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Based on emergency record review and staff interview the Critical Access Hospital (CAH) failed to assure the emergency response time by the physician had not been longer than 30 minutes to residents of the area served by the CAH for 5 of 11 records reviewed (E1, E2, E3, E4 and E5).

Findings include: Five (5) emergency records reviewed had physician response times longer than 30 minutes ( E1, E2, E3, E4 and E5). During record review it was noted the following emergency response times by the physician were greater than 30 minutes:
Record # Date of Service Time physician called: arrived
E1 3/23/10 1920-2000 40 minutes
E2 1/2/10 1840-2000 1 hour 20 minutes
E3 4/9/10 2210-2245 35 minutes
E5 4/24/10 0345-0430 45 minutes
E4 2/26/10 0220-0315 55 minutes

Interview with the Health Information Manager/Quality Manager (HIM/QM) on 5/11/10 at 1:45 p.m. confirmed she had been aware of the problem with physician response times. She indicated the facility had tracked the call time and arrival time of the physician in ER and confirmed with documentation on a spread sheet that this had been an ongoing concern. Further interview with the HIM/QM on 5/12/10 at 10:25 a.m. confirmed the problem had not been documented as part of the discussion within neither the quality council nor the medical staff so that remedial action could be taken.

Based on observation, interview, record review and policy review, the Critical Access Hospital (CAH) was found not to be in compliance with the Conditions of Participation for Physical Environment (CFR 485.623) due to failure to ensure proper procedures were followed related to use of alcohol based skin preparation in anesthetizing locations to prevent the risk of surgical fires. This practice was evident for 6 of 6 surgical patients (S1, S2, S3, S4, S5, and S6) in the sample for whom this type of surgical prep was utilized.

Findings include: The CAH did not implement policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the surgical department. CMS (Centers for Medicare and Medicaid Services) had issued a Survey and Certification Memo dated 1/12/2007, addressing risk reduction techniques to permit safe use of alcohol based skin preparations in inpatient anesthetizing locations in CAHs. The use of an alcohol based skin preparations in inpatient or outpatient anesthetizing locations is not considered safe, unless appropriate fire risk reduction measures are taken, preferable as part of a systemic approach by the CAH to preventing surgery related fires.

On 5/11/2010, at 10:00 A.M. an interview was conducted with the Operating Room Coordinator/circulating registered nurse (S) regarding policy/procedure for use of alcohol based skin preparation. It was verified the CAH routinely used Chloraprep, an alcohol based skin prep, for surgical procedures performed at the CAH. Staff S stated they routinely checked the patient to assure the alcohol based prep had completely dried as required for safety reasons. However, it was learned there was no system currently in place for documentation in the patient record verifying that appropriate procedures were followed ensuring the proper use of the alcohol based skin preparation.

During record review it was noted that Chloraprep, an alcohol based skin preparation had been utilized during six (6) surgical procedures for patients on the following dates: (S1) 12/ /17/09, (S2) 2/18/10, (S3) 4/29/10, (S4) 4/29/10, (S5) 4/29/10, and (S6) 2/18/2010. Review of the Nursing Operative Report for all six (6) patient records confirmed that alcohol skin preparation had been utilized as indicated by the surgical staff. No documentation was evident to indicate the alcohol based skin prep had been dried and/or the appropriate procedure implemented. When queried as to the method of alcohol skin prep application, interview with the OR Coordinator/circulating nurse (S) on 5/11/2010 at 10:00 a.m. revealed the Chloraprep was utilized according to manufacturer's instructions, and was allowed to dry prior to beginning the surgical procedure.

The Madison CAH surgical skin preparation policy indicated the following procedure:
USE of FLAMMABLE PREP AGENTS
If a flammable prep agent is used (Chloraprep, DuraPrep etc.) additional precautions should be taken to minimize the risk of a surgical fire and patient burn injury

Perioperative personnel should be familiar with the flammability characteristics of all prep stored or used in the patient care area.

When flammable agents are used, they should be packaged in small quantities appropriate for a single application or be prepackaged in a unit dose.

The prep agent should not contact fabric or be allowed to pool on or under body parts (leg, umbilicus, groin.)

If pooling occurs, the excess solution should be wicked away. Any solution -soaked materials should be removed from the procedure room before draping or using electrosurgery, laser, or other heat source.

The prep agent should be allowed to dry and vapors to dissipate before application of an incise drape or surgical drape, or use of electrosurgery, laser, or other heat source. The prep agent remains flammable until completely dry.

Active communication between the surgical staff should include that:

A flammable prep agent was used
The application site was dry before draping
Pooling of the prep solution did not occur or has been corrected
Any materials soaked with the prepping agent have been removed from the procedure room

Disposal of unused flammable prep agents must be handled in a manner to decrease the risk of fire.

The surgical team will conduct a "time out" before the start of surgery and will ensure that:
The surgical site is dry before draping and before the use of the electrosurgical unit, cautery and /or laser.
There is no pooling of the prep solution around the patient.

During review of the Madison CAH Patient Safety in the Operating Room policy the following was noted: "Manufacturer's/suppliers instructions and warnings for flammable liquid germicides (Chloraprep and Duraprep) or antiseptics must be carefully followed. All fire reduction strategies must be followed.
Flammable liquid germicides or antiseptics (Chloraprep and Duraprep) shall be packed in unit dose applicators /swabs to ensure a controlled prep of the patient.

Do not allow prep solutions to pool around the patient. Remove any pooling of prep solution with a towel and remove the towel from the operating room before the start of surgery.
Do not allow prep solutions to pool under or around the electrosurgical dispersive pad.

Do not allow flammable prep solutions to be absorbed into the drapes that are in contact with the patient.

Allow solution, tinctures, and aerosols to dry completely and to evaporate and dissipate before draping and before the use of the electrosurgical unit, cautery and /or laser.

Do not activate ignition sources in the presence of flammable prep solutions.
The surgical team will conduct a "time out" before the start of the surgery to ensure that:

the surgical site is dry before draping and before the use of the electrosurgical unit, cautery , and /or laser.
There is no pooling of the prep solution around the patient.

Any solution soaked materials, i.e., towels, are removed from the operating room prior to draping and use of the electrosurgical unit, cautery, and/or laser.

Interview with the Director of Nursing (DON) and the Operating Room Coordinator was conducted on 5/12/10 at 12:00 P.M. It was confirmed there was no documentation evident in patient records regarding drying of the alcohol based skin prep prior to draping, even though the facility's practice had been to check for thorough drying of the area prior to beginning the surgical procedure.

The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to ensure safety from fire during surgery therefore they were unable to meet this condition.

Based on observation and interview, the facility failed to ensure that toxic chemical cleaning solutions were stored in a safe manner and failed to ensure that patient care areas were maintained to prevent potential accidents.

The findings include: The facility failed to store cleaning solutions in locked cabinets.

During the environmental tour on 5/10/10 at 1:30 p.m., and again in the morning of 5/11/10, it was observed that the cleaning solution, Dispatch Hospital Cleaner Disinfectant with bleach was found in the unlocked bathroom of the birthing room. There were two, 32 ounce containers located on a foot stool near the sink and a 64 ounce container on the patient's shelf.

The chemical properties of Dispatch listed on the Material Safety Data Sheet (MSDS) included the hazardous components: sodium hydroxide, sodium metasilicate and sodium hypochlorite.

In an interview with the Maintenance Supervisor at the time of the tour, he was uncertain why the disinfectant was being stored there and agreed it wasn't appropriate due to safety concerns.

In an interview with Registered Nurse-Z at 2:45 p.m. on 5/10/10, she stated she was not sure why it was being stored there and stated "I don't think it belongs there."

It was observed during a tour of the emergency room at 9:25 a.m. on 5/11/2010, that a gallon of Arsenal Q.T. Plus and 2 quart size spray bottles of Q.T.-TB were stored under the sink. The cupboard doors were unlocked and the sink was located adjacent to the examination table. The door to the emergency room was opened and accessible to the public at the time of the tour.

The MSDS (Material Safety Data Sheet) information indicated that Q.T. Plus was corrosive and could cause irreversible eye damage and skin burns. The MSDS information also indicated "Precautions to be taken in handling and storing: Keep away from children". The physical location of the emergency room was not in an area of the CAH that would be readily observed by nursing staff on the nursing unit. Staff were present in the emergency room area only as required by walk-in patients and/or ambulance transports.





02980

The doors in the patient operating room were not maintained in a safe manner.

During a tour of the surgical department/operating room suite on 5/11/10 at 10 A.M. the following was noted: the double sets of wooden doors going into the surgical area from the corridor and the set of doors going into the only surgical suite were noted to be in disrepair. These wooden doors were very chipped, gouged, and marred, with splintered areas evident on the door edges. The metal door frames in the surgical department were noted to have areas of chipped paint.

Interview was conducted with the maintenance supervisor on 5/12/10 at 9:45 A.M. who confirmed the findings. It was indicated the sets of doors in the surgical area were 50 years old and had never been repaired or replaced.

Based on observation, interview and policy review the facility failed to ensure proper temperatures were being taken and monitored for 1 of 1 three compartment sinks and 1of 1 patient refrigerators. Findings include:

During the kitchen tour on 5/11/10 at 10:30 a.m., the dietary manager explained that the facility utilized a 3 compartment sink to wash some pots and pans. She stated she was unable to provide any temperature monitoring sheets for the final rinse water as they were not currently monitoring the temperature of the water. The dietary manager confirmed that the water temperature should be monitored to ensure the final rinse was within the acceptable parameters of sanitation.

In review of the facility's policy, "Sanitation and Safety," with the latest revision 12/3/2009, it was documented under Procedure #3-c: "The three compartment may be used to wash pots and pans. Hot water to a minimum of 171 degrees F (Fahrenheit) should be maintained in the third compartment."

In addition, there was a small refrigerator located in the hospital room 204, which was being used to store snack items/beverages for patients. There was no thermometer in the refrigerator and temperatures of the refrigerator were not being monitored. The dietary manager stated the temperatures should have been monitored on a regular basis to ensure proper food safety.

The facility's policy, "Sanitation and Safety" under Procedure 2 and 5 listed: #2 "Thermometers will be kept in refrigerators/freezers. Refrigerator temperature will be maintained at 40 F -32 F "
# 5 "Patient refrigerators temperatures at Hospital will be recorded daily by dietary staff."

Based on review of facility policies, quality assurance, governing board, medical staff documentation, and staff interview, it was determined the Governing Body of the Critical Access Hospital (CAH) failed to assume full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation.

The findings include: The Governing Body of the CAH failed to assume full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation for ensuring that policies were implemented to provide quality health care in a safe environment (Refer to C241).

Other related deficiencies can be reviewed under the Condition of Participation for Quality Assurance at C330.

The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to maintain an effective organizational structure therefore they were unable to meet this condition.

Based on staff interview and review of governing board bylaws and minutes, medical staff bylaws and meeting minutes and review of credential files, the critical access hospital (CAH) failed to ensure the governing body implemented and monitored policies governing the CAH's total operation in order to provide quality health care.

Findings include: The governing body failed to ensure that CAH policy had been administered, monitored and implemented under it's total operation in order to provide quality health care.

The governing board of the CAH failed to provide evidentiary documentation of current appointment to the medical staff for physician B (primary surgeon providing services), physician S, and for the primary certified registered nurse anesthetist (CRNA) in a timely manner in accordance with the established policies.

Review of the physician and CRNA credential files with the Health Information Manager/Quality Manager was conducted at 2:00 p.m.on 5/11/10. It was noted that physician B had been last approved by the medical staff on 8/17/09, however, the file lacked evidence the governing board had approved the re-appointment to the medical staff. The file for physician S lacked evidence of approval by the medical staff and by the governing board since 10/15/07 and 10/23/07 respectively. The credential file for the primary CRNA providing services in the CAH also lacked evidence of approval by the medical staff and of the governing board since 10/15/07 and 10/23/07, respectively.

Review of the By-Laws of the Medical Staff revealed the Reappointment process included:

4. The Medical Staff representative shall submit a report of recommendation of reappointment to the Medical Staff prior to the expiration of the applicant's current staff appointment period.
5. After receiving the report and recommendations, the Medical Staff at its next regular meeting shall recommend to the Governing Board that the reappointment be accepted, deferred, modified, or rejected.
6. The recommendations of the Medical Staff shall be transmitted to the Governing Board of the hospital by the Administrator.
7. The Governing Board shall either accept the recommendation of the Medical Staff or shall refer it back for consideration, stating the reasons for such action. In no case shall the Governing Board take action on a reapplication contrary to the recommendations of the Medical Staff, refuse to review a reappointment, or cancel an appointment previously made without conference with the Medical Staff.
8. When final action has been taken by the Governing Board, the Administrator of the hospital shall be authorized to transmit this decision in writing to the applicant

The HIM/QM staff was interviewed at 2:10 p.m.on 5/11/10, she confirmed the credential files for physician B and physician S , as well as the CRNA, lacked the appropriate documentation to confirm these providers had been reappointed to the medical staff as required by CAH policy.

The "Quality Improvement Plan" included the following: Each quality council and Professional Activities Committee (PAC) will provide the governing board with a report, prepared by the Quality Improvement Coordinator, of the relevant findings from all performance improvement activities at least on a quarterly basis. The Governing Board has the responsibility to review, approve and provide feedback to the Quality Council and PAC as appropriate. According to the "Quality Improvement Plan" the hospital medical staff "will engage in at least two (2) improvement projects annually that focus on critical areas of patient care in the hospital". Evidence that the medical staff had been engaged in at least two improvement projects that focused on critical areas of patient care was lacking in documentation.

Documentation of quality assurance meeting minutes revealed the only meetings held since 2009 were on the following dates: 1/12/09, 5/18/09 and 1/18/10. No quality control data of hospital wide patient care services had been discussed and/or reviewed by the quality assurance/performance improvement committee for the year 2010 as noted on 5/12/10. The meetings had not been conducted quarterly. The meeting minutes also failed to reflect evidence of at least three (3) interdisciplinary improvement projects annually as required by policy

The "Professional Activities Committee" (PAC) as required by medical staff bylaws dated 3/28/2000 stated: the PAC, as part of the organization-wide quality assurance program shall assume the responsibility for coordinating, reviewing and evaluating the functions most closely related to the provision of hospital medical care and assuring that appropriate action is taken when indicated. The duties of the PAC shall be to identify significant actual and potential problems and related concerns in the care of patients, assess and investigate such problems and concerns, and implement decisions or actions designed to eliminate such problems and concerns through appropriate departments, committee or other group. The Committee shall report to the Quality Management Committee. Monthly meetings of the Committee, not less than seven (7) in each calendar year, shall be held. Documentation of PAC meeting minutes provided since January 2008, revealed only six (6) documented PAC meetings 1/21/08 & 9/17/08, [2 meetings in 2008] 1/8/09 & 4/14/09, 12/21/09 [3 meetings in 2009] and 2/16/10 [1 meeting in 2010].

No further documentation of quality assurance/performance activity nor medical staff accountability to the Governing Board was made evident by the administrator as of 5/12/10.

Based on observation, inventory list review and staff interview, the Critical Access Hospital (CAH) failed to ensure that medications located in the emergency room and the CT scanner room were locked for safe storage.

Findings include: Unlocked medications were noted in the emergency room and the CT scanner room.

During observation at 9:20 a.m. on 5/11/10, the only medication storage cupboard located in the emergency room was not to have been left unlocked. A few of the medications noted on the shelves were: Levaquin, Zithromax/Z-Pak, Amoxil, Augmentin capsules, Doxycycline tabs and Duricef Suspension (antibiotics); Benadryl (antihistamine); Tamiflu (anti-viral); Medrol dose pack (corticosteroid); Indocin (anti-inflammatory); Flexeril (muscle relaxant); Narcan ampules (narcotic antagonist); Atropine injectable; and Epinephrine. The Director of Nurses (DNS) was present with the surveyor at the time and stated, "these should be locked".

During a tour of the CT scanner room at 11:20 a.m. on 5/10/10, and again at 11:38 a.m. on 5/11/10, the door to the CT scanner room remained unlocked. Staff were also not present in the area. Emergency medications were observed to have been unlocked and located in a cart in the room including: Solu-Cortel; Dopamine; Norepinephrine; Ranitidine; Benadryl, Aminophylline and Epinephrine. Interview with the radiology staff at 11:20 a.m. on 5/10/10 confirmed the door to this room was routinely locked "after" hours. However, it was confirmed the CT scanner door to the outside hall had not been routinely locked whenever a patient and/or staff were not in the room during business hours. It was also noted on 5/11/2010 at 11:38 a.m. that the door adjoining the X-ray room and the CT scanner room had been left partially open. It was observed there was easy access between the X-ray room and the CT scanner room. No staff were present in the hallway/area when the observation was noted. The medications on the cart in the CT scanner room were located on the wall adjacent to the shared toilet room between the X-ray and CT scanner rooms.

The DNS produced a list of the medications on the "ER Inventory List" and "CT drug Checklist". The list included the many medications noted to be unlocked. It was confirmed by the DNS at 9:25 a.m. on 5/11/10 that all emergency medications noted should have been secured when staff were not present in the area.

Based on review of infection control committee meeting minutes and staff interview the Critical Access Hospital (CAH) failed to assure the committee followed and implemented the established Infection Control Program policies.

Findings include: The infection control committee had not functioned according to the CAH's established policy.

During review of the infection control meeting minutes on 5/10/10 for the years 2008, 2009 and 2010 it was noted the meetings lacked any attendance by the administrator, activities and OR/CSR (Operating Room/Central Supply Room) staff. It was also noted the committee had failed to meet every other month as defined by policy. Dates of the meetings included 1/16/08, 7/16/08, 9/17/08, 11/19/08 [4 meetings in 2008], 8/19/09 [1 meeting in 2009], and 1/20/10 & 3/17/10 [2 meetings in 2010 as of 5/10/10].

The "Infection Control Program" policy indicated the following: A multidisciplinary Infection Control Committee is established to develop and implement the Infection Control Program. Membership on the Committee included representation from the following: administration; OR/CSR; Nursing services, Environmental services, laboratory, medical staff, activities, dietary and clinic. The committee meets every other month. Findings of the Committee and recommended action are reported in writing to the QI (Quality Improvement)committee, Medical staff and PAC (Professional Activities Committee). The CAH's "Organization Quality Improvement Plan" stated the hospital-wide organized services included all patient-care disciplines. The purpose of the quality council had been to focus on systematic monitoring and evaluations of the quality and appropriateness of patient care in the CAH, in efforts to improve patient care and identification and resolution of patient care problems. The plan listed infection control as part of these organized services. During interview with the Infection Control Officer (ICO) at 10:30 a.m. on 5/11/10, she confirmed she had not been involved in quality performance activities.

Upon further interview with the ICO at 10:30 a.m. on 5/11/10, it was verified the administrator and CSR/OR staff had not attended the meetings as required in policy. It was also confirmed that she had been new to the position since January 2009 and had not been aware that every other month meetings were required by policy and thus the rationale for the lack of meetings between 11/19/08 and 8/19/09 (9 months) and the lack of additional meetings until 1/20/10 (5 months later).

Also during interview at 10:30 a.m. on 5/11/10, the ICO indicated that she had been responsible for surveillance of staff infection control practices as well as the Director of Nursing and the Director of Laboratory, but that documentation was lacking to indicate the implementation of this practice. She confirmed the Committee had not implemented the duties as defined in policy since she had acquired the duties of the ICO in January 2009.

The CAH's Infection Control Program policy documented the duties of the Committee to include: ...(3) review and evaluate asepsis, isolation, and sanitation techniques and requirements to the facility;... (5) Evaluate materials used in sanitation program; (6) Consultation relative to equipment used for sterilization, disinfection, and decontamination; and ...(9) Provide a method of evaluating the effectiveness of the Infection Control Program. (Enclose documentation to support this). Evidence was lacking in the Committee meeting minutes to confirm the Committee had carried out their duties as defined.

Based on record review and staff interview, the Critical Access Hospital (CAH) failed to assure that physician progress notes had been dictated in a timely manner for 2 of 11 emergency progress notes (E1and E3) reviewed; and failed to assure the physician countersigned the progress note dictated by the mid-level [physician assistant (PA-C)] in a timely manner for 1 of 1 emergency progress note reviewed in which the PA-C had provided care (E6).

Findings include: Physician progress notes were missing in record E1, and progress notes in record E3 had not been dictated until 10 days after the patient had been seen for treatment in the emergency room.

During emergency record review it was noted the physician progress note was missing in the electronic record for patient E1. The 5 year old patient had been seen on 3/23/10 for a cough and cold symptoms. During interview with the Director of Nurses (DNS) at 2:00 p.m. on 5/10/10, she confirmed there was no physician progress notes for record E1 on the computer. It was also noted that a 77 year old patient had been seen in the emergency room for "increase in confusion, generally weak and seeing things" on 4/9/10. The physician progress note had not been dictated until 10 days later on 4/19/10. Interview with the Health Information Manager/Quality Manager staff at 1:45 p.m on 5/11/10, confirmed the late dictation and indicated it did not meet with the hospital's standard of practice.

Further review of emergency care provided by the PA-C on 4/9/10 indicated a 50 year old patient had presented to the emergency room with chest pain. The patient (E6) had subsequently been transferred from the CAH by air ambulance. There had been no physician counter signature for review of the progress note until 11:29 a.m. on 5/11/10, after the surveyor had queried the staff regarding the ongoing review of the mid-level's quality and appropriateness of treatment.

Based on record review and staff interview, the CAH failed to ensure that each medical entry by the physician included a timed signature for 3 of 11 emergency records reviewed (E2, E5 and E6), 5 of 20 inpatient records reviewed (I9, I10, I16, I17 and I18), and 6 of 6 surgical records reviewed (S1, S2, S3, S4, S5 and S6).

Findings include: Three emergency room patient records reviewed lacked signatures that included the time of the medical entry. The timed signature entry was lacking on the physician progress notes for patients E2, E5 and E6.

Upon interview with the Health Information Manager/Quality Manger at 1:45 p.m. on 5/11/10, it was verified that entries in the medical records reviewed lacked consistent authentication of the time the entry had been made by the author.


02980

Physician authentication of medical record entries lacked timed signatures in 5 of 20 inpatient records reviewed including records for I9, I10, I16, I17 and I18.

Physician authentication for Pre Operative Physician's Orders lacked timed signatures and/or lacked timed and dated signatures by the surgeon for 6 of 6 surgical records reviewed including S1, S2, S3, S4, S5, and S6.

Interview with the Health Information Manager on 5/12/10 at 12:30 P.M. confirmed that although proper authentication of medical records had improved, there remained a problem with timing and dating of entries as required.

Based on staff interview and review of documented surgical privileges for physicians, the facility failed to ensure that delineation of surgical privileges for the primary surgeon providing services in the CAH was available to the operating suite.

The findings include: the CAH lacked delineation of surgical privileges available to the operating suite for the primary surgeon, physician B.

During a tour of the operating room suite at 10:30 a.m. on 5/11/10, it was noted the Surgical Privilege Roster book available in the Central Supply Room (CSR) lacked the deliniation of privileges for physician B. Interview with the Operating Room Coordinator and the CSR supervisor at that time confirmed the roster lacked the required delineation of privileges for physician B.

A copy of the delineation of surgical privileges for physician B was later provided to the surveyor by the Health Information Manager/ Quality Manager (HIM/QM) at 1:00 p.m. on 5/11/10. The form " Surgical Privileges" for physician B indicated the "Appointment Date" for physician B had been 12/10/02. Interview with the HIM/QM staff was conducted at 1:00 p.m. on 5/11/10. The HIM/QM staff stated during interview that physician B had not changed any of his surgical privileges since 2002. It was confirmed, however, the delineation of privileges form should have been available to the OR suite, and should have been updated every 2 years when the physician was re-appointed to the medical staff.

Based on staff interview and record review, the CAH failed to ensure that a proper anesthesia recovery evaluation had been conducted by a qualified practitioner prior to discharge from the CAH for 6 of 6 surgical records reviewed (S1, S2, S3, S4, S5 and S6).

The findings include: The certified registered nurse anesthetist (CRNA) did not provide documentation of a thorough post anesthesia evaluation for 6 surgical patients whose records were reviewed.

The CRNA documented post anesthesia notes which lacked any reference to assessment of the cardiopulmonary status of the patients following recovery from anesthesia in the following patient records: S1 admitted on 12/17/09 for a total abdominal hysterectomy; S2 admitted on 2/18/10 for a cholecystectomy; S3 admitted on 4/29/10 for hernia repair; S4 admitted on 4/29/10 for cholecystectomy; S5 admitted on 4/29/10 for hernia repair; and S6 admitted on 2/18/10 for Cesarean Section. Review of the Anesthesia Records for each of these 6 patient records revealed the Post Anesthesia Comment had been documented by the CRNA, "Review indicates no post anesthesia complications." No further documentation was evident to indicate an assessment of the patient's cardiopulmonary status had been conducted.

Interview with the Director of Nurses and the Operating Room Coordinator at 11:00 a.m.on 5/12/10 confirmed the lack of documentation by the CRNA of a thorough post anesthesia evaluation for the 6 surgical patient records reviewed.

Based on review of facility policies, quality assurance documentation and interview it was determined the Critical Access Hospital (CAH) failed to ensure periodic evaluation and Quality review of their services. The findings include:

The CAH failed to conduct an annual evaluation of the its total program (Refer to C331).

The CAH failed to conduct evaluate the utilization of service, including at least the number of patients and the volume of services (Refer to C332).

The CAH failed to evaluate its health care policies (Refer to C334).

The CAH failed to evaluate the appropriateness of services provided to patients (Refer to C335).

The CAH failed to have an effective quality assurance plan to evaluate the quality and appropriateness of diagnosis and treatment (Refer to C336).

The CAH failed to evaluate all patient care (Refer to C337).

The CAH failed to evaluate nosocomial infections and medication therapy (Refer to C338).

The CAH failed to integrate the review of the mid-level practitioner by the medical staff into the quality assurance plan (Refer to C339).

The CAH failed to take appropriate remedial action to address deficiencies (Refer to C342).

The CAH failed to document the outcome of all remedial action (Refer to C343).

The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to maintain effective quality assurance processes in order to ensure provision of quality health care. Therefore, the CAH was unable to meet this condition.

Based on policy review, governing board meeting minutes, annual evaluation review and staff interview the Critical Access Hospital (CAH) failed to conduct an annual evaluation of the its total program at least once a year.

Findings include: Documentation was lacking to indicate an annual review of the CAH's total program had been conducted. Interview with the Health Information (HIM)/Quality (QA) Manager at 10:45 a.m. on 5/11/10 confirmed the facility had not conducted an annual evaluation of its total program since 1/12/09 (15 months prior). It was verified the total program evaluation had been overdue. It was further learned through review of the governing board meeting minutes with the HIM/QA manager at 10:15 a.m. on 5/12/10 that the last documentation of the total program annual CAH review by the governing body had been dated 4/14/08 (2 years prior). The facility's policy was reviewed at that time as well and confirmed the facility was to conduct an annual evaluation of its total program.

Based on program evaluation review and staff interview, the Critical Access Hospital (CAH)failed to conduct an evaluation at least once a year that included a review of the utilization of CAH services.

Findings include: The CAH failed to conduct an annual evaluation of its total program which included a review of the utilization of CAH services.

Documentation was lacking to indicate an annual review of the CAH's total program had been conducted when meeting minutes were reviewed. Interview with the Health Information Manager/Quality Manager at 10:45 a.m. on 5/11/10 confirmed the CAH had not conducted an annual evaluation of its total program since 1/12/09, which included a review of the utilization of CAH services. It was verified the total program evaluation was overdue (15 months ago) and should have included the number of patients served and volume of services.

Based on total program review documentation, staff interview and review of committee meetings, the Critical Access Hospital (CAH) failed to review the CAH's health care policies as part of the annual evaluation.

Findings include: During review of meeting minutes it was noted the last review of patient care policies had been conducted on February 9, 2009 (15 months prior). Interview with the Health Information Manager/Quality Manager at 10:45 a.m. on 5/11/10 confirmed the facility had not conducted an annual evaluation of its total program since 1/12/09 which included the CAH's health care policies. The HIM/QA manager confirmed the total program evaluation was overdue. Review of the QA/PI (quality assurance/performance improvement) meeting minutes dated 1/18/10 included: "The CAH Program Review Committee stills needs to meet for 2008-2009".

Based on documentation of meeting minutes and staff interview, the Critical Access Hospital (CAH) had not determined the appropriateness of the services offered nor whether health care policies were appropriate.

Findings include: Documentation was lacking to indicate an evaluation had been conducted to determine whether the utilization of services was appropriate, whether policies were followed & whether any changes were needed.

Although the CAH did trend the utilization of services monthly, it had not evaluated the appropriateness of delivery of services being offered as part of the total program. Interview with the Health Information Manager/Quality Manager at 10:45 a.m. on 5/11/10 confirmed the CAH had not evaluated the appropriateness of delivery of services being offered as part of the total program evaluation. It was verified the most recent annual evaluation of its total program had been dated 1/12/09 (15 months prior). It was verified the total program evaluation was overdue.

Based on review of quality assurance meeting minutes, governing board meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to have an effective program that evaluated the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes so that corrective actions could be evaluated, and measures implemented, to improve quality on a continuous basis.

Findings include: It was noted during review of the quality assurance plan that although all patient services were to be evaluated, the CAH had not evaluated the services provided by the contracted services, ambulance and anesthesia. In addition, the quality assurance plan failed to address how the care furnished by the mid-level was to be integrated into the process.

Interview with the Health Information Manager/Quality Manager (HIM/QM) at 10:45 a.m. on 5/11/10 confirmed the quality assurance process had not been all inclusive. Further interview with the HIM/QM at 10:15 a.m. on 5/12/10 confirmed the quality council was to report performance improvement activities at least quarterly to the governing body. During review of the governing board minutes with the HIM/QM at 10:15 a.m. on 5/12/10, regarding the reporting of quality council activity, the only documentation evident included the dates 1/8/09, 4/14/09 and 3/24/10.

The CAH's "Organizational Quality Improvement Plan" indicated the following responsibilities: ... (3) frequency of meetings: at least quarterly. (4) Scope: Hospital wide organized services, including all patient-care disciplines- Nursing Services, Discharge Planning/Social Services, Anesthesia Services, Emergency Department, Surgical Services, Laboratory Services, Radiology Services, Admissions, Health Information, Dietetic Services, Maintenance/Engineering Services, Laundry Housekeeping, Business Office, Audiology, Home Health Contracted Services, Occupational Therapy and Infection Control. ...(6) Improvement Projects: The Hospital will complete a minimum of three (3) interdisciplinary improvement projects annually. One of these projects will be a Patient Satisfaction Survey. The hospital medical staff will engage in at least two (2) improvement projects annually that focus on critical areas of patient care in the hospital.

During review of the CAH "Quality Improvement Reporting Calendar" the following schedule was noted: Governing Board Report-quarterly; Hospital QI-four times a year; and Community Committee Meeting-Policy Review; and Department Reports-reports due in writing by 15th of month to Quality Manger Coordinator summarizing previous two months' activities, findings and actions.

During interview with the Infection Control Officer (ICO) at 10:30 a.m. on 5/11/10, she confirmed she had not been involved in quality performance activities. Documentation of quality assurance meeting minutes revealed the only meetings held since 2009 were on the following dates: 1/12/09, 5/18/09 and 1/18/10. No quality control data of hospital wide patient care services had been discussed and/or reviewed by the quality assurance/performance improvement committee for the year 2010 at the time of review on 5/12/10. These meeting had not been conducted quarterly. The meeting minutes also failed to reflect evidence of at least three (3) interdisciplinary improvement projects annually as required by policy. Evidence that the medical staff had been engaged in at least two improvement projects that focused on critical areas of patient care was lacking in documentation.

The Quality Improvement Plan also included the following: Each quality council and Professional Activities Committee (PAC) will provide the governing board with a report, prepared by the Quality Improvement Coordinator, of the relevant findings from all performance improvement activities at least on a quarterly basis. The Governing Board has the responsibility to review, approve and provide feedback to the Quality Council and PAC as appropriate.

The "Professional Activities Committee" (PAC) as required by medical staff bylaws dated 3/28/2000 stated: the PAC, as part of the organization-wide quality assurance program shall assume the responsibility for coordinating, reviewing and evaluating the functions most closely related to the provision of hospital medical care and assuring that appropriate action is taken when indicated. The duties of the PAC shall be to identify significant actual and potential problems and related concerns in the care of patients, assess and investigate such problems and concerns, and implement decisions or actions designed to eliminate such problems and concerns through appropriate departments, committee or other group. The Committee shall report to the Quality Management Committee. Monthly meetings of the Committee, not less than seven (7) in each calendar year, shall be held. Documentation of PAC meeting minutes provided since January 2008, revealed only six (6) documented PAC meetings; 1/21/08 and 9/17/08, [2 meetings in 2008] 1/8/09, 4/14/09 and 12/21/09 [3 meetings in 2009] and 2/16/10 [1 meeting in 2010].

Interview with the HIM/QM at 11:30 a.m. on 5/12/10, confirmed the current quality assurance/performance improvement plan had not been implemented consistently within the CAH.

Based on review of quality assurance meeting minutes, governing board meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to have an effective program that evaluated all patient care services.

Findings include: It was noted during review of the quality assurance plan that although all patient services were to be evaluated, the CAH had not evaluated the services provided by the contracted services of ambulance and anesthesia.

During interview with the Health Information Manager/Quality Assurance director at 10:45 a.m. on 5/11/10, she confirmed the quality assurance process had not been all inclusive. Further interview with the HIM/QA director at 10:15 a.m. on 5/12/10, confirmed the quality council was to report performance improvement activities at least quarterly to the governing body. Review of the governing board minutes with the HIM/QM at 10:15 a.m. on 5/12/10, regarding the reporting of the quality council activity, the only documentation evident included the dates 1/8/09, 4/14/09 and 3/24/10.

The Quality Improvement Plan also included the following: Each quality council and Professional Activities Committee (PAC) will provide the governing board with a report, prepared by the Quality Improvement Coordinator, of the relevant findings from all performance improvement activities at least on a quarterly basis. The Governing Board has the responsibility to review, approve and provide feedback to the Quality Council and PAC as appropriate.

The CAH's "Organizational Quality Improvement Plan" indicated the following responsibilities:... (4) Scope: Hospital wide organized services, including all patient-care disciplines- Nursing Services, Discharge Planning/Social Services, Anesthesia Services, Emergency Department, Surgical Services, Laboratory Services, Radiology Services, Admissions, Health Information, Dietetic Services, Maintenance/Engineering Services, Laundry Housekeeping, Business Office, Audiology, Home Health Contracted Services, Occupational Therapy and Infection Control. ... (6) Improvement Projects: The Hospital will complete a minimum of three (3) interdisciplinary improvement projects annually. One of these projects will be a Patient Satisfaction Survey. The hospital medical staff will engage in at least two (2) improvement projects annually that focus on critical areas of patient care in the hospital. The meeting minutes failed to reflect evidence of at least three (3) interdisciplinary improvement projects annually as required by policy. Evidence that the medical staff had been engaged in at least two improvement projects that focused on critical areas of patient care was also lacking in documentation.

Although the Infection Control meeting minutes had been forwarded to the quality council, documentation in the quality assurance meeting minutes failed to reflect any review and/or analysis of the data submitted.

During interview with the Infection Control Officer (ICO) at 10:30 a.m. on 5/11/10, she confirmed she had not been involved in quality performance activities. No quality control data of hospital wide patient care services had been discussed and/or reviewed by the quality assurance/performance improvement committee for the year 2010 as noted on 5/12/10.

During interview with the Director of Nurses at 11:00 a.m. on 5/12/10, she confirmed she had not submitted nursing quality improvement activity yet in 2010. The OR coordinator confirmed also at this time that she had not submitted ongoing activity either. They both indicated they had developed a plan for quality activity for 2010 but had not yet implemented their plans as of 5/12/10.

Based on review of committee meeting minutes and staff interview the Critical Access Hospital (CAH) failed to evaluate medication therapy utilized for nosocomial infections.

Findings include: Medication therapy had not been evaluated as part of the quality assurance program. It was noted during review of the quality assurance meeting minutes that discussion was lacking related to medication therapy and evaluation of nosocomial infections.

Review of the infection control meeting minutes lacked mention of any analysis of medication therapy in relation to infections. Interview with the Infection Control Officer (ICO) at 10:30 a.m on 5/11/10 confirmed she had not been involved in quality performance activities.

Based on review of quality assurance committee minutes and staff interview, the Critical Access Hospital (CAH) failed to assure the quality and appropriateness of the diagnosis and treatment furnished by the physician assistant (PA-C) had been evaluated by a member of the CAH staff who is a doctor of medicine.

Findings include: The quality and appropriateness of the diagnosis and treatment furnished by the physician assistant (PA-C) had not been integrated into the quality assurance process.

It was noted during review of documentation of peer review regarding appropriateness of diagnosis and treatment furnished by the physician, that documentation was lacking to indicate the physician assistant (PA-C) had been included in the process.

Upon interview with the Health Information Manager/ Quality Manager at 1:45 p.m. on 5/11/10, it was learned that the only review of the PA-C had been a countersignature by the supervising physician. Information regarding the quality of diagnosis and treatment had not been integrated as part of the quality improvement process.

Review of emergency care provided by the PA-C on 4/9/10 indicated a 50 yr. patient had presented in the emergency room with chest pain. The patient (E6) subsequently had been transferred from the CAH by air ambulance. The physician had not countersigned the review of the progress note until 11:29 a.m. on 5/11/10, after the surveyor had queried staff regarding the ongoing review of the mid-level quality and appropriateness of treatment.

Based on record review, quality assurance committee minutes review, emergency room record review and staff interview, the CAH failed to take appropriate remedial action to address deficiencies found through the quality assurance program.

Findings include: The CAH failed to document remedial action to address deficiencies found through quality control audits. Review of ER (emergency room) documentation revealed that physician response times had been an ongoing problem (greater than 30 minutes). During record review it was noted the following emergency response times by the physician were greater than 30 minutes:

Record # Date of Service Time physician called: arrived
E1 3/23/10 1920-2000 40 minutes
E2 1/2/10 1840-2000 1 hour 20 minutes
E3 4/9/10 2210-2245 35 minutes
E5 4/24/10 0345-0430 45 minutes
E4 2/26/10 0220-0315 55 minutes

During interview with the Health Information Manager/Quality Manager (HIM/QM) at 1:45 p.m. on 5/11/10, she confirmed she had been aware of the problem with physician response times. She indicated the facility had tracked the call time and arrival time of the physician in the ER and confirmed with documentation on a spread sheet that this had been an ongoing concern.

During additional interview with the HIM/QM at 10:25 a.m. on 5/12/10, she confirmed the pysician response time problem had not been documented as part of the discussion within either the quality council or the medical staff so that remedial action could be taken. It was further verified that remedial action could not be taken for all patient areas since quality control data had not been consistently generated by each patient care department by identification and collection of patient care problems.

Based on review of quality council meeting, medical staff meeting minutes, and staff interview the CAH failed to document the outcome of all remedial action.

Findings include: Documentation was lacking in quality council meeting minutes to confirm the outcome of all remedial action had occurred. During record review it was noted that emergency response times by the physician were greater than 30 minutes for emergecny room patients E1, E2, E3, E4 and E5. Response times had varied from 35 minutes to 1 hour 20 minutes for these patients.

During interview with the Health Information Manager/Quality Manager (HIM/QM) at 1:45 p.m on 5/11/10, she confirmed she had been aware of the problem with physician response times. She indicated the facility had tracked the call time and arrival time of the physician in ER and confirmed with documentation on a spread sheet that this had been an ongoing concern.

During further interview with the HIM/QM at 10:25 a.m. on 5/12/10, she confirmed the problem with physician response in the emergency room had not been documented as part of the discussion within either the quality council or the medical staff so that remedial action could be taken.

The Infection Control Officer was interviewed at 10:30 a.m. on 5/11/10. She verified that she had been responsible for surveillance of staff infection control practices as well as the Director of Nursing and the Director of Laboratory, but that documentation was lacking to indicate the implementation of this practice. The facility staff were unable to provide any additional evidence of documentation of quality assurance/performance improvement activities as of 5/12/10.