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Based on interview and document review, the governing body failed to ensure that the medical staff was following and enforcing their bylaws, in order to be responsible and accountable to the governing body, for the quality of care provided to patients. In so doing, the governing body and medical staff had not ensured that all medical staff members and other professionals had been demonstrated to be qualified and competent for the membership and privileges made available to them. This could lead to under-qualified practitioners providing poor quality of care to patients.

Findings:

On 9/24/12, the Medial Staff Bylaws and the Medical Staff Rules and Regulations charge the Medical Staff (MS) with several key assignments related to being accountable to the governing body for the quality of care provided to patients. Three of those assignments are to: 1.) Ensure that all applicants for medical staff membership and privileges are qualified as specified in the bylaws and rules; 2.) Ensure that all medical staff membership has periodic evaluation of their professional proficiencies based on objective data of past performance; 3.) Ensure that all new members of the Active, Active Ancillary, Courtesy, or Locum Tenens Staff be proctored as specified in the rules.

In order to identify the specific locations in the bylaws and rules, these assignments are stipulated, the following texts are from the Medial Staff Bylaws and Medical Staff Rules and Regulations as they were reviewed from 9/24/12 to 10/4/12:

"Medical Staff Bylaws (June 30, 2011)

"Article I PURPOSE" (page 4) states "the purposes of the Medical Staff are to: (in part) b. ... to promote good patient care. c. Screen and recommend applicants for Medical Staff Membership. d. Review Privileges of Members. e. Monitor, evaluate and assist in improving the work done by the Medical Staff. j. Ensure that quality of care delivered by those with privileges.

Article II, 2.3 - Effects of other affiliations - (page 5) 2.3-1 No individual is entitled to, nor can he or she be denied Membership and/or Clinical Privileges in the Medical Staff merely because of any of the following: a. Degree, b. Membership in professional organizations, c. Certification from a clinical board, d. Previous Medical Staff Membership, e. Current Staff Membership or Clinical Privileges at another health care facility

Article II, 2.7-1 - Active Staff (pages 7 & 8)
a. Qualifications, Active Staff Members: ... (2) Shall have at least 15 Patient Contacts annually.

c. Responsibilities, Active Staff Members: ... (5) Shall have at least 15 Patient Contacts annually such that patient care can be assessed and reviewed.

Article III, Procedure for Appointment, Reappointment, and determination of clinical privileges (page 13) 3.1 General Procedure - The Medial Staff through its designated Departments, committees, and Officers shall evaluate and consider each application for appointment ore reappointment to the Staff and each request for modifications of Staff Membership status or Privileges and shall adopt ant transmit recommendations thereon to the Board. The Medial Staff shall perform the same evaluation and recommendation functions in connection with any AHP (Allied Health Professionals) who seeks to exercise Privileges.

Medical Staff Rules and Regulations (May 2011)
Section H - Proctoring

H-1 Proctoring Requirements -- a. Each newly appointed Member of the Active, Active Ancillary, Courtesy, or Locum Tenens Staff shall be proctored for medical and surgical Privileges ...

H-2 Purposes of Proctoring --
a. Verify technical competence
b. Asses judgment
c. Evaluate pre- and post-procedure management
d. Evaluate medical record keeping and documentation
e. Determine compliance with Medical Staff bylaws, rules, regulations, and policies.

H-5 Determination of extent of proctoring
... The first proctoring review will occur no later than 12 months after the applicant has been granted full privileges."


On 10/1/12 from the provided roster, "All the Medical Staff Members (MSM) and Allied Health Professionals (AHP) currently on staff at the hospital," an initial 9 MSM and AHP were selected for credential file review. An additional physician (MSM 11), who was not listed on the Medical Staff Roster, was selected for review because of an irregular medication order that had been noted. During the afternoon of 10/2/12, the initial list of 10 practitioners was reviewed in the Medical Staff Office with Medical Staff Coordinator 1 (MSC-1), at which time it was learned that MSM 11 was a "Locum Tenens" physician (serving for a limited time to replace another physician) and the hospital currently had other Locum Tenens physicians providing services at the hospital. Two of the listed AHPs, both Clinical Cardiac Perfusionists (CCP: health care technician who operates a heart / lung machine during cardiac surgery to redirect blood flow allowing the surgeon to operate on the unbeating heart) were no longer considered AHP since a change in the AHP Manual (part of the MS Bylaws) that occurred in May 2011. At 3:25 pm on 10/2/12, MSC-1 stated, "that change had been made because the MS felt that since none of the physicians were perfusionists, they should not be doing 'peer review' on the CCPs. The CCPs were treated as hospital employees and their clinical proficiency evaluations were done by the Director of Perioperative Services."

During the afternoon of 10/2/12, the credential file of MSM-11 was reviewed. On 10/3/12, another list of MSMs and AHPs was selected and together with MSM-11 for a total of 13 credential files (MSM-1, MSM-2, MSM-3, MSM-4, MSM-5, MSM-6, AHP-7, MSM-8, MSM-10, MSM-11, MSM-12, MSM-13 & MSM-14) were reviewed in detail with MSC-1, beginning at 10:00 am on 10/3/12. With the following observations noted:

1. Three (3) of the physicians (MSM-11, MSM-12 & MSM-13) were locum tenens, and none of them had available documentation to show that they had been required to undergo proctoring. Proctoring reports were usually maintained in a separate folder (green folder - peer review) and most MSM had such a folder, but not the Locum Tenens physicians. None of the three had been given a specific effective period for their privileges.

2. MSM-12, a locum tenens physician with an advanced specialty, had requested very non-specific privileges and his privilege list had no signatures to indicate what may have been granted, or even if privileges had been granted. The effective date and ending date of privileges were left blank.

3. One (1) MSM-14, a PhD psychologist, was an Active staff member: His credential file and green folder showed that he had been reappointed in 1/12, but had at that time no patient contact data or other data to show his clinical performance of patient contacts over his prior appointment period. A report, dated 6/1/12, documented that from 6/1/10 through 6/1/12, he had only one patient contact. MSM-14's privilege request form documented he was not qualified for the requested core privileges and had hand written beside that fact, "Requesting waiver." However, there was no notation that a waiver had been officially entertained or granted. Although he had been reappointed to the Active Medical Staff, MSM-14's file had no evidence that MSM-14 had treated 15 patients in any one year during his prior medical staff appointment.

4 Of the 13 credential files reviewed, nine (9) (MSM-1, MSM-2, MSM-3, MSM-4, MSM-5, MSM-6, MSM-8, MSM-10 & MSM-14) had hand written modifications to the effective dates for their privilege lists, and review showed that the dates apparently approved by the Medical Executive Committee (MEC) & governing body (GB) had been altered by one of the Medical Staff Office staff members, but there was not notation that the alteration had been directed or approved by any MS officers or anyone with authority to act on behalf of the GB.

5. MSM-8 is a tele-radiologist (physician working from a distant site via computer, who assists with x-ray interpretations) whose file did not have any proctor reports or other peer review on file. When asked for the proctor reports of this individual and the other tele-medicine physicians, MSC-1 redirected the search to two other employees in the Medical Staff Office, MSC-2 and MSC-3 and several stacks of loose papers were provided.

6. The hospital utilized the services of 14 tele-neurologists (a physician working from a distant site via telephone and/or computer, who assists with nervous system evaluations of patients) and had given each Courtesy staff status (MSM-16 through MSM-29). Beginning on the afternoon of 10/3/12 until mid-morning of 10/4/12, a search for proctor reports on these 14 physicians yielded 2 incomplete reports. On 10/4/12 at 9:30 am, MSC-2 provided documentation that MSM-17 and MSM-16 had each been signed off as completing their proctor assignments on 3/18/10. MSC-2 reported each neurologist had submitted six neurological consults for proctoring, so there should have been six proctor reports for each physician. The data attached to each of the proctor completion letters clearly documented that only three proctor evaluations had been done; the other three proctor evaluation documents could not be completed because there was no neurological consult report found to review. The Medical Staff Office had no data to show that the other tele-neurologists (MSM-18 to MSM-29) had been proctored.

7. Similarly, the hospital uses the services of 28 tele-radiologists (MSM-8 and MSM-30 to MSM-56) who are Active medical staff members. On 10/3/12 until mid-morning 10/4/12, a search by the Medical Staff Office staff for evidence of proctoring of these 28 physicians yielded some evidence that they had been proctored or partially proctored. Six proctor reports were required of each physician. Evidence was provided to show that 12 physicians had six proctor reports each (MSM-8, MSM-31, MSM-33, MSM-34, MSM-37, MSM-39, MSM-41, MSM-45, MSM-54, MSM-55 & MSM-56), and two had only one proctor report (MSM-48 & MSM-52). The Medical Staff Office staff could not provide any proctor reports to show that the remaining 14 physicians had been proctored.

On 10/4/12 at 10:15 am, during an interview with the Director of Quality Management (DQM), she acknowledged that the hospital did not have an adequate system in place to collect, maintain, and analyze the critical data needed by the medical staff officers, the hospital administration, and the governing body to ensure that ongoing and periodic professional proficiency evaluations and proctoring were conducted, as required by the Medial Staff Bylaws and Rules. She explained that the hospital had relatively recently purchased a computerized software package that should in the future assist with this, but that had not yet been fully implemented and that the various computer systems of the hospital were not yet able to exchange data from system to system so as to facilitate the collection of the required data.

Based on staff interview and record review, the facility failed to ensure that less restrictive interventions were tried before using restraints for one of 60 sampled patients when Haldol (an antipsychotic medication which has a warning of increased chance of death when used in elderly patients for agitation) by injection into the muscle (IM) and physical restraints were used to restrain Patient 10. This failure had the potential for Patient 10 to be restrained unnecessarily and placed him at risk for medication side effects, entrapment, or death.

Findings:

Review of the facility's policy titled, "Restraints-Hospitalwide," approved on 8/8/12, indicated that the purpose of the policy was "limiting the use of restraints to clinically justified situations only..." The policy included that "Restraints will only be applied after all appropriate alternatives have proven ineffective in maintaining patient safety."

The LexiComp Online Pharmaceutical Reference listed a warning regarding the use of Haldol in the elderly population, "Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo."

On 9/26/12 at 2:30 pm, review of the record with Registered Nurse (RN) 65, revealed that Patient 10, an 83 year old, was given Haldol IM on 9/17/12 at 11:30 pm. The telephone order written at 2300 (11 pm) on 9/17/12 was for Haldol IM "for agitation" and restraints "for patient protection." The orders for both physical (mittens, belt, and side rails) and chemical (Haldol) restraints were written on 9/17/12 at the same time 2300 (11 pm.) There was no documented evidence that other interventions or less restrictive measures were attempted before resorting to using restraints.


Further review of Patient 10's record, revealed nurses notes on 9/17/12 at 21:08 (9:08 pm), indicating that "(The) patient refusing meds." It was also documented that, when a staff member spoke to Patient 10 in his language, the staff member was "...able to get him to take his Remeron." Remeron is an antidepressant medication. This demonstrates that a less restrictive measure, speaking to Patient 10 in a language that he understood, was effective. However, there was no documented evidence that this less restrictive measure was attempted to prevent use of restraints.

Based on staff interview and document review, the governing body (GB) failed to ensure that the hospital had defined, implemented, and maintained an effective program for quality improvement and patient safety that did correct previously identified deficiencies in the Quality Assessment and Performance Improvement (QAPI) Plan program.

This failure hindered the hospital's ability to ensure that patients were treated safely and properly.

Findings:

On 9/24/12 and again on 10/1/12, the hospital's QAPI Plan was requested. On 10/1/12, the policy titled, "Quality Assessment/Performance Improvement Plan-Hospitalwide" was provided. This policy documented that it was "created" in 1990 and "last reviewed/approved" on 2/29/12.

On 10/1/12, the "Board Quality Council Reporting Calendar" was provided, showing that during the six months from 5/12 to 9/12, there had been no modification in the previous planned calendar. The overall "Plan & Annual Evaluation" had been presented once in May and would not again be reviewed until the following May. The "Environmental of Care Plans & Annual Evaluation," only listed topics that dealt with Infection Control issues, was reviewed once annually, had been presented in March, and was not planned again until the following March. The topic of "Environmental of Care" covered the issues of "safety, security, hazardous materials and waste, emergency management, life safety ..." The topic of "Medication Use," medication errors & significant adverse drug reactions ..., had been presented in June and was scheduled for review in September. The topic of "Regulatory Compliance Snapshot" was scheduled for June and December. On 10/2/12, the Director of Quality Management (DQM) verified that the Board Quality Council Reporting Calendar had not been modified to facilitate any corrections.

On 10/2/12, the minutes of monthly GB meetings from 4/12 to date were reviewed and there was no recording that a specific modification to the QAPI program/plan had been made. In the 5/12 meeting, there was a report referencing a 5/17/12 meeting of the Medical Executive Meeting (MEC) and results from the CMS survey in 4/12. Eleven specific anticipated deficiencies were listed and preliminary plans to correct them. The 5/12 meeting contained a copy of the "2011 Annual Report Performance Improvement." The last page of this report documented "Key Findings 2011" that included four surveys and very significant regulatory or accreditation findings for each. However, the report did not focus on any plans for improvement. Documented in the 5/12 minutes was, "Organizational Performance Improvement & Patient Safety Plan 2012 - 2013" without signatures or approval. The 7/12 meeting documented a presentation from the DQM reviewing the survey results. The presentation goes on to state a number of policies that were rewritten or being worked on for deep sedation, surgery services and others. However, QAPI was not referenced and there was no information about planned corrections for the QAPI plan.

On 10/2/12 at 5:25 pm, the DQM was asked for more information about the governing body's involvement and directions pertaining to any modification(s) of the QAPI plan/program after it had been cited as deficient in April 2012. Specifically requested was information about what the GB had done to assure that previously identified, high-risk, high-prevalence and/or problem-prone quality & safety issues were addressed. The DQM indicated that the hospital had been striving to target these areas in a number of administrative staff meetings, but that documentation of many of those meeting had not been recorded. Any indication of the governing body's involvement should be recorded in the minutes of the governing body's Quality Council.

On 10/3/12, the minutes of the Quality Council meetings for 2012 were reviewed and no specific information was apparent that the GB had changed the QAPI program plan or had instructed that corrective action be taken to improve the QAPI program.

On 10/4/12 at 10:15 am, the DQM was interviewed and verified the following:

GB oversight: There was no available documentation that the GB had specified corrective action for the deficient QAPI findings from prior CMS surveys.

Contracted Services: The Performance Measures for the contracted services was incomplete (only 20 of >400 contracts). The Performance Measures for the 20 listed contracts did not have specific objective quality indicators and had either not been measured in a meaningful way or had not been measured.

On 10/4/12, the Chief Clinical Officer (CCO) and Director of Risk Managment (DRM) were interviewed and verified that there was no documentation to substantiate that the GB had taken specific steps to correct the prior deficiencies cited on 4/30/12, for QAPI.

Based on interview and record review, the facility failed to ensure that quality assessment and performance improvement (QAPI) activities were evaluated for the effectiveness of the improvement actions. This failure had the potential for deficient practices to persist and adversely impact patients.

Findings:

On 9/25/12, the facility's Patient Safety, Quality Council, and Board of Directors committee minutes were reviewed for the previous three months. The minutes of these meetings demonstrated that data was collected for performance improvement projects and for regulatory compliance related to the facility's last survey in 4/12. The analysis of the data collected in the regulatory compliance studies documented only whether the indicator data had improved or not. The action plans were not documented or evaluated as to their effectiveness. The analysis of the systems involved or the staff knowledge of the systems were not documented.

On 9/26/12 at 7:30 am, the Director of Quality Management (DQM) was interviewed regarding how the facility planned to correct deficient practices identified in the previous 4/30/12 survey. DQM explained that indicators were developed and the staff were educated on the expectations and Department Managers and Directors were instructed to conduct random audits which were reported to the Quality Management department. The data from these reports were collated and presented to the above committees. DQM stated that actions plans were not documented, evaluated, nor reported to the Quality Council.

Based on interview, the facility failed to ensure that adequate resources for measuring, assessing, improving, and sustaining the hospital's performance were allocated in Quality Management. This failure resulted in the lack of performance improvement in areas previously identified as non-complaint, and could result in poor quality of care and adverse clinical outcomes to patients.

Findings:

On 10/4/12 at 2:40 pm, the Director of Quality Management (DQM) was interviewed regarding the repeated deficiencies in the areas of pharmacy and nursing, and the overall lack of evidence that a credible quality cycle of review (Plan, Do, Check, Act) was implemented. (Refer to A 267, 285, 392, 404, 500). DQM stated that the consultant (VPQM) hired to do the oversight of the quality program left in 5/12 and had not been replaced. DQM explained that the VPQM had proposed increasing the Quality Management staff, prior to her exit. DQM explained that she had added one staff person that was indicated on the plan, but that other positions recommended by the consultant were either not approved by administration or were on hold until a replacement VPQM arrived to hire additional staff. DQM stated that she was unable to do everything that needed to be done to oversee the quality cycle of review with her current staff.

Based on interview and record review, the facility failed to ensure that a contracted wound nurse consultant (WRN 3) had valid, current California State licensure, prior to having direct contact with a patient and performing a wound procedure. (The licensure investigative process would provide information for the issuance and/or denial of licensure in California. Until a nurse is licensed to practice in the State of California they may not have direct patient contact or involvement in the nursing process that would ultimately effect direct patient care).

This failure resulted in one of 60 sampled patients (Patient 26) receiving care that was not in accordance with nationally accepted standards of practice by an unlicensed individual, placing Patient 26 at risk for developing an infection and had the potential for the patient's wounds to worsen.

Findings:

During review of Patient 26's record, review of the emergency room physician's history and physical, dated 6/9/12, indicated that Patient 26 was originally admitted to the facility on 6/9/12 with diagnoses that included acute pneumonia with exacerbation of COPD (chronic obstructive pulmonary disease), MRSA (an antibiotic resistant bacterial infection), Hepatitis C (chronic infection effecting the liver), and a pseudoaneurysm (bulging of the artery caused by collection of blood in the weakened wall of the artery) in the left groin. Patient 26 was transferred to another facility on 6/11/12, for vascular surgery and readmitted to this facility on 6/17/12, with the wounds and blisters (as described above) and in contact isolation for MRSA and Hepatitis C. Patient 26's June 2012 wound treatement records were reviewed and documentation by WRN 3 was noted in the records.

On 9/26/12 at 4:45 pm, in an interview, WRN 3 stated that when she started work at this facility as a consultant wound nurse in early June of 2012, she was not licensed in the State of California to practice nursing and, until she became licensed, she was instructed by hospital Administration not to have any direct patient care contact. WRN 3 stated that she participated in the facility's performance improvement (PI) rounds that were conducted on 6/19/12 with a staff wound nurse (WRN 2) and licensed nurse wound treatment assistant (WTA). A patient (Patient 26) was presented that had an open wound to the left groin as a result of a non-healing wound post vascular surgery, severe edema to the left leg, and multiple fluid filled blisters on his left lower leg, ankle, and foot. WRN 3 stated she entered Patient 26's room to assess the wounds and blisters that Patient 26 had on his left groin, left leg, ankle and foot. WRN 3 stated that she did not have a temporary permit to practice nursing in the State of California on 6/19/12.

WRN 3 stated she did "pop" a blister on Patient 26's foot that "she thought" was on the top of the foot at the bend of the ankle when shown pictures of the blisters on Patient 26's left foot. WRN 3 stated she had put on a gown and gloves and squeezed the blister between her thumb and forefinger with her nails until the blister "popped." WRN 3 stated she then cleaned it and placed a 4 x 4 gauze dressing over it. (WRN 3 was not licensed in California at this time to perform the wound procedure).

When asked why she would pop the blister when she was instructed not to have patient contact, WRN 3 stated another wound nurse (WRN 2) had indicated the blister was an unstageable blood blister because it was dark colored around the edges. WRN 3 stated, "I wanted to prove to her that the blister was filled with clear liquid fluid and was not an unstageable blood blister."

When asked if she understood that standard protocol for wounds indicated that blisters were not to be broken unless for specific reasons, WRN 3 stated, "Yes." When asked if to prove to another nurse that the blister was clear fluid filled rather than blood filled was a valid reason to break the blister, WRN 3 stated, "It was an educational opportunity."

Review of the personnel records for WRN 3 indicated she was hired and began work at the facility on 6/4/12. No documentation of licensure was found until 8/2/12 at 2:03 pm, when a copy of an email from WRN 3 to the Chief Nursing Officer (CNO) read, "I now have a permanent license in CA."

An inquiry was sent to the Board of Registered Nursing (BRN) asking for the date of WRN 3's temporary permit issuance. According to the BRN, WRN 3 was issued a temporary license on 6/26/12 and "she was eligible to practice from that date."

During an interview on 10/1/12 at 2 pm, WRN 2 stated she and WRN 3 were in Patient 26's room on 6/19/12. WRN 2 stated that she left the room to get PolyMem (a soft absorbent foam dressing) to cover the intact blisters and when she returned to the room, WRN 3 was no longer there and WRN 2 noted that three of Patient 26's blisters were broken (no longer intact), wet with fluid leaking, and had no covering over them.

On 10/1/12 at 4:15 pm, an interview was conducted with WTA who stated she was in Patient 26's room when WRN 3 broke a blister on Patient 26's left medial ankle and peeled the skin away from another blister on the back of Patient 26's lower left leg. WTA stated WRN 2 had left the room to get PolyMem dressings, then while WRN 2 was gone, WRN 3 reached over onto the counter top near the bed and took an instrument from an opened wound care kit (she was unsure if it was the hemostat clamp or the tweezers). WTA stated that WRN 3 then grabbed the lower base of the blister on the medial (inner) ankle and pulled up quickly until it broke and "all this fluid just gushed out." WTA stated WRN 3 did not clean the blister area, but did place a 4 x 4 gauze over it. WTA stated that WRN 2 cleaned all the blistered areas when she returned and covered them with the PolyMem. WTA also stated that WRN 3 then went to a blistered area on the left leg behind the knee and peeled away all the loose skin that was over it. WTA stated that WRN 3 did not change her gloves between the wound procedures and did not clean either wound before or after touching them. When asked if WRN 3 cleaned or disinfected the instrument she used to break the blister, WTA stated, "No."

WRN 3 was functioning as a nurse within her specialty when she would enter a patient's room to assess a patient's wounds, evaluate the healing process with visualization of the wounds, and make recommendations for wound care treatments and/or changes to existing orders. The ability to perform these functions requires the skill and expertise of a nurse that was, by law, eligible to practice as a licensed nurse. WRN 3 was not licensed and not eligible to perform patient/wound care treatments on the date (6/19/12), she popped Patient 26's blisters and was not licensed to perform patient assessments, evaluations, and/or recommendations that would be within the nursing process and effect direct patient care until 6/26/12.

On 10/03/12 at 8:30 am, the above identified deficient practices of the facility failing to prevent WRN 3 from having direct contact with and performing a wound procedure on Patient 26, without a license to do so and not in accordance with nationally recognized standards of practice, were discussed with and verified by the Chief Executive Officer.

Based on staff interview and record review, the facility failed to ensure that physicians' verbal/telephone orders were authenticated (verified/signed by the prescriber who gave the order) and/or signed within 48 hours for one of 60 sampled patients (Patient 32) and one outside the sample (Patient 61). This failure resulted in delayed authentication posing a risk for medication errors and related adverse outcomes.

Findings:

1. On 9/24/12 at 3 pm, review of Patient 32's record with the Director of Pharmacy (DP) and Nurse Manager (NM) 15 revealed telephone and verbal orders that were either not authenticated (by the physician), or were cosigned later than 48 hours, which was not consistent with hospital policy.

a. The following orders were not authenticated:

An order for a fentanyl patch (potent pain medication delivered through the skin), dated 9/16/12, was not signed.

An order clarification to discontinue Tylenol, written on 9/22/12, was not cosigned.

An order for Morphine (a potent pain medication) to be given by injection was written on 9/16/12, but was not authenticated.

A clarification order for pain medications (Tylenol, Vicodin, and morphine) was written on 9/15/12, but was not authenticated.

b. The following orders were authenticated later than 48 hours from the time written:

An order to transfer Patient 32 to a critical care area was written on 9/15/12 and cosigned on 9/18/12.

Two orders to change a fentanyl patch were written about 1.5 hours apart on 9/18/12, but were cosigned on 9/21/12.

Review of the the verbal order form showed that the form had specific directions to physicians to "Please authenticate within 48 hours..."

The DP and NM 15 did not find any documented evidence that these orders were authenticated electronically or on paper.

According to the facility's policy titled, "Orders, Transcription and Requisition- Nursing," approved 8/24/12, indicated, "According to FRHG Medical Staff By-laws, verbal/telephone orders must be verified and signed (by hand with date/ time or electronically) by the physician who gave the order within 48 hours."


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2. A record review for Patient 61 with NM 1 was conducted on 10/4/12 at 10:45 am. The following was identified in the record:

On 7/9/12, verbal orders for Insulin Standing Orders were not authenticated by Medical Staff Member (MSM) 59 until 8/4/12, 27 days later.

On 7/11/12, verbal orders for medication changes were not authenticated by MSM 60 until 7/16/12, five days later.

On 7/17/12, verbal orders for speech therapy were not authenticated by MSM 58 until 8/6/12, 20 days later.

On 7/27/12, verbal orders for speech therapy were not authenticated by MSM 57 until 8/4/12, eight days later.

In a concurrent interview, NM 1 stated that several verbal orders were not authenticated by the physician within 48 hours, according to facility policy.

Based on tray line observations, staff interviews, and hospital document review, the hospital failed to ensure the competency of the staff member responsible for taking food temperatures as evidenced by the inability to accurately calibrate food thermometers and take food temperatures. Failure to ensure staff competency in this task may result in foods being cooked and/or held at temperatures that support the bacterial growth associated with foodborne illness. Foodborne illness may result in nausea, vomiting, and in severe instances, death.

Findings:

On 9/25/12 at 11:40 am, Cook B was observed taking food temperatures in preparation of the noon tray line. It was noted there was a 30°F difference between the hospital's and surveyor's thermometers. Upon completion of the task, the surveyor requested Cook B demonstrate the procedure for thermometer calibration. Cook B stated she had already calibrated her own thermometer earlier. Cook B obtained a small silver pan of water and ice. It was noted the pan contained approximately 1/2 ice and the remainder was water. At this time, Cook B realized she was not using her own thermometer that had been calibrated. Upon thermometer stabilization, Cook B adjusted the thermometer to 32°F. At this time, the interim Clinical Nutrition Manager (CNM) instructed Cook B to pour out water and add more ice since the surveyor's digital thermometer was higher than 32°F. Once ice was added Cook B adjusted the thermometer to 32°F. Cook B then went to retake the temperatures of the food on tray line. It was still noted to have 30°F differences between the hospital's and surveyor's thermometers. The CNM informed Cook B to leave the thermometer in the food until the needle stops moving then to wait 15 seconds and record that temperature.

The standard of practice would be to ensure the ice/water mixture had enough ice to ensure a slushy mixture.

On 9/25/12, in a concurrent interview with the interim CNM, interim Director of Food Service, and the interim Patient Services Manager, the CNM stated that Cook B was confusing the procedure on how to take temperatures of the food items. The CNM stated the thermometer needed to stay in the food until the needle stops moving then hold for 15 seconds.

Review of the in-services for 2012-2011, did not show any in-services to Dietetic Service staff regarding thermometer calibration or how to accurately take temperatures of the food.
Review of the hospital's in-service on thermometer calibration and accurate measurement of the food dated 9/26/12, indicated thermometers must be accurate to at least +/- 2°F from 32°F. It showed steps to calibrate a bi-metallic thermometer ice bath method and to fill with 60% cubed ice and to add just enough cold water to cover the ice (40%). Place thermometer in ice water bath at least 3 inches deep for two minutes. If the thermometer does not read 32°F, adjust accordingly. It indicated how to accurately take the temperature of food. It indicated to remove the item from the heating source. Probe the item of food in the middle of the food, making sure the tip does not touch the bottom or sides of the container. It indicated to keep the probe in the item until the needle stops moving then hold for 15 seconds then record the temperature of the item in the log and clean the thermometer.

Based on interview and document review, the governing body failed to ensure that the medical staff was following and enforcing their bylaws, in order to be responsible and accountable to the governing body, for the quality of care provided to patients. In so doing, the governing body and medical staff had not ensured that all medical staff members and other professionals had been demonstrated to be qualified and competent for the membership and privileges made available to them. This could lead to under-qualified practitioners providing poor quality of care to patients.

Findings:

On 9/24/12, the Medial Staff Bylaws and the Medical Staff Rules and Regulations charge the Medical Staff (MS) with several key assignments related to being accountable to the governing body for the quality of care provided to patients. Three of those assignments are to: 1.) Ensure that all applicants for medical staff membership and privileges are qualified as specified in the bylaws and rules; 2.) Ensure that all medical staff membership has periodic evaluation of their professional proficiencies based on objective data of past performance; 3.) Ensure that all new members of the Active, Active Ancillary, Courtesy, or Locum Tenens Staff be proctored as specified in the rules.

In order to identify the specific locations in the bylaws and rules, these assignments are stipulated, the following texts are from the Medial Staff Bylaws and Medical Staff Rules and Regulations as they were reviewed from 9/24/12 to 10/4/12:

"Medical Staff Bylaws (June 30, 2011)

"Article I PURPOSE" (page 4) states "the purposes of the Medical Staff are to: (in part) b. ... to promote good patient care. c. Screen and recommend applicants for Medical Staff Membership. d. Review Privileges of Members. e. Monitor, evaluate and assist in improving the work done by the Medical Staff. j. Ensure that quality of care delivered by those with privileges.

Article II, 2.3 - Effects of other affiliations - (page 5) 2.3-1 No individual is entitled to, nor can he or she be denied Membership and/or Clinical Privileges in the Medical Staff merely because of any of the following: a. Degree, b. Membership in professional organizations, c. Certification from a clinical board, d. Previous Medical Staff Membership, e. Current Staff Membership or Clinical Privileges at another health care facility

Article II, 2.7-1 - Active Staff (pages 7 & 8)
a. Qualifications, Active Staff Members: ... (2) Shall have at least 15 Patient Contacts annually.

c. Responsibilities, Active Staff Members: ... (5) Shall have at least 15 Patient Contacts annually such that patient care can be assessed and reviewed.

Article III, Procedure for Appointment, Reappointment, and determination of clinical privileges (page 13) 3.1 General Procedure - The Medial Staff through its designated Departments, committees, and Officers shall evaluate and consider each application for appointment ore reappointment to the Staff and each request for modifications of Staff Membership status or Privileges and shall adopt ant transmit recommendations thereon to the Board. The Medial Staff shall perform the same evaluation and recommendation functions in connection with any AHP (Allied Health Professionals) who seeks to exercise Privileges.

Medical Staff Rules and Regulations (May 2011)
Section H - Proctoring

H-1 Proctoring Requirements -- a. Each newly appointed Member of the Active, Active Ancillary, Courtesy, or Locum Tenens Staff shall be proctored for medical and surgical Privileges ...

H-2 Purposes of Proctoring --
a. Verify technical competence
b. Asses judgment
c. Evaluate pre- and post-procedure management
d. Evaluate medical record keeping and documentation
e. Determine compliance with Medical Staff bylaws, rules, regulations, and policies.

H-5 Determination of extent of proctoring
... The first proctoring review will occur no later than 12 months after the applicant has been granted full privileges."


On 10/1/12 from the provided roster, "All the Medical Staff Members (MSM) and Allied Health Professionals (AHP) currently on staff at the hospital," an initial 9 MSM and AHP were selected for credential file review. An additional physician (MSM 11), who was not listed on the Medical Staff Roster, was selected for review because of an irregular medication order that had been noted. During the afternoon of 10/2/12, the initial list of 10 practitioners was reviewed in the Medical Staff Office with Medical Staff Coordinator 1 (MSC-1), at which time it was learned that MSM 11 was a "Locum Tenens" physician (serving for a limited time to replace another physician) and the hospital currently had other Locum Tenens physicians providing services at the hospital. Two of the listed AHPs, both Clinical Cardiac Perfusionists (CCP: health care technician who operates a heart / lung machine during cardiac surgery to redirect blood flow allowing the surgeon to operate on the unbeating heart) were no longer considered AHP since a change in the AHP Manual (part of the MS Bylaws) that occurred in May 2011. At 3:25 pm on 10/2/12, MSC-1 stated, "that change had been made because the MS felt that since none of the physicians were perfusionists, they should not be doing 'peer review' on the CCPs. The CCPs were treated as hospital employees and their clinical proficiency evaluations were done by the Director of Perioperative Services."

During the afternoon of 10/2/12, the credential file of MSM-11 was reviewed. On 10/3/12, another list of MSMs and AHPs was selected and together with MSM-11 for a total of 13 credential files (MSM-1, MSM-2, MSM-3, MSM-4, MSM-5, MSM-6, AHP-7, MSM-8, MSM-10, MSM-11, MSM-12, MSM-13 & MSM-14) were reviewed in detail with MSC-1, beginning at 10:00 am on 10/3/12. With the following observations noted:

1. Three (3) of the physicians (MSM-11, MSM-12 & MSM-13) were locum tenens, and none of them had available documentation to show that they had been required to undergo proctoring. Proctoring reports were usually maintained in a separate folder (green folder - peer review) and most MSM had such a folder, but not the Locum Tenens physicians. None of the three had been given a specific effective period for their privileges.

2. MSM-12, a locum tenens physician with an advanced specialty, had requested very non-specific privileges and his privilege list had no signatures to indicate what may have been granted, or even if privileges had been granted. The effective date and ending date of privileges were left blank.

3. One (1) MSM-14, a PhD psychologist, was an Active staff member: His credential file and green folder showed that he had been reappointed in 1/12, but had at that time no patient contact data or other data to show his clinical performance of patient contacts over his prior appointment period. A report, dated 6/1/12, documented that from 6/1/10 through 6/1/12, he had only one patient contact. MSM-14's privilege request form documented he was not qualified for the requested core privileges and had hand written beside that fact, "Requesting waiver." However, there was no notation that a waiver had been officially entertained or granted. Although he had been reappointed to the Active Medical Staff, MSM-14's file had no evidence that MSM-14 had treated 15 patients in any one year during his prior medical staff appointment.

4 Of the 13 credential files reviewed, nine (9) (MSM-1, MSM-2, MSM-3, MSM-4, MSM-5, MSM-6, MSM-8, MSM-10 & MSM-14) had hand written modifications to the effective dates for their privilege lists, and review showed that the dates apparently approved by the Medical Executive Committee (MEC) & governing body (GB) had been altered by one of the Medical Staff Office staff members, but there was not notation that the alteration had been directed or approved by any MS officers or anyone with authority to act on behalf of the GB.

5. MSM-8 is a tele-radiologist (physician working from a distant site via computer, who assists with x-ray interpretations) whose file did not have any proctor reports or other peer review on file. When asked for the proctor reports of this individual a

Based on staff interview and document review, the governing body (GB) failed to ensure that the hospital had defined, implemented, and maintained an effective program for quality improvement and patient safety that did correct previously identified deficiencies in the Quality Assessment and Performance Improvement (QAPI) Plan program.

This failure hindered the hospital's ability to ensure that patients were treated safely and properly.

Findings:

On 9/24/12 and again on 10/1/12, the hospital's QAPI Plan was requested. On 10/1/12, the policy titled, "Quality Assessment/Performance Improvement Plan-Hospitalwide" was provided. This policy documented that it was "created" in 1990 and "last reviewed/approved" on 2/29/12.

On 10/1/12, the "Board Quality Council Reporting Calendar" was provided, showing that during the six months from 5/12 to 9/12, there had been no modification in the previous planned calendar. The overall "Plan & Annual Evaluation" had been presented once in May and would not again be reviewed until the following May. The "Environmental of Care Plans & Annual Evaluation," only listed topics that dealt with Infection Control issues, was reviewed once annually, had been presented in March, and was not planned again until the following March. The topic of "Environmental of Care" covered the issues of "safety, security, hazardous materials and waste, emergency management, life safety ..." The topic of "Medication Use," medication errors & significant adverse drug reactions ..., had been presented in June and was scheduled for review in September. The topic of "Regulatory Compliance Snapshot" was scheduled for June and December. On 10/2/12, the Director of Quality Management (DQM) verified that the Board Quality Council Reporting Calendar had not been modified to facilitate any corrections.

On 10/2/12, the minutes of monthly GB meetings from 4/12 to date were reviewed and there was no recording that a specific modification to the QAPI program/plan had been made. In the 5/12 meeting, there was a report referencing a 5/17/12 meeting of the Medical Executive Meeting (MEC) and results from the CMS survey in 4/12. Eleven specific anticipated deficiencies were listed and preliminary plans to correct them. The 5/12 meeting contained a copy of the "2011 Annual Report Performance Improvement." The last page of this report documented "Key Findings 2011" that included four surveys and very significant regulatory or accreditation findings for each. However, the report did not focus on any plans for improvement. Documented in the 5/12 minutes was, "Organizational Performance Improvement & Patient Safety Plan 2012 - 2013" without signatures or approval. The 7/12 meeting documented a presentation from the DQM reviewing the survey results. The presentation goes on to state a number of policies that were rewritten or being worked on for deep sedation, surgery services and others. However, QAPI was not referenced and there was no information about planned corrections for the QAPI plan.

On 10/2/12 at 5:25 pm, the DQM was asked for more information about the governing body's involvement and directions pertaining to any modification(s) of the QAPI plan/program after it had been cited as deficient in April 2012. Specifically requested was information about what the GB had done to assure that previously identified, high-risk, high-prevalence and/or problem-prone quality & safety issues were addressed. The DQM indicated that the hospital had been striving to target these areas in a number of administrative staff meetings, but that documentation of many of those meeting had not been recorded. Any indication of the governing body's involvement should be recorded in the minutes of the governing body's Quality Council.

On 10/3/12, the minutes of the Quality Council meetings for 2012 were reviewed and no specific information was apparent that the GB had changed the QAPI program plan or had instructed that corrective action be taken to improve the QAPI program.

On 10/4/12 at 10:15 am, the DQM was interviewed and verified the following:

GB oversight: There was no available documentation that the GB had specified corrective action for the deficient QAPI findings from prior CMS surveys.

Contracted Services: The Performance Measures for the contracted services was incomplete (only 20 of >400 contracts). The Performance Measures for the 20 listed contracts did not have specific objective quality indicators and had either not been measured in a meaningful way or had not been measured.

On 10/4/12, the Chief Clinical Officer (CCO) and Director of Risk Managment (DRM) were interviewed and verified that there was no documentation to substantiate that the GB had taken specific steps to correct the prior deficiencies cited on 4/30/12, for QAPI.

Based on interview and record review, the facility failed to ensure that quality assessment and performance improvement (QAPI) activities were evaluated for the effectiveness of the improvement actions. This failure had the potential for deficient practices to persist and adversely impact patients.

Findings:

On 9/25/12, the facility's Patient Safety, Quality Council, and Board of Directors committee minutes were reviewed for the previous three months. The minutes of these meetings demonstrated that data was collected for performance improvement projects and for regulatory compliance related to the facility's last survey in 4/12. The analysis of the data collected in the regulatory compliance studies documented only whether the indicator data had improved or not. The action plans were not documented or evaluated as to their effectiveness. The analysis of the systems involved or the staff knowledge of the systems were not documented.

On 9/26/12 at 7:30 am, the Director of Quality Management (DQM) was interviewed regarding how the facility planned to correct deficient practices identified in the previous 4/30/12 survey. DQM explained that indicators were developed and the staff were educated on the expectations and Department Managers and Directors were instructed to conduct random audits which were reported to the Quality Management department. The data from these reports were collated and presented to the above committees. DQM stated that actions plans were not documented, evaluated, nor reported to the Quality Council.

Based on staff interview and record review, the facility failed to ensure that physicians' verbal/telephone orders were authenticated (verified/signed by the prescriber who gave the order) and/or signed within 48 hours for one of 60 sampled patients (Patient 32) and one outside the sample (Patient 61). This failure resulted in delayed authentication posing a risk for medication errors and related adverse outcomes.

Findings:

1. On 9/24/12 at 3 pm, review of Patient 32's record with the Director of Pharmacy (DP) and Nurse Manager (NM) 15 revealed telephone and verbal orders that were either not authenticated (by the physician), or were cosigned later than 48 hours, which was not consistent with hospital policy.

a. The following orders were not authenticated:

An order for a fentanyl patch (potent pain medication delivered through the skin), dated 9/16/12, was not signed.

An order clarification to discontinue Tylenol, written on 9/22/12, was not cosigned.

An order for Morphine (a potent pain medication) to be given by injection was written on 9/16/12, but was not authenticated.

A clarification order for pain medications (Tylenol, Vicodin, and morphine) was written on 9/15/12, but was not authenticated.

b. The following orders were authenticated later than 48 hours from the time written:

An order to transfer Patient 32 to a critical care area was written on 9/15/12 and cosigned on 9/18/12.

Two orders to change a fentanyl patch were written about 1.5 hours apart on 9/18/12, but were cosigned on 9/21/12.

Review of the the verbal order form showed that the form had specific directions to physicians to "Please authenticate within 48 hours..."

The DP and NM 15 did not find any documented evidence that these orders were authenticated electronically or on paper.

According to the facility's policy titled, "Orders, Transcription and Requisition- Nursing," approved 8/24/12, indicated, "According to FRHG Medical Staff By-laws, verbal/telephone orders must be verified and signed (by hand with date/ time or electronically) by the physician who gave the order within 48 hours."


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2. A record review for Patient 61 with NM 1 was conducted on 10/4/12 at 10:45 am. The following was identified in the record:

On 7/9/12, verbal orders for Insulin Standing Orders were not authenticated by Medical Staff Member (MSM) 59 until 8/4/12, 27 days later.

On 7/11/12, verbal orders for medication changes were not authenticated by MSM 60 until 7/16/12, five days later.

On 7/17/12, verbal orders for speech therapy were not authenticated by MSM 58 until 8/6/12, 20 days later.

On 7/27/12, verbal orders for speech therapy were not authenticated by MSM 57 until 8/4/12, eight days later.

In a concurrent interview, NM 1 stated that several verbal orders were not authenticated by the physician within 48 hours, according to facility policy.