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6847 N CHESTNUT

RAVENNA, OH 44266

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on medical record review and facility staff interview it was determined the facility failed to obtain consent for video recording. This deficient practice affected two (#42 and #43) of two patient records reviewed with the potential to affect all patients receiving sleep studies.

Findings include:

Review of the outpatient records of Patient #42 who received sleep studies on 12/21/13 and Patient #43 who received sleep studies on 01/10/14 revealed no documentation of consent by the patients for video recording during the testing procedure.

During interview with Staff H at 7:30 A.M. on 02/05/14 it was verified that all patients undergoing the sleep studies are under video surveillance for the duration of the testing. Staff H also verified the consent for treatment utilized by the department is the general consent for treatment used by the hospital. Review of the consent form noted the document failed to address the use of video recording equipment during the procedure. Review of the educational materials provided to the patients by the facility also failed to describe the procedure or note the utilization of the video recording equipment.

Staff H stated the patients are informed of the aspects of the procedure by the technician as they are having the electrodes (wires that trace different body responses) applied. Review of the technician notes, however, failed to show evidence this information was provided to Patients #42 and #43. At 7:35 A.M. on 02/05/14 Staff H verified all findings and confirmed that written consent has not been obtained for the utilization of video monitoring equipment.

MEDICAL STAFF BYLAWS

Tag No.: A0353

Based on review of facility documentation and staff interview the hospital failed to abide by it's own medical staff bylaws as it relates to physician suspension for delinquent medical records. This has the potential to affect all patients of the hospital. The current census at the time of the survey was 67.

Findings include:

Review of the hospital delinquent medical records report was completed on 02/06/14. The report indicated as of 02/04/14, the hospital had 631 medical records that were greater than 30 days delinquent. The report indicated the delinquencies dated back to August 1, 2013 forward.

Review of the hospital medical staff bylaws was completed on 02/06/14. The bylaws indicate a medical record that lacks practitioner signature on any progress note, orders or discharge summary greater than 30 days after discharge is considered delinquent. Practitioners with delinquent medical records will be notified by the president of the hospital and the president of the medical staff of the automatic suspension of their hospital privileges.

Interview with Staff N on 02/06/14 at 12:00 PM revealed the last time a practitioner of the hospital was suspended for delinquent medical records was 01/16/09.

The above findings were confirmed with Staff O on 02/06/14 at 2:15 PM.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on medical record review, interview and policy review, the hospital failed to ensure drugs were administered per physician orders for one (Patient #8 ) of 30 medical records reviewed. This had the potential to affect all patients. The hospital's active census at the time of the survey was 67.

Findings include:

1. The medical record review for Patient #8 was completed on 02/03/14. On 01/29/14 at 12:09 AM, a physician ordered Albuterol nebulizer (used to prevent and treat wheezing, shortness of breath, coughing, and chest tightness) treatments every four hours. The medical record contained evidence the patient received the ordered treatment at 6:00 AM on 02/02/14. Patient #8 received the next dose of the ordered Albuterol on 02/02/14 at 1:00 PM. The record did not contain documentation stating the reason the Albuterol was administered seven hours after the 6:00 AM dose. On 2/3/14 at 3:30 PM, the findings were shared with Staff J and confirmed.

On 2/1/14 at 2:08 PM, the hospital's General Medication Guidelines policy was reviewed. The policy stated medications are considered on schedule if administered one hour before or after the prescribed time.






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MEDICAL RECORD SERVICES

Tag No.: A0431

Based on observation, staff interview, review of facility documentation, review of policies and medical staff bylaws, the facility failed to ensure the medical records were completed timely and the integrity and retention of medical records were protected (A438). The cumulative effect of these systemic practices resulted in the facility's inability to ensure that the patient medical records were complete and free from potential water damage. The current patient census was 67.

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on observation, review of facility documentation, review of policy and medical bylaws and staff interview, the facility failed to ensure prompt completion of medical records and failed to protect medical records and xray films from potential water damage. This has the potential to affect all patients of the hospital. The facility's active census was 67.

Findings include:

1. Review of the hospital delinquent medical records report was completed on 02/06/14. The report was from 08/01/13 through 01/04/14 and was printed on 02/05/14. This report revealed the hospital had 631 patient charts missing physician signatures greater than 30 days. The policy on Tracking and Reporting of Incomplete Medical Records, effective on September of 2011 and revised on January of 2014, specified on day 30, an incomplete record shall be considered delinquent. Failure to complete accessible charts within this time frame will initiate automatic suspension according to Article IX, Section 10.4.1 of the Medical Staff ByLaws.

Review of the hospital medical staff bylaws was completed on 02/06/14. The bylaws indicated a medical record that lacks practitioner signature on any progress note, orders or discharge summary greater than 30 days after discharge was considered delinquent. Practitioners with delinquent medical records will be notified by the president of the hospital and the president of the medical staff of the automatic suspension of their hospital privileges.

Interview with Staff N on 02/06/14 at 12:00 PM revealed the last time a practitioner of the hospital was suspended for delinquent medical records was 01/16/09.

2. During a tour of medical records department on 02/05/14 at 2:00 PM, medical records were filed on open rolling shelves. Sprinkler heads were observed on the ceiling over the medical records. During the tour, Staff G indicated the medical records filed on the shelves had not been scanned and there were no plans to scan these files. Staff G revealed there were five sprinkler heads on the ceiling above the medical record files. These medical record files were from 2010 through 2013. Staff G confirmed the medical records would have water damage if the sprinklers were activated.



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3. A tour of the Radiology Department on 02/06/14 at 9:30 AM revealed 13,870 mamogram films stored on open shelves under a ceiling with sprinklers. The Director of Radiology on 02/06/14 at 9:40 AM confirmed the mammogram films must be kept in original condition.

4. A tour of the Pain Management Depatment on 02/04/14 revealed two open shelves of patient records, waiting for the physician to finish and some waiting to be faxed, in a physician's office exposed to sprinklers. The Clinical Coordinator confirmed on 02/04/14 at 3:20 PM these patient records were not protected from water damage.

RECORDS FOR RADIOLOGIC SERVICES

Tag No.: A0553

Based on observation and staff interview the facility failed to ensure the x-ray films were protected from potential water damage. This could potentially affect all patients with radiologic services. The census was 67.

Findings include:

A tour of the Radiology Department on 02/06/14 at 9:30 AM revealed 13,870 mammogram films and other types of x-ray films stored on open shelves under a ceiling with sprinklers. The Director of Radiology on 02/06/14 at 9:40 AM confirmed the mammogram films must be kept in original condition.

ADEQUACY OF LABORATORY SERVICES

Tag No.: A0582

Based on observation, staff interview and review of policies, temperature logs, problem log book, refrigerator manual and manufacturers directions for use the facility failed to ensure lab supplies were stored within a safe temperature range. This affected one of one refrigerator observed with media cards. This could potentially affect all patients. The census was 67.

Findings include:

During tour of the Microbiology lab on 02/04/14 at 11:10 AM with the Medical Technician (Staff C) observation was made of a refrigerator containing Media cards for Identification and Sensitivity testing (used to identify organism and find antibiotics sensitive to it). A digital temperature reading of 7.4 degrees Celsius (C) was observed on top of the closed refridgerator.


Interview with Staff B, the Director of the Lab, on 02/04/14 at 11:45 AM revealed the alarm was on and indicated if the temperature was out of range it would alarm, however, at 12 :08 PM Staff B stated the refrigerator alarm was set at the factory pre-set temperature of 16 degrees C and Staff B stated he/she re-set the alarm between 2 -8 degrees C.


Attached to the outside door of the refridgerator by velcro was a thermometer (identified as certified thermometer) with a connected temperature probe that sat inside the refridgerator which read 9.4 degrees C. The expiration date on the thermometer was 10/13/13.

Staff C stated at 11:20 AM temperature readings are recorded on the log from the second thermometer identifed as a "certified" thermometer. Staff C stated the two temperature readings never match.

A review of the Manufacturer Directions for Use (MDFU) for the Media cards inside this refrigerator indicate the cards are to be stored between 2 and 8 degrees C.

A review of the temperature log form dated 01/01/14 to 02/04/14 revealed all temperature readings were documented between 9.1 - 9.8 degrees C or above the recommended range of 2 - 8 degrees C pre-printed on the top of the log sheet under the column labeled Media.

Staff C, the technician, stated on 02/04/14 at 11:25 AM, "That is what the temperature has always been."

Interview with the Director of the Lab (Staff B) on 02/04/14 at 11: 27 AM stated that "Certified thermometers" are used.

Staff B was asked who monitors the expiration date on the external thermometer (this one expired 10/13/13). Staff B stated, "I assume every area checks their own" and did not know who in the lab was assigned to monitor them.

A review of the Thermometer Quality Assurance Checks policy revealed, all certified thermometers should be recalibrated, recertified or replaced prior to the expiration date of the guarantee of calibration.

Staff C stated on 02/04/14 at 11:30 AM any problems with the temperatures or equipment in the lab would be documented in the Problem Log Book. A review of the Problem Log Book revealed no documentation of any problems with this refrigerator, confirmed by Staff B and C on 02/04/14 at 11:34 AM.

A review of the policy entitled Monitoring of Temperature Controlled Areas on 02/04/14 revealed refrigerator temperatures should be within 2 to 6 degrees C. If the refrigerator temperature exceeds the acceptable limits, appropriate corrective action must be taken immediately. Recheck the temperature in 15 minutes. If the temperature falls outside the acceptable range a second time, all items must be removed and evaluated for possible adverse effects. Engineering and/or supervisory staff will be notified. All corrective action must be documented in the Problem Log Book.


The Director of the Lab (Staff B) on 02/04/14 at 11:55 AM confirmed the temperatures for this refrigerator that contained Media were documented out of safe range, as directed by the MDFU for the product inside, for the past five weeks and confirmed no documentation of any follow up action taken per policy. Staff B also confirmed the lab staff did not monitor or check the expiration date or batteries in the "certified" external thermometer and did not know how to reset the alarm for the temperature on this refrigerator that was used in the lab for over a year.

QUALIFIED DIETITIAN

Tag No.: A0621

Based on record review, review of policy and staff interview, the facility failed to ensure the dietitian and the medical staff collaborated to ensure the patient's nutritional needs were met. This affected one (Patient #15) of one medical records reviewed for patient receiving tube feedings. A total of 25 patient medical records were reviewed. The current census was 67.

Findings include:

Patient #15 was admitted on 01/16/14 with diagnoses including pneumonia and hypoxia. Review of the medical record for Patient #15, on 02/03/14, revealed the patient was receiving tube feeding at the rate of 45 cubic centimeters (cc) per hour. On 01/18/14 at 1:02 PM, the dietitian evaluated Patient #15's nutritional needs and recommended tube feeding at 40 cc per hour, if tube feeding was required for Patient #15.

Review of the physician orders revealed Patient #15 was ordered on tube feeding at 45 cc per hour on 01/19/14. On 01/20/14 at 3:11 PM, the dietitian recommended to decrease rate of tube feeding to 40 cc per hour to provide 1440 kilocalories, 79 grams of protein to meet 100% of the patient's calorie and protein needs. Further review of physician's orders revealed the rate of tube feeding was increased to 50 cc per hour on 01/22/14. On 01/25/14 at 1:48 PM, the dietitian again recommended to decrease tube feeding to 40 cc per hour. On 01/29/14, the physician ordered to decrease tube feeding rate to 45 cc per hour.

Review of the record revealed no indication the physician had reviewed the dietitian's nutritional recommendations.

Review of the facility's policy on Nutritional Assessment indicated the clinical dietitian will assess patients who are potentially at high risk, which included patients with tube feedings. The purpose was to provide information for use by medical staff and nursing to plan for nutritional care of patient.


On 02/03/14 at 1:30 PM, Staff E indicated the dietitian's nutritional recommendations were on the electronic record. Staff E confirmed the physicians had not been transitioned to electronic documentation. No additional information was provided that the physician reviewed the dietitian's recommendations.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on observation of the facility, review of facility documentation and staff interview and verification, the facility failed to ensure the environment was maintained in a manner safe from fire. The facility failed to ensure the corridors were separated from use areas by walls constructed with at least ½ hour fire resistance rating, that smoke barriers were constructed to provide at least a one half hour fire resistance rating in accordance with 8.3., smoke doors in two smoke compartments on the first floor properly closed, that one hour fire rated construction (with ¾ hour fire-rated doors) or an approved automatic fire extinguishing system in accordance with 8.4.1 and/or 19.3.5.4 protected hazardous areas.
When the approved automatic fire extinguishing system option was used, the areas were to be separated from other spaces by smoke resisting partitions and doors. The facility failed to ensure doors were self-closing, that all required smoke detectors were maintained, inspected and tested in accordance with the manufacturer's specifications and that fire and smoke dampers complied with the provisions of NFPA 90A with regards to testing. (A710) The cumulative effect of these systemic practices resulted in the facility's inability to ensure patient safety.

LIFE SAFETY FROM FIRE

Tag No.: A0710

Based on review of facility documentation, facility observation and staff interview and verification, it was determined the facility failed to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association. The facility had a capacity of 302 patient beds with a census of 67 patients at the time of the survey completed on 02/06/14. Potentially all patients, visitors and staff could be affected.

Findings include:

On 02/03/14 through 02/06/14, review of facility documentation and tour of the facility was conducted with facility staff present. The following findings were noted during the life safety code survey completed on 02/06/14:

The facility failed to ensure that corridors were separated from use areas by walls constructed with at least ½ hour fire resistance rating. Please refer to life safety code survey for further detail at (K17).

The facility failed to ensure that smoke barriers were constructed to provide at least a one half hour fire resistance rating in accordance with 8.3. Please refer to life safety code survey for further detail at (K25).

The facility failed to maintain the smoke doors in two smoke compartments on the first floor. Please refer to life safety code survey for further detail at (K27).

The facility failed to ensure that one hour fire rated construction (with ¾ hour fire-rated doors) or an approved automatic fire extinguishing system in accordance with 8.4.1 and/or 19.3.5.4 protected hazardous areas. When the approved automatic fire extinguishing system option was used, the areas were to be separated from other spaces by smoke resisting partitions and doors. Doors were to be self-closing .Please refer to life safety code survey for further detail at (K29).

The facility failed to ensure all required smoke detectors were maintained, inspected and tested in accordance with the manufacturer's specifications. Please refer to life safety code survey for further detail at (K54).

The facility failed to ensure that fire and smoke dampers complied with the provisions of NFPA 90A with regards to testing. Please refer to life safety code survey for further detail at (K67).

No Description Available

Tag No.: A1045

Based on observation and staff interview the hospital failed to maintain the equipment in a safe and clean condition. This could potentially affect all patients with radiology services. The patient census was 67.

Findings include:

The Director of Radiology and Nuclear Medication (Staff F) confirmed on 02/06/14 at 9:40 AM dirty tape was left on the machine bed of a clean x-ray room.

Staff F also confirmed at 10:12 AM a vinyl knee pad (used to position patients) had three pieces of dirty tape left on it and a larger piece of dirty tape was on the bed. Staff F confirmed this room ( CAT Scan Room #2) had been cleaned and was ready for use.