Out of compliance with state regulations, they failed to provide written notification to a patient affected by a serious event within seven days of the occurrence of the event.

Their governing body failed to ensure the Medical Director’s delineation of privileges were approved and granted by someone other than the Medical Director.

They failed to correct deficient practice and failed to follow the Plan of Correction submitted to, and accepted by, the Department of a full State Licensure survey conducted on October 24-25, 2017.

They failed to have an ambulatory surgical facility specific Patient Safety Committee.

They failed to adopt governing body bylaws that were applicable to the surgery center, that described the authority to the person in charge and t the medical staff, and that required the governing body to review and approve the bylaws of the medical staff.

They failed to request and consider reports from the National Practitioner Data Bank on each practitioner who requests privileges.

They failed to ensure policies and procedures were developed for the supervision of Certified Registered Nurse Anesthetists (CRNA) and failed to ensure privileges were approved for the supervision of CRNAs.

They failed to ensure the Locust Street Center Manager or the Assistant Center Manager or other facility staff were assigned to attend the Risk & Quality Management Meetings.

They failed to ensure Nursing Policies and Procedures were established for the facility.

They failed to determine a physical status on all patients before anesthesia or surgery.

They failed to provide a safe and sanitary environment.

The lab refrigerator / freezer had a build up of ice within the refrigerator / freezer.

Failed to properly store gauze sponges. Failed to properly sterilize surgical instruments, wraps, pouches, and metal containers.

The recovery area revealed multiple darkened stained areas on the carpeted floor. The cushion of a patient bench had multiple darkened stains.

They failed to properly store human pathological waste.

An environmental services closet containing used biohazard containers was not locked and appeared that the locking mechanism was not working properly in order to prevent unauthorized access to biohazardous materials.

An unlocked, biohazard storage freezer located on a countertop revealed a heavy accumulation of ice and frost build up and several freezer bags containing red biohazard bags. The red biohazard bags contained “products of conception” – aborted babies. Two of the red biohazard bags were undated.

Sexual intercourse with a child less than 13 years of age is always a crime without regard to the age or relationship of the offender, and without regard to the “consent” of the child. Under Pennsylvania law, a child less than 13 years of age is incapable of consent to sexual intercourse.

Sexual intercourse with a child less than 16 years of age is a crime if the offender is four or more years older than the child, and the child and offender are not married to each other. Under Pennsylvania law, an unmarried individual less than 16 years of age is incapable of consent to sexual intercourse with a person who is four or more years older.

Accordingly, under all circumstances, any child less than 13 years of age who is pregnant, or who is found to have a sexually-transmitted disease or condition, is a child “upon whom injuries have been inflicted in violation of [a] penal law of this Commonwealth.” So is any child less than 16 years of age if the person who caused the pregnancy, or who caused the child to have a sexually-transmitted disease or condition, is four or more years older than the child and is not married to the child. Professional contact with a child less than 13 years of age who is pregnant, or who has a sexually-transmitted disease or condition, therefore triggers a duty, on the part of those health care providers identified in 18 Pa.C.S. 5106 (a), to report under the Crimes Code in all circumstances. Contact with a child less than 16 years of age who is pregnant, or who has a sexually-transmitted disease or condition, triggers a duty to report under the Crimes Code if the person who caused the pregnancy, or who caused the child to have a sexually-transmitted disease or condition, is four or more years older than the child and is not married to the child. Failure to report as required by the Crimes Code is a summary offense punishable by fine and/or imprisonment.

They failed to develop a policy that met the reporting requirements for statutory sexual assault victims as defined in The Pennsylvania Crimes Code and the Child Protective Service Law.

The facility policy incorrectly stated ” … Statutory sexual assault (“statutory rape”) is sexual intercourse when one person is under the age of 16 and the other is 4 or more years older. It is a crime, however it is NOT a mandated reportable incident. … “

The facility cared for unmarried pregnant children under the age of 16 and the facility failed to ascertain if the child had sexual intercourse with an individual who was four or more years older than the child.

Patients listed as 13 year old or 14 year old pregnant showed no documentation that the facility ascertained if the child had sexual intercourse with an individual who was four or more years older than the child.

It was determined that medical records reviewed had documented evidence that sexual intercourse occurred with a child less than 13 years of age and the facility failed to show documented evidence that the facility reported the sexual intercourse to the appropriate authorities.

Facility policy: “Reporting Suspected Child Abuse” Effective Date: November 1, 2011, last updated: January 2, 2013, which revealed ” Many of our reports are generated because a minor has replied “yes” when asked on the history form if he/she has ever been forced to have sex. Center assistants and clinicians are both responsible for following up when this question is answered with a “yes.” As a Center Assistant, you should review the history and ask questions about the incident(s) of forced sex or other abuse.”

One patient was a 13 year old child and had indicated in the sexual history portion of the medical record, that the child’s age at first intercourse was 11. There was no documentation that the facility reported the sexual intercourse at age 11 to the appropriate agencies.

One patient was a 13 year old child and had indicated in the sexual history portion of the medical record, that the child’s age at first sexual intercourse was 12. There was no documentation that the facility reported the sexual intercourse at age 12 to the appropriate agencies.

They continue to fail to ensure the area where drugs were stored was periodically checked by a pharmacist or practitioner.

They continue to fail to maintain temperatures in accordance with established guidelines in the Recovery Area. The temperature recordings were outside of the allowable design temperatures range as listed in the 2010 Facility Guidelines.

The facility remains out of compliance with Life Safety and Fire Safety Minimum Standards.

They failed to ensure that the post operative assessment was completed and contained the minimum criteria on patients following surgery prior to discharge. The facility had not implemented a Recovery Room chart form to include respirations, activity level, pain, or nausea and vomiting, assessed prior to discharge.

Again, they fail to ensure the area where drugs were stored was periodically checked by a pharmacist or practitioner.

They continue to not have the appropriate apparatus to monitor or regulate temperature and humidity in the Post Anesthesia Care Unit area.

The facility remains out of compliance with Life Safety and Fire Safety Minimum Standards.

They failed to provide documentation of the post operative assessment performed on patients following surgery prior to discharge included the minimum criteria for discharge. Respirations, activity level, pain, or nausea and vomiting were not assessed prior to discharge.

They remain out of compliance with Life Safety and Fire Safety Minimum Standards.

Personnel files revealed no documentation that background checks (as required by the recently updated Child Abuse laws) were conducted for any of the employees.

They failed to provide a written policy for discharge of an incompetent patient.

They failed to ensure that drugs were checked periodically by a pharmacist or practitioner.

They failed to have a written policy regarding the retention of medical records.

They failed to have a written policy to specify who has access to medical records, under what conditions records can be removed from the facility, and under what conditions medical record information may be released.

No policy regarding monitoring the temperature and humidity levels in the operating rooms and post anesthesia care unit – operating rooms 1 and 2 and the recovery room.

They failed to ensure that automatic fire extinguishing systems, automatic and manual alarms were inspected by qualified facility personnel at least every three months and records of the inspection were kept on file.

Their internal disaster and fire safety plan did not contain documentation the facility incorporated evacuation procedures for the safety of both closed medical records and the records of those patients being evacuated.

They failed to request an annual inspection by the local fire department.

Operating Rooms 1 & 2 revealed ceilings that were not monolithic and the floors did not have sealed seams. The size of the two operating rooms was not in compliance with the required guidelines of 250 square feet.

The recovery room revealed nine recliner chairs for post operative care. There were no cubicle curtains for privacy between the nine recliner chairs.

Hands-free scrub sinks were not located outside the operating rooms.

Ultrasound Room – A heating cabinet contained two 1000 ml bags of .9% Sodium Chloride used for intravenous use. The bags were not labeled with dates and it could not be determined how long they were in the warmer. The current temperature of the heating cabinet was 100%.

Cleaning Room – Temperature logs were not maintained for the freezer.

Biohazard Room – Several cardboard biohazard boxes were stored directly on the floor. There were containers of used needles on the floor with the needles spilled and scattered on the floor.

Storage Room – The following items were stored directly on the floor: One carton of toilet paper, one carton of 1000 ml. bags of Ringers Lactate IV solution, two cartons of paper cups, four cartons of latex gloves and one carton of exam table rolls.

Recovery Room – A container of used needles was stored directly on the floor.

The first floor front stair tower landing had storage items (large signs) inside the stair tower.

The second floor back stairway entrance door failed to close and positively latch into the frame when tested.

The corridor door to lower level stair #1 failed to close completely and positively latch into the door frame assembly when tested. The stair tower door failed to close completely and positive latch.

They failed to ensure doors to hazardous areas had no impediment to closing and positive latching on one of four levels.

They failed to ensure the automatic sprinkler system was inspected and tested as required.

They failed to ensure the sealed emergency generator battery voltage was tested on a weekly basis on the generator.

They failed to ensure the automatic sprinkler system was inspected and tested as required.

They did not record the times fire drills were performed.

There is still a penetration into the shaft above the ductwork on the second floor, and on the basement level above the waiting room mechanical room door.

It was determined that the facility did not meet the requirements of the Life Safety Code for a new ambulatory surgical facility.

They failed to maintain the proper fire resistance rating of vertical openings to limit the vertical spread of fire through the building. While the ambulatory health care occupancy is located in the Lower Level of the building, vertical openings must be protected throughout the remainder of the building.

They failed to exercise fusible links of fire dampers to verify proper operation.

Out of compliance with state regulations, they failed to provide written notification to a patient affected by a serious event within seven days of the occurrence of the event.

Their governing body failed to ensure the Medical Director’s delineation of privileges were approved and granted by someone other than the Medical Director.

They failed to correct deficient practice and failed to follow the Plan of Correction submitted to, and accepted by, the Department of a full State Licensure survey conducted on October 24-25, 2017.

They failed to have an ambulatory surgical facility specific Patient Safety Committee.

They failed to adopt governing body bylaws that were applicable to the surgery center, that described the authority to the person in charge and t the medical staff, and that required the governing body to review and approve the bylaws of the medical staff.

They failed to request and consider reports from the National Practitioner Data Bank on each practitioner who requests privileges.

They failed to ensure policies and procedures were developed for the supervision of Certified Registered Nurse Anesthetists (CRNA) and failed to ensure privileges were approved for the supervision of CRNAs.

They failed to ensure the Locust Street Center Manager or the Assistant Center Manager or other facility staff were assigned to attend the Risk & Quality Management Meetings.

They failed to ensure Nursing Policies and Procedures were established for the facility.

They failed to determine a physical status on all patients before anesthesia or surgery.

They failed to provide a safe and sanitary environment.

The lab refrigerator / freezer had a build up of ice within the refrigerator / freezer.

Failed to properly store gauze sponges. Failed to properly sterilize surgical instruments, wraps, pouches, and metal containers.

The recovery area revealed multiple darkened stained areas on the carpeted floor. The cushion of a patient bench had multiple darkened stains.

They failed to properly store human pathological waste.

An environmental services closet containing used biohazard containers was not locked and appeared that the locking mechanism was not working properly in order to prevent unauthorized access to biohazardous materials.

An unlocked, biohazard storage freezer located on a countertop revealed a heavy accumulation of ice and frost build up and several freezer bags containing red biohazard bags. The red biohazard bags contained “products of conception” – aborted babies. Two of the red biohazard bags were undated.

Sexual intercourse with a child less than 13 years of age is always a crime without regard to the age or relationship of the offender, and without regard to the “consent” of the child. Under Pennsylvania law, a child less than 13 years of age is incapable of consent to sexual intercourse.

Sexual intercourse with a child less than 16 years of age is a crime if the offender is four or more years older than the child, and the child and offender are not married to each other. Under Pennsylvania law, an unmarried individual less than 16 years of age is incapable of consent to sexual intercourse with a person who is four or more years older.

Accordingly, under all circumstances, any child less than 13 years of age who is pregnant, or who is found to have a sexually-transmitted disease or condition, is a child “upon whom injuries have been inflicted in violation of [a] penal law of this Commonwealth.” So is any child less than 16 years of age if the person who caused the pregnancy, or who caused the child to have a sexually-transmitted disease or condition, is four or more years older than the child and is not married to the child. Professional contact with a child less than 13 years of age who is pregnant, or who has a sexually-transmitted disease or condition, therefore triggers a duty, on the part of those health care providers identified in 18 Pa.C.S. 5106 (a), to report under the Crimes Code in all circumstances. Contact with a child less than 16 years of age who is pregnant, or who has a sexually-transmitted disease or condition, triggers a duty to report under the Crimes Code if the person who caused the pregnancy, or who caused the child to have a sexually-transmitted disease or condition, is four or more years older than the child and is not married to the child. Failure to report as required by the Crimes Code is a summary offense punishable by fine and/or imprisonment.

They failed to develop a policy that met the reporting requirements for statutory sexual assault victims as defined in The Pennsylvania Crimes Code and the Child Protective Service Law.

The facility policy incorrectly stated ” … Statutory sexual assault (“statutory rape”) is sexual intercourse when one person is under the age of 16 and the other is 4 or more years older. It is a crime, however it is NOT a mandated reportable incident. … “

The facility cared for unmarried pregnant children under the age of 16 and the facility failed to ascertain if the child had sexual intercourse with an individual who was four or more years older than the child.

Patients listed as 13 year old or 14 year old pregnant showed no documentation that the facility ascertained if the child had sexual intercourse with an individual who was four or more years older than the child.

It was determined that medical records reviewed had documented evidence that sexual intercourse occurred with a child less than 13 years of age and the facility failed to show documented evidence that the facility reported the sexual intercourse to the appropriate authorities.

Facility policy: “Reporting Suspected Child Abuse” Effective Date: November 1, 2011, last updated: January 2, 2013, which revealed ” Many of our reports are generated because a minor has replied “yes” when asked on the history form if he/she has ever been forced to have sex. Center assistants and clinicians are both responsible for following up when this question is answered with a “yes.” As a Center Assistant, you should review the history and ask questions about the incident(s) of forced sex or other abuse.”

One patient was a 13 year old child and had indicated in the sexual history portion of the medical record, that the child’s age at first intercourse was 11. There was no documentation that the facility reported the sexual intercourse at age 11 to the appropriate agencies.

One patient was a 13 year old child and had indicated in the sexual history portion of the medical record, that the child’s age at first sexual intercourse was 12. There was no documentation that the facility reported the sexual intercourse at age 12 to the appropriate agencies.

They continue to fail to ensure the area where drugs were stored was periodically checked by a pharmacist or practitioner.

They continue to fail to maintain temperatures in accordance with established guidelines in the Recovery Area. The temperature recordings were outside of the allowable design temperatures range as listed in the 2010 Facility Guidelines.

The facility remains out of compliance with Life Safety and Fire Safety Minimum Standards.

They failed to ensure that the post operative assessment was completed and contained the minimum criteria on patients following surgery prior to discharge. The facility had not implemented a Recovery Room chart form to include respirations, activity level, pain, or nausea and vomiting, assessed prior to discharge.

Again, they fail to ensure the area where drugs were stored was periodically checked by a pharmacist or practitioner.

They continue to not have the appropriate apparatus to monitor or regulate temperature and humidity in the Post Anesthesia Care Unit area.

The facility remains out of compliance with Life Safety and Fire Safety Minimum Standards.

They failed to provide documentation of the post operative assessment performed on patients following surgery prior to discharge included the minimum criteria for discharge. Respirations, activity level, pain, or nausea and vomiting were not assessed prior to discharge.

They remain out of compliance with Life Safety and Fire Safety Minimum Standards.

Personnel files revealed no documentation that background checks (as required by the recently updated Child Abuse laws) were conducted for any of the employees.

They failed to provide a written policy for discharge of an incompetent patient.

They failed to ensure that drugs were checked periodically by a pharmacist or practitioner.

They failed to have a written policy regarding the retention of medical records.

They failed to have a written policy to specify who has access to medical records, under what conditions records can be removed from the facility, and under what conditions medical record information may be released.

No policy regarding monitoring the temperature and humidity levels in the operating rooms and post anesthesia care unit – operating rooms 1 and 2 and the recovery room.

They failed to ensure that automatic fire extinguishing systems, automatic and manual alarms were inspected by qualified facility personnel at least every three months and records of the inspection were kept on file.

Their internal disaster and fire safety plan did not contain documentation the facility incorporated evacuation procedures for the safety of both closed medical records and the records of those patients being evacuated.

They failed to request an annual inspection by the local fire department.

Operating Rooms 1 & 2 revealed ceilings that were not monolithic and the floors did not have sealed seams. The size of the two operating rooms was not in compliance with the required guidelines of 250 square feet.

The recovery room revealed nine recliner chairs for post operative care. There were no cubicle curtains for privacy between the nine recliner chairs.

Hands-free scrub sinks were not located outside the operating rooms.

Ultrasound Room – A heating cabinet contained two 1000 ml bags of .9% Sodium Chloride used for intravenous use. The bags were not labeled with dates and it could not be determined how long they were in the warmer. The current temperature of the heating cabinet was 100%.

Cleaning Room – Temperature logs were not maintained for the freezer.

Biohazard Room – Several cardboard biohazard boxes were stored directly on the floor. There were containers of used needles on the floor with the needles spilled and scattered on the floor.

Storage Room – The following items were stored directly on the floor: One carton of toilet paper, one carton of 1000 ml. bags of Ringers Lactate IV solution, two cartons of paper cups, four cartons of latex gloves and one carton of exam table rolls.

Recovery Room – A container of used needles was stored directly on the floor.

The first floor front stair tower landing had storage items (large signs) inside the stair tower.

The second floor back stairway entrance door failed to close and positively latch into the frame when tested.

The corridor door to lower level stair #1 failed to close completely and positively latch into the door frame assembly when tested. The stair tower door failed to close completely and positive latch.

They failed to ensure doors to hazardous areas had no impediment to closing and positive latching on one of four levels.

They failed to ensure the automatic sprinkler system was inspected and tested as required.

They failed to ensure the sealed emergency generator battery voltage was tested on a weekly basis on the generator.

They failed to ensure the automatic sprinkler system was inspected and tested as required.

They did not record the times fire drills were performed.

There is still a penetration into the shaft above the ductwork on the second floor, and on the basement level above the waiting room mechanical room door.

It was determined that the facility did not meet the requirements of the Life Safety Code for a new ambulatory surgical facility.

They failed to maintain the proper fire resistance rating of vertical openings to limit the vertical spread of fire through the building. While the ambulatory health care occupancy is located in the Lower Level of the building, vertical openings must be protected throughout the remainder of the building.

They failed to exercise fusible links of fire dampers to verify proper operation.