Initial Comments:
This report is the result of an initial Registration survey conducted on April 27, 2011, at Hillcrest Women's Center. It was determined that the facility was not 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:
29.33(1) STANDARD
Requirements for Abortion
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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 observation and interview with staff (EMP), it was determined that Hillcrest Women's Medical Center failed to have emergency drugs readily available for resuscitation purposes.
Findings:
1) A tour of the facility was conducted on April 27, 2011, during the tour the crash cart was observed to be in the hallway outside of Procedure Room 2. An inspection of the crash cart revealed a vial of Diazepam (Valium)(benzodiazepine). Further examination of the cart failed to reveal any Flumazenil (Romazicon)(benzodiazepine-receptor antagonist).
2) An interview was conducted with EMP1 on April 27, 2011, at approximately 1:00 PM, "we do not stock Romazicon."
Plan of Correction:Valium no longer in stock here. Romazicon not needed.
29.33(8) STANDARD
Requirements for Abortion
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When there is an abortion performed during the first trimester of pregnancy, the tissue that is removed shall be subjected to a gross of microscopic examination, by the physician or a qualified person designated by the physician to determine if a pregnancy existed and was terminated. If the examination indicates no fetal remains, that information shall immediately be made known to the physician and sent to the Department within 15 days of the analysis. If the examination indicates no fetal remains or villi, the physician shall immediately inform the patient of the possibility of an ectopic pregnancy and shall recommend appropriate follow-up. When there is an abortion performed after the first trimester of pregnancy which the physician has determined as not viable, all such tissue removed at the time of the abortion shall be submitted for tissue analysis to a board eligible or certified pathologist. If the report reveals evidence of viability or live birth, the pathologist shall report such findings to the Department within 15 days and a copy of the report shall also be sent to the physician performing the abortion. The findings of the gross or microscopic examination shall be entered in the medical record of the patient. Each facility, including the hospital, shall provide treatment or referral for treatment of any diagnosed pathological condition.
Observations:
Based on a review of closed medical records and interview with staff (EMP), it was determined that Hillcrest Women's Medical Center failed to indicate whether or not embryonic tissue was identified in ten of twenty three records. (MR1, MR4, MR6, MR12, MR13, MR14, MR15, MR16, MR17, MR18)
Findings:
1) A review of twenty three closed medical and surgical abortion procedure records was performed on April 27, 2011. The record review revealed that the facility utilizes a preprinted, two sided form for documentation. The back side of the form had a section designated "Operative Findings." Under the Operative Findings section was the statement "Embryonic tissue and/or fetal parts identified", with a yes or no check box. It was noted that ten of 23 records had an ambiguous check mark inserted above and between the yes and no box, without a defined designation. MR14 was noted to contain a pathology report although the box was not clearly marked. It was further noted that all ten of the records were completed by the same physician.
2) An interview was conducted with EMP1on April 27, 2011, at approximately 12:30 PM, "I know the doctor, that is just they way they write."
Plan of Correction:Asked doctor involved to properly check "yes" or "no" block on back of chart. Revised policies, educated personal, and we are in 100% compliance.
No POC Required STANDARD
Recommendation
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Observations:
Based on a tour of the facility on April 27, 2011, it was determined that Hillcrest Women's Medical Center failed to maintain a safe and sanitary environment.
Findings:
A tour of the facility was conducted on April 27, 2011, during the tour the following were observed:
1) No complaint poster in the main waiting room.
2) No Patient Safety Committee meeting minutes were able to be produced. The facility Administrator verified that no meetings are scheduled through May 2011, and that they have had regular visits by the Patient Safety Liaison.
3) A sheet of paper taped on the wall near the crash cart, that contained a list of patient names having procedures that day.
4) Several boxes of uncovered biohazard waste (red bags) in the back stairwell.
5) The record review revealed that the facility utilizes a preprinted, two sided form for documentation. The back side of the form has a section designated "Operative Findings." Under the Operative Findings section was the statement "Xylocaine 1% paracervical" with a designated space for the doctor to write in the cc used. Upon further inspection it was noted that Lidocaine, not Xylocaine is being used in the facility. It was noted that 14 of 23 records had documented the patient received Xylocaine when they had in fact received Lidocaine.
6) Procedure Room 1- A sterilized instrument tray with the blue wrapping already open and the procedure had not yet started.
Multi dose vials of Lidocaine on the windowsill. One vial had been uncapped and no date when it was opened was noted on the vial.
Paper hand towels and plastic bottles were noted on the radiator.
Paint brushes and other plastic items were noted under the sink.
One vial of Oxytocin that expired February 2011, and one uncapped vial of Oxytocin and no date when it was opened was noted on the vial.
An uncovered trash receptacle.
7) Procedure Room 2 - A white extension cord was observed to be running along the floor, inside the door threshold out into the hallway and was plugged into the emergency crash cart.
A hole in the wall above the light switch near the doorway.
Peeling decals on the ceiling tiles directly over the procedure table.
Paper hand towels and plastic bottles were stored on the radiator.
Inside the supply cabinet were:
Sterilized instruments with questionable package integrity. One package was noted to have a hole in it, several packages were noted to have water mark- like brown spots on the them, and several had expired in March. Upon further inspection several of the instruments appeared to have the finish worn off and were bare, rusty metal.
12 packs of curettes: five had expiration dates of February 2011, nine had expiration dates of December 2010.
One unidentified white oblong tablet in a plastic cup.
One amber bottle labeled as Doxycycline with a patient's name on it, dated August 11, 2010.
Two patient ultrasound pictures.
Eight large, white cotton swabs, without packaging, scattered throughout the top drawer.
An unwrapped speculum was noted in the bottom drawer.
Multi dose vials of Lidocaine on the windowsill. One vial had been uncapped and had the rubber stopper removed and no date when it was opened was noted on the vial.
A small brown ant was noted to be crawling across the procedure table.
A large pair of scissors with black handles was noted to be placed on top of the supply cabinet in the corner of the room. The Public Health Physician discussed the purpose of the scissors with the facility Medical Director and Administrator. It was verified that the scissors are used to cut the stockinette material that is used in the suction equipment.
An open canister of SaniCloths with a wipe sticking out the top were on the dressing cart.
An uncovered trash receptacle.
8) Ultrasound Room - stacks of blank and preprinted prescription pads that were not tamper resistant were noted in the top shelf of an unlocked supply cabinet.
One opened, almost empty container of Aquasonic ultrasonic gel, without a lid.
Plastic items and paper towels under the sink
25 bottles of Thin Prep Pap Test that expired September 25, 2010
One opened bottle of Sodium Nitrite that was not dated when opened.
One uncovered trash receptacle
Miscellaneous trash stored in cabinet beside sink
9) Recovery Room- An unlocked cabinet held prescription pads
The unlocked cabinet held one opened bottle of Amoxicillin -1000 tablets, one bottle of Acetaminophen -1000 tablets and one opened bottle of Ibuprofen -1000 tablets.
10) Janitors closet in hallway - rags and bottles of cleaning supplies were scattered on the floor, and a paint can and a case of unopened soda bottles.
11) Laboratory - Two Antigen A pregnancy tests expired November 30, 2006.
Three Antigen B pregnancy tests expired November 9, 2006.
Opened control solutions-dates opened were illegible.
An opened bag of 2000 cotton balls stored under the sink
One open, undated bottle of NACL 1000 cc. 9%.
13 red top tubes that expired March 20011.
One box rapid Vue strips that expired June 2007.
The B-Hemoglobin back up machine did not have a preventative maintenance tag.
12) Decontamination/Sterilization Room - The autoclave on the top wooden shelf had a large depressed area and was noted to be heat warped, causing splintering on the underside of the shelf.
Ten bags of 2 curettes expired December 20, 2010, were stored in open plastic bins on the floor under the counter.
Three packaged rapid curved curettes that expired July 1998.
13) The supply cabinet in the hallway next to the crash cart - One amber bottle containing capsules labeled as Doxycycline inside of a brown paper bag.
One cookie inside a clear plastic ziptop bag.
Plan of Correction:1. Poster is in main waiting room.
2. Patient safety commission meeting will be held in June.
3. Procedure list now only has initials and is located in sterilization room.
4. All bio-haz material in covered box in back stairwell.
5. Lidocaine 1% is listed for paracervical block. Xylocaine 1% crossed out per public health physician.
6. Trays will not be unwrapped until doctor is ready to begin procedure.
Window sills, radiators, and sinks have been cleared.
Expired, uncapped, and out-dated meds discarded.
All trash receptacles have been covered.
7. Cord removed and room cleared of unnecessary materials.
Packages were removed, resterilized, destroyed and/or replaced as needed.
Room cleaned of unnecessary, expired, and damaged materials.
8. Rx pads destroyed.
9. Rx pads and meds will be locked in cabinet.
10. Closet cleaned.
11. Expired tests disposed of.
12. Expired curettes destroyed.
Curettes will be rotated in inventory.
13. Supply cabinet cleaned.
There will be a chart inside each procedure room for the employee who works each room to document that they have checked inventory in each room for dates and defects. At the end of each week, the administrator will monitor for compliance.
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