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Based on observation, interview, and record review, the facility's Governing Body failed to:
1. Provide and maintain a sanitary environment for surgical services, to avoid sources and transmission of infections and communicable disease. Implement an infection control program that followed acceptable standards of practice for sterilization process; inspecting sterilized surgical supplies; and storage of sterilized supplies; maintain a sanitary environment in the Operating Room including prevention of storage of sterile surgical supplies with trash, sharps disposals and surgical carts and the storage of cleaned GI scopes in the dirty room where GI surgical equipment was disinfected; and assure qualified personnel performed surgical procedures including cutting of polyps during colonoscopy intraoperatively. ( Refer to A940).
2. The Radiology department failed to provide direct supervision during the dosage and administration of IV contrast to patients; failed to oversee initial proctoring and yearly competency evaluation for Certified Radiology Technicians (CRT's) who administer IV contrast; and failed to monitor the weekly fluoroscopy log and to follow the Physicist recommendation for monitoring and maintenance of the C-ARM (Refer to A528).
3. The Quality Assessment Performance Improvement (QAPI) program failed to implement an infection control program that followed acceptable standards of practice in monitoring; Food storage; sterilization processes; inspecting sterilized surgical supplies; storage of sterilized supplies; monitoring/surveillance and reporting of HAI; maintain the Operating Room as a sterile restricted area; assure qualified personnel performed surgical procedures including cutting of polyps during colonoscopy intraoperatively; monitor storage of OR surgical carts; monitor storage of Colonoscopy supplies; assuring the medical staff obtained current TB and Hep B status; monitor and provide oversight and supervision in radiologic services and Nuclear Medicine; assure CRTs administering IV contrast and radiopharmaceuticals received proctoring , yearly competency and direct supervision; monitoring of the weekly fluoroscopy reading and assuring physicist's recommendations were followed by the radiology department; and assure medication administered by CRT's was documented in the medical records. (Refer to A263)
4. Coordinate and oversee the hospital wide infection control program including: Implementing an infection control program that followed acceptable standards of practice in monitoring; food storage; sterilization processes for the OR; inspecting sterilized surgical supplies; storage of sterilized supplies; monitor storage of OR surgical carts; monitor storage of Colonoscopy supplies; provide and maintain a sanitary environment for surgical services to avoid sources and transmission of infections and communicable disease by creating a restricted and sterile Operating room environment for the surgical procedures; maintain the Operating Room as a sterile restricted area; failure to prevent dirty bronchoscopes from being brought into the OR past the red line and being disinfected inside the Cystoscopy room; monitoring, surveillance and reporting of HAI; and assuring the medical staff obtained current TB and Hep B status (Refer A747)

The cumulative effects of these systemic problems resulted in the Governing Body's inability to ensure the provision of quality health care in a safe and sanitary environment.

Based on interview and record review, the facility failed to ensure that the medical staff adhered to professionally acceptable standards of practice.
In nine out of ten medical staff credential files reviewed, there was no evidence of current Hep B status or waiver. Only MD#5 had a current Hepatitis B status.
During an interview with the Medical Staff Director on 8/30/16, at 10:15 am, the Human Resources Director stated the facility monitored yearly flu vaccine and updated TB testing every two years, however did not document Hepatitis B status.
A review of the facility policy and procedure titled " Medical Staff Bylaws and dated December 2015 "under Membership Qualifications " did not include a requirement of a current TB status or Hepatitis B status.

Based on interviews and record reviews, the hospital staff failed to take reasonable steps to ensure patients received information of the patient's rights, including "An Important Message from Medicare" (IM), for one of 30 sampled patients (16).

Findings:

A review of Patient 16's medical record indicated the patient's diagnoses included agitation, paroxysmal atrial fibrillation [(PAF), irregular heartbeat that can lead to blood clots, stroke, and other heart-related complication]. Patient 16 was admitted to the intensive care unit (ICU) on August 12, 2016. Patient 16 was later transferred to the geriatric Behavior Management Center (BMC) on August 19, 2016. The primary language of Patient 16 was Thai.

A review of the following forms, dated August 12, 2016, indicated Patient 16 was unable to sign to acknowledge the information provided:

a. Important Message From Medicare About Your Rights.

b. Notification of Patient Rights, Safety Responsibilities & Grievance Assistance.

c. Advance Healthcare Directive Documentation.

d. Notice of Privacy Practices (NPP) Acknowledgement.

The same set of forms dated on August 19, 2016, was marked as " Refused " in the patient's signature area.

On August 30, 2016, at 10:35 a.m., during an interview and concurrent review of Patient 1's medical records, the Director of BMC (DIR 5) explained when patients were not able to sign or not in the capacity to understand (the above mentioned information on Patient's rights), the staff should try again later or contact patients ' representatives.

On August 31, 2016, at 7:08 p.m. in Patient 16's room, during an interview, Patient 16's family member (FM) stated the patient could not read or write in English, he could not understand long sentences in English, only simple words.

On September 1, 2016, at 12 p.m., during an interview, the Director of Health Information Management (DIR 6) indicated it is facility's expectation for staff to follow up with patient not able to sign and utilize interpreter services for patients whose primary language were not English.

On September 1, 2016, at 12:45 p.m., DIR 5 confirmed that Patient 16 had been discharged on the night prior. At 2 p.m., the registered nurse (RN 10) confirmed after reviewing Patient 16's medical records, that there was no documentation that Patient 16 or his representative received the IM after the refusal and before his discharge from the facility. There was no record showing interpretation service had been used to communicate the patient rights information.

A review of the facility policy and procedure titled "Communications (Special) Services For Patients and Families" revised on December 2015 revealed "Stratus Video Interpreting Service is used to orally translate the form for the patient, and ask the patient to sign the English form if the patient agrees to the terms and conditions that the interpreter orally stated. If the patient or the legal representative agrees, the nurse will document in the electronic medical record the number of the interpreter and language translated for the patient.

Based on observation, interview and record review, the facility staff failed to ensure the patient's presented concern/grievance was promptly addressed for two of 30 sampled patients (2, 19).

Findings:

1. On August 29, 2016, at 2:05 p.m., during the tour of the hospital inpatient ward with the Chief Executive officer (CEO) and the Charge nurse for the Behavioral Management Center (BMC) and the registered nurse (RN 5), Patient 2 was observed sitting in bed talking with a visitor . Patient 1 called over and asked loudly when will he be able to get a shave. Patient 2 touched his beard and stated he had been asking to have his beard shaved and a shower for three days. He also added he has been asking for apple juice or orange juice and has not received it.

On August 29, 2016, at 2:15 p.m., during an interview RN 5 and RN 6 were asked how long a patient should wait after requesting a shave and a shower. RN 5 stated the shaver was missing and RN 6 stated there was only one shaver for the whole unit and it takes time to clean the shaver.

A review of the facility's document titled "San Gabriel Valley Medical Center (SGVMC) Performance Improvement program plan" CY2016, indicated the Performance Improvement plan was designed to ensure that compassionate, high quality care was provided to the facility's patients and the "the SGVMC Hospital Community Board had the ultimate responsibility for the quality of care provided by the facility.



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2. Patient 19 was observed in bed with peripheral intravenous ( IV) line on the left hand and right lower arm. The patient was on oxygen supplement at three liters per minute via nasal cannula.

A family member was at the patient's bedside. The family member stated the RN 12, assigned to the patient, was not addressing his concern when presented to staff. The patient was administered the medication Nitroglycerin (medication used to prevent chest pain in people with a certain heart condition and to treat high blood pressure) and the family member wanted to know the circumstances around it. The family member stated he came to stay with the patient that day from 8 a.m. and left at 12: 30 p.m. and came back at 4:30 p.m. and still did not get a response from the RN.

Based on observation, interview and record review, the facility staff failed to close a privacy curtain during during provision of care for two of 30 sampled patients (16, 18).

Findings:

1. On August 30, 2016, at around 7:15 a.m., in the presence of a certified nursing assistant (CNA 5), the registered nurse (RN 11) was observed conducting Patietn 16's skin assessment. In the room there were patietn 16's family member and a roommate, who was lying in bed next to Patient 16's bed. There was noprivacy curtain between their beds.

During a concurrent interview, CNA 5 stated the staff provides care in front of or in the presence of other patients. CNA 5 also stated the staff could use a portable partition for privacy. However, at the time of the observation, there was no such privacy partition within the room.


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2. On August 25, 2016, at 11:45 a.m., Patient 18 was observed lying on a special bed and being prepared to receive hemodialysis treatment. The Dialysis Nurse was observed cleaning the dialysis access site which was a femoral catheter in the right groin. The Dialysis Nurse was observed did not draw the privacy curtain and/or close the door while performing the cleaning and preparing the patient for hemodialysis. Patient 18 was in full view of visitors and other facility staff members and passerby.

Concurrently, during an interview, the Dialysis Nurse stated "I should have pulled the privacy curtain and/or close the door to ensure patient privacy."

Based on interviews and record reviews, the facility failed to ensure its staff attempted to implement a less restrictive measures prior to application of soft wrist restraints and to have a justification for continued use of restraints for one of 30 sampled patients (16).


Findings:


On August 30, 2016, at 12:30 p.m. a review of Patient 16's nurses progress notes dated August 12, 2016, indicated Patient 16's diagnoses included agitation, paroxysmal atrial fibrillation (PAF, irregular heartbeat that can lead to blood clots, stroke, and other heart-related complication). Patient 16 was speaking Thai with a little English.

A review of the licensed nurses progress notes, dated August 12, 2016, at around 9:52 p.m., indicated patient 16 was "received from Emergency Department, awake but agitated. Two point soft restraints applied and medical doctor (MD) notified. Heart rate irregular ... " There was no other descriptive documentation of Patient 16's behavior leading to the application of a soft wrist restraints, as well as no evidence that alternative/less restrictive measures were attempted prior to the application of wrist restraints.

On August 31, 2016 at 7:08 p.m. in Patient 16's room, during an interview, Patient 1's family member (FM) stated the patient could not read or write in English and could not understand long sentences in English, only simple words.

A review of the physician's order Non-violent/Non-Behavioral Restraint dated August 13, 2016, at 12 a.m., indicated Patient 16 had soft wrist restraints on both hands. On the order, the following boxes of " indication for restraint " were checked: "unable to comprehend or follow directions to refrain from activities that can injure self " and "Impulsive. Observed disconnecting and/or removing therapeutic device(s). " The order form also indicated the order valid for a maximum of seven days, however, under the "Time Limit" , the order indicated "Restrain for seven hours unless indicated below" with no further indications given. The order form further indicated the " criteria for Release " included: Behavior no longer warrants restraints, Utilizing call light and follows directions, Companion (sitter/family) at bedside. There was no evidence that an interpretation service had been used in attempt to communicate with Patient 16 in his primary language to conduct accurate evaluation/assessment.

A review of Patient 16's Non-Violent/Non-Behavioral Restraint Flowsheets dated from August 13, 2016, at 12 a.m. to August 18, 210, at 10 a.m. indicated Patient 16 had been "non-compliant " in behavior throughout except when sleeping. The flowsheets also indicated the "alternatives prior to restraint and interventions to move to least restrictive/removal " did not include the use of interpreter services to communicate with Patient 16 in his primary language prior to care or treatment.

On September 1,2016, at 10:15 a.m., the informatics nurse indicated the restraint order was continued until the morning of August 19, 2016, upon transfer to the Behavior Management Center (BMC).

However, a review of the licensed nurses progress notes, dated on August 14, 2016, at 5:50 a.m., indicated Patient 16 had "no violence nor aggressive behavior noted during the shift. " According to the nurses progress notes dated August 14, 2016, at 6:46 p.m. Patient 16 was cooperative and had no aggressive action today. " According to the licensed nurses notes dated August 16, 2016, at 11 p.m. he patient was "restless, continuously speaking in Thai, getting agitated,...cooperative after bed change."

On September 1, 2016, at 12 p.m., during an interview, the Director of Health Information Management indicated the facility could utilize a real-time video translator service called " Stratus " to assist in communication with a patient whose primary language is not English.

A review of the facility's policy and procedure, titled " Restraints and Seclusion " revised on January/2016, indicated "Restraint for Non-Violent and Non-Self-destructive is a restraint used to limit mobility or temporarily immobilize an acute care patient for reason specifically related to a medical. Post -surgical, or dental procedure... Physical restraint/seclusion will be terminated at the earliest possible time ... "

Based on observation, interview and record review, the facility did not meet the condition for quality assessment an performance improvement program (QAPI) by failing to:
1. Implement an ongoing Quality Assessment Performance Improvement (QAPI) program activities included high-risk or problem-prone areas: implementing an infection control program that followed acceptable standards of practice including; assuring food was stored in a sanitary environment; monitor sterilization processes; inspecting sterilized surgical supplies; storage of sterilized supplies; maintaining the operating room as a sterile restricted area; monitor storage of operating room surgical carts; monitor storage of colonoscopy supplies, assure qualified personnel performed surgical procedures including cutting of polyps during colonoscopy intraoperatively; monitoring surveillance and reporting of hospital acquired infections (HAI); assuring the medical staff obtained current TB and Hep B status; monitor, oversight and supervision in radiologic services and Nuclear Medicine; assure CRT's administering IV contrast and radiopharmaceuticals received proctoring, yearly competency and direct supervision; monitoring of the weekly fluoroscopy readings; assuring physicist recommendations were followed by the radiology department and assure medications administered by CRT's was documented in the medical records. (Refer to A 0283).

The cumulative effects of these systemic problems resulted in the facility's inability to comply with the condition of participation for QAPI program that monitored and assured patient care was provided in a safe and sanitary environment.

Based on observation, interview and record review, the facility failed to ensure Quality Assessment Performance Improvement (QAPI) program activities included high-risk or problem-prone areas: implementing an infection control program that followed acceptable standards of practice including; assuring food was stored in a sanitary environment; monitor sterilization processes; inspecting sterilized surgical supplies; storage of sterilized supplies; maintaining the operating room as a sterile restricted area; monitor storage of operating room surgical carts; monitor storage of colonoscopy supplies, assure qualified personnel performed surgical procedures including cutting of polyps during colonoscopy intraoperatively; monitoring surveillance and reporting of hospital acquired infections (HAI); assuring the medical staff obtained current TB and Hep B status; monitor, oversight and supervision in radiologic services and Nuclear Medicine; assure CRT's administering IV contrast and radiopharmaceuticals received proctoring, yearly competency and direct supervision; monitoring of the weekly fluoroscopy readings; assuring physicist recommendations were followed by the radiology department and assure medications administered by CRT's was documented in the medical records.

Findings:

During an interview with the QAPI coordinator, on 9/2/16, at 2:20 pm, when asked about the ongoing hospital wide projects, she presented QAPI projects for the last year including: Patient satisfaction; ED wait time; pain management and an ongoing project on reducing HAI and early identification of sepsis.

A review of the monthly QAPI meeting minutes dated: 5/9/16, 3/14/16 and 7/11/16 and the ongoing QAPI program failed to: assure food was stored in a sanitary environment; monitor the sterilization process; inspecting sterilized surgical supplies/storage of sterilized supplies; maintain the operating room (OR) as a sterile restricted area; monitor the storage of OR surgical carts; monitor the storage of Colonoscopy supplies, assure qualified personnel performed surgical procedures including cutting of polyps during colonoscopy intraoperatively; monitoring, surveillance and reporting of HAI; assure the medical staff obtained current TB and Hep B status; monitor,oversight and supervision in radiologic services and Nuclear Medicine; assure CRTs administering IV contrast and radiopharmaceuticals received proctoring, yearly competency and direct supervision; monitoring of the weekly fluoroscopy readings; assuring physicist recommendations were followed by the radiology department and assure medications administered by the CRT's was documented in the medical records.
The facility failed to implement a QAPI program that monitored and assured that patient care was provided in a safe and sanitary environment.

Based on observation, interview and record review, the facility failed to provide ongoing pre/post assessment to a patient who was receiving hemodialysis treatment, failed to ensure a hemodialysis order was accurate and complete to meet patient need, failed to include in a care plan for the risk of bleeding interventions to monitor for drug to drug interaction between Aspirin and Xarelto, failed to ensure additional layers of chux pads (disposable underpad that offers incontinent protection for mattress) were not placed between the patient and the surface of the low air loss (LAL) mattress, failed to implement the facility's policy and procedure on "Weight Frequency", failed to ensure the patient would not receive oxygen supplement without physician's order and failed to ensure a patient received an estimated daily fluid requirement for four of 30 sampled patients (16, 18, 19, 20).

Findings:


1. On August 29, 2016, at 12:05 p.m., during a tour of the Behavior Management Center (BMC), Patient 16 was sitting on a wheelchair in the hallway. Patient 16's right forearm had a large area of blackish red discoloration almost covering the entire right posterior forearm. Within the discolored area, there was a blister or a hematoma like (a solid swelling of clotted blood within the tissues) swelling filled with dark red fluid in the approximate size of a quarter coin.


A review of the licensed nurses progress notes dated August 12, 2016, indicated Patient 16 had no skin issue on admission. Patient 16's diagnoses included agitation, paroxysmal atrial fibrillation (PAF, irregular heartbeat that can lead to blood clots, stroke, and other heart-related complication).


A review of Patient 16's medication orders indicated the patient has been receiving Xarelto (an anticoagulant used to prevent blood clots) and Aspirin since admission to the facility. Patient 16 was admitted on August 12, 2016, to the Intensive Care Unit (ICU) and then later transferred to the BMC on August 19, 2016.


According to the Cardiology Progress Note, for Patient 16 dated August 13, 2016, at 8:03 p.m. the licensed nurses had to monitor the patient for possible bleeding.


On September 1, 2016, at 11:15 a.m., a review of the electronic medical records with the registered nurse (RN 10) indicated there was a care plan with interventions to monitor for bleeding starting on August 22, 2016, at 4:23 p.m. However, there was no evidence that a physician was notified of the increase in the sizes of the bruises, as well as the development of the swelling of dark red fluid within the skin tissue located where the right forearm bruises were.


A review of Patient 16's multiple wound assessments indicated the discolored area on the forearm was noted on August 10, 12 and 24, 2016.


On September, 2016, at 12:45 p.m. Pharmacist 1 presented evidence of drug-drug interaction for Patient 16's Xarelto and Aspirin which indicated a major risk of bleeding. Pharmacist 1 confirmed there was no documentation of any clinical intervention performed related to the above mentioned drug interaction.


A review of facility's policy and procedure, titled " Documentation: Education, plan of Care " dated July 2015, indicated " ...interdisciplinary team members will ... initiate ... update the Plan of care according to Care/Nursing Process from admission to discharge in the EMR (electronic medical record) ... "


2. On August 30, 2016, at around 7:15 p.m., an observation of RN 11 performing Patient 16's skin assessment was conducted in with the presence of a certified nursing assistant (CNA 5), Patient 16's family member and other health facility evaluator nurse. Patient 16 was lying on a low air loss mattress with two chux pads between Patient 16 and the top of the mattress with flat sheet.

A review of the facility's policy and procedure, titled "Linen Utilization" dated May 2015, indicated "addition layers of linen items or incontinent pads should not be placed not placed between patient and the mattress. Excessive linen defeat the purpose of the therapeutic LAL mattress."


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3. A review of the medical record indicated Patient 16 was transferred from the intensive care unit to the Behavioral Medicine Center (BMC) on August 19, 2016.

A review of the Graphic and intake and output (I & O) record from August 19 to 30, 2016, indicated upon admission on August 19, 2016, Patient 16's weight was 103 pounds (lbs) (GM bed scale). There was no other weight documented after the admission weight.

During an interview on August 31, 2016, at 2:20 p.m., the charge nurse on duty at the BMC during the 7 a.m. to 7 p.m. shift, after reviewing the I & O flow sheet stated the patient should have been weighed on August 29, 2016.

During an interview on September 1, 2016, at 12:10 p.m., the registered dietician (RD), after reviewing the Patient 16's I&O record, stated there were no other weights recorded.

A review of the facility's policy and procedure titled "Weight Frequency" dated December 2015, stipulated patients will be weighed on admission and weekly unless ordered more often by the physician. Record weight on the Electronic Medical Record under Graphic Record or Unit-specific flowsheet. Indicate the type of scale used. Use the same scale whenever possible.

4. A review of Patient 16's Comprehensive Nutritional assessment dated August 24, 2016, indicated the patient's estimated fluid requirement was 1341 milliliter (ml) daily.

A review of the I&O indicated the following:
1. On August 20, 2016, the patient received 720 ml.
2. On August 21, 2016, the patient received 240 ml.
3. On August 22, 2016, the patient received 720 ml.
4. On August 23, 2016, the patient received 770 ml.
5. On August 24, 2016, the patient received 445 ml.
6. On August 25, 2016, the patient received 880 ml.
7. On August 27, 2016, the patient received 1390 ml.
8. On August 26, 2016 the patient received 700 ml.
9. On August 28, 2016, the patient received 400 ml.
10. On August 29, 2016, the patient received 101 ml.
11. On August 30, 2016, the patient received 150 ml.

During an interview on September 2, 2016, at 12:05 p.m., the charge nurse stated the patient needed assistance with fluid intake. After reviewing the I&O record from August 20 to 30, 2016 the charge nurse confirmed fluid was not offered to the patient as estimated daily needs.

A review of Lippincott Nursing Procedures Seventh Edition provided by the facility regarding recording fluid I&O stipulated to notify the practitioner if amounts differ significantly over a 24 hour period.



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4. On August 25, 2016, at 11:45 a.m., Patient 18 was observed lying on a special bed and being prepared to receive hemodialysis treatment.
The patient was connected to the hemodialysis machine and the dialysis treatment started. The patient was observed dialyzed on a 2 K (Potassium) and 2.5 Ca (Calcium) bath, using a F160 NR dialyzer, with blood flow rate (BFR) of 300 and dialysate flow rate (DFR) of 500.

According to the laboratory test result dated August 17, 2016, the patient's Hepatitis B antibody (Surf Ab) was less than five.

A review of the Hemodialysis Record indicated the following:
a. On August 29, 2015, Dialysis Nurse (DN) documented F160 dialyzer, BFR of 300, DFR of 500 and administered 100 milliliters (ml) of fluid twice during treatment indicating vital signs stable.

There was no written documentation of the type of fluid administered and why it was administered. During pre/post treatment assessment, there was no written documentation of patient's actual weight taken. During pre-treatment assessment, it was documented the patient had +3 edema (swelling) on the lower extremities. During post-treatment assessment there was no written documentation to indicate edema was assessed after treatment.

A review of the physician's order dated August 28, 2016 indicated dialysis in the morning 3 ½ hours, large dialyzer, 2 K bath, no Heparin, and support blood pressure (B/P) with Saline.

b. On August 27, 2016, DN documented F160 dialyzer, 2 K bath, BFR of 250 and DFR of 500. During pre/post treatment assessment, there was no written documentation of patient 's actual weight taken. During pre-treatment assessment, it was documented under edema the patient had "same."

A review of the physician's order dated August 24, 2016, indicated dialysis in the morning 3 ½ hours, large dialyzer, 2 K bath, no Heparin, support B/P with Saline.

c. On August 25, 2016, DN documented F160 dialyzer, 2 K bath, BFR of 300, DFR of 500 , and administered 100 ml of fluid five times, 50 ml once and 160 ml once during treatment. It was documented that Epogen of 10,00 units was administered subcutaneously (SQ) after hemodialysis (HD).

There was no written documentation of the type of fluid administered and why it was administered. During pre/post treatment assessment, there was no written documentation of patient's actual weight taken. During pre-treatment assessment, it was documented the patient had +3 edema on the lower extremities. During post-treatment assessment there was no written documentation to indicate edema was assessed after the treatment.

A review of the physician's order dated August 24, 2016, indicated dialysis in the morning, 3 ½ hours, large dialyzer, 2 K bath, no Heparin, support B/P with Saline and Epogen 10,000 unit SQ after HD.

d. On August 23, 2016, DN documented F160 NR dialyzer, 3 K bath, BFR of 300, DFR of 500 , administered 200 ml of Normal Saline during treatment without written documentation to indicate why it was administered. During pre/post treatment assessment, there was no written documentation of patient's actual weight taken. During pre-treatment assessment, it was documented the patient had increased bilateral edema.

There was no written documentation of the assessment of the location of the edema and the degree of the edema. During post-treatment assessment there was no written documentation to indicate edema was assessed after treatment.

A review of the physician order dated August 22, 2016, indicated dialysis in the morning 3 1/3 hours, large dialyzer, 3 K bath, no Heparin and support B/P with Saline.

Further review of the Hemodialysis Record on August 21, 19, 17, 15, 13, 11, 10 and 8, 2016, indicated similar concerns like aforementioned records.

During an interview with Dialysis Nurse on September 1, 2016, at 8:50 a.m., while reviewing the patient's clinical record, she stated the physician hemodialysis treatment orders was incomplete as the there was no Calcium bath, no blood/dialysate flow rate (B/DFR) , the type of dialyzer, amount of Saline to be administered to support the B/P reading parameter of the patient. DN further stated they only have F160 NR dialyzer in their supply. The presence and/or absence of edema pre and post treatment should be assessed, including the location and degree of the edema, amount of Normal Saline administered and documented in the Hemodialysis Record. The physician should be notified or referred to the physician regarding patient's Hepatitis B status for suitable action.

5. Patient 19 was observed in bed with peripheral IV lines on the left hand and right lower arm. Patient 19 was receiving oxygen at three liters per minute via nasal cannula. The oxygen line did not have a label to indicate when it was initially in use.

The oxygen saturation cord and oxygen tubing were noted to be on the floor and the staff was observed placing them back on the bed without disinfecting/or cleaning cord and tubing first.

During an interview with Patient 19, at the time of observation, she stated the IV lines were placed yesterday on August 22, 2016, and staff is just labeling it now. The patient added that she was on oxygen supplement since her admission which was five days ago.

6. On August 25, 2016, at 8:45 a.m., together with the registered nurse (RN 13), Patient 20 was observed in bed and receiving three liters of oxygen per minute via nasal cannula. A review of Patient 20's clinical record with RN 13, indicated there was no written documentation of a physician order for oxygen. Concurrently, during an interview RN 13 confirmed there was no physician's order for oxygen.

Based on observation and record review, the facility failed to ensure the staff labeled medications in procedural or patient care areas, failed to ensure its staff accurately documented the administration of medication and failed to ensure its staff followed the nursing pain assessment guidelines for patient who was on Morphine (a narcotic analgesic and a potent opioid for pain management) patient controlled analgesia (PCA) for two of 30 sampled patients (12,16).

This failure had the potential of inadequate patient monitoring leading to unnecessary pain suffering, adverse side effects, and/or medication errors. and/or adverse effects.


Findings:

1. On August 23, 2016 at around 12 p.m. during an inspection of a Computerized Tomography[(CT), a series of x-ray images taken from different angles and uses computer processing to create detail image inside the body] Scan room with the Director of Pharmacy and Imaging Services (Dir 1) and Staff 5, there was no patient in the CT Scan room.

In a corner of the CT Scan room, there was a pole. The pole had a vial of Omnipague (a diagnostic contrast solution) and a bag of intravenous (IV) normal saline solution hanging on it. The vial of Omnipague was full and there was a set of IV tubing connected to vial. there was no medication label affixed to the vial of Omnipague indicating patient's name, medication name and dose, date and time of administration. There was no indication when the vial of Omnipague was spiked (the act of connecting the IV tube to the vial). On the bag of Normal Saline, there was a written marking of " 8/23/16 " , however, there was also no label as to patient's name, medication name and rate of administration.

A review of the facility's policy and procedure, titled " Medication Management Medication Labeling," dated October 2015, indicated " ...to label all medications, medication containers ... in perioperative and all other procedural settings ... Medications include any prescription medication, ... diagnostic and contrast agents used on or administered to a person ... radioactive medications, respiratory therapy treatments, parenteral nutrition, blood derivatives, intravenous solutions ... and any product designated by the Federal Drug Administration (FDA) as a drug. "


2. On August 30, 2016, at 1:40 p.m., a review of Patient 16's medication records indicated Xarelto 15 milligram (mg) to be given daily starting on August 13, 2016. The medication record indicated there were two administration records of Xarelto for Patient 16 by the same nurse on August 18, 2016, at 12:25 p.m. and at 12:31 p.m. respectively. Xarelto is an oral anticoagulant, a blood thinner, used to reduce the risk of stroke and prevent blood clots in patient with certain heart problems. The adverse effect of Xarelto includes risk of bleeding.


During a concurrent review and an interview, Pharmacist 1 acknowledged the potential medication error implied by these two administration records on August 18, 2016. Pharmacist 1 stated the two records might be duplicated entries, a mistake, by the administering nurse. The nurse who made the two administration entries was not available for interview. There was no nursing documentation related to the two consecutive medication administration entries.

A review of the facility policy and procedure, titled " Medication Management: Medication Administration Record (MAR), revised on October 2015, indicated MAR as the "only permanent and complete record of all medications that the patient has received at the facility. Chart the administration of medications immediately after administration. "


3. On August 30, 2016, at around 2:15 p.m., a review of Patient 12's Post-Op Major Surgery Orthopaedic Pain Protocol, dated on August 15, 2016 at 7 p.m., revealed Patient 12 was receiving Morphine PCA to manage post-surgery pain. The order also indicated nursing staff to "Monitor respirations, blood pressure, sedation level and pain 30-60 minutes after any dosage change per Nursing Pain Reassessment guidelines, then every two hours while on PCA. "

During concurrent review of Patient 12's licensed nurses progress notes with Admin 1 confirmed there was no evidence that nursing staff monitored Patient 12 every two hours.

Based on observation and interview, the facility failed to protect medical records from destruction.

Findings:

During a tour of the medical records department on August 23, 2016, at 2:15 p.m., the medical records were observed stored on open rolling shelves. The room was sprinklered.

At the same time, during an interview, the health Information Management technician stated the open rolling shelves were always used to store the medical records.

Based on interview and record review, the facility staff failed to follow the facility's policy and procedure in alteration and amendment of a patient's record. A nursing erased signature information on the original record instead of amending or creating a new record for one of 30 sampled patients (16). This deficient practice had the potential for incomplete and inaccurate medical record.

Findings:

A review of Patient 16's medical record indicated patient was admitted to the intensive care unit (ICU) on August 12, 2016 and was later transferred to the geriatric Behavior Management Center (BMC) on August 19, 2016.


On August 29, 2016 at around 12:10 p.m. a review of Patient 16's "Telephone and Visiting Consent " dated August 19, 2016 at 8 p.m. indicated the contact information of a family member. However, "Refused " was written in the area of "Patient Signature " with a witness. The rest of the form was left mostly blank.


On August 30, 2016 at 10:45 a.m., director of behavioral management (DIR 5) stated when patient is not able to sign or not in the capacity to understand, as in this case, staff should try again in a few hours or contact patient's representatives.


On August 30, 2016 at 6 p.m. DIR 5 presented another copy of Patient 16's "Telephone and Visiting Consent " and stated the BMC used this form to obtain consent from Patient to release admission information to family member. A review of this copy presented by DIR 5 compared to the copy received earlier indicated the signatures and witness signatures appeared to have been erased and altered: where it was noted " refused " , now had an illegible scribble and a different witness signature. However, both copies had the same date and time of documentation. When asked who the witnesses were, DIR 5 could not answer.


On August 30, 2016 at 7 p.m. during an interview and a review of the forms mentioned above, the Director of Information Technology (DIR 8) stated the copies were printout of the electronic version. DIR 8 also stated the signature fields on the consent form should not be altered by staff. DIR 8 confirmed that the date and time fields of the electronic form were editable. The date/time fields allowed free text and did not auto-population of the time of documentation. DIR 8 presented a copy of the screen shot indicating the above mentioned electronic form was last updated by the registered nurse (RN 11) on August 30, 2016 at 5:59 p.m.


On August 30, 2016 at 7:20 p.m., during an interview, RN 11 stated DIR 5 had instructed her to follow up with Patient 16 regarding the " Refused " in the signature field on the " Telephone and Visiting Consent." RN 11 proceeded to demonstrate how she could erase previously entered information from the electronic form on a computer workstation. RN 11 stated she printed out the paper form after erasing the " Refused " note in the Patient signature field then had Patient 16 signed. RN 1 stated she forgot to change the date and time. RN 11 agreed previous record should not be altered and stated she should have started a new form instead of changing the previous form.


On September 1, 2016 at 12:12 p.m., during an interview, DIR 6 stated the "Telephone and Visiting Consent " form is considered a part of the patient health record. DIR 6 stated any update or changes in the medical record should have documentation of revised or amended date and time. DIR 6 agreed patient signature fields in electronic forms should not be deleted or erased after the form had been submitted; staff should generate a new form with the revised date and time.


A review of the facility's policy and procedure, titled " Alteration in the Patient Health Record (PHI) " and dated July 2015, indicated "The patient ' s health record may not be changed or altered in any manner ... Amendments to the health care record are additions (by the health care staff) which: 1. provide additional facts not available at the time original entries are made. 2. Provide evidence that the information originally recorded in the record is in error ...3. Explains or clarifies missing or incomplete entries ...The original entry in a health record is never altered, destroyed, or removed from the record. An amendment is included in the original record and contains ... date and time of amendment ... "

Based on interviews and records review, the facility failed to ensure the prescriber timed and signed or authenticated written medication orders of Morphine Sulfate (MS) Contin and Oxycodone (morphine and morphine derivative, both are controlled substance class II used in pain management) for one of 30 sample patients (12). This failure has the potential for incomplete medical record and/or medication error.

Findings:

On August 30, 2016 at around 12:30 p.m., a review of Patient 12's medical records revealed a written physician's order of MS Contin and Oxycodone dated on August 17, 2016. However, the order date, nurses signature, physician's 's signature, date and time were blank. There was a color sticker attached to right edged of the order as a reminder to the physician to sign the order. There was a pre-printed note above the physician's order form: " IGN, TIME & DATE ALL ORDERS; SIGN TIME & DATE ALL TELEPHONE ORDERS WITHIN 48 HOURS " .

On August 30, 2016 at around 2:15 p.m., during an interview, Administration 1 stated the prescriber should sign all orders within 48 hours.

A review of the facility's policy and procedure, titled "Orders: Physician" dated December 2015, "Color-coded indicators are to be placed on the Physician's order sheet to identify that the physician's signature is required ... "

Based on medical review and interview, the facility failed to implement their policy and procedure titled Admission Procedure.

Findings:

A review of Patient 16's medical record indicated the patient was admitted to the intensive care unit (ICU) on August 12, 2016.

A Personal Valuables Notification dated August 12, 2016 was completed indicating the patient had no valuables. On the Patient's Signature, the following was written "Patient unable to sign-5150. "

During an interview on September 2, 2016, at 12:15 p.m., the Health Information Management director stated there was no Personal Valuables Notification form completed during the admission on August 12, 2016 in the ICU.

A review of the facility's policy and procedure titled Admission Procedure dated October 2015, stipulated all clothing and other items are sent home with the family/significant other but clothing and other items retained by the patient(including hearing aids, dentures, and glasses) is listed on the " Inventory of Personal Belongings " form. The electronic form is in medical record along with the admission assessment form. The form is updated each time a patient is transferred or discharged as a means of tracking patient's possessions.

Based on observation and record review, the facility failed to ensure an emergency drug supply (a malignant hyperthermia cart) had a list of the contents on the outside of the cart, failed to ensure the medication storage area in the Emergency Department (ED) had sufficient space for medication storage and preparation and failed to ensure medications and food were stored separately.

This deficient practices had the potential to cause delay during a medical emergency, medication error and hazardous work environment.


Findings:

1. On August 25, 2016 at 2:30 p.m., during an inspection of the Malignant Hyperthermia [(MH), is a rare but potentially fatal reaction to certain medications used in anesthesiology) cart in the presence of the Director of Pharmacy and Imaging Services (Dir 1), Pharmacist 1, and the registered nurse (RN 7), Director 1 confirmed the MH cart did not have a content list on the outside of the cart.


2. On August 25, 2016 at 11:40 a.m., during an inspection of the medication room in the ED with Director 1, Director 2, and Pharmacist 1, there were two 2-shelves push carts full of phlebotomy supplies inside the medication room. The carts were blocking access to the medication refrigerator, medication cabinets, and the counter space.


3. On August 23, 2016, at 12:25 p.m., during an inspection of the medication area inside X-ray room 1 with Director 1, the following food items were found inside the medication cabinet on the left and above the sink: three packs of saltine crackers, one cup of apple sauce, and one cup of peaches. Director 1 stated there should not be food items in the medication storage area.

Based on observations and interviews, the facility failed to ensure the medication refrigerator located in the Neonatal Intensive Care Unit (NICU) patient care area was locked properly. This failure had the potential to allow unauthorized access to medications (controlled and non-controlled substances) which may or may not affect patient safety.

Findings:

On August 25, 2016 at 10 am, during a tour of the NICU in the presence of multiple NICU staff and Pharmacist 1, there was a medication refrigerator located in the patient care area next to the crash cart and between two rolls of NICU beds. When Evaluator asked if the refrigerator was locked, the registered nurse (RN 6) replied affirmatively. However, Evaluator was able to pull the refrigerator door opened; RN 6 did not engage the hasp over the metal loop before placing the padlock through the loop.

A review of the facility's policy and procedure, titled "Medication Management: General " dated October 2015, indicated all medications (non-controlled, controlled, and refrigerated medications) had to be locked.

Based on observations and interviews, the facility failed to ensure keys to unlock the medication cabinets were not accessible to non-licensed staff in the Radiology Department.

Findings:

On August 23, 2016 at 12:15 p.m., during a tour of the Radiology Department, Evaluator asked to inspect the locked medication cabinets. Evaluator and the Director of Pharmacy and Imaging Services (Dir 1) followed Staff 5 to the Radiology department file room. Upon entry to the room, Staff 5 pulled out a key chain of many keys from an unlocked top drawer of a desk located on the left of the entrance. There were multiple staff members in the room. Dir 1 confirmed there were both licensed and non-licensed staff in the room and they had access to the room. There was potential for non-licensed staff to access the key thus gaining access to the medication storage areas.

According to the facility policy and procedure, titled "Medication Management: Administration of Medications by Ancillary," dated 10/2015, under Diagnostic Imaging Services, "these drugs are double locked and key, in the Special Procedures area. "

A review of the facility policy and procedure, titled " Medication Management: General," dated October 2015, indicated all medications (non-controlled, controlled, and refrigerated medications) will be locked. This policy also implied licensed staff requiring access will be given access. Non-licensed staff need access must be observed by a licensed staff.

Based on observation, interview and record review, the facility failed to meet the condition for radiologic services as follows:
1. The radiology department failed to oversee the weekly fluoroscopy monitoring. There was no documentation of following the physicist recommendation and contacting the physicist to recalculate the Baselines for fluoroscopy. (Refer to A 0537)
2. The radiology department failed to directly supervise procedures requiring contrast and train and proctor CRT's. There were no radiologic services, initial training, proctoring and yearly competency evaluation of certified radiology technicians (CRT) who administer IV contrast to patients. (Refer to A 0547)
The cumulative effects of these systemic problems resulted in the facility's inability to provide Radiology services in a safe Manner and failed to follow recommended guidelines for the safe use of the C-Arm guidelines provided by the physicist.

Based on observation, interview and record review, the facility failed to ensure that periodic inspection of lead shielding apron was made and hazards/concerns identified must be corrected and failed to ensure the radiology department oversee the weekly fluoroscopy monitoring.


Findings:


1. On August 25, 2016, at 2:15 p.m., during the tour of the surgical suites with Director 9, it was noted that there were seventeen lead shielding aprons were observed hanging on a metal rack by the hallway. One of the seventeen lead shielding aprons did not have a label to identify it.

Director 1 provided a Lead Shielding Devices Inventory List indicating seventy six (76) total number of lead shielding aprons, 23 of which was for surgery department, 27 of which was for special procedure, 21 of which for X-ray #4, ultra sound (US), nuclear medicine (NM), CT Scan, portable and Dexa and 5 of which was for women center (WC), ultra sound/Mammography.

A review of the Semi- Annual Check of Lead Shielding Devices indicated the following:

a. For Surgery Department dated February 26, 2016, indicated there were 24 listed and one of the lead shielding's operating room (OR 5A) had small pin hole and it was retained for use. On August 16, 2016 indicated there were 24 listed and the documentation was "Ok" to all . The lead shielding item No. OR 5A was checked in February 26, 2016, that had pin hole when re-checked in August 26, 2016 indicated it was "OK" and was retained for use.

b. For Special Procedure, X-ray, Room 1 dated January 7, 2016, indicated there were 42 lead aprons were checked. The report indicated Items No. LLT, LLU, LLL had small crack, G18 had a small crack and 5AA had small pin hole and disposition was to retain the lead shielding's for use. On July 14, 2016, indicated there were 27 lead shielding checked. The report indicated item number G18 had line crack and the disposition was to retain the lead shielding for use.

c. For CT Scan, US, Dexa, Mammo, WC, Room 2, Room 4 and NM dated January 7, 2016, indicated there were 32 lead shielding were checked. The report indicated items number 2 B had small pin hole, T1 had small pin hole, 4AA had small hole, J1 had small line crack, 5C had small crack and the disposition was to retain the lead shielding for use. Item number DX had big crack and disposition was to use only in Dexa.

d. For X-ray number 4, US, Nuclear Med, CT, Portable and Dexa dated July 15, 2016, indicated there were 21 lead shielding checked. The report indicated items number J2 had small line crack and 2B had pin hole and disposition was to retain for use. Item number Dexa had cracks and disposition was to use on Dexa only.

During an interview with Staff 5 on August 29, 2016, at 9:30 a.m., in the presence of Director 1, stated it is his job to make sure lead shielding (apron) was checked for leaks, pin holes, any tears and cracks under fluoroscopy. If there's any small cracks, tears, the apron is taken out of use. When the log was shown with item number indicating cracks/holes/tears and the disposition was retained for use or use only in Dexa scan. He stated the vendor told them the Dexa scan does not emit radiation but he doesn't believe but the apron was still in use. Then log into the Semi-Annual Check of Lead Shielding Device Form and the image was saved in PACS (Pictures Archive Communication System) and retrieved. However, there was no written indication what type of shielding devices were tested and no written signature or initial as who did the shielding test in the Semi-Annual Check of Lead Shielding Device form. He also stated that the Radiation Safety Officer and/or the Director of Radiology was never inform of the test results.

During an interview with Director 1 on the same day at 10 a.m., he concurred that there was no oversight from the Radiation Safety Officer or Director of Radiology after the shielding test had been performed. The decision to remove and/or retained lead shielding for use that had big/small cracks/tears/holes lays on the technologist.

A review of the facility policy titled "Radiation Safety Program" indicated bi-annual test are done on all lead aprons, gloves and protective shielding for patients and staff that are used, are tested with the fluoroscopy machine for any tears, folds and any defects and any defective protective gear are pulled from the department and disposed of properly.


31993

2. On August 24, 2016, at 3:00 pm, during an interview, radiology director (RD) stated there were four fluoroscopy machines (C-ARMS). A review of the Facility Fluoroscopy logs, RD and RS indicated the Fluoroscopy monitoring log was completed weekly by a CRT. A review of the Fluoroscopy log titled "Weekly Fluoroscopy Monitoring " indicated Shiatsu room 1(C-ARM 1); (Mobile Philips C-Arm (C-ARM 2) Mobile GE C-ARM in cyst (CARM 3); Mobile Siemens CARM (CARM 4) had last documented Fluoroscopy monitoring on July 24, 2016. When RS was asked why no entries were made after July 24, 2016, he did not know. A review of C-ARM 4 did not have any baseline value in the reference section from February 2016 to July 2016 according to the Fluoroscopy monitoring log. When RS was asked if MD 6 reviewed the weekly Fluoroscopy log, he indicated she did not review the logs weekly.

During an interview with RS on August 24, 2016, at 3:15 pm, he indicated a contracted physicist reviews the radiation equipment annually. All repairs and maintenance of the radiation emitting equipment is done by the manufacturer or the contracted service provider. A review of the list of service calls from September 1, 2015 to August 1, 2016 indicated 22 service calls including preventive maintenance (PM) and repair of the Facility C-ARMS. When asked if the physicist had evaluated the C-Arms after repair, he indicated the physicist had not evaluated the C-ARMS after repair service. There was no documentation that the fluoroscopy reading Baselines were recalculated by the physicist.

A review of a facility document titled, "Weekly Fluoroscope Monitoring indicated, "Baseline values are the measurements taken at the time the yearly physicist report is performed. New baseline values must be established if any repairs or maintenance is performed on this machine. If indicated kVP or mA is outside of the above range, notify your Department Manager immediately. This machine CANNOT be used until repaired."

There was no documentation on the Weekly Fluoroscope Monitoring indicating the physicist established new baseline for the kVP range and the mA range for any of the four C-ARMS after a service repair or maintenance.

There was no documentation on the Weekly Fluoroscopy Monitoring log after July 24, 2016. The radiology department failed to oversee the weekly fluoroscopy monitoring. There was no documentation of following the physicist recommendation and contacting the physicist to recheck the Baselines for fluoroscopy. A review of the Radiology safety committee meetings minutes dated March 22, 2016 and June 15, 2016 did not discuss these findings. There was no documentation of following the physicist recommendation and contacting the physicist to recalculate the Baselines for fluoroscopy.


A review of the facility policy and procedure, undated and titled, "Diagnostic Imaging Services, Department Safety and Maintenance" stipulated the " The Imaging services are under the direct supervision of the Medical Chief Radiologist, who is responsible to the Chief Medical of the Medical Staff and the Governing Body."

The Facility failed to follow its own policy and Procedure and provide Direct Supervision during Radiologic procedures and while writing IV contrast orders; follow physicist guidelines for maintenance of C-ARMS and provide direct supervision radiology services in a safe environment. The facility also failed to provide documentation of radiology consultant reviews, training of personnel qualified to use the radiologic equipment, and quality improvement studies regarding radiological services.

Based on observation, interview and record review, the radiology department failed to directly supervise procedures requiring contrast and train and proctor certified radiology technicians (CRT).

Findings:

During an initial tour of the computed tomography (CT) room on 8/23/16 at 11:30am, there were no patients or staff present. There was a 500ml bag of normal saline intravenous (IV) solution bag attached to IV tubing, with no patient name and with a time label of 8/23/16 at 11:30 and an Omnipaque 150 ml with no patient name was hanging on an IV pole. When asked who prepared the Normal saline IV and the IV contrast, the Radiology Department Director (RD) and the Radiology Technician Supervisor (RS) explained that certified radiology technician 2 (CRT2) was preparing the contrast for a patient getting a CT and would be right back. At 11:40 am, on 8/23/16 CRT2 returned to the CT room. When asked if he prepared the IV solution hanging, he stated he prepared it for Patient 2 in the emergency department (ED) for a CT of the abdomen with contrast but had to wait and take another patient from the ED with a head injury first. When asked if CRT2 would administer the IV contrast to Patient 2 without the direct supervision of a radiologist, both the RS and RD stated CRT can set up and administer contrast for patients without the presence of a physician in the CT room. When asked how the CRT calculates the dosage for contrast given to the patients, the RD provided a document providing instruction and the RS explained the computer also calculates the dosage.

During a review of Patient 2's, medical record dated 8/23/16, there was an order from MD12 indicating "CT Abdomen Pelvis W IV only no PO contrast." A review of the medical record did not include an order from the Radiologist indicating the dosage of contrast to be administered. A review of the radiology report dated 8/23/16 and titled "CT Scan of the Abdomen and Pelvis with Contrast," the procedure was signed by MD11 and did not include documentation of administration of IV contrast for the CT of the abdomen with contrast by CRT2. On 8/24/16 at 4:50 pm, when asked why the administration of contrast by CRT2 was not included in the procedure note signed by MD11, both MD6 and RD indicated there is a place in the computer where the CRT inputs the information about administration of IV contrast; however it is not printed as part of the Medical record. When RD and CRT1 were asked to print the documentation of the IV contrast dosage and administration documented by CRT2, they were unable to print the requested document.

During an interview with the RD on 8/24/at 2:45 pm, when asked where the Radiologist order for the CT with contrast for Patient 2 was documented, there was no Radiologist order available for review. CRT2 stated that all the Radiology Technicians (RT's) use a protocol for all CT with contrast orders. When asked if there was an initial training, proctoring or yearly competency including dosage and administration of IV contrast solution, he indicated there was none. When asked about inservices, initial and yearly proctoring for radiology procedures by the CRT, including administration of IV contrast, there were none.

During an interview with MD6 on 8/24/16 at 4:40pm, MD6 indicated the Certified Radiology Technicians were trained prior to being hired at the Facility. MD6 indicated CRTs knew how to give IV contrast and could work independently. MD6 discussed the protocol for IV administration and indicated CRTs give contrast without a radiologist present.

On 8/24/16 at 10:50am, during a review of CRT2 credential files with the HR director, it included a document titled "employee progress report" signed 5/7/14 by CRT2 and RD and a document titled "Performance Appraisal and Competency Evaluation" signed 11/12/15 by CRT2 and RD. A review of CRT2's competencies included CT procedures and CT assisted biopsy. When asked were there any initial clinical skills competency and proctoring of any of the CRTs upon initial hire, he indicated the "employee progress report" and the "Performance Appraisal and Competency Evaluation" reviewed above were the only documents which were signed off by RD. There was no documentation of any initial proctoring and yearly skills competency evaluation of the CRT's by a qualified medical personnel.

A review of the Facility Policy and Procedure dated 3/8/12 and titled, "Diagnostic Imaging Agents" stipulated "The radiologist performing the procedure will specify the type and amount of contrast material to be used" and "When contrast material is required for examination, it will only be administered by a qualified physician." And, " During an angiographic or CT scan, the contrast material may be given via the Media pressure injector ...under the direct supervision of the performing physician. And "Only Technologists with training ...are permitted to inject IV iodinated contrast under the direct supervision of a staff radiologist and /or physician."

Based on interview and record review the facility failed to ensure its policy and procedure for "Look Back for Red Cross Positive Donor" included documentation about patients' notification regarding potentially infected blood product.

Findings:

A review of 21 notifications from the blood collecting agency to the facility of potentially infected blood products from 2014 to 2016 indicated 17 required no notification as per medical director's review. There was one case where the blood product was discarded in 2015 per collecting agency's recommendation. There were two cases where the physician was notified (one case in 2014 and one case in 2015). There was one case in 2014 where three attempted phone calls were made to the patient and the medical director documented in the notification letter.

During an interview on August 23, 2016, at 2:40 p.m., the director of laboratory services stated the medical director of laboratory services reviewed the notification letters from the blood collecting agency regarding potentially infected blood products. The medical director made the decision whether notification was necessary or not. He stated he was not aware if there was documentation in the patient's medical records that the patient was notified.

During an interview on August 25, 2016, at 9 a.m., the medical director for laboratory services stated there was no documentation in the patient's medical record regarding the notification of potentially infected blood. He further stated he was not aware if the physician documented in the patient's medical record about it.

A review of the facility's policy and procedure titled Look Back for Red Cross Positive Donors indicated it did not include documentation of patient notification in the patient's medical record.

Based on observation, interview and record review, the facility failed to maintain a clean and safe environment.

Findings:

1. During a tour of the facility on August 23, 2016, at 2:02 p.m., in the room with the sign "Education Department Learning Center" there were four linen carts from the contracted linen company. There was one linen bin with the date of August 21, 2016, on the attached paper. There were two linen bins with the date August 22, 2016, on the attached paper. There was one linen bin with the date August 19, 2016, on the attached paper. The clean linen inside the bins were observed being exposed and not in plastic. There was a cloth cover partially covering the clean linen.


During an interview on August 23, 2016, at 2:08 p.m., the director of environmental services stated the cloth cover should be on the top portion of the bin.


2. During a tour of the intensive unit (ICU) on August 23, 2016, from 2:55 p.m. to 4 p.m., the following was observed:

a. ICU rooms 1 to 11 had material like lining on the door. There was a Contact Precaution sign posted on the wall outside the door for Room 1, 7 and 10.

b. In the ICU, in the Tower, rooms 21-28 had material like lining on the doors. Concurrently, during an interview, the director of environmental services (EVS) stated the material like lining on the doors were sealers.

During an interview on August 26, 2016, at 5:05 p.m., the director of EVS stated EVS staff hardly cleans doors in the intensive care units.

3. During a tour of the facility on August 24, 2016, at 8 a.m., in the boiler room located in the basement there was a window screen detached with accumulation of dust.

4. During a tour of the facility on August 24, 2016, at 6:50 p.m., an EVS staff member was pulling a linen bin in the hallway. The bin contained five bundles of blankets with five blankets in each bundle. The clean blankets were not covered. Concurrently, during an interview, the EVS staff member stated he was bringing the blankets to the emergency department.

5. During a tour of the loading dock on August 25, 2016, at 8:39 a.m., there was a linen bin with a date of August 24, 2016, that was filled with carton boxes.

During an interview on August 25, 2016, at 8:50 a.m., the director of environmental services stated the linen bins were used because there was only one trash bin (tipper) available for the empty carton boxes.

6. During a tour of the telemetry unit on the second floor, on August 25, 2016, from 4 p.m.- to 4:56 p.m., the following was observed:

a. In the soiled utility room, the linen bin had trash and debris. There was trash on the floor.

b. In the clean utility room, the hot water pedal in the handwash sink was not visible. Only cold water pedal was in place for staff to use.

c. In room 208, in the restroom, a pile of clean paper towel was stored on top of a wall mounted shelf. The paper towel dispenser was empty.

d. Same day at 4:18 p.m., the janitor closet was left unlocked.

e. In the storage closet, there were two pairs of crutches and a wheelchair. The floor was dusty, the ceiling vent was covered with thick layer of dust and cobwebs.

f. At 4:26 p.m., in the dirty utility room, the floor was dirty.

g. At 4:31 p.m., in the restroom of room 220 (a two beds room), the ceiling was dusty. Clean paper towel was stored on top of the paper towel dispenser. The geri-chair had torn upholstery. The window screen was detached. On the lower section of the side table fro bed B, there was a sequential compressor device and a tubing. The patient in bed B was discharged at 3 p.m., the day before.

h. At 4:40 p.m., in the restroom of room 218, there was a plastic pitcher inside the access panel on the wall. Concurrently, during an interview, the facilities director stated there was a leak in the water line and repairs were needed.

i. In room 218, bed A, there was an urinary catheter drainage bag attached to the base of the bed. The catheter drainage bag was touching the base of the over the bed table. Concurrently, during an interview, the nurse manager of the unit stated the drainage bag should not be touching the base of the over the bed table.

j. In the restroom of room 216, clean paper towel was stored on top of the paper towel dispenser. One of the drawers was detached. There was an intravenous (IV) pump inside the drawer. There were parts of the bed in the side table. Room 216 was a two beds room. Both patients were discharged that morning.

k. In room 212, in the restroom, there was a bed pan stored on the floor.

l. At 4:52 p.m., in room 211, the patient in bed B was discharged on August 20, 2016. There was lotion, oral care kit, admission kit, a plastic basin containing bathing supplies, saline and skin cleaner. Concurrently, during an interview, the unit manager stated all drawers should be emptied out after a patient is discharged.

7. During a tour of the fifth floor on August 26, 2016, from 8:15 a.m. to 8:56 a.m., the following was observed:

a. In room 514, the recliner chair had torn upholstery in the left armrest. There was a chair with a missing plastic cover on the right armrest. Concurrently, during an interview, the charge nurse on duty stated the room was ready for a new admission.

b. In the storage closet where baby formulas were stored, the ceiling vent was thickly covered with dust.

c. In room 503, the two sanitizer dispensers had no catch pan. The room was ready for a new admission.

8. During a tour of the fourth floor on August 26, 2016, from 9:10 a.m., to 9:55 a.m., the following was observed:

a. In room 411, there was a phone in the drawer. In the restroom, the ceiling vent was dusty. The chair had a stain. An EVS staff was observed cleaned the chair with a bleach germicidal wipe and the stain came off. Concurrently, during an interview, the nursing director of the unit stated the room was ready for a new admission.

b. In room 412, the refrigerator had food debris. There was a plastic decoration (branch design) measuring approximately 1 ½-2 feet in length on a glass vase that was dusty. The bed was made and there was dust on top of the sheets. In the restroom, the ceiling vent was dusty. Concurrently, during an interview, the nursing director stated the unit was ready for a new admission.

c. In room 416, there was a staff member changing a light bulb. The box containing light bulbs was placed on top of the clean sheet on the bed that was made.

d. In room 422, on top of the over bed table, there was a tent card that read " This room has been cleaned August 23, 2016. " In the restroom, the trash receptacle was overflowing. Inside the drawer, there was a damaged canister, an IV pump with a biomed sticker dated 1/2013. At the same time, the nursing director stated the IV pump was no longer used by the facility. The patient in bed A was discharged on August 23, 2016.

e. In the storage closet next to room 410, there were three oxygen cylinders stored. together with wheelchairs, walkers and commodes. At the same time, during an interview, the nursing director could not explain why the oxygen cylinders were stored with equipment for patients.

f. At 9:50 a.m., in room 407, the soiled linen hamper was full.

g. At 9:51 a.m., in room 405, the soiled linen hamper was full.

During an interview on August 26, 2016, at 4:32 p.m., the director of environmental services stated environmental staff cleaned environmental surfaces of the room after a patient is discharged. He was not aware it was agreed upon by his company and the facility that the drawers in the patient rooms had to be opened when a patient is discharged.

9. During a tour of the emergency department on August 29, 2016, from 8:25 a.m. to 8:56 a.m., the following was observed:

a. The call light above the door in room 10 and 11 did not light up when the call button was activated. During an interview on August 29, 2016, at 8:53 a.m., the facilities staff stated the light bulbs of the call light were "busted."

b. The treatment rooms 14, 15 and 16, used for fast track patients did not have hand washing sinks.

A review of the facility's contracted company for environmental services policy and procedure titled Linen Services with an issue date of June 1, 2016 indicated when transporting, clean linen must be covered. When storing, clean linen must be in carts with covers, closed cupboards, or place a temporary covering to keep them dry and free from soil and body substance contamination. Do not overfill the covered linen cart. The bag inside the cart must be replaced when it is ¾ full to allow the ends to be closed and tied.

A review of the facility's contracted company for environmental services policy and procedure titled Ceiling and Vent cleaning with an issue date of October 1, 2015, stipulated high dust vent using high dusting tool or back- pack vacuum.

A review of the facility's contracted company for environmental services policy and procedure titled Furniture Cleaning dated October 1, 2015, stipulated in a heavily soiled areas work cleaner into fabric with upholstery brush on surface of chair, paying attention to armrests, headrests and stubborn stains, or places where perspiration or oils have come into contact with the surfaces.

A review of the facility's contracted company for environmental services policy and procedure titled Discharge Room Cleaning Procedure dated October 1, 2015, stipulated remove patient/resident room trash from the receptacle. Include the waste can in the restroom. Sanitize all patient contact surfaces starting with the bed. Proceed to clean over the bed table, bedside table, phone, chairs, low ledges and counter, light switches and door knobs.

A review of the facility's contracted company for environmental services policy and procedure titled Intensive Care Unit dated October 1, 2015, stipulated wash walls, doors, door frames, electrical outlets, rubber hoses, fixtures attached to the walls, and outside surfaces of cabinets or shelves with germicidal detergent.

Based on observation, interview and record review, the facility failed to monitor temperature and humidity in the intensive care unit.

This deficient practice had the potential for temperature and humidity not to be maintained within acceptable parameters promoting bacterial growth and infection.

Findings:

1. During a tour of the intensive care unit on August 23, 2016, at 2:55 p.m., there were no temperature and humidity devices installed in the unit.

At the same time, during an interview, the charge nurse on duty stated they did not monitor the temperature and humidity in the unit.

During a tour of the ICU Tower on August 23, 2016, at 3:55 p.m., there were no temperature and humidity devices installed in the unit.

2. During a tour of the Neonatal Intensive Care Unit (NICU) on August 25, 2016, at 3:42 p.m., there was temperature/humidity gauge. The temperature was 72 degrees Fahrenheit and the humidity was 60%.

At the same time, during an interview, the charge nurse on duty stated they did not keep a log of the temperature.

3. During an interview on August 29, 2016, at 10:12 a.m., the director of peri-operative services stated the temperature and humidity was not monitored and logged in the recovery room.
4. During an interview on August 29, 2016, at 10:20 a.m., the facilities director stated the temperature and humidity was not monitored and logged in the recovery room (C-section).
5. A review of the operating rooms temperature and humidity log from May-August, 2016 indicated the acceptable parameter for temperature was 68-73 degrees Fahrenheit and the acceptable parameter for humidity was 35%-65%.
California 2010 Mechanical code stipulated the acceptable parameter in the operating room temperature is 68-75 degrees Fahrenheit and humidity is 30%-60%.

Based on observation, interview, and record review, the facility failed to provide a sanitary environment, failed to have active infection control program to prevent, control, and investigate infections and communicable diseases.

These failures placed the patient population, visitors and staff at risk for hospital acquired infections when the facility's infection control program failed to:

1. Ensure sterilized peel packs and sterile trays (eye, hand and dilation and curettage (D&C) containing surgical instruments with hinges would not have hinges closed, would not have colored tape on the handles, there would not be rusty stains and markings and multiple surgical instruments would not be stacked on top of each other. There were two (2) single use (disposable) needles found in a sterilized eye tray. Failed to provide a functional and sanitary environment when infection control practices were not implemented in accordance with hospital policy and nationally recognized standards and when surgical instruments were not processed to ensure sterility Refer to A 479).

2. Ensure that soiled carts with plastic container with used sharps inside, plastic bin which contained trash; soiled nerve block cart, soiled cardiovascular cart and general plastic cart were not stored in the supply room/utility clean room with sterile supplies (Refer to A 479).

3. Ensure, in different areas of the facility, there would not be expired supplies mixed with current supplies in use (Refer to A 479).

4. Ensure the scrub/hand washing sink faucets would not have aerators (Refer to A 479).

5. Ensure floor tiles in the decontamination and sterilization areas were without stain/markings and without cracks/gaps to prevent possible harboring of unwanted organism in the patient care areas (Refer to A 479).

6. Ensure the facility staff followed the disinfectant contact time with the surface recommended by the manufacturer for cleaning operating table mattress (Refer to A 479).

7. Ensure intravenous (IV) lines and tubing were labeled with date, time and person who hang it (Refer to A 479).

8. Ensure each step for high level disinfecting (HLD - complete elimination of all microorganisms in or on an instrument, except for small spores), were performed according to manufacturer guidelines by hospital staff in Ultrasound Room 5 and in the Women's Center (Refer to A 479).

9. Ensure a sink used to pre-clean bronchoscopes, a sterilizer, and a medivator, a machine used to clean and process scopes (endoscopes - an instrument used to perform a procedure in which a thin scope with a light and camera at its tip is used to look inside the upper digestive tract and bronchoscopes - an instrument inserted into the airways, usually through the nose or mouth, or occasionally through a tracheostomy to visualize the inside of the airways) were cleaned or maintained to prevent the risk of cross contamination and infection and to ensure a sanitary environment was maintained (Refer to A 479).

10. Ensure scopes for esophagogastroduodenoscopy [(EGD) endoscopic examination of the interior of the esophagus and stomach] were stored according to manufacturer's recommendations and nationally recognized infection control standards (Refer to A 479).

11. Ensure dirty transesophageal echocardiography scopes (TEE, scopes used to perform a test that produces pictures of your heart), were cleaned in an operating room used for performing sterile procedures (Refer to 479).

12. Ensure the Immediate use Steam Sterilizer [(IUSS)- a machine used to sterilize dirty instruments which were intended for immediate use and not stored for future use] was used according to nationally recognized infection control standards (Refer to A 479).

13. Ensure food items were stored under sanitary condition. The facility's food storage room located in the basement had several exposed sewer pipes exposed above storage rack with food items. The room ceiling section was stained with black-brown discoloration measured approximately 8.0 feet by 10 feet with condensation (Refer to A 479).

14. Ensure a personnel entering the facility's kitchen had hairnets worn inside the food preparation area (Refer to A 479).

15. Ensure sanitizing solution had the acceptable sanitizer concentration range 150 to 400 pats per million to disinfect the food preparation surfaces (Refer to A 479).

16. The hospital and governing body in governance of the infection control officer and in accordance with hospital policy and nationally recognized infection control standards failed to ensure an effective, active system wide infection surveillance control program for prevention, control, and investigation of infections and communicable diseases and failed to designate a qualified Infection Control Preventionist (Refer to A 748).



The cumulative effects of these systemic problems resulted in the facility's inability to maintain ongoing infection control program that seeks to minimize infections and communicable diseases, to prvide a sanitary environment placing all patients, staff and visitors at risk of being exposed to infections and communicable diseases.

Based on interview, and record review, the facility and governing body in governance of the infection control officer (ICO), and in accordance with facility's policies and nationally recognized infection control standards, failed to ensure they had a designated infection control officer to provide an active system wide infection surveillance program, and to ensure the ICO developed and implemented infection control (IC) policies throughout the hospital, as evidence by:
The hospital failed to designate an effective and qualified Infection Control Preventionist (ICP) to oversee the hospital's Infection Control program. This failure resulted in inadequate infection control oversight.

Findings:

During an interview, with the Infection Control Manager (ICM), on August 29, 2016, at 12:45 p.m., stated she was the only individual designated as an Infection Control Manager and there was no other person responsible for the hospital infection control program and no other infection control individual who provided oversight of her.

According to the ICM, she had been in the position for 10 years, she did "not really" develop infection control policies and "only" provided infection control training to the "new hires" (new employees). She also stated that surveillance/rounds of surgical services were not performed on a daily basis and environmental surveillance of the hospital was performed twice a year.

A record review of the ICM's employee file and a concurrent interview were conducted on August 31, 2016. at 2:20 p.m. The file contained no documented evidence to show that the ICM received training in sterile processing, high level disinfecting (HLD) or scope cleaning and disinfecting. The file also contained no documented evidence to show that the ICM had received ongoing training in infection control. The most recent documented training found was for 2012. The ICM stated that she had not received any ongoing infection control training other than "small webinar type courses" but did not have documentation or certificates to show as evidence, because "sometimes they don't provide them." The ICM also stated that she did not provide oversight of staff in sterile processing or scope cleaning and disinfecting because she did not have any training and the department managers trained their staff.

During the same record review, three (3) hospital "Job Descriptions & Competency Evaluations" were found in ICM's employee file:

1. "Infection Control Analyst" signed by ICM on February 8, 2006 which stipulated under "Position Summary: Responsible for monitoring, data collection, data abstraction, report preparation and participation in Infection Control Program. Also responsible participating in planning, implementing and evaluating infection control and prevention within the hospital to include staff and physician education ... " Under " Education/Training/Experience: ...knowledge of infection control and epidemiology (the study and analysis of the patterns, causes, and effects of health and disease conditions in defined populations), from an accredited school. There was no documented evidence in ICM's job application to indicate if she received education in infection control and epidemiology.

2. "Infection Control Practitioner" signed by ICM on May 13, 2007 which stipulated under "Position Summary: Responsible for monitoring, controlling and reducing nosocomial infections. Also responsible for planning, implementing and evaluating infection control and prevention within the hospital ... "

3. "Infection Control Manager" signed by ICM on 8/31/10 which stipulated under "Position Summary: Responsible for monitoring, controlling and reducing nosocomial infections. Also responsible for planning, implementing and evaluating infection control and prevention within the hospital ... "

Also found in ICM's employee file was a letter addressed to ICM from the hospital on October 6, 2015 informing her that the head of Infection Control position typically required either (1) Registered Nurse license in California with a Bachelor's degree in Nursing (which according to her, she did not have), or a "Bachelor's degree in Microbiology or Epidemiology (according to ICM, her Bachelor's degree was in Health Administration). In addition, it indicated that being Certified in Infection Control (CIC) was also required (which according to her, she did not have). The letter stipulated that if ICM did not obtain her CIC by October 1, 2016, it would result in termination of employment.

Following an immediate interview with the ICM, she stated that when she initially was hired by the hospital, she was hired as an "Infection Control Analyst" and in 2010, her job description changed to "Infection Control Manager". She also stated that she was aware that if she did not become certified in infection control, she would be terminated. According to ICM, she was in the process of trying to become certified (no documentation was provided to show as evidence).

Based on observation, interview and record review, the hospital failed to develop and implement measures to govern the identification, prevention, and control of infections and communicable diseases in accordance with internal policies and procedures, nationally recognized infection control practices, and guidelines and regulations, failed to failed to store food under sanitary conditions and failed to implement their guidelines on nutrition assessment/reassessment.
These failures placed patients at an increased risk for developing a hospital acquired infection (HAI), had the potential for food contamination and contamonated food born ilnesses.

The facility's infection control program failed to:

1. Ensure sterilized peel packs and sterile trays (eye, hand and dilation and curettage (D&C) containing surgical instruments with hinges would not have hinges closed, would not have colored tape on the handles, there would not be rusty stains and markings and multiple surgical instruments would not be stacked on top of each other. There were two (2) single use (disposable) needles found in a sterilized eye tray. Failed to provide a functional and sanitary environment when infection control practices were not implemented in accordance with hospital policy and nationally recognized standards and when surgical instruments were not processed to ensure sterility.

2. Ensure that soiled carts with plastic container with used sharps inside, plastic bin which contained trash; soiled nerve block cart, soiled cardiovascular cart and general plastic cart were not stored in the supply room/utility clean room with sterile supplies.

3. Ensure, in different areas of the facility, there would not be expired supplies mixed with current supplies in use.

4. Ensure the scrub/hand washing sink faucets would not have aerators.

5. Ensure floor tiles in the decontamination and sterilization areas were without stain/markings and without cracks/gaps to prevent possible harboring of unwanted organism in the patient care areas.

6. Ensure the facility staff followed the disinfectant contact time with the surface recommended by the manufacturer for cleaning operating table mattress.

7. Ensure intravenous (IV) lines and tubing were labeled with date, time and person who hang it.

8. Ensure each step for high level disinfecting (HLD - complete elimination of all microorganisms in or on an instrument, except for small spores), were performed according to manufacturer guidelines by hospital staff in Ultrasound Room 5 and in the Women's Center.

9. Ensure a sink used to pre-clean bronchoscopes, a sterilizer, and a medivator, a machine used to clean and process scopes (endoscopes - an instrument used to perform a procedure in which a thin scope with a light and camera at its tip is used to look inside the upper digestive tract and bronchoscopes - an instrument inserted into the airways, usually through the nose or mouth, or occasionally through a tracheostomy to visualize the inside of the airways) were cleaned or maintained to prevent the risk of cross contamination and infection and to ensure a sanitary environment was maintained.

10. Ensure scopes for esophagogastroduodenoscopy [(EGD) endoscopic examination of the interior of the esophagus and stomach] were stored according to manufacturer's recommendations and nationally recognized infection control standards.

11. Ensure dirty transesophageal echocardiography scopes (TEE, scopes used to perform a test that produces pictures of your heart), were cleaned in an operating room used for performing sterile procedures.

12. Ensure the Immediate use Steam Sterilizer [(IUSS)- a machine used to sterilize dirty instruments which were intended for immediate use and not stored for future use] was used according to nationally recognized infection control standards.

13. Ensure food items were stored under sanitary condition. The facility's food storage room located in the basement had several exposed sewer pipes exposed above storage rack with food items. The room ceiling section was stained with black-brown discoloration measured approximately 8.0 feet by 10 feet with condensation.

14. Ensure a personnel entering the facility's kitchen had hairnets worn inside the food preparation area.

16. Ensure sanitizing solution had the acceptable sanitizer concentration range 150 to 400 pats per million to disinfect the food preparation surfaces.


Findings:


1a. On August 25, 2016, at 3:30 p.m., during the tour of the Clean Utility Room/Sterile Room, there were double peel packs containing surgical instruments such as forceps, scissors, trocar, retractor, clamps, poole suction and Beaver handles. The peel packs contained multiple instruments in a pack, hinged instruments were closed, and rusty brown/reddish colored stains/markings and colored tapes on the handle of the surgical instruments. Out of the 167 surgical instruments, two (2) were found to have no concern.

A central processing technician (CPT 1) and the registered nurse (RN 7) were requested to open a D&C tray which contained a total of 17 surgical instruments. In the tray were observed a sponge stick used as stringer, instruments with closed hinges, colored tapes on the handles and instruments were stacked on top each other. The metal tray handles were with colored tape on it.

The next tray was was opened was a hand tray which contained 67 surgical instruments. The surgical instruments were observed stacked on top of each other, with closed hinges, colored tape on the handles, bunched together and with presence of rust colored stains/markings.

The instrumentation technician (IT 1) opened an eye tray, used for cataract procedure. This tray did not have an accompanying list of instruments. There were two (2) disposable needles inside the sterilized eye tray. The eye muscle retractor and forceps had rusty colored stains/markings. The base of the tray was lined with rusty brown colored material. In between the rubber spikes in the blue mat were black, white and rust colored material. Concurrently, during an interview, RN 14 stated those needles should have been discarded after use during the procedure. RN 14 stated the instrument were not safe for use as it could be potential for infection.

On August 26, 2016, at 4:30 p.m., during a visit to the sterile processing department (SPD), IT 2 was observed working on twelve (12) peel packs that contained surgical instruments with tapes and stains. The IT 2 was observed taking the surgical instrument out of the incorrectly processed peel pack and without instruments undergoing cleaning/decontamination, was placing them in a new peel pack. During an interview with IT 2, at the time of observation, IT 2 was unable to explain why he did not clean/decontaminated the instruments before placing them into new pill pack for sterilization.


1b. On 8/29/16 at 11:45 a.m., an observation of sterile instruments in Sterile Processing Department was conducted in an attempt to abate the immediate jeopardy situation identified by the survey team on August 26, 2016. Accompanied by the ICM, a Central Processing Technician (CPT 1) was asked to unwrap three trays which had previously been cleaned and sterilized, three of three trays contained multiple instruments, and the following observations of the instruments were made:

a. One major tray, which according to CPT 1, included approximately 70 to 90 instruments; multiple instruments (approximately 10 to 15), contained etching/engraving on the handles of the instruments with the initials of the hospital, and multiple instruments (approximately greater than 10), contained brown staining, some of the stains could be wiped off and some stains were unable to be wiped off. CPT 1 verified the findings.

b. One minor tray, which according to CPT 1, included approximately 60 or more instruments, which contained the same findings, approximately 10 or more instruments, contained etching and brown staining which in some cases were able to be wiped off. CPT 1 verified the findings.

c. One two layer, Retina tray (used for surgeries/procedures performed on the eyes), which according to CPT 1, included about 16 instruments on the top layer and about 17 on the bottom layer. One of the instruments (an eye speculum), was cracked (broken) and in between the broken piece was a black stain which part of it could be removed. According to CPT 1, could have been " rust " .

According to ICM, who verified the findings, she indicated on a previous interview, on 8/29/16, that they follow nationally recognized infection control standards from AORN, AAMI, CDC (Centers for Disease Control) and APIC. She also stated that surveillance/rounds of the hospital ' s surgical processing are not performed daily and she did not have any training
AAMI's Technology Information Report (TIR) 30: 2011 5.2.4 specifies:

"Rinsing
Adequate rinsing is necessary to remove all traces of enzymes, detergents, and residual soil. Water quality should be considered when developing and testing cleaning procedures. Water hardness, temperature, and the type of soil can have an impact on the effectiveness of cleaning products and rinsing and, consequently, the efficacy of the cleaning process. Water quality varies from one area to another and from season to season within the same area."
Additionally, AAMI TIR-34 2007 also specifies:

"Patient infection resulting from the use of contaminated devices (e.g., salt or organic deposits from the water used in reprocessing could inactivate the disinfectant or sterilant or could protect microorganisms from the disinfection or sterilization process; a disinfected or sterilized device could transmit an infection if rinsed with water containing unacceptable levels of microorganisms)."


1c. On August 28, 2016, at 10:20 a.m., during a tour of the labor and delivery (L&D) operating room (OR) with RN 14, the following was observed:

a. In OR 1, there were five (5) towel clippers, one had a residual tape and two (2) had rust colored stain/markings. The grounding pad with a plastic cover was placed on top of the black mattress on operating table. The black mattress had residual tapes and markings of the grounding pad as it was placed back when mattress was still wet.

b. In OR 2, there was a pair of regular scissors, four (4) towel clamps, one of which had a colored tape and labeled "Do not remove", a pliers with blue handle and grounding pad with plastic cover on top of the black mattress on the operating table. There was Vital Signs- Pressure Infuser Bag observed exposed and not in sealed plastic container. The bag indicated "do not re-use." The black leather arm rest had residual tapes on it.

During an interview with obstetric technician (OB Tech 1) at the time of observation, stated "we have been using the grounding pad with plastic cover for a long time." OB Tech 1 stated the towel clippers and scissors were an equipment only used in the OR and stayed in the OR. Single use items should be discarded after use.

According to the facility policy number Sterile Processing Department (SPD) 302 titled " Cleaning and Disinfection indicated all instruments in a tray or instruments in basins will be inspected upon arrival in the decontamination area. Instruments will be soaked in an enzymatic solution. Gross contamination will be removed at this time manually (hand washed). The items will then be processed through the washer/decontaminator. All instruments trays shall be placed on washer shelves; instruments must be in the open position.

According to the Association of Operating Room Nurses (AORN), Perioperative Standards and Recommended Practices for Cleaning and Care of Surgical Instruments Recommendation IV (2014) the following had to be in place:

a. Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents ... Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.

b. IV.c - Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces. Sterilant contact is necessary for sterilization to be achieved.

c. IV.h - Items to be sterilized should be placed in the package or tray in an open or unlocked position.


1d. An observation of sterile processing (an area were surgical instruments are sterilized and processed) and of the decontamination area (where surgical instruments are cleaned) and a concurrent interview were conducted on August 29, 2016, at 2:15 p.m., in the presence of ICM and CPT 1. The following was identified:

a. A large stainless steel machine labeled, "Castle Steam Sterilizer Sybron " contained large amounts of brown staining and white and brown powdered matter, inside and outside of the machine, in-between the door, around the hinges and on the racks of the machine. The powdery matter was able to be wiped off with a white paper towel, leaving brown marks on the paper towel.

According to CPT 1, he believed housekeeping cleaned the exterior of the machine and they (Sterile processing staff), cleaned the interior of the machine. CPT 1 stated they did not keep documentation or a log to indicate the machine was cleaned.


2. On August 25, 2016, at 3:05 p.m., during the tour of the Supply Room /Utility Clean Room with Director of Perioperative Services, there were soiled carts with sharps containers filled with soiled sharps, plastic thrash bin with trash, nerve block cart, cardiovascular cart and general plastic cart stored together with the sterile supplies. The nerve block tray had a box of Triumph Surgical Gloves with expiration date of July 2016. The microvascular plastic cart contained 4 packs of surgical blades with expiration dates of March and September 2015 and a packet of Feberwire with expiration date of May 2010.

During an interview at the time of observation, the Director 9, stated soiled carts should not be stored in the Supply Room/Utility Clean Room together with the sterile supplies due to cross contamination.

There was a sharps container with needles and scalpel, bio-hazard container, soiled linen container with 10 green-colored single use towels and plastic bin labeled scrubs only stored in the decontamination room.


3a. On August 25, 2016, at 2:15 p.m., during the tour of the surgical area with Director 9, in the hallway there was an open container mixed with current surgical supplies and the following expired items were observed:

a. There was a packet of laryngeal mask airway 2.5 with expiration date of November 2015.

b. There was a packet of Ultra Site Intravenous Set for Outlook Safety Infusion with expiration date of January 2016.

c. There were four (4) packets of Hi-Lo Oral Nasal Tracheal Tube 4.0 cuffed with expiration dates of March 2016 and July 2016.

d. There were four (4) packets of Hi Oral/Nasal Tracheal Tube 3.0 cuffed with expiration date of April 2016.

During an interview with Supply Technician 1, at the time of observation, stated the container should not have expired supplies because she checked it two weeks ago.


3b. On August 25, 2016, at 4:20 p.m., during a visit in the gastro-intestinal (GI)/Endoscopy room, in the cabinet, there were four boxes of surgical gloves with expiration date July 2016, and a bottle of Infant Relief Simethecone opened and undated.


4. On August 25, 2016, at 2:15 p.m., the scrub sinks' faucets, in the surgical suites, had aerators with mineral deposits in it. One of the faucets in the scrub sink was not working.


5. The decontamination room and sterile processing room were observed to have floor with stains and cracks and could harbor unwanted organism.

There was a gallon container of Medline Dual Enzymatic Detergent and Presoak with expiration date July 28, 2016, by the sink, for cleaning surgical instruments in the decontamination room.


6. On August 25, 2016, at 4:35 p.m., during the tour of the surgical suites 3 and 5, the operating table and the table's arm pad was observed covered with linen and ready for use. The linen cover was requested to be taken off to inspect the condition of the mattress. There was Megadyne grounding pad (green in color) on top of the black mattress which was wet with cleaning solution. When the grounding pad was lifted , there were marks left on the black mattress of the grounding pad. The black mattress had residual tapes on it , Betadyne solution and small tears/holes.

In the hallway, there was parked Big Wheel Gurney Stryker parked. When the mattress was lifted off the gurney it was observed to have a rust color stain, a tear with red colored stain and residual tapes.

Concurrently, during an interview with Director 9, stated the grounding pad was placed back on the black mattress without waiting for it to dry. The cleaning solution used was the Clorox Hydrogen Peroxide. According to the cleaning solution label the surface and to be wipe until completely wet, allow solution to remain wet for contact time listed on the label and let it air dry completely.


7. On August 23, 2016, at 11:30 a.m., during the tour of the intensive care unit (ICU) with Administrator 3, the following was observed:

a. In Room 23, Patient 21 had a peripheral intravenous line (IV) on the upper left arm which had no label when it was placed. There was a piggy bag line for an antibiotic drip without label to indicate the date it was placed. The patient's restraint ties were on the floor and RN placed it back on the bed without cleaning the restraint ties first.

b. In Room 25, Patient 22 had a peripheral IV line on the right arm and right upper arm without label to indicate when it was placed. The IV tubing hanging for the medication Potassium was without label to indicate when it was initiated.

c. In Room 26, Patient 19 had a peripheral IV line on the left hand and right lower arm. Both did not have labels to indicate when it was placed. The patient was receiving oxygen of three liters per minute through a nasal cannula. The oxygen tubing did not have a label as to when it was initially use. The oxygen saturation cord and oxygen tubing were noted on the floor and the staff placed it on the bed without disinfecting/or cleaning the cords first.

During an interview with the patient, at the time of observation, stated the IV lines were placed yesterday on August 22, 2016, and the staff was labeling it now. The patient stated she was on oxygen since her admission which was five days ago.

d. In Room 27, Patient 23 was on ventilator, the ventilator circuit had no label to indicate the date when it was placed.

There was Jevity 1.2 a 1000 milliliters (ml) feeding container with 500 ml left in the bottle but the there was no label to indicate the date, rate and nurse initials.

A review of the facility's policy titled " Administering Formula" indicated to label feeding formula container with date and time when hung, infusion rate and nurse initials.

e. On August 25, 2016, at 8:45 a.m., together with RN 13, Patient 20 was observed in bed receiving oxygen at three liters per minute via nasal cannula. There were two (2) bottles of 0.9% Sodium Chloride Irrigation and Normal Saline bottle for IV flush open and undated.

During an interview with RN 13, stated that when Sodium Chloride/Normal Saline first opened should be dated.

On August 23, 2016, at 5 p.m., during an interview with RN 15, stated when IV line, heplock (is an intravenous (IV) catheter that is threaded into a peripheral vein, flushed with heparin or saline, and then capped off for later use) or a peripherally inserted central catheter (PICC) lines were started or changed it should be labeled with date, time and initialed who did it.


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8a. During an observation of Ultrasound Room 5 and a concurrent interview with an Ultrasound Technician (UT 1), on August 30, 2016 at 10:10 a.m., UT 1 demonstrated the hospital's manual HLD process of their transvaginal probes (ultrasound transducer or probe in the vagina to visualize organs within the pelvic cavity). UT 1 stated that they used Cidex OPA (a solution used for high level disinfection of semi critical instruments such as a transvaginal probe) to disinfect their probes. The following observations were made:

a. Wearing gloves, UT 1 wiped the probe with a paper towel after removing a plastic probe cover (a cover used for the procedure, which is replaced with each patient).

b. UT 1 rinsed the probe with a bottle of sterile water, by pouring some of the water over the probe in a hand washing sink.

c. UT 1 dried the probe with a paper towel and stated that they placed the probe in a plastic cylinder container filled with the Cidex OPA solution (uncovered), for 12 minutes.

d. UT 1 stated that they rinsed the probe a total of 3 times, after removing it from the Cidex solution, by pouring sterile water over the probe.

e. UT 1 stated that they test the Cidex OPA solution once a shift but not prior to performing the HLD process with each probe.


8b. During an observation of Woman's Imaging Center and a concurrent interview with an Ultrasound Technician (UT 2), on August 30, 2016, at 10:30 a.m., UT 2 demonstrated the hospital's manual HLD process of their transvaginal probes. UT 2 stated that they used Cidex OPA to disinfect their probes. The following observations and interviews were made:

a. Wearing gloves, UT 2 cleaned and disinfected the probe in a bathroom sink which was used for staff and patients.

b. UT 2 removed the probe cover and discarded it in the bathroom's trash can.

c. UT 2 wiped the probe with a paper towel and rinsed it, according to UT 2 for "less than a minute to remove the gel" , then wiped the probe again with a paper towel and discarded it in the bathroom's trash can.

d. UT 2 stated that she placed the probe in a container filled with the Cidex solution (uncovered), for 12 minutes and then wiped it with Hydrogen peroxide wipes.

e. UT 2 demonstrated and stated, " I pour the water over the transducer (probe) three times. "When she was asked for the length of time she rinsed it, she stated, "No time, just pour the water three times."

f. UT 2 stated that they check the temperature of the solution once a shift but not before they perform HLD of the probes.

According to the Centers for Disease Control (CDC), transvaginal probes were semi-critical devices and should undergo high level disinfection following each use.

During a review of a hospital policy titled, "Cidex Test Strips, reviewed 11/15, no references," provided by the facility, the policy stipulated, "The staff will be responsible for testing solution before disinfecting or sterilizing equipment..."

During a review of the hospital's policy titled, "Cidex OPA Solution Usage and Disposal, reviewed on 9/14," the policy stipulated, "Cidex OPA solution is tested for efficacy before each use...It is essential that proper personal protective equipment (e.g. gloves, fluid-repellent gown, eye protection) be worn when working with Cidex OPA Solution ...Thoroughly clean all instruments with a mild protein-dissolving detergent and rinse with large amounts of fresh water. Remove excess moisture from the instruments by drying gently. Follow the directions for use on the bottle label and package insert prior to pouring Cidex OPA Solution into a tray or appropriate container. Immerse clean, dry instruments completely in the CIdex OPA Solution. Cover the tray securely and soak instruments for 12 minutes at 20 degrees Celsius (68 degrees Fahrenheit). Rinse instruments thoroughly for a total of three rinses. Each rinse should us a fresh bottle of sterile water ... "

On August 30, 2016, a two page document provided by the facility titled " Cidex OPA" for its intended use, storage and disposal directions for use ...stipulated, " See Cidex OPA Solution e-ifu (instructions for use) for complete information ... "The two page document was used by the hospital to guide them with the HLD process however; the document did not contain complete instructions. The Cidex OPA solution ' s complete instructions for use was obtained and immediately reviewed and stipulated the following:

a. In the section titled, "Rinsing Procedure - 1. Manual Processing: Following removal from Cidex OPA Solution, thoroughly rinse the semi-critical medical device by immersing it completely in a large volume (e.g., two gallons) of water ...Keep the device totally immersed for a minimum of one minute in duration, unless a longer time is specified by the reusable device manufacturer ...Always use fresh volumes of water for each rinse ...Repeat the procedure TWO (2) additional times, for a total of THREE (3) RINSES, with large volumes of fresh water to remove Cidex OPA Solution residues. Residues may cause serious side effects. SEE WARNINGS: THREE (3) SEPARATE, LARGE-VOLUME WATER IMMERSION RINSES ARE REQUIRED ... "

The AORN "Guidelines for Perioperative Practice (2016), Guideline for High Level Disinfection (HLD)," were reviewed. Recommendation IX, indicated documentation should be completed to:"...demonstrate compliance with regulatory and accrediting agency requirements." According to the guidelines ..., HLD processing records should be kept and include, test results before each load, indicating the solution used was at the proper concentration and within the expiration date.


9a. On August 30, 2016, at 10:55 a.m., an observation of a dirty utility room (located in the Respiratory Department) and a concurrent interview, with a Respiratory Care Practitioner III (RCP 3) were conducted. According to RCP 3, they performed their pre-cleaning of their bronchoscopes in the dirty utility room, not at the point of care/bedside. The following observations of the sink and the area around the sink were identified:

a. The sink's drain was contained brown staining that was able to be wiped off with a white paper towel The paper towel used had brown residue.

b. The bottom of the sink contained brown markings and white powder like material that was able to be wiped off with a paper towel.

c. The counter top contained yellowish brown staining.

During an immediate interview, RCP 3 stated that he cleans the area however they do not document or log it.

9b. An observation of a scope reprocessing room and a concurrent interview, with an Instrument Technician (IT 1), were conducted on August 30, 2016, at 11:50 a.m. In the room, the following was identified:

a. There was a large machine labeled, Medivator DSD-201, used to process scopes. The machine had large amounts of brown, yellow, green and white stains and particles located on the exterior, interior, filters, door openings, and on the drain. The brown stains were able to be wiped off with a white paper towel, as well as brownish black particles.

During an immediate interview with IT 1, he stated that he did clean the Medivator but it was difficult to reach some areas. IT 1 also stated there were not logs or documentation to show the machine was cleaned and they did not have a policy to provide guidance on cleaning the machine.

According to ICM, on a previous interview, on August 29,2016, she stated that they followed nationally recognized infection control standards from AORN, AAMI, CDC (Centers for Disease Control) and APIC. She also stated that surveillance/rounds of the hospital ' s surgical processing are not performed daily.

The hospital did not have a policy to address or provide staff guidance for cleaning the area.

According to CDC's "Guideline for Disinfection and Sterilization in Healthcare Facilities, medical equipment and surfaces can become contaminated with infectious agents and contribute to the spread of health-care-associated infections ... Environmental surfaces also could potentially contribute to cross-transmission by contamination of health-care personnel from hand contact with contaminated surfaces, medical equipment, or patients."

According to AORN Guidelines for Perioperative Practice (2016), Guideline for Environmental Cleaning, IV.e.:
"Sterile processing areas should be terminally cleaned. Terminal cleaning (physical cleaning followed by disinfection with an approved hospital disinfectant) and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used ...sterile processing areas where decontamination occurs have some of the highest risks for environmental contamination of all perioperative areas."


10. During an observation on August 30, 2016, at approximately 12 p.m., of a scope reprocessing (a working area were scopes are cleaned and disinfected) room and a concurrent interview, with an Instrument Technician (IT 1), were conducted. In the room was a storage closet used to store endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body), with eight scopes. IT 1 was asked to open the storage closet.

IT 1 stated the scopes were kept in the same area that they are cleaned in because they have no other area to store them. He also stated there was no method to know what the temperature and humidity were in the room but that at times it gets very hot, making it difficult to work in there. IT 1 stated they follow the manufacturer ' s guidelines for processing and storing the scopes.

A record review was conducted on August 31,2016, of the scope manufacturer's recommendations. Under the section titled, " 9-1-1. Storage - Endoscopes should be stored in a manner that will protect them from contamination. The storage area should be clean, well - ventilated, and dust free, thus discouraging any microbial contamination. ..CAUTION NEVER store the endoscope in areas of high humidity, high temperatures or in direct exposure to sunlight or X-rays ... "

According to ICM, she indicated on a previous interview, on 8/29/16, that they followed nationally recognized infection control standards from AORN, AAMI, CDC (Centers for Disease Control) and APIC. She also stated that surveillance/rounds of the hospital ' s surgical processing are not performed daily and she did not have any training.

According to CDC's Infection Control Healthcare Practices Advisory Committee Guidelines for Disinfection and Sterilization in Healthcare Facilities " , the relative humidity in all work areas of a hospital should be 30 percent (%) to 60%.


11. On September 2, 2016, at 11:10 a.m., an observation was made of the hospital's practice of their cleaning and decontamination process of transesophageal echocardiography scopes (TEE -scopes used to perform a test that produces pictures of your heart). An echocardiogram technician (ET 1) demonstrated the procedure and facility's practice and the following concerns were identified:

a. A TEE scope which was used at a patient's bedside, is then taken from a dirty or unrestricted area to a sterile (operating room - OR) or restricted area to be cleaned and disinfected.

b. The supplies needed (a sterile bucket) are obtained from OR staff.

c. Wearing only gloves, ET 1 indicated the TEE probe was "submerged in a Cidex OPA solution for 15 minutes" then obtains a sterile bucket , poured sterile water and re -submerged the probe for 1 minute and repeats the process for a total of three times. ET 1 was unsure of the amount of water used to rinse the probe.

d. Sterile gauze is obtained to wipe the probe and handle and then wipes it with alcohol or hydrogen peroxide.

e. Placed the TEE probe in a clean bag to transport it to the storage area for the probes.

f. The soiled bucket used to clean the probe was discarded in another room (OR area) across the hallway from the room used to clean the probe. The trash can used was a "regular trashcan" not a biohazard trash can.

g. ET 1 stated that if the cyctoscopy room was being used for a procedure then he would hold on to the dirty TEE scope or take it to the dirty utility room located in the imaging department.

According to ICM, she indicated on a previous interview, on August 29, 2016, that they followed nationally recognized infection control standards from AORN, AAMI, CDC (Centers for Disease Control) and APIC. She also stated that surveillance/rounds of the hospital's surgical processing are not performed daily and she did not have any training.

During a review of a hospital policy titled, "Cidex OPA Solution Usage and Disposal", reviewed on 9/14, the policy stipulated, " Cidex OPA solution is tested for efficacy before each use ...It is essential that proper personal protec

Based on observation, interview and record review the facility failed to:
1. Provide and maintain a sanitary environment for surgical services to avoid sources and transmission of infections and communicable disease by creating a restricted and sterile Operating room (OR) environment for the surgical procedures; implement an infection control program that followed acceptable standards of practice for the sterilization of surgical supplies; prevent dirty bronchoscopes from being brought into the OR past the red line and being disinfected inside the Cystoscopy room (Refer to A749).
2. Assure that only qualified personnel performed surgical procedures including cutting of polyps during colonoscopy procedures (Refer to A945).

The cumulative effects of this systemic lack of oversight in surgical services and infection control in the operating room resulted in the facility's inability to perform surgeries in a safe and sanitary manner.

Based on observation, interview and record review, the facility failed to assure that only qualified personnel performed surgical procedures including cutting of polyps during colonoscopy intraoperatively.
During an observation of a colonoscopy for Patient #5 on 8/26/16 at 2:00 pm, Central Sterilization Technicians (CST4) was observed performing a polypectomy while MD12 operated the snare. During an interview at 4:35 pm, CST4 indicated he assisted MD12 by closing the snare to cut polyps during colonoscopies. During an interview with the operating room Nurse Supervisor on 8/26/16 at 4:50 pm, when asked if the physicians or himself train, proctor and check yearly competency for the CST4 to perform polypectomies, he indicated there was no training.
A review of Patient 5's operative note indicated Patient #5 had a polyp removed during the colonoscopy. The surgeon did not identify CST4 as the assistant during the procedure.
A review of CST4 credential file indicated his job description was for a Central Sterilization Technician. CST4's listed duties included: decontamination, sterilization, and restocking. There were not patient care duties identified or that he would be assisting a physician during surgery. CST4's skill competency, titled "Sterile reprocessing - Department Competency Check list" was completed on 6/1/16 and indicated competency in disinfection of endoscopes only. There was no competency listed in assisting a physician with a polypectomy.
A review of a facility document titled "Surgery Manual Gastroenterology Lab," dated 11/15, stipulated "The GI Lab will be staffed by a qualified RN and qualified surgical technician/pct. The staff will work under the direct guidance of the physician "
A review of an undated facility document titled "Medical Staff Rules and Regulation: Perioperative services" stipulated "It is the responsibility of the surgeon to have ....a qualified assistant during surgery."

Based on observation, interview and record review, the facility failed to deliver Radioactive Isotopes to patients in a safe manner
On 8/23/16, at 4:20 pm, during a tour of Nuclear medicine, CRT3 indicated she administers the Nuclear medicine and completed the imaging studies ordered by the floor.
A review of a facility document titled " Department of Nuclear Medicine, Radiopharmaceutical Log Book " dated 8/23/16, documented a list of Patients receiving Nuclear medicine on 8/23/16 including the dose and route of administration and that a CRT signed off on all the medication administered.
During a review of Patient #3's medical record dated 8/22/16, it included the following physician orders: "A Lexi scan Cardiac Test." There was no Radiology order for dosage of Thallium and a physician procedure notes dated 8/23/16 and titled " Nuclear Medicine Myocardial Perfusion Sect Scan " indicated the procedure and was signed by MD11. There was no Radiologist order including Thallium dosage in the medical record. There was no Medical record note documentation of Thallium administration by RT3.
On 8/24/16, at 2:45 pm, during an interview with the Radiology Director (RD), when asked if there was an initial training, proctoring or yearly competency including dosage and administration of IV contrast solution, he indicated there was none. When asked about in-services, initial and yearly proctoring for radiology procedures by CRT, including admiration of IV contrast and Nuclear medicine, there were none.

During an interview with MD6 on 8/24/16 at 4:40pm, MD6 indicated the Certified Radiology Therapist are trained prior to being hired at the Facility , MD6 indicated CRTs know how to give IV contrast and can work independently. MD6 discussed the protocol for IV administration and indicated CRT's give contrast without a radiologist present.

On 8/24/16 at 10:35am, during a review of CRT3 credential files with the HR director, it included a document titled " Performance Appraisal and Competency Evaluation " signed 11/12/15 by CRT3 and RD. A review of CRT3' s competencies included administration of Radioactive Isotopes and assist physician in Radioactive Iodine therapy and Spinal Tap. When asked were there any initial clinical skills competency and proctoring of any of the CRT's upon initial hire, he stated the " employee progress report " and the " Performance Appraisal and Competency Evaluation " were the only Documents which were signed off by the RD. There were no documentation of any initial proctoring and yearly skills competency evaluation of the CRT's by a qualified medical personnel.


A review of the Facility Policy and Procedure dated 3/8/12 and titled "Diagnostic imaging Agents" stipulated "The radiologist performing the procedure will specify the type and amount of contrast material to be used " and "When contrast material is required for examination, it will only be administered by a qualified physician" and "During an angiographic or CT scan, the contrast material may be given via the Media pressure injector ...under the direct supervision of the performing physician" and "Only Technologists with training ...are permitted to inject IV iodinated contrast under the direct supervision of a staff radiologist and /or physician."

A review of the Facility Policy and Procedure dated 3/8/12 and titled "Diagnostic imaging Agents" stipulated "The radiologist performing the procedure will specify the type and amount of contrast material to be used" and "When contrast material is required for examination, it will only be administered by a qualified physician. The facility's policy/procedure also stipulated "During an angiographic or CT scan, the contrast material may be given via the Medirad pressure injector ...under the direct supervision of the performing physician and "Only Technologists with training ...are permitted to inject IV iodinated contrast under the direct supervision of a staff radiologist and /or physician."
A review of the facility policy and procedure, undated and titled "Diagnostic Imaging Services, Department Safety and Maintenance" stipulated the "The Imaging services are under the direct supervision of the Medical Chief Radiologist, who is responsible to the Chief Medical of the Medical Staff and the Governing Body."

Based on observation, interview and record review, the facility failed to ensure its policy for the disposal of radioactive waste is up-to-date with State guideline and reflected the actual practice by its staff.

Findings:

On 8/23/2016 at 4 p.m., during an inspection of the Nuclear medicine department in the presence of Staff 5 and Director of Pharmacy and Imaging Services (Dir 1), and an interview with Staff 8, Staff 8 demonstrated the measuring of the radioactivity. Staff 8 stated when the activity of the radioactive waste is below <5000 counts per minute (CPM, a measure of radioactivity, a unit of measurement for a Geiger counter), the waste would be disposed via a contracted vendor pick up. A concurrent review of the "Waste Disposal Log" in the department indicated the form was preprinted with a different measuring unit of radioactivity.

On 8/25/2016 at around 4 p.m., during a concurrent interview and review of the facility policy and procedure, titled "Waste Disposal Policy" for the Diagnostic Radiology and dated 2/1/2008, Dir 1 indicated the policy referred to a different measuring unit of radioactivity and the disposal of into the sanitary sewerage system. Dir 1 acknowledged the policy did not match with the observed procedure at the facility and the policy would need revision to reflect the latest State guideline for radioactive waste disposal.