QA Investigation Results

Pennsylvania Department of Health
PPNMPBC - ALLENTOWN
Health Inspection Results
PPNMPBC - ALLENTOWN
Health Inspection Results For:


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Initial Comments:

This report is the result of an annual Registration survey conducted on May 1, 2012, at the Planned Parenthood of Northeast and Mid-Penn - Allentown Health Center. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health Regulations Pa Code, Chapter 29, Subchapter D, Ambulatory Gynecological Surgery in Hospitals and Clinics.

The facility is required to submit a plan of correction for the deficiency cited in Tag 0001 - Requirements for abortion.

Safe and Sanitary recommendations were provided to the facility in Tag 9999 - Recommendations. The facility is encouraged to provide a Plan of Correction for the recommendations, but it is not required.










Plan of Correction:




29.33(1) STANDARD
Requirements for Abortion

Name - Component - 00
Each medical facility shall have readily available equipment and drugs necessary for resuscitation. If local anesthesia is utilized to perform an abortion in a medical facility during the first trimester, then the following equipment shall be ready to use for resuscitative purposes:

(i) Suction Source
(ii) Oxygen Source
(iii) Assorted size oral airways and endotracheal tubes
(iv) Laryngoscope
(v) Bag and mask and bag and endotracheal tube attachments for assisted ventilation
(vi) Intravenous fluids including blood volume expanders
(vii) Intravenous catheters and cut-down instrument tray
(viii) Emergency drugs for shock and metabolic imbalance
(ix) An individual to monitor respiratory rate, blood pressure and heart rate.

Observations:

Based on review of facility documents, observation and staff interview (EMP), it was determined that the facility failed to ensure that all equipment was contained in the facility's cut-down instrument tray in each examination room.

Findings include:


Review on May 1, 2012, of the facility's policy and procedure manual revealed no documented evidence the facility developed a policy or procedure for identifying or monitoring equipment in the facility's cut-down instrument tray.

Observation on May 1, 2012, of the facility's Examination Room's 3 and 4 revealed a red box in each room. EMP1 identified the red boxes as the facility's cut-down instrument trays. Further observation of the contents of the red boxes revealed the cut-down instrument trays did not contain a sterile hemostat (an instrument used to compress or treat bleeding vessels).

An interview conducted on May 1, 2012, at approximately 11:30 AM with EMP1 confirmed the facility did not have a policy or procedure for identifying or monitoring equipment in the facility's cut-down instrument tray. Further interview with EMP1 confirmed the facility's cut-down instrument trays did not have a sterile hemostat forcep.
















Plan of Correction:

ACTION:
1. A check list for the contents of the emergency cart, including the cut down tray (which include hemostats) was revised by the RQM Coordinator and given to the Center Manager. This will be monitored by the lead clinician when she is doing the emergency kit and other monthly tasks. It will be added to the Abortion Centerís Daily, Weekly, Monthly task sheet.
-List completed 05/11/12
-Monitoring will be done monthly

2. The center will follow the affiliate sterilization policy which includes using an indicator strip in the pack during autoclaving. The integrity of the packaging will be checked during the monthly audit. There will be an extra hemostat placed in the tray to ensure there is a sterile one in an emergency.
-There is documented evidence of infection control/sterilization policy in personnel files
-Center Manager placed extra hemostat 05/24/12

3. The Lead Clinician will be using the monthly log to monitor the cut-down instrument trays and emergency cart.

4. All monitoring is assigned and the Center Manager has the responsibility for ensuring that assigned tasks are carried out. If this monitoring is not done properly, the Center Manager will document non-compliance and the staff with have a performance improvement plan.

5. The checklist monitoring, the contents of the cut down tray and emergency equipment have been communicated and reviewed with all staff by the Associate Medical Director and Center Manager
-Completed 05/24/12
-Agenda and sign in sheet will be
kept in facility file for follow-
up visit

6. The RQM coordinator will ensure that the plan of correction will be reviewed at the next Patient Safety Committee and the next RQM committee which are both in July 2012. It will be put on the RQM workplan to ensure monitoring is accomplished with proper results.

7. The Vice President of Medical Services will present the Plan of Correction to the Board at their June 2012 meeting.



No POC Required STANDARD
Recommendation

Name - Component - 00


Observations:

Based on review of facility documents, observation and staff interview (EMP), it was determined that Planned Parenthood of Northeast and Mid-Penn - Allentown Health Center failed to maintain a safe and sanitary environment.

Findings include:

Observation on May 1, 2012, of the facility's Examination Rooms three and four revealed a sharps container containing used needles in a wall mounted holder. Further observation revealed that the holder lock had keys in the lock allowing access to the sharps container.

Interview with EMP1 on May 1, 2012, at approximately 10:30 AM and 11:00 AM confirmed that the keys were in the locks of the sharps container holder and that patients would have access to the used needles in the sharps container by unlocking the lock and removing the sharps container from the wall mounted holder.
__________

Observation on May 1, 2012, of the facility's Recovery Room revealed six reclining chairs for patient use to recover following a procedure. Further observation revealed no curtains between the chairs to provide privacy to patients.

Interview with EMP1 on May 1, 2012, at approximately 11:30 AM confirmed there were no curtains between the six chairs in the recovery room to provide patient privacy.

Repeat recommendation
June 16, 2011.
__________

Review on May 1, 2012, of the facility's policy and procedure manual revealed no documented evidence the facility developed a policy or procedure for cleaning the blankets and cloth heating pad covers after each patient use.

Observation on May 1, 2012, of the facility's recovery room revealed six reclining chairs with a blanket and heating pad with cloth cover on each chair.

The facility was not able to provide documentation that the blankets and cloth heating pad covers were washed after each patient use.

Interview with EMP1 on May 1, 2012, confirmed the facility does not have a policy or procedure for cleaning the blankets and cloth heating pad covers after each patient use and that there was no documented evidence that the blankets and cloth heating pad covers were cleaned following the last patient's use.

Repeat recommendation
June 16, 2011.
__________

Observation on May 1, 2012, of the facility's Recovery Room revealed a cabinet containing six bottles of Doxycycline (an anti-biotic) 100 milligrams (mg); two bottles of Misoprostol (a medication used for medical abortion) 200 micrograms (mcg); four bottles of Methergine (a medication used to control bleeding following a medical abortion) 0.2 mg; two boxes of Laminaria (used to dilate the cervix); one bottle of Ibuprofen 200 mg and one bottle of Tylenol. Further observation revealed the cabinet where the medications were stored was not locked.

Interview with EMP1 on May 1, 2012, at approximately 11:15 AM confirmed the cabinet containing these mediations was not locked and that it should have been locked.
__________

Review on May 1, 2012, of the facility's policy and procedure manual revealed there was no policy or procedure for properly labeling medications drawn up into a syringe.

Observation on May 1, 2012, of the facility's laboratory revealed a box containing 7 - 25 milliliter (ml) syringes labeled Lidocaine (a local anesthetic). The syringes were not labeled with the medication strength, date and time the medication was drawn up, the expiration date, or the person who drew up the medication.

Interview with EMP1 on May 1, 2012, at approximately 11:20 AM confirmed the facility does not have a policy or procedure for proper labeling and drawing medication from a primary container into a syringe. Further interview with EMP1 confirmed the syringes were not labeled with the medication strength, date and time the medication was drawn up, the expiration date, or the person who drew up the medication
__________

Review on May 1, 2012, of the facility's "Personal Protective Equipment - Laundry Procedures," last reviewed November 22, 1999, revealed "... Please clean out lint filter before loading."

Observation on May 1, 2012, of the facility's dryer vent revealed lint measuring the approximate size of a golf ball.

Interview with EMP1 on May 1, 2012, at approximately 12:00 PM confirmed the lint in the facility's dryer measuring approximately the size of a golf ball.
_______

Observation on May 1, 2012, of the facility's Exam Room 4 revealed 10 packages of sterilized instruments with brown, rust colored spots on the instruments. One blue wrapped sterilized package was noted to have an instrument sticking out of the wrapping, which broke the integrity of the sterility of the instruments.

Interview on May 1, 2012, at approximately 10:45 AM with EMP1 confirmed the presence of brown, rust colored spots on the sterilized instruments and the instrument showing through the sterile blue wrap.
__________

Observation on May 1, 2012, of the facility's Lab area revealed an ultrasonic cleaner with a sticker indicating the next preventative maintenance to be completed in January 2012. This preventative maintenance check was not completed.

Interview with EMP1 at approximately 10:50 AM on May 1, 2012, confirmed the preventative maintenance check was not completed on the ultrasonic cleaner.
__________

Observation on May 1, 2012, of the facility's Exam Room 3 revealed two areas where two inches of paint was scraped off of the wall.

Interview with EMP1 on May 1, 2012, at approximately 10:50 AM confirmed the areas where paint was scraped off of the wall.
__________

Review of the facility's emergency cart oxygen tank revealed it was difficult to open with the wrench that was provided.

Interview with EMP1 on May 1, 2012, at approximately 12:15 PM confirmed the facility's emergency cart oxygen tank was difficult to open with the wrench that was provided.
__________

Review of the facility's emergency medication box revealed the following outdated medications: two 10 unit vials of Pitocin (a medication used to induce labor) with expiration dates of February 2012; six 20 Unit vials of Vasopressin (a medication used to reduce urine output) with expiration dates of February 2012, and one 250 cc bag of Lactated Ringers (an intravenous solution) with an expiration date of November 2011.

Interview with EMP1 on May 1, 2012, at approximately 11:00 AM confirmed the Pitocin, Vasopressin and Lactated Ringers were expired.

Repeat recommendation
June 16, 2011.
__________

Review on May 1, 2012, of the facility's content list for the emergency medication box lists the box should contain four 3 cc syringes; four tuberculin syringes, and intravenous tubing.

Observation on May 1, 2012, of the emergency medication box revealed two 3 cc syringes, three tuberculin syringes and no intravenous tubing.

Interview with EMP1 on May 1, 2012, at approximately 11:10 AM confirmed the emergency drug box did not contain the established required number of syringes and intravenous tubing.













Plan of Correction:

POC is optional and not required.
While this plan of correction is not required, Planned Parenthood of Northeast and Mid-Penn (PPNMP) is opting to respectfully submit a POC.

Sharps Container: Management has moved keys from the sharps container and placed them in a labeled box in a drawer in an office that is locked each night.

Recovery Room: This is not a requirement of the Pennsylvania Abortion Control Act so Planned Parenthood is in full compliance. The reclining chairs are appropriate for patient care since patients are awake, fully dressed and all receive similar post-op instructions. The nurse must have an unobstructed view of the patients for monitoring purposes.

Laundry: A policy and a log have been developed to document the cleaning of blankets and cloth heating pad covers.

Locked medication cabinet: It is the policy of PPNMP to lock the cabinet every day after procedures. This was an oversight that day. To avoid this situation, an "end of the day" checklist is being developed for the last person leaving the medical center.

Lidocaine: A new policy, specific to Lidocaine will be developed and then will be reviewed with all staff. PPNMP will perform several onsite audits to ensure the policy is being followed.

Dryer Lint: It is the PPNMP policy to clean out the lint trap before loading the wet laundry. We will change that policy to say "clean out lint filter AFTER drying".

Rust on instruments: The rust/oxidation on metal equipment is caused by soaking the instruments in a liquid cleaning solution before sterization. PPNMP has discarded all instruments with rust and has ordered new soaking solution.

Ultrasonic Cleaner: PPNMP has not used this cleaner for approximately one year. PPNMP will either discard the marchine or schedule preventative maintainance.

Chipped Paint: PPNMP will schedule cosmetic improvements of this facility into our maintainace calendar.

Wrench: A more compatible wrench has been purchased and installed with the oxygen tank.

Medication: The expired medications have been removed.

Emergency medication: The contents have been updated and/or resupplied.