QA Investigation Results

Pennsylvania Department of Health
PHILADELPHIA WOMEN'S CENTER
Health Inspection Results
PHILADELPHIA WOMEN'S CENTER
Health Inspection Results For:


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Initial Comments:

This report is the result of an full registration survey conducted on December 5, 2012, at Philadelphia Women's 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.




Plan of Correction:




Initial Comments:

This report is the result of a full State Licensure survey conducted on December 5, 2012, and completed December 12, 2012 at The Philadelphia Women's Center. It was determined that the facility was in substantial 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:




555.3 (d)(1) LICENSURE
Requirements

Name - Component - 00
555.3 Requirements for membership and privileges.

(d) Granting of clinical privileges shall follow established policies and procedures in the bylaws or similar rules and regulations the procedures shall provide the following.
(1) Written record of the application, which includes the scope of
privileges sought and granted. The delineation "clinical privileges" shall address the administration of anesthesia.


Observations:

Based on a review of the Medical Staff Bylaws, credential files (CF) and interview with staff (EMP), it was determined the facility failed to ensure that each practitioner's written record of application included the scope of privileges sought for five of five credential files reviewed (CF1, CF2, CF3, CF4, CF5).

Findings include:
]
Review of facility's "Bylaws of the Medical Staff of The Philadelphia Women's Center Section IX- Rules and Regulations" dated June 15, 2012, revealed "4. Credentialing Requirements: a. On initial employment or contract with a physician, the facility will have the physician completed an application including a request for privileges ..."

1) A review conducted on December 5, 2012, of physician CF1, CF2, CF5, CF6, revealed there was no documented evidence in each application of the scope of privileges requested by the practitioner.

2) A review conducted on December 5, 2012, of CF3 and CF4 revealed there was no documented evidence in each application of the scope of privileges that were requested.

3) An interview conducted on December 12, 2012, with EMP2 at approximately 2:00 PM confirmed there was no documented evidence in each credential file reviewed of the privileges sought.




Plan of Correction:

Deficiency # S 53D1- 555.3 (d) (1) Requirements for Membership & privileges
�� the facility failed to ensure that each practitioner�s written record of application included the scope of privileges sought�

Plan of Correction:
1. The deficiency will be corrected as it relates to the individual by ensuring that all practitioners� with medical privileges will complete an application with the scope of privileges sought.
2. To protect patients in similar situations, all practitioners� written records of application will include the scope of privileges sought from the corrective action completion date and going forward.
3. To ensure the problem does not recur, the Administrator will oversee all practitioners� written records of application and verify that each one includes the scope of privileges sought.
4. To ensure these solutions are sustained, the Governing Body will not grant privileges to a practitioner unless the practitioner�s written application includes the scope of privileges sought.
5. This corrective action will be completed by January 25, 2013.



555.11 (a) LICENSURE
MEDICAL ORDERS - Written

Name - Component - 00
555.11 Medical orders
Written orders

(a) Medication or treatment shall be administered by authorized persons to administer drugs and medications only upon written and signed orders of a practitioner acting within the scope
of the practitioner's license.


Observations:

Based on review of medical records (MR), facility policies, and interviews with staff (EMP), it was determined the facility failed to ensure physician orders were obtained for the administration of medication for 8 of 8 medical records reviewed. (MR1, MR3, MR5, MR8, MR11, MR19 and MR20).

Findings include:

Review on December 5, 2012, of facility document "Bylaws of the Medical Staff of The Philadelphia Women's Center last reviewed June, 2012," revealed "Section IX-Rules and Regulations ...7. Medication and Treatment Orders: ... B. Written Orders: Medication or treatment shall be administered by the authorized persons to administer drugs and medication upon written and signed orders of a practitioner acting within the scope of the practitioner's license.

A review conducted on December 5, 2012, of MR1 revealed the following document "Medical Notes, Recovery Room, Medication given/Dispensed." The documentation indicated the following medications were administered, "November 11, 2012, at 12:30 PM Doxycycline 100 (antibiotic) POx1 stat (one dose by mouth now), Ibuprofen 800 mg (pain medicine) POx1 stat." Further review revealed no documented evidence of a physician order for the medications that were administered.

Review of MR3 on December 5, 2012, of facility document "Medical Notes, Recovery Room, Medication given/Dispensed" revealed the following medications were administered, "November 7, 2012, at 10:35 AM Doxycycline 100 POx1 stat, Ibuprofen 800 mg POx1 stat." Further review revealed no documented evidence of a physician order for the medications that were administered.

Review of MR5 on December 5, 2012, of facility document "Medical Notes, Recovery Room, Medication given/Dispensed" revealed the following medications were administered, "November 23, 2012, at 10:10:10 AM Doxycycline 100 POx1 stat, Ibuprofen 800 mg POx1 stat." Further review revealed no documented evidence of a physician order for the medications that were administered.

Review of MR8 on December 5, 2012, of facility document "Medical Notes, Recovery Room, Medication given/Dispensed" revealed the following medications were administered, "October 5, 2012, at 10:50 AM Doxycycline 100 POx1 stat, Ibuprofen 800 mg POx1 stat." Further review revealed no documented evidence of a physician order for the medications that were administered.

Review of MR11 on December 5, 2012, of facility document "Medical Notes, Recovery Room, Medication given/Dispensed" revealed the following medications were administered, "October 10, 2012, at 4:00 PM Zofran 4mg IM, 5:15 PM Doxycycline 100 POx1 stat, Ibuprofen 800 mg POx1 stat." Further review revealed no documented evidence of a physician order for the medications that were administered.

Review of MR19 on December 5, 2012, of facility document "Medical Notes, Recovery Room, Medication given/Dispensed" revealed the following medications were administered, "September 15, 2012 at 1:55 PM: Doxycycline 100 mg PO x1 dose stat, Ibuprofen 800 mg PO x1 stat and Rhogam IM (intramuscularly): Mini." Further review revealed no documented evidence of a physician order for the medications that were administered.

Review of MR20 on December 5, 2012, revealed the following medications were administered, "September 1, 2012 at 10:43 AM: Doxycycline 100 mg POx1 dose stat, Ibuprofen 800 mg POx1 stat." Further review revealed no documented evidence of a physician order for the medications that were administered.

An interview conducted on December 5, 2012, at approximately 2:30 PM with EMP2 confirmed there was no documented evidence of a physician order for the administration of medications to MR1, MR3, MR5, MR8, MR11, MR19, and MR20.









Plan of Correction:

Deficiency # S 551 A- 555.11 (a) Medical Orders- Written
�� the facility failed to ensure physician orders were obtained for the administration of medication�

Plan of Correction:
1. The deficiency was corrected as it relates to the individual by ensuring that all patient records will include a written order for the administration of medication that will be signed by the physician.
2. To protect patients in similar situations, this order record will be completed on all patient records from the corrective action completion date and going forward.
3. To ensure the problem does not recur, the DON will inform each physician of the necessity of providing orders for medication that is administered in each patient record. The DON will inform all RN staff of the need to obtain physician order for medication administration.
4. To ensure that this solution is sustained, each chart will have a quality assurance check, under the supervision of the DON, to ensure a physician order is obtained for all medication administered.
5. This corrective action will be completed by January 25, 2013.



555.22 (a)(1-2) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Pre-operative Care

(a) Pertinent medical histories and physical examinations, and supplemental information regarding drug sensitivities documented day of surgery or one of the following:
(1) If medical evaluation, examination and referral are made from a private practitioner's office, hospital or clinic, pertinent records thereof shall be available and made part of the clinical record at the time the patient is registered and admitted tot he ASF. This information is considered valid no more than 30 days prior to the date of surgery.
(2) A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record.



Observations:

Based on review of facility policy and procedures, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure pertinent physical examinations were documented on the day of surgery or 30 days prior to the date of surgery for five of five medical records reviewed. (MR8, MR11, MR13, MR14, MR15).

Findings include:

Review on December 12, 2012, of facility policy "Form and Content of Record" dated June 15, 2012, revealed " ... Medical Records shall include at least the following ... (2) Pertinent medical history and results of physician examination."

1) Review on December 12, 2012, of MR8, MR11, MR13, MR14 and MR15 revealed these patients presented to the facility between September 2, 2012, and November 14, 2012, for a procedure with local anesthesia. Further review revealed there was no documented evidence that a physical examination was performed.

2) Interview on December 12, 2012, with EMP2 at approximately 1:00 PM confirmed that patients who receive local anesthesia are given a gynecological exam by the physician. There was no documented evidence in MR8, MR11, MR13, MR14, MR15, that a physical examination was performed prior to the procedure.




,













Plan of Correction:

Deficiency # S 552A- 555.22 (a)(1-2) Surgical services- Preoperative Care
�� the facility failed to ensure pertinent physical examinations were documented on the day of surgery or 30 days prior to the date of surgery�

Plan of Correction:
1. The deficiency was corrected as it relates to the individual by creating a written policy documenting the minimum components of pertinent physical examinations to be performed at Philadelphia Women�s Center prior to surgery.
2. To protect patients in similar situations, the policy shall be followed for all patients receiving surgery and physical examination results will continue to be documented in patient charts.
3. To ensure that the problem does not recur, practitioners and staff will be notified of the creation of the written policy by the DON.
4. To sustain this solution, the policy shall remain in place and all charts will have a quality assurance check, under the supervision of the DON, to ensure the continued implementation of practice.
5. This corrective action will be completed by January 25, 2013.



555.33 (d)(1) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(1) A patient requiring anesthesia shall have a pre-anesthesia evaluation by a practitioner, with appropriate documentation of pertinent information regarding the choice of anesthesia.


Observations:

Based on review of facility policies and procedures, documents, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure a pre-anesthesia evaluation was performed by a practitioner before surgery for five of five medical records reviewed. (MR1, MR2, MR3, MR4 and MR5).

Findings include:

Review of facility policy "Preoperative Procedures" dated June 15, 2012, revealed " ... (a) (2) A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record."

1) Review on December 5, 2012, of the "Pre-operative Assessment " and "Anesthesia Record" for MR1, MR2, MR3, MR4, and MR5 revealed these patients received intravenous sedation for a procedure. Further review for MR1, MR2, MR3, MR4, and MR5 revealed there was no documented evidence that a practitioner reviewed or signed the "Pre-operative Assessment" or the "Anesthesia Record."

2) Interview on December 5, 2012 with EMP2 confirmed the "Pre-operative assessment" was the preanesthesia evaluation and there was no documented evidence that a practitioner reviewed or signed either the "Pre-operative assessment" or the "Anesthesia Record" for MR1, MR2, MR3, MR4 and MR5. Further interview with EMP2 confirmed the facility believed the CRNA was practicing within the scope of the Nurse Practice Act 1721."
























Plan of Correction:

Deficiency # S 5559- 555.33 (d)(1) Anesthesia Policies and Procedures
�� the facility failed to ensure a pre-anesthesia evaluation was performed by a practitioner before surgery�

Plan of Correction:
1. The deficiency will be corrected as to the individual by ensuring that a patient requesting anesthesia shall have a documented pre-anesthesia evaluation by a practitioner, with appropriate documentation of pertinent information regarding the choice of anesthesia.
2. To protect patients in similar situations the documented practitioner pre-anesthesia evaluation and choice of anesthesia shall be included in the medical record of all patients.
3. To ensure the problem does not recur, all practitioners shall be notified of the need for a documented pre-anesthesia evaluation.
4. To sustain this solution, each surgical chart will have a quality assurance check, under the supervision of the DON, that ensures that patients requesting anesthesia have had their documented pre-anesthesia evaluation by a practitioner. Surgical charts will be checked for such documentation for a period of three months to ensure sustained compliance.
5. This corrective action will be completed by January 25, 2013.



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 review of facility policy and procedures and interview with staff (EMP), it was determined the facility failed to ensure that the area in the ASF (Ambulatory Surgical Facility) where drugs are stored were periodically checked by a responsible pharmacist or practitioner and proper logs maintained.


Findings include:

Review on December 12, 2012, of facility policy "Storage (Pharm)" dated June 15, 2012, revealed "Under the supervision of the Director of Anesthesia, the Director of Nursing with assistance from the CRNA (Certified Registered Nurse Anesthetist) providing patient care shall periodically check the area in the ASF where drugs are stored and proper logs maintained.

1) Interview on December 5, 2012, with EMP2 at approximately 3:00 PM confirmed there was no documented evidence that the Director of Anesthesia periodically checked the area where drugs were stored and that proper logs were maintained.




Plan of Correction:

Deficiency # S 6126- 561.13 Storage
�� the facility failed to ensure that the area in the ASF where drugs are stored were periodically checked by a responsible pharmacist or practitioner and proper logs maintained�

Plan of Correction:
1. The deficiency will be corrected as to the individual by ensuring that the Director of Anesthesia checks the area where the drugs are stored and provides documentation of his/her check at a minimum of two times a year.
2. To protect patients in similar situations, the documentation of the Director of Anesthesia�s periodic reviews will be maintained in the Policy and Procedure Manual and the current policy will be updated to reflect this practice.
3. To ensure the problem does not recur, the DON or Administrator will ensure that the Director of Anesthesia is scheduled to check the area where drugs are stored at a minimum of two times a year.
4. This solution will be sustained by having the Administrator report to the Governing Body of the bi-annual checks by the Director of Anesthesia.
5. This corrective action will be completed by January 25, 2013.



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 unauthorized access.

Findings include:

Review on December 5, 2012, of facility policy "Storage of Medical Records reviewed 6/15/2012" revealed "the medical records of Philadelphia Women's Center are kept locked in file cabinets throughout the facility. Only personnel are given access."

1. Observation tour on December 5, 2012, at approximately 10:30 AM revealed five large green metal cabinets each having four shelves with sliding doors. Further observation revealed the five cabinet doors are each secured by a single lock located at the top of the filing cabinet. The cabinets lined the hallway; the hallway provides access to the administrative areas and patient care areas. Continued observation revealed the doors of all five cabinets were unlocked and opened approximately one inch.

Interview with EMP1 on December 5, 2012, at approximately 10:30 AM confirmed the filing cabinets were unlocked and accessible to anyone walking thru the hallway to the administrative and patient care areas. EMP1 also confirmed the cabinets are opened at the start of the day and locked at the end of the day.

2. Observation on December 12, 2012, at approximately 11:00 AM revealed five metal filing cabinets that are used to store patient medical records were unlocked. Further observation revealed there were four patients sitting in the hallway and one staff member.

3. Observation on December 12, 2012, at approximately 2:45 PM of the medical record storage area revealed the storage cabinets remained unlocked. There was no staff in the hallway monitoring the security of the medical records.

Interview with EMP2 on December 12, 2012, at approximately 3:00 PM confirmed the cabinets remain unlocked during the day and the facility staff monitors the filing cabinets to prevent unauthorized access. "Staff are filing all day someone is always around."






Plan of Correction:

Deficiency # S 6350- Storage of Medical Records
�� the facility failed to ensure medical records were stored in a manner to prevent unauthorized access�

Plan of Correction:
1. The deficiency will be corrected as to the individual by keeping the medical record storage cabinets locked while patients are in the facility and upon closing. The current policy will be updated by the Administrator to reflect this practice.
2. To protect patients in similar situations the medical record storage cabinets will remain locked while patients are in the facility and upon closing.
3. To ensure the problem does not recur all staff will be informed of the policy to keep medical record storage cabinets locked while patients are in the facility and upon closing.
4. This solution will be sustained by having the Administrator routinely visualize the medical records storage cabinets to make sure that they are locked while patients are in the facility an upon closing.
5. This corrective action will be completed by January 25, 2013.



567.53 (1) LICENSURE
Sterilization Control

Name - Component - 00
567.53 Sterilization control

There shall be written policies to establish the following:

(1) A method of control to assure sterilization of supplies and water.

Observations:

Based on review of manufacturer's recommendations, facility policy and procedures, facility documents and interview with staff (EMP), it was determined the facility failed to ensure that quality control testing was completed on newly opened bottles of testing strips for a disinfectant solution that was used for sanitizing equipment.

Findings include:

1) Review of the manufacturer's recommendations for quality control testing for MetriCide OPA Plus test strips revealed, "3. Testing Frequency ... It is recommended that the testing of positive and negative controls be performed on each newly opened test strip bottle of MetriCide OPA Plus Solution Test Strips. After this initial testing, it is recommended that testing of freshly prepared positive and negative controls be performed on a regular basis as established by your own quality control procedures and program. This testing program will serve to minimize errors between different users, use of outdated materials or product that has been improperly stored or handled."

2) Review of facility policy "Metricide OPA Plus Police and Procedure Use," revised December 5, 2012, revealed "Metricide OPA Plus Test Strips controls are run daily and to manufacturer's instructions."

3) Review of the facility document, "Philadelphia Women's Center 2012 MetriCide OPA Plus Solutions testing Calendar" dated August 1, 2012, through December 4, 2012, revealed no documentation of the manufacturer's recommended initial testing of positive and negative controls performed on each newly opened test strip bottle of MetriCide OPA Plus Solution test strips.

4) Interview with EMP3 on December 5, 2012, at approximately 10:15 AM confirmed there was no documented evidence that testing of positive and negative controls was performed on each newly opened test strip bottles of MetriCide OPA Plus Solution test strips.

5) Interview with EMP1 on December 12, 2012, at approximately 2:15 PM confirmed the facility policy for Metricide OPA Plus was revised during the survey on December 5, 2012, to include test strip controls would be run to manufacturer's recommendations.











Plan of Correction:

Deficiency # S 6751- 567.53 (1) Sterilization Control
�� the facility failed to ensure that quality control testing was completed on newly opened bottles of testing strips for a disinfectant solution that was used for sanitizing equipment�

Plan of Correction:
1. The deficiency will be corrected as to the individual by ensuring that quality control testing is completed, according to the package insert, on all test strips for MetriCide Opa, the disinfectant solution used for sanitizing equipment. The Infection Control Coordinator will update the current policy to reflect the new procedure.
2. To protect patients in similar situations, the quality control testing will be done as often as is indicated on the package insert and documented on the MetriCide OPA log.
3. To ensure the problem does not recur, the Medical Coordinator will have an in-service for all staff who work in Sterilization educating them as to the process for quality control testing on test strips and the documentation of this in-service will be located in In-Service and Meeting Minutes Binder.
4. This solution will be sustained by having the Infection Control Coordinator document weekly random checks of the log for a period of three months to ensure sustained compliance.
5. This corrective action will be completed by January 25, 2013.