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Based on record review and interview, the medical staff failed to provide quality of care and (Gynecological) services to meet the needs of 1 (SP #2) out of 3 sample patients (SP).

Findings include:

Review of sample patient (SP) #2 medical record showed she came to the Emergency Department (ED) on 01/18/2019 with complaints of 4 weeks of pregnancy now with vaginal bleeding with clots for the last hour. The ED Physician notes review of systems showed patient with vaginal bleeding with clots. The HCG (pregnancy test) was positive. The ultrasound dated 01/18/2019 showed a single viable intrauterine gestation. The patient condition improved and she was discharged.

On 01/28/2019, sample patient #2 returned to the ED with vaginal bleeding, last night started very heavy. The ED physician notes review of systems showed vaginal bleeding. The Ultrasound OB transvaginal showed an abortion in progress/ fetal demise.

Record review of the Radiology results for SP #2: US (Ultrasound) transvaginal on 1/28/2019 showed impression: Abortion in progress/ fetal demise, with abnormal sac and early pregnancy within the cervical canal. Record review of the Radiology results: US (Ultrasound) transvaginal on 1/29/2019 showed impression: possible retained products as described.

Review of the physician's orders and medication administration record dated 01/29/2019 to 01/31/2019 showed the patient received several doses of Misoprostol (Cytotec). See boxed WARNINGS: Abortions caused by Cytotec may be incomplete.

Review of the GYN physician's Progress notes dated 01/29/2019 at 21:08 PM showed Hemoglobin dropped from 13.0 on admission to 10.0 today patient admitted to dizziness and briefly fainting while sitting on the toilet. The repeat US (Ultrasound) was inconclusive for retention of fetal parts. Patient agreed to continue Cytotec instead of dilation and curettage.

Review of SP #2 laboratory results dated 01/30/2019 showed a hemoglobin (Hgb) of 7.9 (normal range: 12 to 16 g/dl), and Hematocrit (Hct) 23.2 (normal range: 36 to 48%).

Review of the Transvaginal Pelvic Ultrasound dated 01/31/2019 a comparison to the January 20, 2019 and the January 29, 2019 Ultrasound showed endometrium with small amount of complex fluid in the endometrial canal most likely representing blood products although retained products of conception cannot be completely excluded.

Review of the nursing notes dated 01/31/2019 at 14:01 PM, SP#2 stated she feels very dizzy and she wants to know if she is safe to be discharge. [Named GYN physicians] team at bedside seeing the patient.

Review of the physician's discharge summary dated 01/31/2019 at 17:20 PM showed on day 2 after admission patient received several more doses of misoprostol (Cytotec) but subsequent transvaginal ultrasound results remained inconclusive.

Patient Education Record provided to SP #2 with the discharge instructions showed information for a diagnosis of an incomplete miscarriage. The treatment states that usually, a dilation and curettage ( D&C) procedure is performed. During a D&C procedure, the cervix is widened (dilated) and any remaining fetal or placental tissue is gently removed from the uterus.

There is no mentioned in the record that SP#2 was not a candidate for a D&C.

Review of SP#2 visit to the ED on 02/20/2019 showed per patient she does not have the money to follow-up in the office, she went to the hospital yesterday and was told that she still had something in her uterus, she is here to be evaluated for continued retained products of conception. She was given Cytotec when she was last admitted here. Patient reports that she is having mild to moderate bleeding for about 1 month. She was admitted for a D&C but per patient she never had the procedure done. Review of systems: vaginal bleeding. A consult was called to gynecologist recommends cytotec 800 mcg now and 200 mcg bid x 5days- patient is refusing to be discharge -says she wants a D&C. Per [named Gyn], she does not need a D&C for RPOC ( retained products of conception) but may be admitted for cytotec treatment and to be monitored.

History and Physical on 02/20/2019 showed she presented with complaints of bleeding. The pelvic ultrasound evaluation is consistent with retained products in the cervical canal. The patient declined outpatient treatment and she was therefore admitted for observation and cytotec treatment. Assessment: incomplete abortion. Plan: Cytotec treatment for incomplete abortion. Discharge patient home when stable.

Record review of the Radiology results for SP #2: transvaginal ultrasound 2/20/2019 impression 1. Findings consistent with retained products of conception within the endocervical canal.

Review of the Inpatient Depart Summary dated 02/21/2019 at 17:28 PM showed medications: misoprostol (Cytotec 200 mcg oral tablets). The education regarding the medication showed what is the most important information I should know about misoprostol (Cytotec) include incomplete miscarriage. The discharge instructions showed information for Sp #2 diagnosis of an incomplete miscarriage. The treatment states that usually, a dilation and curettage (D&C) procedure is performed. During a D&C procedure, the cervix is widened (dilated) and any remaining fetal or placental tissue is gently removed from the uterus.
There is no mentioned in the record that SP#2 was not a candidate for a D&C.

Interview with Physician B on 4/2/2019 at 1:44 PM revealed when he took care of the patient. She was at an early miscarriage case. The standard of care is either treat her as an outpatient or as an inpatient to let her pass the tissue or the product of conception. It was explained to her. You start with the least invasive medical management of removing retained products of conception. She passed the product of conception. Patient was having menstrual bleed. Cytotec contracts the uterus. You avoid the surgery. He stated what we do is best for the pt. and for her case, the cytotec is the best.

Interview with Staff C on 4/2/2019 at 1:15 PM , staff C stated the OB team came. They were deciding to have D & C or not. The team decided the cytotec. Pt was upset when they told her it is for her best interest to have the cytotec.

Interview with the Clinical Quality Director on 4/2/2019 at 9:30 AM. The Clinical Quality Director stated on the second admission, pt requested for D&C. Again, it was not at her best interest. It is best to go the noninvasive procedure which is the cytotec (misoprostol). Ultrasound showed abortion in progress, fetal demise. As per physician's professional judgement, she needed more cytotec. More doses were ordered. She stayed in the facility. She was instructed she will continue to bleed during the process. The product of conception has to pass. She was stable when discharged, and again provided with appropriate discharge instructions with follow up with her physician. She was told she will continue to bleed. She did not go and see the physician. She went to the (name of another facility) ED. From there it was told she has retained foreign object. To go back to us. Pt was admitted with diagnosis of retained product of conception from incomplete abortion a month ago.

Based on record review and interview, the medical staff failed to provide integrated (Gynecological) services to meet the needs of 1 (SP #2) out of 3 sample patients (SP).

Findings include:

Review of sample patient (SP) #2 medical record showed she came to the Emergency Department (ED) on 01/18/2019 with complaints of 4 weeks of pregnancy now with vaginal bleeding with clots for the last hour. The ED Physician notes review of systems showed patient with vaginal bleeding with clots. The HCG (pregnancy test) was positive. The ultrasound dated 01/18/2019 showed a single viable intrauterine gestation. The patient condition improved and she was discharged.

On 01/28/2019, sample patient #2 returned to the ED with vaginal bleeding, last night started very heavy. The ED physician notes review of systems showed vaginal bleeding. The Ultrasound OB transvaginal showed an abortion in progress/ fetal demise.

Record review of the Radiology results for SP #2: US (Ultrasound) transvaginal on 1/28/2019 showed impression: Abortion in progress/ fetal demise, with abnormal sac and early pregnancy within the cervical canal. Record review of the Radiology results: US (Ultrasound) transvaginal on 1/29/2019 showed impression: possible retained products as described.

Review of the physician's orders and medication administration record dated 01/29/2019 to 01/31/2019 showed the patient received several doses of Misoprostol (Cytotec). See boxed WARNINGS: Abortions caused by Cytotec may be incomplete.

Review of the GYN physician's Progress notes dated 01/29/2019 at 21:08 PM showed Hemoglobin dropped from 13.0 on admission to 10.0 today patient admitted to dizziness and briefly fainting while sitting on the toilet. The repeat US (Ultrasound) was inconclusive for retention of fetal parts. Patient agreed to continue Cytotec instead of dilation and curettage.

Review of SP #2 laboratory results dated 01/30/2019 showed a hemoglobin (Hgb) of 7.9 (normal range: 12 to 16 g/dl), and Hematocrit (Hct) 23.2 (normal range: 36 to 48%).

Review of the Transvaginal Pelvic Ultrasound dated 01/31/2019 a comparison to the January 20, 2019 and the January 29, 2019 Ultrasound showed endometrium with small amount of complex fluid in the endometrial canal most likely representing blood products although retained products of conception cannot be completely excluded.

Review of the nursing notes dated 01/31/2019 at 14:01 PM, SP#2 stated she feels very dizzy and she wants to know if she is safe to be discharge. [Named GYN physicians] team at bedside seeing the patient.
Review of the physician's discharge summary dated 01/31/2019 at 17:20 PM showed on day 2 after admission patient received several more doses of misoprostol (Cytotec) but subsequent transvaginal ultrasound results remained inconclusive.

Patient Education Record provided to SP #2 with the discharge instructions showed information for a diagnosis of an incomplete miscarriage. The treatment states that usually, a dilation and curettage ( D&C) procedure is performed. During a D&C procedure, the cervix is widened (dilated) and any remaining fetal or placental tissue is gently removed from the uterus.

There is no mentioned in the record that SP#2 was not a candidate for a D&C.

Review of SP#2 visit to the ED on 02/20/2019 showed per patient she does not have the money to follow-up in the office, she went to the hospital yesterday and was told that she still had something in her uterus, she is here to be evaluated for continued retained products of conception. She was given Cytotec when she was last admitted here. Patient reports that she is having mild to moderate bleeding for about 1 month. She was admitted for a D&C but per patient she never had the procedure done. Review of systems: vaginal bleeding. A consult was called to gynecologist recommends cytotec 800 mcg now and 200 mcg bid x 5days- patient is refusing to be discharge -says she wants a D&C. Per [named Gyn], she does not need a D&C for RPOC ( retained products of conception) but may be admitted for cytotec treatment and to be monitored.

History and Physical on 02/20/2019 showed she presented with complaints of bleeding. The pelvic ultrasound evaluation is consistent with retained products in the cervical canal. The patient declined outpatient treatment and she was therefore admitted for observation and cytotec treatment. Assessment: incomplete abortion. Plan: Cytotec treatment for incomplete abortion. Discharge patient home when stable. Record review of the Radiology results for SP #2: transvaginal ultrasound 2/20/2019 impression 1. Findings consistent with retained products of conception within the endocervical canal.

Review of the Inpatient Depart Summary dated 02/21/2019 at 17:28 PM showed medications: misoprostol (Cytotec 200 mcg oral tablets). The education regarding the medication showed what is the most important information I should know about misoprostol (Cytotec) include incomplete miscarriage. The discharge instructions showed information for Sp #2 diagnosis of an incomplete miscarriage. The treatment states that usually, a dilation and curettage (D&C) procedure is performed. During a D&C procedure, the cervix is widened (dilated) and any remaining fetal or placental tissue is gently removed from the uterus.

There is no mentioned in the record that SP#2 was not a candidate for a D&C.

Interview with Physician B on 4/2/2019 at 1:44 PM revealed when he took care of the patient. She was at an early miscarriage case. The standard of care is either treat her as an outpatient or as an inpatient to let her pass the tissue or the product of conception. It was explained to her. You start with the least invasive medical management of removing retained products of conception. She passed the product of conception. Patient was having menstrual bleed. Cytotec contracts the uterus. You avoid the surgery. He stated what we do is best for the pt. and for her case, the cytotec is the best.

Interview with Staff C on 4/2/2019 at 1:15 PM , staff C stated the OB team came. They were deciding to have D & C or not. The team decided the cytotec. Pt was upset when they told her it is for her best interest to have the cytotec.

Interview with the Clinical Quality Director on 4/2/2019 at 9:30 AM. The Clinical Quality Director stated on the second admission, pt requested for D&C. Again, it was not at her best interest. It is best to go the noninvasive procedure which is the cytotec (misoprostol). Ultrasound showed abortion in progress, fetal demise. As per physician's professional judgement, she needed more cytotec. More doses were ordered. She stayed in the facility. She was instructed she will continue to bleed during the process. The product of conception has to pass. She was stable when discharged, and again provided with appropriate discharge instructions with follow up with her physician. She was told she will continue to bleed. She did not go and see the physician. She went to the (name of another facility) ED. From there it was told she has retained foreign object. To go back to us. Pt was admitted with diagnosis of retained product of conception from incomplete abortion a month ago.