QA Investigation Results

Pennsylvania Department of Health
PPSP FAR NORTHEAST HEALTH CENTER
Health Inspection Results
PPSP FAR NORTHEAST HEALTH CENTER
Health Inspection Results For:


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Initial Comments:

This report is the result of an annual Registration survey conducted on August 10, 2016, 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 full State Licensure survey conducted on August 10, 2016, at Planned Parenthood Far Northeast. It was determined that 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 (7) LICENSURE
Governing Body Responsibilities

Name - Component - 00
Governing Body responsibilities include:
(7) Assuring that the quality of care is evaluated and that identified problems are appropriately addressed.


Observations:

Based on review of facility documentation and staff interview (EMP), it was determined that the facility failed to ensure that reports of findings of "PPSP Far Northeast Health Center" Quality Assurance and Improvement, Infection Control, and Patient Safety Committees were evaluated by the Governing Body and that identified problems were appropriately addressed.

Findings include:

Review on August 10, 2016, of facility's "Planned Parenthood Southeastern Pennsylvania By-laws," undated, revealed no requirement to ensure that findings of the Quality Assurance and Improvement, Infection Control, and Patient Safety Committees were evaluated by the Governing Body and that identified problems were appropriately addressed.

Review on August 10, 2016, of "PPSP Medical Committee meeting minutes," dated May 12, 2016, revealed no documentation that findings of the Quality Assurance and Improvement, Infection Control, and Patient Safety Committees were evaluated by the Governing Body and that identified problems were appropriately addressed for the PPSP Far Northeast Health Center.

Interview on August 10, 2016, at 2:20 PM with EMP1 confirmed the above findings.










Plan of Correction:

An approved Plan of Correction is not on file.


553.3 (13)(i-iv) LICENSURE
Govern Body Responsibilities

Name - Component - 00
Governing Body responsibilities include:
(13) Approving major contracts or arrangements affecting the medical care provided under its auspices, including, those concerning;
(i) The employment for contractual arrangements with practitioners and others providing direct patient care.
(ii) The provision of all treatment related services including, radiology, medical laboratory, pathology , anesthesia and pharmaceutical services.
(iii) The provision of care by other health care organizations.
(iv) The provision of education to students and post graduate trainees.



Observations:

Based on review of facility documents, and interview with staff (EMP), it was determined the facility failed to review the facility's contracted services to ensure they were provided in a safe and effective manner.

Findings include:

Review of facility's "Planned Parenthood Southeastern Pennsylvania By-laws, "undated, revealed no requirement to ensure that contracted services were provided in a safe and effective manner.

Review on August 10, 2016, of the facility's document "Risk and Quality Management Fiscal Year 2016 ... Plan, "undated, revealed no requirement for the governing body to ensure that contracted resources were provided in a safe and effective manner.

Review of facility documents revealed the contracted services included housekeeping, linen, heating and ventilation systems services, electrical system services, anesthesia services, infectious waste removal, ambulance services, pest control, hospital transfer agreement, laboratory services, equipment preventative maintenance, water service, environmental systems, and fire alarms services.

Review on August 10, 2016, of the facility's "Quality Improvement Meeting Minutes," dated February 5, 2016, April 20, 2016, and June 15, 2016, revealed no documentation the quality assurance program reviewed the facility's contracted services.

Interview on August 10, 2016, at 2:20 PM with EMP1 confirmed there was no documentation of quality analysis conducted for contracted resources.












Plan of Correction:

An approved Plan of Correction is not on file.


553.4 (g) LICENSURE
Other Functions

Name - Component - 00
553.4 OTHER FUNCTIONS

(g) The governing body shall ensure the licensee provides to the Department, the documents under 551.53 (relating to presurvey preparation).


Observations:

Based on review of facility documentation and interview with staff (EMP), it was determined that the facility failed to provide records of continuing education for the nursing staff, staffing schedules, and a list of approved operative procedures performed at the facility.

Findings include:

Multiple requests were made to EMP1 on August 10, 2016, at 11:30 AM, 2:30 PM and 3:35 PM, for continuing education records of nursing staff, staffing schedules, and a list of approved operative procedures performed at the facility. None of the before mentioned documents were provided.

Review on August 10, 2016, of the Department's material list for an annual licensure survey provided to the facility on July 11, 2016 via email, revealed "Please send a copy of the following material which is highlighted ... The remainder (material list) is to be made available on the first day of survey ... g. Continuing Education Program, h. List of procedures performed at the facility ... 7. ...c. Staffing Schedules ...".

Interview on August 10, 2016, at 10:00 AM, with EMP1 confirmed EMP1 received an email on July 11, 2016, that contained the list of documents required to be available on the day of the survey, to be reviewed onsite for licensure compliance.










Plan of Correction:

An approved Plan of Correction is not on file.


561.13 LICENSURE
Storage

Name - Component - 00
561.13 Storage

The area in the ASF where drugs are stored shall be periodically checked by a responsible pharmacist or practitioner and proper logs maintained.


Observations:

Based on a review of facility policy and staff interviews (EMP), it was determined that the facility failed to ensure all medication storage areas were periodically checked by a responsible pharmacist or practitioner.

Findings include:

Review on August 10, 2016, of facility's policy "Periodic Provider Drug Checks," dated June 12, 2012, revealed "The area in the ASF where drugs are stored shall be periodically checked by a responsible pharmacist or practitioner and proper logs maintained".
Request was made to EMP1 on August 10, 2016, for documentation to indicate that the facility's areas containing medications were checked by a responsible pharmacist or practitioner. No documentation was provided.
Interview on August 10, 2016, at 3:30 PM, with EMP1 confirmed that the facility has no documentation to show the area was checked by a responsible pharmacist or practitioner.








Plan of Correction:

An approved Plan of Correction is not on file.


563.5 LICENSURE
Storage of Medical Records

Name - Component - 00
563.5 Storage of Medical Records

Medical records shall be stored to provide protection from loss, damage
or unauthorized access.


Observations:

Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure medical records were stored in a manner to prevent loss, damage and unauthorized access.

Findings include:

Review on August 10, 2016, of facility policy "Medical Records," no review date, revealed "Retention of Files ... 4. Safeguards against loss and use by unauthorized persons must be maintained."

1. Observation on August 10, 2016, at 12:10 PM of the facility's medical record storage area revealed a locked storage area that contained 29 cardboard boxes of medical records and building maintenance supplies that included paint, ladders, light bulbs, cleaning chemicals. Further observation revealed the boxes were stored on open metal shelving and the room contained one smoke detector and no manual or automatic fire extinguishing equipment.

Interview with EMP1 August 10, 2016, at the time of the observation confirmed the card board boxes stored in the area contained patient information from 2007 to 2014, that included medical records from procedures completed at the facility, pregnancy testing results, family planning and fetal ultrasound documents. Further interview confirmed equipment and supplies for the maintenance of the facility are also stored in the medical record storage area.

Interview with EMP1 on August 10, 2016, at 12:38 PM confirmed the facility's maintenance staff have access to the medical record storage area, aresulting in unauthorized access to confidential patient information. Further interview confirmed medical records stored in cardboard boxes would not be protected from smoke, fire and water damage if there was fire in the location.

2. Observation on August 10, 2016, at 12:20 PM of the Lab room sump pump closet revealed patient medical records "AB (abortion) Procedure Logs, dated from January 1, 2011 to December 31, 2011, and January 1, 2012, to January 31, 2012, stored on a shelf in the closet.

Interview with EMP1 August 10, 2016, at the time of the observation confirmed the log books were placed in the closet for storage prior to shredding the documents.

Interview with EMP1 on August 10, 2016, at 12:38 PM confirmed the facility's maintenance staff and unauthorized staff have access to the sump pump closet.








Plan of Correction:

An approved Plan of Correction is not on file.


563.6 (c) LICENSURE
Preservation of Medical Records

Name - Component - 00
563.6 Preservation of medical records

(c) If an ASF discontinues operation, it shall make known to the
Department where its records are stored. Records are to be stored in a
facility offering retrieval services for at least 5 years after the closure
date. Prior to destruction, public notice shall be made to permit former
patients or their representatives to claim their own records. Public notice
shall be in at least two forms, legal notice and display advertisement in a
local newspaper of general circulation.


Observations:

Based on a review of facility policy and staff interview (EMP), it was determined the facility failed to incorporate all requirements for the preservation of medical records in the event the facility should discontinue operations.

Findings include:

A review on August 10, 2016, of the facility"s policy "Medical Records" no review date, revealed no documented evidence the facility had a plan in place to notify the Department where medical records would be stored if operations would be discontinued and no provisions to publicaly notify patients or their representatives to claim their own records prior to destruction.

An interview conducted on August 10, 2016, at 11:00 am AM with EMP1 confirmed that the facility policy did not incorporate all required state requirements for the preservation of medical records.

















Plan of Correction:

An approved Plan of Correction is not on file.


567.41 LICENSURE
MAINTENANCE SERVICE - Principle

Name - Component - 00
567.41 Principle

The ASF shall be equipped, operated and maintained to sustain its
safe and sanitary characteristics and to minimize health hazards in the ASF
for the protection of patients and employes.


Observations:

On August 10, 2016, a request was made for a policy regarding the storage of Formalin and none was provided.

Review on August 10, 2016, of the MSDS (Material Safety Data Sheet) for 10% Neutral Buffered Formalin, dated January 2013," revealed "Section 2: Hazards Identification ... P405- Store locked up."

Observation on August 10, 2016, at 1:00 PM revealed 60 clear plastic containers of 10% Neutral Buffered Formalin in an unlocked cabinet located in an area adjacent to the procedure rooms.

Interview on August 10, 2016, with EMP1 confirmed [they] did not know Formalin was to be locked up, and confirmed the Formalin containers were stored in an area accessible by unauthorized staff.








Plan of Correction:

An approved Plan of Correction is not on file.


569.32 LICENSURE
Fire Inspection

Name - Component - 00
569.32 Fire Inspection

The ASF shall request an annual inspection by its local fire
department.


Observations:

Based on a review of facility documents and staff interview (EMP), it was determined the facility failed to request an annual inspection by the local fire department for the year 2015.

Findings include:

Review on August 10, 2016, of policy "Fire Safety Program," dated June 19, 2012, revealed "... PPSP's Director of Facilities is responsible for the ongoing compliance of annual fire inspection and requesting our annual inspections from the local fire departments."

Request was made to EMP1 on August 10, 2016, for documentation to indicate that the facility requested an annual inspection from its local fire department for the year 2015. No documentation was provided.

Interview on August 10, 2016, at 1:30 PM, with EMP1 confirmed the facility did not request an inspection by the local fire department for 2015.







Plan of Correction:

By September 30, 2016, the Manager of Facilities will submit a request for inspection to the local fire department. The Manager of Facilities is responsible for making this request annually and providing record of the request to the ASF person-in-charge. Records of fire inspections and/or request for inspections will be available for Department review.