QA Investigation Results

Pennsylvania Department of Health
HILLCREST WOMENS' MEDICAL CENTER - HARRISBURG, P.C.
Health Inspection Results
HILLCREST WOMENS' MEDICAL CENTER - HARRISBURG, P.C.
Health Inspection Results For:


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Initial Comments:


This report is the result of an unannounced special monitoring survey conducted on June 5 and June 7, 2017, at Hillcrest Women's Medical Center. It was determined 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(4) STANDARD
Requirements for Abortion

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Each medical facility shall arrange for at least one physician who is board eligible by the American Board of Obstetrics and Gynecology or the American Osteopathic Board of Obstetric and Gynecology to be available either as a staff member or as a consultant for the purpose of providing consultation as needed and to advise staff members with respect to maintenance of a satisfactory quality of treatment.

Observations:

Based on a review of facility documents and staff interview (EMP) the facility failed to demonstrate that one consultant physician was board eligible for the purpose of consultation to advise staff members with respect to satisfactory quality of treatment.

Findings include:

On June 5, 2017, the facility was asked to produce the consultant physician's credential file. In response to that request, the facility provided a transfer agreement and letter of agreement by the consultant physician to manage patients referred from Hillcrest Women's Medical Center. Documentation demonstrating the current board eligibility of the consultant was not available onsite. A second request was made on June 6, 2017, for the documentation. As of June 8, 2017, the facility has not provided evidence of board eligibility.

A review on June 5, 2017, of 29.33(4) Requirements for Abortion revealed that the facility continued to be non-compliant with this regulation. The final anticipated completion date of the PoC was April 21, 2017.

The PoC revealed, "A CV, license, and board certification will be faxed to the examiner. We will contact the physician's office each year and ask for their office to supply our clinic with the most current information."

An interview conducted on June 5, 2017, at 1:00 PM with EMP1 confirmed there was no documentation, onsite, demonstrating the current board eligibility of the consultant.




Plan of Correction:


Hillcrest Women's Medical Center has a written agreement with a board-certified OB/GYN who is also a Fellow of the American Board of Obstetrics and Gynecology, to provide consultation to Hillcrest as needed and to advise staff members with respect to maintenance of a satisfactory quality of treatment. Current documentation of the consultant physician's board certified status, curriculum vitae, and written agreement between the consulting physician and Hillcrest Women's Medical Center are on file at Hillcrest and available for inspection.

The administrator will maintain this documentation on site and will contact the consultant physician prior to the expiration of the board certification so that Hillcrest can maintain current documentation of the consulting physician's board-certified status.


Initial Comments:


This report is the result of an unannounced special monitoring survey conducted on June 5 and June 7, 2017, at Hillcrest Women's Medical Center. 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:




551.101 LICENSURE
Correction of Deficiency - Policy

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551.101 Policy

If an ASF notifies the Department that it has completed a plan of correction and corrected its
deficiencies, the Department will conduct a survey to ascertain completion of the plan of correction.
Upon finding full or substantial compliance, as defined in 551.82 (b)(relating to a regular license),
the Department will issue a regular license.


Observations:

Based on an unannounced on-site special monitoring visit, review of the approved "Plan of Correction" (PoC), facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to correct deficient practices.

Findings include:

A review on June 5, 2017, of 561.25 Distressed drugs, devices and cosmetics revealed that the facility continued to be non-compliant with this regulation. The final anticipated completion date of the PoC was April 5, 2017.

The PoC revealed, "All expired drugs in our inventory has[sic] been discarded. All medicals[sic] supplies that were expired have been discarded. ..."

An interview conducted on June 5, 2017, at 11:00 AM with EMP1 and EMP2 confirmed that medications were expired.

Cross reference 561.25 Distressed drugs, devices and cosmetics.
______________________

A review on June 5, 2017, of 555.33 (d)(5) Anesthesia Policies and Procedures revealed that the facility continued to be non-compliant with this regulation. The final anticipated completion date of the POC was June 30, 2017.

The PoC revealed, "...The Dr. shall document the administration of the local anesthetic, including the name of the agent, strength and total amount administered. The time of the administration and route will be dictated by the Dr. and the findings will be documented in the patient's chart. ..."

A review of MR1-MR5 revealed MR1 had a surgical abortion performed in the facility on May 31, 2017. The name, dose or route of administration was not recorded on the Intraoperative notes.

An interview conducted on June 5, 2017, at 1:45 PM with EMP2 confirmed the name, dose or route of administration was not recorded on the Intraoperative notes.













Plan of Correction:


All expired drugs and supplies have been appropriately disposed of.

Hillcrest Women's Medical Center will implement the following policy to ensure that there are no expired drugs or supplies in the facility: The Licensed Practical Nurse or administrator will inspect all medications and supplies in the facility twice per month. If any medication or supply is dated to expire within two weeks of inspection, it shall be disposed of immediately. A log will be kept and signed off on when the LPN or administrator has completed this task.

The administrator will oversee the LPN's efforts and ensure that the twice monthly checks are completed, and that the log is being appropriately maintained.


561.14 LICENSURE
Space

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561.14 Space

There shall be adequate space provided for pharmaceutical operations, and the storage of drugs
at a satisfactory location with proper lighting. Ventilation and temperature controls shall be in accordance with 49 Pa. Code 27.15 - 27.16 (relating to sanitary standards construction requirements).


Observations:


Based on review of facility policy, facility tour, and staff interview (EMP), it was determined that the facility failed to ensure that proper refrigerator temperatures were maintained and monitored.

Findings include:

A review of policy "Policy on Storage of Pharmaceutical Samples and Medications" last reviewed May 2017, revealed "...Medications requiring refrigeration be stored in a refrigerator between 2 degrees C (36 degrees F) and 8 degrees C (46 degrees F)..."

1. Observation on June 5, 2017, at 11:50 AM , revealed the recovery room refrigerator temperature was out of range for fourteen days from November 12, 2016, thorough June 2, 2017. The temperatures ranged from 31 to 34 degrees. The refrigerator stored Rhogam (Medication given to Rh negative mothers). There was no documentation to address the out of range temperatures.

An interview conducted on June 5, 2017, at 11:50 AM with EMP1 and EMP2 confirmed the refrigerator temperatures were out of range and there was no documentation of corrective action.

2. Observation of the lab refrigerator on June 5, 2017, at 11:55 AM revealed that the temperature was only documented for six days in May 2017.

An interview conducted on June 5, 2017, at 11:55 AM with EMP1 and EMP2 confirmed the lab refrigerator temperature was documented for six days in May 2017. Further interview with EMP2 confirmed the facility documented temperatures only on days patients were in the facility. Further interview with EMP2 confirmed the facility did not have a policy to address the monitoring of the lab refrigerator temperatures.











Plan of Correction:


Hillcrest Women's Medical Center has implemented the following policy to address the proper maintenance of refrigerators in the clinic: The LPN or administrator checks the temperatures of the lab and recovery room refrigerators on a daily basis. The LPN or administrator ensures that temperatures remain between 2 degrees C (36 F) and 8 degrees C (46 F). She then records each check in a temperature log, which is kept on the front of each refrigerator. Any variations in temperature are corrected, recorded in the temperature log, and brought to the attention of the clinic administrator. This policy will additionally become a component of the Hillcrest Quality Assurance Program.


561.25 LICENSURE
Distressed drugs, devices and cosmetics

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561.25 Distressed drugs, devices and cosmetics

Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.


Observations:


Based on review of policy, observation and staff interviews (EMP), it was determined that the facility failed to dispose of outdated medications and supplies.

Findings include:

A review of facility policy "Policy on Storage of Pharmaceutical Samples and Medications" dated May 2017, revealed "... Medications shall not be kept in stock after expiration date on the label; and no contaminated or deteriorated shall be available for use. The clinic will dispose of such medications in a manner prescribed by law..."

A tour of the facility on June 5, 2017, revealed the following outdated medication/supplies:

1. Procedure room 1 - Nine curettes with expiration dates of 4/17.

2. Procedure room 2 - Dextrose syringe expired June 1, 2017, Nitroglycerin (given for chest pain) bottles (2) expired May 2017, 1cc tuberculin syringes (2) with yellowed, cracked open paper, LMA (used for intubation) expired October 28, 2015, cut down tray (used for emergency vascular access) sides taped shut, cracked open with unreadable expiration date.

3. Recovery Room - Rhogam (Medication given to RH negative mothers) expired May 13, 2017.

4. Lab Room - Urine controls (for pregnancy tests) with opened dates of February 4, 2017. EMP2 verified through the manufacturer that opened controls were good for three months (expired May 4, 2017).

Interview conducted on June 5, 2017 at 10:30 AM with EMP1 and EMP2 confirmed that the medication and supplies were expired.


















Plan of Correction:


Hillcrest Women's Medical Center will implement the following policy to address the proper documentation of administered anesthesia: The medical director will appropriately document all anesthesia administered in each patient's chart. The documentation will include the name of anesthetic agent, amount and concentration administered, and route of administration. The administrator will spot check the documentation weekly to verify consistency in charting. Any omissions in documentation will immediately be brought to the attention of the medical director.


567.1 Principle LICENSURE
CHAPTER 567 - ENVIRONMENTAL SERVICES

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567.1 Principle

The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.


Observations:


Based on observations and staff interview (EMP), it was determined that the facility failed to provide a functional and sanitary environment by not maintaining ceiling tiles, exam tables, housekeeping closet door, and front yard.

Findings include:

Observation on June 5, 2017, at approximately 11:30 AM of staff breakroom revealed approximately seven ceiling tiles that were stained with a brown substance. The stains were approximately 6 to 10 inches in diameter. Further observation revealed, in a hallway, two tiles that were stained with a brown substance and the stains were approximately 6 inches to a foot in diameter.

An interview conducted on June 5, 2017, at 11:30 AM with EMP1 confirmed the tiles were stained.

Observation on June 5, 2017, at 11:45 AM of exam table in Room #1 revealed the exam table had torn padding of approximately 1 ft x 2 ft; Room #2 revealed the exam table had two torn areas of approximately 8 inches x 3 inches.

An interview conducted on June 5, 2017, at 11:45 AM with EMP1 and EMP2 confirmed that the exam tables padding were torn.

Observation on June 5, 2017, at 11:40 AM of a housekeeping closet revealed the door was off the track and leaning against the wall.

An interview conducted on June 5, 2017, at 11:40 AM with EMP1 and EMP2 confirmed the doors were off the track and leaning against the wall.

Observation on June 5, 2017, at 9:20 AM of front yard revealed the grass was approximately 2 to 3 ft tall.

An interview conducted on June 5, 2017, 9:45 AM with EMP1 confirmed that the facility could not provide a policy to address the issues noted. Further interview with EMP1 confirmed the grass had not been mowed recently and that they have been without a landscape contract since March 2017.


















Plan of Correction:


All stained ceiling tiles have been removed and replaced. One exam table has been replaced, and the second exam table has been removed from the facility and is being replaced. The closet door has been reseated. The front yard has been mowed and Hillcrest now has an arrangement with a service provider for weekly lawn mowing.

Hillcrest Women's Medical Center will implement the following policy to address physical appearance and functionality of the facility: The administrator will perform a thorough visual inspection of the physical plant once per month. She will share the results of the monthly inspection with the medical director.
If any maintenance or repair issues are discovered, the administrator will promptly arrange for any necessary maintenance or repair services.

All inspections will be noted in a log called "Inspections, Physical Plant." The log will include notations of facility cleaning.
Prior to providing any patient services, the facility will undergo a thorough professional cleaning. Professional cleaning will occur one to two times per week as part of an ongoing quality assurance program to ensure the health and safety of patients.


567.53 (2) LICENSURE
Sterilization Control

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567.53 Sterilization control

There shall be written policies to establish the following:

(2) Processing of sterile supplies at specified intervals.

Observations:


Based on observation and staff interview(EMP), it was determined that the facility failed to process sterile supplies at specified intervals.

Findings include:

A tour of the facility on June 5, 2017, revealed the following outdated sterile supplies:

1. Procedure room 1 - Twenty four expired miscellaneous sterile instruments used for abortion procedures. The expiration dates on the packaging of the sterile instruments ranged from March 4, 2016, to January 19, 2017.

2. Procedure room 2 - Thirty one expired miscellaneous sterile instruments used for abortion procedures. The expiration dates on the packaging of the sterile instruments ranged from May 2, 2016, to May 30, 2017.

A interview conducted on June 5, 2017, at 10:45 AM with EMP1 and EMP2 confirmed that the sterile instruments were expired. Further interview with EMP2 revealed the facility did not have a policy to address sterilization intervals.












Plan of Correction:

All expired sterile supplies have been appropriately disposed.

Hillcrest Women's Medical Center will implement the following policy to address the correct processing of sterile supplies: All instruments shall be stored and checked by the LPN so the oldest sterilized items shall be used first. These applies to all sterilized items in the center as well as abortion packs and speculum. The checking of instruments will be done every 2 weeks. The LPN will have a written log and it will be reviewed quarterly at our quarterly quality assurance staff meetings. The staff will be trained quarterly as well by the administrator. All new staff members will be trained by the administrator in how to sterilize, store and check sterilized items this will be completed by 8/31/2017.