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Based on a review of facility documents, medical records (MR), and staff interviews (EMP), it was determined the facility failed to notify CMS Regional Office that an off-campus provider based location was added, and failed to ensure that Outpatient Lab Services located at Saint Marys Community Medical Building met the required location requirements.

1. Surveyor reviewed Penn Highlands Elk's Hospital/CAH Database Worksheet, dated November 3, 2016, and it was noted that the Saint Marys Community Medical Building Outpatient Lab Services was not listed as a provider based off site location.

2. Interview with EMP2 on June 12, 2018 and June 19, 2018, revealed that this outpatient Lab draw location was closed under Penn Highlands DuBois on January 20, 2017 and was placed under Penn Highlands Elk on January 23, 2017. EMP2 stated that this Lab draw location is utilizing Penn Highlands Elk CCN number (CMS Certification Number) and treating this Lab draw as part of Penn Highlands Elk. EMP2 confirmed on June 19, 2018, that neither Penn Highlands DuBois or Penn Highlands Elk requested approval prior to their changing provider's CCN.

3. A telephone interview with EMP1 on July 3, 2018, revealed that in addition to Lab blood draws, the collection of urine and stool specimens, sputum specimens, throat and nasopharyngeal swabs, are all collected at this Lab site, and all are subsequently sent to Penn Highlands Elk Hospital for processing.

4. The location of the Saint Marys Community Building is 1100 Million Dollar Highway, Saint Marys, PA, and the location of Penn Highlands DuBois Hospital is 100 Hospital Avenue, DuBois, PA.

Based on a review of facility documents, medical records (MR), and staff interviews (EMP), it was determined the facility failed to ensure that space/services utilized for the Outpatient Lab Services at the off-site location at the Saint Marys Community Medical Building was limited to said provider (distinct entity requirements) (C-0241).

1. A telephone interview with EMP9, on June 19, 2018, at approximately 2:30PM, revealed "The patient presented to the Saint Marys Community Building Lab ... the Rad Tech (Penn Highlands DuBois) drew the blood ... Sometimes they come over from Radiology (Penn Highlands DuBois) to help. I got involved because EMP4 is a DuBois employee ... leased by Elk. Sometimes Elk staff covers the Lab. This change, from DuBois to Elk, occurred ... January 2017." EMP9 also stated that Registration is shared between Radiology (Penn Highlands DuBois) and Lab area (Penn Highlands Elk).

2. A telephone interview with EMP10 on June 21, 2018, at 10:00AM, with EMP1, revealed that the Registration staff of the Lab Draw Station are Penn Highlands DuBois employees. EMP10 continued by stating that the Rad Techs help with phlebotomy when it is busy, and stated that Radiology is a service of Penn Highlands DuBois.

3. A telephone interview with EMP12, with EMP2 on June 21, 2018, at approximately 2:45PM, regarding the Registration process at Saint Marys Community Medical Building, revealed "First the patient takes a number, and they are called to office one or two. I'll call the Lab and then the Lab staff gets them. We do the registration and get the consent signed." When asked about consents, EMP12 stated that for Lab they use the Penn Highlands Elk consent, and for Radiology, EKG, and Ultrasound they use Penn Highlands DuBois consent. EMP12 stated that they utilize DuBois policies and patient rights handouts are all DuBois. EMP12 stated that there is one big Waiting Room and Registration for both facilities.

4. A telephone interview with EMP4 with EMP8, on June 22, 2018, at approximately 8:45AM, revealed "... I go by what I've done for DuBois for ... years. I make sure it's the right doctor, right account, patient and birth date. We're sending labs to Elk. They lease me and reimburse DuBois for me. On my days off, they use Elk's staff. It's been a little under a year and a half ... When you bring up accounts, it shows whether the encounter was for Imaging, PT. The two hospitals are intermingled." EMP8 stated that the Waiting Room is shared.

Based on a review of facility documents, medical records (MR), and staff interviews (EMP), it was determined the facility failed to ensure that patients entering the outpatient Lab Services location at the Saint Marys Community Medical Building were aware they were entering Penn Highlands Elk Hospital, failed to ensure the effective use of the time of the patient and failing to avoid personal discomfort of the patient for two of two medical records reviewed (MR1, MR2) by failing to ensure that outpatient Lab Services were integrated with inpatient Lab services, (C-0280) and by failing to adopt and/or provide staff education on policies relevant to laboratory services, patient identification and informed consent policies for the staff at the Outpatient Lab Services located at the Saint Marys Community Medical Building (C-0271).

Findings include:

Review of Penn Highlands Elk policy entitled "Informed Consent", effective date June 14, 2017, revealed "... It is the policy of Penn Highlands Elk to establish patient consent prior to provision of medical services offered by the hospital ... ."

Review of Penn Highlands Elk policy entitled "Identification of Patients", dated July 2016, revealed "... Purpose: The purpose of this policy is to ensure that at all times, the identity of each patient is known with a high degree of certainty in order to minimize the risk of mismatching patients and their treatments. Responsibilities: This policy applies to all staff who come into contact with patients and all staff who deal with patient documentation and samples taken from patients. It is the responsibility of all staff to ensure that patients are properly identified using two unique identifiers and that information regarding failure to comply with this policy is directed to the department manager. It is essential that all healthcare professionals ensure the correct patient identification before the following procedures are undertaken ... Obtaining blood or other specimens from the patient ... ."

Review of Penn Highlands Elk policy entitled "Patient Identification", dated April 27, 2017, revealed "... Seven ways to Identify a Patient: ... Account Number ... Full Name ... Partial Name ... Unit Number ... Social Security Number ... Enter Date of Birth ... Enter Sex Search then using at least two identifiers pick the patient you working with from the List. Then pick the encounter you want to use. When typing in a patient, the preferred way is to use the Account Number or DOB ... ."

1. Review of photographs of the signage at the Saint Marys Community Medical Building, were received by EMP2 June 21, 2018. The entrance of the building was noted to state Penn Highlands Healthcare, Imaging and Lab Services. Other pictures of interior signage was reviewed related to the Imaging and Lab Services area, which included view of the Registration desk, and a photo of the Lab window. No signage was noted that indicated Penn Highlands Elk was providing the outpatient Lab services.

2. Review of MR1, revealed a demographic page which indicated the medical service to be Laboratory, and listed the facility as Penn Highlands Elk, on March 21, 2018. A review of the consent signed by the patient, on March 21, 2018, revealed " ... I present myself to Penn Highlands Elk for medical care, I consent to diagnostic procedures, telehealth/telemedicine and /or treatments as prescribed by the attending physician or his designees as needed ... I furthermore authorize payment directly to Penn Highlands Elk ... ." Review of other documentation relative to MR1 revealed that the patient had chemistry lab work (PSA) specimen collected again on March 28, 2018.

3. Review of medical record documents for MR2, revealed that the PSA test result from March 21, 2018, for MR1, was reported relative to the patient associated with MR2. It was noted that the patient relevant to MR2 was sent for a Urology Consult as a result of this testing, at which time biopsy was discussed.

4. A telephone interview with EMP9, on June 19, 2018, at approximately 2:30PM, revealed "The patient presented to the Saint Marys Community Building Lab. EMP4 entered the order for the blood work. (They are) a phlebotomist, but the Rad Tech drew the patient's blood. The results went to the wrong patient, because they went by the name only, didn't use two identifiers. Sometimes they come over from Radiology to help. I got involved because EMP4 is a DuBois employee. (They are) leased by Elk. Sometimes Elk covers the lab. This change (from DuBois to Elk) ... was January 2017."

5. A telephone interview with EMP10 on June 21, 2018, at 10:00AM, with EMP1 revealed "We received a call from the patient stating their lab results had not gone to their doctor. EMP3 took care of getting the patient to come back. They notified me of the incident. I did report it. I spoke to Penn Highlands DuBois Laboratory Supervisor and the Assistant VP of Lab." When asked about the DOE (Department Order Entry) process, EMP10 stated that this is a Penn Highlands DuBois process, and that this Lab draw location uses the Penn Highlands DuBois DOE (Departmental Order Entry) process. EMP10 stated that EMP4 informed them of what happened and that Penn Highlands DuBois followed up with EMP4. When asked about the other Penn Highlands Elk policies that were provided for surveyor to review, EMP10 stated that staff at the Lab draw located at the Saint Marys Community Medical Building would not be aware of these, as they are Penn Highlands Elk policies, and stated that staff would not have had any education related to these policies. EMP10 stated that these policies are relative to the hospital only. EMP10 stated that EMP4 placed the order and that on March 21st, the patient was registered by Penn Highlands DuBois Registration personnel. EMP10 continued by stating that the Rad Techs help with phlebotomy when it is busy, and stated that Radiology is a service of Penn Highlands DuBois. When asked about the process for placing an order, EMP10 stated that you are to look at the patient's account, name, birth date and financial number and that at least two items are to be verified when placing the order, and stated that patient identification is what broke in the process. EMP10 stated that they didn't know how the lab draw was set up, and stated that they do not supervise that area.

6. A telephone interview with EMP3 with EMP1 on June 21, 2018, at 11:00AM, revealed "I was initially contacted by the patient, they were concerned that their doctor hadn't received their PSA results ... I have no oversight over the Community Medical Building." When asked if staff at the Lab draw located at the Saint Marys Community Medical Building would be provided with education on Penn Highlands Elk policies or be involved in Lab Department meetings, EMP3 stated "They would not have education on our policies or would be involved in our department meetings. The patient called me, that is why I got involved."

7. A telephone interview with EMP12 with EMP2, on June 21, 2018, at approximately 2:45PM, regarding the registration process at Saint Marys Community Medical Building, revealed "First the patient takes a number, and they are called to office one or two. I'll call the Lab and then the Lab staff gets them. We do the registration and get the consent signed." When asked about consents, EMP12 stated that for lab it is the Penn Highlands Elk consent and, for Radiology, EKG, and Ultrasound it is Penn Highlands DuBois consent. EMP12 stated they had education when hired, but nothing with Elk. EMP12 stated that they utilized DuBois policies and patient rights handouts are all DuBois.

8. A telephone interview with EMP4 with EMP8, on June 22, 2018, at approximately 8:45AM, revealed "A patient came in the day before with a similar name, with just one letter short. The patient was in the day before, andthe results went under them ... To the best of my knowledge, I used identifiers, but I must not have. It is a Penn Highlands DuBois policy, because we're DuBois staff, most of us." When asked about any policies related to Elk, EMP4 stated "They have a little policy but is very vague. It was recent, after this event ... I go by what I've done for DuBois ... We're sending labs to Elk. They lease me and reimburse DuBois for me. On my days off, it's Elk staff ... ."

9. A telephone interview with EMP11 with EMP8, on June 22, 2018, revealed "I don't remember this very well. I'm one of five Radiology techs that rotate. We help out when the Lab is busy. When Saint Marys took over the Lab, they had their own system, so they learned a whole new way of ordering... ." When asked, if there is a policy to describing the process, EMP11 stated it was a Penn Highlands DuBois Protocol, Outpatient.

Based on a review of facility documents, medical records (MR), and staff interviews (EMP), it was determined the facility failed to ensure informed consent was obtained for one of one medical records (MR1) (C0304), failed to maintain an accurate medical record for one of one medical records reviewed (MR1) (C0308), and failed to ensure access to medical records was limited to the provider that was providing services.

Findings include:

Review of Penn Highlands Elk policy entitled "Informed Consent", effective date June 14, 2017, revealed "... It is the policy of Penn Highlands Elk to establish patient consent prior to provision of medical services offered by the hospital ... ."

1. Review of medical record documents for MR1, revealed a demographic page which indicated the medical service to be Laboratory, and listed the facility as Penn Highlands Elk, on March 21, 2018. An informed consent was noted to be executed on March 21, 2018. Review of other documentation relative to MR1 revealed that the patient had chemistry lab work (PSA) specimen collected again on March 28, 2018. It was noted that there was no informed consent executed for the encounter dated March 28, 2018.

2. Review of medical record documents for MR2, revealed that the PSA test result from March 21, 2018, for MR1, was reported relative to the patient associated with MR2.

3. A telephone interview with EMP10 on June 21, 2018, at 10:00AM confirmed that there was not a second consent obtained for the second law draw relative to MR1.

4. A telephone interview with EMP9, on June 19, 2018, at approximately 2:30PM, revealed "The patient presented to the Saint Marys Community Building Lab ... Everything went to the wrong patient ... ."

5. A telephone interview with EMP4 on June 22, 2018, at approximately 8:45AM, revealed "A patient came in the day before with a similar name, with just one letter short. The patient was in the day before, and the results went under them ... When you bring up accounts, it shows whether the encounter was for Imaging, PT (Physical Therapy). The two hospitals are intermingled."

Cross Reference with:
103.22 (b)(16) Implementation
125.1 Clinical/Anatomical Pathology Services