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Based on review of documentation, interviews, the Hospital's internal investigation of the complaint file and the Hospital Policy for resolution of patient complaints, the Hospital failed to ensure that the Complainant received a written notice of its decision that contained the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process and the date of completion for one of ten patient record reviews.

Findings included:

Background information:

The Complainant alleged that the Patient presented to the Emergency Department [ED] on 4/26/11 in her 8th week of pregnancy for an ultrasound to determine if the fetus was still viable. The Complainant alleged the ED Physician never performed the ultrasound. The Complainant alleged the ED Physician and Nurse Practitioner each performed vaginal exams and determined the fetus was not viable. The Complainant said the Patient was seen by her Obstetrician the following day and confirmed the fetus was viable by ultrasound. The Complainant alleged the Patient was emotionally destroyed by the incorrect diagnosis of fetal demise.

Findings included:

1) The Complainant said the Patient phoned the Hospital two days after the ED visit [4/28/11] to file a complaint regarding the ED Physician's actions. The Complainant said the Patient Relations contact asked the Patient what they could do to make things better. The Patient could not articulate anything at that time.

2) Review of the Hospital File for the investigation of the complaint indicated the Patient Advocate [PA] received the verbal complaint on 4/28/11 by telephone. The complaint indicated the Complainant was upset because no ultrasound was done to confirm the viability of the fetus. The Complainant had a prior stillbirth at 40 weeks the previous year in August. The Complainant was informed the fetus was nonviable and told to follow-up with her Obstetrician within 48 hours. The Complainant did see her Obstetrician where an ultrasound was performed and the pregnancy was intact with a viable fetus.

3) The PA documented the complaint was referred to the ED Director the same day at 11 am with a request the complaint be looked at that day and to expedite the review.

The PA said she e-mailed the complaint to the Director of the ED, who then forwarded it to the Assistant Director of the ED for investigation.

The Assistant Director of the ED responded the same day at 3:35 pm and indicated the Nurse Practitioner [NP] was interviewed. Documentation indicated the NP was not surprised there was a complaint being filed because the NP observed the Family was upset with the ED Physician. The NP said the Family was upset because the ED Physician went into too much detail about the miscarriage process and what the Patient should expect and the discussion upset the Family.

The Assistant Director of the ED documented the ED cannot obtain an ultrasound after 11 pm. Ultrasounds are only obtained after 11 pm for certain diagnoses, and the Patient's intrauterine pregnancy/probable demise was not one of the approved diagnoses, so no ultrasound was obtained. Documentation indicated "the definitive diagnosis with an ultrasound could not be obtained at the time the patient was in our ED."

4) Review of the Hospital internal investigation indicated that no further action was taken to investigate the incident.

5) As of the date of the survey, 5/4/11, it was confirmed that there was no written letter/response to the Complainant.

6) Review of the Hospital policy titled, "Patient Complaint Resolution and Response Policy" indicated that "An attempt to resolve a grievance as soon as possible is made in all cases. On average, a timeframe of seven days for the provision of a written response is considered appropriate. If the investigation, resolution and written response to the complaint are not completed within seven calendar days, a written notification must be sent within seven calendar days of receipt of the grievance to the complaint stating that [hospital] is still working to resolve the complaint and will follow up with another written response within a specified number of days. The letter shall provide the name and contact information for the staff member responsible for coordinating the resolution."

The Patient Advocate who received the telephone complaint from the Complainant was interviewed in person on 5/5/11 at 10:45 am.

The PA provided this Surveyor with a copy of a written response to the Complaint on the day of the survey [5/4/11] which was exactly 7 days after the receipt of the complaint. The letter was written, but not mailed to the Complainant. The PA inquired if the copy of the letter "counted" for the Hospital's 7 day response timeframe for response to complaints according to policy.

This Surveyor proceeded with the investigation.

7) The Director of the ED was interviewed in person on 5/4/11 at 11:30 am. The Director of the ED said he knew of the case and that he interviewed the NP by email, there was no direct communication. The ED Director did not speak to the ED Physician or the Patient.

Based on review of documentation, interviews, review of ED ultrasound services availability after 11 pm and licensure data that indicates the Hospital does not provide maternity services, the Hospital failed to ensure that Patient #1 had the right to participate in the development and implementation of the plan of care.

Findings included:

1) Review of the ED visit dated 4/27/11 was consistent with information supplied by the Complainant and the following clinician interviews. However, documentation did not reflect that Patient #1 presented to the ED specifically for an ultrasound confirmation for viability of the pregnancy.

2) The Director of the ED was interviewed in person on 5/4/11 at 11:30 am. The Director of the ED said the Hospital does not provide maternity services. The Director of the ED said they have Gynecological consultation available and the link to the Obstetrical consultation is made through that service. No medical consultation was requested in this case for either Gynecological or Obstetrical services. The ED Director confirmed that no ultrasound services are available after 11 pm.

3) The ED NP was interviewed by telephone on 5/4/11 at 2:05 pm. The ED NP said she knew Patient #1 was speaking with her OB while in the waiting area. The ED NP told her Patient #1 said the OB wanted an ultrasound done while the Patient was there. If no ultrasound could be done, Patient #1 would have one done in the OB's office the following morning. However, the ED NP never documented that Patient #1 specifically requested an ultrasound be performed.

4) The ED Nurse was interviewed by telephone on 5/5/11 at 9:10 am. The ED Nurse said it was a very busy night. The ED Nurse said Patient #1 reported her prior obstetrical history and that the OB wanted an ultrasound done, but if one could not be obtained, they would perform one the next morning. However, the ED Nurse did not document that Patient #1 presented to the ED specifically for an ultrasound to be performed.

5) The Chairman of Radiology was interviewed in person on 5/4/11 at 2:30 pm. The Chairman of Radiology said that ultrasounds are limited after 11 pm. The Chairman of Radiology said there are specific indications for OB/GYN cases and that was to rule out an ectopic pregnancy. The Chairman of Radiology also said the Hospital does not have a vaginal probe to conduct an intra vaginal ultrasound.
The Chairman of Radiology said they have a limited pool of ultrasound technicians and they perform ultrasounds only if the ED Physician is going to "act on it clinically." The Chairman of Radiology said there was nothing they could do clinically for this Patient even if an ultrasound was done. The Chairman of Radiology said that in this situation, if the Patient was having a miscarriage, they would not act on it in the middle of the night.

The Chairman of Radiology said that if the Attending Physician wants an ultrasound in the middle of the night, they can call for one and discuss the need for obtaining one. The Chairman of Radiology looked up this case and noted there was no record of a call on this Patient for a radiologic exam.

6) The ED Clinicians did not inform the Patient that ultrasounds are not performed after 11 pm for the purpose of confirming fetal viability so that the Patient could decide if she would continue to accept clinical evaluation and treatment. The ED NP and the ED Physician both conducted vaginal exams and visually assumed Patient #1 had an incomplete miscarriage. The ED Physician informed Patient #1 that the fetus was not viable. Patient #1 had an ultrasound performed at the OB's office the next day and it was confirmed the fetus was still viable.

Based on review of Patient #1's medical record, interviews with ED Clinicians and interview with the Complainant, the Hospital failed to ensure that Patient #1 had the right to make informed decisions regarding the plan of care in the ED.

Please see also Tag 130


Findings included:1) Patient #1 presented to the ED on 4/26/11 after her OB directed her to go to the ED for an ultrasound to confirm viability of an 8 week pregnancy. Patient #1 informed both the ED Nurse and the ED NP that she specifically was seeking ultrasound confirmation of the viability of the fetus. Neither the ED Nurse or the ED NP informed Patient #1 that ultrasound services were available after 11 pm.

2) Patient #1 was interviewed by telephone on 5/4/11 at 1 pm. Patient #1 said she arrived at the ED after midnight and was never informed that ultrasound services were not available after 11 pm. Patient #1 said the ED NP took several vials of blood for analysis, but was never told what tests would be done. Patient #1 was told that a pelvic exam would be done and when Patient #1 questioned why this was necessary since she had just been at the OB's office the preceding day, Patient #1 was told this was routine. Patient #1 said she had to undergo two pelvic exams and the second one performed by the ED Physician was very painful because pincers were used to attempt to remove what the ED Physician thought was products of conception from the cervical opening. Patient #1 said the ED Physician did not inform her what he was doing when severe pain was caused by the pincers. Patient #1 said the ED Physician said, Wait a minute and I'll tell you. Patient #1 said the ED Physician informed her AFTER the probing that she was in the process of a miscarriage. Patient #1 went to the OB the following morning where an ultrasound confirmed the viability of the fetus.

3) Patient #1 said she was emotionally upset by the vaginal exams and the incorrect diagnosis made by the ED Physician . Patient #1 said she would have left soon after arriving if only she knew an ultrasound could not be performed. Patient #1 said she is still concerned the probing of the cervical opening with pincers may cause a miscarriage.

Complaint #11-0530

Based on review of documentation, interviews and review of the root cause analysis, the Hospital failed to ensure that performance improvement activities tracked medical errors and adverse patient events, analyzed their causes and implemented preventative actions and mechanisms that included feedback and learning throughout the hospital. The Hospital failed to develop or revise policies to reflect the change for correct site identification for Thoracenteses and take preventative actions to eliminate distractions during invasive procedures performed in patient rooms for 11 of 20 cases reviewed.


Background information:

The Hospital reported a wrong site surgical procedure in which a Thoracentesis [a needle is inserted into the lung space and fluid is removed] was performed on the left lung when the correct site was the right lung.

Review of the medical record indicated Patient #11 was admitted to the Hospital on 3/28/11 with shortness of breath related to multilobar pneumonia and congestive heart failure. The admission chest x-ray indicated the presence of fluid in the right lung. A Thoracentesis was recommended to reduce difficulty breathing and shortness of breath. Review of Physician Progress notes indicated Patient #11 declined the Thoracentesis procedure at that time.

Review of Physician Progress notes dated 4/1/11 indicated Patient #11 had changed his/her mind and now was agreeing to the Thoracentesis to remove excess fluids in the right lung.


Findings included:

1) Review of the Consent to Thoracentesis form dated 4/1/11 indicated Patient #11 consented to "R/L" Thoracentesis under local anesthesia. The consent form contained no specific narrative highlighting the recommended right lung for the procedure.

2) Review of the Physician Progress notes dated 4/1/11 at 7:55 am indicated the Attending Pulmonary Physician [APP] documented the ultrasound obtained just prior to the Thoracentesis on the left side demonstrated pleural effusion [presence of fluid and/or a mass] on both sides. There was more fluid in the right lung. Documentation indicated that "unfortunately, we inadvertently performed initial Thoracentesis [on the] left [side]." "Approximately 30 cc [of fluid was] removed. This was recognized immediately." A chest x-ray was checked and there was no pneumothorax (hole in the lung which eliminates the negative pressure environment for normal inhalation and exhalation to occur). Documentation indicated the error was discussed with Patient #11 and he/she was "understanding of our mistakes. All questions were answered to his/her satisfaction." Documentation indicated Patient #11 was agreeable to repeating Thoracentesis on the right lung. Patient #11 tolerated the procedure well and approximately 250 cc of fluid was removed.

3) Review of the Universal Protocol Documentation form dated 4/1/11 for the left Thoracentesis procedure indicated that the pre-procedure verification and time out (pause) was performed.

Complaint #11-0585

Based on review of Patient #1's medical record interviews and interviews, the Hospital failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to Patient #1 during the ED visit on 4/27/11.

Findings included:

1) Patient #1 said the ED NP performed a pelvic exam and then said the ED Physician would be arriving to perform another pelvic exam.

Patient #1 said the ED Physician then entered the room and began conducting another pelvic exam and obtained more cultures. Patient #1 stated the pelvic exam became very uncomfortable and it felt like the ED Physician was probing and digging at her cervix. Patient #1 asked the ED Physician, what are you doing? Patient#1 was told by the ED Physician, wait a minute and I'll tell you. Patient #1 reported feeling a strong sensation of digging and pulling at the cervix and saw the ED Physician was using pincers. Patient #1 was concerned and again asked what was going on. At no point during the pelvic exam was Patient #1 informed by the ED Physician what was going on [trying to remove products of conception] or what the ED Physician thought the issue was. The ED Physician finally said he thought the Patient had an incomplete miscarriage and he saw tissue lodged at the entrance of the cervix which he felt was products of conception. The ED Physician said he was trying to dislodge it, but it was stuck. The ED Physician also thought there was an infection and obtained a specimen jar to send tissue off for analysis.

2) The ED Physician then informed Patient #1 she had had an incomplete miscarriage and began to discuss the process of the remains "working themselves out in time" and the need to potentially schedule a dilation and curettage [D&C] with the OB to make sure the contents were completely expelled.

Patient #1 and her Spouse became extremely upset by receiving the news. The Spouse tried to stop the ED Physician from continuing to talk about the miscarriage process and scheduling a D&C to allow the Patient to cope with the news of the fetal demise. Patient #1 said the ED Physician continued despite this request because the ED Physician felt it was his duty to inform Patient #1 about the miscarriage process. Patient #1 and her Spouse left the ED devastated. Patient #1 presented with some light brown spotting and now was bleeding bright red blood. Patient #1 was completely crushed and left the ED in a state of utter hopelessness and loss.

Patient #1 presented to her Primary OB the following day and the OB asked if an ultrasound was obtained. Patient #1 reported that two pelvic exams were done and they had visually determined the Patient had miscarried. Patient #1 said the OB said that was "ridiculous" - you cannot not confirm an incomplete miscarriage visually! The OB then conducted an ultrasound where the pregnancy was confirmed and the fetus was still viable. The OB reported that the tissue the ED Physician visualized was a polyp [piece of tissue] and NOT products of conception. The OB said it was not appropriate to have told Patient #1 she had miscarried without confirmation by Doppler [device placed on the pregnant abdomen which audibly transmitted the sound of a heartbeat] or ultrasound visualization of the fetal heart to confirm a heartbeat/movement of the heart.

3) The ED Physician was interviewed in person on 5/5/11 at 7:35 am. The ED Physician [ED MD] said he was aware of Patient #1's prior stillbirth and that the Patient had an ultrasound the previous day. The ED MD said he performed a pelvic exam and noted fresh blood at the cervical opening along with a white solid protrusion which he thought was products of conception. The ED MD said he tried to remove the tissue "gently", but it did not come out. The ED MD said he felt it was a incomplete miscarriage.

The ED MD said he was sorry the news was upsetting, but he felt Patient #1 was loosing the pregnancy, so he proceeded to inform the Patient about what the next steps might be in terms of expelling the uterine contents. The ED MD said the process usually proceeds on its own within 24-48 hours and if not, the Patient would need to follow up with her OB for a D&C. The ED MD said that at that point, the Spouse told him to stop speaking, but the ED MD said Patient #1 had asked what would happen next and he felt it was reasonable for him to explain. The ED MD said the Spouse was very upset and it was a terrible loss, but he felt he did the right thing in explaining the miscarriage process.

4) The ED MD said the Hospital does not have a transvaginal probe to obtain gynecological/obstetrical ultrasounds and does not perform ultrasounds after 11 pm.

5) The Director of the ED was interviewed in person on 5/4/11 at 11:30 am. The ED Director did not speak to the ED Physician or Patient#1 directly for the investigation of the complaint.

The Director of the ED said the Hospital does not provide maternity services. The Director of the ED said they have Gynecological consultation available and the link to the Obstetrical consultation is made through that service. No medical consultation was requested in this case for either Gynecological or Obstetrical services. The ED Director confirmed that no ultrasound services are available after 11 pm. The ED Director said the hospital does not have a vaginal probe to perform a transvaginal ultrasound.



Complaint #11-0530

The Hospital failed to ensure that the medical staff was well organized and accountable to the governing body for the quality of medical care provided to patients. The Hospital failed to ensure that distractions caused by beepers is eliminated while physicians performed invasive procedures in settings other than the operating room. The Hospital failed to take immediate corrective actions to implement a plan to develop a coverage system for physician's beepers while performing invasive procedures as of the date of the survey: 5/4 and 5/11.

Please refer to Tag 288 for additional information.

Findings included:

1) The Pulmonary and Critical Care Attending Physician [APP] who was responsible for the supervision of the Pulmonary Fellow who performed the right and left Thoracentesis, was interviewed in person on 5/4/11 at 8:15 am.
The APP said that distraction was a factor in the error. The APP said that both he and the Pulmonary Fellow carried beepers and they both responded to the beepers. The APP said they were rushed and both were entering and leaving the room to answer pagers/beepers during the procedure.


7) The Pulmonary Fellow [PF] was interviewed in person on 5/4/11 at 9:10 am. The PF said she was on call for all consultation cases that day from 6:45 am to 9 pm. The PF said it was a busy day with 12 patients on the service. The PF said that three Thoracentesis were performed that day on patients on the unit and all were on the left side/lung.

The PF said the APP returned to the unit to supervise the Thoracentesis. The PF said the APP instructed her to remove her lab coat and leave everything outside the room. The PF said that about 5 pm, several calls/pages were received regarding sign out details, calls from outside the hospital. The APP was also receiving several calls/pages on his beeper. Both the PF and the APP left the room several times to answer calls/pages.

Based on review of documentation and interviews with the Chairman of Radiology, the Hospital failed to ensure that the Hospital maintained or had available, radiologic services according to the needs of the patients.

Please see Tags A 123, 130, 131 and 347 for additional information.

Findings included:

1) The Chairman of Radiology was interviewed in person on 5/4/11 at 2:30 pm. The Chairman of Radiology said that ultrasounds are limited after 11 pm. The Chairman of Radiology said there are specific indications for OB/GYN cases and that was to rule out an ectopic pregnancy. The Chairman of Radiology said they have a limited pool of ultrasound technicians and they perform ultrasounds only if the ED Physician is going to "act on it clinically." The Chairman of Radiology said there was nothing they could do clinically for this Patient even if an ultrasound was done. The Chairman of Radiology said that in this situation, if the Patient was losing the baby, they would not act on it in the middle of the night.

The Chairman of Radiology said that if the Attending Physician wants an ultrasound in the middle of the night, they can call for one and discuss the need for obtaining one. The Chairman of Radiology looked up this case and noted there was no record of a call on this Patient for a radiologic exam.

The Chairman of Radiology also said the Hospital does not have a vaginal probe to conduct an intra vaginal ultrasound.

2) The Hospital does not provide Maternal-Newborn Services. The ED does have access to Gynecological consultation, but a consult was not requested for this case.

3) Patient #1 presented to the ED specifically for an ultrasound confirmation that the fetus was still viable, but was not informed the Hospital did not provide ultrasound services after 11 PM.

Based on review of documentation and interviews, the Hospital failed to ensure that ED services were integrated with other departments of the hospital. The Hospital failed to ensure that Patient #1 was informed of what services the Hospital could and could not provide for her clinical presentation.

Findings included:

1) The ED service does not have access to ultrasound services after 11 pm at night. Patient #1 was 8 weeks pregnant and was concerned she was having a miscarriage. Patient #1 was instructed by her OB to have an ultrasound performed to confirm viability of the fetus. Patient #1 was not informed there were no ultrasound services available at that time of night. During interview, Patient #1 said she was not aware the Hospital did not provide Maternal-Newborn Services. 2) The Hospital licensure data indicates the Hospital does not provide Maternal- Newborn Services.

3) Patient #1 was determined to be clinically stable and did not present with a clinical emergency.