HospitalInspections.org

Based on policy review, graduate medical education file review, medical record review and staff and physician interview the hospital's governing body failed to ensure the medical staff was accountable for the quality of care provided to patients by failing to ensure an attending physician examined 1 of 4 sampled newborn infants to verify a resident physician accurately assessed an infant (#4).

The findings include:

Review of the hospital's policy, "Graduate Medical Trainees and Attending Physicians Patient Care Activities and Supervision Responsibilities", effective 10/21/2002, revealed "...Graduate medical trainees must be supervised by teaching staff in such a way that trainees assume progressively increasing responsibility according to their level of education, ability and experience. ...A. DEFINITIONS: Attending Physician: A licensed independent practitioner who holds admitting and/or attending physician privileges consistent with the requirements delineated in the Bylaws, Rules and Regulations of the Medical Staff of (named hospital)...Trainee: A physician who participates in an approved graduate medical education (GME) program. The term includes interns, residents and fellows in GME programs... . B. ATTENDING PHYSICIAN RESPONSIBILITIES: ...The medical staff has overall responsibility for the quality of the professional services provided by individuals with clinical responsibilities. In a hospital, the management of each patient's care (including patients under the care of participants in professional graduate medical education programs) is the responsibility of a member of the medical staff with appropriate clinical privileges...The attending physician is expected to:....In general, the degree of attending involvement in patient care will be commensurate with the type of care that the patient is receiving and the level of training, education and experience of any medical trainee(s) involved in the patient's care. The intensity of supervision required is not the same under all circumstances; it varies by specialty, level of training, the experience and competency of the individual trainee, and the acuity of the specific clinical situation.... For Inpatient Care:....b. Examine the patient within 24 hours of admission, when there is a significant change in patient condition, or as required by good medical care...".

Closed record review of Patient #4 revealed a 37 week female infant with prenatally-diagnosed ventriculomegaly (enlarged ventricles of the brain) born via Cesarean section at the hospital on 02/04/2010 at 1613. Record review revealed the infant weighed 3.655 kilograms and had an APGAR (assessment of newborn immediately after birth, with 10 as the highest score) score of 8 at one minute and five minutes of birth. Record review revealed the newborn was transported via bassinet from the operating room to the Intensive Care Nursery (ICN) in stable condition. Record review revealed a dictated "Neonatal Universal Admission Data" dated 02/04/2010 at 1658, dictated and electronically signed by Physician #1(a pediatric resident) on 02/05/2010 at 0245 and by Physician #2 (the neonatology attending physician) on 02/05/2010 at 0737. Review of the dictated "Neonatal Universal Admission Data" revealed "...GU(genitourinary)/Rectal: Normal GU Exam. No Focal Abnormalities..." Further record review revealed Patient #4 had a right cerebral (brain) shunt placed by a neurosurgeon on 02/05/2010. Further record review revealed the infant was examined by Physician #3 (a pediatric fellow) on 02/05/2010, a neurosurgery attending on 02/05/2010, a pediatric resident and a pediatric fellow on 02/06/2010, 02/07/2010, 02/08/2010, 02/09/2010, 02/10/2010, 02/11/2010, 02/12/2010, 02/13/2010, 02/14/2010, 02/15/2010, 02/16/2010, 02/17/2010, 02/18/2010 and 02/19/2010. Record review revealed a discharge summary dated 02/22/2010 dictated by a pediatric resident "...GU/Rectal: Normal GU exam. No focal abnormalities...". Record review revealed the infant was discharged to home 02/19/2010 at 1030.

Further record review revealed a "telephone note" dictated by a physician on 02/19/2010 at 1852 (8 hours, 22 minutes after discharge), "Mom called regarding her daughter, a 15 day old infant born with prenatally diagnoses hydrocephalus s/p (status post) VP shunt, concerned that she does not have an anus. Mom states that she changed her diaper today and she could not find the anus and that her stool was coming out of her vagina instead of her anus. They live 1.5 hours away are close to both (names of 2 hospitals). I have advised them to go to either of those hospitals for an exam to determine if she has an anus or not. She has been advised to call back at...."

Review of Patient #4's medical record from another hospital revealed the patient was admitted to the other hospital on 02/20/2010 (1 day after discharge) with the chief complaint of "stooling from vagina". Review of the admission History and Physical dated 02/20/2010 revealed "...Assessment and Recommendation...imperforate anus and presumed rectovaginal fistula...." Review of the record revealed an operative report dated 02/22/2010 with a preoperative diagnosis of imperforate anus and a post-operative diagnosis of imperforate anus with rectovestibular fistula. Record review revealed the patient was discharged 03/01/2010.

Graduate medical education file review of Physician #1 revealed the physician graduated from medical school in June 2009 and is currently a first year pediatric resident. Review revealed Physician #1 is an associate member of the hospital's medical staff. Review revealed Physician #1 completed the physical exam competency on 08/24/2009.

Interview on 03/31/2010 at 0955 with Physician #2 revealed the physician is a pediatric/neonatology attending physician and "has a supervisory role over residents and nurse practitioners". Interview revealed "residents perform assessments unsupervised". Interview further revealed "I co-signed the admission assessment of (Patient #4) after talking with the resident". Interview further revealed "I examined the baby on February 5th around 1:00 (1300). I completed the progress note before I did a head to toe assessment". Interview further revealed "I would have expected (Physician #1) to pick up on an imperforate anus. He should be proficient in physical assessment. We monitor procedural competency but not exams". Interview further revealed "I didn't pick up on it because when I examined her she was a fresh post-op. It was an assumption on my part that the anus was patent and that was wrong on my part. I didn't look close enough at the baby's bottom". Interview further revealed "this was missed on a lot of levels. It shouldn't have happened".

Interview on 03/31/2010 at 1020 with Physician #3 revealed the physician is a pediatric/neonatology fellow. Interview revealed "(name of Physician #1) is a first year resident or intern. This is his first year out of medical school". Interview further revealed "he should be proficient in performing physical exams". Interview revealed "the discharge summary was done by looking at previous assessments. I co-signed with the resident but did not examine the baby myself". Interview further revealed "the faculty missed it because they are problem focused. This case highlights that attendings should do complete exams, not just problem focused exams". Interview further revealed "the whole team missed this".

Interview on 03/31/2010 at 1350 with Physician #1 revealed the physician graduated medical school in June 2009. Interview revealed "I started my ICN (Intensive Care Nursery) rotation on February 1 and completed it February 28". Interview further revealed "one of my duties is to examine babies and report my findings to the senior residents and attendings". Interview revealed "I performed the physical assessment of (name of Patient #4). I was at the delivery so I performed the initial assessment". Interview further revealed "I have been doing physical assessments since my second year of medical school. I don't know how I missed this. Nothing I saw alarmed me."

Interview on 04/01/2010 at 0900 with the pediatric residency program director revealed "residents are always supervised by attendings. It would be my expectation that first year residents' physical exams are always followed up by an attending physician".

Based on review of the hospital's job description for nurses, review of competency validation criteria for neonatal nurses, medical record review, personnel file review and staff interviews the nursing staff failed to evaluate and supervise nursing care by failing to ensure a complete gastrointestinal/genito-urinary assessment was performed on 3 of 4 sampled newborns (#4, 7 and 8).

The findings include:

Review of the hospital's job description for a Clinical Nurse II, effective May 2001, revealed "...I. Job Responsibility Evidence of Nursing Process: Assessment Standard ...Performs and documents comprehensive admission, initial assessment and reassessments at regular intervals...Identifies areas of concern which need further investigation...Completes assessment data base...II. Job Responsibility Evidence of Nursing Process: Problem Identification Standard Identifies, prioritizes and documents patient problems/needs/diagnoses by analysis of data...."

Review of the hospital's competency validation criteria for neonatal nurses, effective 06/2008, revealed "...General Assessments...2. Assesses patient per unit routine with specific attention to:...Anus - patency...."

1. Closed record review of Patient #4 revealed a 37 week female infant with prenatally-diagnosed ventriculomegaly (enlarged ventricles of the brain) born via Cesarean section at the hospital on 02/04/2010 at 1613. Record review revealed the infant weighed 3.655 kilograms and an APGAR (assessment of newborn immediately after birth, with 10 as the highest score) score of 8 at one minute and five minutes of birth. Record review revealed the newborn was transported via bassinet from the operating room to the Intensive Care Nursery (ICN) in stable condition. Record review revealed an initial assessment performed on 02/04/2010 at 1634 by RN (Registered Nurse) #1. Record review revealed no documented evidence that the newborn's anus was assessed for patency. Further record review revealed an assessment was performed by RN #2 on 02/04/2010 at 2000 with no documented evidence that the newborn's anus was assessed for patency. Record review revealed Patient #4 was assessed by neonatal nurses on 02/05/2010 at 0000, 0400, 0800, 1300, 1700, 2100; 02/06/2010 at 0100, 0500, 0841, 1200, 1652 and 2000; 02/06/2010 at 0000, 0400, 0841, 1200, 1652 and 2000; 02/07/2010 at 0000 and 0400. Review of the assessments revealed no documented evidence that the newborn's anus was assessed for patency. Record review revealed an assessment performed on 02/07/2010 at 0800 by RN #3. Review of the assessment revealed "...Pt. Elimination Rectal Stool Amount- Smear Stool Color -Black Stool Consistency - meconium". Further review of the record revealed assessments performed by neonatal nurses on 02/08/2010 at 0400, 02/08/2010 at 2000, 02/09/2010 at 1500, 02/09/2010 at 2000, 02/10/2010 at 0000, 2/10/2010 at 0400, 0900, 1200 and 1500, 02/11/2010 at 0300, 0600, 0900, 1200, 1500 and 1800, 02/12/2010 at 0000, 0300, 0900, 1530 and 2100, 02/13/2010 at 000, 0300, 0600, 0900, 1700, 2000 and 2300, 02/14/2010 at 0200, 0500, 0800, 1100 and 1400. Review of the assessments revealed "...Pt. Elimination Elimination Route - Rectal...". Record review revealed Patient #4 was transferred to the pediatric unit from the ICN on 02/14/2010. Review of the nurses' assessments of Patient #4 from 02/14/2010 until discharge on 02/19/2010 revealed no documented evidence that the newborn's anus was assessed for patency.

Further record review revealed a "telephone note" dictated by a physician on 02/19/2010 at 1852 (8 hours, 22 minutes after discharge), "Mom called regarding her daughter, a 15 day old infant born with prenatally diagnoses hydrocephalus s/p VP shunt, concerned that she does not have an anus. Mom states that she changed her diaper today and she could not find the anus and that her stool was coming out of her vagina instead of her anus. They live 1.5 hours away are close to both (names of 2 hospitals). I have advised them to go to either of those hospitals for an exam to determine if she has an anus or not. She has been advised to call back at...."

Review of Patient #4's medical record from another hospital revealed the patient was admitted to the other hospital on 02/20/2010 (1 day after discharge) with the chief complaint of "stooling from vagina". Review of the admission History and Physical dated 02/20/2010 revealed "...Assessment and Recommendation...imperforate anus and presumed rectovaginal fistula...." Review of the record revealed an operative report dated 02/22/2010 with a preoperative diagnosis of imperforate anus and a post-operative diagnosis of imperforate anus with rectovestibular fistula. Record review revealed the patient was discharged 03/01/2010.

Personnel file reviews for RNs #1, 2 and 3 revealed a "Competency Validation Criteria". Review of the competency validation revealed "...General Assessments...2. Assesses patient per unit routine with specific attention to:...Anus - patency...". File reviews revealed RNs #1, 2 and 3 had completed the competency validation for assessment of the anus for patency.

Interview on 03/30/2010 at 1355 with administrative nursing staff revealed "a total body assessment by the nurse should be done on admission and each shift thereafter". Interview further revealed "we heard about this incident. It is very unusual for us to miss this". Further interview revealed "rectal temps (temperatures) are not part of our assessment because of the risk of perforation but due to this incident, we are rethinking our position".

Interview on 03/31/2010 at 0840 with administrative nursing staff revealed "I would expect nurses to pull the butt cheeks apart. The anus should separate and they should visualize stool coming from there". Interview revealed "they assumed the stool was coming from the anus when actually they saw stool in the diaper".

Interview on 03/31/2010 at 1415 with RN #2, an ICN staff registered nurse, revealed "I remember her (Patient #4) stooling. Nothing looked abnormal to me. Now we're going to be opening up buttocks to assess for anal patency".

RNs #1 and 3 were not available for interview.

2. Open record review on 03/31/2010 of Patient #7 revealed a newborn delivered at 27 weeks gestation on 03/29/2010 (2 days old). Record review revealed an initial nursing assessment performed 03/29/2010 at 1400. Review of the assessment revealed no documented evidence that the newborn's anus was assessed for patency.

Interview on 03/31/2010 at 1430 with an ICN (intensive care nursery) staff nurse confirmed that Patient #7 had not been assessed for a patent anus. Interview revealed "this should be done on admission".

Interview on 04/01/2010 at 1030 with administrative nursing staff revealed "I would have expected this baby to have been assessed on admission to our unit for a patent anus. We should not assume it's patent. We have to look. We need to do more education and follow-up".

3. Open record review on 03/31/2010 of Patient #8 revealed a newborn delivered at 27 weeks gestation on 03/30/2010 (1 day old). Record review revealed an initial nursing assessment performed 03/30/2010 at 1929. Review of the assessment revealed no documented evidence that the newborn's anus was assessed for patency.

Interview on 03/31/2010 at 1430 with an ICN (intensive care nursery) staff nurse confirmed that Patient #8 had not been assessed for a patent anus. Interview revealed "this should be done on admission".

Interview on 04/01/2010 at 1030 with administrative nursing staff revealed "I would have expected this baby to have been assessed on admission to our unit for a patent anus. We should not assume it's patent. We have to look. We need to do more education and follow-up".


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