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Based on staff interviews and review of facility documents, the governing body of the facility failed to ensure the contracted services had internal quality assurance activities to track performance failures. The findings created the potential for negative patient outcome.

The findings were:

On 1/11/2012, interviews were conducted at approximately 2:00 p.m. with the Quality Improvement Specialist and a Quality Department staff member. The facility failed to provide documentation that the contracts were assigned to a person or department responsible for reviewing, monitoring and evaluating the effectiveness of the contract. There was no process in place to ensure all hospital clinical contracts were assessed and quality assurance information forwarded to the Governing Body to ensure oversight and effectiveness by the appropriate personnel or department responsible for the contracted services provided to the facility. However, when contracted services did not meet the expectations of the facility, actions were taken by the facility and the facility's governing body.

Based on staff interview and review of facility documents, the facility failed to ensure it established a process for the prompt resolution of patient grievances and informed each patient of its process and whom to contact to file a grievance. As part of its notification of patient rights, the facility did not provide the patient or patient's representative a phone number and address for lodging a grievance with the State agency. This failure created the potential for a negative outcome.

The findings were:

A joint interview was conducted with the Chief Clinical Officer and a Quality staff member on 1/11/12 at approximately 1:40 p.m. When asked where grievance information was in the patient rights notification, they stated they thought it was posted in Registration and in the Emergency Department and also on their website. However, it was noted that the website stated Joint Commission and hospital contact information, but not the State agency contact information. The Patient Rights pamphlet, provided to each patient upon admission, stated on the "Customer Service Representative" contact phone number and no other information about complaints, grievances, or State agency contact information. When asked how patients would know how to file a complaint, the Chief Clinical Officer stated, "By the posting and by calling the number on the Patient Rights hand-out." S/he stated if the patient was not satisfied with the facility's resolution, the facility would give the patient the Health Department information.

The Patient Rights pamphlet provided to each patient, entitled "YOUR RIGHTS AND RESPONSIBILITIES AS A PATIENT," stated the following, in pertinent part: "The following is an explanation of your rights while in this facility. If you have questions about any of these rights, contact the Customer Service Representative by calling..." The State agency's contact information was not provided in the pamphlet, nor was an explanation of the facility's complaint and grievance processes. No other documentation provided to patients included the required information.

Based on staff interview and review of facility documents, the facility failed to ensure it established a clearly explained procedure for the submission of a patient's written or verbal grievance to the hospital. Specifically, the information provided to patients did not explain the grievance procedures. This failure created the potential for a negative outcome.

The findings were:

A joint interview was conducted with the Chief Clinical Officer and a Quality staff member on 1/11/12 at approximately 1:40 p.m. When asked where grievance information was in the patient rights notification, they stated they thought it was posted in Registration and in the Emergency Department and also on their website. However, it was noted that the website stated Joint Commission and hospital contact information, but not the State agency contact information. The Patient Rights pamphlet, provided to each patient upon admission, stated the "Customer Service Representative" contact phone number and no other information about complaints, grievances, or State agency contact information. When asked how patients would know how to file a complaint, the Chief Clinical Officer stated, "By the posting and by calling the number on the Patient Rights hand-out." S/he stated if the patient was not satisfied with the facility's resolution, the facility would give the patient the Health Department information.

The Patient Rights pamphlet provided to each patient, entitled "YOUR RIGHTS AND RESPONSIBILITIES AS A PATIENT," stated the following, in pertinent part: "The following is an explanation of your rights while in this facility. If you have questions about any of these rights, contact the Customer Service Representative by calling..." There was no additional information or explanation about the facility's complaint and grievance processes. No other documentation provided to patients included the required information.

Based on review of facility documents, policy/procedure, and staff interview, the facility failed to ensure written notice of its decision of the resolution of a patient grievance was provided. Specifically, three patient complaints were reviewed, deemed to meet the definition of a grievance, however the facility did not send out letters to the patients and/or their representatives with the name of the hospital contact person, steps taken to investigate the grievance, results of the grievance process, and date of completion. This failure created the potential for a negative outcome.

The findings were:

Information provided on the complaints/grievances stated the following, in pertinent part:

#1 - "Pt called to complain about the treatment [s/he] received during [his/her] sleep study the night before. Pt complained tech 'threw the blanket over [his/her] face' and pt felt disrespected. Stated if staff are going to treat patients like this they should not be working here. States [s/he] had a bad impression of [the facility] because of this person. Spanish speaking only, so interpreters used during phone calls. No interpreter used for episode of care - possible language barrier???"

#2 - "Pt called to complain that [s/he] was seen in H & V clinic on [date of service] post cardiac cath. Pt states [s/he] had increased SOB (shortness of breath) and fever [two days later] and called the H & V answering service and was told 'there is no one on call.' Pt was advised to contact the ED. Pt states [s/he] called the ED and was told 'we cannot wake up [the physician - s/he] is sleeping.' Pt states [s/he] 'suffered' all night long and called [the facility's] Administration in the am. Pt was advised to call H & V clinic and they arranged for [the patient] to be seen that day. Pt seen by RN in H & V clinic with vitals and event monitor review. [The physician] reviewed results and ordered a 24 hour pulse ox and pt instructed to go to ED if symptoms got worse. [The physician] did not see pt in clinic face to face. Pt was upset that [s/he] was told [the physician] was not on call by the answering service, that the ED staff would not wake [the physician] to talk to [him/her] on the phone when [s/he] called the ED and that [the physician] would not see [him/her] in the clinic the next day."

#3 - "Pt's daughter wrote a letter to [the CEO] stating how unhappy they were with her [parent's] discharge process during his/her stay. Daughter states she did not feel her [parent] was ready for discharge as [s/he] was still having nausea and vomiting, but was told if [s/he] had wanted to appeal the discharge [s/he] had to do it before [s/he] was discharged and it was too late. Pt's daughter asked that pt not be discharged until daughter was off work at 4 pm and could come and pick her up herself and take her back to [facility]. Case manager had someone from [the facility] sign the discharge papers and called them to come and pick [her parent] up without her daughter knowing about it. [The facility the patient was being discharged to] called the daughter and she called the case manager to hold the pt until she got there. Pt began to vomit on the wheelchair ride to the car and RN did not know what to do. They feel they were treated like a homeless person with no insurance and were constantly reminded that Medicare would only pay for three days. The daughter feels that they never should have discharged her [parent.]"

An interview was conducted with the Customer Service Manager (CSM), responsible for resolving all billing complaints, on 1/12/12 at approximately 8:30 a.m. The Risk Manager, who is responsible for resolving all care complaints, was not physically available the week of the survey.

When asked about complaint #1, the CSM stated the complaint was made to the Risk Manager, who contacted the Director, who followed-up with the tech that provided the care. The CSM stated, "The only thing that would have resolved his concern was to fire the employee, which was not appropriate. So, I do not know why a letter was not sent. I was not really involved in that complaint."
When asked about complaint #2, the CSM stated, "I don't know why a letter wasn't sent." The CSM stated the outpatient services were not part of their responsibilities, but then they were later told they were. The CSM continued, "The complaint went to Administration first and then went back down to Risk. It was not documented as resolved on the form."

When asked about complaint #3, the CSM stated that the Case management had a detailed conversation with the complainant. The CSM continued, "There was conflicting information between the letter and care notes. The resolution was to ensure it doesn't happen to anyone else." The CSM agreed the incident met the facility's definition of a grievance, however it was confirmed that Case Management, who handled the complaint, did not send a letter.

On 1/12/12 at approximately 9:15 a.m., Quality staff confirmed with the Risk Manager that a letter was not sent to any of the three complainants.

The facility's policy titled "ADMIN - PATIENT/FAMILY COMPLAINT OR GRIEVANCE," last revised 4/11, stated the following, in pertinent part:
"Definitions:
* Complaint - Verbal complaint about a current concern that is resolved at the time of the complaint - Verbal complaint about a past situation that could have been resolved at the time by staff present had it been known - Verbal or written billing issue
* Grievance - Complaint about a patient care issue not resolved at the time by staff present - Allegation of abuse, neglect, or patient harm - Complaint regarding failure to comply with CMS requirements - Request that the complaint be handled as a formal complaint or grievance - All written (non-billing) complaints including fax and e-mail...
The grievance should be resolved as soon as possible. If a lengthy investigation is anticipated, the department manager will provided the patient or their representative with information regarding the process including estimated date of completion and his or her name and telephone number as a contact person if questions arise. A written response will be provided to the patient or representative within seven (7) business days after the investigation is completed for all grievances filed. The response will contain the steps taken on behalf of the patient to investigate the complaint, the results of the evaluation and the name of the hospital contact for further information..."

Based on facility tour/observations and staff interview, the facility failed to ensure patients received care in a safe setting. Specifically, the facility had expired sutures in rotation in their labor and delivery rooms, improperly labeled glucometer control solution in their Emergency Department, and expired supplies in their surgical areas. This failure created the potential for a negative patient outcome.

The findings were:

1. Expired Sutures
Tour of the Maternal/Labor and Delivery Unit was conducted on 1/9/12 at approximately 12:30 pm with the Chief Clinical Officer and the Maternal Unit Managers. The Labor and Delivery Unit contained five patient rooms and room #4 was toured. Near the door were patient care supplies used during a delivery, including several boxes of sutures (used to stitch patients), which each included several packs. Four boxes were found to be expired: O Vicryl expired July '09, 2-O Chromic Gut expired July '10, O PDS II expired July '08, and 4-O Vicryl expired January '10. Additionally, five pack of 4-O Monocryl sutures, expired July '08, and four packs of 4-O Monocryl sutures, expired July '07, were setting beside all the suture boxes. The Managers and Chief Clinical Officer both confirmed the boxes should have been removed from rotation. A later tour on 1/10/12 revealed the unit had a new process to obtain sutures and that all expired sutures had been removed from the patient rooms.


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2. Glucometer Controls
A facility policy titled, "Blood Glucose Monitoring, Point of Care" last revised 11/2009 stated the following, in pertinent part:
"...Key Steps...5. Test strip vial and control solution vials are to labeled with date opened. They must be discarded 3 months after opening...
QUALITY CONTROL...d. Check expiration date on control solutions and test strip vial. Discard, if date has expired or if more than three months since vial was opened..."

Observations were conducted in the Emergency Department (ED) on 1/9/2012 at approximately 11:45 a.m. with the Quality Improvement Specialist and the Clinical Supervisor of the ED. It was found that the Emergency Department utilized a point-of-care blood glucose monitor. The ED had two bottles of quality control solution that had no written indication of when the solutions had been opened for use nor when the bottles needed to be discarded.

An interview with the Clinical Supervisor of the ED at the time of the observation revealed that s/he was not aware of a facility policy or manufacturer specification that the quality control solution needed to be discarded after being opened for three months.

3. Expired Supplies in Surgical Areas
A tour of the surgical services areas of the hospital was conducted on 1/10/2012 with the Quality Improvement Specialist. At approximately 8:40 a.m., in the preoperative patient care area, a flat of lavender blood test tubes was found to be available for patient care that had a manufacturer's expiration date of 12/2011. Additionally, the lavender tubes were available in the trays used for starting intravenous lines on patients receiving surgery. The expiration dates were confirmed with the Director of Outpatient Surgical Services. At approximately 9:15 a.m. a sterile package was found in OR Room #4 that contained a laboratory test tube that had a manufacturer's expiration date of 7/2009. The expiration date was confirmed with the Director of Outpatient Surgical Services. At approximately 11:15 a.m., the Cardiac Cath Lab was found to have four packs of tubing for an intravenous fluid warmer that had manufacturer's expiration dates of 9/2010. Additionally, in the procedure room a lavender test tube was found available for patient care that had a manufacturer's expiration date of 12/2010. The Director of the Cardiac Cath Lab confirmed the expiration of the identified supplies.

Based on staff interview, review of the facility's policies/procedures and medical records, the facility failed to follow their restraint policy and procedure in one (#16) of five restraint medical records (#4, #5, #6, #27)reviewed. This failure created the potential for restraints to be used inappropriately, which created a potential for a negative outcome for patients in the facility.

The findings were:

The facility's policy and procedure entitled, "Restraints" revised March 2010, stated the following in pertinent part:
"3. Restraint Orders for nonviolent/non self-destructive patients
a. The order for the use of restraints must be made by an MD, DO, LIP or their authorized PA or APN.
b. All orders for restraints must be based on the assessed need of the patient.
c. If LIP or his/her authorized PA or APN is not available, a nurse may initiate a call to an LIP to obtain a telephone order as soon as possible, but within 12 hours or immediately, if based on a significant change in the patient's condition.
d. An examination and written order by the LIP is entered into the medical record within 24 hours.
e. The order must be dated and timed and must specify type of restraints and reason for restraints.
h. Restraint orders must be reevaluated and reordered once every calendar day.
i. The physician must base the reordering of restraints on a face-to-face reassessment of the patient."

The inpatient medical record for sample patient #16 was reviewed on 1/11/12. The patient was admitted to the facility on 12/30/11 to the Intensive Care Unit (ICU) with diagnoses of cellulitis and ETOH (alcohol) withdrawals. The patient was being restrained since admission with a brief removal of restraints on 12/31/11.

The facility's restraint form entitled, "Restraint Orders for Non-violent/Non-Self-Destructive Patient," was a two-part form. The first portion was completed by the nurse and the second portion was to be completed by the physician or designee as stated in the policy and procedure. The statement in the physician portion reads as follows: "In accordance with CMS Conditions of Participation, I have evaluated this patient and have determined the need to use/continue restraints as specified by this order." It was noted during medical record review that the following days did not have the physician's portion of the restraint orders completed: 1/5/12, 1/8/12 and 1/9/12.

An interview was conducted on 1/11/12 at approximately 4:00 p.m. with various ICU staff members. The ICU staff stated that restraint orders were like all other physician orders, the physician had 30 days to sign them.

In summary, according to documentation the physician had not completed a face-to-face assessment on three different days prior to the reordering of restraints. The three days of restraints noted above were continued by the assessment criteria of a Registered Nurse (RN) and not by a physician and/or designee. There was no documentation that the RN had attempted to initiate a call and obtain a telephone order as soon as possible. The facility not only failed to follow their policy/procedure but also failed to be "in accordance with CMS Conditions of Participation" as noted on the restraint form.

Based on credential file review, review of the facility's Medical Staff Bylaws, Rules/Regulations, and staff interview the facility failed to ensure that practitioners were granted specific privileges when placed on the medical staff. Specifically, the facility failed to delineate what tasks/activities/procedures the practitioners were granted privileges to perform.

The findings were:

A review of the facility's Medical Staff Bylaws, last approved by the facility's Governing Body on 4/27/2010, revealed the following, in pertinent part:
"... SECTION 3. CLINICAL PRIVILEGES
3.1 Exercise of privileges
3.1.1 A practitioner providing clinical services at the hospital may exercise only those privileges granted to him/her by the Board or emergency and disaster privileges as described herein. Privileges may be granted by the Board upon recommendation of the MEC to practitioners who are not members of the medical staff. Such individuals may be Advance Practice Registered Nurses (APRN's), Physician Assistants (PA's), physicians serving short locum tenens positions, telemedicine physicians or others deemed appropriate by the MEC and Board.
3.2 Requests
3.2.1 When applicable, each application for appointment or reappointment to the medical staff must contain a request for the specific clinical privileges desired by the applicant. Specific requests must also be submitted for temporary privileges and for modifications of privileges in the interim between reappointments..."

A review of a sample of ten credential files that were reviewed on 1/11/2011 revealed that six (credential files #1, #2, #4, #6, #8, and #10) of the ten credential files contained a privilege request form for "Core Privileges" which did not specifically indicate that individual privileges were granted to practitioners. Additionally, four (credential files #1, #2, #4, and #8) of the six files did not contain a form that allowed the practitioner to limit portions of the core block of privileges granted.

Credential File #1 was the file of a Radiologist that contained a form that stated the following, in pertinent parts:
"...Requested Core privileges in diagnostic radiology include the ability to examine, consult, diagnose and treat diseases using radiological diagnosis, nuclear radiology, diagnostic ultrasound, magnetic resonance, computed tomography, interventional procedures, and other forms of radiant energy. Core privileges include but are not limited to the following:
Radiographic Studies/Fluoroscopy - interpretation and performance of:
- Plain x-ray exams including orthopedic, chest, specimen radiography
- Genitourinary exams including excretory urogram (IVP), voiding cystourethrogram, hysterosalpingogram
- Gastrointestinal exams including barium swallow, contrast esophagram, upper GI contrast enema, small bowel follow through, small bowel enteroclysis
- Fluoroscopically-guided exams including arthrography, myelography, percutaneous nephrostomy, venography, fistula injection, biopsy, drainage, percutaneous catheter injection
Computed Tomography - interpretation of and performance of:
- Neurologic CT exams including head/spine CT, CT myelography, intracranial perfusion imaging
- Musculoskeletal CT exams
- CT angiography exams including coronary, carotid, intracranial, pulmonary, aortic, lower extremity runoff
- Body imaging exams including neck/chest/abdomen/pelvis CT, CT enterography and CT colonography
-CT guided biopsy/drainage
Ultrasound - performance and interpretation of:
- obstetrical/gynecologic exams
- Body exams including ultrasound of the chest, abdomen and pelvis
- Small parts exams including scrotal, thyroid and breast ultrasound
- Pediatric intracranial, spinal, hip ultrasound
- Vascular exams including portal venous, renal, extremity venous/arterial and abdominal aorta ultrasound
- Ultrasound-guided biopsy, fine needle aspiration and drainage
Nuclear Medicine - interpretation of/supervision of:
- Cardiothoracic exams including myocardial perfusion, MUGA, ventilation/perfusion and breast scans
- Neurologic exams including brain perfusion scans
- Musculoskeletal exams including bone scans
- Gastrointestinal exams including gastric emptying, hepatobiliary, Meckel's, tagged red cell, tagged white blood cell, gallium, indium and neuroendocrine scans
- Thyroid exams including uptake and scan, whole body 1-181 scan
- Thyroid 1-131 therapy dose administration (as allowed by the hospital's nuclear license) Mammography - interpretation of/performance of:
- Film-screen and digital mammography
- Galactography
- Stereotactically-guided breast biopsy
Magnetic Resonance Imaging - interpretation of/performance of:
- Neurologic exams including brain, spine and brachial plexus MRI
- Body exams including neck, chest, abdomen and pelvis MRI
- Musculoskeletal exams including shoulder, knee, wrist, hand, hip, knee, ankle and foot
- Vascular exams including intracranial, neck, aorta/renal, extremity MR arteriography and MR venography
- Cardiac MRI
- Breast MRI
Teleradiology
- Interpretation of radiologic studies via teleradiology..."
The core privileges did not specify the specific procedures that the hospital could support and would allow the specialty physicians to perform and thus would be able to exclude by striking through the specific procedures that the practitioner did not feel comfortable or competent to perform. Additionally, the form did not allow for the practitioner to limit the core group of privileges that were granted to a radiologist requesting privileges.

Credential File #2 was the file of a Gynecologist that contained a form that stated the following, in pertinent parts:
"...Requested Core privileges in Gynecology include the ability to admit, evaluate, diagnose, treat and provide consultation to patients, in both the inpatient and outpatient settings include the following:
Examination, consultation, diagnosis and treatment of full range of medical and surgical gynecologic problems for patients of all ages, including primary and preventive gynecologic care. Core privileges include but are not limited to the following: Ambulatory primary care; counseling and education regarding nutrition, exercise, health maintenance, and high-risk behaviors; endometrial ablation; family planning to include the provision of reversible contraceptive and sterilization procedures; gynecologic laparoscopic surgery; gynecologic laser surgery; management of critically ill gynecologic patients; hysterectomy, abdominal, vaginal, and laparoscopic medical and surgical management of pelvic floor dysfunction, urinary and/or fecal incontinence; medical and surgical termination of pregnancy; medical and surgical treatment of non-malignant breast diseases; medical or surgical management of ectopic pregnancy; postmenopausal care; psychosomatic and psychosexual counseling; reproductive endocrinology and infertility; sacrospinous ligament suspension; gynecologic ultrasonography to include transabdominal and transvaginal evaluation of the pelvis, and sonohysterography..."

The core privileges did not specify the specific procedures that the hospital could support and would allow the specialty physicians to perform and thus would be able to exclude by striking through the specific procedures that the practitioner did not feel comfortable or competent to perform. Additionally, the form did not allow for the practitioner to limit the core group of privileges that were granted to a gynecologist requesting privileges.

Credential File #4 was the file of a Hospitalist that contained a form that stated the following, in pertinent parts:
"...Hospitalist core clinical privileges are considered to be the same as those for general internists, or equivalent training in Family Practice including but are not limited to: admission, H&P examination, diagnostic evaluation (including consultation) and non-surgical treatment of illnesses, injuries or conditions that fall within the usual and customary scope of practice of a fully trained general internist. Such privileges include abdominal paracentesis, arthrocentesis, bone marrow aspiration, and biopsy, stress testing and interpretation, cardioversion, central venous catheter placement, preliminary echocardiogram interpretation, endotracheal intubation, sigmoidoscopy (rigid or flexible), lumbar puncture, peripheral venipuncture, Foley catheter insertion, pulmonary function test interpretation, ECG, thoracentesis, arterial lines, Swan-Ganz catheterization, and ventilator management..."
The core privileges did not specify the specific procedures that the hospital could support and would allow the specialty physicians to perform and thus would be able to exclude by striking through the specific procedures that the practitioner did not feel comfortable or competent to perform. Additionally, the form did not allow for the practitioner to limit the core group of privileges that were granted to a hospitalist requesting privileges.

Credential File #6 was the file of an Otorhinolaryngologist that contained a form that stated the following, in pertinent parts:
"...OTOLARYNGOLOGY CORE: Admission, workup, diagnosis and provision of non-surgical care to patients presenting with illnesses, injuries and disorders of the head and neck affecting the ears, facial skeleton, and/ respiratory and upper alimentary system. These privileges include sinus endoscopy, surgery involving temporal bone, nasal and paranasal sinus, skull-base maxillofacial, esthetic, plastic, reconstructive, thyroid, parathyroid, pituitary, salivary glands, and lymphatic tissue of head and neck. These privileges do not include any of the special requests listed below..."
The core privileges did not specify the specific procedures that the hospital could support and would allow the specialty physicians to perform and thus would be able to exclude by striking through the specific procedures that the practitioner did not feel comfortable or competent to perform.

Credential File #8 was the file of a Urologist that contained a form that stated the following, in pertinent parts:
"...Urology core clinical privileges include the following: Evaluation and management of adult
and pediatric genitourinary disease, including medical and surgical treatment of disorders of, and injuries to the genitourinary tract, including the adrenal gland; adrenal surgery, renal surgery, open bladder surgery; endoscopy of the urinary tract, including biopsy, resection, stone removal; extracorporeal shock wave lithotripsy (ESWL); penile prosthesis implantation; artificial urinary sphincter implantation; open penile/urethral surgery; female surgical treatment of incontinence; male surgical treatment of incontinence; laparoscopic surgery; pelvic lymphadenectomy; retroperitoneal lymphadenectomy; partial, radical, simple nephrectomy; prostate biopsy; radical, simple, endoscopic prostatectomy; prostatic ultrasound; reconstructive urology; retrograde pyelography/urethrography; scrotal surgery (including scrotal contents); testicular surgery; transurethral catheterization; ureteral surgery; urinalysis; urinary diversion; urodynamics; vasectomy, reversal of same..."
The core privileges did not specify the specific procedures that the hospital could support and would allow the specialty physicians to perform and thus would be able to exclude by striking through the specific procedures that the practitioner did not feel comfortable or competent to perform. Additionally, the form did not allow for the practitioner to limit the core group of privileges that were granted to a urologist requesting privileges.

Credential File #10 was the file of a General Surgeon that contained a form that stated the following, in pertinent parts:
"...GENERAL SURGERY CORE: Privileges include the performance of surgical procedures (including related admission, consultation, work-up, pre- and post-operative care) to correct or treat various conditions, illnesses and injuries to the:
> alimentary tract
> abdomen/pelvis and its contents
> breasts, skin and soft tissue
> head and neck
> vascular system, excluding the intracranial vessels, the heart, and those vessels intrinsic and immediately adjacent thereto
> endocrine system
> minor extremity surgery (biopsy, I&D, varicose veins, foreign body removal, skin grafts
> comprehensive management of trauma including musculoskeletal, hand and head injuries
> complete care of critically ill patients with underlying surgical conditions in the Emergency Department and Intensive Care Unit...
THORACIC SURGERY: Admission, work up, operative, perioperative and surgical critical care of patients with acquired and congenital pathologic conditions within the chest. Management of the airway and injuries to the chest are also within the scope of care, Thoracic surgery includes procedures involving the lungs, pleura, and/or chest wall; involving the esophagus, mediastinum, diaphragm, pacemaker implantations/closed EP; bronchoscopy and endoscopy,.."

The core privileges did not specify the specific procedures that the hospital could support and would allow the specialty physicians to perform and thus would be able to exclude by striking through the specific procedures that the practitioner did not feel comfortable or competent to perform.

An interview with the facility's Director of Medical Staff Services on 1/11/2012 at approximately 10:00 a.m. revealed the hospital did not list specific procedures the hospital could support and would allow practitioners to perform. S/he stated practitioners could strike out portions of the core privileges or could break out what they could perform in addition to the core privileges. S/he stated that each section chair goes through the requests and the performance evaluations of each practitioner before granting privileges to each physician.

Based on observations, staff interviews, and review of the facility's policies/procedures, the facility failed to ensure that unauthorized individuals could not gain access to or alter patient records. Specifically, the facility failed to ensure that medical records within an outpatient clinic as well as radiology records within the radiology department of the hospital were secured.

The findings were:

A review of the facility's policy titled "Administrative Safeguards to Protect the Security and Integrity of Protected Health Information" last revised 11/03, stated the following, in pertinent part: "5. Physical Safeguards: a) The organization should take appropriate physical safeguards to protect PHI. For example: i) Securing areas where PHI is stored, in order to limit access, by putting a lock on doors, cabinets, or drawers; ii) Shredding documents containing PHI before disposing of them; iii) Using a sign-in and escort procedure to account for visitors and deliveries on the organization's premises, as appropriate; and iv) Not leaving documents containing PHI unattended and unsecured..."

A tour of the facility's outpatient Cancer Center clinic was conducted on 1/10/2012 at approximately 3:00 p.m. with the Quality Improvement Specialist and the Director of the Cancer Center. A room that contained cabinets with medical records was noted to have no lock on the door. When asked how the records were secured when staff was not present, the Director of the Cancer Center stated that the cabinets were not locked on a regular basis. S/he also stated that personnel that did not have a need to access the medical records could have access after hours when cleaning was performed. S/he stated that the cabinets would be locked on a regular basis starting that evening.

Cross Reference to A-0553: Records for Radiologic Services for findings related to the facility's failure to ensure records of radiologic services were maintained in a secure manner. Specifically, the facility stored old radiology films and images in an unsecured room within the radiology department.

Based on review of policy/procedure and staff interview, the facility failed to ensure drugs and biologicals were automatically stopped after a reasonable time that was predetermined by the medical staff. This failure created the potential for a negative outcome.

The findings were:

An interview was conducted with the Director of Pharmacy on 1/10/12 at approximately 11:00 a.m. When asked if the facility had a stop order policy in place, s/he stated, "Yes, on certain things... PRN narcotics, Toradol. We recently stopped on antibiotics through the P&T Committee because several of our physicians never sent in the renewal notice (for the antibiotics). We look at all antibiotics every day and felt we had controls in place to lessen the use of antibiotics." S/he continued, "Every thirty days everything will automatically stop and need reordering." The Director was asked if there would be an order in writing to restart all of the medications in the chart of a patient who had been admitted over thirty days. S/he stated, "I don't think so." S/he stated it was a Meditech (the facility's Electronic Medical Record charting system) parameter that after thirty days everything has to get renewed, but that the pharmacists most likely "just reorder them."

The facility policy titled "MEDICATION/DRUG REORDER PROCEDURE" last revised 6/10, stated the following, in pertinent part:
"Purpose: To identify medications that need to be evaluated by the physician for continued use, and provide a method for alerting the physician that the evaluation is needed...
Key Steps/Procedure:
1. The medications identified as requiring an evaluation at a specified time frame are as follows:
a. Antibiotics - followed daily by Pharmacy for appropriate use and duration.
b. PRN Schedule II narcotics -- 10 days (excluding Schedule CIIs such as Morphine Sulfate contin)
c. Ketoralac -- 5 days
2. The "automatic stop date" feature combined with the "soft stop" feature in Meditech will be utilized to provide notification. The orders will not automatically discontinue at the renewal date, but will be continued for the greatest amount of time available for the soft stop feature (9 days).
3. A report will print every morning in the Pharmacy providing renewal notices to be placed in the Physician's Order section of the chart for the physician to address. These will continue to print until the order is addressed and the stop date changed in the computer by pharmacy..."

Based on staff interview and observations, the facility failed to ensure periodic inspection of equipment was made of all areas where radiologic services were provided, including outpatient areas. This failure created the potential for a negative outcome.

The findings were:

An interview was conducted with the Director of Radiology on 1/11/12 at approximately 8:30 a.m. When asked about inspections on equipment, s/he stated the State policy requires it annually and they have a 30-day window on the expiration date. When asked about the equipment found to be expired at the facility's off-site Outlaw Clinic, s/he stated, "We have no oversight on X-ray at the Outlaw Clinic." When asked about the lead and dosimetry badges at the Outlaw Clinic, s/he again stated they had no oversight there and "Radiology has never been out there. They must take care of their dosimetry badges as well." The Director confirmed that his/her department serviced all other outpatient areas. When asked if the contracted maintenance company would go to the Outlaw Clinic for service, s/he stated, "If called."

Review of the radiology and nuclear medicine maintenance logs revealed no logs for the Outlaw Clinic's equipment.

Cross Reference A1077 - Integration of Outpatient Services for observations and findings of the facility's failure to ensure organization and integration with inpatient services.

Based on facility tour, staff interview, and review of policy/procedure, the facility failed to ensure records of radiologic services were maintained in a secure manner. Specifically, the facility stored old radiology films and images in an unsecured room within the radiology department. This failure created the potential for a negative outcome.

The findings were:

Tour of the radiology department was conducted on 1/11/12 with the Director and Chief Clinical Officer at approximately 8:30 a.m. When asked where old imaging films were stored, s/he revealed a very large room that was entirely full of old films. The room was unfinished with a concrete floor and contained approximately five long rows of file cabinets which spanned the room, each with multiple shelves full of radiology films. Behind all the file cabinets were more imaging storage. The Director stated the room was an old CT room and the films had just been moved here. The Director stated the entire department was locked after hours, but the housekeepers have keys to the room and clean the floor after 5 p.m. Upon entrance to the room, the door was noted not to be locked/secure. This was confirmed with the Director who stated the door was kept open during the day. The Director confirmed housekeeping staff were not accompanied when in the room and, during the day, any staff with a badge could enter the radiology department. The Director was informed that radiology films are part of the medical record and need to be secured as such.

An interview was conducted with the Director of Medical Records on 1/10/12 at approximately 1:00 p.m. S/he stated was was not aware of the storage of radiology films.

Facility staff was asked for a policy related to security of medical records. The policy titled "Administrative Safeguards to Protect the Security and Integrity of Protected Health Information" last revised 11/03, was provided. It stated the following, in pertinent part: "5. Physical Safeguards: a) The organization should take appropriate physical safeguards to protect PHI. For example: i) Securing areas where PHI is stored, in order to limit access, by putting a lock on doors, cabinets, or drawers; ii) Shredding documents containing PHI before disposing of them; iii) Using a sign-in and escort procedure to account for visitors and deliveries on the organization's premises, as appropriate; and iv) Not leaving documents containing PHI unattended and unsecured..."

Based on staff interview, review of policies/procedures, and facility agreement/contract, the facility failed to ensure its agreement with an outside blood collection agency contained all necessary components. This failure created the potential for a negative outcome.

The findings were:

An interview with the Director of Laboratory was conducted on 1/10/12 at approximately 2:00 p.m. The Director stated the facility collected blood donations only for autologous transfusions and all other blood collection was furnished by an outside collection establishment, specifically a nearby larger hospital. When asked if the contract with that outside hospital contained the necessary timeframe notification dates, s/he stated s/he had communicated with that facility to inquire about similar concerns. The facility's agreement was reviewed with the Director and the Chief Clinical Officer and found to not contain these dates and data, as required in portion (3) of this regulation. Additionally, the agreement did not specify sections (7), (8), or (10) or this regulation. The Director and Chief Clinical Officer both confirmed this agreement/contract was under review and would be revised prior to final approval.

The facility was requested to obtain the policies/procedures from the contracted blood supplier. Such were provided, titled "Quarantine of Previous Products After Positive Testing" and "Look Back Policy and Procedure" which contained all of the necessary patient notification timeframes and details, as specified in this regulation. However, the details of these policies were not included in the facility's agreement with the outside supplier.

The facility's agreement stated, in pertinent part:
"IV. LOOKBACK, QUARANTINE, AND RECALL
A. Records related to blood donors will be retained permanently for use in actions requiring investigation of increased risk for transmitting HIV and other required infectious disease markers in situations of look-backs.
B. HOSPITAL agrees to cooperate in the investigation and follow-up of lookback cases, post-transfusion disease transmission and recall notices.
C. HOSPITAL agrees to report to the BLOOD CENTER any suspected post-transfusion disease transmission.
V. HOSPITAL'S RESPONSIBILITIES
A. HOSPITAL will store all blood products according to current FDA and AABB regulations.
B. HOSPITAL agrees to make available to BLOOD CENTER storage records and equipment records for equipment to store blood.
C. HOSPITAL will complete the shipping temperature documentation provided with the blood shipment and return such to the BLOOD CENTER..."

Based on the manner and degree of the deficiency cited, the facility failed to be in compliance with the Condition of Participation of Physical Environment. The facility failed to ensure that all equipment and supplies were appropriately maintained and periodically inspected for safety, efficacy and expiration dates, in order to ensure safe delivery of patient care.

The facility failed to meet the following standards under the Condition of Physical Environment:

Reference Tag A 724 Facilities, Supplies, Equipment Maintenance
The facility failed to ensure equipment and supplies were maintained to ensure an acceptable level of safety and quality. Specifically, the facility failed to adhere to manufacturer's labeling of the expiration on compressed oxygen gas cylinders.

Reference Tag A 726 Ventilation, Light, and Temperature Controls
The facility failed to assure proper temperature control monitoring was utilized in the storage of pharmaceutical supplies and in the food preparation area. Specifically, the following failures were identified:
1. No back-up freezer/refrigerator thermometers in the food preparation area,
2. Medication refrigerator temperatures were not being consistently monitored on the OB (obstetrical) unit,
3. Sterile water bottles were not dated and were stored at higher temperatures than recommended on the OB unit,
4. "Rapid Aid" hot packs were inappropriately stored on the OB and Acute Care Units.

Based on the onsite Life Safety Code validation survey completed 1/13/2012, the facility failed to comply with the regulations set forth for Life Safety Code and, therefore, deficiencies were cited under the Life Safety Code tags. See survey event ID #IULR21 for full details of the cited deficiencies.

Based on observations, staff interview and review of facility documents, the facility failed to ensure equipment and supplies were maintained to ensure an acceptable level of safety and quality. Specifically, the facility failed to adhere to manufacturer's labeling of the expiration on compressed oxygen gas cylinders.

The findings were:

Observations were conducted during tours of departments of the hospital and outpatient clinics on 1/10/2012 and revealed that the facility had the following expired oxygen tanks available for patient use:

Outlaw Medical Clinic: two tanks that had manufacturer's expiration date of 6/3/2010 and 8/11/2009
Surgical Department: one oxygen tank that had manufacturer's expiration date of 5/14/2010
Endoscopy Department: one oxygen tank that had manufacturer's expiration date of 3/17/2010.

An interview with the Quality Improvement Specialist at the times of the observations revealed s/he was not aware the manufacturer had specified an expiration date on oxygen tanks. The Department Directors present during the observations had confirmed the observations of the expiration dates, but all stated they were not aware the manufacturer had specified an expiration date for the facility's oxygen tanks.

The facility's Quality Improvement Specialist stated s/he spoke with a representative of the oxygen vendor, but was unable to get documentation from the vendor that spoke to the safety and efficacy of the oxygen in the cylinders by the survey exit date of 1/12/2012 at approximately 11:00 a.m.

Based on facility tours/observations, staff interview and review of the facility's policies/procedures, the facility failed to assure proper temperature control monitoring was utilized in the storage of pharmaceutical supplies and in the food preparation area. Specifically, the following failures were identified:
1. No back-up freezer/refrigerator thermometers in the food preparation area,
2. Medication refrigerator temperatures were not being consistently monitored on the OB (obstetrical) unit,
3. Sterile water bottles were not dated and were stored at higher temperatures than recommended on the OB unit,
4. "Rapid Aid" hot packs were inappropriately stored on the OB and Acute Care Units.

The findings were:

1. Food preparation area

The facility's policy and procedure entitled "Storage Temperature" revised 3/2011, stated the following in pertinent part:
"Each mechanically refrigerated unit storing potentially hazardous food shall be provided with a numerically scaled indicating thermometer...located to measure the air temperature in the warmest part of the unit and located to be easily readable. Recording thermometers...may be used in lieu of indicating thermometers.

Each refrigerated storage unit shall have a hanging thermometer in addition to the built-in thermometer. The thermometer shall be placed in the warmest part of the unit, typically near the door, readily accessible and placed so that it is not in the direct line of the air stream from the unit's fan."

The facility's policy and procedure entitled "Food Handling Guidelines (HACCP) (Hazard Analysis Critical Control Point(s))" revised 9/2011, stated the following in pertinent part:
"Cold Holding - Record internal temperatures twice daily."

A tour/observation was conducted in the food preparation area on 1/10/12 at approximately 8:30 a.m. with the Dietary Manager. During the tour it was observed that there were no back-up thermometers in the refrigerators or the freezers. That omission included the free standing units as well as the walk-in units. During the tour the Manager stated s/he would place thermometers in all the units if that was recommended.

In summary, the Dietary Manager was not aware of the facility's policies/procedures regarding the placement of internal back-up thermometers in all the refrigerator/freezer units.


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Tour of the nursing units was conducted with the Chief Clinical Officer and Unit Managers on 1/9/12, beginning at 12:00 p.m. Issues were identified with temperature control pharmaceuticals and patient use items.

2. Pharmaceutical storage

The facility had five labor and delivery patient rooms. Tour was conducted on one of the rooms, #4. The Maternal Unit Manager stated they had a new process of one medication refrigerator for each room which contained emergent labor and delivery medications. S/he stated the temperature monitoring was not hardwired down to the pharmacy, as it was with other medication refrigerators throughout the hospital, and it was the nurses' responsibility to check those temperatures. Observation of the log on the outside of the refrigerator revealed the temperature had only been monitored one of the nine days of the month, on January 5th. Several temperature sensitive medications were present in the refrigerator.

An interview was conducted with the Director of Pharmacy on 1/10/12 at approximately 11:00 a.m. When asked about temperature monitoring of each medication refrigerator in the labor and delivery rooms, s/he stated "Nurse will do daily temp logs. If they are out of parameters, they are to notify us." The Director was not aware of the observations made the previous day wherein the temperatures were found not to be monitored or documented.

The facility's policy, titled "PHARM - MEDICATION REFRIGERATORS" last revised 6/10, stated the following, in pertinent part:
"Policy: To provide for secure, safe storage of medications requiring refrigeration...
Procedure: 1. Medications requiring refrigeration will be stored in the medication refrigerator... 3. Temperature is to be maintained between 36 - 46 degrees F. The refrigerator temperature will be under continuous monitoring with a traceable alarming thermometer or through PYXIS Smart Remote monitoring. The monitor will be set to alarm for up to at least 12 hours when the temperature goes out of the above range. A log will be maintained on the refrigerator to document actions taken when the alarm goes off..."

3. Fluid warming

Tour of the maternal unit revealed five sterile water 1000 ml bottles (Baxter brand) which were stored in a blanket warmer and were all without label dates. The Maternal Unit Manager was asked if the bottles were to be date labeled and s/he stated there were to be rotated so the oldest ones were pulled out of the Pyxis and used. S/he stated they had tracked them in the past and they were used too frequently so they stopped tracking. However, the fluids were in a blanket warmer, not a fluid warmer, and the temperature was found to be 149 degrees.

An interview was conducted with the Director of Physical Environment/Biomed on 1/10/12 at approximately 10:30 a.m. S/he provided the operation and care manual for the type of blanket warmer machine used throughout the hospital. S/he stated that the machines were designed specifically for fluids or blankets. When asked what temperature was safe to warm the fluids, s/he stated, "For my Operating Room, I keep it at 104 degrees." When asked if 149 degrees was appropriate, s/he stated it was "too high."

The facility policy titled "OR - SAFETY IN THE OPERATING ROOM" last revised 6/11, stated the following, in pertinent part: "7. Irrigation/infusion solutions are kept in warmers regulated at less than 104 degrees F or kept at room temperature for use during surgical intervention. a. All fluids in warming cabinets are rotated out of the cabinet every 2 weeks..."

A second tour was conducted of the maternal unit on 1/10/12 at approximately 10:45 a.m. The sterile waters were all still present and unlabeled within the blanket warmer and were extremely expanded from high heat. Interview with the Manager determined the fluids were used only used on external portions of patients' bodies, however the warming was still deemed not to be appropriate as done.

4. Patient use item storage

Tour of several different unit revealed "Rapid Aid" hot packs stored within the blanket warmers. One of those units was the maternal unit, where five total were found. The temperature of the blanket warmer was noted to be over 140 degrees. The directions on the Rapid Aid hot packs stated they were to be microwaved in order to be re-warmed. No documentation on the packs referenced storage within a warmer or what temperature was safe to do so. The Maternal Unit Manager stated storage within the warmer was preferred so "they never got too hot." A second observation was made on the Acute Care Unit where four hot packs were found in a blanket warmer which was at 150 degrees.

An interview was conducted with the Director of Physical Environment/Biomed on 1/10/12 at approximately 10:30 a.m. S/he provided the operation and care manual for the type of blanket warmer machine used throughout the hospital. The manual stated the following, in pertinent part: "1. This warming cabinet is designed to safely store and warm blankets and/or irrigation/injection fluids. No other use for this appliance is authorized or recommended..."

On 1/10/12, the Maternal Unit Manager provided the manufacturer's guidelines for the hot packs. The guidelines stated the following, in pertinent part: "Rapid Relief Gel Compresses remain flexible when frozen and safe for microwave use - offering easy, moldable cold or hot therapy almost immediately..." The temperature range stated: "Cold 10 - 20 degrees F...and Microwaved 125 - 130 degrees F..." There were no guidelines for extended storage in a warmer.

Based on facility tours, staff interviews, review of manufacturer guidelines, and policy/procedures, the facility failed to ensure it developed a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. Specifically, the facility failed to ensure refrigerator and freezer temperatures were monitored and food storage areas were maintained appropriately and per policy/procedure. Additionally, the facility failed to ensure patient care supplies were not placed/stored directly on the floor. This failure created the potential for a negative patient outcome.

The findings were:

1. Food Handling/Storage
Tour of the nursing units was conducted with the Chief Clinical Officer and Unit Managers on 1/9/12, beginning at 12:00 p.m. Tour of each nursing care unit revealed inconsistent and/or absent temperature monitoring of the patient nutrition refrigerators and/or freezers.

Tour of the Critical Care Unit revealed a small separate patient nutrition freezer without any temperature monitoring. This freezer contained ice cream and popsicles. The temperatures of the refrigerator, which contained patient nutrition items, were only monitored four of the last eight days. The Critical Care Manager stated that kitchen staff was responsible for monitoring the temperatures.

Tour of the Family Birth Place/Maternal unit revealed the large side-by-side refrigerator only had documented temperatures for four of the last eight days. The freezer had no documented temperatures, as space was not afforded on the monitoring form and an additional form was not present on the freezer.

Additionally, many items were in the patient fridge that were unlabeled and undated, including a large bottle of Viva milk, a Thai/Chinese takeout box of food, a salad box, Lays chip dip, a container of macaroni salad, and several other plastic bags of food items. The Maternal Unit Manager stated, "When housekeeping checks, they throw everything out that is not labeled." Within the freezer was a small bag of unlabeled and undated breast milk, which the Maternal Unit Manager confirmed. S/he stated it should not be stored there and immediately disposed of it. Additionally, eight bags of unlabeled/undated cookie dough was found in the freezer. The Maternal Unit Manager stated it was stored there because "that is where they cook it and they are just for this unit." One of the plastic bags was noted not to be sealed. Lastly, four sealed bags of unlabeled/undated dark sauce were found in the freezer.

Tour of the Acute Care Unit revealed two different patient nutrition refrigerators. Again, the freezer temperatures were not monitored, however only one of the two freezers contained nutrition items. Only four of the previous eight days contained documented temperature monitoring. One of the patient nutrition refrigerators contained an unlabeled and undated sandwich wrap in plastic and a second sandwich in tin foil. Additionally, the freezer contained four bags of unlabeled/undated cookie dough.

An interview was conducted with the Director of Food and Dietary on 1/01/12 at approximately 8:30 a.m. When asked about the patient nutrition refrigerator/freezer monitoring, s/he stated dietary staff was responsible for monitoring temperatures on the nursing units. When asked about removal of patient food items, such as unlabeled or undated items, s/he stated, "We don't touch those. That is my understanding." When asked about the unlabeled/undated cookie dough in two of the nursing unit freezers, s/he stated, "We provide it weekly, so those are new bags every week. We can label them as well."

An interview was conducted with the Infection Control Nurse on 1/9/12 at approximately 2:00 p.m. S/he stated s/he used to monitor all the patient nutrition refrigerators and freezers but stopped doing so because there were no issues noted.

A second tour was conducted of the Maternal Unit on 1/10/12 at approximately 10:45 a.m. It revealed the bags of cookie dough in the patient nutrition freezer had been labeled to state they were cookie dough, but no date had been put on the bags as to when the food items had first been cooled and/or placed in the freezer or when they were to expire or be removed.

On 1/9/12 at approximately 4:00 p.m., the Chief Clinical Officer explained how hard-wiring of all refrigerators and freezers was on the capital budget for the next year. However, when asked if the monitoring should be occurring presently prior to obtaining such equipment, s/he stated it should be.

The facility's policy titled "BREAST MILK, STORAGE & USE" last revised 3/10, stated the following, in pertinent part: "1. Storage of breast milk...Before storing, all breast milk (even that collected at home for use at home) must be labeled with the the time and date of collection. Milk that will be used in the hospital must also be labeled with the baby's name and medical record number...2. Handling of breast milk by nursing personnel. a. Breast milk is considered a body fluid substance and must be handled as such..." Additionally, the facility policy titled "IC - EXPOSURE CONTROL PLAN" stated the following, in pertinent part: "Blood/body fluid specimens will only be placed in designated contaminated areas where there is no food/drink allowed..."

The facility's policy titled "NURSING UNIT STOCK" last revised 3/11, stated the following, in pertinent part:
"... - Food or supplements that have not been consumed, but have been in a patient's or resident's room, may not be returned for storage to the Food and Nutrition Services Department, unit pantry or refrigerator in unit pantry because of the risk of cross contamination...
- Food and Nutrition Services personnel are responsible for daily temperature monitoring of unit refrigerator(s) on a posted temperature sheet...
- Nursing is responsible for the security of the pantry stores.
- Discarding of expired items is the responsibility of foodservice and is done according to established guidelines..."

The facility's polity titled "FOOD HANDLING GUIDELINES (HACCP)" last revised 9/11, stated the following, in pertinent part: "Cooling...All food being cooled must be identified with Morrison label. Complete all information on label including date and time food began cooling process. Policy B007 should be referenced for storage standards. Foods transported outside of the kitchen to other hospital areas should adhere to same storage temperature/labeling and dating..."


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2. Patient Care Supplies on Floor
A tour of the surgical services areas of the hospital were conducted on 1/10/2012 with the Quality Improvement Specialist and the Directors of each department. At approximately 10:45 a.m., in the storage room for the Endoscopy department, there were found to be eight boxes of patient care supplies being stored directly on the floor. The boxes contained packs used for each endoscopy procedure. The Director of the Endoscopy department stated the boxes were normally stored directly on the floor due to the lack of shelf space in the storage room. At approximately 11:30 a.m., in the storage room for the Cardiac Cath Lab, there were found to be six boxes of patient care supplies being stored directly on the floor. The boxes contained "cath packs" that were used for the invasive procedures conducted in the Cardiac Cath Lab. The Director of the Cardiac Cath Lab stated the boxes were "just delivered" and staff had not had the opportunity to put the supplies on shelves yet.

Based on observations, staff interview, and facility document review, the facility failed to ensure outpatient services were appropriated integrated with inpatient services. Specifically, the facility failed to ensure radiology services provided at the facility's Outlaw Clinic were integrated into the facility's inpatient radiology department.

The findings were:

A tour of the hospital's outpatient services departments was conducted with the facility's Quality Improvement Specialist on 1/10/2012. At approximately 1:35 p.m., the facility's Outlaw Clinic was visited. It was discovered the clinic provided plain x-rays to patients of the clinic. When asked if the hospital tested the lead aprons of the clinic, the radiology technician stated the aprons were checked by the clinic. When asked if the checks were documented, s/he stated they were not documented. Observations of the x-ray equipment revealed the sticker indicating when the physicist had last checked the equipment had an expiration date of November 2011.

An interview with the Director of the Radiology Department on 1/11/2012 at approximately 3:45 p.m. revealed the Director did not have any knowledge or oversight of the radiology services at the Outlaw Clinic. The Chief Clinical Officer of the facility (also present during the interview) confirmed the Director of Radiology has "never" had any oversight of the radiology services at the Outlaw Clinic.

Cross Reference to A-0537: Periodic Equipment Maintenance for findings related to the facility's failure to ensure periodic inspection of equipment was made of all areas where radiologic services were provided, including outpatient areas.