The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MAMMOTH HOSPITAL 85 SIERRA PARK ROAD PO BOX 660 MAMMOTH LAKES, CA 93546 June 19, 2015
VIOLATION: SURGICAL SERVICES Tag No: C1140
The facility failed to ensure that the Condition of Participation: Surgical Services was met by failing to ensure that there was a process/system in place, where policies and procedures were evaluated, reviewed or revised, as part of the annual program evaluation by the Department of Surgery to ensure the integrity of the sterile instrumentations transported by, and received from an outside, contracted, surgical-supply vendors remain sterile upon arrival when used immediately in the operating room. This failure had the potential to result in the patients receiving implants and instrumentation that were not sterilized according to AORN standards as promulgated by the facility. This failure had the potential to increase the possibility of contaminated instruments transmitting infectious microorganisms to all patients having surgery in the facility. (Refer to C-0335)

The cumulative effect of this systemic deficient practice resulted in the failure of the facility to deliver care in compliance with the Condition Participation for Surgical Services.
VIOLATION: PERIODIC EVALUATION Tag No: C0335
Based on observation, interview and record review, the facility failed to ensure there was a process/system in place, where policies and procedures were evaluated, reviewed or revised, as part of the annual program evaluation by the Department of Surgery to ensure the integrity of the sterile instrumentations transported by, and received from an outside, contracted vendor was implemented to ensure that "trunk deliveries" (delivery of sterile implants used for surgery) remain sterile when delivered directly into the Operating Room for immediate use during surgery. This failure had the potential to result in surgical patients receiving unsterile instrumentations during the surgical procedure and increasing the risk of possible contaminated instruments transmitting infectious microorganisms to patients receiving surgical services.

Findings:

On April 15, 2015 at 1:16 PM, the facility's Infection Preventionist (IP) reported an incident to California Department of Public health (CDPH) regarding an alleged event that occurred in April 9, 2015, when surgical equipment was found with boxes opened in the back bed of a truck that was uncovered and exposed to the elements and awaiting delivery to the Department of surgery.

During an interview with the Infection Preventionist (IP) on June 17, 2015 at 7:45 AM, the IP stated, as she was walking out of the facility to her car on April 9, 2015, she observed Vendor 1's Sales Representative (SR), in the parking lot in front of the ER (emergency room ) entrance. She observed SR loading boxes and supplies that had been used during the surgical case for Patient 1 earlier that day, onto a pick-up truck that did not have a shell (a cover at the back of the truck). The SR was pulling out the "peel pack (sterile "boxes"). The IP stated she had questioned the SR on how the boxes and supplies was transported as it could have been exposed to elements (to the outside, exposed to wind, dirt, rain or snow) during the transport and appeared inappropriate. In addition, the IP stated it also appeared that the SR was "a different guy" who had never delivered surgical instruments to the facility before. The IP stated, in the past, sterile instrumentations were shipped in sealed cardboard boxes and delivered by the sales representatives through the" backdoor "of the Surgery Department. The backdoor, which was mainly used by the maintenance and the housekeeping staff, was kept locked but had to be "keyed" to open the door. When asked how the facility monitored and tracked what and how the vendor's representatives would deliver sterile instrumentations into the facility, the IP stated there was no tracking system; "that's a purchasing performance and purchasing department issue." The IP stated no one ever witnessed how and what the sales representatives would deliver to the Surgery Department. When asked how does the facility ensure that the integrity of the sterile instruments transported by and received from the outside vendor remained or maintained in a sterile condition, the IP stated, "We don't, we have a hole in the system; We're relying on the vendor companies for sterilization of their own trunk deliveries (sterile instruments that are used for surgery delivered by outside vendor to the OR unit)."

According to the AORN Journal, dated February 2013, when transporting sterile instruments, it noted, " ...sterilized instruments are to be transported in a vehicle that is completely enclosed with an interior made of cleanable material and the means to separate sterile from dirty instruments (e.g. an enclosed van, the open bed of a truck or trunk of an automobile is not acceptable) ... "

On June 16, 2015 at 12:25 PM, the survey team observed the Housekeeping staff (HK 1) walking through the back door (coming from the outside of the facility) while pushing a gray trunk/cart through the hallway outside of the Surgery Department.

During a concurrent interview with HK 1, she stated the "back door" was used only for housekeeping staff to enter the facility to pick up trash.

During an interview with the Perioperative Assistant (PA 1) on June 16, 2015 at 12:50 PM, PA 1 stated the OR staff would not open the trunk deliveries that were delivered by the sales representatives. The sales representatives would bring the trunk deliveries (sterile instruments) in plastic tubs that would remain in the hallway until ready for surgery. When asked how the facility tracked the trunk deliveries, PA 1 stated there was no tracking log to track the trunk deliveries. PA 1 stated "Trunk Deliveries" do not get sterilize by the facility upon delivery.

During an interview with the Operating Room Nurse (OR Nurse) on June 16, 2015 at 1:10 PM, OR Nurse stated they do not sterilize the implants (surgical objects or devices embedded during surgery).

During an interview with the Perioperative Assistant, in the presence of IP, on June 17, 2015 at 8:30 AM, when asked how the OR unit staff monitored and tracked what and how the vendor companies sales representatives delivered the sterile instrumentations to the OR unit, the PA stated the sales representatives would "bring their stuff and we don't know; I didn't pay attention."

During a phone interview with the Corporate Counsel of Vendor 1 on June 18 at 3:10 PM, when asked what guidelines the company followed regarding sterilization of the trunk deliverances, he stated the company followed FDA guidelines.

During an interview with the IP on June 19, 2015 at 10:06 AM, when asked what guidelines the Surgery Department followed to ensure sterility of all trunk deliveries, she stated, the facility followed the Association of Perioperative Registered Nurses (AORN) guidelines.

During an interview with the Materials Manager (MM), in the presence of the IP conducted on June 17, 2015 at 9:30 AM, when asked what the contract and agreement between the facility and Vendor 1 indicated to ensure the integrity of the sterile instrumentations transported by, and received from the outside vendors, MM confirmed the contract did not indicate so. MM stated there was no tracking system when the facility received the trunk deliverance; "It's consignment." During a concurrent review of a copy provided by MM of Vendor 1's "Rebate Program Agreement," MM confirmed, "It's a financial agreement only."

During an interview with the Quality Coordinator (QC), the Chief Nursing Officer (CNO), and the IP, on June 17, 2015 at 11 AM, when asked what the facility has done to ensure the integrity of the sterile instrumentations (trunk deliveries) transported by, and received from the outside vendors, when the problem was first identified by the IP on April 9, 2015, they stated they had "started the ball rolling but the written process was not done yet." They stated that they were doing research by calling other hospitals to find out if any of the other hospitals had a policy and procedure on "trunk deliveries " They stated it was "not a finished product yet." IP stated staff education was provided upon identification of the problem but was unable to show a documented evidence of what was provided and who had attended. They confirmed there was no defined process/system in place to ensure the integrity of the sterile instrumentations (trunk deliveries) transported by, and received from the outside vendors, remained sterile upon arrival and upon immediate use.

There was no documented evidence that a policy and procedure, approved by the Governing Body, was in place to ensure that surgical equipment, supplied by an outside, contracted vendor, remained sterile upon immediate use in the OR that followed AORN standards.

A review of the facility's policy and procedure titled, "Policy and Procedure Development and Maintenance" Revised 10/27/2011 revealed under Policy Approval, "Policies shall be valid and applicable only after being signed by the approving authority for a given policy.
VIOLATION: GOVERNING BODY OR RESPONSIBLE INDIVIDUAL Tag No: C0962
Based on interview and record review, the facility failed to ensure that the required competencies were completed for a Medical Doctor (MD 1). The Medical Staff Coordinator (MSC) was not able to provide current competencies to meet the required Medical Staff Bylaws.This deficient finding had the potential to adversely affect the patient's quality of care under the care of Medical Doctor 1.

Findings:

During record review of the MD's personnel file on June 18, 2015 at 11:45 AM, with the MSC, the MSC reviewed the personnel file of the MD 1 and was unable to find documentation of current demonstrated competencies. The most recent competencies in the personnel file was dated 4/2/07-2/27/09, (Over 6 years from the current date).

During an interview with the MSC on June 18, 2015 at 11:45 AM, she stated MD 1 did not have updated competencies in the personnel file as reviewed. The MSC stated that the MD should have current competencies per the Medical Staff Bylaws. When asked who is responsible for ensuring the competencies are current and updated for the medical staff, the MSC stated, it was her (MSC) responsibility to make sure that competencies are current and updated for all medical staff. The MSC further stated, we are working on updating competencies.

A review of the Medical Staff Bylaws "Article 4 Procedure For Appointment and Reappointment 4.4-2 Basis for Reappointment," indicated, "Recommendation for reappointment to the medical Staff and for renewal of privileges shall be based upon a reappraisal of the member's performance at this hospital and in other settings."(every 2 years)
VIOLATION: PROVISION OF SERVICES Tag No: C1004
The facility failed to ensure that the Condition of Participation for Provision of Services was met when the facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections in the Department of Surgery when the Surgery Department failed to implement a policy and procedure of having all surgical instruments sterilized prior to immediate use during surgery. The facility failed to follow AORN (Association of Perioperative Registered Nurses) standards by the Department of Surgery to ensure that all sterilized surgical instruments, transported by an outside, contracted vendor, which was delivered directly into the Operating Room, were maintained and remained sterile. On June 18, 2015 at 11:38 AM, an Immediate Jeopardy was called due to the facility's failure to ensure that there was an approved policy and procedure by the governing body, to ensure the integrity of the sterile instrumentations transported by, and received from an outside contracted vendor were reprocessed according to AORN recommendations. This deficient practice had the possibility to transmit infectious microorganisms to patients and increase the risk of surgical site infections to all patients who receive surgical services. (Refer to C-0278)

The cumulative effect of these systemic problems had the possibility to transmit infectious microorganisms to patients and increase the risk of surgical site infections to all patients who received surgical services. The facility failed to deliver care in compliance with the Condition Participation for Provision of Services.
VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
Based on interview and record review, the facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections in the Surgery Department when the facility failed to implement their policy and procedure (following AORN Standards-Association of Perioperative Nurses) ensuring that all surgical instruments, transported by an outside, contracted vendor, when delivering instruments directly into the Operating Room, remain sterile prior to its immediate use during surgery. This deficient practice had the possibility to transmit infectious microorganisms to patients and increase the risk of surgical site infections to all patients who receive surgical services.

Findings:

During an interview with the Infection Preventionist (IP) on June 17, 2015 at 7:45 AM, the IP stated, she was walking out of the facility to her car on April 9, 2015, she observed Vendor 1's Sales Representative (SR), in the parking lot in front of the emergency room (ER) entrance. She observed the SR loading boxes and supplies that had been used during the surgical case for Patient 1 earlier that day, onto a pick-up truck that did not have a shell (a cover at the back of the truck). The SR was pulling out the "peel pack (sterile instrument "boxes"). The IP stated she had questioned the SR on how the boxes and supplies were transported as it could have been exposed to the elements (outdoors-exposed to the wind, dirt, rain, snow) during the transport to the hospital. In addition, the IP stated, the SR was "a different guy" who had never delivered instruments to the facility before. The IP stated usually the sterile instruments were shipped in sealed cardboard boxes and delivered by the sales representatives through the "backdoor" of the Operating Room (OR) Department. The IP stated, "the backdoor" which was mainly used by the maintenance and the housekeeping staff, was kept locked but had to be "keyed" to open the door. When asked how the facility monitored and tracked what and how outside, contracted vendors would deliver sterile instrumentations to the facility, IP stated there was no tracking system; the IP stated, "That's a purchasing performance and Purchasing (department) should do that." The IP was asked, how do you ensure the integrity of the sterile instrumentation transported by and received from the outside vendor remain sterile, the IP stated, "I can't, we have a hole in the system; We're relying on the vendor companies for meeting sterilization standards on their own acccord when delivering their instruments to the facility.

According to the AORN Journal, dated February 2013, when transporting sterile instruments, it noted, " ...sterilized instruments are to be transported in a vehicle that is completely enclosed with an interior made of cleanable material and the means to separate sterile from dirty instruments (e.g. an enclosed van, the open bed of a truck or trunk of an automobile is not acceptable) ... "

During an interview with the IP on June 19, 2015 at 10:06 AM, when asked what guidelines the facility followed to ensure sterility of all outside, contracted vendor's "trunk deliveries" she stated, the facility followed the Association of Perioperative Registered Nurses (AORN) guidelines.

During a phone interview with the Corporate Counsel of Vendor 1 on June 18, 2015, at 3:10 PM, when asked what guidelines the company followed regarding sterilization of the trunk deliveries, he stated the company followed "FDA (Federal Drug Administration) guidelines."

There was no documented evidence provided by the facility that a policy and procedure was implemented for sterilizing surgical instruments; transported by all, outside, contracted, surgical-supply vendors when delivering sterile instruments directly into the operating room during surgery that followed AORN recommendations for infection control guidelines.

On June 17, 2015 at 8:30 AM, Surgical Perioperative Assistant (PA 1) was asked how the OR staff monitored and tracked what and how outside, contracted vendor's delivered sterile instrumentations directly in the Operating Room (OR), PA 1 stated the sales representatives (vendors) would "bring their stuff and we (OR staff) don't know; we didn't pay attention."

During an interview with Perioperative Services Manager (PSM) on June 17, 2015 at 3:15 PM he confirmed, there was no log book for the "trunk deliveries" of the implants (a surgical object or device embedded in the body during surgery) and instruments delivered by the vendors.

There is no documented evidence that the facility documented (logged) its surveillance activities, in the Surgery Department, of all surgical instruments transported and delivered by an outside, contracted vendor, including measures selected for monitoring and analysis conducted in accordance with recognized infection control surveillance practices such as the Healthcare Safety Net (NHSN-organization associated with the Centers for Disease Control and Prevention-requiring hospitals to report data of infections)

According to the AORN (Association of Preoperative Registered Nurses), titled, "RECOMMENDED PRACTICES FOR CLEANING AND CARE OF SURGICAL INSTRUMENTS AND POWERED EQUIPMENT", dated 2011, stipulated in Section 1(a) (1): The manufacture's written instructions should identify requirements related to cleaning equipment and processing methods.

According to the Healthcare Infection Control Practice Advisory Committee (HICPAC), under the heading, "GUIDELINES FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES" , dated 2011 " ...The aim of Central Processing (the process of sterilizing instruments) of medical and surgical instruments are to protect patient from infections while minimizing risks to staff. Ensuring consistency of sterilization practices requires competency and proper methods of cleaning and wrapping instruments and monitoring of the entire process ... "

During an interview with the Materials Manager (MM), in the presence of the IP conducted on June 17, 2015 at 9:30 AM, when asked what the contract agreement between the facility and Vendor 1 to ensure the integrity of the sterile instrumentations transported by, and received from the outside, contracted, surgical supply vendors, MM stated the contract did not indicate so. MM stated there was no tracking system when the facility received the trunk deliveries; "It's consignment (a relationship of trust)." During a concurrent review of a copy provided by MM of Vendor 1's "Rebate Program Agreement," MM confirmed, "It's only a financial agreement."

During an interview with the Quality Coordinator (QC), the Chief Nursing Officer (CNO), and the IP, on June 17, 2015 at 11 AM, when asked what the facility has done to ensure the integrity of the sterile instruments (trunk deliveries) transported by, and received from the outside vendors, since the problem was identified by IP on April 9, 2015. The IP stated they had "started the ball rolling but the written process was not done yet." They stated that they were doing some research by calling other hospitals to find out if any of the other hospitals had a policy and procedure on "trunk deliveries" They stated it was "not a finished product yet."

On June 17, 2015, at 1:40 PM, the IP and the Operating Room Manager, stated staff education was provided upon identification of the problem but was unable to show a documented evidence of what was provided and who had attended.

On June 17, 2015, at 12:00 PM, a concurrent review of three policies and procedures titled, "Cleaning and Care of Surgical Instruments," "Reprocessing of Single-Use Devices," and "Event Related Shelf Life and Sterile Packaging," was conducted.

The Quality Control Officer, the Chief Nursing Officer, and the Infection Preventionist confirmed that these three policy and procedures did not address "trunk deliveries " They confirmed there was no defined process to ensure the integrity of the sterile instrumentations (trunk deliveries) transported by, and received from outside vendors, had been reviewed and approved by the facility's Governing Body.

A review of the facility's policy and procedure titled, "Policy and Procedure Development and Maintenance" Revised 10/27/2011, revealed under Policy Approval, "Policies shall be valid and applicable only after being signed by the approving authority for a given policy. "

On June 18, 2015 at 11:38 AM, an Immediate Jeopardy was called in the presence of the hospital Chief Executive Officer, the Chief Nursing Officer, and the Quality Coordinator due to the facility's failure to ensure that there was a approved policy and procedure by the governing body, to ensure the integrity of the sterile instruments transported by, and received from an outside contracted vendor who were delivering instruments directly into the operating room were reprocessed according to AORN recommendations. This failure had the potential to result in the patients receiving unsterile instrumentations during the surgical procedure that could cause signs and symptoms of infection and surgical site infections.

On June 18, 2015 at 5:45 PM, Immediate Jeopardy was abated (removed) in the presence of the hospital Chief Executive Officer, the Chief Nursing Officer, and the Quality Coordinator, after an acceptable corrective action plan was developed by the facility that a written policy and procedure that all instruments delivered by an outside, contracted, surgical supply vendor will remain sterilized according to AORN standards was presented to the survey team for evaluation, confirmation and approval.
VIOLATION: PATIENT CARE POLICIES Tag No: C1020
Based on interview and record review, the facility failed to ensure that the required certification for the dietary supervisor was documented in his personnel file. The Human Resources Generalist (HRG) was not able to provide a Food Service Manager Certificate to meet the required certification requirements per the job description. This deficient finding had the potential to result that all nutritional needs of all patients in the hospital were being met and meeting all acceptable standards of practice.

Findings:

A record review of the Dietary Supervisor's (DS) personnel file with the Human Resources Generalist (HRG), was conducted on June 17, 2015 at 10:50 AM. In reviewing the personnel file of the Dietary Supervisor, the HRG was unable to find documentation of the Food Safety Manager Certificate qualifying him through experience or training to be the Facility Dietary Supervisor.

During an interview with the HRG, on June 17, 2015 at 10:55 AM, she stated, the DS did not have the Food Safety Manager Certificate in the personnel file. The HRG stated, DS date of hire was August 22, 2011 and was promoted to Dietary Supervisor on august 12, 2013. The HRG further stated, the DS should have the Food Safety Manager Certificate per the job description requirements.

A record review of the "Job Description" for Dietary Supervisor on June 17, 2015, at 11:00 PM, revealed "Certification/Licensure Requirements" stipulated, "Must have a Food Safety Manager certificate or acquire one within 30 days days of hire."

During an interview with the DS on June 17, 2015 at 1:10 PM, the DS stated, he was not aware the Food Safety Manager Certificate was a requirement. The DS further stated, he will be attending the class to receive the Food Safety Manager Certificate on Friday June 26, 2015.

A review of the facility's policy and procedure titled "Licensure and Certification Verification Policy" dated May 1, 1996, it indicated "It is the policy of (Name of Facility) to employ only those individuals who have proper licensure or certification by the appropriate agency in those job requiring such status."
VIOLATION: NURSING SERVICES Tag No: C1046
Based on interview and record review, the facility failed to ensure the required certification was current for the Chemotherapy (cancer treatment) Registered Nurse (CRN). The Human Resource Generalist (HRG) was not able to provide an updated ACLS (Advanced Cardiovascular Life Support) certification to meet the required certification requirements per the job description. This deficient finding had the potential to adversely affect the patient's health and safety for these patients requiring Chemotherapy treatment.

Findings:

During observation and record review of the CRN's personnel file on June 17, 2015 at 4:15 PM with the HRG, the HRG reviewed the personnel file of the CRN and was unable to find documentation of a current ACLS certification. The ACLS certification that was in the personnel file, expired on October, 2014.

During a record review of the "Job Description" for Chemotherapy RN on June 17, 2015 at 4:25 PM, revealed "Certification/Licensure Requirements" states, "BLS (Basic Life Support) and ACLS Required."

During an interview with the HRG on June 18, 2015 at 8:00 AM, she stated the ACLS card on file expired on October, 2014. The HRG further stated, she spoke with the Chief Nursing Officer (CNO) and was told the CRN did not require ACLS certification since she did not provide chemotherapy services to inpatients. The chemotherapy services are provided only to outpatients.

During an interview with the CNO on June 18, 2015 at 3:45 PM, she stated the CRN's ACLS certification is expired. The CNO further stated, the Chemotherapy Registered Nurse job description does require ACLS certification.

A review of the facility's policy and procedure titled "Licensure and Certification Verification Policy" dated May 1, 1996, indicated "It is the policy of (Name of Facility) to employ only those individuals who have proper licensure or certification by the appropriate agency in those job requiring such status."