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.

MILFORD HOSPITAL, INC 300 SEASIDE AVENUE MILFORD, CT 06460 Sept. 22, 2011
VIOLATION: CARE OF PATIENTS - MD/DO ON CALL Tag No: A0067
Based on review of hospital documentation and interviews with facility personnel, the governing body failed to address issues identified with the OB/GYN on-call schedule. The findings include:

Review of the Board of Director's minutes dated 1/25/11 identified that the CEO discussed issues related to the OB/GYN physicians' coverage for on-call. Review of the Board of Directors minutes from March '11 through September '11 failed to identify that a plan was implemented to address OB/GYN MD coverage. Review of hospital policy with the Director of QI on 9/22/11 identified that the hospital had no policy for on-call coverage for OB/GYN physicians. Interview with the CEO on 9/22/11 identified that he/she had brought the issue of having an OB/GYN physician in house after hours, but the physicians had refused to provide the coverage and the issue was never resolved. Interview with the Director of OB/GYN on 9/22/11 identified that the hospital does provide coverage, however, when a second OB/GYN is to be called, the on call OB/GYN has to call from a list of OB/GYN physicians until he/she can find one to come in.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Review of the hospital documentation and interviews with facility personnel identified that the facility failed to report on QI areas within the Department of Anesthesia, a contracted service to the Quality Improvement (QI) committee. The findings include:

Review of hospital documentation and interviews with facility personnel on 9/21/11 identified that the Department of Anesthesia is a contracted service. Further review failed to identify that Department of Anesthesia was evaluated by the hospital's QI. Interview with the Director of QI on 9/22/11 identified that the Department Anesthesia was not evaluated through the hospital's QI program.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review of hospital documentation and interviews with facility personnel, the hospital failed to measure the aspects of performance through their QI process with a contracted service. The findings include:

Review of the hospital's contracted services identified that the Department of Anesthesia was a contracted service. Review of the Quality Improvement minutes dated January '11 through September '11 failed to identify that the Department of Anesthesia's performance was measured and/or analyzed through the hospital's Quality Improvement program. Interview with the Director of QI on 9/22/11 identified that the Department of Anesthesia was not part of quality assurance, even though it was a contracted service. Further interview identified that the departments of anesthesia, surgery and OB/GYN all fell under the department of medicine and not reviewed by the hospital's QI program.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on review of hospital documentation and interviews with facility personnel, the hospital failed to measure the aspects of performance through their QI process with a contracted service. The findings include:

Review of the hospital's contracted services identified that the Department of Anesthesia was a contracted service. Review of the Quality Improvement minutes dated January '11 through September '11 failed to identify that the Department of Anesthesia's performance was measured and/or analyzed through the hospital's Quality Improvement program. Interview with the Director of QI on 9/22/11 identified that the Department of Anesthesia was not part of quality assurance, even though it was a contracted service. Further interview identified that the departments of anesthesia, surgery and OB/GYN all fell under the department of medicine and not reviewed by the hospital's QI program.
VIOLATION: MEDICAL STAFF Tag No: A0338
This CONDITION is not met as evidenced by:

Based on clinical record review, staff interviews, and review of facility policies and procedures for one of ten mother and infant couplets, (Patient #44), reviewed in the labor and delivery area, the physician failed to monitor and/or to direct the monitoring of a mother and infant couplet prior to the initiation of an emergent cesarean section birth.
(See A 347)
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on clinical record review, staff interviews, and review of facility policies and procedures for one of ten mother and infant couplets, (Patient #44), reviewed in the labor and delivery area, the physician failed to monitor and/or to direct the monitoring of a mother and infant couplet prior to the initiation of an emergent cesarean section birth. The findings include:

Patient #44 was admitted on [DATE] at forty weeks gestation with complaints of frequent contractions and suspected leakage of amniotic fluid. A fern test was completed and was found to be negative for the presence of amniotic fluid. Patient #44 was kept under observation and monitoring while labor was progressing with Category one fetal monitor tracing (Category one fetal tracings are considered normal). On 8/15/11 at approximately 10:00 AM, the patient developed a temperature of 100.6 Fahrenheit (F) and at 12:00 PM Patient #44 ' s temperature increased to 101F. Antipyretics and intravenous antibiotics were administered. In addition an epidural was placed for pain control. During this time fetal monitoring continued with Category One fetal tracing's. According to the clinical record at approximately 2:25 PM Category Two fetal tracings ("Category Two tracing are considered indeterminate" and "requires evaluation and surveillance" ACOG, June 22, 2009, retrieved September 29, 2011 www.ACOG.org) were identified. Interventions that were provided included the administration of oxygen, position change, and a bolus of intravenous fluids. Patient #44 was examined and found to be 5-6 centimeters dilated. Fetal tracing continued to be monitored with labor progressing. At 3:30 PM Patient #44 continued with a temperature of 101F, antipyretics were administered again, the patient was examined and found to be 8 centimeters dilated. At approximately 5:00 PM Patient #44 was 9 centimeters dilated in the presence of fetal tachycardia with moderate variability, but increasing variable decelerations ("a variable deceleration is a decrease in the fetal heart rate below the baseline" caused by umbilical cord compression (Advanced Electronic Fetal Monitoring - Interview). At approximately 5:13 PM the possibility of a cesarean section was discussed by the team with the patient and at 5:23 PM the decision was made to proceed with a primary cesarean section in light of fetal tachycardia and worsening fetal heart decelerations. At 5:23 PM an internal fetal monitor was placed to obtain the fetal tracings. According to the clinical record at approximately 5:31 PM while preparations were made for the cesarean section Category 3 tracings ("Category three tracings are considered abnormal, require prompt evaluation" and "may require providing oxygen" to the pregnant women, "changing the women ' s position", among other things." If the tracings do not return to normal, the fetus should be delivered" ACOG, June 22, 2009, retrieved September 29, 2011 www.ACOG.org), were identified. At 5:34 PM the fetal heart rate decelerated to 60 beats per minute. The patient was taken off maternal and fetal monitors and was rushed for an emergent cesarean section. Patient #44 was in the operating room at 5:37 PM. An external fetal tracing was obtained and noted to go from 180 to 140 beats per minute from 5:37 PM to 5:38 PM. Interview with RN #15 on 9/8/11 at 12:30 PM identified that the mother's heart rate prior to entering the operating room was 148 beats/minute on the pulse oximeter. Further interview with RN #15 indicated she informed MD #11 that she could not ascertain if the fetal tracing was that of the mother or the baby and Patient #44's pulse and/or apical heart rate was not taken in the operating room until 5:45 PM when the patient was placed on the monitor by anesthesia. As the surgical team prepared for the operation the anesthesiologist gave Patient #44 medication via the epidural catheter. The patient reported pain at the site of the intended incision. At that time the decision to use general anesthesia was made by the obstetrician, MD #11. According to the clinical record the anesthesiologist indicated that the screen required to monitor the patient's vital signs for general anesthesia was not working and requested another one. On 9/8/11 at 12:40 PM, RN #15 indicated that a monitor was provided by the nursery in the next room, the infant equipment was replaced for adult monitor use and applied to Patient #44. Further review of the clinical record identified that general anesthesia was induced and the infant was delivered at 5:51 PM with a tight nuchal cord and a heart rate of 20-30 beats/minute. Apgar scores were zero at one and five minutes after birth (Range 1- 10). Despite cardiopulmonary resuscitation, intubation, the use of Epinephrine and volume the baby was pronounced deceased at 6:20 PM. Review of the autopsy report dated 9/1/11 identified that Chorioamnionitis was the cause of death. Interview and review of the clinical record with MD #11 on 9/9/11 at 11:00 AM indicated that the mother and infant were not monitored from 5:39- 5:45 PM, and he/she did not obtain or direct the medical staff to take the mothers pulse or apical heart rate. Interview with the Director of Obstetrics on 9/9/11 at 1:45 PM identified that the maternal heart rate should have been taken at 5:37 PM in the operating room to ascertain if the heart rate was that of the mother or the infant so that medical interventions could have been evaluated and implemented as necessary, and as timely as possible. The hospital policy for an emergent cesarean birth, in part, identified that when the patient is transferred to the operating room continued monitoring should be implemented when possible of both uterine activity and the fetal heart rate. The policy further directed to leave the fetal spiral electrode attached until the abdominal preparation is completed, and continue to monitor if possible.
VIOLATION: NURSING SERVICES Tag No: A0385
This CONDITION is not met as evidenced by:
Based on clinical record review, staff interviews, and review of facility policies and procedures for one of ten mother and infant couplets, (Patient #44), reviewed in the labor and delivery area, the facility failed to monitor the mother and/or infant prior to the initiation of an emergent cesarean section birth. (See A395)

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VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on clinical record review, staff interviews, and review of facility policies and procedures for one of ten mother and infant couplets (Patient #44), reviewed in the labor and delivery area the facility failed to monitor the mother and/or infant prior to the initiation of an emergent cesarean section birth. The findings include:

Patient #44 was admitted on [DATE] at forty weeks gestation with complaints of frequent contractions and suspected leakage of amniotic fluid. A fern test was completed and was found to be negative for the presence of amniotic fluid. Patient #44 was kept under observation and monitoring while labor was progressing with Category one fetal monitor tracing (Category one fetal tracings are considered normal). On 8/15/11 at approximately 10:00 AM the patient developed a temperature of 100.6 Fahrenheit (F) and at 12:00 PM Patient #44 ' s temperature increased to 101F. Antipyretics and intravenous antibiotics were administered. In addition an epidural was placed for pain control. During this time fetal monitoring continued with Category One fetal tracing's. According to the clinical record at approximately 2:25 PM Category Two fetal tracings ("Category Two tracing are considered indeterminate" and "requires evaluation and surveillance" ACOG, June 22, 2009, retrieved September 29, 2011 www.ACOG.org), were identified. Interventions that were provided included the administration of oxygen, position change, and a bolus of intravenous fluids. Patient #44 was examined and found to be 5-6 centimeters dilated. Fetal tracing continued to be monitored with labor progressing. At 3:30 PM Patient #44 continued with a temperature of 101F, antipyretics were administered again, the patient was examined and found to be 8 centimeters dilated. At approximately 5:00 PM Patient#44 was 9 centimeters dilated in the presence of fetal tachycardia with moderate variability, but increasing variable decelerations ("a variable deceleration is a decrease in the fetal heart rate below the baseline" caused by umbilical cord compression (Advanced Electronic Fetal Monitoring, - Interview). At approximately 5:13 PM the possibility of a cesarean section was discussed and at 5:23 PM the decision was made to proceed with a primary cesarean section in light of fetal tachycardia and worsening fetal heart decelerations. At 5:23 PM an internal fetal monitor was placed to obtain the fetal tracings. According to the clinical record at approximately 5:31 PM while preparations were made for the cesarean section Category 3 tracings ("Category three tracings are considered abnormal, require prompt evaluation" and "may require providing oxygen" to the pregnant women, "changing the women ' s position", among other things." If the tracings do not return to normal, the fetus should be delivered" ACOG, June 22, 2009, retrieved September 29, 2011 www.ACOG.org), were identified. At 5:34 PM the fetal heart rate decelerated to 60 beats per minute. The patient was taken off maternal and fetal monitors and was rushed for an emergent cesarean section. Patient #44 was in the operating room at 5:37 PM. An external fetal tracing was obtain and noted to be 180-140 beats per minute from 5:37 PM to 5:38 PM. Interview with RN #15 on 9/8/11 at 12:30 PM identified that the mother's heart rate prior to entering the operating room was 148 beats/minute on the pulse oximeter. Further interview with RN #15 indicated she informed MD #11 that he/she could not ascertain if the fetal tracing was that of the mother or the baby and Patient #44's pulse and/or apical heart rate was not taken in the operating room until 5:45 PM when the patient was placed on the monitor by anesthesia. As the surgical team prepared for the operation the anesthesiologist gave Patient #44 medication via the epidural catheter, however, the patient felt pain at the site of the intended incision. The decision to use general anesthesia was made by the obstetrician, MD #11. According to the clinical record the anesthesiologist indicated that the screen required to monitor the patient's vital signs for general anesthesia was not working and requested another one. On 9/8/11 at 12:40 PM RN #15 indicated that a monitor was provided by the nursery from the next room, the infant equipment was replaced for adult monitor use and applied to Patient #44. Further review of the clinical record identified that general anesthesia was induced and the infant was delivered at 5:51 PM with a tight nuchal cord, a heart rate of 20-30 beats/minute. Apgar scores were zero at one and five minutes after birth. Despite cardiopulmonary resuscitation, intubation, the use of Epinephrine and volume the baby was pronounced deceased at 6:20 PM. Review of the autopsy report dated 9/1/11 identified that Chorioamnionitis was the cause of death. Interview and review of the clinical record with MD #11 on 9/9/11 at 11:00 AM indicated that the mother and infant were not monitored from 5:39- 5:45 PM. Interview with the Director of Obstetrics on 9/9/11 at 1:45 PM identified that the maternal heart rate should have been taken at 5:37 PM in the operating room to ascertain if the heart rate was that of the mother or the infant so that medical interventions could have been evaluated and implemented as necessary and as timely as possible. The hospital policy for an emergent cesarean birth, in part, identified that when the patient is transferred to the operating room continued monitoring should be implemented when possible of both uterine activity and the fetal heart rate. The policy further directed to leave the fetal spiral electrode attached until the abdominal preparation is completed, and continue to monitor if possible.
VIOLATION: WRITTEN MEDICAL ODERS FOR DRUGS Tag No: A0406
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Review of clincal records and interviews with facility personnel for one of nine sampled patients, (Patient #41), the facility failed to ensure that a physician's order was obtained before medication adminstration. The findings include:


Patient #41 was admitted on [DATE] for a cholecystectomy. Review of the the PACU record dated 9/21/11 identified that the patient received Dilaudid 0.5 mg IV at 11:40 am, 11:55 am, 12:15 pm and 1:00 pm. Review of the physician orders dated 9/21/11 identified that, although the orders were for Morphine Sulfate 2-4 mg IVP every three minutes, titrate to a pain score of three or less, the patient had received Dilaudid without a physician's order. Review of hospital policy identified that a physician's order is required prior to medication adminstration. Interview with the OR Nurse Manager on 9/22/11 identified that the nurse did not obtain a physician's order for Dilaudid prior to medication administration.