Initial Comments:
This report is the result of an unannounced on-site pre-licensure and occupancy survey conducted on June 7, and 8, 2012, at Philadelphia Women's Center. Based on the occupancy survey, it was determined the facility was not in compliance with all applicable 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 and the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities.
Plan of Correction:
551.21 (e)(1-3) LICENSURE
Criteria for ambulatory surgery
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551.21 Criteria for ambulatory surgery
(e) In obtaining informed consent, the practitioner performing the surgery shall be responsible for disclosure of:
(1) The risks, benefits and alternatives associated with the anesthesia which will be administered.
(2) The risks, benefits and alternatives associated with the procedure which will be performed.
(3) The comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital.
Observations:
Based on review of facility documents and interview with staff (OTH), it was determined the facility failed to ensure practitioners documented informed consent that included the disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgery facility (ASF) instead of a hospital.
Findings include:
Review on June 7, 2012, of the facility's "Consent to Abortion (Termination of Pregnancy)," undated, revealed it did not contain the disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in the ASF instead of a hospital.
Interview on June 7, 2012, with OTH1 confirmed the facility's informed consent form did not contain the disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in the ASF instead of a hospital.
Plan of Correction:1.The deficiency was corrected as it relates to the individual by altering the �Consent to Abortion (Termination of Pregnancy)� form to include the following wording, �There is very little evidence comparing the safety of abortions performed in outpatient facilities with those performed in hospitals; the evidence that does exist indicates abortions are equally safe in both settings."
2.To protect patients in similar situations the revised �Consent to Abortion (Termination of Pregnancy)� form will be given to all patients seeking abortion services.
3.To ensure that the problem does not recur, all copies of the old version of the form have been destroyed. All blank charts and stacks of chart paperwork contain the new version of the form.
4.To sustain this solution, the staff performing QA on charts will check to make sure the revised version of the form is in all charts from June 25, 2012 on.
5.This corrective action will be completed by June 25, 2012.
553.3 (8) LICENSURE
Governing Body Responsibilities
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553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
Observations:
Based on review of the Child Protective Services Law, facility documents, and staff interview (OTH), it was determined the facility failed to ensure processes were in place to meet the requirements for background checks as required by Act 179 of 2006 and Act 73 of 2007.
Findings include:
The Child Protective Services Law (CPSL), 23 Pa.C.S. 6344.2 requires employees hired after July 1, 2008, who have a significant likelihood of regular contact with children in the form of care, guidance, supervision or training must obtain three background checks as condition of employment: Pennsylvania State police Clearance, Department of Public Welfare (DPW) Childline Clearance and Federal (FBI) Criminal Background Check.
Review on June 7, 2012, of the facility's policy and procedure manual revealed no facility policy that required employees hired after July 1, 2008, who had a significant likelihood of regular contact with children in the form of care, guidance, supervision or training obtained the three background checks as condition of employment, i.e. the Pennsylvania State Police (PSP) Clearance, Department of Public Welfare (DPW) Childline Clearance and Federal (FBI) Criminal Background Check.
Interview with OTH1 on June 7, 2012, confirmed the facility performed surgery on pediatric patients. Further interview with OTH1 confirmed there were no policies and procedures in place that required the three background checks for CPSL.
Plan of Correction:1.The deficiency will be corrected as it relates to the individual by undertaking background checks for new hires and persons hired since July 1, 2008, who hold, or seek to hold, the following positions at PWC: Doctors, CRNAs, Full time RNs, Senior Counselor, Administrator, Medical Coordinator, and Clinical Coordinator. Those persons will be required to submit to all requirements set forth in section 6344(b), and shall be subject to the requirements of section 6344 (c).
2.To protect patients in similar situations background checks will be done on all new hires in the positions listed above from this point forward.
3.To ensure the problem does not recur the Administrator will oversee all background checks for the applicable positions and will document the findings in the employee files.
4.To ensure these solutions are sustained, the Administrator will report to the Governing Body annually on compliance with the background check requirements.
5.This corrective action will be completed by July 20, 2012.
567.43 LICENSURE
Ventilation System
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The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under
Chapter 571 (relating to construction standards).
Observations:
Based on staff interviews (OTH), it was determined the facility failed to monitor temperature and humidity in three of three rooms used by the facility to perform surgical procedures.
Findings include:
On June 7, 2012, the surveyor requested the temperature and humidity documentation for three surgical procedure rooms.
Interview with OTH1 on June 7, 2012, confirmed the facility did not monitor or maintain a record of the temperature and humidity levels in surgical procedure rooms.
Plan of Correction:1.The deficiency was corrected as it relates to the individual by monitoring the temperature and humidity in three of three rooms used by the facility to perform surgical procedures.
2.To protect patients in similar situations temperature and humidity levels will continue to be monitored four times daily when services are provided.
3.To ensure the problem does not recur, staff will maintain temperature and humidity logs, which will be kept as documentation.
4.To ensure that this solution is sustained, Management staff will check the temperature and humidity log daily.
5.This corrective action will be completed by June 25, 2012.
569.34 LICENSURE
Electrical Safety
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569.34 Electrical Safety
Appliances, instruments and installations shall be tested before
use to determine compliance with grounding, current leakage and other
device safety requirements to ensure protection of patients and employees. A
program of routine maintenance shall be effectively enforced to ensure that
electrical receptacles and plugs, wires and connectors are safe. If an
appliance requiring three wire circuitry for grounding is attached to
as two wire outlet, the adaptor plug pigtail shall be attached to a
ground.
Observations:
Based on interview with staff (OTH), it was determined the facility failed to ensure there was a program of routine maintenance for the electrical receptacles, plugs, wires, and connectors.
Findings include:
On June 7, 2012, the surveyor requested the routine maintenance documentation of the facility's electrical testing for electrical receptacles. No documentation was provided.
Interview on June 8, 2012, with OTH1 confirmed there was no documentation of routine maintenance for the electrical testing for the electrical receptacles.
Plan of Correction:1.The deficiency was corrected as it relates to the individual by commencing a program of monitoring the safety of the electrical receptacles, plugs, wires and connectors.
2.To protect patients in similar situations inspections of electrical safety will be done on a routine basis. Specifically, the Administrator or a designee will monitor electrical safety by inspecting electrical receptacles, plugs, wires and connectors at least quarterly.
3.To ensure that the problem does not recur, the Administrator or designee will maintain an inspection log, which will be kept as documentation.
4.To ensure this solution is sustained, the Administrator will report to the Governing Body annually on the timing and findings of the electrical safety inspections.
5.This corrective action was completed on June 20, 2012.
571.1 LICENSURE
CHAPTER 571 - Construction Standards
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571.1 Minimum Standards
ASF construction shall be in accordance with the latest edition of the "Guidelines for Design and Construction of Hospital and Health Care Facilities," as published by the American Institute of Architects/Academy of Architecture for Health including those guidelines established for various outpatient facilities. In the alternative, a facility shall meet the construction guidelines for specified types of surgical procedures as listed in appendix A. Where renovation or replacement work is performed within an existing facility, all new work or additions shall comply with the requirements for new construction.
Observations:
Based on review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, observation, and interview with staff (OTH), it was determined the facility failed to ensure it was in compliance with the current construction guidelines.
Findings include:
1) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed "3.8-3.4.2.2 Cubicle curtains or other provisions for privacy during post-operative care shall be provided.
Observation on June 7, 2012, of the patient recovery room area revealed seven patient recovery chairs for post-operative care located directly across from five pre-operative patient chairs. The privacy cubicle curtains for the seven recovery chairs were located on each side of the chair but did not have a provision for closure directly in front of the patient to ensure complete privacy. The pre-operative patient chairs did not have privacy curtains.
Interview on June 7, 2012, with OTH1 confirmed the cubicle curtains for the post-operative recovery room chairs did not completely enclose the patient to ensure privacy. OTH1 confirmed these post-operative chairs were located facing patients in the pre-operative chairs.
2) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed 3.8-5.1.2.2 Clean/assembly workroom. Clean and soiled work areas shall be physically separated.
Observation on June 7, 2012, of the facility's Sterilization Room revealed it was used for decontamination and disinfecting of medical/surgical instruments and also for the clean assembly of medical/surgical equipment.
Interview on June 7, 2012, with OTH1 confirmed there were not separate clean and soiled work areas.
3) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed 3.8-3.6.9 Clean Storage, a clean storage area, including space for preparing instruments and supplies for surgery shall be provided.
Observation on June 7, 2012, of the facility's Sterilization Room revealed it was used for decontamination and disinfecting of medical/surgical instruments and also for the clean assembly of medical/surgical equipment. Further observation of the facility revealed a clean storage closet was located in the hallway next to the laboratory waiting room that contained different sizes of curettes, hydrogen peroxide, Betadine, specimen containers, surgical gloves, empty plastic red sharp containers, blue pads, hand soap, aerosol cleaning cans and liquid cleaning supplies.
Interview on June 7, 2012, with OTH1 confirmed the clean/sterile packs were wrapped in the Sterilization Room and then taken and stored in the operating/procedures room. OTH1 confirmed the clean storage closet located in the hallway next to the laboratory waiting room contained both patient and cleaning supplies.
4) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed 3.8-5.1.2.3 Storage for clean/sterile supplies (1) Storage for packs, etc., shall include provisions for ventilation, humidity, and temperature control.
Observation of the facility on June 7, 2012, revealed clean/sterile supplies were brought into the operating/procedure rooms for storage. There was also a clean supply closet located in the hallway next to the laboratory waiting room that contained patient supplies. On June 7, 2012, surveyor requested documentation for temperature and humidity levels for these areas. The documentation was not provided.
Interview on June 7, 2012, with OTH1 confirmed the ventilation, humidity and temperature control were not monitored for the areas where clean/sterile supplies were stored.
Plan of Correction:1)3.8-3.4.2.2 Cubicle curtains or other provisions for privacy during post-operative care shall be provided.
Plan of Correction
1.The deficiency will be corrected as to the individual by purchasing more privacy curtains and/or screens.
2.To protect patients in similar situations newly purchased privacy curtains and/or screens will be set up in PACU.
3.To ensure the problem does not recur, PACU staff will be instructed on the correct positioning of privacy curtains and screens to ensure that provisions for patient privacy are afforded in compliance with the regulation.
4.This solution will be sustained by having the Director of Nursing ensure that privacy curtains are used properly while services are provided at the facility.
5.This corrective action will be completed by July 20, 2012.
2)3.8-5.1.2.2 Clean/assembly workroom. Clean and soiled work areas shall be physically separated.
Plan of Correction:
1.The deficiency will be corrected by repurposing rooms in the facility. The room currently used for decontamination and sterilization will become a soiled workroom, and the room across the hall will be used exclusively as a sterilization room.
2.Protecting patients in similar situations will not be a concern once the repurposing has taken place.
3.To ensure the problem does not recur the new room designations according to ASF guidelines will be kept in place.
4.This solution will be sustained by keeping the new room designations according to ASF guidelines.
5.This corrective action will be completed by July 20, 2012.
3)3.8-3.6.9 Clean Storage, a clean storage area, including space for preparing instruments and supplies for surgery shall be provided.
Plan of Correction:
1.The deficiency will be corrected by repurposing rooms in the facility. The room currently used for decontamination and sterilization will become a soiled workroom, and the room across the hall will be used exclusively as a sterilization room. This new sterilization room � with its storage cabinets, sink and counter - will meet the requirement for a clean storage area, including space for preparing instruments and supplies for surgery.
2.Protecting patients in similar situations will not be a concern once the repurposing has taken place.
3.To ensure the problem does not recur the new room designations according to ASF guidelines will be kept in place.
4.This solution will be sustained by keeping the new room designations according to ASF guidelines.
5.This corrective action will be completed by July 20, 2012.
4)3.8-5.1.2.3 Storage for clean/sterile supplies (1) Storage for packs, etc., shall include provisions for ventilation, humidity, and temperature control.
Plan of Correction:
1.The deficiency was corrected as it relates to the individual by monitoring the temperature and humidity in the rooms where sterile packs are stored.
2.To protect patients in similar situations temperature and humidity levels will continue to be monitored four times daily when services are provided.
3.To ensure the problem does not recur, staff will keep temperature and humidity logs, which will be kept as documentation.
4.Management staff will ensure the temperature and humidity log is completed daily.
5.This corrective action will be completed by June 25, 2012.
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