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275 SANDWICH STREET

PLYMOUTH, MA 02360

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on interview and documentation review, it was determined Hospital bylaws, rules and regulations or other document approved by the governing body did not specify the individuals qualified to conduct Medical Screening Examinations (MSEs).

Findings included:

A review of the Hospital's Medical-Dental Staff Bylaws and Rules and Regulations revealed they did not specify individuals qualified to conduct MSEs.

The Hospital's Senior Director of Clinical Reliability and Risk Manager were interviewed in person throughout the Survey. They said the Hospital did not have a document approved by the governing body or any other policy specifying individuals qualified to conduct MSEs.

A review of medical records associated with 25 patients presenting to the Hospital's Emergency Department or Birthing Center for evaluation of potential emergency medical conditions during the time period of 9/6/09-3/14/10 revealed MSEs were completed by Emergency Department physicians, Obstetricians and Certified Nurse Midwives.

STABILIZING TREATMENT

Tag No.: A2407

Based on interviews and documentation review, it was determined the Hospital failed to provide stabilizing treatment within its capability and capacity to 1 of 25 patients in a sample of patients transferred from the Emergency Department (ED) or Birthing Center (BC) during the time period of 9/6/09-3/14/10.

Findings included:

Medical record documentation indicated Patient #1 presented to the ED with complaint of nausea, vomiting, diarrhea, abdominal cramping and urinary frequency at 7:32 AM. Patient #1 was 30 weeks pregnant with twins and had gestational insulin-dependent diabetes and stable vital signs. Patient #1 was triaged to the BC and arrived there by wheelchair; at 7:55 AM.

BC documentation indicated Patient #1: was receiving obstetric care from an Obstetric Practice associated with Hospital #2 (Obstetric Practice A); planned to deliver at Hospital #2; had a history of a preterm cesarean delivery due to a non-reassuring fetal heart rate (FHR); was assessed by Staff RN #1 at 8:21 AM; had fetal movement and stable vital signs; acknowledged (uterine) contractions commencing at 8:00 PM the evening before and; denied rupture of the fetal membranes and vaginal bleeding. BC documentation also indicated: an external fetal monitor (monitors FHR and maternal contractions) was attached to Patient #1; Fetus A had a compound presentation (position) and Fetus B had a breech presentation (the fetal body part entering the maternal pelvis was the buttocks); fetal monitoring revealed mild contractions lasting 30-50 seconds every 2-3 minutes and reassuring FHRs and; Certified Nurse Midwife (CNM) #1 was notified of Patient #1's arrival and clinical status. Documentation did not indicate the On-Call Obstetrician was notified of Patient #1's arrival/clinical status.

Staff RN #1 was interviewed in person at 8:10 AM on 3/29/10. Staff RN #1 said the On-Call Obstetrician was not notified of Patient #1's arrival/clinical status; CNM #1 was.

CNM #1 was interviewed in person at 8:50 AM on 3/29/10. CNM #1 reported obtaining Patient #1's history and reviewing the fetal monitoring data. CNM #1 said gastrointestinal (GI) illness was going around the community, the BC staff had evaluated several obstetric patients with it, and Patient #1 indicated her toddler had it. CNM #1 reported thinking Patient #1's contractions were due to dehydration secondary to GI illness and ordering intravenous (IV) fluid. CNM #1 said the On-Call Obstetrician was not notified of Patient #1's arrival/clinical status as it wasn't necessary/Patient #1's situation could be managed by a CNM.

The Hospital's policy titled "Privileges: Certified Nurse Midwife" indicated: the purpose of the Policy is to provide the nursing staff with guidelines on the scope of practice of CNMs; CNMs function as part of a team composed of 1 or more active staff physician members of the Department of Obstetrics and Gynecology; CNMs are permitted to provide antenatal, intrapartum and postpartum care to low risk obstetrical patients who anticipate and desire a normal, spontaneous delivery and who have no medical problems and; physician supervision is provided by consultation antepartally, during labor, and at any other time when problems arise, as detailed in protocols (included in the Policy). The Protocols included the following bullet points: CNMs may independently manage women who are determined to be in good health/who present with no major medical disorder such as diabetes, heart disease and epilepsy/who in the course of pregnancy present no symptoms of pre-eclampsia (a complication of pregnancy characterized by hypertension, protein in the urine and edema), polyhydramnios (an excessive of amniotic fluid), placenta previa (a placenta that is implanted in the lower uterine segment), abruption (the premature detachment of the placenta), malpresentation (of the fetus), multiple gestation and/or hypertensive disorders of pregnancy/who have had neither a prior cesarean section or uterine scar and when these criteria are not met, the CNM must consult with the obstetrician; intrapartally, the CNM must consult with the obstetrician if the patient's onset of labor is at less than 36 weeks gestation and/or the patient has gestational diabetes or a prior uterine incision and; intrapartum management of women with multiple gestation and malpresentation will be assumed by the attending physician.

A review of CNM #1's credential file revealed she is part of a team composed of 3 Active Staff Physicians of the Department of Obstetrics and Gynecology and the On-Call Obstetrician is not 1 of the 3 physicians.

Documentation indicated CNM #1 ordered a 1 liter IV bolus of lactated Ringer (LR) solution to be followed by an infusion (of LR) to run at 250 milliliters (mls)/hour for Patient #1. Documentation did not detail Patient #1's GI illness (i.e. onset, severity, etc.) and blood testing was not ordered.

Documentation indicated an IV line was inserted into Patient #1, the fluid bolus was initiated, and Patient #1 complained of feeling crampy at 8:40 AM. Documentation also indicated: fetal monitoring revealed reassuring FHRs; the monitoring of Fetus A was discontinued at 9:08 AM; Patient #1 was having mild contractions lasting 40-60 seconds every 2-3 minutes and Fetus B had a reassuring FHR at 9:30 AM; CNM #1 instructed Staff RN #1 to remove the monitoring from Fetus B and it was discontinued at 9:30 AM; Patient #1 was out of bed to the bathroom at 9:35 AM; the Patient reported urinary frequency/burning and a urine sample was sent to the Laboratory for culture; point-of-care urine testing did not reveal abnormalities, and at 9:55 AM; Patient #1 had received 700 mls of LR, but reported feeling more uncomfortable and was still having contractions every 2-3 minutes, and CNM #1 was notified.

CNM #1 said when Patient #1's contractions did not diminish or subside with hydration; a preterm labor (PTL) evaluation was initiated. CNM #1 said the On-Call Obstetrician was (still) not notified of Patient #1's arrival/clinical status as it wasn't necessary/Patient #1's situation could be managed by a CNM. CNM #1 also said: a speculum was inserted into Patient #1's vagina in order to test for fetal fibronectin (the presence of fetal fibronectin can be indicative of labor; the absence of fetal fibronectin rules out labor), but the test could not be performed because Patient #1 had bloody show (discharge) at the os (opening of the cervix); Patient #1's cervix was 100% effaced (thinned/shortened) and 1 centimeter (cm) dilated (the cervix becomes 100% effaced and 10 cms dilated for birth); the bag of waters (fetal sac) was bulging; there was no presenting (fetal) part; a transfer to Hospital #3 (a tertiary care hospital) was discussed with Patient #1 (because the Hospital is a community hospital and does not have the capability of caring for neonates born before 35 weeks gestation) and; Patient #1 indicated she wanted to be transferred to Hospital #2.

Staff RN #1 said the cervical exam was performed on Patient #1 at 10:00 AM (and medical record documentation indicating it was performed at 1:45 PM was incorrect).

CNM #1 reported contacting Hospital #2 (a community hospital) to find out if they accepted PTL patients at 30 weeks gestation, speaking with an obstetrician associated with Obstetric Practice A (Obstetrician #2), and learning that Hospital #2 had the capability of caring for 30-week gestation neonates. CNM #1 said Obstetrician #2 indicated Patient #1 should be given magnesium sulfate (an anticonvulsant medication that is administered IV to manage PTL), betamethasone (a corticosteroid medication that is administered to pregnant women who are likely to deliver before 34 weeks gestation that helps fetal lungs with surfactant production) and ampicillin (an antibiotic), and then; transported to Hospital #2. CNM #1 reported ordering the magnesium sulfate, betamethasone and ampicillin, putting a call in to the On-Call Obstetrician, and instructing the Unit Clerk to call for a Stat (immediate) ambulance; almost simultaneously.

Obstetrician #2 (an obstetrician in Obstetric Practice A) was interviewed by telephone at 1:25 PM on 4/1/10. Obstetrician #2 said CNM #1 telephoned around 10:10 AM indicating Patient #1 was at the Hospital having contractions, and asked if Hospital #2 accepted PTL patients at 30 weeks gestation or if the Patient needed to be referred to Hospital #3. Obstetrician #2 reported informing CNM #1 Hospital #2 accepted patients at 30 weeks gestation and since Patient #1 had been receiving obstetric care from Obstetric Practice A and planned to deliver at Hospital #2, the Patient should be transferred to Hospital #2. Obstetrician #2 could not clearly recall all of her conversation with CNM #1, but recalled that CNM #1 indicated Patient #1's cervix was 1 cm dilated, the fetuses were OK, and Patient #1 had not been administered magnesium sulfate or betamethasone. Obstetrician #2 reported discussing the administration of magnesium sulfate, betamethasone and an antibiotic with CNM #1 and instructing CNM #1 to have Patient #1's nurse call a Report when Patient #1 was ready for transfer.

Documentation indicated: CNM #1 individualized and signed standardized Preterm Labor On Magnesium Sulfate Orders for Patient #1 at 10:15 AM; the Orders included orders for continuous fetal monitoring, physician notification of a non-reassuring FHR, intramuscular betamethasone, IV ampicillin, an IV bolus of magnesium sulfate to be administered over 20 minutes, and a maintenance magnesium sulfate infusion to follow the bolus; the betamethasone was administered at 10:15 AM; Patient #1 signed a Transfer Consent Form for transfer to Hospital #2 at 10:20 AM; the Patient vital signs were stable; the magnesium sulfate bolus was initiated at 10:25 AM; the ampicillin was administered at 10:30 AM and; Patient #1's reflexes and respiratory status were monitored (depressed reflexes and respirations are signs of impending magnesium toxicity). Documentation did not indicate the fetuses were placed back on fetal monitoring or that FHRs were obtained or that blood testing was ordered.

CNM #1 said Staff RN #1 was to accompany Patient #1 in the ambulance to Hospital #2. CNM #1 also said the On-Call Obstetrician did not call back and was re-paged at 10:15 AM.

Documentation on Patient #1's Ambulance Care Report indicated the ambulance was summoned at 10:18 AM and arrived at the Patient's bedside at 10:30 AM.

The nurse in charge of the BC during Patient #1's stay (Charge Nurse #1) was interviewed in person at 9:30 AM on 3/29/10. Charge Nurse #1 said Patient #1 had PTL and needed to be transferred. Charge Nurse #1 reported instructing CNM #1 and/or the Unit Clerk to call the On-Call Obstetrician's office and/or cell phone when the Obstetrician was being paged for the second time. Charge Nurse #1 also reported intervening and calling the On-Call Obstetrician's cell phone and leaving a voice mail, and that CNM #1 called the On-Call Obstetrician's office, and left a message.

CNM #1 reported calling the On-Call Obstetrician's cell phone and leaving a voice mail. CNM #1 also reported calling the On-Call Obstetrician's office, being told the Obstetrician was in a room with a patient, a requesting that the On-Call Obstetrician call back as soon as possible.

BC documentation indicated CNM #1 ordered 10 milligrams (mgs) of IV Nubain (a narcotic pain medication; normal adult IV dose = 10-20 mgs) for Patient #1 at 10:30 AM and at 10:40 AM: Staff RN #1 administered the Nubain and initiated the maintenance magnesium sulfate infusion; CNM #1 said goodbye to the Patient; paramedics placed the Patient on the ambulance stretcher and; Patient #1, Staff RN #1 and the Paramedics left for Hospital #2. Documentation did not indicate a cervical exam was performed on Patient #1 or FHRs were checked before the transfer.

CNM #1 and Staff RN #1 said a cervical exam was not performed on Patient #1 following the initiation of the magnesium sulfate therapy and/or prior to the Patient's transfer to Hospital #2. (Hospital staff involved in Patient #1's transfer therefore did not know if the Patient's emergency medical condition [PTL] had been stabilized.)

CNM #1 reported believing Patient #1 was stable for transfer.

Staff RN #1 said a Report regarding Patient #1 was not called to Hospital #2 prior to the transfer. Staff RN #1 also said: Patient #1 was disconnected from the fetal monitor prior to transfer; the On-Call Obstetrician did not call or come to the BC prior to the transfer; Hospital nurses do not perform cervical exams on PTL patients; FHRs were not checked prior to, or during the transfer, but the fetuses had been reactive; Patient #1 didn't act like someone in labor; delivery of the fetuses didn't seem imminent and; an emergency delivery kit and neonatal resuscitation equipment were brought to the ambulance/on the transfer.

CNM #1 said the On-Call Obstetrician telephoned almost immediately following the request for a call back made through the Office, but Patient #1 had already left and other things were happening, and they spoke about the other things; not Patient #1. (CNM #1 did not inform the On-Call Obstetrician of Patient #1's presentation to the BC, care or transfer.)

Documentation on Patient #1's Ambulance Care Report indicated the driving distance from the Hospital to Hospital #2 was 25+ miles and the ambulance: left the Hospital at 11:03 AM; traveled without the utilization of lights and/or siren and; arrived at Hospital #2 at 11:36 AM.

Documentation obtained from Hospital #2 indicated Patient #1 arrived in the BC at 11:50 AM having painful contractions 3-4 minutes apart and was immediately evaluated by Obstetrician #3 (another obstetrician in Obstetric Practice A). The documentation also indicated: an exam revealed Patient #1's cervix was 100% effaced and 5 cms dilated and a bulging bag of waters; a bedside ultrasound (imaging) revealed a breech Fetus with feet in the bag of waters/through the cervix; Patient #1 was counseled regarding the need for urgent (cesarean) delivery (given advancing dilation and malpresentation of twins) and moved to an Operating Room; a Neonatal Intensive Care Team was summoned; the fetal membranes spontaneously ruptured at 12:09 PM and the (amniotic) fluid was bloody; Patient #1 was administered spinal anesthesia at 12:15 PM; Twin A had placental abruption and was born at 12:21 PM; Twin B was born at 12:24 PM; Twin A's Apgar score (a system for evaluating the neonate's physical condition at birth; the maximum total score is 10 and a score of 7-10 indicates the neonate is in good to excellent condition) was 5 at 1 minute and 8 at 5 minutes and; Twin B's Apgar score was 7 at 1 minute and 8 at 5 minutes.

APPROPRIATE TRANSFER

Tag No.: A2409

Based on interviews and documentation review, it was determined:
1.) One (1) of 4 patients in a sample of patients transferred from the Hospital's ED or BC
with an unstabilized emergency medical condition (EMC) during the time period of 9/6/09-3/14/10 was transferred without physician certification indicating that based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweighed the increased risks to the patient or, in the case of a woman in labor, to the woman or the unborn child, from being transferred.
2.) Four (4) of 4 patients in a sample of patients transferred from the Hospital's ED or BC
with an unstabilized EMC during the time period of 9/6/09-3/14/10 were transferred without a physician certification containing a summary of the risks and benefits upon which the transfer decision was based.
3.) One (1) of 4 patients in a sample of patients transferred from the Hospital's ED or BC
with an unstabilized EMC during the time period of 9/6/09-3/14/10 was transferred without sufficient medical record information (Patient #1).

Findings included:

1.) Please see Tag A-2407 for information related to Patient #1.

A cervical exam was not performed on Patient #1 following the initiation of magnesium sulfate therapy and/or prior to the Patient's transfer to Hospital #2 and Hospital staff involved in Patient #1's transfer therefore did not know if the Patient's EMC (PTL) had been stabilized.

The On-Call Obstetrician was not notified of Patient #1's arrival to, or transfer from, the Hospital (until sometime following the transfer).

Patient #1's Authorization For Transfer Form indicated: Patient #1 had been stabilized such that, within reasonable medical probability, no material deterioration of condition was likely to result from or occur during the transfer and; the reason for transfer was PTL with twins at 30 weeks gestation. The Form was signed by CNM #1.

2.) Please see #1 for information regarding Patient #1's Authorization For Transfer Form. Documentation on the Form did not include a summary of the risks and benefits upon which the transfer decision was based.

Patient #4 presented to the ED unresponsive following a motorcycle accident and was provided with medical treatment including intubation (the insertion of a tube into the airway to maintain the airway and to facilitate mechanical ventilation) within the Hospital's capability and capacity, but was not stabilized, and required (a Medflight) transfer to a tertiary care hospital. Patient #4's Authorization For Transfer Form did not include a summary of the risks and benefits upon which the transfer decision was based.

Patient #7 presented to the ED in cardiac arrest and intubated, and was resuscitated. Patient #7 was also provided with medical treatment within the Hospital's capability and capacity, but was not stabilized, and required (a Medflight) transfer to a tertiary care hospital. Patient #7's Authorization For Transfer Form did not include a summary of the risks and benefits upon which the transfer decision was based.

Patient #15 presented to the ED with severe chest pain and was diagnosed with an acute inferior myocardial infarction (heart attack). Patient #15 was also provided with medical treatment within the Hospital's capability and capacity, but was not stabilized, and required (an Advanced Life Support) transfer to a tertiary care hospital. Patient #15's Authorization For Transfer Form did not include a summary of the risks and benefits upon which the transfer decision was based.

3.) Please see Tag A-2407 for information related to Patient #1.

Staff RN #1 reported documenting notes regarding Patient #1's care including the administration of medications on the Patient's External Fetal Monitoring (Recording) Strip because there was no time to complete the usual computerized documentation. Staff RN #1 also reported transferring Patient #1 to Hospital #2 without completing the computerized or other written documentation, but bringing the Fetal Monitoring Strip, and; not documenting during and/or about Patient #1's transfer.

The nurse who received Patient #1 at Hospital #2 (Staff RN #2) was interviewed by telephone at 12:15 PM on 4/1/10. Staff RN #2 said Obstetrician #2 indicated a transfer patient could be coming from the Hospital, but no one from the Hospital had called to confirm the transfer, and it had been over an hour since the transfer had been discussed, and Obstetrician #3 decided to call the Hospital and check on the potential transfer patient's status. Staff RN #2 said Obstetrician #3 had just picked up the telephone when the (potential transfer) patient (Patient #1) came through the door! Staff RN #2 said Patient #1 was uncomfortable and was brought right into a room, transferred onto an obstetric bed, and evaluated by Obstetrician #3.

Staff RN #2 reported leaving Patient #1 to obtain a verbal report from the transferring nurse (Staff RN #1). Staff RN #2 said usually transfer patients and staff arrive with a packet of information related to the patient, but Staff RN #1 didn't have the usual documents, and proceeded to read information related to Patient #1 off a Fetal Monitoring Strip.

Staff RN #1 reported being surprised Staff RN #2 was not taking notes while she was giving Report regarding Patient #1. Staff RN #1 said at one point, Staff RN #2 indicated information regarding a medication would be on Patient #1's MAR (Medication Administration Record), and was informed: the only documentation of the Patient's care/medications was the Fetal Monitoring Strip and; the Strip could not be left at Hospital #2 because it was needed for documentation to be completed at the Hospital.

Neither Staff RN #1 nor Staff RN #2 could clearly recall discussion regarding photocopying Patient #1's Hospital Fetal Monitoring Strip.

Staff RN #1 reported writing out Patient #1's Hospital medication administrations on a piece of paper and leaving the paper for Staff RN #2.

Staff RN #2 said the Report regarding Patient #1 was cut short because Patient #1's bag of waters broke. Staff RN #2 did not recall receiving a paper with Patient #1's Hospital medication administrations written on in.

Patient #1's Hospital #2 medical record did not contain a paper listing medication administrations at the Hospital.