Initial Comments:
This report is the result of an unannounced Special Monitoring survey conducted on April 15, 2024, at Allegheny Reproductive Health 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:
551.22 (3)(i) LICENSURE
Criteria for Performance on Pediatirc Patient
Name - Component - 00
551.22. Criteria for Performance of Ambulatory Surgery on Pediatric Patients
In addition to the criteria set forth at 551.21 (relating to criteria for ambulatory surgery), the following criteria shall apply to the performance of ambulatory surgery on children under 18 years of age.
(3) Surgical procedures on persons older than 6 months and younger than 18 years of age shall be performed only under the following conditions:
(i) Anesthesia services shall be provided by an anesthesiologist who is a graduate of an anesthesiology residency program accredited by the accreditation council for graduate medical education or its equivalent, or by a certified registered nurse anesthetist trained in pediatric anesthesia, either of whom shall have documented demonstrated historical and conditions competence in the care of such patients.
Observations:
Based on review of facility documents, medical record review (MR), and staff interview (EMP), it was determined the facility failed to ensure that anesthesia services for pediatric patients were provided by a qualified practitioner for two of 20 medical records reviewed (MR9 and MR16).
Findings include:
A review, on April 15, 2024, at 11:15 A.M., of the facility's medical staff bylaws, date October 2023, revealed ..." ... 4. ANESTHESIA SERVICES 4.1. Principle. (a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon the recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per Abortion Facility license. ... 4.2. Administration of anesthesia. (a) Anesthesia shall be administered by a certified registered nurse anesthetist (CRNA) or Medical Doctor.(b) Monitored anesthesia care (MAC) shall be administered by a certified registered nurse anesthetist. (c) Light/moderate/monitored anesthesia sedation shall be administered by a certified registered nurse anesthetist (CRNA) or Medical Doctor. ... ".
A review of MR9 on April 15, 2024, revealed that the pediatric patient received 50 mg of Ketamine Intramuscular (IM) administered by registered nurse (RN) EMP2, on April 9, 2024.
A review of MR16 on April 15, 2024, revealed that the pediatric patient received 50 mg of Ketamine IM administered by RN EMP3, on January 6, 2024.
During an interview on April 15, 2024 at approximately 12:45 PM, EMP1 confirmed the above findings.
Plan of Correction:Based on the recommendation of the DOH in regards to our Class 2B ASF status, we will cease to administer ketamine at this time since the DOH considers this medication general anesthesia.
555.31 (a) LICENSURE
ANESTHESIA SERVICES - Principle
Name - Component - 00
Anesthesia Services
555.31 Principle
(a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per ASF licence.
Observations:
Based on review of facility documents, medical record review (MR), and staff interview (EMP), it was determined that the facility failed to ensure only techniques approved for a Class B Surgery Center were provide to patients for two of 20 medical records reviewed (MR9 and MR16).
Findings include:
A review, on April 15, 2024, at 11:15 A.M., of the facility's medical staff bylaws, date October 2023, revealed ..." ... 4. ANESTHESIA SERVICES 4.1. Principle. (a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon the recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per Abortion Facility license. ... 4.2. Administration of anesthesia. (a) Anesthesia shall be administered by a certified registered nurse anesthetist (CRNA) or Medical Doctor.(b) Monitored anesthesia care (MAC) shall be administered by a certified registered nurse anesthetist. (c) Light/moderate/monitored anesthesia sedation shall be administered by a certified registered nurse anesthetist (CRNA) or Medical Doctor. ... ".
A review of MR9 on April 15, 2024, revealed that the pediatric patient received a general anesthetic of 50 mg of Ketamine Intramuscular (IM) administered by EMP2, on April 9, 2024.
A review of MR16 on April 15, 2024, revealed that the pediatric patient received a general anesthetic of 50 mg of Ketamine IM that was administered by EMP3, on January 6, 2024.
During an interview on April 15, 2024 at approximately 12:45 PM, EMP1 confirmed the above findings.
Plan of Correction:Based on the recommendation of the DOH in regards to our Class 2B ASF status, we will cease to administer ketamine at this time since the DOH considers this medication general anesthesia.
555.32 (a) LICENSURE
Administration of Anesthesia
Name - Component - 00
Anesthesia Services
555.32 Administration of anesthesia
(a) Anesthetics shall be administered by anesthesiologists and certified registered nurse anesthetist and dentist anesthetists as defined in 551.3 (relating to definitions).
Observations:
Based on review of facility documents, medical (MR), and staff interview (EMP), it was determined the facility failed to ensure that anesthesia was administered by an Anesthesiologist or Certified Registered Nurse Anesthetist who is trained and qualified for two of 20 medical records reviewed (MR9 and MR16).
Findings include:
A review, on April 15, 2024, at 11:15 A.M., of the facility's medical staff bylaws, date October 2023, revealed ..." ... 4. ANESTHESIA SERVICES 4.1. Principle. (a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon the recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per Abortion Facility license. ... 4.2. Administration of anesthesia. (a) Anesthesia shall be administered by a certified registered nurse anesthetist (CRNA) or Medical Doctor.(b) Monitored anesthesia care (MAC) shall be administered by a certified registered nurse anesthetist. (c) Light/moderate/monitored anesthesia sedation shall be administered by a certified registered nurse anesthetist (CRNA) or Medical Doctor. ... ".
A review of MR9 on April 15, 2024, revealed that the pediatric patient received 50 mg of Ketamine Intramuscular (IM) administered by Registered Nurse (RN) EMP2, on April 9, 2024.
A review of MR16 on April 15, 2024, revealed that the pediatric patient received 50 mg of Ketamine IM administered by a Registered Nurse EMP3, on January 6, 2024.
During an interview on April 15, 2024 at approximately 12:45 PM, EMP1 confirmed the above findings.
Plan of Correction:Based on the recommendation of the DOH in regards to our Class 2B ASF status, we will cease to administer ketamine at this time since the DOH considers this medication general anesthesia.
|