HospitalInspections.org

1. Based on medical record review, policy review and staff interview, it was determined that the governing body failed to ensure a PKU (Phenylketonuria-newborn screening test performed on newborns after 24 hours of life to detect genetic abnormalities) blood sample was collected in accordance with facility ' s policy in one (1) of 19 patient records. Patient #2.


The findings included:


The United Medical Center Administrative Policy, "Admission and Continuing Care of the Low Risk Newborn Policy (MBU-003), entitled, "Admission Newborn Care", last reviewed June 2016, stipulates, " PURPOSE: To establish guidelines for the admission and care of the low-risk term and near-term infant to the mother/baby unit. ... 7. Prior to discharge, all infants will receive PKU- this must be obtained after 24 hours of life, 8. Discharge documentation includes the following: Verification of the PKU, Logbook for pending laboratory results if applicable ..."


The PerkinElmer "Letter Contract for Metabolic screening/testing for newborns" agreement with the United Medical Center, originally dated November 4, 2010 (revolving contractual agreement) stipulates: ... "I. Provide Hospital with secure internet access to results that will enable Hospital to download and print results ...II. During the term of this letter contract, Hospital shall: A. for Newborn Screening Services, collect specimens utilizing Filter Papers from newborns between twenty-four (24) and forty-eight (48) hours of age ... E. for Newborn Screening Services ship Filter Papers to PerkinElmer Genetics overnight via UPS (United Parcel Services) or another overnight courier designated by PerkinElmer Genetics no later than twenty-four (24) hours after specimen collection ..."


Patient #2 was born on February 10, 2017 at 22:40 (10:40 PM). The PKU was collected on February 11, 2017, at 10:21 AM. Date received at PerkinElmer Lab: February 14, 2017.


Patient 2 ' s specimen was collected less than 24 hours as per hospital policy and contractual agreement and the specimen was received at the outside lab on February 14, 2017, (three (3) days subsequent to obtaining specimen). Additionally, there was no indication on the PerkinElmer lab slip indicating who collected the PKU sample.


A face-to-face interview was conducted with Employees #9 and #14 on September 11, 2017, at approximately 1:00 PM. When queried on the process for blood sample collection of PKU ' s on the neonate, he/she responded; "The nursery nurses draw the PKU. The lab only draws the blood if they are called to do it." Employee #14 further stated that the nurse, who collects the blood sample, put their initials in the "drawn by" space on the lab form.
Both employees acknowledged the aforementioned findings.



2. Based on medical record review, policy review and staff interview, it was determined that the governing body failed to establish a monitoring mechanism to ensure that all PKU ' s (Phenylketonuria-newborn screening test performed on newborns after 24 hours of life to detect genetic abnormalities)were tracked after initial sample collection in eight (8) of 19 patient records. Patients #2, 4, 6, 13, 14, 15, 16, and 17.


The findings included:


The United Medical Center Administrative Policy, "Admission and Continuing Care of the Low Risk Newborn Policy (MBU-003), entitled, "Admission Newborn Care", last reviewed June 2016, stipulates, " PURPOSE: To establish guidelines for the admission and care of the low-risk term and near-term infant to the mother/baby unit. ... 7. Prior to discharge, all infants will receive PKU- this must be obtained after 24 hours of life, 8. Discharge documentation includes the following: Verification of the PKU, Logbook for pending laboratory results if applicable ..."

The PerkinElmer "Letter Contract for Metabolic screening/testing for newborns" agreement with the United Medical Center, originally dated November 4, 2010 (revolving contractual agreement) stipulates: ... "I. Provide Hospital with secure internet access to results that will enable Hospital to download and print results ...II. During the term of this letter contract, Hospital shall: A. for Newborn Screening Services, collect specimens utilizing Filter Papers from newborns between twenty-four (24) and forty-eight (48) hours of age ... E. for Newborn Screening Services ship Filter Papers to PerkinElmer Genetics overnight via UPS (United Parcel Services) or another overnight courier designated by PerkinElmer Genetics no later than twenty-four (24) hours after specimen collection ..."


Patient #2- Date of Birth -February 10, 2017 at 22:40 (10:40 PM); PKU collected on February 11, 2017 at 10:21 AM. Date received at PerkinElmer Lab: February 14, 2017.


Patient 2 ' s specimen was collected less than 24 hours as per hospital policy and contractual agreement and the specimen was received at the outside lab on February 14, 2017, (three (3) days subsequent to obtaining specimen). Additionally, there was no indication on the PerkinElmer lab slip indicating who collected the PKU sample.


Patient #4- Date of Birth- November 18, 2016 at 15:41 (3:41 PM); PKU collected on November 19, 2016 at 19:50 (7:50 PM). Date received at PerkinElmer Lab: November 22, 2016. Patient 4 ' s specimen was received at the outside lab three (3) days subsequent after obtaining the specimen.


Patient #6- Date of birth- April 12, 2017 at 21:32 (9:32 PM); PKU collected on April 13, 2017 at 21:40 (9:40) PM. Date received at PerkinElmer Lab: April 17, 2017. Patient #6 ' s specimen was received at the outside lab four (4) days subsequent to obtaining the specimen.


Patient #13- Date of birth- February 7, 2017 at 18:29 (6:29 PM); PKU collected on February 8, 2017 at 22:35 (10:35PM). Date received at PerkinElmer Lab: February 10, 2017. Patient #13 ' s specimen was received at the outside lab two (2) days subsequent to obtaining the specimen.


Patient #14- Date of birth- February 8, 2017 at 07:20 (7:20 AM); PKU collected on February 9, 2017 at 23:55 (11:55 PM). Date received at PerkinElmer Lab: February 14, 2017. Patient #14 ' s specimen was received at the outside lab five (5) days subsequent to obtaining the specimen.


Patient #15 - Date of birth- February 8, 2017 at 10:16 (10:16 AM); PKU collected on February 10, 2017 at 00:20 (12:20 AM). Date received at PerkinElmer Lab: February 14, 2017. Patient #15 ' s specimen was received at the outside lab four (4) days subsequent to obtaining the specimen.


Patient #16- Date of birth- February 8, 2017 at 12:17 (12:17 PM); PKU collected on February 10, 2017 at 01:55 (1:55 AM). Date received at PerkinElmer Lab: February 14, 2017. Patient #16 ' s specimen was received at the outside lab four (4) days subsequent to obtaining the specimen.


Patient #17 - Date of birth- February 11, 2017 at 01:05 (1:05 AM); PKU collected on February 12, 2017 at 02:05 (2:05 AM). Date received at PerkinElmer Lab: February 14, 2017. Patient #17 ' s specimen was received at the outside lab two (2) days subsequent to obtaining the specimen.

A face-to-face interview was conducted with Employee #9 on September 11, 2017, at approximately 1:00 PM. When queried on the process for blood sample collection of PKU ' s on the neonate, Employee #9 responded; "The nursery nurses draw the PKU. The lab only draws the blood if they are called to do it."

According to the instructions located on the back of the filter paper form reveals, "Sending to the Screening Laboratory- Place the filter paper in the return envelope, and send it to the laboratory as soon as possible to ensure accurate and timely processing. If you are unable to send the specimen immediately, place it in a plastic bag and store it in a freezer (preferable) or a refrigerator ...."

There was no documented evidence that a tracking log was implemented to indicate when UPS picked up blood sample(s) for delivery to the outside lab located in Pennsylvania.

There were no policies and procedures in place for a process used in tracking PKU ' s pickups from the facility.

There was no evidence that the blood samples were stored in a freezer/or a refrigerator as indicated on the filter paper form instructions.

A face-to-face interview was conducted with Employee #4 on September 11, 2017, at approximately 1:30 PM regarding the process for collecting PKU blood samples from the neonate. Employee #4 responded, "The nurses draw the blood after 24 to 48 hours of life. The blood sample is collected on the PerkinElmer lab slip. The specimen collection sample is packaged in a UPS express envelope and placed in a designated bin for UPS pickup. The bin is located in material management..."

Also, through an interview, Employee#4 stated that the providers do not have secure internet access to download and print the results from the outside contracted lab
.
All the aforementioned findings were acknowledged by Employees # 3, #4, and #9.



3. Based on medical record review, and staff interview, it was determined that the physician failed to address and document the risks and benefits of a vaginal delivery in the comprehensive assessment for one (1) of 19 patients records, who was identified as "High -Risk- HIV (Human Immunodeficiency Virus ) Positive." Patient #3.

The findings included:


The physician's history and physical dated November 18, 2016, at 0554 (5:54 AM) revealed; "40-year-old pregnant female with no prenatal care for - [six] 6 months and HIV"+", presents with contractions. EDC (Estimated Date of Confinement) 11/30 (November 30), EGA (Estimated Gestational Age) -38 weeks. The patient admits to having a prior child vaginally while on current antiretroviral medication. Refuses cesarean delivery."


A physician's note dated November 18, 2016, at 0632 (06:32 AM) revealed; " .... [Employee #7] repeated the obstetric strategy to minimize exposure to her baby by performing a cesarean delivery. She is now willing to proceed with cesarean if her viral load is >400 copies/ml. Will obtain a viral load along with admission labs."


The viral load blood sample was drawn on November 18, 2016, at 9:00 AM; however, the test had to be sent to an outside laboratory. The results were returned on November 20, 2016, at 9:04 AM

.
According to an "LD (Labor and Delivery) Post Procedure Progress Note" dated November 18, 2016, at 17:06 (5:06 PM), the method of delivery was an NSVD (Normal Spontaneous Vaginal Delivery). The Pre-op indication/diagnosis was "Term IUP (intrauterine pregnancy)/HIV Positive; Complications: None, Disposition: Regular Care."


The medical record lacked evidence of any subsequent notes after a physician's note dated November 18, 2016, at 6:32 AM; to reflect that a discussion was held with Patient #3 regarding the risks and benefits of having a vaginal versus C-section delivery to decrease HIV exposure to the newborn.


Additionally, there was no documentation regarding the turnaround results of the viral load. There was no indication that an infectious disease consult was requested.


A telephone interview was conducted with Employee #7 on September 6, 2017, at approximately 4:20 PM regarding the aforementioned findings. Stated the patient had initially agreed to the C-section; and he had the C-section team in place. Employee #7 stated he wanted to perform the C-section before going off duty. Further stated, that he knew the viral load would not be readily available before delivery of the baby. When queried, if "an infectious disease consult was requested to assist with informing the patient of the risks and benefits of having a vaginal delivery versus a C-section?" He stated, no, because the patient was not previously seen by infectious disease.

A face-to-face interview was conducted with Employee #8 on September 7, 2017, at approximately 10:30 AM. Stated, an infectious disease consult was requested; however, it was a verbal order. Further, stated she did not include in her comprehensive assessment the discussion regarding the risks of having the delivery vaginal versus the C-section and the viral load results were not readily accessible.


4. Based on medical record review, policy review and staff interview, it was determined that the governing body failed to ensure that the nursing staff adhered to the hospital's documentation policy as evidenced by inconsistent documentation on obstestrical patient care flow sheets for (1) of 19 patient records. Patient #1.

The findings included:

According to the DC Fire & EMS (Emergency Medical Services), Patient #1 arrived on the Labor and Delivery unit on February 10, 2017, at 19:57 (7:57 PM) for obstetrical services
.
A review of the medical record revealed; "The Pre-operative routine checklist was dated February 9, 2017; however, the "Pre-operative Record" is dated February 8, 2017, at 2300 (11:00 PM). The "Delivery Room Count Sheet Cesarean Section" was dated February 9, 2017 [no time recorded]. The [Circulator Nurse, RN], signed all forms.

The "Labor and Delivery Summary" sheet was dated February 9, 2017, at 01:00 (1:00 AM) revealed "Delivery of Infant, month- 2, day-9 at 22:40 (10:40 PM)" and signed by the [Circulator Nurse, RN].

According to the physician's "Operative Note "dated 2/10/2017 at 2330 (11:30 PM)" revealed: "Date of Procedure: 2/10/2017; Postoperative Diagnosis: Term pregnancy ..., Operation: Repeat low transverse cesarean section ...."

The medical record lacked consistent dates for the obstetrical services for Patient #1.

The nursing staff failed to accurately and consistently document dates on the pre-operative record(s) and the labor and delivery summary.

A face-to-face interview was conducted on September 11, 2017, at approximately 2:00 PM with Employees #3, 4, and 20 regarding the aforementioned findings. All acknowledged the findings.

Based on medical record review and staff interview for one (1) of 19 patient records, it was determined that the physician failed to consult and act with timeliness, in notifying the infectious disease physician as it related to the management of a high-risk obstetrical patient. Patient #3.

The finding included:

According to the physician's history and physical dated November 18, 2016, at 0554 (5:54 AM) revealed; "40-year-old pregnant female with no prenatal care for - [six] 6 months and HIV"+", presents with contractions. EDC (Estimated Date of Conception) 11/30, EGA (Estimated Gestational Age) -38 weeks. The patient admits to having a prior child vaginally while on current antiretroviral medication. Refuses cesarean delivery."

A physician's note dated November 18, 2016, at 0632 (06:32 AM) revealed; " .... [Employee #7] repeated the obstetric strategy to minimize exposure to her baby by performing a cesarean delivery. She is now willing to proceed with cesarean if her viral load is >400 copies/ml. Will obtain a viral load along with admission labs."

The viral load blood sample was collected on November 18, 2016, at 9:00 am; however, the test had to be sent to an outside laboratory. The results were returned on November 20, 2016, at 9:04 AM

According to Employee #8's "LD (Labor and Delivery) Post Procedure Progress Note" dated November 18, 2016, at 17:06 (5:06 PM), the method of delivery was an NSVD (Normal Spontaneous Vaginal Delivery). The Pre-op indication/diagnosis was "Term IUP (intrauterine pregnancy)/HIV Positive; Complications: None, Disposition: Regular Care."

The medical record lacked evidence of any documentation that an infectious disease consult was requested.

A telephone interview was conducted with Employee #7 on September 6, 2017, at approximately 4:20 PM regarding the aforementioned findings. He stated; that the patient had initially agreed to the C-section; and he had the C-section team in place. Employee #7 stated he wanted to perform the C-section before going off duty. Further stated, that he knew the viral load would not be readily available before delivery of the baby. When queried, if "an infectious disease consult was requested to assist with informing the patient of the risks and benefits of having a vaginal delivery versus a C-section?" He stated, no, because the patient was not previously seen by infectious disease.

A face-to-face interview was conducted with Employee #8 on September 7, 2017, at approximately 10:30 AM. Stated, an infectious disease consulted was requested; however, it was a verbal order.

Employee #7 and Employee #8 acknowledged the aforementioned findings.

Based on medical record review, policy review and staff interview, it was determined that the facility failed to ensure that the nursing staff adhered to the hospital's documentation policy as evidenced by inconsistent documentation of the date of delivery for a newborn in one (1) of 19 patients. Patient #1.


The findings included:


According to the DC Fire & EMS (Emergency Medical Services), Patient #1 arrived on the Labor and Delivery unit on February 10, 2017, at 19:57 (7:57 PM) for obstetrical services.


A review of the medical record revealed; "The Pre-operative routine checklist was dated February 9, 2017; however, the "Pre-operative Record" is dated February 8, 2017, at 2300 (11:00 PM). The "Delivery Room Count Sheet Cesarean Section" was dated February 9, 2017 [no time recorded]. Employee #15 [Nurse, RN], signed all forms.

The "Labor and Delivery Summary" sheet was dated February 9, 2017, at 01:00 (1:00 AM) revealed "Delivery of Infant, month- 2, day-9 at 22:40 (10:40 PM)" and signed by Employee #15 [Nurse, RN].


According to the physician's "Operative Note "dated 2/10/2017 at 2330 (11:30 PM)" revealed: "Date of Procedure: 2/10/2017; Postoperative Diagnosis: Term pregnancy ..., Operation: Repeat low transverse cesarean section ...."

The medical record lacked consistent dates for the obstetrical services for Patient #1.

The nursing staff failed to accurately and consistently document dates on the pre-operative record(s) and the labor and delivery summary.

A face-to-face interview was conducted on September 11, 2017, at approximately 2:00 PM with Employees #3, 4, and 20 regarding the aforementioned findings. All acknowledged the findings.

Based on medical record review and staff interview for one (1) of 19 patients, it was determined that the facility failed to obtain a nutritional consult in accordance with physician's orders. Patient #5.


The findings included:


Patient #5 was admitted on April 12, 2017, to the labor and delivery unit in active labor. A Babyboy was delivered via normal spontaneous vaginal delivery and was discharged home on April 14, 2017.


According to a physician's order dated April 13, 2017, at 02:25 (2:25 AM) directed; "Nutrition Consult."


A review of the medical record lacked evidence that Patient #5 had a nutritional consult as ordered by the physician
.

Employee#4 acknowledged the aforementioned findings on September 8, 2017, at approximately 2:00 PM.

Based on medical record review, policy review and staff interview for one (1) of 19 patients, it was determined that facility staff failed to ensure laboratory services were provided in a timely manner. Patient #3.

The findings included:

The United Medical Center Administrative Policy, Title #" GLP 0049, revised 7/12/13, stipulates; "Policy: .....All stat [immediately] in-house testing is reported within one (1) hour of receipt in the laboratory and may be reported in the same manner as routine tests .... Stat testing may consist of: BHCG qualitative and quantitative, Basic Metabolic Profile, Complete Blood Count, BO RH & Antibody Screen, Urinalysis, Spinal fluid glucose and Total protein, Spinal Fluid Cell Count, PT, APTT, Therapeutic Drug Levels, Urine Drug Screens, Troponin Levels, CK-MB Levels ... ..."



The physician's history and physical dated November 18, 2016, at 0554 (5:54 AM) revealed Patient #3 was a; "40-year-old pregnant female with no prenatal care for - [six] 6 months and HIV"+", presents with contractions. EDC (Estimated Date of Conception) 11/30, EGA (Estimated Gestational Age) -38 weeks. Patient admits to having a prior child vaginally while on current antiretroviral medication. Refuses cesarean delivery."


A physician's order dated November 18, 2016, at 05:44 (5:44 AM) directed; "HIV Antibody (lab) ..."



A review of the "Lab Specimen Log "sheet indicated that the blood specimen was collected at 07:30 AM on November 18, 2016, and was received in the lab at 7:46 AM. The "positive" result was called to the nurse at 9:12 AM on November 18, 2016. There was approximately a 3-hour delay in receiving the lab results from when the blood was actually collected from the patient.


The facility laboratory policy lacked evidence that a turnaround time for "STAT" orders is clearly defined. Additionally, HIV antibody labs or other blood collections for labor and delivery are not included in the list of "stat testing."


A face-to-face interview was conducted with Employees # 9, 10 and 20 on September 6, 2017, at approximately 2:00 PM regarding the aforementioned findings. Employee #9 stated that all labor and delivery blood work is "STAT". Further stated, all the "phlebotomist" know that all orders (blood collections) are to be "STAT." After reviewing the facility lab policy, he/she acknowledged that the turnaround time for stat was not clearly defined; and labor and delivery were not included in the list of "stat testing."

Based on the review of the Infection Control Log and staff interview, it was determined that the facility failed to show documentation when the State Agency is notified of positive HIV (Human Immunodeficiency Virus) testing. Patient #3 and #19.

The findings included:


According to the October and November 2016, infection control log for "HIV" positive patients revealed two (2) patients tested positive for HIV on November 15, 2016.

A review of the log revealed a representative's signature from the State Agency on January 5, 2017.


There was no documented evidence on the log when the State Agency was initially notified of the positive results.

Through an interview with Employee #6 regarding the aforementioned findings. He/she stated that the positive findings are reported to the State Agency and a representative from the health department comes out and review the patients' charts. Further stated that the date the state is notified should be documented on the infection control log; however, it is not.

Based on record review, policy review and staff interview, it was determined that staff failed to ensure two (2) of 19 patients was screened to address psychosocial needs as it relates to discharge planning for high-risk obstetrical patients. Patients' #3 and #4.

The findings included:


According to the hospital's policy; "Discharge Planning/Inpatient- Policy No: CM-102, Revised 07/2020" stipulates; " ... Procedure: 1. the discharge planning process starts with the patient's admission. In addition, information is gathered from the nursing admission assessment; from case management review of the daily census, and referrals from physicians, family, and other allied health professionals. Referrals for case management services will be acknowledged within 48 hours with documentation noted as to any intervention. 2. All patients will receive discharge instructions; those in need of comprehensive discharge planning will be screened and followed by the case management staff. 3. Case management will document comprehensive assessments to include medical history, demographic information, financial needs, and functional and psychosocial needs ... 9.Upon discharge or transfer, acceptance and understanding of the final discharge plan will be discussed with patient/family or other qualified person and notation as to acceptance will be documented in the medical record ..."


According to the physician's history and physical dated November 18, 2016, at 0554 (5:54 AM) revealed; "40-year-old pregnant female with no prenatal care for - [six] 6 months and HIV"+", presents with contractions. EDC (Estimated Date of Confinement) 11/30, EGA (Estimated Gestational Age) -38 weeks. The patient admits to having a prior child vaginally while on current antiretroviral medication. Refuses cesarean delivery."


According to an "LD (Labor and Delivery) Post Procedure Progress Note" dated November 18, 2016, at 17:06 (5:06 PM), the method of delivery was an NSVD (Normal Spontaneous Vaginal Delivery), Findings/Description of Surgery: VMI (Viable Male Infant) ..."


Patient #4- Date of Birth- November 18, 2016, at 15:41 (3:41 PM); discharged home on November 22, 2016, with Mom.


According to a physician order dated November 18, 2016, at 17:26 (5:26 PM) directed; "Care Mgt [Management]/Social Service Cons [Consult] ..."


A review of Patient #3's medical record revealed a case manger's note dated November 19, 2016, at 1450 (2:50 PM) revealed; "I spoke with the mother and informed her that I would be sending a script for the baby to receive his AZT (anti-HIV medicine). I asked her if someone from the family can pick it up and she said that it be here to do it... [SIC] ..."
The medical record lacked any subsequent notes regarding discharge planning/case management assessments/interventions.

A review of Patient #4's medical record revealed the following case manager's note dated, November 22, 2016, at 0750 (7:50 AM) revealed, "CVS (local pharmacy) on Alabama Avenue has prescription ready. Called [Patient #3] yesterday and informed her she can pick it up and then come to the hospital to pick up Babyboy. Will also leave resources for [Patient #3]. No further services needed at this time..."

A review of Patient #4's medical record revealed a nursing noted dated November 22, 2016, at 1218 (12:18 PM); "Mom came to pick up her baby. Discharge instructions reviewed with her and instructed to have baby followed by infectious disease... Discharged to home in stable condition with Mom and sister."

The medical record lacked evidence that a comprehensive discharge planning assessment of the patients' needs [e.g. financial needs, functional and psychosocial needs] were documented prior to discharge, to include an overview of resources available to support mother and baby in the community. Additionally, there was no documented evidence that the mother picked up the AZT prior to taking the baby home.

A face-to-face interview with Employees #17 and #18 was conducted on September 8, 2017, at approximately 3:00 PM. Both acknowledged the aforementioned findings.