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.

FRYE REGIONAL MEDICAL CENTER 420 N CENTER ST HICKORY, NC 28601 Sept. 6, 2018
VIOLATION: APPROPRIATE TRANSFER Tag No: A2409
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on EMTALA policy review, Medical Staff Bylaws review, Medical Record reviews, and Physician and Staff interviews the hospital failed to ensure patients with an emergency medical condition were appropriately transferred by failing to ensure all required elements were completed prior to transfer for 2 of 7 sampled transfer patients (#5, #26)

The findings include:

Review of the "EMTALA-Medical Screening and Treatment of Emergency Medical Conditions" policy, last revised 08/2017, revealed "...If an Emergency Medical Condition is found to exist, the Hospital will...(b) an appropriate transfer to another medical facility...Appropriate transfer occurs (once a physician has certified the need for transfer or the patient has requested transfer after an explanation of the risks and the Hospital's obligation to provide stabilizing services) when: 1. the transferring Hospital provides medical treatment within its capacity that minimizes the risks to the individual's health and in the case of a woman in labor, the health of the unborn child; 2. the receiving facility has available space and qualified personnel for the treatment of the individual and has agreed to accept transfer of the individual and to provide appropriate medical treatment; 3. the transferring Hospital sends to the receiving Hospital all medical records...related to the Emergency Medical Condition for which the individual has presented...4. the transfer is effected through qualified personnel, transportation and equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer..."

1. L&D record review, on 09/04-05/2018, of Patient #5 revealed the Patient arrived to the hospital at 0800 "...for triage and observation for PPROM (Preterm Premature Rupture of Membranes)....Amnisure (test for ruptured membranes) positive. ..." Review of current symptoms noted "pelvic pressure" but no contractions were noted. The record stated MD #1 was in the room at 0814. Review of a Physician Progress Note, timed at 0825, revealed "...G (Gravida) 5 - just moved to (City name) 2 months ago....EDD (Estimated Delivery Date) 10/31 - 28 wks (weeks) by previous care in (State name) until 2 months ago. No care since moving....SROM (spontaneous rupture of membranes) clear this AM....no pain. Large amount clear fluid....No UC (uterine contractions) on monitor. ..." The Progress Note stated a vaginal exam was done and the patient was 2 cm dilated, 80% effaced, breech presentation, and minus 2 (-2) station. Review of Physician Orders revealed an order, at 0825, to transfer Patient #5 to Hospital C.

Review of a form titled "REQUEST FOR TRANSFER/CONSENT TO TRANSFER/ CERTIFICATION FOR TRANSFER", dated 08/09/2018 at 0822, revealed a diagnosis of PROM (Premature Rupture of Membranes). The reason for transfer was handwritten as "Level 3 NICU". In regards to "Patient Condition upon Transfer", the form review revealed a checkmark beside the statement "...Stable: No material deterioration of the patient's medical condition, within reasonable medical probability, is likely to result from or occur during transfer. ..." Form review revealed sections for risks and benefits of transfer. In regards to "Risks of Transfer" an x mark was placed in the box beside "Risks related to condition" with "Premature Delivery" handwritten in. Form review did not reveal the name of the receiving facility, but did include the name of the accepting physician and the name of the facility staff member who confirmed available space and qualified personnel. Transfer form review did not reveal notation of which hospital documents were sent with Patient #5 during transfer. Further form review revealed the Physician's Certification for Transfer stated "I confirm the patient's condition and the benefits\risks of transfer as stated above. Based on the information available at this time, I have determined the medical benefits....outweigh the increased risks to this patient and, in the case of labor, to the unborn child." Review showed that MD #1 signed the certification on 08/09/2018 at 0835. Review of a form titled "HOSPITAL-HOSPITAL TRANSFER", dated 08/09/2018 and also signed by MD #1 at 0835 revealed lab results and progress notes were attached at transfer and the destination for transport was Hospital C. Review revealed the word "good" was circled as the condition at time of transfer. The form, per review, was signed by a RN (no time documented). Further review did not reveal a signature of the "Responsible Party receiving Medical Record for Transfer". Review of the Discharge Summary, dictated 08/11/2018 at 0345, revealed "...HOSPITAL COURSE: The patient is a 32-year-old, gravida 5....She has had no OB here in (City Name) and has moved here....two months ago. At her previous OB.... 28 weeks 1 day by that EDD (Estimated Delivery Date). She presented to Labor and Delivery at 8 a.m., with spontaneous rupture of membranes with clear fluid but with no pain.... On the monitor, we had uterine contractions (different from Progress Note which stated no contractions) with fetal heart tones reactive at 140s to 150s. On exam, cervix is 2 cm, 80% (effaced), breech, -3.... FINAL IMPRESSION: This 28 weeks with spontaneous rupture of membranes. I discussed with MFM (Maternal Fetal Medicine) at (Hospital C)....with Dr. (Name), who agrees to accept the patient in transfer.... EMS will be called to transfer and the patient will be transferred via EMS. ..." L&D Record review revealed Patient #5 was transported off the unit via EMS at 0948 (1 hour 13 minutes after MD signed the certification).

Review of the Medical Record from Hospital B revealed Medical Record review from Hospital B, on 09/04/2018, revealed Patient #5 was transferred by ambulance from Hospital A. Review of the EMS record, dated 08/09/2018, revealed "...Team: ALS....Crew 1: Primary Caregiver (Name) EMT-P...Crew 2: Driver (Name) EMT-P. ..." Review revealed "...Pt. Condition: Worse. ..." and listed the receiving hospital as Hospital B. EMS record review revealed EMS left Hospital A at 0952 and arrived at Hospital B at 1011. Review of EMS Notes stated "Pt had come into the ER around 8 am with complications of her pregnancy.... Pt was stable no complaints at time of arrival, due to high risk Paramedic (Name) consulted .... about this transport and we were advised if pt stable and we were comfortable with pt to transport....Once we started transport pt was advised if she became uncomfortable or started having any contractions to let us know. Pt again was pain free....We had gotten to (city name) and pt stated she was hurting and felt like the baby was going to deliver ....we diverted to (Hospital B) due to distance to (City of Hospital C). ..."

Review of Hospital B Notes, on 08/09/2018 at 1025, revealed " ...pt in via (ambulance) pt being transported from (Hospital A) to (Hospital C), pt told EMS feelings. EMS routed to (Hospital B). pt taken to ER room. ..." At 1035 documentation of the cervical exam stated the cervix was dilated to 4 centimeters, was 80% effaced), and fetal station was -2 (minus 2). Review of the History and Physical (H&P) revealed "...She was being transferred to (Hospital C)....but in route she started having vag pressure so the transfer was diverted to (Hospital B). I was call (sic) to come to the ED to evaluate the pt upon arrival.....SVE 4/80/-2 /most likely vertex (head presentation)....Magnesium sulfate 2 gm/hr was infusing. This continued....Decision was made to continue with routine antepartum care. ..." On 08/20/2018 at 0502, record review revealed "...At 4am awakened ....complaining of contractions... ." Review of the "Delivery Record" revealed Patient #5 delivered on 08/20/2018 (11 days after arrival to and transfer from Hospital A).

Telephone interview, on 09/05/2018 at 1300, with MD #1 revealed Patient #5 came to L&D because of preterm premature rupture of membranes. MD #1 stated he examined the patient, and she was 2 centimeters dilated. Interview revealed it was unusual for a patient to be 2 cm at that point, "it could make you wonder about labor", but MD #1 stated she had no contractions. Interview revealed the Discharge Summary note which stated uterine contractions were noted was not accurate, it was a "misnote". Interview revealed Patient #5 was not reexamined prior to transfer. MD #1 stated he examined the patient and then did the transfer paperwork required. Interview revealed MD #1 did not see Patient #5 after the examination at 0835 and left the department around 0900. Interview revealed MD #1 thought Patient #5 was safe to be transferred by EMS and thought she would be leaving shortly after he left the department. In relation to explaining the risks and benefits of transfer, interview revealed MD #1 wrote preterm delivery because the patient had a greater risk of preterm delivery in general. Preterm delivery was not discussed with the patient as a risk of transfer. MD #1 stated if he thought she was in labor he would not have put her in the ambulance. MD #1 further stated he did not specifically discuss any risks of transfer with Patient #5, he told her it would be safer to be in a hospital with a NICU. Interview revealed MD #1 discussed benefits of transfer, but not risks associated with transfer.

Interview with RN #2, on 09/05/2018 at 1335, revealed she was the Charge Nurse on 08/09/2018 and completed the EMS form. Interview revealed she could not specifically recall, but most likely called EMS. RN #2 stated the Hospital - Hospital Transfer form was filled out by nursing and RN #2 probably was the one who circled the patient was in good condition, which would have been based on what the doctor stated. Interview revealed RN #2 could not recall what records were sent during transfer and stated they should have gotten EMS to sign the form stating that records were received.

2. Medical record review for Patient #26, revealed the [AGE] year old pregnant patient arrived to the hospital L&D unit on 02/19/2018 at 1122 " ...for observation & transfer due to PPROM ....states she noticed she was leaking clear fluid around 0900 that would not stop, this was confirmed by Dr. (Name of MD #4) in the office that she was PPROM & was sent to L&D. Denies any uc's (uterine contractions) or abd. (abdominal) tightening ....States good FM (fetal movement). ..." The record stated Patient #26 was a gravida 4, para 4 and the gestational age of the fetus was listed as 29 weeks.

Review of form titled "REQUEST FOR TRANSFER/CONSENT TO TRANSFER/CERTIFICATION FOR TRANSFER", dated 02/19/2018 at 1430, revealed the patient's diagnosis was "PPROM" and the transfer was because of the "Need for level 3 NICU". The form stated "Patient Condition upon Transfer...Stable. ..." In the "Acknowledgment & Name of Receiving Facility" section "Staff Person Name" was stated, with an underlined area to be completed and under the line was a statement "Receiving facility staff person confirming available space and qualified personnel for treatment". Handwritten above the line was "(Hospital C name) Maternal-Fetal", with the time contacted noted as 1100. Review did not reveal the name of a specific staff person who confirmed the receiving facility had available space and qualified personnel. Form review also revealed a statement "Accepting Physician Name" and on that line was handwritten "(Hospital C name) Labor & Delivery" and the accepting time 1100. Form review did not indicate the name of a specific physician who accepted Patient #26. Further review of the Request for Transfer form revealed the "Physician or Qualified Medical Person's Certification for Transfer" was signed by MD #5 on 02/19/2018 at 1250 (1 hour, 40 minutes prior to Patient #26's transfer out of Hospital A). Review of the "HOSPITAL-HOSPITAL TRANSFER" form noted MD #5's signature and the time 1250. Further review revealed a RN signature timed at 1427 (1 hour 37 minutes after MD #5 signed). Record review failed to reveal any Progress Notes or Discharge Notes from MD #4 or MD #5 while Patient #26 was in Hospital A. Review revealed the only physician documentation noted while in L&D were the signatures of MD #5 on the "REQUEST FOR TRANSFER/CONSENT TO TRANSFER/CERTIFICATION FOR TRANSFER" form, the "HOSPITAL-HOSPITAL TRANSFER" form, and the EMS form. .

Interview with MD #4, on 09/06/2018 at 1505, revealed MD #4 saw Patient #26 in the office on the morning of 02/19/2018. Interview revealed the patient was 1 cm dilated and was leaking amniotic fluid. Interview revealed Patient #26 was not having contractions. MD #4 stated she sent Patient #26 to the hospital to prepare for transfer to a "Level 4 for maternal fetal medicine care". Interview revealed Patient #26 had an emergency medical condition. MD #4 stated she was "stable" but needed transfer and a steroid and antibiotics prior to transfer. Further interview revealed MD #4 did not see Patient #26 in the hospital, that a partner (MD #5) was already at the hospital. Interview revealed "I think she saw her (Patient #26)". MD #4 indicated they had talked about possibly sending Patient #26 directly from the office to Hospital C but they wanted meds and labs and a physician to physician transfer. Interview revealed MD #4 contacted Hospital C, but did not record the name of the doctor who accepted the patient, and did not realize that was necessary.

Telephone interview, on 09/14/2018 at 1225, with MD #5 revealed MD #5 was on the unit and the nurses stated MD #4 had seen a patient in the office and would be coming over to the hospital to do the paperwork. MD #5 stated she told nursing that was not necessary, she would do the paperwork. Interview revealed MD #5 filled out the transfer forms. MD #5 stated she did not examine the patient and did not write any notes. MD #5 stated MD #4 had assessed the patient in the office and determined she had ruptured membranes. Then, the patient came to L&D, the nurse monitored her, she had no contractions, the fetal heart tones and vital signs were stable, so that was a medical assessment. Interview revealed MD #5 based the certification that Patient #26 was stable on MD #4's assessment in the office and the nurse assessment at the hospital. Interview revealed MD #5 signed the form at 1250, left the unit and had no involvement after that. MD #5 stated she felt sure she walked in and spoke with Patient #26 but did not examine or evaluate her. Interview revealed if MD #4 had not seen the patient in the office or if anything on the monitor strip was concerning, then MD #5 would have seen her. Further interview revealed it was the only time this type of situation had happened, MD #4 was coming to sign the paperwork, MD #5 was already there and said that was not needed, MD #5 would sign it and did.

NC 012
VIOLATION: COMPLIANCE WITH 489.24 Tag No: A2400
Based on EMTALA policy review, Medical Staff Bylaws, Labor and Delivery medical record reviews, and physician and staff interviews; the hospital failed to comply with 42 CFR 489.20 and 489.24.

Findings include:

The hospital's medical staff failed to provide an appropriate ongoing medical screening examination to an individual who presented with preterm premature rupture of membranes for 1 of 8 sampled patients presenting to the hospital's Labor and Delivery (L&D) department for evaluation and treatment. (Pt #26)

~ Cross refer to 489.24(a) and (c) Medical Screening Exam, Tag A2406.

The hospital failed to to ensure patients with an emergency medical condition were appropriately transferred by failing to ensure all required elements were completed prior to transfer for 2 of 7 sampled transfer patients (#5, #26)

~ Cross refer to 489.24(e) Transfer - Tag A2409
VIOLATION: MEDICAL SCREENING EXAM Tag No: A2406
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on EMTALA policy review, Medical Staff Bylaws review, medical record reviews, and physician and staff interviews the hospital medical staff failed to provide an appropriate ongoing medical screening examination to an individual who presented to the hospital's Labor and Delivery (L&D) department with preterm premature rupture of membranes (PPROM) for 1 of 8 sampled patients who presented to the hospital's L&D department for evaluation and treatment. (Pt #26)

The findings include:

Review of a policy titled "EMTALA-Medical Screening and Treatment of Emergency Medical Conditions", last revised 08/2017, revealed "Any individual who comes to the Hospital Property or Premises requesting examination or treatment is entitled to and shall be provided an appropriate Medical Screening Examination performed by a physician or other Qualified Medical Personnel to determine whether or not an Emergency Medical Condition exist...ii. Medical Screening Examination is the process required to reach with reasonable clinical confidence, the point at which it can be determined whether or not an Emergency Medical Condition exists or a woman is in labor. Such screening must be done within the facility's capability and available personnel, including on-call physicians. The Medical Screening Examination must be performed by a Physician or other Qualified Medical Personnel. The Medical Screening Examination is an ongoing process and the medical records must reflect continued monitoring based on the patient's needs and must continue until the patient is either stabilized or appropriately transferred....3....A Medical Screening Examination is not an isolated event. It is an on-going process. The record must reflect continued monitoring according to the patient's needs and must continue until he/she is stabilized or appropriately transferred. There should be evidence of this evaluation documented in the medical record prior to discharge or transfer..."

Review of the "Medical Staff Bylaws", last reviewed 07/2018, revealed "...5.3....Patients at term (defined as 37 or more weeks gestation), determined to be complaining of labor onset and not suffering from any apparent complications, will be transported to the Labor and Delivery Unit with qualified medical personnel...For patients at term and without other complications, the medical screening examination required....may be performed by a qualified RN under the orders of and in telephone contact with the obstetrical physician where permitted under state law...5.4 PATIENTS PRESENTING TO LABOR AND DELIVERY UNIT Any patient admitted directly to the Labor and Delivery Unit for onset of labor by order of her treating physician or otherwise shall undergo the screening described in Section 5.2, above...6.1 (a) Screening... (3) All patient shall be examined by qualified medical personnel, which shall be defined as a physician, or in the case of a woman in labor, a registered nurse trained in obstetric nursing, where permitted under state law and Hospital policy, who may determine true, false or no labor but may not make a medical diagnosis..."

Labor and Delivery (L&D) Medical Record review, on 09/06/2018, revealed Patient #26 presented to the L&D unit after seeing her obstetrician in the office. Review of Patient #26's Obstetrician's office notes revealed " ...Appt. Date/Time 02/19/2018 10:10AM" and a chief complaint (CC) of "ob check". Review revealed a Prenatal Flowsheet and noted the patient was 29 weeks, with ".... PPROM (Preterm Premature Rupture of the Membranes-Amniotic membrane surrounding the baby breaks (ruptures) before 37 weeks of pregnancy). See a/p (assessment/plan). ..." Review of these notes revealed " ...HPI : [AGE] year old G4P2104 ....who present (sic) today.... for leakage of fluid. She states it started this morning. She was lying in bed when she felt a large gush of fluid. She has continued to leak clear fluid since it happened. She denies contractions, cramping and vaginal bleeding + (positive) fetal movement. ..." Form review revealed a Review of Systems and a Physical Exam were completed in the office. Review of the Physical Exam revealed " ...Pelvic: ....on speculum exam + pooling in vagina + leakage ....visually 1 cm dilated, + nitrazene, + ferning (tests for rupture of membranes). Sterile vaginal exam: deferred. ..." Further review of Women's Services Notes revealed an Assessment/ Plan that stated " ...1. PPROM ....Will refer/send to (Hospital C) MFM .... First to (Hospital A) for: 1. NST (Non stress test) 2. Begin antibiotics ....3. Begin betamethasone (In-Utero steroid-medication used to treat pre-term labor)....4. Begin magnesium )Magnesium Sulfate medication used to treat Pre-term labor) ....5. Order CMP/CBC (blood tests) ....7. OB US (ultrasound). ..."

Review of Patient #26's Labor and Delivery record noted a Telephone Order from MD #4 on 02/19/2018 at 1100 to "Triage & observe for PPROM ... ." (prior to Patient #26's arrival to L&D). Review of the "LABOR AND DELIVERY OBSERVATION RECORD" revealed the [AGE] year old patient arrived to the hospital 02/19/2018 at 1122 " ...for observation & transfer due to PPROM ....states she noticed she was leaking clear fluid around 0900 that would not stop, this was confirmed by Dr. (Name of MD #4) in the office that she was PPROM & was sent to L&D. Denies any uc's (uterine contractions) or abd. (abdominal) tightening ....States good FM (fetal movement). ..." The record stated Patient #26 was a gravida 4, para 4, with 4 living children. An estimated due date was documented as 05/19/2018 with a gestational age of 29 weeks. Per the record, an electronic fetal monitor was applied in L&D and fetal heart baseline ranged from 125-130. No contractions were noted. At 1135, documentation noted an IV was inserted and labs were drawn and at 1135 an indwelling urinary catheter was inserted. An Amnisure test (checks for ruptured membranes) was noted as done with a result of negative. The L&D Observation Record noted at 1224 that the fetal monitor was off for a bedside ultrasound, and noted Betamethasone was given as ordered at 1300, followed by Ampicillin (antibiotic) and Magnesium Sulfate. At 1355, documentation noted a category one tracing on the fetal monitor, and at 1357 Erythromycin was administered as ordered. Fetal heart baseline at 1415 was noted as 130. At 1430 contractions were documented as 0 and vital signs were documented as Temperature 98.2, Pulse 83, Respirations 16, BP 105/70. Per record review, the bolus of Magnesium Sulfate was completed and a bag of IV fluid with Magnesium Sulfate was hung at 1430, after which report was given to EMS and Patient #26 was transferred to Hospital C.

Review of form titled "REQUEST FOR TRANSFER/CONSENT TO TRANSFER/CERTIFICATION FOR TRANSFER", dated 02/19/2018 at 1430. Review revealed documentation that the patient's diagnosis was "PPROM" and the transfer was because of the "Need for level 3 NICU". The form stated "Patient Condition upon Transfer ...Stable. ..." Further review of the form revealed the "Physician or Qualified Medical Person's Certification for Transfer" was signed by MD #5 on 02/19/2018 at 1250 (1 hour, 40 minutes prior to Patient #26's transfer out of Hospital A). Review of the "HOSPITAL-HOSPITAL TRANSFER" form noted MD #5's signature and the time 1250. Further review revealed a RN signature timed at 1427.

Review of a form called "(Hospital Name) (County Name) EMERGENCY MEDICAL SERVICE CERTIFICATION OF MEDICAL NECESSITY FOR AMBULANCE TRANSPORTATION" revealed, at the top of the form, "(County Name) EMS Physician Certification Statement for Non-Emergency Ambulance Services". Form review revealed three (3) sections, the first of which was labeled "SECTION I - GENERAL INFORMATION". This section noted Patient #26's name and date of birth, and stated a transport date of 02/19/2018. On page 2 of the form was "SECTION III - SIGNATURE OF PHYSICIAN ..." which showed MD #5's signature, with the date signed noted as 02/19/2018.

Record review failed to reveal any Progress Notes or Discharge Notes and did not reveal any physician documentation of a Medical Screening Exam while in the Labor and Delivery Department on 02/19/2018. Review revealed the only physician documentation was a medical examination done in the physician's office prior to sending Patient #26 to the L&D unit for care, ongoing evaluation, and transfer. Review revealed the only physician documentation while Patient #26 was in Hospital A were the signatures of MD #5 on the "REQUEST FOR TRANSFER/CONSENT TO TRANSFER/CERTIFICATION FOR TRANSFER" form, the "HOSPITAL-HOSPITAL TRANSFER" form, and the EMS form.

Interview with MD #4, on 09/06/2018 at 1505, revealed MD #4 saw Patient #26 in the office on the morning of 02/19/2018. Interview revealed the patient was 1 cm dilated and had positive nitrazine and ferning, and it was determined Patient #26 was leaking amniotic fluid. Interview revealed MD #4 sent Patient #26 to the hospital for a non-stress test, to prepare for transfer to a "Level 4 for maternal fetal medicine care", and to receive medications including Betamethasone and antibiotics. Interview revealed Patient #26 was found in the office to have emergency medical condition. MD #4 stated the patient was "stable" but needed transfer and a steroid and antibiotics prior to transfer. Interview revealed MD #4 did not see Patient #26 in the hospital, and stated she thought the H&P in the office was a part of the hospital record and all that was needed. MD #4 noted that a partner (MD #5) was already at the hospital and stated "I think she saw her (Patient #26)". MD #4 stated MD #5 may have felt it was duplicate work and indicated they had talked about possibly sending the patient directly from the office but they wanted meds and labs and a physician to physician transfer.

Telephone interview, on 09/14/2018 at 1225, with MD #5 revealed she was in L&D and learned from nursing that MD #4 had seen a patient in the office and would be coming over to do transfer paperwork. Interview revealed MD #5 told nursing that was not necessary, she would do the paperwork. MD #5 stated she did the transfer paperwork, but did not examine the patient and did not write any notes. MD #5 stated she did not do a Medical Screening Examination on Patient #26. MD #5 stated MD #4 had assessed the patient in the office and determined she had ruptured membranes. Then, the patient came to L&D, the nurse put her on the monitors, she had no contractions, the fetal heart tones and vital signs were stable, that was a medical assessment. Interview revealed MD #5 based her certification that Patient #26 was stable on MD #4's office examination and the nurse assessment at the hospital. MD #5 stated "I'm sure I walked in and spoke with her (Patient #26)" and further stated if MD #4 had not seen the patient in the office or if anything on the monitor strip was concerning, then MD #5 would have examined Patient #26. Further interview revealed MD #5 signed the Transfer forms and then left the unit. Interview revealed MD #5 was literally passing through the unit and was helping MD #4 out so she did not have to come to the hospital. Interview revealed this was the only time in her career that this situation had happened. In this case, MD #5 stated, MD #4 had seen the patient in the office, was coming to sign the paperwork, MD #5 was already at the hospital and said she would sign it and she did.