Initial Comments:
This report is the result of an Annual Registration survey conducted on September 21, 2022, at PPSP Far Northeast 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 State licensure survey conducted on September 21, 2022, at PPSP Far Northeast 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 (8)(i) 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:
(i) Require the employment of personnel with qualifications commensurate with a job's responsibilities and authority, including appropriate licensure and certification.
Observations:
Based on review of facility documents, personnel files (PF) and interview with staff (EMP), it was determined the facility failed to ensure the Recovery Room Registered Nurse (RN) was certified in advanced cardiovascular life support (ACLS) and/or pediatric advanced life support (PALS) for one of two personnel files reviewed (PF1, EMP5).
Findings include:
A review of facility document "Mandatory certifications for staff working in abortion services" revised January 30, 2018, revealed "Recovery Room Nurses (RNs): RNs in an ASF must be certified in BLS (basic life support), ACLS (advanced cardiovascular life support) and PALS (pediatric advanced life support). This includes regular RN staff at SUFN (PPSP Far Northeast Health Center)."
A review on September 21, 2022, of PF1, EMP5, a registered nurse, revealed a signed job description dated February 24, 2022, with the following: "Qualifications: BLS, ACLS, and/or PALS certifications required." Further review revealed, the facility was unable to provide evidence of documentation of ACLS and or PALS certification as requested by the surveyor.
An interview conducted on September 21, 2022, at 1:32 PM with EMP1 confirmed the facility was unable to provide documentation of ACLS and or PALS certification as requested by the surveyor for EMP5.
Plan of Correction:By 9/30/2023, the facility will update the documents "SOP: Mandatory Certifications for Staff Working in Abortion Services"" and Recovery Room Registered Nurse (RN) Job Description to include a specific timeline for completing required certifications including BLS (basic life support), ACLS (advanced cardiovascular life support) and PALS (pediatric life support) as required for their position. The RN will have up to 90 days from date of hire to complete the required certifications. The facility manager (Center Manager) will work with the RN to arrange training courses within the 90-day timeline. During this time, the Center Manager (CM) will ensure another medical professional certified in ACLS is present until patients have been discharged in compliance with 28 Pa Code Chapter 555.24.
Completion of certifications will be monitored by the Center Manager (CM) and Human Resources (HR). Record of completed certification will be held in the RN's personnel file and Human Resources will keep track of renewal dates. The Director of Human Resources is responsible for updating the job description and ensuring the system is in place within HR to track completion and renewal dates, including auditing of personnel files for all required documentation.
The Director of Patient Services is responsible for updating the "SOP: Mandatory Certifications...", communicating updates to the Center Manager, and ensuring RNs are provided with timely training opportunities. The Director of Patient Services will present these updates (timeline for meeting certification requirements) to the facility CRQM Committee (next meeting mid-late September 2023), and the Chief Operations Officer (COO) will include this update (finding and Plan of Correction) in the CRQM report to the Governing Board (October 26, 2023). The COO is responsible for ensuring implementation of and compliance with the plan of correction.
555.3. (a-f) LICENSURE
Requirements for membership & privileges a-f
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§ 555.3. Requirements for membership and privileges.
(a) To receive favorable recommendation for appointment, or reappointment,
members of the medical staff shall always act in a manner consistent with the
highest ethical standards and levels of professional competence.
(b) Privileges granted shall reflect the results of peer review or utilization
review programs, or both, specific to ambulatory surgery.
(c) Privileges granted shall be commensurate with an individual ' s qualifications,
experience and present capabilities.
(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) A written record of the application, which includes the scope of privileges
sought and granted. The delineation ' ' clinical privileges ' ' shall address
the administration of anesthesia.
(2) A review, summarized on record with appropriate documentation, of
the qualifications of the applicant.
(e) Reappraisal and reappointment shall be required of every member of the
medical staff at regular intervals no longer than every 2 years.
(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 policy, credential files (CF), and interview with staff (EMP), it was determined that the facility failed to maintain a written record of the privileges granted to PPSP Far Northeast Health Center (SUFN) for one of three credential files reviewed (CF3).
Findings include:
Review of facility policy "Board Policy-Abortion Staff" dated June 19, 2012, revealed "Hiring. All contracted providers for abortion services and all employee medical staff will go through a hiring process which includes Credentialing procedures...Board Appointments. The Board may grant clinical privileges to qualified, licensed practitioners in accordance with their training, experience and demonstrated competence and judgement based on the peer review policy approved by the board. A written record of the application for clinical privileges, and the scope of privileges granted, shall be maintained. The board shall conduct a review, summarized on the record with appropriate documentation, of the qualification of the applicant."
Review on September 21, 2022, of CF3, a certified registered nurse anesthetist, revealed a "Medical Staff appointment Renewal and Clinical Privileges Application" signed by a representative of the Governing Body on January 14, 2022. Further review revealed the location for privileges granted did not document PPSP Far Northeast Health Center (SUFN).
An email communication received September 30, 2022, at 11:49 AM authored by EMP1 confirmed CF3 had provided monitored anesthesia care with moderate sedation during an abortion procedure for MR1, MR2, MR3, MR4, MR5 and MR6 on August 5, 2022. EMP1 also confirmed CF3 had provided monitored anesthesia care with moderate sedation during an abortion procedure for MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15 and MR16 on August 13, 2022.
An interview conducted on September 21, 2022, at 3:54 PM with EMP1 confirmed PPSP Far Northeast Health Center (SUFN) was not listed as a location for CF3 to provide monitored anesthesia care with moderate sedation.
Plan of Correction:By 9/30/2023, all CRNA credential/personnel files will be reviewed, and locations approved to work will be communicated to the Center Manager and the Anesthesia provider scheduling coordinator. This will ensure only CRNAs with documented privileges for PPSP Far Northeast (SUFN) will be scheduled to work at this location. The Center manager will be responsible for monitoring (and managing) CRNA scheduling to ensure compliance with any work location limits. The Director of Human Resources (HR) working with the Patient Services Director is responsible for completing the CRNA credential/personnel file review.
The Director of Patient Services will provide a brief training/review of the Medical Staff Appointment and Request for Clinical Privileges process and document for the Center Manager, Human Resources, and the Anesthesia Provider agency. Training will be provided via web-based meeting with screen share presentation and follow-up email.
The Director of Patient Services will work with the Anesthesia provider to update all CRNA clinical privilege requests (as needed) to include any location they may be scheduled to work to include SUFN. All requested clinical privilege updates will be presented to and approved by the Governing Board prior to their scheduled October meeting.
The Director of Human Resources (HR) will ensure credential/personnel files are kept up to date and any work location restrictions are communicated to the Center Manager. The Center manager will be responsible for monitoring (and managing) CRNA scheduling to ensure compliance with any work location limits.
The Center Manager (or DPS) will present this finding and corrective action during an upcoming CRQM (late September 2023) or Patient Safety Meeting (November 2023), and the Chief Operations Officer (COO) will include this in the CRQM report to the Board (next meeting October 26, 2023). The COO is responsible for ensuring implementation of and compliance with the plan of correction.
567.1 LICENSURE
CHAPTER 567 - ENVIRONMENTAL SERVICES
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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 the facility policy, observation, and interview with staff (EMP), it was determined the facility failed to have a sanitary environment for storage of human pathology waste until disposal in accordance with facility policy.
Findings include:
A review of facility policy "Infection Control Plan" dated February 20, 2020, revealed "MEDICAL WASTE MANAGEMENT. All infectious waste must be disposed of in accordance with the disposal regulations of the state of Pennsylvania. Proper handling of waste is necessary to ensure employees safety, public and environmental safety, and compliance with federal and state laws for waste disposal. ...Human pathological waste removed during surgery, or a medical procedure shall be bagged and frozen or packaged in formalin and stored until it is picked-up by the waste hauler. ...The waste should be stored in a specified location where the integrity of the packaging is protected from water or other damage."
An observation on September 21, 2022, at 10:15 AM with EMP2 in the Decontamination Room revealed a large plastic measuring cup lined with a red biohazard bag located on the back rim of the clinical sink (hopper). Further observation revealed liquid waste resembling human pathology waste in the large plastic measuring cup lined with an unsealed red bag.
An interview conducted on September 21, 2022, at 10:16 AM with EMP2 confirmed the measuring cup lined with an unsealed red bag was used to collect human pathology waste throughout the day. Further interview confirmed the facility failed to bag, seal, and freeze or package the human pathological waste in formalin and securely store it until it was picked up by the waste hauler.
Plan of Correction:On 8/25/23, the Center Manager (facility manager) and the Director of Patient Services observed staff working in the decontamination room to understand procedures being followed and found that post-procedure pathological waste was either being placed in formalin for send out to the laboratory or being placed in a red biohazard bag and held until the end of the day when it was closed, placed in a zip-sealed bag and placed in the freezer per agency policy. The Director of Patient Services and Center Manager met to identify procedures for improving the management of pathological waste and began individually bagging and sealing all specimens prior to being placed in the plastic container with the red biohazard bag the following day.
By 9/30/23, the Medical Waste Management section of the Infection Control Plan will be updated with more specific guidance for the management of pathological waste post-procedure to include requirement to individually bag and seal all specimens. The Director of Patient Services is responsible for updating the Infection Control Plan and communicating these updates to the facility manager and staff. The Center Manager (facility manager) will provide staff training on new procedures with hands-on demonstration. A training log will be used to document training and will be available for Department review.
By 9/30/23, the updated procedures will be included in decontamination room rotation training and compliance audit tools and compliance will be monitored through direct observation of staff working in the decontamination room by the Center Manager (CM) or Charge person. The CM (facility manager) is responsible for monitoring staff working in the decontamination room using the updated audit tool and will immediately address any issues which will be documented on the audit tool. To ensure compliance, monitoring will take place weekly for one month (through 10/31/23), then monthly for 3 months (through January 2024), and if compliance is maintained auditing will return to annual review as part of rotation evaluation.
The Center Manager (facility manager) will present this finding and plan of correction at the next Infection Control Committee meeting (planned for November 2023). The Director of Patient Services is responsible for ensuring implementation of and compliance with the plan of correction.
567.3 (b) (11) LICENSURE
Policies and Procedures
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567.3 Polcies and procedures
(b) Current written policies and procedures to assure definite and
valid infection control shall include,but not be limited to, the
following:
(11) Staff health status requirements
Observations:
Based on a review of facility policy, personnel files (PF) and interview with staff (EMP), it was determined the facility failed to ensure staff received an assessment of tuberculosis status prior to hire in one of two personnel files reviewed (PF2).
Findings include:
A review of facility policy "Infection Control Plan" dated February 20, 2020, revealed "TB (Tuberculosis) Testing Guidance added May 2021. ...Appendix: Occupational Health Program. ...Initial Employment Health Evaluation. Every new clinical employee and volunteer involved in direct patient care must show freedom from any communicable diseases that may pose a risk to others. ...An assessment of TB status must be made. ...New Employees. New employees who have not been screened within the last 12 months shall be screened for presence of infection with M. tuberculosis using the Mantoux PPD skin test. If the test is negative, the person is classified as uninfected. In addition to the PPD, new employees should be screened for indicators of risk for TB."
A review on September 21, 2022, of PF2, a registered nurse hired June 2, 2022, revealed a Tuberculin Fact Sheet and Diagnostic Screening Consent Form signed by PF2 on June 2, 2022. There was "X" in the box next to "I am eligible to receive the PPD test." The spaces to indicate the details of the PPD testing including date, administration site, and result was not completed.
An interview conducted on September 21, 2022, at 4:08 PM with EMP1 confirmed PF2 did not contain documentation that a Mantoux PPD skin test for TB was completed. Further interview confirmed the Tuberculin Fact Sheet and Diagnostic Screening Consent Form for performance of the PPD testing was incomplete.
Plan of Correction:By 9/30/2023, the Occupational Health Appendix of the Infection Control Plan for the facility will be updated to include the roles and responsibilities of Human Resources and Patient Services staff within the process for ensuring assessment and documentation of staff health status. Specifically, the Director of Human Resources in consultation with the Director of Clinical Services will ensure new employees are screened and tested (as needed) for Tuberculosis (TB) per policy. Updated procedure steps will be added as follows, new employees upon hire will meet with the Human Resources (HR) staff and will be evaluated for the need TB testing. If the employee has not had a TB test in the past year, HR staff will notify the Center Manager who will arrange for the employee to be tested within the first week of employment. A licensed provider will administer the PPD and will ensure the test is observed in 3 days. Once the result is completed and documented, the TB results are communicated to Human Resources and maintained in the personnel file. If TB testing is required and not completed within the first week, the employee will not be allowed to work until completed. HR and the Center Manager will work together to ensure compliance to this established workflow.
The Director of Clinical Services is responsible for updating the Infection Control Plan and we provide training on the new workflow for the HR team and the Center Manager. The Director of Human Resources is responsible for ensuring HR system supports the assessment and documentation of TB status among new hires and maintaining up to date personnel files. HR will routinely monitor personnel files for compliance and alert the Center Manager of any missing or delayed records, as well as any work restrictions.
The updated Infection Control Plan will be presented to the Governing Board for approval (9/28/23) and the Director of Clinical Services will present the finding and updates at the next Patient Safety/Infection Control Committee Meeting (expected 11/23). The Chief Operating Officer is responsible for ensuring implementation and compliance to the plan of correction.
567.53 (1) LICENSURE
Sterilization Control
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567.53 Sterilization control
There shall be written policies to establish the following:
(1) A method of control to assure sterilization of supplies and water.
Observations:
Based on observation, review of facility policy and interview with staff (EMP), it was determined that the facility failed to ensure facility policies detailed a workflow to ensure safety in the decontamination and processing of surgical instruments prior to patient use.
Findings include:
A review of facility policy "Infection Control Plan" dated February 20, 2020, revealed "Source of Standards. All aspects of the PPSP (Panned Parenthood Southeastern Pennsylvania) Infection Control Plan are based on evidence-based, nationally recognized standards....Re-usable Equipment-Ensure that reusable medical equipment and surgical instrument is cleaned and reprocessed appropriately prior to use on another patient."
An observation on September 21, 2022, at 11:26 AM in the Decontamination Room with EMP2 and EMP7 revealed a metal table directly adjacent to a clinical sink (hopper). Further observation revealed two basins was on the metal table, one containing water and one containing a mixture of water and enzymatic solution used for soaking contaminated instruments. Further observation revealed there was no measures in place to prevent cross contamination between the clinical sink (hopper) and the area utilized for decontamination and processing of surgical instruments.
An interview conducted on September 21, 2022, at 11:30 AM with EMP2 and EMP7 confirmed the above findings.
Plan of Correction:By 9/30/23, the facility will update workflow and physical plant measures to improve infection control in the decontamination room. The Infection Control Plan will be updated to include specific instructions for the flow of instruments to ensure separation of basins and the clinical sink and the facility manager will work with facilities staff to install a plastic barrier around the sink. The manager will train the staff on the use of the barrier and the updated flow of instruments including the requirement that that once cleaned and rinsed, surgical instruments are immediately placed in the approved passthrough to the Autoclave room.
Auditing tools used for observing staff processing surgical instruments in the decontamination room will be updated to include monitoring for cross contamination. To ensure compliance, monitoring will take place weekly for one month (through 10/31/23), then monthly for 3 months (through January 2024), and if compliance is maintained auditing will return to spot check and annual review as part of rotation evaluation.
The Director of Patient Services will update the Infection Control Plan and present the updated plan to the Governing Board for review and approval (9/28/23). The Center Manager (facility manager) will present this finding, plan of correction and audit results at the next Infection Control Committee meeting (planned for November 2023).
The Director of Patient Services is responsible for ensuring implementation of and compliance with the plan of correction.
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