HospitalInspections.org

Based on findings from document review, interview and observation, the facility failed to provide appropriate care to a pediatric patient (Patient #1) at Camden Family Clinic (CFC) (a hospital extension clinic.) Specifically, (1) Patient #1's mother called CFC (on 8/4/15), spoke to a Licensed Practical Nurse (LPN) and relayed her daughter's urinary symptoms (i.e., frequent urination) and requested an appointment with a provider. The LPN did not inform or seek the advice/recommendation from the provider at the time of the mother's call. The LPN requested an order for a urinalysis from the provider on 8/6/15 (two days later), the morning Patient #1's mother brought in the urine sample. Urinalysis results were reviewed by the provider on 8/9/15 and were noted to be normal, however lab results indicated glucose was elevated. This resulted in Patient #1's medical condition not being addressed. (2) The LPN did not perform within his/her scope of practice. (3) Lack of appropriate oversight of clinic operations and supervision of clinic personnel by non-clinical staff. (4) An adverse event involving a CFC patient (Patient #1) was not reported to the hospital. Additionally, there was a lack of integration of CFC with hospital Conditions of Participation (CoPs) i.e., quality assurance performance improvement (QAPI), pharmacy and infection control. Also, there was a lack of effective policies and procedures (P&Ps) to ensure CFC was providing safe patient care due to a lack of processes i.e., participation in QAPI, monitoring medications and solutions, ensuring emergency equipment functionality and providing adequate infection control measures and monitoring. These findings could adversely affect patient care.

Findings regarding (1) include:

-- Review of the facility's P&P titled "Communications," last reviewed 10/2014, indicated for "Miscellaneous Patient Complaint of Illness Calls, "the nurse will consult with the provider face to face if he/she is available or send the triage note as 'urgent' to the provider to determine if the patient should be seen in the clinic or seek emergent care. The LPN may not perform triage, therefore must consult with a provider before sending a patient to the emergency department (NYSED [New York State Education Department] Office of the Professions)."

-- Review of Patient #1's medical record (MR) revealed on 8/4/15 at 1:51 pm Patient #1's mother called stating Patient #1 was having frequent urination and wanted an appointment. Staff A (LPN) received the message and left a message for the mother instructing her to bring in a urine sample. There is no documentation Staff A (LPN) informed or consulted with Staff B (Physician's Assistant [PA]). Staff B (PA) was notified on 8/6/15 at 3:38 pm (2 days later) that an order for a urinalysis was needed. The provider, Staff B (PA), then placed the order for the test.

-- During interview of Staff B (PA) on 1/19/17 at 9:10 am, he/she acknowledged this finding.

-- Review of the facility's P&P titled "Lab Test Result Notification," last reviewed 2/2016, indicated all laboratory reports are signed by the appropriate provider before notifying the patient of test results. Nursing staff may contact the patient with results upon approval from the provider.

-- Review of Patient #1's MR dated 8/10/15 at 8:10 am, revealed the urine report was reviewed by Staff B (PA) and signed off as normal. The urinalysis results showed urine glucose - 1000 mg/dl (normal is negative), urine ketones 2+ mg/dl (normal is negative), urine specific gravity 1.039 (normal is 1.005 - 1.030). A triage note sent by Staff C (Receptionist) dated 8/14/15 at 3:59 pm, indicated Patient #1's mother called the clinic requesting urine results. Staff D (LPN) documented a triage note on 8/14/15 at 4:08 pm indicating a message was left on the mother's telephone. No further documentation was written regarding what, if any information was provided in the message.

-- Per review of Patient #1's MR, dated 9/3/15 at 11:49 am, revealed Staff E (Receptionist) documented "Mom was in today very upset that she was told Patient #1's urine was negative. She ended up in the Emergency Department (ED) and was diagnosed with Type 1 (Juvenile) Diabetes. She states doctors in the ED were very surprised that she was still alive as her levels were very high. She would like to know why no one told her to bring Patient #1 back in for further testing. She would like a call." (Message sent to Staff B [PA].)

-- Per interview of Staff B (PA) on 1/19/17 at 9:10 am, he/she reviewed Patient #1's urine results and signed off on them as normal in error. He/she spoke with Patient #1's mother, however, there is no documentation of the specific contents of the above conversation.

Findings regarding (2) include:

-- Per review of the facility's P&P titled "Communications," last reviewed 10/2014, noted above, the LPN may not perform triage.

-- However, review of Patient #1's MR revealed Staff A (LPN) did perform triage. When Staff A was notified of message left by Patient #1's mother, that Patient #1 was experiencing urinary frequency, Staff A determined a urine test should be done and instructed mother to bring a urine sample to the clinic. He/she did not consult with a provider prior to this action. Staff B (Physician's Assistant [PA]) was not notified of this until 2 days later when Staff A requested an order for urinalysis.

-- During interview of Staff B (PA) on 1/19/17 at 9:10 am, he/she acknowledged this finding.

Findings regarding (3) include:

-- During interview of Staff A (LPN) on 1/19/17 at 9:00 am, he/she revealed the CFC PA oversees the LPNs. He/she is the PA's nurse and triages patients, checks patient's vital signs, prepares the patient for the PA, answers patient's questions, receives messages for prescriptions, seeks prior authorizations as needed and takes phone calls from patients.

-- During interview of Staff B (PA) on 1/19/17 at 9:10 am, he/she revealed the CFC physician oversees the LPNs. The LPN "rooms" patients, administers medications and triages phone calls. Staff B was under the impression the clinic physician oversees the LPN.

-- During interview of Staff F (Office Manager), a non-clinical staff member, on 1/19/17 at 9:30 am, he/she revealed the CFC physician oversees the LPNs. The LPNs refer to the physician with any problems. Staff F (Office Manager) does the LPN's performance evaluations. Per his/her job description he/she provides oversight of CFC staff.

-- During interview of Staff G (physician) on 1/19/17 at 8:45 am, he/she does not know if the nurses at CFC are Registered Nurses (RNs) or LPNs. He/she did not seem clear on the role of oversight of the LPNs.

-- During interview of Staff H (Vice President [VP]/Chief Nursing Officer [CNO]) on 1/20/17 at 12:45 pm, he/she indicated the LPNs in the clinics are overseen by the RN/nurse practitioner (NP). However, there are no RNs or NPs at the CFC site. Staff F (Office Manager), enforces the LPN's scope of practice. Staff H (VP/CNO) has oversight over nursing scope of practice. Staff H (VP/CNO) does site visits quarterly or every six months or as needed and performs casual observation, however, he/she does not formally assess/address facility operations. As noted above the office manager, a non-clinical staff member, is responsible for LPN oversight and evaluation of job performance.

Findings regarding (4) include:

There was no evidence the operator ensured oversight as multiple issues related to QAPI, medications, emergency equipment and infection control were identified.

QAPI:
-- Review of the facility's P&P titled "Quality Improvement Plan - Offsite Clinics," revised 8/2014, indicated healthcare providers (Physician, NP and PA) and other clinical staff should participate in a systemic, ongoing evaluation of the quality of care and services provided to patients. Included are peer reviews, competency and profiling activities of licensed professionals.

-- Per interview of Staff G (physician) on 1/19/17 at 8:45 am, he/she does not participate in any QAPI for CFC.

-- Per interview of Staff A (LPN) on 1/19/17 at 9:00 am, he/she is not aware of any QAPI done at CFC.

-- Additionally, the adverse event described above occurred. However, during interview of Staff F (Office Manager) on 1/24/17 at 9:00 am, there is no documentation by clinic staff i.e., the physician, Office Manager and/or VP of Physician Practices regarding this adverse event. Also, there was no evidence that this event was reported to the hospital at the time it occurred. Review of Staff B's (PA) personnel file lacked documentation of this occurrence. Also, there was no documentation of counseling provided to Staff B (PA) or corrective actions taken in regards to this complaint.

Pharmacy:
-- Review of the facility's P&P titled "Pharmacy Responsibility for Rome Memorial Hospital's Outpatient Clinics," revised 6/2014, indicated the Director of Pharmacy or designee is responsible for the proper acquisition, storage and distribution of medications used at the outpatient clinics. Medication storage and use at these clinics are subject to all applicable hospital P&Ps. Inspections are to be conducted monthly by clinic or pharmacy personnel.

-- Review of the facility's P&P titled "Drug Samples," last revised 5/2013, indicated clinic personnel are required to check expiration dates of all samples at least monthly and to remove any samples that will expire by the end of the month.

-- Per interview of Staff A (LPN) on 1/19/17 at 9:00 am, he/she and the PA check medication expiration dates and the PA and the other LPN in clinic check the emergency cart. However, interview with both LPNs (Staff A and Staff L) confirmed it was not clearly defined who was responsible for checking medications for expiration dates and how the process is performed.

-- Per interview of Staff B (PA) on 1/19/17 at 9:10 am, he/she checks in sample medications. The sample medications are checked for expiration dates monthly by him/herself or the LPN. However, per observation of the clinic's sample medications there was evidence of outdated samples.

-- During interview of Staff J (Director of Pharmacy) on 1/20/17 at 1:45 pm, he/she indicated visits to clinics are performed at a minimum of quarterly, to check for expiration dates. However, he/she relies on staff to pull out expired medication for pharmacy pickup and disposal. He/she does not inspect clinic medication areas.

The facility failed to follow their P&P regarding medication monitoring. Multiple expired medications were available for patient use as follows:

Exam Room #6 Treatment Room
-One 10 milliliter (ml) vial of Lidocaine 1% opened 10/1/15
-One 10 ml vial of Lidocaine 1% open, not dated
-One 10 ml vial of Lidocaine 2% open, not dated
-One Dexamethasone 30 ml vial open and not dated, expired 12/15
-One 400-gram jar of Silvadene Cream expired 1/2016

Exam Room #3
-One 500 ml bottle of normal saline expired 4/2016

Exam Room #1
-One 4 oz. tube of Dynalube expired 10/2015

Sample medications:
-Four sample Tribenzor 20 mg/5 ml/12.5 mg seven (7) day pack expired 10/2016
-Nine sample Boost bottles 8 ounces expired 10/2016
-One bottle of Nitrostat 0.4 mg/tablet expired 8/2016

Medications stored in the cupboard in the nurse's station:
-Ondansetron 4 mg and 8 mg tablets expired 12/2016
-One Lidocaine Hydrochloride Oral Topical solution 2%100 ml expired 11/2011
-One Naproxen Sodium 220 mg caplet expired 7/2014
-One Azithromycin 250 mg tablet expired 5/2016
-One Duexis (Ibuprofen and Famotidine) 800 mg tablet expired 10/2012
-One Dexilant 60 mg tablet expired 7/2016

--The above findings were confirmed at time of observation by Staff A (LPN), Staff F (Office Manager) and Staff I (VP/Physician Practices).

Emergency Equipment in the nurse's station
-Three packages of Adult ECG Electrodes on the emergency cart expired 10/2016
-One of three oxygen tanks registered "Zero refill"
-Defibrillator covered in dust and last checked 10/2016 by hospital preventative maintenance

-- The above findings were confirmed at time of observation by Staff A, F and I (LPN, Office Manager and VP/Physician Practices).

Infection Control:
Exam Room#7
Lack of separation of "clean" and "dirty". Specifically, urine testing supplies were housed next to throat culture testing supplies. Also, nebulizer for patient respiratory treatments was stored in the room.

-- During interview of Staff A (LPN) on 1/19/17 at 10:00 am, he/she revealed urine testing and preparation is performed in Room #7 prior to urine specimens being sent to the laboratory. He/she indicated the nebulizer in the room was functioning and used for patients as needed. He/she stated they do not keep disinfecting wipes in the rooms because patients will open them. However, Staff A (LPN) indicated this room is not utilized for patient care.

Patient Bathroom
-Evidence of urine samples that were not clearly labeled or identified. Specifically, two urine samples were observed in the patient bathroom. One sample was labeled with a date of birth and the other specimen was unlabeled.

Exam Room #6 Treatment Room
Lack of general maintenance/housekeeping of disposable equipment, i.e., a disposable unwrapped surgical tray was stored in a cupboard and several unwrapped disposable surgical instruments (e.g., scissors and forceps) were stored in a drawer.

Exam Room #5
-Wall hand sanitizer container was empty
-One container of Sani-cloths (disinfecting wipes) on counter expired 9/2015

-- During tour of the facility, cleaning/disinfecting supplies were not readily available to clean exam rooms between patients.

-- Additionally, all sharps containers lacked a 30-day expiration date. Per New York State regulation 70-2.2 (e) (1) (2) sharps containers shall be removed from the patient care areas to a room or area designated for regulated medical waste storage, whenever the container has reached the fill line indicated on the container. Sharps containers shall be removed from patient care areas within thirty (30) days or upon the generation of odors or other evidence of putrification, whichever occurs first, without regard to fill level.

-- Staff A (LPN) confirmed the above findings at the time of observation.

-- Per interview of Staff I (VP/Physician Practices) on 1/19/17 at 10:45 am, no routine infection control audits are done at CFC. Additionally the hospital Infection Control Preventionist (ICP) does not conduct audits at CFC.

Based on findings from document review and interview, 1 of 2 credentialing files (Staff G [physician]) lacked medical staff peer reviews. Both non-professional (Office Manager) and professional (LPNs) staff were not operating within their job responsibilities or scope of practice. Specifically, Staff F (Office Manager) a non-clinical staff member, evaluated clinical staff members (LPNs) and LPNs did not practice within their scope of practice per the NYSED (New York State Education Department) Office of the Professions. This could impact the quality of care provided to patients.

Findings include:

-- Per review of Staff G's (physician) credentialing file, it lacked documentation of any peer reviews.

-- During interview of Staff K (Director of Medical Staff) on 1/20/17 at 2:45 pm, he/she confirmed there were no peer reviews in Staff G's (physician) credentialing file.

-- During interview of Staff A (LPN) on 1/19/17 at 9:00 am, he/she revealed the CFC PA oversees the LPNs.

-- During interview of Staff B (PA) on 1/19/17 at 9:10 am, he/she revealed the CFC physician oversees the LPNs. The LPN "rooms" patients, administers medications and triages phone calls. However, Staff B (PA) was under the impression the clinic physician oversees the LPN.

-- During interview of Staff F (Office Manager), a non-clinical staff member, on 1/19/17 at 9:30 am, he/she revealed the CFC physician oversees the LPNs. The LPNs refer to the physician with any problems. Staff F (Office Manager) does the LPN's performance evaluations. Per his/her job description he/she provides oversight of CFC staff.

-- During interview of Staff G (physician) on 1/19/17 at 8:45 am, he/she does not know if the nurses at CFC are Registered Nurses (RNs) or LPNs. He/she did not seem clear on the role of oversight of the LPNs.

-- During interview of Staff H (Vice President [VP]/Chief Nursing Officer [CNO]) on 1/20/17 at 12:45 pm, he/she indicated the LPNs in the clinics are overseen by the RN/nurse practitioner (NP). However, there are no RNs or NPs at the CFC site. As noted above the office manager is responsible for LPN oversight and evaluation of job performance and enforces the LPNs scope of practice. Please see findings in Tag A1076.