The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

HARLAN ARH HOSPITAL 81 BALL PARK ROAD HARLAN, KY 40831 June 28, 2017
VIOLATION: COMPLIANCE WITH 489.24 Tag No: A2400
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews, review of the facility's Labor and Delivery Logbook, medical record review, and review of facility policies, it was determined the facility failed to ensure stabilizing medical treatment was provided for two (2) of twenty (20) sampled patients (Patient #1 and Patient #3) that presented to the facility's Labor and Delivery Department for an Emergency Medical Condition. Interviews revealed Patient #1 and Patient #3 presented to Labor and Delivery on 06/14/17 with complaints of questionable labor.

Patient #1 presented at thirty (30) weeks gestation, gravida 6, para 4 (six pregnancies with four live births) with possible rupture of membranes (clear fluid leaking from vaginal area). Patient #1 was provided a medical screening exam by Registered Nurse (RN) #1 and informed she had ruptured membranes and was dilated one (1) centimeter (cm). RN #1 contacted the Obstetrician (OB) on call (Physician #1) and informed him of Patient #1's condition. Physician #1 directed RN #1 to discharge Patient #1 to go to Facility #2 (78 miles away) in a private vehicle because Facility #2 is where Patient #1 was followed on an outpatient basis. Patient #1 was discharged at 11:42 PM on 06/14/17. Patient #1 went by private vehicle to Facility #2 and was admitted on [DATE] at 1:15 AM with diagnoses of 30.6 weeks gestation, Preterm Premature Rupture of Membranes, Preterm Labor, and Chronic Drug Abuse. Facility #2 made arrangements to transfer Patient #1 to Facility #3 due to Facility #2 only having a Level I Nursery. Facility #2 transferred Patient #1 on 06/15/17 at 3:16 AM via ambulance to Facility #3. Facility #3 admitted Patient #1 on 06/15/17 with a diagnosis of Preterm Premature Rupture of Membranes. Patient #1 delivered a viable male baby on 06/24/17 via Cesarean Section. Facility #3 was still treating Patient #1 and Baby Boy #1 as of the date of this investigation.

Patient #3 presented to Facility #1 on 06/14/17 at thirty-five (35) weeks gestation, gravida 3, para 2 (three pregnancies with two live births). Patient #3 received a medical screening exam from RN #1 and was informed that she was dilated two to three (2 to 3) cm with effacement of sixty (60) percent. RN #1 contacted Physician #1 and was given orders to discharge Patient #3 to Facility #2 (78 miles away) in a private vehicle where the patient had been followed on an outpatient basis. Facility #2 admitted Patient #3 on 06/15/17 with diagnoses of Intrauterine Pregnancy at 38 weeks with labor, Subutex (a drug used in the treatment of opioid dependence) Dependent, and Positive Urine Drug Screen for Methamphetamines. Patient #3 delivered a viable female baby on 06/15/17 at 11:43 AM. Facility #2 discharged Patient #3 on 06/17/17.

Refer to 42 CFR 489.24 (d)(1-3) Stabilizing Treatment (A2407).
VIOLATION: STABILIZING TREATMENT Tag No: A2407
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews, review of the facility's Labor and Delivery Logbook, medical record review, and review of facility policies, it was determined the facility failed to ensure stabilizing medical treatment was provided for two (2) of twenty (20) sampled patients (Patient #1 and Patient #3) that presented to the facility's Labor and Delivery Department for an Emergency Medical Condition. Interviews revealed Patient #1 and Patient #3 presented to Labor and Delivery on 06/14/17 with complaints of questionable labor.

Patient #1 presented at thirty (30) weeks gestation, gravida 6, para 4 (six pregnancies with four live births) with possible rupture of membranes (clear fluid leaking from vaginal area). Patient #1 was provided a medical screening exam by Registered Nurse (RN) #1 and informed she had ruptured membranes and was dilated one (1) centimeter (cm). RN #1 contacted the Obstetrician (OB) on call (Physician #1) and informed him of Patient #1's condition. Physician #1 directed RN #1 to discharge Patient #1 to go to Facility #2 (78 miles away) in a private vehicle because Facility #2 is where Patient #1 was followed on an outpatient basis. Patient #1 was discharged at 11:42 PM on 06/14/17. Patient #1 went by private vehicle to Facility #2 and was admitted on [DATE] at 1:15 AM with diagnoses of [DIAGNOSES REDACTED]#1 to Facility #3 due to Facility #2 only having a Level I Nursery. Facility #2 transferred Patient #1 on 06/15/17 at 3:16 AM via ambulance to Facility #3. Facility #3 admitted Patient #1 on 06/15/17 with a diagnosis of [DIAGNOSES REDACTED]#3 was still treating Patient #1 and Baby Boy #1 as of the date of this investigation.

Patient #3 presented to Facility #1 on 06/14/17 at thirty-five (35) weeks gestation, gravida 3, para 2 (three pregnancies with 2 live births). Patient #3 received a medical screening exam from RN #1 and was informed that she was dilated two to three (2 to 3) cm with effacement of sixty (60) percent. RN #1 contacted Physician #1 and was given orders to discharge Patient #3 to Facility #2 (78 miles away) in a private vehicle where the patient had been followed on an outpatient basis. Facility #2 admitted Patient #3 on 06/15/17 with diagnoses of [DIAGNOSES REDACTED]. Facility #2 discharged Patient #3 on 06/17/17.

The findings include:

Review of the facility's policy titled "EMTALA-Stabilization," reviewed 10/14/08, revealed the facility was to provide such medical treatment as was necessary to assure, within reasonable medical probability, that no material deterioration of the condition was likely to result from, or occur during, the transfer of the individual from the facility; or, with respect to a pregnant woman who was having contractions and who cannot be transferred before delivery without a threat to the health and safety of the woman or unborn child, that the woman has delivered the child and the placenta.

Review of the facility's policy titled "EMTALA-Transfer," reviewed 10/14/08, revealed the facility provided further medical examination and treatment, including hospitalization , if necessary, as required to stabilize the medical condition within the capabilities of the staff and facilities available at the hospital; or to transfer to another more appropriate or specialized facility after provision of treatment necessary to minimize the risks to the health of the individual or, in the case of a pregnant female, to the unborn child. Further review of the policy revealed any legally responsible person acting on the patient's behalf must first be fully informed of the risks of a transfer, the alternatives to transfer, and of the facility's obligations to provide further examination and treatment sufficient to stabilize the patient's Emergency Medical Condition or by a physician's order with the appropriate physician certification. The policy stated that to provide an appropriate transfer the following was required: the transferring facility must within its capability provide treatment to minimize the risks to the health of the individual or unborn child; the receiving facility must have available space and qualified personnel for the treatment of the individual and must have agreed to accept the transfer and provide appropriate treatment; and the transferring facility must send copies of all available medical records pertaining to the individual's emergency condition to the facility where the patient is being transferred.

Review of the credentialing file for Physician #1 on 06/26/17 at 2:00 PM revealed Physician #1 was appointed privileges on 11/02/76 and reappointed on 11/01/16; however, there was no documented evidence the facility oriented/educated Physician #1 on their EMTALA policies.

Review of the Labor and Delivery Logbook revealed Patient #1 (MDS) dated [DATE] at 11:00 PM with a chief complaint of questionable rupture of membranes (her water broke). Continued review of the logbook revealed Patient #1 was discharged on [DATE] at 11:55 PM with a disposition of "home to go to [Facility #2]." Further review of the Labor and Delivery logbook revealed Patient #3 (MDS) dated [DATE] at 10:55 PM with a chief complaint of questionable labor. Patient #3 was discharged at 12:00 AM on 06/15/17 with a disposition of "home to go to [Facility #2]."

1. Review of Patient #1's medical record revealed the facility received Patient #1 on 06/14/17 with a diagnosis of [DIAGNOSES REDACTED]. RN #1 documented Patient #1 had ruptured membranes (clear fluid seen leaking from vagina), with no bleeding, dilation of one (1) centimeter (cm), effacement" thick," and station -2. Continued review of the record revealed RN #1 had documented at 11:30 PM a phone call to Physician #1. RN #1 documented that she informed Physician #1 that Patient #1 had been on the monitor for fifteen (15) minutes and that the patient was at 30.5 weeks gestation, gravida 6, para 4. RN #1 stated that she had performed a medical screening exam and that the patient had a clear fluid observed trickling from her vagina with a nitrozine level of 7.5.

Further review of Patient #1's medical record revealed RN #1 documented that Physician #1 stated, "I think the best thing to do is discharge [Patient #1] and tell her to go on to [Facility #2] where she had planned to deliver to her regular doctor." RN #1 then documented that she asked Physician #1, "Do you want to transfer her to [Facility #2]?" Physician #1 stated, "No, [Patient #1] is not having contractions and she is only dilated to one (1) centimeter. It will be faster to discharge her and instruct her to go on her own." Again RN #1 stated, "[Patient #1's] water is broke, do you want to transfer her? We can try to get an ambulance if you call and get an accepting doctor." RN #1 documented that Physician #1 stated, "No, tell her to go on over there now, we don't have a NICU [neonatal intensive care unit] here and we can't keep a 30-week baby; it will be better to just go on down there where her regular doctor is." RN #1 then documented that she stated to Physician #1, "I want to clarify with you that you know [Patient #1] is at 30 weeks and her water is broke and that you told me to discharge her and instruct her to go to [Facility #2]?" Physician #1 stated, "Yes, she is not contracting, discharge her now and tell her to go to her regular doctor and hospital." Facility #1 discharged Patient #1 at 11:55 PM.

Interview with RN #1 on 06/26/17 at 3:30 PM revealed that she was working in Labor and Delivery on 06/14/17 and conducted the medical screening exam on Patient #1. RN #1 stated she checked Patient #1 when she first arrived and the patient was dilated to one (1) centimeter at that time. RN #1 stated that Patient #1 came in with a "towel between her legs and clear fluid leaking from her vagina." RN #1 stated that Patient #1 had ruptured membranes and she was very concerned because Patient #1 was only at 30 weeks gestation. RN #1 stated, "We always transfer patients like her, we never discharge them." RN #1 stated that when she contacted Physician #1, she expected to receive a transfer order and when she did not, she stated she questioned Physician #1 for "several minutes." RN #1 stated once she hung up with Physician #1, she contacted the House Supervisor because she did not agree with Physician #1's order for Patient #1. RN #1 stated the House Supervisor instructed her to contact the OB Manager. Continued interview with RN #1 revealed that the OB Manager instructed her to follow Physician #1's orders. RN #1 stated she then discharged Patient #1 from the facility.

Interview with the OB Manager on 06/26/17 at 12:00 PM revealed that she was contacted by RN #1 on 06/14/17 regarding Patient #1. The OB Manager stated that she did instruct RN #1 to follow Physician #1's orders. Continued interview with the OB Manager revealed that she stated she thought about the situation for a few minutes and then contacted the House Supervisor so she could contact the Administrator on Call for direction. The OB Manager stated she then contacted RN #1 but by that time, Patient #1 had been discharged from the facility. The OB Manager stated that a patient with those circumstances should never be discharged , they should be monitored and transferred.

Interview with Physician #1 on 06/26/17 at 1:21 PM revealed he was the on-call OB on 06/14/17 for Facility #1. Physician #1 stated that he did speak with RN #1 regarding Patient #1. Physician #1 stated that Facility #1 did not have the capability to care for a 30-week newborn and that he was "saving" time when he gave the order to discharge rather than to transfer. Physician #1 stated that sometimes it takes hours to have an ambulance respond to a request to transport a patient to another facility and he did not want to take the chance of the baby being delivered at Facility #1. Further interview with Physician #1 revealed that he thought Facility #2 had a Level II NICU nursery to provide care for the newborn baby. Physician #1 stated that because Patient #1 was only dilated to 1 centimeter and not contracting, he felt it was safe to discharge her by private vehicle and go on her own to Facility #2.

Interview with Physician #2 on 06/26/17 at 5:00 PM revealed he was the Medical Director for the OB unit at Facility #1. Physician #2 stated that given the set of circumstances surrounding Patient #1, he professionally would not have discharged the patient. He stated that he would have transferred her via ambulance to another facility. Further interview with Physician #2 revealed that had the Administrator on Call contacted him regarding this situation, he would have instructed RN #1 to follow Physician #1's orders because Physician #1 was his partner and it was difficult to go against his medical opinion.

Review of Patient #1's medical record from Facility #2 revealed the facility admitted Patient #1 on 06/15/17 at 1:15 AM with diagnoses of [DIAGNOSES REDACTED]#1 to Facility #3 due to Facility #2 only having a Level I Nursery. Facility #2 transferred Patient #1 on 06/15/17 at 3:16 AM via ambulance to Facility #3.

Facility #3 admitted Patient #1 on 06/15/17 with a diagnosis of [DIAGNOSES REDACTED]#3 was still treating Patient #1 and Baby Boy #1 as of the date of the investigation. Patient #1's baby boy was diagnosed with [DIAGNOSES REDACTED]'s response to infection causes injury to its own tissues and organs), Feeding problems of a newborn, [DIAGNOSES REDACTED] status post surfactant (a syndrome in premature infants caused by developmental insufficiency of pulmonary surfactant production and structural immaturity in the lungs; it can also be a consequence of neonatal infection), and Hypotension (low blood pressure).

2. Review of the medical record for Patient #3 revealed Facility #1 admitted the patient on 06/14/17 at 10:55 PM with a chief complaint of questionable labor. Patient #3 stated she was at thirty-nine (39) weeks gestation, gravida 3, para 2. Patient #3 received a medical screening exam from RN #1 and informed the patient that she was dilated two to three (2 to 3) centimeters with effacement of sixty (60) percent. RN #1 contacted Physician #1 at 11:30 PM and informed Physician #1 that he was the OB on call for unassigned patients and that Patient #1 was at 39 weeks gestation, gravida 3, para 2 with questionable labor and dilated 2-3 centimeters. RN #1 documented that Physician #1 stated, "Tell her to go to [Facility #2] to her doctor." RN #1 documented that she asked Physician #1 again to clarify that he wanted to discharge Patient #3 and Physician #1 stated, "Yes, discharge her and tell her to go to [Facility #2] where she goes to the doctor." RN #1 documented that she contacted the House Supervisor and the OB Unit Manager and informed them of Physician #1's orders to discharge Patient #3 to Facility #2 and that she was instructed to "do what [Physician #1] told you to do." Patient #3 was discharged at 12:00 AM on 06/15/17 with a disposition of "home to go to [Facility #2]."

Review of the medical record for Patient #3 from Facility #2 revealed the facility admitted Patient #3 on 06/15/17 at 3:45 AM with diagnoses of [DIAGNOSES REDACTED]. Facility #2 discharged Patient #3 on 06/17/17.

Interview with RN #1 on 06/26/17 at 3:30 PM revealed that she was working in Labor and Delivery on 06/14/17 and conducted the medical screening exam on Patient #3. RN #1 stated that Patient #3 was at 39 weeks gestation and dilated to 2-3 centimeters. RN #1 stated that she informed Physician #1 of Patient #1's symptoms and that he gave her orders to discharge Patient #3 to home to go to Facility #2. RN #1 stated that she contacted the House Supervisor and OB Unit Manager and was told to follow Physician #1's orders so that is what she did.

Interview with Physician #1 on 06/26/17 at 1:21 PM revealed he was the on-call OB on 06/14/17 for Facility #1. Physician #1 stated that he did speak with RN #1 regarding Patient #3. Physician #1 stated that he recalled that Patient #3 was a term pregnancy and the baby was in a breech position. Physician #1 stated that from the information that RN #1 told him he was unsure if Patient #3 was in labor and he gave orders to discharge Patient #3 to home and for her to go to Facility #2 where her OB delivered babies and for her to follow up with them. Physician #1 stated that he felt like he gave orders that were in the best interest of the baby.

Interview with the Chief Nursing Officer (CNO) and the Risk Manager on 06/26/17 at 3:30 PM revealed that they became aware of the incident on 06/15/17 when they were contacted by Facility #2. The Risk Manager stated that Physician #1 should have transferred Patient #1 and Patient #3 rather than discharging them. The CNO and the Risk Manager stated that on 06/19/17 all OB staff was re-educated on EMTALA policies and on 06/21/17 all Providers were re-educated on EMTALA policies and procedures. Physician #1 and Physician #2 were educated separately on 06/26/17 and Facility #1 held a Medical Staff Meeting on 06/26/17 where the Chief Executive Officer, the CNO, and the Risk Manager spoke regarding EMTALA policies and procedures to the entire medical staff.