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Based on interview and record review, the facility failed to examine the quality of the physician's work at the time of reappointment in 1 of 7 sampled medical staff credentials files (Provider 18). Refer to A-84. The deficient practice reduced the usefulness of the credentialing process as a means of ensuring competence and quality.

Based on interview and record review, in 2 of 7 sampled medical staff credentials files (Providers 12 and 14), the facility failed to document the physician's recent experience in the privileges requested. Refer to A-341 Part 1. The deficient practice eliminated the mechanism by which the physicians' relevant experience could be considered by those reviewing the files to decide medical staff membership and privileges, and had the potential to allow physicians to provide care in areas where they did not have recent experience.

Based on interview and record review, the facility failed to ensure proposed capital expenditures over $600,000 were reviewed by a committee which included medical staff representatives. The deficient practice had the potential to cause limited resources to be invested in a manner inconsistent with clinical needs.

Findings:

Review of an undated flow-chart describing the facility's capital planning process indicated that requests for capital expenditures were reviewed by the vice presidents, who could reject proposals or approve them for further consideration by the facility's capital committees. The flow-chart further indicated there were five capital committees which met every fall to consider the requests approved by the vice presidents. Review of the membership rosters of the five committees indicated that the IT (information technology) Steering Committee as well as the Facilities, Construction, Non-Medical Committee did not include representatives of the medical staff. Review of the capital expenditures approved by the committees for 2014 indicated the Facilities, Construction, Non-Medical Committee had approved $800,000 for burner upgrades and the IT Steering Committee had approved $1,700,000 for computer operating system updates. Review of the capital expenditures denied by the Facilities, Construction, Non-Medical Committee indicated they included $1,060,000 for a radio frequency asset security system.

In an interview on 5/15/14 at 10:07 a.m., the Chief Operating Officer (COO) confirmed that some requests can be rejected before they go to a committee, and that the IT Steering Committee did not have medical staff representatives. He stated he did not think the Facilities, Construction, Non-Medical Committee had representatives of the medical staff.

Based on interview and record review, the facility failed to measure the quality of the service provided by the telemedicine critical care (eICU) contractor. The deficient practice had the potential to allow substandard care.

Findings:

Review of the "eICU PHYSICIAN SERVICES AND ADMINISTRATION AGREEMENT" dated 2/1/13 indicated that the facility's governing body had contracted with a medical group to provide telemedicine services to its patients in the intensive care unit (ICU).

In an interview on 5/15/14 at 10:44 a.m., the chief medical executive (CME) stated the eICU contractor helped collect data used to measure the quality of the facility's bricks and mortar ICU. He stated the facility used the eICU infrequently, so a small percent of the quality data regarding the physical ICU included the results of patient management by the eICU physicians. He stated if there were an adverse patient outcome, the facility could see who was involved in the care of that patient. He stated the facility's credentials files included OPPE (ongoing professional practice evaluations) of each eICU physician, and that the contractor also maintained its own OPPE regarding each physician in its files. He stated the facility's evaluation of the contract as a whole depended on review of the overall ICU quality data, and that the eICU contractor contributed a small percent of those results.

Review of the quality data provided by the CME indicated that it included the eICU contractor's own OPPE for 4 of its physicians, an "eICU Communication Call Log" indicating there had been 2 calls between the facility and the eICU contractor in May, performance indicators regarding the facility's bricks and mortar ICU prepared by the eICU contractor, and an "ICU Patient Quality of Care Committee" report dated 12/11/13 addressing the quality of care at the facility's ICU as well as other facilities' ICU's. No data addressing the performance of the eICU contractor were present, other than the contractor's own data regarding four of its individual physicians.

Review of Provider 18's credentials file indicated he was a member of the medical group which was the eICU contractor and had been reappointed for the term 1/1/14 through 12/31/14, contingent upon his completion of proctoring requirements. Comparison of Provider 18's file to the quality data presented by the CME indicated Provider 18 was not one of the four physicians for which the CME had presented the eICU contractor's own OPPE. No data regarding the quality of Provider 18's work were present in the credentials file. Review of an online quality profile for Provider 18 indicated there was no data regarding his accuracy at identifying sepsis, complications following bronchoscopies, or medical record suspension days. The profile indicated Provider 18 had not been the subject of complaints and had not attended any educational conferences at the facility (as was also the case for the entire pulmonary division at the facility and at two other hospitals operated by the facility's governing body).

In an interview on 5/14/14 at 2:31 p.m., the Director of Clinical Informatics and Reporting stated very little of the OPPE data applied to Provider 18.

Based on interview and record review, the facility failed to consistently include the nature and scope of the service on its list of contracts. The deficient practice affected 58 of 291 contracts and had the potential to limit management and regulatory oversight of contracted services.

Findings:

Review of the facility's list of contracted services dated 5/14/14 indicated 58 of 291 listed contracts did not include a description of the service. The surveyor was unable to ascertain the nature of the services missing a description even though the listing included the name of the vendor, the type of contract (for example service agreement or business associate agreement), and the responsible department. In an interview on 5/15/14 at 3:32 p.m., VP1 stated the missing descriptions would need to be filled in and asked the surveyor which contracts he was interested in.

Based on interview and record review, the facility failed to examine the quality of the physician's work at the time of reappointment in 1 of 7 sampled medical staff credentials files (Provider 18). The facility also failed to maintain the data in the credentials files that it had considered at reappointment regarding each physician's recent experience in the requested privileges for 2 of 7 sampled credentials files (Providers 13 and 20). The deficient practices reduced the usefulness of the credentialing process as a means of ensuring competence and quality and made it difficult to reliably determine what information that process had considered.

Findings:

1. Refer to A-84 regarding the lack of relevant quality data for Provider 18.

Review of the facility's medical staff bylaws dated 11/7/13 indicated the credentials committee would consider the documented results of peer review and quality assurance activities at reappointment, and that those factors were also considered when determining a medical staff member's privileges. Review of the facility's policy "ONGOING PROFESSIONAL PRACTICE EVALUATION" (OPPE, revised 12/12) indicated, "If no data is available for a particular privilege or there is minimal clinical activity, data may be obtained from outside sources and will be reviewed according to targets established by the Department/Division."

2. Refer to A-341 regarding the lack of documented experience by type of radiology study in the credentials files for Providers 13 and 20.

Based on interview and record review, in 2 of 7 sampled medical staff credentials files (Providers 12 and 14), the facility failed to document the physician's recent experience in the privileges requested. In an additional 2 of 7 sampled credentials files (Providers 13 and 20), the facility failed to maintain documentation of the provider's experience considered at the time of reappointment in the credentials file. The deficient practices eliminated the mechanism by which the physicians' relevant experience could be considered by those reviewing the files to decide medical staff membership and privileges, eliminated accountability regarding whether or not experience had been considered, and had the potential to allow physicians to provide care in areas where they did not have recent experience.

Findings:

1. Review of Provider 12's credentials file indicated he was appointed to the facility's medical staff on 7/1/13. The file indicated Provider 12 had completed training in an occupational medicine residency on 6/30/12 and was board certified as an occupational medicine specialist until 1/31/23. Provider 12's privileges included managing workplace injuries, conducting employee medical evaluations, educating employees on the proper use of respirators, and interpreting drug screen results. A description of Provider 12's residency program was present, but there was no documentation regarding how often Provider 12 had performed the tasks for which he was requesting privileges, with the exception of a notation that he had not previously interpreted drug screen results.

Review of Provider 14's credentials file indicated she was appointed to the facility's medical staff on 10/31/12. The file indicated Provider 14 had completed training in an emergency medicine residency on 6/30/11 and was board certified as an emergency medicine specialist from 6/13/13 through 12/31/23. Provider 14's privileges included treating patients in the emergency room, including a list of 41 specific procedures. The file indicated Provider 14's recent experience performing ultrasounds and administering sedation, but did not document her experience treating emergency room patients or performing the other 40 procedures for which she had privileges.

In an interview on 5/14/14 at 2:08 p.m., the chair of the credentials committee (CCC) stated the facility had verification that Provider 12 completed residency on 6/30/12 as well as a description of the residency, and since the privileges Provider 12 requested were outpatient evaluation and management that was core to the specialty he did not feel further quantification of Provider 12's experience was necessary. The CCC stated for Provider 14 that the privileges were core to the practice of emergency medicine and that one would consider completion of residency to include relevant experience. In an interview on 5/14/14 at 3:10 p.m., the Director of Medical Staff Services stated that the facility had also considered that Provider 12 had similar privileges elsewhere. The CCC stated the facility also had peer references attesting to both Provider 12's and Provider 14's competence.

Review of the facility's medical staff bylaws dated 11/7/13 indicated privileges at another health care facility and board certification were not sufficient for the granting of medical staff membership and privileges. The bylaws stated the minimum qualifications included both training and experience acceptable to the medical staff, and that completion of residency and board certification were both considered evidence of training. The bylaws stated applicants for appointment and reappointment were required to document their training, their professional experience, and their specialty certifications. The bylaws stated peer references and a history of medical staff membership and privileges elsewhere were both required in addition to (not instead of) the other requirements. Comparison of the facility's medical staff bylaws to Title 42 of the Code of Federal Regulations, sections 482.12(a)(6) and 482.12(a)(7) indicated the bylaws provisions demanding that experience be considered separately from training, and prohibiting use of board certification as the sole criterion for granting privileges were also required by federal regulations for Medicare providers.

2. Review of Provider 13's credentials file indicated she was reappointed to the facility's medical staff on 3/31/13. Review of Provider 20's credentials file indicated he was reappointed to the facility's medical staff on 6/1/13. Both physicians' privileges included preliminary interpretation of conventional radiographs, CT (computed tomography), MRI (magnetic resonance imaging), and ultrasound via teleradiology. Both physicians' files indicated the number of interpretations he or she had performed for the facility and for all hospitals, but did not specify how many of each modality the physician had performed.

In an interview on 5/14/14 at approximately 10:45 a.m., the chair of radiology stated the facility did consider how many of what type of study each physician interpreted but that the data were not in the credentials files. He stated the facility did not require minimum numbers for the basic studies, that a board certified radiologist could legally read any study, and that he wouldn't exclude a privilege for which the physician didn't have recent experience. He did not explain the apparent contradiction between his statements that procedure-specific experience was considered, yet wouldn't make a difference.

Based on interview and record review, the facility failed to maintain an accurate job description for the chief medical executive (CME, the appointed physician leader of the hospital administration) that distinguished his areas of responsibility regarding supervision of department chairs from the chief of staff (COS, the elected leader of the medical staff). The deficient practice contradicted federal regulations requiring that one person be responsible for the conduct of the medical staff, and had the potential to undermine checks and balances between the medical staff and hospital administration.

Findings:

In an interview on 5/13/14 at approximately 10:00 a.m., the CME stated the COS reported to him. In an interview on 5/13/14 at 12:10 p.m., the COS stated he was the voice of the medical staff and the CME was a member of hospital administration.

Review of the CME's job description dated 4/29/13 indicated "The CME oversees medical department chairs... The CME reports directly to the Chief Executive Officer (CEO)..." The job description stated the CME's direct reports included "chairs of clinical departments" and that the CME was responsible to "Hire, supervise, and review the performance of direct reports... The incumbent has the authority to interview, hire, train, evaluate, counsel, discipline, and recommend salary increases, set work schedules, and assign and review work."

Review of the facility's undated medical staff roster indicated the CME was a member of the Administrative staff. Review of the facility's medical staff bylaws dated 11/7/13 indicated, "The Administrative Staff shall include physicians... who are retained by the hospital or medical staff solely to perform ongoing medical administrative activities. The Medical Executive Committee [MEC] shall provide input to the CEO in selection and retention of Administrative Staff... The Administrative Staff shall... assist administration and the medical staff in carrying out medical-administrative functions..."

The bylaws stated the COS was elected by a plurality of the medical staff and could be removed by a 2/3 vote of the medical staff. The bylaws stated, "The Chief of Staff shall... be responsible for the functioning of the Medical Staff organization of the Hospital and shall keep, or cause to be kept, a careful supervision over the clinical work in all departments..." The bylaws further indicated that department chairs were accountable to the MEC and the COS regarding the work in the department, and were appointed after a recommendation to the MEC by a search committee selected by the COS with the approval of the MEC. The bylaws stated a department chair's term was five years after which he or she would be considered for reappointment by a Reappointment Review Committee which was selected by the COS with the approval of the MEC and which submitted its recommendations to the MEC. The bylaws indicated department chairs could only be removed after a request by 20% of the department's members or a majority of the MEC, review by three members of the MEC appointed by the COS, and a majority vote of both the MEC and the members of the department.

In an interview on 5/15/14 at 1:32 p.m., the CME stated the department chairs report to both the CME and the COS. He stated physician conduct and quality of care issues go to the COS while issues regarding hospital operations, utilization review, and equipment go to the CME.

This STANDARD is not met as evidenced by: Based on observations, staff interviews, and document reviews the infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with facility policy and nationally recognized infection control guidelines as evidenced by the failure to ensure:

1. Laryngeal Mask Airways were reprocessed or stored in accordance with manufacturer's guidelines.

Findings:

1. On May 15, 2014, at 9:10 am, during observation and interview at Facility 3, a random Laryngeal Mask Airway (LMAs, an airway management device indicated for use in achieving and maintaining control of airway during anesthetic procedures) " Usage Tracking Form " was reviewed with AT 1. A random " ProSeal " Laryngeal Mask Airway (P4 8VNABAMA) was reviewed with AT 1. The "Usage Tracking Form" indicated the "Date of First Use" as "10/5/12" (1 year and 7 months old) and reprocessed 39 times. The Laryngeal Mask Airway was in a clear bag in an equipment storage area and, according to AT 1, available for use.
According to the "Laryngeal Mask Company" manufacturer's warranty printed at the bottom of the "LMA Usage Tracking Form: " This device is warranted against faulty materials or manufacturing defect for forty (40) uses or a period of one (1) year from date of invoice, whichever comes first ... "
The facility provided the following document: Laryngeal Mask Company, 40 Use Program, Section 2, Our Position on 40 Uses, " 4/04, " with the following text highlighted: " Due to this material degradation, the manufacturer recommends that an LMA airway be used up to 40 times and only if the device passes the pre-use performance checks specified in the instructions before each use. Consistent with this data, the product warranty states that LMA airways are warranted against faulty materials or manufacturing defects for forty uses or a period of one year from date of invoice, whichever comes first. It is not the intention of the warranty statement that LMA airways that have been used fewer than 40 times be discarded after one year. Such devices should be discarded if they fail the performance tests."
On May 16, 2014, at 11:25 am, during phone interview, a Laryngeal Mask Company product representative was unable to confirm the manufacturer currently endorsed the document provided by the facility (40 Use Program, Section 2, Our Position on 40 Uses, " 4/04 ").
According to Laryngeal Mask Company, "ProSeal" Instructions for Use, 2013: " Precautions: A 40-Use record card is supplied with every device to record the number and date of usage. Completion of the record card validates the warranty of the device.Manufacturer's Warranty: The LMA is reusable ...for forty (40) uses or a period of one (1) year from date of purchase (whichever is earlier) ...
Performance Tests Warning: All of the non-clinical tests described below must be conducted before each use of LMA ProSeal. The performance tests should be conducted in an area and in a manner consistent with accepted medical practice that minimizes contamination of the airway device before insertion. Failure of any one test indicates that the device has passed its useful life and should be replaced. Warning: Do not use the LMA airway or any of the accessories if they are damaged in any way. Performance Test 1: Visual Inspection: Examine the surface of the airway tube, cuff and drain tube for damage, including cuts, tears, or scratches. Examine the interior of the airway tube, mask bowl and drain tube to ensure that they are free from blockages or loose particles. Any particles present in the tubes should be removed. Examine the transparency of the tubes. Reusable airway tubes will gradually discolor with age and re-use. Warning: Do not use the LMA ProSeal if the tubes are discolored, as this impairs the ability to see and effectively remove foreign particles during cleaning or to see regurgitated fluids during use. Warning: Do not use the LMA ProSeal if it is damaged or if visible particles cannot be removed from inside the airway tube as they may be inhaled by the patient after insertion. Examine the 15 mm connector. It should fit tightly into the outer end of the airway tube. Ensure that it cannot easily be pulled off by hand using reasonable force. Do not use excessive force or twist the connector as this may break the seal. Warning: Do not use the LMA ProSeal if the mask connector does not fit tightly into the outer end of the airway tube.Ensure that the section of the LMA ProSeal drain tube lying within the bowl of the mask is not torn or perforated, and that there is no contamination between the tube and the mask. Examine the rear cuff of the LMA ProSeal, if present, for wrinkles or folds suggesting herniation. Performance Test 2: Inflation and Deflation. Carefully insert a syringe into the valve port and fully deflate the device so that the cuff walls are tightly flattened against each other. To deflate the LMA ProSeal, make sure the red plug is closed. Remove the syringe from the valve port. Examine the cuff walls to determine whether they remain tightly flattened against each other. Warning: Do not use the device if the cuff walls reinflate immediately and spontaneously, even if only slightly. Examine the fully deflated LMA ProSeal mask for wrinkles or folds suggesting herniation. If obvious wrinkles are apparent, the rear cuff may be severely herniated and the LMA ProSeal should not be used. Inflate the cuff with 50% more air than the recommended maximum clinical inflation volume. Any tendency of the cuff to deflate indicates the presence of a leak and should be evident within two minutes. Examine the symmetry of the inflated cuff. There should be no uneven bulging at either end or sides. Warning: Do not use the LMA airway if cuff leakage is present or if there is uneven bulging of the cuff. While the device remains 50% over-inflated, examine the inflation balloon. The balloon shape should be a thin, slightly flattened elliptical shape, not spherical. Warning: Do not use the LMA airway if the inflation balloon is spherical or irregularly shaped as it may be difficult to gauge the pressure of the cuff. While the device remains 50% over-inflated, inspect the interior of the LMA ProSeal drain tube from both ends of the mask. Ensure that the tube is not collapsed or perforated. Warning: Use of an LMA ProSeal with a collapsed or occluded drain tube may prevent venting of the stomach or insertion of a gastric tube and may permit inflation of the stomach and possible regurgitation. Use of a perforated or torn drain tube may prevent the LMA ProSeal from being inflated or allow for escape of anesthetic gases. "
On May 16, 2014, at 12:00 pm, during interview, Performance Test documentation for reusable Laryngeal Mask Airways was requested from VPSX.
On May 16, 2014, at 5:21 pm, a document (" Standard Work Instruction Sheets: All Campuses: To Insure Proper Testing of Non Disposable Laryngeal Mask Airways ...Version #: 1. Date: May 16, 2014 ") was received via email from VPSX that detailed the procedure for conducting a Performance Test; however, no documentation detailed a completed Performance Test of a Non Disposable Laryngeal Mask Airway.

Based on observation, interview and record review, the facility failed to ensure surgical care services policies and procedures were implemented for disinfecting, decontamination and sterilization of instruments when scissors were sterilized/stored in the closed position, which did not guarantee sterility. These deficient practices had the potential for cross-contamination and to expose all patients undergoing surgery to microorganisms-causing infection.

Findings:

In an observation/interview on 5/15/14 at 10:00AM, twenty seven of thirty facility packaged surgical scissors (Potts, Metzenbaum and Mayo scissors) were in the closed position. One pair of three Potts scissors had a tip protector on the edges and two metzenbaum scissors had tip protectors. SPD Supervisor said that the scissors must have been closed during handling after sterilization but was unable to ensure that sterilant had come in contact with the scissor edge.

Record review Policy and Procedure - Packaging Procedures for Preparing Items for Sterilization 10.64.0.11(4) (reviewed 4/14) indicated, "Tip protectors should be used on all sharp edged and lock boxes should be open". According to the Association of periOperative Nurses (AORN), Perioperative Standards and Recommended Practices, Recommendation XII.c. indicated "Instruments with hinges should be opened and those with removable parts should be disassembled when placed in trays designed for sterilization, unless the manufacturer has provided validated instructions to the contrary" and
"Sterilization occurs only on surfaces that have direct contact with the sterilant. Disassembly of multiple-part instruments and those with sliding parts (eg, retractors) enables the sterilant to contact all surfaces".
Further review of AORN Recommendation XII.d. indicated, "Delicate and sharp instruments should be protected using a device such as a tip protector. The tip protector should be used according to the manufacturer ' s instructions.
Review of Centers for Disease Control and Prevention (CDC) - Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) - Packaging, citing Association for the Advancement of Medical Instrumentation (AAMI) standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices.
Standards and Recommended Practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), as well as U.S. Technical Advisory Groups (TAGs). The AAMI guidelines indicated "hinged instruments should be opened".
In an interview on 5/16/14 at 9:25 AM,VPSX said, "We know our work processes and direct staff to open scissors...I know the staff...I trust they are doing it right", and said that the staff had been working in the department over thirty years so they know what they're doing".
In a concurrent interview, Sterile Processing Manager (SPD2) said, "Instruments should be in the appropriate size pouch with the box locks open, scissors should be open so the tips are splayed....we do not use tip protectors" and said that he would consider the identified scissors sterile because of what he knew about the processing department. VPSX and SPD2 were not able to validate that scissor edges were exposed to sterilant during the sterilization process.