Initial Comments:
This report is the result of an initial registration survey conducted on June 16, 2011, at Planned Parenthood of Northeast and Mid-Penn - Allentown Health Center. It was determined that 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.
Safe and Sanitary recommendations were provided to the facility in Tag 9999 - Recommendations. The facility is encouraged to provide a plan of correction.
Plan of Correction:
No POC Required STANDARD
Recommendation
Name - Component - 00
Observations:
Based on a tour of the facility on June 16, 2011, and staff interview (EMP), it was determined that the Planned Parenthood of Northeast and Mid-Penn - Allentown Health Center failed to maintain a safe and sanitary environment.
Findings include:
Upon entry into the facility, there were two patients at the front desk conversing with the receptionist (EMP3) through a solid glass window. The conversation could be heard clearly by the patients in the waiting room. The surveyor moved to the back of the waiting room. The conversation remained clear and audible to the visitors in the waiting room and the surveyor at the far end of the waiting room. EMP3 confirmed this finding.
Further observation of the patient waiting area revealed that the facility did not have the required Department of Health (DOH) posting. The posting includes the complaint number to lodge a complaint with the DOH.
A tour of the facility was initiated at 10:20 AM on June 16, 2011, with facility staff. The following findings were noted:
Examination room 1 - There was a sterilized forceps dated January 23, 2010, that had an accumulation of a red - brown solid substance on the handle and in the joint of the instrument. EMP3 confirmed these findings.
The POC (Products of Conception) lab - There were 12 packages of six foot PVC tubing with handles and fittings which expired January 2011. The POC freezer did not have a biohazard identifying label on it to indicate that its contents biohazardous. There was a 10 milligram (mg) / milliliter (ml) bottle of 1 percent Lidocaine open, partially used, and undated. EMP3 confirmed these findings.
Examination Room 2 - There were two drawers in the examination table that held 14 unwrapped metal speculums. There was a warm heating pad under the speculums in the first drawer.
Examination room 3 - There were nine sterilized packages of forceps that had an accumulation of a red - brown solid substance on the handles and in the joints of the instruments. In the hallway outside examination room 3, there were stained ceiling tiles. EMP3 confirmed these findings.
Examination Room 4 - There were 22 sterile instrument packages with an accumulation of a red - brown substance on various areas of the instruments. The red garbage can contained a bloody gauze and catheter inside. There was no garbage bag present. EMP1 confirmed these findings.
Storage Room - There were 44 boxes of various supplies such as, underpads, sheets, distilled water, curettes, sponges, and specimen containers stored directly on the floor. Inside the door, on the left, there were two large cardboard boxes lined with red biohazard bags with no lids covering them. Several black garbage bags were inside one of the boxes. EMP1 confirmed these boxes were used to store biohazard waste until they were picked up by the disposal company. EMP1 also confirmed that the boxes were not covered with lids.
Recovery Room - There were six reclining chairs for patients with no curtains between the chairs to provide privacy. There was a blanket and a heating pad with a cloth cover on each of the chairs. EMP1 stated the cloth heating pad covers and the blankets were washed at the end of each day, not after each patient use. The Sharps container in this room was not secured. EMP1 confirmed these findings.
Emergency Kit - The following expired medications were noted: three vials containing one milliliter (ml) of Phenylephrine with expiration dates of April 2011, and two ampules containing one ml of Epinephrine with expiration dates of 1 June 2011. The following items listed on the facility Emergency Kit Checklist were not available: sterile 4 x 4 gauze and Vasopressin. EMP1 confirmed these findings.
The facility transfer agreement dated December 6, 2005, revealed the signatures of Planned Parenthood administrative staff. There was no evidence that the accepting facility reviewed and or signed the transfer agreement. EMP1 confirmed this finding.
Review of the Patient Safety meeting minutes revealed that the facility incorporated all the facilities into one set of meeting minutes. It was discussed with EMP1 the importance of separating out each facility's patient safety concerns, identifying the Patient Safety reviews for each facility as well as any follow-up. EMP1 confirmed these findings.
Plan of Correction:Planned Parenthood of Northeast and Mid-Penn has been informed by the Department of Health that NO corrective plan of action is necessary.
However, we would like to respond to each finding to ensure clarification and to show our compliance with all regulations.
1. Entry way:
PPNMP has a strict policy regarding the discussion of confidential patient information. All patients are brought into a private area for confidential discussions. A patient is never engaged in a discussion of HIPAA or personal information at the front desk.
The solid glass window is for the safety of employees and there is an opening for speaking. Patients do not need to shout to be heard.
ACTION : None needed
2. DOH posting:
The DOH required posting was in the patient recovery area for all abortion care patients to see and was placed according to previous instructions.
ACTION: The posting has been moved to the patient check-in area as per DOH request.
3. Exam Room 1:
Red brown solid substance referred to by DOH surveyor is rust/oxidation.
ACTION: Proper care of instruments was reviewed with staff and a lubricating and rust inhibiting wash will be used with every cleaning and sterilization.
4. POC lab:
Some tubing has manufacture dates and no expiration date while others have expiration dates.
ACTION: These were disposed of immediately. This was reviewed with new and current staff for clarification.
5. POC Freezer:
ACTION: A biohazard label has been affixed to the freezer as recommended.
6. Lidocaine:
According to the manufacturer of the lidocaine, opened containers expire on the expiration date already noted on the label.
ACTION: Staff has been trained to additionally label the lidocaine with the date it was first opened.
7. Exam Room 2:
The speculua identified are not utilized in abortion care, and as a result are not required to be treated as �sterile�. This equipment is compliant with necessary procedures as �non-sterile, sanitized� use.
ACTION: None needed
8. Exam Room 3:
Red brown solid substance referred to by DOH surveyor is rust/oxidation.
ACTION: Proper care of instruments was reviewed with staff and a lubricating and rust inhibiting wash will be used with every cleaning and sterilization.
9. Ceiling tiles:
The roof had some water damage after a recent storm. The roof repair was completed prior to the DOH visit.
ACTION: New ceiling tiles have been ordered and will be in place by July 29, 2011
10. Exam Room 4:
Red brown solid substance referred to by DOH surveyor is rust /oxidation.
ACTION: Proper care of instruments was reviewed with staff and a lubricating and rust inhibiting wash will be used with every cleaning and sterilization.
11. Red garbage can:
ACTION: The red garbage can, a designated biohazard waster container was cleaned and staff reminded of importance of biohazard bags in cans.
12. Storage room:
These 44 boxes were stored in their shipping boxes in a dry, controlled, employee only area of the center.
ACTION: Arrangements are underway to place shelving on the floor of the storage room. This will be in place by July 29, 2011.
13. Biohazard boxes:
ACTION: Biohazard trash boxes have been relocated to a �dirty� closet that is kept locked.
Biohazard trash cans with lids will be obtained by July 29, 2011.
14. Recovery Room:
ACTION: Biohazard trash boxes have been relocated to a �dirty� closet that is kept locked.
Biohazard trash cans with lids will be obtained by July 29, 2011
15. Sharps container:
ACTION: Will be affixed to the wall by July 29, 2011
16. Emergency Kit:
PPNMP does not carry phenylephrine in its emergency kits. We would like confirmation that this is accurate and not a possible typo.
The audit occurred on the 16th day of the month.
ACTION: The staff audit the contents on the first day of the month and to ensure that meds expiring are removed.
Gauze has been replaced.
Vasopressin has been ordered and will be present in the emergency kit by July 29, 2011
17. Hospital Transfer Agreement:
The current transfer agreement with St Luke�s Hospital was reviewed by their legal team and signed by the Chairman of the Department of OB/GYN and the Director of the OB/GYN residency program.
The current transfer letter is compliant with the PA Abortion Control Act.
ACTION: None needed. However, PPNMP has requested an updated transfer agreement to include an administrator at St Luke�s Hospital.
18. Patient Safety Meeting Minutes:
The committee will hold it�s regularly scheduled quarterly meeting on July 11, 2011. PPNMP has a strong commitment to its RQM program including the Patient Safety Committee. PPNMP meets all DOH requirements
ACTION: Beginning July 11, 2011, the two facilities will hold separate meetings, including meeting minutes. These minutes will be forwarded to the DOH.
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