Initial Comments:
This report is the result of an unannounced Special Monitoring survey completed on April 15, 2021, at Allentown Womens' Center, Inc. It was determined 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 an unannounced onsite Special Monitoring survey, completed on April 15, 2021, at Allentown Womens' Center, Inc. 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:
551.21 (d)(4) LICENSURE
Criteria for ambulatory surgery.
Name - Component - 00
551.21. Criteria for ambulatory surgery.
(d) Surgical procedures may not be of a type that:
(4) Are emergency or life threatening in nature, unless no hospital is available
for the procedure and the need for the surgery could not have been anticipated.
Observations:
Based on a review of facility policy and procedures, facility documents, medical records (MR), and interviews with facility staff (EMP), it was determined the facility failed to meet the surgical procedures criteria for ambulatory surgery facilities by performing a procedure that was an emergency or life threatening in nature in one of one medical records reviewed (MR1).
Findings include:
Review on April 12, 2021 of policy, "Allentown Women's Center Procedural (formerly Surgical) Abortion Protocols - 2020" revealed, "IV. Ineligible Patients and Referrals to Other Agencies A) Indications ... 2. Medical condition warrants a procedure in a hospital setting. This is determined through consultation with the Medical Director, the physician performing the procedure, AWC support staff, and the patient's own private physician(s)."
Review of facility document on April 15, 2021 revealed, "Patient was seen for abortion procedure on 3/19/21 at 17 weeks of gestation. Procedure was WNL [within normal limits]. Recovery Room showed all vitals WNL after being monitored for 35 minutes as well. This included bleeding status ... patient then left the building. Patient returned approximately 1.5 hours later... stating that she had very heavy bleeding. Patient had visible bleed soaking pants. Patient was examined by physician and a re-evac was done which caused bleeding to slow. Patient was then monitored in Recovery where her bleeding gradually increased again after 10-15 minutes. Patients vitals were typically stable but Hgb did decrease which prompted physician to call for ER transfer ..."
Review on April 8, 2021 of MR1 revealed the patient had a procedure on March 19, 2021, and was discharged at approximately 1:30 PM. Further review of MR1's "Physician Progress Note" revealed "Patient had been discharged from RR [recovery room] (feeling well, VSS [vital signs stable]) and returned 90 minutes later after having experienced heavy vaginal bleeding. Felt tired. Mild/mod [moderate] abdominal pain. She had soaked through her clothes. Brought to procedure room. Minimal bleeding from cervix on speculum exam. U/S [ultrasound] showed minimal amount of blood which was removed. No free fluid seen. Uterus firm. Patient feels better now. No active bleeding seen ..."
Further review of MR1 on April 8, 2021 revealed, "Pt [patient] came into RR [recovery room] bleeding through her pants at 2:45 pm, Pt had gone through 1 maxi pad in a span of 1-2 hours. Pt felt nauseous and stated she had to use the bathroom. Pt started to have dry heaving and diarrhea simultaneously. RN [registered nurse] started to bimanually massage lower abdomen ... Pt was AOX4 [alert and orientated] ... Pt continued to monitor [sic] in RR after D&C [dilation and curettage] ... Pt has 0/10 pain and states "I feel way better" ... 3:33PM - Pt cx [complains of] 10/10 pain. Increased bleeding noted. MD [Doctor of Medicine] notified ... Pt to be transferred to ER [emergency room] for continued 10/10 pain and increased bleeding ..."
Review of acute care hospital medical record (which is the same patient as in MR1) on April 15, 2021 revealed, "18 y.o. [year old] ... admitted [March 19, 2021 at approximately 4:16 PM to the emergency department and received emergency treatment] with postpartum hemorrhagic & DIC [disseminated intravascular coagulation] after termination of 17 wk pregnancy via D&E [dilation and evacuation] at Allentown Women's Center. Patient was emergently taken to operating room secondary to development of hemodynamic instability & unstable hemoglobin ... She underwent exam under anesthesia, D&C [dilation and curettage], diagnostic laparoscopy, & repair of cervical laceration. Surgery complicated by DIC requiring multiple uterotonics & placement of intrauterine balloon for tamponade. She received 4u PRBC [4 units packed red blood cells], 4u FFP [4 units fresh frozen plasma], & 1u [1 unit] cryoprecipitate intraoperatively. Postoperatively, she was transferred to ICU [intensive care unit] for higher level monitoring ..."
Review of acute care hospital medical record on April 15, 2021 revealed, "... [patient] is a 18 y.o [year old]... postop day 0 from a termination of pregnancy via D&E [dilation and evacuation] at Allentown Women's Center at 17 weeks gestation today. Initially post-procedure the patient was doing well. She then had a large gush of vaginal bleeding in the recovery room. There she was taken back to the OR [operating room] for repeat D&C [dilation and curettage] as bedside ultrasound demonstrated clots vs retained POCs [products of conception]. She then had minimal bleeding after this repeat D&C... Patient continues to note vaginal bleeding soaking her clothes in the ambulance. Denies dizziness or lightheadedness. Feels cold. Denies chest pain, palpitations or SOB [sic] ..."
Further review of acute care hospital medical record on April 15, 2021 revealed, "18y/o [year old] F [female] transferred from Allentown Women's clinic s/p [status post] elective termination of pregnancy at 17 weeks gestation by D&E [dilation and evacuation]. Per report from AWC [Allentown Women's Center], minimal bleeding noted with initial procedure, followed by increased bleeding in recovery area. Due to increased bleeding, she was taken back to the OR [operating room] at AWC for repeat evaluation that revealed mild to moderate bleeding, no retained products of conception on bedside ultrasound and uterus with appropriate tone. She was then re-evaluated again post-procedure and noted to have some continued bleeding with point of care Hgb [hemoglobin] from 13.0 to 10.0. At this time, they called an ambulance to transfer patient to the ED [emergency department] for further evaluation. On initial evaluation by me and [physician name removed], patient with two gushes of bleeding with fundal check and no additional bleeding. Fundus continues to be firm and bedside ultrasound revealed an appropriate endometrial stripe with no evidence of retained products of conception. Patient with stable vitals and denies any symptoms of severe anemia. At this time, the decision was made to admit for observation, monitor bleeding, serial fundal checks and repeat labs. Approximately 15 minutes after initial evaluation, ED notified us that the patients vital signs show evidence of hemodynamic instability with hypotension and tachycardia and the patient had large amounts of bleeding on exam. Hgb returned at 7.8 at this time. Patient was re-evaluated by me and the resident physician and found to have continued bleeding. At this time, Level 1 case communicated to OR staff for exam under anaesthesia, suction D&C [dilation and curettage], and under ultrasound guidance, possible diagnostic laparoscopy, possible laparotomy and other indicated procedure. Blood transfusion was initiated. Methergine x 1 dose was ordered and TXA [tranexamic acid] x 1 dose was ordered. Patient was quickly transferred to OR..."
Plan of Correction:Upon conducting a thorough review of our facilities protocol and staffing knowledge regarding these protocols, the Allentown Women's Center will correct the deficiency by doing the following:
1. A full staff meeting will be held by the end of May to review its emergency protocol with all of its staff and ensure every staff is aware of the steps to take during an emergency transfer. Additionally, a review of scenarios, that are deemed emergent, will be reviewed will all staff members. A mock drill will also be done during this staff meeting to further solidify what has been gone over that day.
2. All physicians will be notified separately by May 22, 2021 and emphasize the importance of transferring a patient to a medical facility immediately when a patient is deemed to be an emergency or life threatening in nature.
3. The medical director and director of nursing will work collaboratively by evaluating staff performances in emergency transfers and ensure that solutions are sustained.
4. Both the medical director and director of nursing will monitor to ensure continued implementation of this plan of correction.
553.3 (6) LICENSURE
Governing Body Responsibilities
Name - Component - 00
Governing Body responsibilities include:
(6) Adopting policies or procedures necessary for the orderly conduct of the ASF.
Observations:
Based on a review of facility policies and procedures, review of medical record (MR) and interviews with staff (EMP), it was determined the facility failed to enforce their policy for emergency transfers to an acute care hospital in one of one medical records reviewed (MR1).
Findings:
Review on April 15, 2021, of facility policy "Medical Emergency Transfer of Patient", dated August 11, 2014, revealed, "...a. Assign someone to complete Emergency Response Sheet.. c. Prepare packet for patient to take with her to the hospital ... 1. Complete Medical Transfer of Patient form and copy 2. Complete Hospital referral form and copy ..."
Review on April 15, 2021, of MR1 revealed there was no documented evidence that the Medical Transfer of Patient and Hospital Referral Forms were completed.
Interview with EMP2 on April 15, 2021, at approximately 11:55 AM confirmed the Medical Transfer of Patient form and the Hospital Referral Form were not completed as required by facility policy.
Interview with EMP1 on April 15, 2021, at approximately 12:02 PM confirmed the Medical Transfer of Patient form and the Hospital Referral Form were not completed as required by facility policy.
Plan of Correction:Upon conducting a thorough review of our facilities protocol and staffing knowledge regarding these protocols, the Allentown Women's Center have done the following to correct the deficiency:
1. Staff that were responsible for preparing the medical transfer form and hospital referral form were verbally educated and reprimanded to prevent future deficiencies regarding this matter.
2. During the full staff meeting, at the end of May, it will be re-emphasized to all employees the importance of sending out the said forms above, as well as documenting these forms were sent with the patient to provide best patient care.
3. This will also be addressed at the next patient safety and quality assurance meetings, which is scheduled to be held in June and July 2021.
4. The medical director and director of nursing will work collaboratively by evaluating staff performances in emergency transfers and ensure that solutions are sustained.
5. Both the medical director and director of nursing will monitor to ensure continued implementation of this plan of correction.
553.23 LICENSURE
Discharge by transfer
Name - Component - 00
553.23 Discharge by transfer
Prior arrangements made for admissions.
Clinical records shall accompany the patient.
Observations:
Based on review of facility policies and procedures, medical record (MR), and interviews with staff (EMP), it was determined that the facility failed to ensure medical records were sent with the patient upon transfer to an acute care hospital for one medical record reviewed (MR1).
Findings include:
Review on April 15, 2021, of facility policy "Medical Emergency Transfer of Patient" dated August 11, 2014, revealed, "... c. Prepare packet for patient to take with her to the hospital ... 1. Complete Medical Transfer of Patient form and copy 2. Complete Hospital referral form and copy ..."
Review of MR1 on April 15, 2021, revealed there was no documented evidence that the patient's medical record accompanied the patient (MR1) to the acute care hospital.
Interview with EMP2 on April 15, 2021, at approximately 11:55 AM confirmed there was no documented evidence the medical record accompanied the patient (MR1) to an acute care hospital.
Interview with EMP1 on April 15, 2021, at approximately 12:02 PM confirmed there was no documented evidence the medical record accompanied the patient (MR1) to the acute care hospital.
Plan of Correction:Upon conducting a thorough review of our facilities protocol and staffing knowledge regarding these protocols, the Allentown Women's Center have done the following to correct the deficiency:
1. Staff that was responsible for documenting that the medical records were sent with the patient upon transfer to the hospital was educated on the importance of doing this.
2. This will also be addressed at the next patient safety and quality assurance meetings, which is scheduled to be held in June and July 2021.
3. During the full staff meeting, expected to occur at the end of May, proper documentation will be reviewed with all staff members to ensure complete documentation and continued patient care.
4. The medical director and director of nursing will work collaboratively by evaluating staff documentation and ensure complete documentation is occurring.
5. Both the medical director and director of nursing will monitor to ensure continued implementation of this plan of correction.
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