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The Hospital was out of compliance for the Condition of Participation for Laboratory Services.

Based on interviews and records reviewed, the Hospital failed to ensure accurate collection, identification and handling of newborn screening specimens for two (Patient #1 and Patient #2) patients of 13 sampled patients. For Patients #1 and #2, the Hospital collected and submitted blood samples for the newborn screening program (a screening program that screens newborns for many serious but treatable congenital diseases using a small sample of blood taken from a newborn ' s heel) on two different dates. These two separate specimens were determined by the outside state lab to be adult blood belonging to the same adult rather than neonatal specimens.

Cross Reference: §482.27(a) Standard: - Adequacy of Laboratory Service (0582)

Based on interviews and records reviewed, the Hospital failed to provide adequate laboratory services. The newborn screening specimens for two patients (Patient #1 and Patient #2), collected on two different dates and submitted by nursing staff, were determined by the outside state lab to be adult blood belonging to the same adult rather than neonatal specimens.

Findings include:

Review of Patient #1 ' s medical records indicated that a newborn screening specimen was collected by Registered Nurse (RN) #1 on 7/28/25 at 5:15 A.M. and was received by the outside state laboratory on 7/29/25 at 11:12 A.M. Review of Patient #1 's Newborn Screening Summary Results dated 8/1/25 at 8:32 A.M. indicated that Patient #1 was out of range for several targeted disorders/disorder groups. Review of the outside state laboratory report, undated, indicated the specimen submitted by the Hospital for Patient #1 was identified as adult blood not neonatal blood.

Review of Patient #2 ' s medical records indicated that a newborn screening specimen was collected by RN #1 on 8/3/25 at 5:15 A.M. and was received by the outside state laboratory on 8/5/25 at 10:48 A.M. Review of Patient #2's Newborn Screening Summary Results dated 8/6/25 at 8:04 A.M. indicated that Patient #2 's specimen was unsatisfactory. Review of the outside state laboratory report, undated, indicated the specimen submitted by the Hospital for Patient #2 was identified as the same adult blood as the specimen for Patient #1 and was not neonatal blood.

During an interview on 8/25/25 at 6:38 A.M., RN #1 acknowledged she collected the newborn screenings for both patients (Patient #1 and Patient #2) via heel stick. RN #1 said she always follows the process on obtaining blood samples from the newborn, which includes putting on gloves and identifying the patient. RN #1 said she does not know how Patient #1 and Patient #2 ' s samples came back as adult blood. RN #1 said after she obtains the specimen for the newborn screening, she brings it to the Special Care Nursery (SCN) where it is stored on a drying rack, upright, and separated from other samples. RN #1 said once the sample is placed in the drying rack her part is done.

During an interview on 8/25/25 at 9:00 A.M., and throughout the survey, the Director of the Center for Women and Infants said newborn screenings are obtained by nurses via heel stick. The Director said once the specimen is obtained, the nurse brings it to the SCN where it is stored on a drying rack in an unlocked cabinet. The Director said everyday an outside parcel delivery service arrives to the SCN to pick up the specimens between 3:00 P.M and 4:00 P.M. The Director said the unit secretary will obtain the newborn screening from the drying rack and put them in an envelope for the outside delivery service, which is tracked, and delivered to the newborn screening state lab. The Director said although there is no Hospital policy and/or process to ensure accurate collection of the specimen, she does receive a report once a month from the newborn screening lab that shows specimens that resulted as unsatisfactory which could be due to the specimen being oversaturated or undersaturated with blood, consents not signed or timing of specimens sent to the lab. She said the newborn screening lab also looks for trends that are unusual and in response will reach out to the Hospital to notify them of their findings. The Director said they have never received a report indicating unusual trends.

During an interview on 8/27/25 at 12:47 P.M., the Director of Laboratory Services said the newborn screening specimens are collected on the floor by nursing staff and sent out directly to the state newborn screening laboratory. He said the Hospital ' s laboratory has no involvement in the process; therefore, there is no policy and/or process outlined to ensure accurate collection of the specimens or to maintain specimen integrity prior to submission to the state laboratory.