HospitalInspections.org

Based on an inspection of six separate stocks of medication samples: (ipratropium/albuterol vials for inhalation via a nebulizer device supplied in COPD [lung disease] Starter Kits, one supply of Advair Diskus, two supplies of Dexilant, and two supplies of Crestor all of which samples were intended for free distribution) stored in the medication storage areas of the Rural Health Clinic Children and Adult Services (RHCCA), inspection of medication sample log sheets (used to log in and track donated medication samples to a charitable institution that are not intended for resale but for free distribution to patients of the clinic), and staff interview, the facility failed to maintain accurate records sufficient for complete accountability and auditing of drug sample stocks as required by Title 21 Code of Federal Regulations Section 203.39(f) for all six of these stocks. One such supply (the ipratropium/albuterol for inhalation) had been out dated for two months at the time of survey and staff was not able to determine who had received these medications with the potential that patients who may have received expired medications could not be contacted and so informed that the medication was expired. Ipratropium/albuterol is inhaled and used to treat shortness of breath associated with COPD. Advair Diskus contains powder that is inhaled and used to treat asthma. Dexilant is used to reduce excess stomach acid that could result in symptoms of heartburn and damage to the esophagus. Crestor decreases high cholesterol blood levels. These failures had the potential to result in adverse health effects.

Findings:

1. Title 21 Code of Federal Regulations Section 203.39 provides for "Donation of drug samples to charitable institutions." Paragraph (f) of that regulation stipulates: "Each recipient charitable institution shall maintain complete and accurate records of donation, receipt, inspection, inventory, dispensing, redistribution, destruction, and returns sufficient for complete accountability and auditing of drug sample stocks." A charitable institution is defined at Title 21 Code of Federal Regulations Section 203.3(f) as "...a nonprofit hospital ...that has been granted an exemption under section 501(c)(3) of the Internal Revenue Code of 1954, as amended."

On 2/28/13 at 9:16 am during an interview of Administrative Staff Z, she produced a letter from the Internal Revenue Service (IRS) dated May 30, 2007. A review of this letter at that time indicated the letter documented that the IRS considered the hospital to be a charitable institution under Section 501(c)(3) of the IRS code.

On 2/27/13 at 3:12 pm an inspection of the medication storage area in the RHCCA indicated that staff had stored six boxes labeled as "COPD Care Program. Patient First Dose Nebulizer Kit" (COPD First Dose Kits) in this area. The surveyor observed the Director of Pharmacy inspecting these boxes at that time and the surveyor observed sealed foil packages on the floor next to these boxes. Inspection of the sealed foil packages indicated there were 12 of them and the label of each package indicated it contained five 3 milliliter (ml) vials of ipratropium 0.5 milligrams (mg) and albuterol 3 mg. All of them had been labeled by the manufacturer with an expiration date of 11/12 so these had expired 2 months prior to the survey. During a concurrent interview of the Director of Pharmacy, he stated he was unaware that the kits contained medication until that time.

Inspection of the labeling on the side of the kits, at that time, indicated the manufacturer had printed "Enclosed Kit includes: combination of albuterol sulfate, ipratropium bromide" on the side of the COPD First Dose Kit boxes.

Inspection of the drug storage area indicated that staff maintained sheets of paper in a three ring binder and the sheets were titled COMPLIMENTARY SAMPLES OF DANGEROUS DRUGS LOGBOOK. The log provided prompts for the clinic staff to fill in the lot number (of the medication), expiration date (of the medication), date (clinic received the medication) name of medication received, the number of tablets (per box [or doses per container] of medication, the number of boxes (of medication) received, the name of the manufacturer, the name of the company representative, the name of the receiving physician, the date of dispensing to a clinic patient, the patient' s name, and the number of boxes dispensed (to the patient). An inspection of the drug sample logs indicated that these COPD First Dose Kits did not appear on the sample logs.

During an interview of Staff Nurse X on 2/27/13 at 3:18 pm in the RHCCA, she identified the COPD First Dose Kits as samples provided by the manufacturer. She stated that she would not log these kits onto the drug sample logs unless they were or contained medications. She stated she did not know that the kits contained medication (prior to the survey observation) and she did not know if any of the kits had been dispensed to clinic patients. She said she did not know how long the RHCCA had been in possession of the kits.

2. On 2/27/13 an inspection of the drug storage area in the RHCCA indicated that staff maintained sheets of paper in a three ring binder and the sheet were titled COMPLIMENTARY SAMPLES OF DANGEROUS DRUGS LOGBOOK. The surveyor noted the following irregularities at that time:

a. At 4:13 pm, a review of one log sheet indicated that on 9/6/12 the RHCCA staff had logged in a stock of five boxes of Advair Diskus with lot number 2ZP9168. Staff had not logged any boxes out as dispensed to any patient yet only two such boxes of Advair Diskus with the documented lot number remained in stock at the time of the survey. During an interview of Staff Nurse X at that time she verified this observation and stated she did not know what happened to the other boxes of Advair Diskus.

b. At 4:30 pm, a review of one log sheet indicated that on 12/14/12 the RHCCA staff had logged in a stock of 28 boxes of Dexilant with lot number C19140. Staff had logged out six boxes of Dexilant (each box documented to contain five "tablets" but the product actually comes as capsules) as dispensed to three patients yet only nine such boxes of Dexilant with the documented lot number remained in stock at the time of the survey leaving 13 boxes unaccounted for. During an interview of Staff Nurse X at that time, she verified this observation and stated she did not know what happened to the other boxes of Dexilant.

c. At 4:36 pm, a review of one log sheet indicated that on 9/6/12 the RHCCA staff had logged in a stock of four boxes of Dexilant with lot number B18440. Staff had logged out one box of Dexilant as dispensed to one patient yet no such boxes of Dexilant with the documented lot number remained in stock at the time of the survey leaving three boxes unaccounted for. During an interview of Staff Nurse X at that time, she verified this observation and stated she did not know what happened to the other boxes of Dexilant.

d. At 4:44 pm, a review of the one log sheet indicated that on 2/21/12 the RHCCA staff had logged in a stock of six boxes of Crestor 10 mg with lot number AA5052. Staff had logged out two boxes of Crestor (each box documented to contain seven tablets) as dispensed to one patient yet only one such box of Crestor with the documented lot number remained in stock at the time of the survey leaving 3 boxes unaccounted for. During an interview of Staff Nurse X at that time, she verified this observation and stated she did not know what happened to the other boxes of Dexilant.

e. At 4:46 pm, inspection of the medication sample supply stored in the medication storage area of the RHCCA indicated it contained a stock of six boxes of Crestor 10 mg tablets each with lot number AH5030. Further inspection indicated there was no log sheet for this product in the three ring binder used to store the sample log sheets and this observation was verified with Staff Nurse X at that time.

Based on observation, interview, and record review, the facility failed to ensure that preventative maintenance was performed annually on patient care equipment and the ice machine. This failure had the potential for food borne illnesses, medication errors, and inaccurate patient assessments.

Findings:

1. On 2/25/13 at 9 am, the following items were noted to have outdated preventative maintenance stickers:
- Otoscope/Ophthalmoscope in medical surgical unit, dated 2/03;
- Mobile blood pressure cuffs (1479, 1480, 1481, 1486, 1487, 1488, one without a tag), dated 11/12;
- Kangaroo feeding pump, dated 11/12; and
- Emergency department blanket warmer, dated 12/12.

In a concurrent interview, the above findings were acknowledged by Nurse Manager 1.

On 2/26/13 at 10 am, Maintenance Worker 3 stated that the preventative maintenance for patient care equipment was to be done annually and acknowledged that he had not performed the maintenance for the above items.



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2. On 2/25/13 at 9:10 am, the ice machine in the medical surgical unit was observed to have a large amount of white scale build up on the lower exterior of the machine.

On 2/26/13 at 9:45 am, Maintenance Staff 6 opened the ice machine for inspection and more scale was observed on the inside of the machine and a dark substance was also observed on the lower right corner of the machine. The ice machine manufacturer's instructions were reviewed with Maintenance Staff 6 and he acknowledged that the ice machine had not been cleaned according to the manufacturer's instructions.

Based on food storage observations, dietary staff interview and document review, the hospital failed to ensure the required food supplies planned for use in a disaster: 1) were adequate to meet the hospital developed plan; and 2) included therapeutic diets such as puree. Failure to ensure a planned, comprehensive disaster menu would put medically frail patients at risk in the event of a disaster that required the hospital to shelter in place.

Findings:

During review of disaster meal planning on 2/25/13 beginning at 10:00 am, it was noted that the plan was for 60 patients and staff for three days. It was noted that the hospital was short one case (72 servings) of beef stew. It was noted that there was a one day repeating menu for three days. There was only beef stew and beef ravioli on the menu. There was no menu for puree diets.

In a concurrent interview with the Registered Dietitian (RD), the RD stated her inventory checklist indicated only two cases not three cases as according to the plan. The RD stated they get patients on puree diets from at times but they do not have a written plan or menu for puree diets. The RD acknowledged there was beef served for both lunch and dinner for three days and that could be a concern if someone did not eat beef.

Based on document review and staff interview, the facility failed to ensure that the requirements of the medical staff rules and regulations were implemented by having the medical staff approve symbols and abbreviations that may be used in the medical records.

Findings:

The Medical Staff Rules and Regulations, approved 11/12, were reviewed on 2/25/13. Section B. 8 states: "Symbols and abbreviations may be used only when they have been approved by the Medical Staff. An official record of approved abbreviations must be kept on file in the HIM" (Health Information Management department).

During the review of medical record 28 on 2/26/13, the abbreviations "DVT" and "PE" were used. This finding was confirmed by Staff HIM Director on 2/27/13 and she said that the facility was in the process of creating a list of acceptable abbreviations, but at this time did not have such a list that had been approved by the medical staff.

Based on observation, interview, and record review, the hospital failed to ensure that the provision of services was done in a safe manner, as evidenced by:

1. Failure to ensure the contents of emergency drug carts were not outdated and stocked appropriately, and to develop policies to guide the accurate stocking of emergency carts. (Refer to C 271, items 1-3)

2. Failure to provide communication regarding drug shortages for drugs used in an emergency. (Refer to C 276, item 1)

3. Failure to develop a policy that included guidelines for the safe titration of Fentanyl transdermal patches (pain medication). (Refer to C 276, item 2)

4. Failure to provide proper drug storage, labeling, and removal of expired drugs. (Refer to C 276, items 3-5)

5. Failure to perform a comprehensive assessment of adverse drug reactions. (Refer to C 277, items 1-2)

6. Failure to ensure that staff were knowledgeable of disinfection practices. (Refer to C 278 and C 320, items 2a and b)

7. Failure to ensure safe food handling practices and nutritional interventions were performed, according to policy. (Refer to C 279, items 1 and 2)

8. Failure to provide radiology services as a direct service, and have systems in place to assure patients and staff were not exposed to radiation hazards. (Refer to C 283, items 1-2)

9. Failure to maintain a complete list of all services provided by contracts, arrangements or agreements. (Refer to C 291)

9. Failure to accurately administer medications for two of three patients Patients 6 and 7). (Refer to C 297, items 1-2)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Provision of Services.

Based on observation, interview, and record review, the facility failed to ensure that patient services were furnished, in accordance with facility policies and State law:

1. Failure to ensure the malignant hyperthermia (MH: a rare but potentially lethal side effect of medications used in the practice of anesthesiology such as the volatile anesthetic gases used to induce an maintain anesthesia during surgical procedures) cart and the adult and pediatric medication trays in one out of four crash carts in the hospital (the Medical/Surgical Nursing Unit crash cart: contained medications and equipment used to manage medical emergencies) contained accurate records of when emergency drugs were to expire.

2. Failure to ensure that emergency drug carts were stocked, according to the contents list.

3. Failure to develop policies that directed what contents were to be stocked on emergency carts.

All of the above is required by State regulation and could result in the inability to respond effectively in a patient emergency.

Findings:

1. California Code of Regulations, Title 22, Section 70263(f)(2) stipulates that a content list and the date of the first drug to expire will be posted outside of an emergency medication supply. The regulation only requires that the earliest date of the first drug to expire be posted outside of the cart but if the hospital chooses to list other expiration dates, it is expected those expiration dates will accurately reflect the expiration date of the product contained within the emergency supply.

a. On 2/26/13 at 10:22 am, an inspection of the MH Cart in the PACU indicated that the externally posted content list (required by State regulation) documented that the Cart contained three 3 liter bags of normal saline (NS: 0.9% sodium chloride solution) and that all three of these bags would expire at the end of June 2013. Inspection of the cart indicated that manufacturer had printed an expiration date of September 2013 on each of these bags, so the hospital had failed to ensure that the expiration dates were accurately recorded on the content list. This observation was verified by interview of the Director of Pharmacy at the time of inspection.

b. On 2/26/13 at 11:03 am, an inspection of the single crash cart located on the Medical/Surgical Nursing Unit indicated that the externally posted content list documented that the vasopressin (used to induce spontaneous return of circulation in medical emergencies) would expire 8/1/14. Inspection of the crash cart indicated they would not expire until the end of August 2014 (30 days later). This observation was verified during an interview of Staff Pharmacist V at the time of inspection.

2. California Code of Regulations, Title 22, Section 70263(f)(2) stipulates that a content list will be posted outside of an emergency medication supply. It is a standard of practice to stock the cart as indicated by the content list.

On 2/26/13 at 11:03 am, an inspection of the single crash cart located on the Medical/Surgical Nursing Unit indicated that the externally posted content list documented that the cart contained "Filter Needles #4" (used to filter out glass fragments that may be in an ampule after the neck is snapped open) in the adult medication tray and that the pediatric medication tray contained a three way stop cock (one can close of the flow of solution from an IV bag to a patient and redirect the flow to a port to which staff attach a syringe and then inject a medication into the patient, followed by closure of the syringe route and re-opening of the line to the IV bag). Inspection of the adult medication tray indicated that it did not contain the filter needles and inspection of the pediatric medication tray indicated it contained a four way, instead of a three way, stop cock.

During an interview of Staff Pharmacist V at the time of inspection, she stated that the filter needles were an artifact in that they were placed there at a time when the medication tray included glass ampules. When such ampules are opened by snapping the neck of the ampule off broken glass can enter the solution and filter needles are used when drawing the fluid up into a syringe then removed and replaced with a regular needle before the medication is administered to a patient. No reason was supplied why they still appeared on the content list (but until such time as the organized medical staff chose to remove this item from the list staff should stock the tray as indicated by the content list). She stated she had no explanation as to why the pediatric tray contained a four way stop cock instead of a three way stop cock.

3. California Code of Regulations, Title 22, Section 70263(f)(1) stipulates that a hospital will develop written policies and procedures that establish the contents and procedures for use of emergency medications supplies.

On 2/27/13, a review of the policy and procedure titled, "Emergency Kits and Contents," (formulated 3/08, no revision date) indicated that it did not establish the contents of the crash carts (or any other emergency supply) nor did it provide procedures for use of the crash carts. No other policies that established contents or procedures for use of the crash carts could be found.

On 2/27/13 at 12:13 pm, during an interview with the Director of Pharmacy, he stated that he was not aware of any hospital policy and procedure that established the contents of the crash carts or that provided procedures for use of the crash carts.

Based on observation, interview, and record review, the facility failed to ensure proper storage, labeling, and dating of drugs available for patient use.

1. Inspection of one of four crash carts (the Medical/Surgical Unit crash cart: contained medications and supplies used to manage medical emergencies) in the hospital, inspection of one open foil packet of budesonide for inhalation (used for the maintenance treatment of asthma) in the pharmacy, review of the hospital approved Fentanyl transdermal system (a sustained release product applied to the skin that contains the potent synthetic opiate - like opium - Fentanyl: a pain reliving medication) policy and procedure and staff interview:

a. The hospital failed to ensure procedures were developed to ensure that the Pharmacy Department communicated shortages, to the organized medical staff and to the nursing staff, of drugs used to stock the single crash cart on the Medical Surgical Unit so that these staff members representing their separate disciplines could be aware that the shortages had resulted in changes in the emergency drug supply and so that these staff members could have input on how the hospital should deal with the shortage, as recommended in a guideline regarding medication shortages published by the American Society of Health System Pharmacists. As a result, physician staff did not have the opportunity to provide input on the potential need to acquire these supplies by alternate means and neither the nursing nor the physician staff would be aware of the shortage until the cart was opened to treat a medically emergent situation which could result in an adverse outcome for a patient during the treatment of a medical emergency.

b. The hospital failed to develop a policy and procedure for the Fentanyl transdermal system (Fentanyl patch) that reflected the product labeling for dose escalation for the Fentanyl transdermal system. If hospital staff were to increase the Fentanyl patch too soon on a given patient, the patient could develop a significant decrease in their breathing rate (respiratory depression) that could require medical intervention. The policy failed to stipulate that dose escalations of the Fentanyl transdermal system should only occur every six days after the first dosage increase, and that all dose escalations should be based on supplemental immediate release opiate pain reliever use over the six day period in question, as documented in the Fentanyl patch product labeling.

c. The hospital failed to ensure that a process was in place to enable the pharmacy staff to track the shortened shelf life of budesonide for inhalation (used in the maintenance treatment of asthma: shelf life decreases to two weeks once staff opens the foil pouch the vials are stored in) when staff opened the foil pouch that the vials were packaged in by the manufacturer. One budesonide vial remained from the five that the foil package originally contained and a pharmacy staff member could not say when the package had been opened, which rendered the vial unusable and potentially unsafe for administration.

2. Intravenous solutions (IV - through a vein) were stored in unclean, unsanitary conditions.

3. Expired IV solutions were available for use with patients.

These failures placed patients at risk of medication errors, infection, adverse outcomes, and ineffective response in the event of an emergency.

Findings:

1. The American Society of Health System Pharmacists (ASHP) is a nationally recognized organization that sets standards of practice for hospital pharmacies. This organization has published ASHP GUIDELINES ON MANAGING DRUG PRODUCT SHORTAGES IN HOSPITALS AND HEALTH SYSTEMS in which it describes a "Phased Approach to Planning for Drug Shortages". This approach includes identifying the shortage, analyzing the impact the shortage will have on the hospital, and establishing a final plan. It documents that "Information about the drug product shortage, alternative therapies, temporary therapeutic guidelines, and implementation plans should be communicated to clinical staff ...Communication of this information is essential for ensuring patient safety and preventing medication errors ..." and "Clear communication with all affected clinicians about the status of a shortage is vital."

On 2/26/13 at 11:30 am, an inspection of the crash cart located on the Medical/Surgical Unit indicated the fifth drawer contained one Adult Advanced Cardiac Life Support (ACLS) medication tray and one Pediatric ACLS medication tray. Further inspection indicated the following:

a. The externally posted content list documented the Adult ACLS medication tray in the fifth drawer of the crash cart contained four 10 milliliter (ml) pre-filled syringes (PFSs) of epinephrine (used to help restore spontaneous circulation in medical emergencies) 1 milligram/milliliter (mg/ml). Inspection indicated it contained three, not four, such syringes.

b. The externally posted content list documented the Adult ACLS medication tray in the fifth drawer of the crash cart contained one 30 ml vial of epinephrine 1 mg/ml and pharmacy staff had entered "unavailable" into the column where staff would normally document the expiration date of the product in question.

c. The externally posted content list documented the Pediatric ACLS medication tray in the fifth drawer of the crash cart contained six 10 ml PFSs of Infant 25% dextrose (used to treat low blood sugar) and pharmacy staff had entered "unavailable" into the column where staff would normally document the expiration date of the product in question. However, pharmacy staff had placed an identical content list inside the sealed Pediatric ACLS tray on which the staff had crossed off the word "unavailable" and written in the expiration date "11/1/14." Inspection of the contents of the tray indicated it did contain six Infant 25% dextrose PFSs.

On 2/26/13 at 11:40 am and again at 12:16 pm, during an interview with Staff Pharmacist V, she stated the Adult ACLS medication tray was short one PFS of epinephrine because they were temporarily not available from the wholesaler that supplied the hospital medications. She said she had just found this out yesterday when she restocked the tray. She planned to replace the missing syringe as soon as it was available. She stated she had not communicated this shortage to the nursing staff. Pharmacist V stated that the 30 ml vial of epinephrine had been on backorder since 1/15/13 and she was not sure if that fact had been brought to the attention of the Medical Staff.

Pharmacist V stated that the Infant 25% dextrose PFSs had not been available but when the Infant 25% dextrose PFSs became available from the supplier, she stated she updated the internal content list by hand, but failed to update the external content list.

She stated that there was no formal process in the hospital for dealing with medication shortages that effected medications used in the hospital crash carts.

On 2/26/13 at 3:09 pm, during an interview with the Director of Pharmacy, he stated that several crash cart items had been affected by drug shortages. He stated it was unpredictable when one would get a shipment of the affected item. He stated he had not discussed the shortages of these items in relation to emergency medication supplies with the organized Medical Staff, via the Pharmacy and Therapeutics (P&T) Committee. He discussed shortages during P&T Committee meetings, but not in relation to the emergency medication supplies. He stated there was no hospital procedure for dealing with medication shortages and there were no formal procedures to inform the nursing staff regarding drug shortages in the crash carts. He stated there were no procedures for modifying the content list and notifying hospital staff of these changes. He stated he was aware of the AHSP guidelines dealing with drug shortages, but he had not read it. He stated he could offer no reason as to why one should not follow the ASHP guidelines regarding drug shortages as an ongoing problem.

2. The Fentanyl transdermal system also called a Fentanyl patch contains Fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the Fentanyl patch documents that "Respiratory depression and death may occur with the use of the (Fentanyl patch), even when (it) has been used as recommended and not misused or abused." It documents, in the "Titration and Maintenance of Therapy" section that after an initial Fentanyl patch of a given dose has been placed, that the dosage can be increased after three days based on use of supplemental immediate release opioid pain relievers for breakthrough pain, but that subsequent dosage increases should only occur after evaluation of the patient who has worn the increased dose through two 3 day cycles.

On 2/25/13, a review in the pharmacy of the policy and procedure titled, "FENTANYL TRANSDERMAL PATCH" indicated that it stipulated that "Adjustment of fentanyl patch dose (dose escalation requires a minimum interval of 3 days)."

On 2/28/13 at 1:29 pm, during an interview of the Director of Pharmacy during which he reviewed the hospital Fentanyl patch policy, he stated that the dose titration section did not follow the product labeling guidelines. He stated that he thought that this section had been corrected (to bring it into line with the product labeling) but it had not been so corrected. He stated that dosage increases after the first dosage increase should only take place after a six day period had passed.

3. On 2/25/13 at 3:09 pm, during an inspection of the pharmacy stock in the pharmacy, the surveyor noted on open foil pouch that contained one 2 ml vial of budesonide suspension for inhalation (used for the maintenance treatment of asthma by inhalation via a nebulizing device). The manufacturer had printed the following language on the foil package: "Once the foil envelope is opened, use the vials within 2 weeks" and the following prompt "Date opened:______" that prompted staff to fill in the date they opened the pouch. The space in which staff could write a date was blank. The surveyor verified these observations by interview of Staff Pharmacist V at the time of inspection. During the interview, Staff Pharmacist V stated she did not know when the pouch had been opened but she felt it had been over two weeks, prior to the survey.




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4. On 2/25/13 at 9:30 am, the storage cabinet for IV solutions was observed to have dust and debris built up in the corners of the cabinet. In a concurrent interview, Nurse Manager (NM) 1 acknowledged that the cabinet did not meet cleanliness standards for the storage of IV solutions.

5. On 2/25/13 at 9:30 am, two bags of IV solution with potassium were observed to have expired. In a concurrent interview, NM 1 acknowledged that the IV solutions were expired and should not be available for use with patients.

Based on staff interview and document review, the hospital failed to ensure that staff filled out the preventability section (Section 6) of the Adverse Drug Reaction (ADR) reports titled, ADVERSE DRUG EVENTS DATA COLLECTION FORM, and therefore, failed to ensure that the preventability of these reactions were routinely assessed. Only 26 out of 52 ADR forms with Section 6 had the preventability assessed. If a preventable adverse drug reaction is allowed to happen this would be considered a medication error hence the hospital failed to assess medication errors, as required by Health and Safety Code Section 1339.63. In addition, the hospital failed to ensure that the ADR report appended to the policy and procedure titled, ADVERSE DRUG REACTION (ADR) REPORTING in the Pharmacy Policy and Procedure Manual was the form consistently used by hospital staff to report potential adverse reactions to the pharmacy. An additional five unapproved forms had been used by staff so the hospital failed to ensure that staff only used the approved ADR form to investigate and evaluate adverse drug reactions. These failures placed patients at risk for further adverse drug events.

Findings:

1. On 2/27/13, a review of the policy and procedure, titled, ADVERSE DRUG REACTION (ADR) REPORTING in the pharmacy indicated it contained an example of the ADR reporting form, titled, ADVERSE DRUG EVENTS DATA COLLECTION FORM. This form had six sections to fill out and Section 6 was entitled"Preventability Assessment." A review of the Adverse Drug Reaction binder, that contained filled out ADR forms, at this time indicated that it contained 52 of these ADVERSE DRUG EVENTS DATA COLLECTION FORM forms, nine of which had a Section 6 titled, "Preventability Assessment-Optional"and 43 of which Section 6 was titled, "Preventability Assessment" (i.e. it was not optional). The "optional" verbiage did not appear on the form appended to the hospital policy. Staff had filled out Section 6 in six of the nine forms that indicated that section six was "optional". Staff had filled out Section 6 in 20 out of 43 forms that matched the form appended to the policy (Section 6 was not listed as "optional"). A total of 26 out of 52 forms had the "preventability" section filled out.

The preventability of an adverse medication reaction should be evaluated because a "preventable adverse drug reaction" indicates that if the hospital had taken appropriate action, the adverse drug reaction should not have occurred, and therefore, could be considered a medication error.

2. On 2/27/13, a review of the policy and procedure titled, ADVERSE DRUG REACTION (ADR) REPORTING in the pharmacy revealed it contained an example of an ADR reporting form, titled, ADVERSE DRUG EVENTS DATA COLLECTION FORM. A review of the ADR binder, at this time, revealed that it contained a total of 57 ADR forms of which only 43 matched the example included with the policy and procedure (it was the one with section six entitled"Preventability Assessment)." The binder contained nine forms that indicated that Section 6 was "optional". It contained four forms entitled "Adverse Drug Reaction Report" and one form entitled "Adverse Drug Reaction/Experiences Report Form," neither of which matched the form appended to the hospital policy. The latter form had "Created 11/05/2012" printed on the bottom of the form.

On 2/27/13, during an interview of the Director of Pharmacy in the pharmacy at this time, he stated that adverse drug reaction form attached to the policy was the current Pharmacy and Therapeutics Committee approved form for reporting adverse drug reaction in the hospital. He reviewed the "Adverse Drug Reaction/Experiences Report Form" and then stated that to his knowledge this form had not been approved by the Pharmacy and Therapeutics Committee. He reviewed the Pharmacy and Therapeutics Committee Meeting Minutes for 10/12 and 12/12 (which bridged the period this form was documented to have been "created") and could find no evidence that the committee had reviewed or approved the form. He then called Administrative Staff W who he said typed these preprinted forms. He said she told him the form was not approved.

On 2/27/13 at 2:12 pm, during an interview of Administrative Staff W, she verified that the "Adverse Drug Reaction/Experiences Report Form" was not a hospital approved form.

Based on interview and record review, the facility failed to ensure that that radiology staff were knowledgeable of proper disinfection techniques. This failure had the potential to result in infections.

Findings:

On 2/28/13 at 10:20 am, during a tour of the CT (computerized tomography - cross sectional x-ray) Scan mobile unit, Radiology Technician U was asked about the process he uses to prepare for the next patient's CT scan. He stated that he used Quat spray on the table (patient lies on) and leaves for one minute and then wipes it off.

The Quat disinfectant cleaner product information stated that the surface must remain thoroughly wet for 10 minutes and then may be wiped off.

On 2/28/13 at 11:05 am, Radiology Technician V confirmed that Radiology Technician U had not stated the proper practice for the use of Quat disinfectant.

Based on observations, staff interview, medical record review, and dietary document review, the hospital failed to ensure safe food handling practices and nutritional interventions as evidenced by: 1) retention of expired foods; 2) lack of timely follow up for Patient 17; 3) nutrition screening criteria not consistent with hospital policy and procedure. Failure to ensure comprehensive dietetic services systems may put patients at risk for foodborne illness. Lack of accurate and effective clinical nutrition care may result in a complete lack of, or delay in medical nutrition therapy. Lack of timely and effective nutrition interventions may result poor dietary intake, weight loss and malnutrition, further compromising patients' medical status.

Findings:

Food Service
1. On 2/25/13 at 12:07 pm the nourishment room located on the medical wing of the hospital had a refrigerator containing three sandwiches (roast beef, turkey, and ham) dated 2/22 to 2/24, and one sandwich (labeled ham and cheese) dated 2/21 to 2/23.

On 2/25/13 at 3:30 pm, Registered Dietitian (RD) stated the dietary staff should have pulled out the sandwiches when they deliver the breakfast trays. The RD stated the sandwiches should be pulled by the date on the label.

According to the hospital policy and procedure, titled, "Infection Control Practices," revised 10/08, indicated food storage on the nursing unit that all foods must be dated and discarded according to expiration date in the refrigerator.

Nutrition Care
2. Review of Patient's 17 medical record indicated Patient 17's chief complaint was vomiting, diarrhea, dehydration, and chest pain. Patient 17 was admitted on 1/21/13 with diagnoses that included early diabetic ketoacidosis (Diabetic ketoacidosis is a problem that occurs in people with diabetes. It occurs when the body cannot use sugar (glucose) as a fuel source because there is no insulin or not enough insulin. Fat is used for fuel instead. Byproducts of fat breakdown, called ketones, build up in the body.), acute gastroenteritis [medical condition characterized by inflammation ("-itis") of the gastrointestinal tract that involves both the stomach ("gastro"-) and the small intestine ("entero"-), resulting in some combination of diarrhea, vomiting, and abdominal pain and cramping]; and history of pancreatitis [inflammation of the pancreas which requires immediate medical attention and hospitalization during an attack that has multiple causes and symptoms. It occurs when pancreatic enzymes (especially trypsin) that digest food are activated in the pancreas instead of the small intestine).

Review of the nutrition screen indicated it was completed on 1/21/13. The nutrition screen was negative for the following: poor appetite or oral intake greater than or equal to five days prior to admission; unintentional weight loss greater than or equal to 10 pounds in one month; stage 1-4 decubitus ulcer (localized injuries to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear and/or friction); nausea, vomiting, or diarrhea greater than or equal to five days; parenteral (PPN) or enteral nutrition (alternate nutrition feeding by the gut or vein).

Review of the nutrition assessment dated 1/24/13 indicated Patient 17 was at a moderate risk. The RD indicated the patient was receiving alternate nutrition by the vein. It was providing 1155 calories per day and 42 grams of protein. The RD indicated this was inadequate. The RD indicated the patient's estimated nutrition needs were 1575 to 1890 calories per day and 63-76 grams of protein per day. The nutrition concerns included swallowing difficulty due to a torn esophagus and the patient reports bloody vomiting. The nutrition intervention indicated to provide clear liquid diet, and to have a naso-jejunal tube feeding placement tomorrow. The RD recommended tube feeding (TF, which is enteral nutrition) of Vivenox to run continuous at the goal rate of 65 milliliters (ml) per hour to provide 1560 calories and 78 grams of protein.

Review of the nutrition reassessment dated 1/28/13 indicated the patient was receiving tube feeding of Vivenox at 40 ml per hour and the PPN was discontinued today and the oral diet was advanced from full liquid to low fat. The RD indicated the patient was at high nutrition risk and the TF plus the oral diet meets his estimated nutrition needs.

Review of the hospital's policy and procedure titled, "Initial Nutrition Assessment," dated revised 9/08, indicated nursing gathers information from patients within 24 hours of admission based on pre-determined criteria. The criteria included dysphagia (swallowing problems), anorexia (loss of appetite), impaction, constipation, nausea/vomiting, diarrhea, skin status, and weight loss. Based on the results and the patient has greater than or equal to two of the criteria listed then they will consult the RD. The nutrition screening form was not consistent with all the criteria listed in the hospital policy.

Review of the hospital's policy titled, "Nutritional Assessment Prioritization Guidelines," dated 9/08, indicated PPN is a priority 1 and high nutrition risk therefore should be seen within 1-2 days. The reassessment or monitoring time frame for high nutrition risk is one to three days. The RD assessment of Patient 17 indicated the patient was at moderate risk and the reassessment of the patient was completed four days later instead of one to three days later.

On 2/27/13 at 11:00 am, an interview was conducted with the RD. The RD stated the patient should have been at high nutritional risk on the assessment and that the follow up should have been sooner. The RD stated the policy was this when she started working at the hospital. The RD stated she only worked Monday through Thursday therefore she did not follow up on the patient until Monday which was 1/28/13. The RD stated she had not realized the hospital policy was not the same as the nutrition screening on the form. The RD acknowledged the policy was not based on standards of practice or nutrition care of the patients and more about the RD availability.

Based on staff interview and document review, the facility failed to provide Radiology services as a direct service by facility staff and failed to have in place a system to assure that patients and staff were never exposed to radiation hazards.

Findings:

On 2/26/12 at 3:00 pm, the Administrative Director of Imaging Services (Rad Tech V) was asked for information about radiation safety practices at the facility. He explained that to his knowledge, there was not a designated radiation safety officer, and he was the individual that was on site and responsible to assure radiation safety in the department. He stated he "had a handle on the department safety" because he was present and able to observe how things were run. When asked if problems had been addressed in the past, he responded "not really."

He was unaware of any reporting of radiation safety data that had been forward to the facility's Quality Coordinator, the Medical Executive Committee (MEC) or facility administration. The physician "Consulting Radiologist" was located in Redding (70 minutes away), and was never present to provide radiation safety monitoring or training for the technical staff.

He explained that a radiation physicist did visit and inspect the radiation emitting equipment regularly and he did receive related reports, however, he had not been forwarding them to those responsible for quality.

Although he said all department staff members were to wear radiation dose badges and he was the individual that received the radiation dosimetry reports, he was unable to provide copies of any recent radiation dose reports. He also stated that he had not been tracking staff radiation exposure data and that neither the reports nor any radiation data analysis was forwarded to the Consulting Radiologist, the Quality Coordinator or other senior staff members.

On 2/27/12 at 9:15 am, the Administrator, Chief Nursing Officer, and Quality Coordinator met to discuss the facility's quality program. Those present indicated that there was no information forwarded from the imaging department concerning staff or patient radiation exposure data and that radiation safety had not been considered as possible indicator that should be followed. They verified that the physician in charge of the imaging department, the Consulting Radiologist, was off site and did not visit the facility.

On 2/28/13 at 1:05 pm, Rad Tech V provided the dosimetry "reports" that he had previously been unable to locate. Included was a single 4-page "Radiation Dosimetry Report," dated 6/5/12. He again verified that this report had not been forwarded to others and acknowledged that he did not have other reports for comparison.

Based on staff interview and document review, the facility failed to maintained a complete list of all services provided by contracts, arrangements or agreements, and the partial list(s) available did not detail the nature and scope of those services furnished. This potentially could result in not identifying and resolving inadequate contracted services.

Findings:

On 2/25/13, the facility was asked to provide the facility's list of all services provided under contracts or arrangements. On 2/26/13, a list of all contracted or arranged services was again requested, and a large ringed binder containing many contracts was offered, but a list was not provided. On 2/27/13 at 9:15 am, during an interview with the Administrator, Chief Nursing Officer, and Quality Coordinator, a list of all contracted or arranged services was requested and those present acknowledged that the hospital did not maintain a list that satisfied this section of the regulation. The Administrator indicated that he kept a list of contracted physicians posted on his wall and the Chief Financial Officer (CFO) may have a list for contracts that needed to be paid. However consolidated list did not exist and the quality improvement program did not utilize such a list. Also the quality improvement program did not utilize any quality indicators related to contracted services. During the afternoon of 2/27/13 a newly printed and partial "Vendor Agreements" list was placed on the conference room table used by the survey team.

On 2/28/13 at 12:45 pm, during a meeting with the Administrator and Chief Executive Officer (CEO), the partial Vendor Agreement list was reviewed and they acknowledged that the hospital did not have a complete list of all contracted services that detailed the scope and nature of the agreements. They also acknowledged that contracted services were not reviewed to assure that services were provided in a manner that assured regulatory compliance.

Based on observation of two nurses passing medications to three patients on two separate day shifts, the hospital failed to ensure that two out of three patients (Patients 6 and 7) received one medication each, as ordered by their physicians. Patient 6 received twice the dose (125 milligrams [mg] instead of 60 mg, as ordered) of methylprednisolone (an anti-inflammatory medication related to cortisone) and Patient 7 received one oyster shell calcium supplement that did not contain vitamin D when the physician had ordered a calcium supplement with vitamin D (vitamin D is required for the proper utilization of calcium by the body). Two medication errors were made out of a total of 16 opportunities for error.

Findings:

1. On 2/27/13 at 9:13 am, Staff Nurse T administered 2 milliliters (ml) of methylprednisolone 125 milligrams/milliliter (mg/ml) intravenously to Patient 6. A review of Patient 6's clinical record indicated that on 2/25/13 at 12:50 pm, the prescribing physician had ordered methylprednisolone 125 mg/2ml: 0.96 ml twice a day. A volume of 0.96 ml of a solution at a concentration of 125 mg/2 ml would deliver a dose of 60 mg. A review of the medication administration record (MAR: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) for Patient 6 indicated that Patient 6 was to receive 0.96 ml of methylprednisolone 125 mg/ml twice a day.

During an interview of Staff Nurse T on 2/27/13 at 10:29 am, she reviewed the MAR entry and verified that 0.96 ml was the correct dose to have given Patient 6.

2. On 2/28/12 at 9:39 am, Staff Nurse U administered one oyster shell calcium tablet 500 (contains 1250 mg of calcium carbonate which provide 500 mg of elemental calcium) to Patient 7. On 2/28/12, a review of Patient 7's clinical record indicated that on 2/27/13, the prescribing physician had ordered that Patient 7 continue to receive oyster shell calcium plus vitamin D as she had been taking at home and this observation was verified with the Director of Pharmacy by interview at that time. A review of Patient 7's MAR on that date indicated it documented that Patient 7 was to receive "plain" oyster shell calcium 500 mg (without vitamin D).

Based on medical record and document review, and staff interview, the facility failed to ensure that records were complete with dates, times, missing words and patient identifiers on each page in 5 of 6 records reviewed. This may result in misinformation and incomplete orders.

Findings:

The Medical Staff Rules and Regulations, approved November 2012, were reviewed on 2/25/13. Section B. 4 and 7 required progress notes to be dated and timed, and that all clinical entries shall be accurately dated.

During medical record review on 2/26/13, the following items were noted and confirmed by the Director of Health Information Management on 2/27/13 at 9:05 am:
1. a. Record 12 contained outpatient progress note, dated 12/5/12, that was not timed, and an update to a history and physical that was not dated or timed.
b. Record 14 contained a post op note that was not dated or timed.
c. Record 15 contained physician's orders, dated 2/1/13, that were not timed.
d. Record 31 contained a physician's surgery progress note and a post-anesthesia order that were not dated or timed.
e. Record 27 contained a discharge physician's order that was not dated or timed when signed by the physician.
f. Record 26 contained a physician's surgery progress note and an order that were not timed. The forms contained a pre-printed line indicating where the time was to be documented.

2. Records 27, 28, and 30 contained Nursing Admission Assessment and Daily Assessment flowsheets that did not have a patient identifier on each fold-out section of the form.

3. Records 27 and 30 contained dictated/transcribed reports (a history and physical and an emergency room visit summary) that contained blank spaces, which were to indicate to the author that word(s) were missing because the transcriptionist could not understand the dictation. These reports had been signed by the physician and were considered "complete" even though the missing information had not been added.



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4. On 2/26/13, Patient 15's record was reviewed. Patient 15 was admitted on 2/8/13 for a surgical procedure. Patient 15's record contained physicians orders, dated 2/1/13, that contained an order # 10 which was illegible.

On 2/28/13 at 12:15 pm, Nurse Managers 1 and 2 reviewed the record and were unable to discern the meaning of the order.

Based on review of medical record/document review and staff interview, the hospital failed to have a diet order prescribed by the physician in the swing bed medical records for two of two patients (Patients 11 and 16). Failure to have a physician prescribed diet order can result in the patient receiving food items that could compromise their medical status.

Findings:

1. During the lunch tray line on 2/25/13 at 11:50 am, Patient 16's diet card indicated the patient was on a regular diet with Ensure 2 cans per day, dated 2/21/13. Patient 11's diet card indicated the patient was on a regular diet, dated 2/22/13. The patients received on their lunch tray the following items: beef stew with potatoes and vegetables, creamy garbanzo bean salad, cornbread, ice cream, and milk.

Review of the medical record for Patient 16 indicated the patient was admitted to the swing bed on 2/20/13. Review of the physician's orders, dated 2/22/13, indicated dietary was to provide two cans of Ensure (nutrition supplement) daily. There were no other diet orders in the medical record.

2. Review of the medical record for Patient 11 indicated he was admitted to the swing bed on 2/23/13. Review of the physician's orders, dated 2/25/13 and timed 4:50 pm, indicated two cans of chocolate Ensure daily. There were no other diet orders in the medical record.

On 2/26/13 at 10:35 am, an interview was conducted with licensed nurse (LN) 16. LN 16 stated the diet orders are carried over from the acute admission, however, there should be a new diet order by the physician. LN 16 acknowledged there was no diet order in the charts.

Review of the hospital's policy and procedure titled, "Diet Orders," with a revised date of 10/08, indicated diets are ordered in writing in the medical chart. The policy indicated the physician writes a diet order in the medical record.

Based on document review and staff interview, the facility failed to ensure that safeguards against unauthorized use of record information were provided, due to the lack of a written agreement with an outside photocopy company. This resulted in the potential unauthorized use of record information.

Findings:

During an interview with Health Information Management Director on 2/26/13 at 9:05 am, she stated that the hospital uses an outside company who has been coming once a week to photocopy medical records and take the copies to their office to be mailed to persons requesting them. The facility was unable to provide an agreement with this company, which delineated the responsibilities, functions, objectives, term and financial arrangements.

Based on interview and record review, the hospital failed to ensure that surgical procedures were performed in a safe manner.

History and physicals were not timely, and done in accordance with the medical staff rules and regulations for five of 10 sampled surgical patients.

Staff were not knowledgeable of the proper techniques used in terminal cleaning of the operating room (OR) to ensure disinfection of high touch surfaces.

These failures had the potential for an inadequate assessment of patient risk for surgery and post surgical infections.

Findings:

1. On 2/26/13 review of Patients 2, 3, 12, 14, and 31's records for their surgical admissions showed that each record did not have a qualified admission H&P. The records of Patients 2, 3, 12, 14, and 31 contained Outpatient Progress Records (OPP) outlining the patient's health conditions and consent for surgery.

- Patient 12's OPP was done on 12/5/12, for surgery on 2/13/13, 71 days later.

- Patient 14's OPP was done on 12/6/12, for surgery on 2/5/13, 61 days later.

A review of the Medical Staff Rules and Regulations (Rules), dated 11/15/12, document at Section B. Medical Records - 2. "...copies of physician's office records (OPP) will not suffice to replace or to substitute for completion of a recorded H&P." The Rules further stipulated that H&P's must be done within 30 days prior to the surgery date.

On 2/28/13 at 12:15 pm, Nurse Manager (NM) 2 reported that the above Outpatient Progress Records were accepted by nursing staff as the history and physical (H&P) required prior to surgery. NM 2 acknowledged that the OPP for Patient 12 and 14 were greater than 30 days old and should not have been accepted because they were greater than 30 days old. NM 2 was not aware of the Medical Staff Rules and Regulations that did not permitted an OPP to be used as a H&P.

2. a. On 2/26/13 at 9:30 am, Housekeeping Staff (Hskp) 4 was observed preparing to clean the OR suite. Hskp 4 had a bucket with approximately two quarts of water and poured approximately two tablespoons of Quat (disinfectant cleaner) into the bucket. Hskp 4 was asked how she would know if there was enough disinfectant to be effective and she replied she did not know but she had used strips in the past to test if the amount of disinfectant was appropriate. Hskp 4 further stated that she did not have access to any testing strips.

On 2/28/13, the product information for Quat Disinfectant cleaner instructed the user to use 1/2 ounce of the product per gallon of water.

On 2/27/13 at 1:30 pm, Nurse Manager (NM) 2 was unable to state the amount of Quat disinfectant cleaner needed to clean the OR suite.

On 2/28/13 at 11:30 am, NM 2 stated that she had referred to the Housekeeping Supervisor and found that the Quat disinfectant cleaner was automatically dispensed in the appropriate dilution and further dilution was not necessary.

2. b. In a continued observation of the OR suite cleaning, Hskp 4 was observed to clean IV poles and cabinets from the bottom to the top. When asked if she was taught to clean from the top to the bottom or the bottom to the top, she responded that she was taught from the top to the bottom but that she did not always remember to do that. Hskp 4 was further observed in her cleaning routine and again started at the bottom of the cart and proceed to the top.

The facility policy, titled, "End of Daily Schedule Terminal Cleaning of O.R.," dated 6/12, did not address top to bottom cleaning or the dilution of the disinfectant cleaner.

On 2/27/13 at 1:30 pm, NM 2 stated that she had trained Hskp 4 in the cleaning of the OR and they had an assessment program (Ecolab) using fluorescent pens and black lights that demonstrated the effectiveness of the cleaning. NM 2 reported that she had done this evaluation of Hskp 4 on 1/7/13 and Hskp 4 did not pass the baseline evaluation. NM 2 stated she gave on the spot instruction after the evaluation but had not re-evaluated her current performance. NM 2 acknowledged that Hskp 4 was instructed to clean from top to bottom to clear dust (which contains bacteria) and to avoid accidently bringing contaminants from the floor (the dirtiest area of a room) to high touch surfaces in the OR.

Based on staff interview, document review and medical records reviewed, for three of 10 sampled surgical patients (Patient 2, 3 and 31), the facility failed to ensure that each patient undergoing surgery was examined immediately before surgery to evaluate the risk of the surgical procedure and the risk of anesthesia. This failure had the potential, for those patients affected, to expose them to unrecognized risk while undergoing anesthesia and/or surgery which could lead to potential complications during or after surgery.

Findings:

1. On 2/25/13, Patient 31's record indicated she was admitted on 1/3/13 for oral surgery. Patient 31's record contained a history and physical dated 12/20/12. Patient 31's record did not contain a physical examination of Patient 31 immediately prior to surgery by a qualified practitioner to evaluate the risk of surgery. Patient 31's anesthesia was evaluated and provided by a CRNA, (Certified Registered Nurse Anesthetist). The medical record did not contain documentation that a physician, dentist or other practitioner qualified under hospital rules and CFR 485.639(a) had examined Patient 31 immediately prior to surgery to evaluate the risk of the surgical procedure.

2. On 2/27/13, Patient 2's record was reviewed. The record indicated she had been admitted on 1/21/13 for an orthopedic surgical procedure. Patient 2's record contained no admission history and physical examination (H&P) and did not have documentation that she had been physically examined by the surgeon at any time prior to the surgery. The record contained an "Anesthesia Record" written and signed by a CRNA, (Certified Registered Nurse Anesthetist). However the anesthesia record did not have clear documentation of any physical exam findings and the signature had no date and no time.

On 2/28/13 at 1:30 pm, the Health Information Manager (HIM) reviewed the Patient 2's record of 1/21/13 and acknowledged that it did not contain an admission H&P nor any documentation of an examination by a physician on the day of surgery. She also acknowledged that the anesthesia record was not dated and times as is required by the hospital.

3. On 2/25/13 the "Medical Staff Rules and Regulations" (Rules) were reviewed, and on 2/27/13 Patient 3's record was reviewed. Patient 3's record indicated he had been admitted on 12/13/12 for a planned surgical procedure.

The Rules state at Section B. Medical Records - 2. "...copies of physician's office records will not suffice to replace or to substitute for completion of a recorded H&P."

Patient 3's medical record of the admission and surgery on 12/13/12 does not contain an admission H&P, but does contain physician's office notes dated 12/3/12 and 12/5/12. The record does not document a qualified physical examination or other evaluation of the Patient 31 or his risk related to the surgical procedure prior to the surgery.

On 2/28/13 at 13:30 am, the HIM reviewed the Patient 3's record of 12/3/12 and acknowledged that it did not contain an acceptable admission H&P or any documentation of an examination by a physician or other practitioner qualified to do the surgical risk evaluation on the day of surgery.

On 2/28/13 at 12:15 pm, the Chief Nursing Officer (CNO), and Nurse Managers 1 and 2 reviewed the above records and acknowledged that a physical examination was not done by a qualified practitioner immediately prior to the surgery for Patients 2, 3, and 31.

Based on document review and staff interview, the facility failed to ensure that an effective quality improvement program (QAPI) had been developed, designed and implemented to evaluate the quality, appropriateness and safety of all services, including outside resources, affecting patient health.

1. Failure to conduct quality evaluations of services provided by agreement with outside entities for Health Information Management (HIM) and Radiological Services.

2. Dietetic and nutrition care services were not effectively evaluated or monitored.

3. The timeliness of pre-surgical history and physical (H&P) reports, and physical examinations immediately prior to surgery were not incorporated into the QAPI program.
This failure resulted in no monitoring of quality and timeliness of work performed by outside contractors, nutrition care data, and incomplete H&Ps.

Findings:

1. a. The facility arranges for all the dictated physician reports to be transcribed by an outside service. The one-page agreement with a transcriptionist was reviewed on 2/27/13. There was no mention of any process to monitor the quality and timeliness of the work performed by the service. During interviews with the HIM Director on 2/27/13 at 11:20 am, she stated there were about three (3) different people transcribing reports, such as history and physicals, emergency room visit summaries, operative reports, and discharge summaries. She was not aware of any quality monitoring done by the service and that there was none performed by the facility staff.

b. The facility has been using an outside company to photocopy portions of medical records and mail to the requestor on a weekly basis for at least the past three (3) years, per an interview with HIM Director on 2/27/13 at 11:20 am. There has been no monitoring or evaluation of the quality of their work.

c. The HIM department has one employee who assigns final diagnostic and procedure codes for all the patients seen in the hospital. During the same interview with HIM Director on 2/27/13, she stated there was no process to monitor and evaluate the quality of this work. These codes are used as the basis for financial reimbursement.

2. On 2/26/12 at 3 pm, the Administrative Director of Imaging Services (Rad Tech V) was interviewed and provided the following information. (See C283 for details.)

a. The facility has been utilizing the services of an outside radiation physicist consultant to inspect the facility's radiation emitting equipment. However reports received from the consultant by the imaging department have not been routinely forwarded to the Quality Coordinator (QC) for inclusion in the quality program, or to the Administrator for review of the physicist's performance and contract review.

b. The facility has been utilizing the services of an out of state vendor who provides radiation dosimetry badges and readings of the staff's monitored radiation exposure. However the radiation dosimetry reports have not been routinely forwarded to the QC for inclusion in the quality program, or to the Administrator for review of the vender's performance and contract review.

c. The facility has been utilizing the services of a consulting radiologist to provide physician supervision and guidance related to the department. However the radiologist has not been providing radiation safety training and has not been reporting any related information to the facility to be included in the quality program. There is no data to show that the radiologist's performance in this capacity has been monitored.

On 2/27/12 at 9:15 am, the Administrator, Chief Nursing Officer (CNO), and QC met to discuss the facility's quality program. Those present indicated that there was no information forwarded from the imaging department concerning staff or patient radiation exposure data and that radiation safety had not been considered as possible indicator that should be followed.



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3. Dietetic and Nutrition Care Services
In an interview on 2/26/13 at 3:10 pm, and concurrent document review of performance improvement activities for dietetic services and clinical nutrition care was reviewed. The Registered Dietitian (RD) was asked to describe the activities within the department. The RD stated her yearly plan for the department was to monitor the temperatures of all food items for the salad/sandwich bar twice a day; when defrosting frozen juice boxes, dietary staff will label the boxes with the pull date and the expiration date of 10 days past the pull date; the RD will ensure the concentration of the sanitation bucket is above 200 parts per million; and the dietary staff will use the two stage cool down method for leftovers and record the process on the cool down log and on the leftover log. The RD acknowledged there was no indicators she was monitoring for nutrition care.

Further review indicated each indicator would only be monitored for one quarter (three months) then the next indicator would start. Each indicator had a benchmark or threshold of 95%. Review of the report for the temperatures of the salad/sandwich bar dated 7/12-9/12, indicated in 9/12 the compliance dropped from 98% to 93% and then was no longer monitored. In an concurrent interview with the RD, she stated she stopped monitoring because according to her plan she was only going to monitor each indicator for three months and that was the last month. The RD stated she did do an action plan to make sure the afternoon temperature was taken but did not monitor to see if that action improved the problem. The RD stated the first Quality Improvement Meeting was conducted on 1/23/13. The RD stated she would give all data and plan to the Quality Coordinator (QC).

On 2/27/13 at 9:15 am, an interview was conducted with QC, CNO and Administrator. The QC stated the department managers decide what indicators are submitted and she is then responsible for making sure what the department submits is part of the overall plan for quality improvement. The QC stated the RD should have kept monitoring that indicator if fell below threshold even though the three months were up. QC confirmed that there was no nutrition care data that was being evaluated or monitored.


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4. On 2/25 through 2/28/13, Patients 2, 3, 12, 14, and 31 did not have qualified admission H&Ps, Patients 12 and 14 did not have a H&P done within 30 days of surgery, and Patient 2, 3, and 31 did not have an examination immediately prior to surgery by a qualified practitioner in accordance with the medical staff rules and regulations. (See C 320 and C 322 for further information)

On 2/26/13 at 2:30 pm, Nurse Manager (NM) 2 stated she was aware that there was not a system in place to assure the physical examination was documented immediately prior to surgery, and that H&Ps were not done timely prior to surgery.

On 2/27/13 at 9:15 am, the Administrator, CNO, and QC met to discuss the facility's quality program. QC stated that each department developed their own set of indicators. In reviewing the indicators, the QC stated she did not provide advice or guidance for departments to include indicators that demonstrated regulatory compliance or other high risk items. QC stated that as problems were identified they were included in the QAPI plan with indicators and monitoring reported to the Quality Committee.

On 2/28/12 at 12:15 pm, NM 2 and CNO acknowledged that they were aware of problems with H&Ps prior to surgery but had not included these concerns as indicators in their QAPI program.

Based on observation, interview and record review, the facility failed to ensure that each patient was informed of his or her visitation rights. This failure had the potential for discrimination and the patient's wishes for a designated support person to not be honored.

Findings:

On 2/28/13 at 11:45 am, the facility's patient rights posters were observed. The posters did not include the language of the above regulation.

On 2/28/12 at 11:50 am, the registration clerk in the emergency room (the most frequent avenue of admission to the facility) was unable to to produce the written information regarding patient's visitation rights.

On 2/28/13, the facility policy, titled, "Patient's Right to Visitation," dated 7/12, read, "The organization shall inform patients (or the patient's support person, where appropriate) of their visitation rights. This information shall be provided in writing, whenever possible, before the organization provides or stops care....The medical record must contain documentation that the written notice was provided..."

On 2/28/13 at 12:10 pm, Administrative Manager 5 reviewed the policy and confirmed that the facility was not providing patients with the written notice as required in the policy.