Initial Comments:
This report is the result of an annual registration survey conducted on December 18, 2020, and completed on December 23, 2020, at PPSP Surgical Locust Street Health Center. It was determined the facility was iin 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 an state licensure survey conducted on December 18, 2020, and completed off-site on December 23, 2020, 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:
553.25 (1-6) LICENSURE
Discharge Criteria
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553.25 Discharge Criteria
A patient may only be discharged from an ASF if the following physical status criteria are met:
(1) Vital signs. Blood pressure, heart rate, temperature and respiratory rate are within the normal range for the patient's age or at preoperative levels for that patient.
(2) Activity. The patient has regained preoperative mobility without assistance or syncope, or function at his usual level considering limitations imposed by the surgical procedure.
(3) Mental status. The patient is awake, alert or functions at his preoperative mental status.
(4) Pain. The patient's pain can be effectively controlled with medication.
(5) Bleeding. Bleeding is controlled and consistent with that expected from the surgical procedure.
(6) Nausea/vomiting. Minimal nausea or vomiting is controlled and consistent with that expected from the surgical procedure.
Observations:
Based on review of facility policy, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure that patients were evaluated for activity prior to discharge for two of two medical records reviewed (MR1 and MR2).
Findings include:
A review of the facility's policy "Discharge Criteria" dated October 31, 2019, revealed "A patient may only be discharged from our ASF licensed sites...if the following physical status criteria re met (1) Vital signs...(2) Activity...(3)Mental Status...(4) Pain...The RN working receovery will assess all patients for required criteria and document physical status of required discharge criteria in the patient's medical record. Assessment and documentation of Discharge Criteria will be included in medical record audits and monitored at least annually."
Review of MR1, admitted on December 11, 2020, for a surgical abortion revealed no evidence of documentation that MR1 had met the required discharge assessment criteria for vital signs, pain and bleeding prior to discharge.
Review of MR2, admitted on December 11, 2020, for a surgical abortion revealed no evidence of documentation that MR2 had met the required discharge assessment criteria for vital signs, pain and bleeding prior to discharge.
An interview conducted on December 18, 2020, at 3:06 PM with EMP1 confirmed MR1 and MR2 did not contain documentation of the required discharge assessment criteria for vital signs, pain and bleeding prior to discharge from the facility.
Plan of Correction:All recovery room staff (RNs) will receive retraining on patient discharge requirements including the requirement to evaluate (and document) status of vital signs, pain, and bleeding for all surgical patients prior to discharge. The training will also include Electronic Medical Record workflow that ensures completed patient note is included in the visit summary. Evidence of training will be documented in facility training files and available for review. The Director of Clinical Services is responsible for providing training to recovery room nurses and the Center Manager will maintain the training records.
The Risk and Quality Management Coordinator or designee will monitor 10 patient records weekly for 100% compliance to discharge criteria for one month, then monitor 30 patient records monthly for two months. As needed, remediation will be provided by the Director of Clinical Services. Monitoring activities and audit results will reported to the Patient Safety Committee (meets quarterly). Annual monitoring will resume after 3 months as long as no further issues found. Audit results will be included in the CRQM quarterly report to the Board of Directors (Governing Body) which meets every other month. The Director of Patient Services is responsible for implementation and monitoring of 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 review of facility policy, credential files (CF), and interview with staff (EMP), it was determined the facility failed to adhere to the facility's policy for certifying the privileges of the medical staff every two years for two of two credential files reviewed (CF1 and CF2).
Findings include:
A review on December 18, 2020, of facility policy "Abortion Provider Privileging and Medical Staff Appointment" last revised October 18, 2018, revealed "Per ASF (ambulatory surgery facility) and Quad-A regulations and the PPSP Abortion Policy Manual, abortion providers must apply to the PPSP Board of Directors for appointment to the medical staff of PPSP, upon hire/engagement and every two years thereafter. For initial appointments and biennial re-appointments, all of these actions must be completed by one (1) month prior to the Board's scheduled review: 1. The Medical Director will certify the provider's clinical privileges related to abortion care (Medication Abortion, Surgical Abortion, Ultrasound, Local Paracervical Block, Molar Pregnancy Management, Ectopic Pregnancy Management, Early Pregnancy Loss Management) by completing a Certification of Clinical Privilege form and submitting it to the Director of Human Resources. If the provider seeking privileging and appointment is the Medical Director, then the responsibility for certifying the Medical Director's clinical privileges will be delegated by the Medical Director to a physician who holds all relevant privileges."
Review on December 18, 2020, of CF1 with EMP1 revealed the providers' clinical privileges for abortion care was last certified by the Medical Director on May 17, 2017.
Review on December 18, 2020, of CF2 (the Medical Director) with EMP1 revealed the providers' clinical privileges for abortion care was last certified by a physician who holds relevant privileges on October 5, 2018.
An interview conducted on December 18, 2020, at 2:40 PM with EMP1 confirmed CF1's clinical privileges related to abortion care was last certified on May 17, 2017. EMP1 further confirmed CF2's clinical privileges related to abortion care was last certified on October 5, 2018. EMP1 stated "Privileges are granted and they stay in place, forever, as long as the provider is in good standing."
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Based on review of facility policy, documents, credential files (CF) and interview with staff (EMP), it was determined the facility failed to ensure the privledges of certified registered nurse anesthetist (CRNA) were certified every one year in accordance with the registration status approved by the "Department" for a Abortion/Class B surgical facility for two of two credential files reviewed (CF3 and CF4).
Findings include:
Review of facility policy "Governing Body Responsiblities" last revised November 30, 2019, revealed "Board Appointments: The board may grant clinical privileges to qualified, licensed practitioners (physicians, certified registered nurse anesthetists, nurse practitioners) working in the ASF... 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 December 18, 2020, of facility document for CF3, a certified registered nurse practitioner (CRNA) dated December 19, 2019, revealed "It is my pleasure to inform you that the Board of Directors has approved your appointment to the active medical staff of Planned Parenthood Southeastern Pennsylvania, with the granting of requested privileges as documented in your personnel file. This is a one-year appointment and is for the period 12/19/19 to 12/19/20."
Review on December 18, 2020, of facility document for CF4, a certified registered nurse practitioner (CRNA) dated December 19, 2019, revealed "It is my pleasure to inform you that the Board of Directors has approved your appointment to the active medical staff of Planned Parenthood Southeastern Pennsylvania, with the granting of requested privileges as documented in your personnel file. This is a one-year appointment and is for the period 12/19/19 to 12/19/20."
Review on December 18, 2020, of CF3, a certified registered nurse practitioner (CRNA) with EMP1 revealed no evidence of documentation of anesthesia privileges for monitored anesthesia care. Further review revealed a letter addressed to CF3, with appointment dates of December 19, 2019, through December 19, 2020.
Review on December 18, 2020, of CF4, a certified registered nurse practitioner (CRNA) with EMP1 revealed no evidence of documentation of anesthesia privileges for monitored anesthesia care. Further review revealed a letter addressed to CF4, with appointment dates of December 19, 2019, through December 19, 2020.
An interview conducted on December 18, 2020, at 2:59 PM with EMP1 confirmed CF3 and CF4 did not contain evidence of documentation of clinical privileges for providing monitored anesthesia care services. Further interview revealed CF3 and CF4 did not contain an application for the appointment dates of December 19, 2019, through December 19, 2020.
Plan of Correction:By 3/31/21, facility leadership (Director of Patient Services and Director of Human Resources) will review and update the facility policy "Abortion Provider Privileging and Medical Staff Appointment" including the development of a new medical appointment application form. The updated policy will be presented to the Governing Board for approval at the March meeting and the new appointment process will be implemented once approved. The Director of Human Resources will audit credentialing files against new policy and initiate updates to exiting providers privileging certification as needed. Human Resources will audit credential files at time of appointment or reappointment, and annually to ensure ongoing compliance. The Director of Patient Services will ensure Plan of Correction is completed and monitor facility for compliance.
By 5/31/21, all contracted CRNAs will have documentation of granted clinical privileges for monitored anesthesia care in their credential files. To complete the privileging process, CRNAs will submit an application for privileges and medical staff appointment. The Director of Patient Services and Director of Human Resources will develop the application and update the CRNA policy "Credentials and Training Requirements for CRNAs" to reflect this new procedure. The policy will be presented to the Governing Body at the March 2021 meeting. The Director of Anesthesia will conduct peer review and initial privileging of all CRNAs and prepare recommendation for the Governing Body. Recommendations will be presented The application, evidence of privileges, and peer view will be maintained in the credential files. The Director of Human Resources will audit credentialing files at time of appointment and annually to ensure compliance. The Director of Patient Services will ensure Plan of Correction is completed and monitor facility for compliance.
557.4 (a)(1-4) LICENSURE
Quality Assurance & Improvement Committee
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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 a review of facility policy, documents and interview with staff (EMP), it was determined the facility failed to ensure the required committee members of the Quality Committee (QC) Meeting were in attendance as representatives of the ambulatory surgical center (ASC) during the Compliance, Risk & Quality Management Committee meetings.
Findings include:
Review on December 18, 2020, of facility document "Planned Parenthood Southeastern Pennsylvania Risk and Quality Management ..Program Overview and Work Plan revealed " ... Committee members include: ... A Center Manager or Assistant Center Manager ... Other staff as assigned based upon agenda items and/or program review".
Review on December 18, 2020, of the facility's Quality Committee (Compliance, Risk & Quality Management) meeting minutes dated June 16, 2020, revealed facility representatives from administration and an other health care personnel was not in attendance at the Compliance, Risk & Quality Management Committee meetings.
An interview conducted on December 18, 2020, at 2:34 PM with EMP1 confirmed the required committee members were not in attendance at the Compliance, Risk & Quality Management Committee meetings conducted on June 16, 2020, for the ambulatory surgical center.
Plan of Correction:The Compliance, Risk and Quality Management (CRQM) Plan will be updated to include required attendance of a physician that is not an owner, administrator, registered nurse and "an other healthcare personnel" per PA regulations. The updated CRQM Plan will be submitted to the Board of Directors (Governing Body) for approval at next meeting (scheduled 4/29). The Director of Patient Services will meet with the Center Manager to review the updated facility Compliance, Risk and Quality Management (CRQM) Plan and confirm the requirement of attendance at the CRQM Committee meetings. To ensure required facility administrator representation, the Center Manager will identify an alternative member of the facility leadership team that will attend if she is unable. Meeting attendance is documented in the CRQM Committee meeting minutes. Evidence of Center Manager retraining and understanding of requirements will be documented via email. The Director of Patient Services will monitor quarterly CRQM Committee meeting minutes for compliance to required attendance. The Director of Patient Services will ensure Plan of Correction is completed by 5/15/21.
567.1 Principle 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 observation, review of facility, policy, and interview with staff (EMP), it was determined the facility failed to provide a safe and sanitary environment for the delivery of patient care services.
Findings include:
An observation tour on December 18, 2020, at 1:32 PM in the instrument decontamination room with EMP1 and EMP4 revealed one sink and one basin were used for instrument decontamination. The directions on the bottle of detergent used for instrument decontamination read "one scoop per 2 gallons of water.
A review on December 18, 2020, of facility policy "Infection Control Plan" last updated February 20, 2020, revealed "Following the procedure, instruments should be kept wet by soaking in a detergent or enzymatic cleaning solution."
Review of facility policy "Infection Control Plan-Locust Street Surgical Center last revised February 20, 2020, revealed "In using Standard Precautions, we assume all human blood, certain human body fluids and Other Potentially Infectious Materials (OPIM) are known to be infectious and use precautions with every patient and every procedure to reduce risk in the workplace. These practices are designed to both protect health care staff and to prevent staff from spreading infections among patients."
An interview conducted on December 18, 2020, at 1:32 PM with EMP4 who stated "We are unable to measure the amount of water to add to the detergent for instrument decontamination. Instruments stay in the procedure room and we bring them back here(decontamination room) for processing . We rinse the instruments in the first sink and then soak them for about five minutes in the detergent. I put about a scoop (of detergent) in the bucket and fill the green bucket about halfway. There really is no way to measure how much water goes in the green bucket."
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An observation tour on December 18, 2020, at 1:48 PM, in the post anesthesia recovery unit (PACU) with EMP1 revealed the refrigerator contained one-liter bottle of gingerale. The liter bottle of gingerale was opened, and did not contain documentation as to when the bottle was opened and no discard date was noted on the bottle. Further observation revealed the facility did not record temperatures for items kept in the patient nourishment refrigerator and the refrigerator did not have a thermometer to record temperatures
An interview on December 18, 2020, at 1:48 PM with EMP1 confirmed the nourishment refrigerator was for patient use. EMP1 further confirmed there was no discard date on the open bottle of gingerale. EMP1 confirmed the refrigerator did not have a thermometer and temperatures were not recorded for this patient nourishment refrigerator.
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An observation tour on December 18, 2020, at 1:55 PM in the PACU with EMP6 revealed the medication refrigerator contained a opened vial of tuberculin solution dated October 10, 2020. No date for discard was documented on the vial.
An interview on December 18, 2020, at 1:55 PM with EMP6 confirmed the tuberculin solution was opened October 10, 2020. No discard date was documented on the vial of the tuberculin solution. EMP6 stated "I think the vial is good for 30 days after opening, so it's expired now."
Plan of Correction:The Center Manager is responsible for maintaining a safe and sanitary environment and will address findings no later than 4/30/21.
In the instrument decontamination room, a new soaking bin and measurement pitcher (gallon) has been purchased and is now in use. The Center Manager (CM) provided staff training on the procedure for instrument soak from the Infection Control Plan at their 2/16/21 site meeting. Documentation of this training will be maintained in training files. The CM is responsible for ensuring compliance to instrument soaking procedure and will monitor staff weekly for 4 weeks addressing any concerns immediately. The CM will then monitor monthly for 3 months on an unannounced schedule and resume annual review. The facility conducts annual monitoring of staff in this rotation and on all infection control procedures. Documentation of monitoring will be completed via email and available for review. The CM will report on monitoring efforts at next quarterly Infection Control Committee. Reports from the Infection Control Committee are included in the quarterly CRQM report to the Board of Directors (Governing Body). The Director of Patient Services will ensure completion of the Plan of Correction.
The facility maintains multiple refrigerators - lab reagents/lab specimens, medication, and patient nourishment.
For the patient nourishment fridge, a temperature log will be added which will require daily monitoring of temperature and will increase monitoring of gingerale found is this fridge. The Center Manager will review the requirement to note date open on each bottle and how to determine expiration date for the gingerale (either on the bottle or using the company code for determining date) with all recovery room staff and document training using sign-off sheet.
In the medication fridge, the opened vial of tuberculin solution was removed and discarded immediately. All facility staff will receive training (retraining) on the Infection Control Plan related to proper storage and labeling of medication. In addition, labels with storage requirements will be added to all refrigerators. The Center Manager (in collaboration with Director of Clinical Services) will provide staff retraining, maintain documentation of training, and monitor compliance. The Center Manager will monitor the refrigerators weekly for 4 weeks and if compliant monthly monitoring will resume. Monitoring and any findings will be documented using the temperature logs, which are specific to each fridge. The CM will report on remediation and monitoring efforts at next quarterly Infection Control Committee. Reports from the Infection Control Committee are included in the quarterly Compliance, Risk, and Quality Management (CRQM) report to the Board of Directors (Governing Body). The Director of Patient Services will ensure completion of the Plan of Correction.
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