of and compliance with the policies and procedures in the MS&Gs that are applicable to the nursing staff at PPSP. All staff, including Surgical Locust Street nursing staff, are required to comply with the MS&Gs. The DCS ensures that upon hire, nursing staff are educated on the MS&Gs, with particular focus on the policies relevant to nursing including abortion services and recovery care. The DCS ensures ongoing education and training of nursing staff on any updates to MS&Gs as well. The current version (updated 11/16) was distributed and reviewed in February 2017; evidence of nursing staff review of updates (attestations) is maintained by DCS. The MS&Gs are maintained at the facility for easy access (and reference) to the nursing staff and available for on-site Department review.

To ensure that the DCS's role as Director of Nursing and corresponding job duties are clear, and that we fully document our compliance with this requirement, the Director of Clinical Services (DCS) job description will be updated by 1/6/18 to include specific language regarding their role as Director of Nursing for our ASF facilities and their responsibility for the development and maintenance of nursing policies and procedures. The Director of Patient Services will update the DCS job description and submit it to PPSP's Vice President of Human Resources and Organizational Development for approval. The updated job description will be presented to the DCS for review and signature and once signed will be maintained in the personnel file (and available for Department review).




Initial Comments:

This report is the result of a full State Licensure survey conducted on October 24-25, 2017, at Ppsp Surgical Locust Street Health Center. It was determined the facility was in compliance with the requirements of 35 P.S. 448.809 (b).






Plan of Correction: